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J&J COVID-19 vaccine wins unanimous backing of FDA panel
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
COVID-19 vaccination recommended for rheumatology patients
People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.
“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”
The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.
“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.
So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
Some risks are real
The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.
Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.
It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.
The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.
Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.
Although it might be optimal to administer the vaccines when rheumatic diseases are quiescent, the urgency of getting vaccinated overrides that consideration, Dr. Curtis said. “By and large, there was a general consensus to not want to delay vaccination until somebody was stable and doing great, because you don’t know how long that’s going to be,” he said.
How well does it work?
One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.
The guidelines specify that some drug regimens be modified when patients are vaccinated.
For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”
The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.
It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.
For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.
For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.
None of this advice should supersede clinical judgment, Dr. Curtis said.
A version of this article first appeared on Medscape.com.
People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.
“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”
The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.
“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.
So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
Some risks are real
The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.
Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.
It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.
The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.
Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.
Although it might be optimal to administer the vaccines when rheumatic diseases are quiescent, the urgency of getting vaccinated overrides that consideration, Dr. Curtis said. “By and large, there was a general consensus to not want to delay vaccination until somebody was stable and doing great, because you don’t know how long that’s going to be,” he said.
How well does it work?
One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.
The guidelines specify that some drug regimens be modified when patients are vaccinated.
For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”
The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.
It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.
For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.
For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.
None of this advice should supersede clinical judgment, Dr. Curtis said.
A version of this article first appeared on Medscape.com.
People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.
“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”
The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.
“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.
So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
Some risks are real
The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.
Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.
It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.
The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.
Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.
Although it might be optimal to administer the vaccines when rheumatic diseases are quiescent, the urgency of getting vaccinated overrides that consideration, Dr. Curtis said. “By and large, there was a general consensus to not want to delay vaccination until somebody was stable and doing great, because you don’t know how long that’s going to be,” he said.
How well does it work?
One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.
The guidelines specify that some drug regimens be modified when patients are vaccinated.
For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”
The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.
It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.
For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.
For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.
None of this advice should supersede clinical judgment, Dr. Curtis said.
A version of this article first appeared on Medscape.com.
7 key changes: The 2021 child and adolescent immunization schedules
Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.
Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
2021 childhood and adolescent immunization schedule
One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.
In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.
Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.
Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
COVID-19 vaccines
Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.
Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.
One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.
Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
More vaccine news: HPV and influenza
Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.
A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.
William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.
Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
2021 childhood and adolescent immunization schedule
One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.
In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.
Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.
Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
COVID-19 vaccines
Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.
Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.
One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.
Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
More vaccine news: HPV and influenza
Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.
A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.
William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
Each February, the Centers for Disease Control and Prevention, along with multiple professional organizations, releases an updated Recommended Child and Adolescent Immunization Schedule.
Recent years have seen fewer changes in the vaccine schedule, mostly with adjustments based on products coming on or off the market, and sometimes with slight changes in recommendations. This year is no different, with mostly minor changes in store. As most practitioners know, having quick access to the tables that accompany the recommendations is always handy. Table 1 contains the typical, recommended immunization schedule. Table 2 contains the catch-up provisions, and Table 3 provides guidance on vaccines for special circumstances and for children with specific medical conditions.
2021 childhood and adolescent immunization schedule
One update is a recommendation that patients with egg allergies who had symptoms more extensive than hives should receive the influenza vaccine in a medical setting where severe allergic reactions or anaphylaxis can be recognized and treated, with the exclusion of two specific preparations, Flublok and Flucelvax.
In regard to the live attenuated influenza vaccine (LAIV), there are several points of reinforcement. First, the nomenclature has generally been changed to “LAIV4” throughout the document because only quadrivalent preparations are available. There are specific recommendations that patients should not receive LAIV4 if they recently took antiviral medication for influenza, with “lockout” periods lasting from 2 days to 17 days, depending on the antiviral preparation used. In addition, there is an emphasis on not using LAIV4 for children younger than 2 years.
Two updates to the meningococcal group B vaccine are worth reviewing. The first is that children aged 10 years or older with complement deficiency, complement inhibitor use, or asplenia should receive a meningitis B booster dose beginning 1 year after completion of the primary series, with boosters thereafter every 2 or 3 years as long as that patient remains at greater risk. Another recommendation for patients 10 years or older is that, even if they have received a primary series of meningitis B vaccines, they should receive a booster dose in the setting of an outbreak if it has been 1 year or more since completion of their primary series.
Recommendations have generally been relaxed for tetanus prophylaxis in older children, indicating that individuals requiring tetanus prophylaxis or their 10-year tetanus booster after receipt of at least one Tdap vaccine can receive either tetanus-diphtheria toxoid or Tdap.
COVID-19 vaccines
Although childhood vaccination against COVID-19 is still currently limited to adolescents involved in clinical trials, pediatricians surely are getting peppered with questions from parents about whether they should be vaccinated and what to make of the recent reports about allergic reactions. Fortunately, there are several resources for pediatricians. First, two reports point out that true anaphylactic reactions to COVID-19 vaccines appear quite rare. The reported data on Pfizer-developed mRNA vaccine demonstrated an anaphylaxis rate of approximately 2 cases per 1 million doses administered. Among the 21 recipients who experienced anaphylaxis (out of over 11 million total doses administered), fully one third had a history of anaphylaxis episodes. The report also reviews vaccine reactions that were reported but were not classified as anaphylaxis, pointing out that when reporting vaccine reactions, we should be very careful in the nomenclature we use.
Reporting on the Moderna mRNA vaccine showed anaphylaxis rates of about 2.5 per 1 million doses, with 50% of the recipients who experienced true anaphylaxis having a history of anaphylaxis. Most of those who experienced anaphylaxis (90% in the Moderna group and 86% in the Pfizer group) exhibited symptoms of anaphylaxis within 30 minutes of receiving the vaccine. The take-home point, and the current CDC recommendation, is that many individuals, even those with a history of anaphylaxis, can still receive COVID-19 vaccines. The rates of observed anaphylaxis after COVID vaccination are far below population rates of a history of allergy or severe allergic reactions. When coupled with an estimated mortality rate of 0.5%-1% for SARS-CoV-2 disease, that CDC recommends that we encourage people, even those with severe allergies, to get vaccinated.
One clear caveat is that individuals with a history of severe anaphylaxis, and even those concerned about allergies, should be observed for a longer period after vaccination (at least 30 minutes) than the 15 minutes recommended for the general population. In addition, individuals with a specific anaphylactic reaction or severe allergic reaction to any injectable vaccine should confer with an immunologist before considering vaccination.
Another useful resource is a column published by the American Medical Association that walks through some talking points for providers when discussing whether a patient should receive COVID-19 vaccination. Advice is offered on answering patient questions about which preparation to get, what side effects to watch for, and how to report an adverse reaction. Providers are reminded to urge patients to complete whichever series they begin (get that second dose!), and that they currently should not have to pay for a vaccine. FAQ resource pages are available for patients and health care providers.
More vaccine news: HPV and influenza
Meanwhile, published vaccine reports provide evidence from the field to demonstrate the benefits of vaccination. A study published in the New England Journal of Medicine reported on the effectiveness of human papillomavirus (HPV) vaccine in a Swedish cohort. The report evaluated females aged between 10 and 30 years beginning in 2006 and followed them through 2017, comparing rates of invasive cervical cancer among the group who received one or more HPV vaccine doses with the group who receive none. Even without adjustment, the raw rate of invasive cervical cancer in the vaccinated group was half of that in the unvaccinated group. After full adjustment, some populations experienced incident rate ratios that were greater than 80% reduced. The largest reduction, and therefore the biggest benefit, was among those who received the HPV vaccine before age 17.
A report from the United States looking at the 2018-2019 influenza season demonstrated a vaccine effectiveness rate against hospitalization of 41% and 51% against any ED visit related to influenza. The authors note that there was considerable drift in the influenza A type that appeared late in the influenza season, reducing the overall effectiveness, but that the vaccine was still largely effective.
William T. Basco Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
Another COVID-19 Adverse Effect: Routine Vaccinations Declined Steeply
COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.
Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.
Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.
The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.
Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.
COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.
Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.
Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.
The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.
Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.
COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.
Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.
Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.
The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.
Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.
Native Americans Embrace the COVID-19 Vaccines ‘to Protect the Community and Preserve the Culture’
A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.
According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.
Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.
The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.
The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.
Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day.
But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.
Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”
Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”
A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”
That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.
Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.
Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”
A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.
According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.
Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.
The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.
The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.
Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day.
But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.
Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”
Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”
A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”
That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.
Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.
Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”
A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.
According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.
Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.
The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.
The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.
Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day.
But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.
Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”
Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”
A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”
That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.
Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.
Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”
Oxford launches COVID-19 vaccine study in children
Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.
At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.
“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.
The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.
COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.
The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.
“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.
“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.
A version of this article first appeared on WebMD.com.
Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.
At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.
“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.
The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.
COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.
The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.
“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.
“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.
A version of this article first appeared on WebMD.com.
Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.
At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.
“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.
The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.
COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.
The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.
“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.
“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.
A version of this article first appeared on WebMD.com.
COVID-19 vaccines: New candidates & answers to commonly asked questions
REFERENCES
- CDC. COVID-19 vaccination. Accessed February 22, 2021.
- CDC. COVID data tracker. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1922-1924. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2021;69:1653-1656. Accessed February 22, 2021.
- Gee J, Marquez P, Su J, et al. First month of COVID-19 vaccine safety monitoring—United States, December 14, 2020–January 13, 2021. MMWR Morbid Mortal Wkly Rep. ePub: February 19, 2021. Accessed February 22, 2021.
- CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine—United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70:125-129. Accessed February 25, 2021.
REFERENCES
- CDC. COVID-19 vaccination. Accessed February 22, 2021.
- CDC. COVID data tracker. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1922-1924. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2021;69:1653-1656. Accessed February 22, 2021.
- Gee J, Marquez P, Su J, et al. First month of COVID-19 vaccine safety monitoring—United States, December 14, 2020–January 13, 2021. MMWR Morbid Mortal Wkly Rep. ePub: February 19, 2021. Accessed February 22, 2021.
- CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine—United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70:125-129. Accessed February 25, 2021.
REFERENCES
- CDC. COVID-19 vaccination. Accessed February 22, 2021.
- CDC. COVID data tracker. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1922-1924. Accessed February 22, 2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine—United States, December 2020. MMWR Morbid Mortal Wkly Rep. 2021;69:1653-1656. Accessed February 22, 2021.
- Gee J, Marquez P, Su J, et al. First month of COVID-19 vaccine safety monitoring—United States, December 14, 2020–January 13, 2021. MMWR Morbid Mortal Wkly Rep. ePub: February 19, 2021. Accessed February 22, 2021.
- CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine—United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70:125-129. Accessed February 25, 2021.
One-third of health care workers leery of getting COVID-19 vaccine, survey shows
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
Zika vaccine candidate shows promise in phase 1 trial
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
FROM ANNALS OF INTERNAL MEDICINE
2021 ACIP adult schedule released
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has updated its recommended immunization schedule for adults for 2021.
A summary of the annual update was published online Feb. 11 in the CDC’s Morbidity and Mortality Weekly Report and is available in Annals of Internal Medicine and on the CDC website.
It features a special section on vaccination during the pandemic as well as interim recommendations on administering the Pfizer-BioNtech and Moderna COVID-19 vaccines.
The authors, led by Mark S. Freedman, DVM, MPH, DACVPM, of the CDC’s National Center for Immunization and Respiratory Diseases, in Atlanta, note that this year’s recommendations for adults – persons aged 19 years and older – are largely the same as last year’s. “There have been very few changes,” Dr. Freedman said in an interview. “Changes to the schedule tables and notes were made to harmonize to the greatest extent possible the adult and child/adolescent schedules.”
Changes in the schedule include new or updated ACIP recommendations for influenza, hepatitis A, hepatitis B (Hep B), and human papillomavirus (HPV) as well as for meningococcal serogroups A, C, W, and Y (MenACYW) vaccines, meningococcal B (MenB) vaccines, and the zoster vaccine.
Vaccine-specific changes
Influenza
The schedule highlights updates to the composition of several influenza vaccines, which apply to components in both trivalent and quadrivalent formulations.
The cover page abbreviation for live attenuated influenza vaccine (LAIV) was changed to LAIV4. The abbreviation for live recombinant influenza vaccine (RIV) was changed to RIV4.
For individuals with a history of egg allergy who experience reactions other than hives, the following procedural warning has been added: “If using an influenza vaccine other than RIV4 or ccIIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions.”
Zoster
The zoster vaccine live (Zostavax) has been removed from the schedule because it is no longer available in the United States. The recombinant zoster vaccine Shingrix remains available as a 2-dose regimen for adults aged 50 years or older.
HPV
As in previous years, HPV vaccination is routinely recommended for persons aged 11-12 years, with catch-up vaccination for those aged 26 or younger. Catch-up vaccination can be considered with shared decision making for those aged 27 through 45. In this year’s schedule, in the pregnancy column, the color pink, which formerly indicated “delay until after pregnancy,” has been replaced with red and an asterisk, indicating “vaccinate after pregnancy.”
HepB
ACIP continues to recommend vaccination of adults at risk for HepB; however, the text overlay has been changed to read, “2, 3, or 4 doses, depending on vaccine or condition.” Additionally, HepB vaccination is now routinely recommended for adults younger than 60 years with diabetes. For those with diabetes who are older than 60, shared decision making is recommended.
Meningococcal vaccine
ACIP continues to recommend routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for persons at increased risk for meningococcal disease caused by serogroups A, C, W, or Y. The MenQuadfi (MenACWY-TT) vaccine, which was first licensed in 2020, has been added to all relevant sections of MenACWY vaccines. For MenACWY booster doses, new text addresses special situations, including outbreaks.
Improvements have been made to text and layout, Dr. Freedman said. An example is the minimizing of specialized text. Other changes were made to ensure more consistent text structure and language. Various fine-tunings of color and positioning were made to the cover page and tables, and the wording of the notes sections was improved.
Vaccination in the pandemic
The updated schedule outlines guidance on the use of COVID-19 vaccines approved by the Food and Drug Administration under emergency use authorization, with interim recommendations for the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older and the Moderna COVID-19 vaccine for people aged 18 and older.
The authors stress the importance of receiving the recommended routine and catch-up immunizations notwithstanding widespread anxiety about visiting medical offices. Last spring, the CDC reported a dramatic drop in child vaccinations after the declaration of the national emergency in mid-March, a drop attributed to fear of COVID-19 exposure.
“ACIP continued to meet and make recommendations during the pandemic,” Dr. Freedman said. “Our recommendation remains that despite challenges caused by the COVID-19 pandemic, adults and their healthcare providers should follow the recommended vaccine schedule to protect against serious and sometimes deadly diseases.”
Regular vaccines can be safely administered even as COVID-19 retains its grasp on the United States. “Healthcare providers should follow the CDC’s interim guidance for the safe delivery of vaccines during the pandemic, which includes the use of personal protective equipment and physical distancing,” Dr. Freedman said.
Dr. Freedman has disclosed no relevant financial relationships. Coauthor Henry Bernstein, DO, is the editor of the Current Opinion in Pediatrics Office Pediatrics Series, is a Harvard School of Public Health faculty member, and is a member of the data safety and monitoring board for a Takeda study on intrathecal enzymes for Hunter and San Filippo syndromes. Coauthor Kevin Ault, MD, has served on the data safety and monitoring committee for ACI Clinical.
A version of this article first appeared on Medscape.com .
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has updated its recommended immunization schedule for adults for 2021.
A summary of the annual update was published online Feb. 11 in the CDC’s Morbidity and Mortality Weekly Report and is available in Annals of Internal Medicine and on the CDC website.
It features a special section on vaccination during the pandemic as well as interim recommendations on administering the Pfizer-BioNtech and Moderna COVID-19 vaccines.
The authors, led by Mark S. Freedman, DVM, MPH, DACVPM, of the CDC’s National Center for Immunization and Respiratory Diseases, in Atlanta, note that this year’s recommendations for adults – persons aged 19 years and older – are largely the same as last year’s. “There have been very few changes,” Dr. Freedman said in an interview. “Changes to the schedule tables and notes were made to harmonize to the greatest extent possible the adult and child/adolescent schedules.”
Changes in the schedule include new or updated ACIP recommendations for influenza, hepatitis A, hepatitis B (Hep B), and human papillomavirus (HPV) as well as for meningococcal serogroups A, C, W, and Y (MenACYW) vaccines, meningococcal B (MenB) vaccines, and the zoster vaccine.
Vaccine-specific changes
Influenza
The schedule highlights updates to the composition of several influenza vaccines, which apply to components in both trivalent and quadrivalent formulations.
The cover page abbreviation for live attenuated influenza vaccine (LAIV) was changed to LAIV4. The abbreviation for live recombinant influenza vaccine (RIV) was changed to RIV4.
For individuals with a history of egg allergy who experience reactions other than hives, the following procedural warning has been added: “If using an influenza vaccine other than RIV4 or ccIIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions.”
Zoster
The zoster vaccine live (Zostavax) has been removed from the schedule because it is no longer available in the United States. The recombinant zoster vaccine Shingrix remains available as a 2-dose regimen for adults aged 50 years or older.
HPV
As in previous years, HPV vaccination is routinely recommended for persons aged 11-12 years, with catch-up vaccination for those aged 26 or younger. Catch-up vaccination can be considered with shared decision making for those aged 27 through 45. In this year’s schedule, in the pregnancy column, the color pink, which formerly indicated “delay until after pregnancy,” has been replaced with red and an asterisk, indicating “vaccinate after pregnancy.”
HepB
ACIP continues to recommend vaccination of adults at risk for HepB; however, the text overlay has been changed to read, “2, 3, or 4 doses, depending on vaccine or condition.” Additionally, HepB vaccination is now routinely recommended for adults younger than 60 years with diabetes. For those with diabetes who are older than 60, shared decision making is recommended.
Meningococcal vaccine
ACIP continues to recommend routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for persons at increased risk for meningococcal disease caused by serogroups A, C, W, or Y. The MenQuadfi (MenACWY-TT) vaccine, which was first licensed in 2020, has been added to all relevant sections of MenACWY vaccines. For MenACWY booster doses, new text addresses special situations, including outbreaks.
Improvements have been made to text and layout, Dr. Freedman said. An example is the minimizing of specialized text. Other changes were made to ensure more consistent text structure and language. Various fine-tunings of color and positioning were made to the cover page and tables, and the wording of the notes sections was improved.
Vaccination in the pandemic
The updated schedule outlines guidance on the use of COVID-19 vaccines approved by the Food and Drug Administration under emergency use authorization, with interim recommendations for the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older and the Moderna COVID-19 vaccine for people aged 18 and older.
The authors stress the importance of receiving the recommended routine and catch-up immunizations notwithstanding widespread anxiety about visiting medical offices. Last spring, the CDC reported a dramatic drop in child vaccinations after the declaration of the national emergency in mid-March, a drop attributed to fear of COVID-19 exposure.
“ACIP continued to meet and make recommendations during the pandemic,” Dr. Freedman said. “Our recommendation remains that despite challenges caused by the COVID-19 pandemic, adults and their healthcare providers should follow the recommended vaccine schedule to protect against serious and sometimes deadly diseases.”
Regular vaccines can be safely administered even as COVID-19 retains its grasp on the United States. “Healthcare providers should follow the CDC’s interim guidance for the safe delivery of vaccines during the pandemic, which includes the use of personal protective equipment and physical distancing,” Dr. Freedman said.
Dr. Freedman has disclosed no relevant financial relationships. Coauthor Henry Bernstein, DO, is the editor of the Current Opinion in Pediatrics Office Pediatrics Series, is a Harvard School of Public Health faculty member, and is a member of the data safety and monitoring board for a Takeda study on intrathecal enzymes for Hunter and San Filippo syndromes. Coauthor Kevin Ault, MD, has served on the data safety and monitoring committee for ACI Clinical.
A version of this article first appeared on Medscape.com .
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has updated its recommended immunization schedule for adults for 2021.
A summary of the annual update was published online Feb. 11 in the CDC’s Morbidity and Mortality Weekly Report and is available in Annals of Internal Medicine and on the CDC website.
It features a special section on vaccination during the pandemic as well as interim recommendations on administering the Pfizer-BioNtech and Moderna COVID-19 vaccines.
The authors, led by Mark S. Freedman, DVM, MPH, DACVPM, of the CDC’s National Center for Immunization and Respiratory Diseases, in Atlanta, note that this year’s recommendations for adults – persons aged 19 years and older – are largely the same as last year’s. “There have been very few changes,” Dr. Freedman said in an interview. “Changes to the schedule tables and notes were made to harmonize to the greatest extent possible the adult and child/adolescent schedules.”
Changes in the schedule include new or updated ACIP recommendations for influenza, hepatitis A, hepatitis B (Hep B), and human papillomavirus (HPV) as well as for meningococcal serogroups A, C, W, and Y (MenACYW) vaccines, meningococcal B (MenB) vaccines, and the zoster vaccine.
Vaccine-specific changes
Influenza
The schedule highlights updates to the composition of several influenza vaccines, which apply to components in both trivalent and quadrivalent formulations.
The cover page abbreviation for live attenuated influenza vaccine (LAIV) was changed to LAIV4. The abbreviation for live recombinant influenza vaccine (RIV) was changed to RIV4.
For individuals with a history of egg allergy who experience reactions other than hives, the following procedural warning has been added: “If using an influenza vaccine other than RIV4 or ccIIV4, administer in medical setting under supervision of health care provider who can recognize and manage severe allergic reactions.”
Zoster
The zoster vaccine live (Zostavax) has been removed from the schedule because it is no longer available in the United States. The recombinant zoster vaccine Shingrix remains available as a 2-dose regimen for adults aged 50 years or older.
HPV
As in previous years, HPV vaccination is routinely recommended for persons aged 11-12 years, with catch-up vaccination for those aged 26 or younger. Catch-up vaccination can be considered with shared decision making for those aged 27 through 45. In this year’s schedule, in the pregnancy column, the color pink, which formerly indicated “delay until after pregnancy,” has been replaced with red and an asterisk, indicating “vaccinate after pregnancy.”
HepB
ACIP continues to recommend vaccination of adults at risk for HepB; however, the text overlay has been changed to read, “2, 3, or 4 doses, depending on vaccine or condition.” Additionally, HepB vaccination is now routinely recommended for adults younger than 60 years with diabetes. For those with diabetes who are older than 60, shared decision making is recommended.
Meningococcal vaccine
ACIP continues to recommend routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for persons at increased risk for meningococcal disease caused by serogroups A, C, W, or Y. The MenQuadfi (MenACWY-TT) vaccine, which was first licensed in 2020, has been added to all relevant sections of MenACWY vaccines. For MenACWY booster doses, new text addresses special situations, including outbreaks.
Improvements have been made to text and layout, Dr. Freedman said. An example is the minimizing of specialized text. Other changes were made to ensure more consistent text structure and language. Various fine-tunings of color and positioning were made to the cover page and tables, and the wording of the notes sections was improved.
Vaccination in the pandemic
The updated schedule outlines guidance on the use of COVID-19 vaccines approved by the Food and Drug Administration under emergency use authorization, with interim recommendations for the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older and the Moderna COVID-19 vaccine for people aged 18 and older.
The authors stress the importance of receiving the recommended routine and catch-up immunizations notwithstanding widespread anxiety about visiting medical offices. Last spring, the CDC reported a dramatic drop in child vaccinations after the declaration of the national emergency in mid-March, a drop attributed to fear of COVID-19 exposure.
“ACIP continued to meet and make recommendations during the pandemic,” Dr. Freedman said. “Our recommendation remains that despite challenges caused by the COVID-19 pandemic, adults and their healthcare providers should follow the recommended vaccine schedule to protect against serious and sometimes deadly diseases.”
Regular vaccines can be safely administered even as COVID-19 retains its grasp on the United States. “Healthcare providers should follow the CDC’s interim guidance for the safe delivery of vaccines during the pandemic, which includes the use of personal protective equipment and physical distancing,” Dr. Freedman said.
Dr. Freedman has disclosed no relevant financial relationships. Coauthor Henry Bernstein, DO, is the editor of the Current Opinion in Pediatrics Office Pediatrics Series, is a Harvard School of Public Health faculty member, and is a member of the data safety and monitoring board for a Takeda study on intrathecal enzymes for Hunter and San Filippo syndromes. Coauthor Kevin Ault, MD, has served on the data safety and monitoring committee for ACI Clinical.
A version of this article first appeared on Medscape.com .