COVID-19 booster shots to start in September: Officials

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Changed
Thu, 08/26/2021 - 15:43

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



A version of this article first appeared on WebMD.com.

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Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



A version of this article first appeared on WebMD.com.

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



A version of this article first appeared on WebMD.com.

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Latest data show increase in breakthrough COVID-19 cases

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Thu, 08/26/2021 - 15:43

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

A version of this article first appeared on WebMD.com.

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Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

A version of this article first appeared on WebMD.com.

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

A version of this article first appeared on WebMD.com.

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FDA approves Pfizer’s tick-borne encephalitis vaccine

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Wed, 08/18/2021 - 14:32

The U.S. Food and Drug Administration has approved Pfizer’s TicoVac vaccine for the treatment of tick-borne encephalitis (TBE). The vaccine is approved outside of the United States, and more than 170 million doses have been administered since 1976. The World Health Organization recommends vaccination for everyone in areas where the annual incidence of clinical disease is highly endemic, defined as more than five cases per 100,000 population, which is primarily the Baltic countries of Europe but includes some regions of Central and East Asia.

GlaxoSmithKline’s Encepur is also approved outside the United States, as is a vaccine from China and two from Russia. The efficacy of all the vaccines is greater than 95%. Pfizer’s protection is 98.7% to 100.0% after the three-dose course. With the new approval, American travelers will be able to get immunized before their departure instead of waiting until they are overseas to start the series.

TicoVac can cause injection-site pain, headache, myalgia, and fever, as is typical with many vaccines.
 

Tick-borne encephalitis

TBE is caused by a flavivirus and is transmitted by the bite of an infected Ixodes scapularis, or deer tick. Like the Powassan virus, another flavivirus, infection can be transmitted in minutes through the tick’s saliva, so early removal of the tick might not prevent illness. This is different than Lyme disease, where vigilance and early removal of the tick can prevent transmission.

Reservoirs for the virus include mice, voles, and shrews. Large mammals (deer, sheep, cattle, goats) also serve to support tick multiplication. In addition to tick bites, ingestion of unpasteurized milk from infected mammals can transmit TBE.

TBE symptoms can range from none to severe encephalitis (brain inflammation). One-quarter of infected people develop encephalitis. Most recover fully, but one-third of those infected can develop lifelong damage and paralysis or cognitive deficits. Death is rare, except in those infected with the Russian strain.

The first phase of a TBE infection is typical of viral infections, with nonspecific fever, headache, nausea, and myalgia. The next phase involves an asymptomatic interval of about a week (range, 1 to 33 days), followed by symptoms of a central nervous system infection.

There is no treatment for TBE and no antivirals with proven benefit. However, a recent case report describes the successful treatment of TBE with favipiravir.

For now, if you are unvaccinated, prevention is the only viable option. If you plan to travel to an endemic region and anticipate participating in outdoor activities (such as hunting or hiking), wear permethrin-treated clothes, use an insecticide, and don’t eat or drink unpasteurized dairy products.

Judy Stone, MD, is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

A version of this article first appeared on Medscape.com.

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The U.S. Food and Drug Administration has approved Pfizer’s TicoVac vaccine for the treatment of tick-borne encephalitis (TBE). The vaccine is approved outside of the United States, and more than 170 million doses have been administered since 1976. The World Health Organization recommends vaccination for everyone in areas where the annual incidence of clinical disease is highly endemic, defined as more than five cases per 100,000 population, which is primarily the Baltic countries of Europe but includes some regions of Central and East Asia.

GlaxoSmithKline’s Encepur is also approved outside the United States, as is a vaccine from China and two from Russia. The efficacy of all the vaccines is greater than 95%. Pfizer’s protection is 98.7% to 100.0% after the three-dose course. With the new approval, American travelers will be able to get immunized before their departure instead of waiting until they are overseas to start the series.

TicoVac can cause injection-site pain, headache, myalgia, and fever, as is typical with many vaccines.
 

Tick-borne encephalitis

TBE is caused by a flavivirus and is transmitted by the bite of an infected Ixodes scapularis, or deer tick. Like the Powassan virus, another flavivirus, infection can be transmitted in minutes through the tick’s saliva, so early removal of the tick might not prevent illness. This is different than Lyme disease, where vigilance and early removal of the tick can prevent transmission.

Reservoirs for the virus include mice, voles, and shrews. Large mammals (deer, sheep, cattle, goats) also serve to support tick multiplication. In addition to tick bites, ingestion of unpasteurized milk from infected mammals can transmit TBE.

TBE symptoms can range from none to severe encephalitis (brain inflammation). One-quarter of infected people develop encephalitis. Most recover fully, but one-third of those infected can develop lifelong damage and paralysis or cognitive deficits. Death is rare, except in those infected with the Russian strain.

The first phase of a TBE infection is typical of viral infections, with nonspecific fever, headache, nausea, and myalgia. The next phase involves an asymptomatic interval of about a week (range, 1 to 33 days), followed by symptoms of a central nervous system infection.

There is no treatment for TBE and no antivirals with proven benefit. However, a recent case report describes the successful treatment of TBE with favipiravir.

For now, if you are unvaccinated, prevention is the only viable option. If you plan to travel to an endemic region and anticipate participating in outdoor activities (such as hunting or hiking), wear permethrin-treated clothes, use an insecticide, and don’t eat or drink unpasteurized dairy products.

Judy Stone, MD, is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved Pfizer’s TicoVac vaccine for the treatment of tick-borne encephalitis (TBE). The vaccine is approved outside of the United States, and more than 170 million doses have been administered since 1976. The World Health Organization recommends vaccination for everyone in areas where the annual incidence of clinical disease is highly endemic, defined as more than five cases per 100,000 population, which is primarily the Baltic countries of Europe but includes some regions of Central and East Asia.

GlaxoSmithKline’s Encepur is also approved outside the United States, as is a vaccine from China and two from Russia. The efficacy of all the vaccines is greater than 95%. Pfizer’s protection is 98.7% to 100.0% after the three-dose course. With the new approval, American travelers will be able to get immunized before their departure instead of waiting until they are overseas to start the series.

TicoVac can cause injection-site pain, headache, myalgia, and fever, as is typical with many vaccines.
 

Tick-borne encephalitis

TBE is caused by a flavivirus and is transmitted by the bite of an infected Ixodes scapularis, or deer tick. Like the Powassan virus, another flavivirus, infection can be transmitted in minutes through the tick’s saliva, so early removal of the tick might not prevent illness. This is different than Lyme disease, where vigilance and early removal of the tick can prevent transmission.

Reservoirs for the virus include mice, voles, and shrews. Large mammals (deer, sheep, cattle, goats) also serve to support tick multiplication. In addition to tick bites, ingestion of unpasteurized milk from infected mammals can transmit TBE.

TBE symptoms can range from none to severe encephalitis (brain inflammation). One-quarter of infected people develop encephalitis. Most recover fully, but one-third of those infected can develop lifelong damage and paralysis or cognitive deficits. Death is rare, except in those infected with the Russian strain.

The first phase of a TBE infection is typical of viral infections, with nonspecific fever, headache, nausea, and myalgia. The next phase involves an asymptomatic interval of about a week (range, 1 to 33 days), followed by symptoms of a central nervous system infection.

There is no treatment for TBE and no antivirals with proven benefit. However, a recent case report describes the successful treatment of TBE with favipiravir.

For now, if you are unvaccinated, prevention is the only viable option. If you plan to travel to an endemic region and anticipate participating in outdoor activities (such as hunting or hiking), wear permethrin-treated clothes, use an insecticide, and don’t eat or drink unpasteurized dairy products.

Judy Stone, MD, is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

A version of this article first appeared on Medscape.com.

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CDC officially endorses third dose of mRNA vaccines for immunocompromised

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Thu, 12/15/2022 - 14:37

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

 

 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

  • Receiving treatment for solid tumors or blood cancers
  • Taking immunosuppressing medications after a solid organ transplant
  • Within 2 years of receiving CAR-T therapy or a stem cell transplant
  • Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
  • With advanced or untreated 
  • Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
  • With certain chronic medical conditions, such as  or asplenia – living without a spleen
  • Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

 

 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

A version of this article first appeared on Medscape.com.

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Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

 

 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

  • Receiving treatment for solid tumors or blood cancers
  • Taking immunosuppressing medications after a solid organ transplant
  • Within 2 years of receiving CAR-T therapy or a stem cell transplant
  • Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
  • With advanced or untreated 
  • Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
  • With certain chronic medical conditions, such as  or asplenia – living without a spleen
  • Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

 

 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

A version of this article first appeared on Medscape.com.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

 

 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

  • Receiving treatment for solid tumors or blood cancers
  • Taking immunosuppressing medications after a solid organ transplant
  • Within 2 years of receiving CAR-T therapy or a stem cell transplant
  • Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
  • With advanced or untreated 
  • Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
  • With certain chronic medical conditions, such as  or asplenia – living without a spleen
  • Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

 

 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

A version of this article first appeared on Medscape.com.

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25% of patients with cancer lack immunity against measles

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Thu, 12/15/2022 - 14:37

Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

A version of this article first appeared on Medscape.com.

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Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

A version of this article first appeared on Medscape.com.

Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.

“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.

Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.

So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.

They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.

The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.

“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.

And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.

“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.

In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said

“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.

The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
 

Three subgroups more likely to have deficits

The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits:  those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.

In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.

As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.

A study author explained why the study included mumps, a less threatening infection.

“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.

Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.

The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.

A version of this article first appeared on Medscape.com.

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Pathology society first to call for nationwide vaccination mandate

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Tue, 08/17/2021 - 09:04

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

A version of this article first appeared on Medscape.com.

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The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

A version of this article first appeared on Medscape.com.

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

A version of this article first appeared on Medscape.com.

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Fauci says ‘unprecedented’ conditions could influence COVID vaccine approval for kids

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Thu, 08/26/2021 - 15:43

 

“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

Dr. Anthony S. Fauci
Early in the COVID-19 pandemic, the data suggested that children could become infected, but that serious outcomes were unlikely, said Dr. Fauci. Now, with the delta variant surging in the United States and globally, “what we are seeing is really quite disturbing,” as more children are impacted and hospitalized with serious illness, he noted.

The reasons for this shift remain unclear, he said.

Dr. Beers emphasized the ability of pediatric hospitalists to be flexible in the face of uncertainty and the evolving virus, and asked Dr. Fauci to elaborate on the unique traits of the delta variant that make it especially challenging.

“There is no doubt that delta transmits much more efficiently than the alpha variant or any other variant,” Dr. Fauci said. The transmissibility is evident in comparisons of the level of virus in the nasopharynx of the delta variant, compared with the original alpha COVID-19 virus – delta is as much as 1,000 times higher, he explained.

In addition, the level of virus in the nasopharynx of vaccinated individuals who develop breakthrough infections with the delta variant is similar to the levels in unvaccinated individuals who are infected with the delta variant.

The delta variant is “the tough guy on the block” at the moment, Dr. Fauci said.

Dr. Fauci also responded to a question on the lack of winter viruses, such as RSV and the flu, last winter, but the surge in these viruses over the summer.

This winter’s activity remains uncertain, Dr. Fauci said. However, he speculated “with a strong dose of humility and modesty” that viruses tend to have niches, some are seasonal, and the winter viruses that were displaced by COVID-19 hit harder in the summer instead. “If I were a [non-COVID] virus looking for a niche, I would be really confused,” he said. “I don’t know what will happen this winter, but if we get good control over COVID-19 by winter, we could have a very vengeful influenza season,” he said. “This is speculation, I don’t have any data for this,” he cautioned.

Dr. Beers raised the issue of back-to-school safety, and the updated AAP guidance for universal masking for K-12 students. “Our guidance about return to school gets updated as the situation changes and we gain a better understanding of how kids can get to school safely,” she said. A combination of factors affect back-to-school guidance, including the ineligibility of children younger than 12 years to be vaccinated, the number of adolescents who are eligible but have not been vaccinated, and the challenge for educators to navigate which children should wear masks, Dr. Beers said.

“We want to get vaccines for our youngest kids as soon as safely possible,” Dr. Beers emphasized. She noted that the same urgency is needed to provide vaccines for children as for adults, although “we have to do it safely, and be sure and feel confident in the data.”

When asked to comment about the status of FDA authorization of COVID-19 vaccines for younger children, Dr. Fauci described the current situation as one that “might require some unprecedented and unique action” on the part of the FDA, which tends to move cautiously because of safety considerations. However, concerns about adverse events might get in the way of protecting children against what “you are really worried about,” in this case COVID-19 and its variants, he said. Despite the breakthrough infections, “vaccination continues to very adequately protect people from getting severe disease,” he emphasized.

Dr. Fauci also said that he believes the current data support boosters for the immune compromised; however “it is a different story about the general vaccinated population and the vaccinated elderly,” he said. Sooner or later most people will likely need boosters; “the question is who, when, and how soon,” he noted.

Dr. Fauci wrapped up the session with kudos and support for the pediatric health care community. “As a nonpediatrician, I have a great deal of respect for the job you are doing,” he said. “Keep up the great work.”

Dr. Beers echoed this sentiment, saying that she was “continually awed, impressed, and inspired” by how the pediatric hospitalists are navigating the ever-changing pandemic environment.

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“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

Dr. Anthony S. Fauci
Early in the COVID-19 pandemic, the data suggested that children could become infected, but that serious outcomes were unlikely, said Dr. Fauci. Now, with the delta variant surging in the United States and globally, “what we are seeing is really quite disturbing,” as more children are impacted and hospitalized with serious illness, he noted.

The reasons for this shift remain unclear, he said.

Dr. Beers emphasized the ability of pediatric hospitalists to be flexible in the face of uncertainty and the evolving virus, and asked Dr. Fauci to elaborate on the unique traits of the delta variant that make it especially challenging.

“There is no doubt that delta transmits much more efficiently than the alpha variant or any other variant,” Dr. Fauci said. The transmissibility is evident in comparisons of the level of virus in the nasopharynx of the delta variant, compared with the original alpha COVID-19 virus – delta is as much as 1,000 times higher, he explained.

In addition, the level of virus in the nasopharynx of vaccinated individuals who develop breakthrough infections with the delta variant is similar to the levels in unvaccinated individuals who are infected with the delta variant.

The delta variant is “the tough guy on the block” at the moment, Dr. Fauci said.

Dr. Fauci also responded to a question on the lack of winter viruses, such as RSV and the flu, last winter, but the surge in these viruses over the summer.

This winter’s activity remains uncertain, Dr. Fauci said. However, he speculated “with a strong dose of humility and modesty” that viruses tend to have niches, some are seasonal, and the winter viruses that were displaced by COVID-19 hit harder in the summer instead. “If I were a [non-COVID] virus looking for a niche, I would be really confused,” he said. “I don’t know what will happen this winter, but if we get good control over COVID-19 by winter, we could have a very vengeful influenza season,” he said. “This is speculation, I don’t have any data for this,” he cautioned.

Dr. Beers raised the issue of back-to-school safety, and the updated AAP guidance for universal masking for K-12 students. “Our guidance about return to school gets updated as the situation changes and we gain a better understanding of how kids can get to school safely,” she said. A combination of factors affect back-to-school guidance, including the ineligibility of children younger than 12 years to be vaccinated, the number of adolescents who are eligible but have not been vaccinated, and the challenge for educators to navigate which children should wear masks, Dr. Beers said.

“We want to get vaccines for our youngest kids as soon as safely possible,” Dr. Beers emphasized. She noted that the same urgency is needed to provide vaccines for children as for adults, although “we have to do it safely, and be sure and feel confident in the data.”

When asked to comment about the status of FDA authorization of COVID-19 vaccines for younger children, Dr. Fauci described the current situation as one that “might require some unprecedented and unique action” on the part of the FDA, which tends to move cautiously because of safety considerations. However, concerns about adverse events might get in the way of protecting children against what “you are really worried about,” in this case COVID-19 and its variants, he said. Despite the breakthrough infections, “vaccination continues to very adequately protect people from getting severe disease,” he emphasized.

Dr. Fauci also said that he believes the current data support boosters for the immune compromised; however “it is a different story about the general vaccinated population and the vaccinated elderly,” he said. Sooner or later most people will likely need boosters; “the question is who, when, and how soon,” he noted.

Dr. Fauci wrapped up the session with kudos and support for the pediatric health care community. “As a nonpediatrician, I have a great deal of respect for the job you are doing,” he said. “Keep up the great work.”

Dr. Beers echoed this sentiment, saying that she was “continually awed, impressed, and inspired” by how the pediatric hospitalists are navigating the ever-changing pandemic environment.

 

“From a public health standpoint, I think we have an evolving situation,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a moderated session with Lee Beers, MD, president of the American Academy of Pediatrics, at the virtual Pediatric Hospital Medicine annual conference.

Dr. Anthony S. Fauci
Early in the COVID-19 pandemic, the data suggested that children could become infected, but that serious outcomes were unlikely, said Dr. Fauci. Now, with the delta variant surging in the United States and globally, “what we are seeing is really quite disturbing,” as more children are impacted and hospitalized with serious illness, he noted.

The reasons for this shift remain unclear, he said.

Dr. Beers emphasized the ability of pediatric hospitalists to be flexible in the face of uncertainty and the evolving virus, and asked Dr. Fauci to elaborate on the unique traits of the delta variant that make it especially challenging.

“There is no doubt that delta transmits much more efficiently than the alpha variant or any other variant,” Dr. Fauci said. The transmissibility is evident in comparisons of the level of virus in the nasopharynx of the delta variant, compared with the original alpha COVID-19 virus – delta is as much as 1,000 times higher, he explained.

In addition, the level of virus in the nasopharynx of vaccinated individuals who develop breakthrough infections with the delta variant is similar to the levels in unvaccinated individuals who are infected with the delta variant.

The delta variant is “the tough guy on the block” at the moment, Dr. Fauci said.

Dr. Fauci also responded to a question on the lack of winter viruses, such as RSV and the flu, last winter, but the surge in these viruses over the summer.

This winter’s activity remains uncertain, Dr. Fauci said. However, he speculated “with a strong dose of humility and modesty” that viruses tend to have niches, some are seasonal, and the winter viruses that were displaced by COVID-19 hit harder in the summer instead. “If I were a [non-COVID] virus looking for a niche, I would be really confused,” he said. “I don’t know what will happen this winter, but if we get good control over COVID-19 by winter, we could have a very vengeful influenza season,” he said. “This is speculation, I don’t have any data for this,” he cautioned.

Dr. Beers raised the issue of back-to-school safety, and the updated AAP guidance for universal masking for K-12 students. “Our guidance about return to school gets updated as the situation changes and we gain a better understanding of how kids can get to school safely,” she said. A combination of factors affect back-to-school guidance, including the ineligibility of children younger than 12 years to be vaccinated, the number of adolescents who are eligible but have not been vaccinated, and the challenge for educators to navigate which children should wear masks, Dr. Beers said.

“We want to get vaccines for our youngest kids as soon as safely possible,” Dr. Beers emphasized. She noted that the same urgency is needed to provide vaccines for children as for adults, although “we have to do it safely, and be sure and feel confident in the data.”

When asked to comment about the status of FDA authorization of COVID-19 vaccines for younger children, Dr. Fauci described the current situation as one that “might require some unprecedented and unique action” on the part of the FDA, which tends to move cautiously because of safety considerations. However, concerns about adverse events might get in the way of protecting children against what “you are really worried about,” in this case COVID-19 and its variants, he said. Despite the breakthrough infections, “vaccination continues to very adequately protect people from getting severe disease,” he emphasized.

Dr. Fauci also said that he believes the current data support boosters for the immune compromised; however “it is a different story about the general vaccinated population and the vaccinated elderly,” he said. Sooner or later most people will likely need boosters; “the question is who, when, and how soon,” he noted.

Dr. Fauci wrapped up the session with kudos and support for the pediatric health care community. “As a nonpediatrician, I have a great deal of respect for the job you are doing,” he said. “Keep up the great work.”

Dr. Beers echoed this sentiment, saying that she was “continually awed, impressed, and inspired” by how the pediatric hospitalists are navigating the ever-changing pandemic environment.

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Summer campers spread COVID at home, follow-up finds

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Thu, 08/26/2021 - 15:43

After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

 

 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

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After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

 

 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

After SARS-CoV-2 spread at a sleepaway camp in Georgia last summer, researchers described the efficient spread and high attack rates at camp.

In a report published online in The New England Journal of Medicine, researchers found that campers spread COVID to household members after returning home – but transmission was more likely from some than others. Distancing and masking helped reduce the risk.

Victoria T. Chu, MD, MPH, with the Centers for Disease Control and Prevention, Atlanta, and colleagues with the agency and the Georgia Department of Health followed up with 224 camp attendees, aged 7 to 19 years, who had evidence of SARS-CoV-2 infection on laboratory testing.

These index patients – 88% of whom had symptoms – had 526 household contacts, mainly parents and siblings. Of 377 household contacts who underwent testing, 46 (12%) tested positive. Another two cases in household contacts were identified using clinical and epidemiologic criteria.
 

Family members hospitalized

Of the 41 adult household contacts who were infected, four (about 10%) were hospitalized. Their hospital stays ranged from 5 to 11 days. Of the seven infected household contacts who were younger than 18 years, none were hospitalized.

The four hospitalized adults were parents and grandparents aged 45 to 80 years, Dr. Chu said. Two of the four had underlying conditions. None of the household contacts died.

In an adjusted analysis, campers who had practiced physical distancing were less likely to transmit the virus at home, compared with those who had not practiced physical distancing (adjusted odds ratio, 0.4). Household members who had had close or direct contact with the index patients were more than 5 times more likely to become infected, compared with family members with minimal or no contact, analyses showed.

“This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of COVID-19,” the researchers write. “In households in which transmission occurred, half the household contacts were infected.”

The secondary attack rates in this report may be an underestimate because testing was voluntary and participants reported the results themselves, the authors note. It is possible that infected household contacts spread the virus further, but this study did not address that question, Dr. Chu said.

For the study, investigators interviewed all camp attendees and their parents or guardians by phone between July 17, 2020 and Aug. 24, 2020, to collect information about demographic and clinical characteristics, SARS-CoV-2 testing, and preventive measures. The researchers’ analysis excluded households in which illness onset in a household contact occurred before or less than 2 days after a camper became sick.

About a third of the index patients began to have symptoms while still at camp. These campers may have been less infectious by the time they got home, compared with those whose symptoms started after they returned.

Two-thirds of the index patients adopted physical distancing at home, which “probably reduced the transmission of SARS-CoV-2 in the household,” Dr. Chu and colleagues wrote.

“Children who have had a known COVID-19 exposure should quarantine and obtain testing if they develop symptoms within the 14 days of returning home,” Dr. Chu advised. “If a child develops COVID-19, the child should be cared for and monitored using the proper combination of physical distancing, isolation when feasible, and mask use to prevent household transmission as much as possible. In addition, any person over the age of 12 is now eligible for vaccination in the United States. If eligible, children attending camp and their family members should get vaccinated to protect themselves and others, as vaccinations are our most effective public health prevention strategy.”
 

 

 

Mitigation can help

Another report regarding four overnight camps in Maine – in which three campers tested positive after they arrived last summer – shows that “aggressive mitigation strategies can be effective” in limiting transmission of the virus, William T. Basco Jr., MD, writes in a commentary for this news organization.

This summer, a range of factors, including vaccination rates at the camp, may influence transmission dynamics, Dr. Chu said in an interview. In July, the Associated Press reported outbreaks tied to summer camps in several states.

“Transmission dynamics will probably vary from summer camp to summer camp depending on many factors, such as vaccination rates of camp attendees, the mitigation measures in place, and the number of individual introductions during camp,” Dr. Chu said. “We would expect that a camp with a low vaccination rate among attendees and no enforcement of mitigation measures” still may experience a large outbreak.

“On the other hand, a large proportion of vaccinated individuals and appropriate implementation of multiple mitigation measures, such as wearing masks, may be quite effective at keeping their transmission rates low,” Dr. Chu added. “For camps with younger children who are not currently eligible for vaccination, implementing layered prevention strategies (e.g., mask use, physical distancing, and encouraging outdoor activities when feasible) is important to prevent transmission.”

Although COVID-19 transmission from children to adults, potentially leading to hospitalization, is not a new phenomenon, “data on the extent of transmission driven by children and adolescents in different settings are still quite sparse,” Dr. Chu said. “A better understanding of their impact on household and community transmission to help guide public health recommendations is particularly important, as most children are still not eligible for vaccination, and in-person schools will be reopening this fall.”

A version of this article first appeared on Medscape.com.

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Delta variant could drive herd immunity threshold over 80%

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Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Dr. Ricardo Franco, assistant professor of medicine at the University of Alabama at Birmingham
Dr. Ricardo Franco

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Dr. Ezekiel J. Emanuel

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

 

 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

A version of this article first appeared on Medscape.com.

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Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Dr. Ricardo Franco, assistant professor of medicine at the University of Alabama at Birmingham
Dr. Ricardo Franco

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Dr. Ezekiel J. Emanuel

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

 

 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

A version of this article first appeared on Medscape.com.

Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upward of 80% or more, experts say.

Dr. Ricardo Franco, assistant professor of medicine at the University of Alabama at Birmingham
Dr. Ricardo Franco

Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status, according to a media briefing on Aug. 3 sponsored by the Infectious Diseases Society of America.

Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations – and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.

“The problem here is that the Delta variant is ... more transmissible than the original virus. That pushes the overall population herd immunity threshold much higher,” Ricardo Franco, MD, assistant professor of medicine at the University of Alabama at Birmingham, said during the briefing.

“For Delta, those threshold estimates go well over 80% and may be approaching 90%,” he said.

To put that figure in context, the original SARS-CoV-2 virus required an estimated 67% of the population to be vaccinated to achieve herd immunity. Also, measles has one of the highest herd immunity thresholds at 95%, Dr. Franco added.

Herd immunity is the point at which enough people are immunized that the entire population gains protection. And it’s already happening. “Unvaccinated people are actually benefiting from greater herd immunity protection in high-vaccination counties compared to low-vaccination ones,” he said.
 

Maximize mask protection

Unlike early in the COVID-19 pandemic with widespread shortages of personal protective equipment, face masks are now readily available. This includes N95 masks, which offer enhanced protection against SARS-CoV-2, Ezekiel J. Emanuel, MD, PhD, said during the briefing.

Dr. Ezekiel J. Emanuel

Following the July 27 CDC recommendation that most Americans wear masks indoors when in public places, “I do think we need to upgrade our masks,” said Dr. Emanuel, who is Diane v.S. Levy & Robert M. Levy professor at the University of Pennsylvania, Philadelphia.

“It’s not just any mask,” he added. “Good masks make a big difference and are very important.”

Mask protection is about blocking 0.3-mcm particles, “and I think we need to make sure that people have masks that can filter that out,” he said. Although surgical masks are very good, he added, “they’re not quite as good as N95s.” As their name implies, N95s filter out 95% of these particles.

Dr. Emanuel acknowledged that people are tired of COVID-19 and complying with public health measures but urged perseverance. “We’ve sacrificed a lot. We should not throw it away in just a few months because we are tired. We’re all tired, but we do have to do the little bit extra getting vaccinated, wearing masks indoors, and protecting ourselves, our families, and our communities.”
 

 

 

Dealing with a disconnect

In response to a reporter’s question about the possibility that the large crowd at the Lollapalooza music festival in Chicago could become a superspreader event, Dr. Emanuel said, “it is worrisome.”

“I would say that, if you’re going to go to a gathering like that, wearing an N95 mask is wise, and not spending too long at any one place is also wise,” he said.

On the plus side, the event was held outdoors with lots of air circulation, Dr. Emanuel said.

However, “this is the kind of thing where we’ve got a sort of disconnect between people’s desire to get back to normal ... and the fact that we’re in the middle of this upsurge.”

Another potential problem is the event brought people together from many different locations, so when they travel home, they could be “potentially seeding lots of other communities.”
 

Boosters for some, for now

Even though not officially recommended, some fully vaccinated Americans are seeking a third or booster vaccination on their own.

Asked for his opinion, Dr. Emanuel said: “We’re probably going to have to be giving boosters to immunocompromised people and people who are susceptible. That’s where we are going to start.”

More research is needed regarding booster shots, he said. “There are very small studies – and the ‘very small’ should be emphasized – given that we’ve given shots to over 160 million people.”

“But it does appear that the boosters increase the antibodies and protection,” he said.

Instead of boosters, it is more important for people who haven’t been vaccinated to get fully vaccinated.

“We need to put our priorities in the right places,” he said.

Emanuel noted that, except for people in rural areas that might have to travel long distances, access to vaccines is no longer an issue. “It’s very hard not to find a vaccine if you want it.”

A remaining hurdle is “battling a major disinformation initiative. I don’t think this is misinformation. I think there’s very clear evidence that it is disinformation – false facts about the vaccines being spread,” Dr. Emanuel said.
 

The breakthrough infection dilemma

Breakthrough cases “remain the vast minority of infections at this time ... that is reassuring,” Dr. Franco said.

Also, tracking symptomatic breakthrough infections remains easier than studying fully vaccinated people who become infected with SARS-CoV-2 but remain symptom free.

“We really don’t have a good handle on the frequency of asymptomatic cases,” Dr. Emanuel said. “If you’re missing breakthrough infections, a lot of them, you may be missing some [virus] evolution that would be very important for us to follow.” This missing information could include the emergence of new variants.

The asymptomatic breakthrough cases are the most worrisome group,” Dr. Emanuel said. “You get infected, you’re feeling fine. Maybe you’ve got a little sneeze or cough, but nothing unusual. And then you’re still able to transmit the Delta variant.”
 

The big picture

The upsurge in cases, hospitalizations, and deaths is a major challenge, Dr. Emanuel said. “We need to address that by getting many more people vaccinated right now with what are very good vaccines.”

“But it also means that we have to stop being U.S. focused alone.” He pointed out that Delta and other variants originated overseas, “so getting the world vaccinated ... has to be a top priority.”

“We are obviously all facing a challenge as we move into the fall,” Dr. Emanuel said. “With schools opening and employers bringing their employees back together, even if these groups are vaccinated, there are going to be major challenges for all of us.”

A version of this article first appeared on Medscape.com.

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No higher risk of rheumatic and musculoskeletal disease flares seen after COVID-19 vaccination

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Thu, 08/26/2021 - 15:43

Double-dose vaccination against SARS-CoV-2 in patients with rheumatic and musculoskeletal diseases (RMDs) doesn’t appear to boost the risk of flares, a new study shows. The risk of adverse effects after vaccination is high, just as it is in the general population, but no patients experienced allergic reactions.

Dr. Caoilfhionn Connolly

“Our findings suggest that COVID-19 vaccines are safe in patients with rheumatic and musculoskeletal diseases. Overall, rates of flare are low and mild, while local and systemic reactions should be anticipated,” lead author Caoilfhionn Connolly, MD, MSc, a rheumatology fellow at Johns Hopkins University, Baltimore, said in an interview. “Many of our patients are at increased risk of severe infection and or complications from COVID-19. It has been shown that patients with RMDs are more willing to reconsider vaccination if it is recommended by a physician, and these data should help inform these critical discussions.”

The study appeared Aug. 4 in Arthritis & Rheumatology.

According to Dr. Connolly, the researchers launched their study to better understand the effect of two-dose SARS-CoV-2 messenger RNA vaccinations authorized for emergency use by the Food and Drug Administration (Pfizer and Moderna vaccines) on immunosuppressed patients. As she noted, patients with RMDs were largely excluded from vaccine trials, and “studies have shown that some patients with RMDs are hesitant about vaccination due to the lack of safety data.”

Some data about this patient population have started to appear. A study published July 21 in Lancet Rheumatology found that patients with systemic lupus erythematosus (SLE) reported few flares within a median of 3 days after receiving one or two doses of various COVID-19 vaccines. Side effects were common but were mainly mild or moderate.

For the new study, researchers surveyed 1,377 patients with RMDs who’d received two vaccination doses between December 2020 and April 2021. The patients had a median age of 47, 92% were female, and 10% were non-White. The patients had a variety of RMDs, including inflammatory arthritis (47%), SLE (20%), overlap connective tissue disease (20%), and Sjögren’s syndrome and myositis (each 5%).



A total of 11% said they’d experienced a flare that required treatment, but none were severe. In comparison, 56% of patients said they had experienced a flare of their RMD in the 6 months prior to their first vaccine dose. Several groups had a greater likelihood of flares, including those who’d had COVID-19 previously (adjusted incidence rate ratio [IRR], 2.09; P = .02). “COVID-19 can cause both acute and delayed inflammatory syndromes through activation of the immune system,” Dr. Connolly said. “Vaccination possibly triggered further activation of the immune system resulting in disease flare. This is an area that warrants further research.”

Patients who took combination immunomodulatory therapy were also more likely to flare after vaccination (IRR, 1.95; P < .001). And patients were more likely to report flares after vaccination if they experienced a flare in the 6 months preceding vaccination (IRR, 2.36; P < .001). “This may suggest more active disease at baseline,” Dr. Connolly said. “It is difficult to differentiate whether these patients would have experienced flare even without the vaccine.”

A number of factors didn’t appear to affect the likelihood of flares: gender, age, ethnicity, type of RMD, and type of vaccine.

Local and systemic side effects were frequently reported, including injection site pain (87% and 86% after first and second doses, respectively) and fatigue (60% and 80%, respectively). As is common among people receiving COVID-19 vaccines, side effects were more frequent after the second dose.

As for future research, “we are evaluating the long-term safety and efficacy of the COVID-19 vaccines in patients with RMDs,” study coauthor Julie J. Paik, MD, assistant professor of medicine at Johns Hopkins, said in an interview. “We are also evaluating the impact of changes in immunosuppression around vaccination.”

Dr. Julie J. Paik

The study was funded by the Ben-Dov family and grants from several institutes of the National Institutes of Health. Dr. Connolly and Dr. Paik reported no relevant disclosures. Other study authors reported various financial relationships with pharmaceutical companies.

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Double-dose vaccination against SARS-CoV-2 in patients with rheumatic and musculoskeletal diseases (RMDs) doesn’t appear to boost the risk of flares, a new study shows. The risk of adverse effects after vaccination is high, just as it is in the general population, but no patients experienced allergic reactions.

Dr. Caoilfhionn Connolly

“Our findings suggest that COVID-19 vaccines are safe in patients with rheumatic and musculoskeletal diseases. Overall, rates of flare are low and mild, while local and systemic reactions should be anticipated,” lead author Caoilfhionn Connolly, MD, MSc, a rheumatology fellow at Johns Hopkins University, Baltimore, said in an interview. “Many of our patients are at increased risk of severe infection and or complications from COVID-19. It has been shown that patients with RMDs are more willing to reconsider vaccination if it is recommended by a physician, and these data should help inform these critical discussions.”

The study appeared Aug. 4 in Arthritis & Rheumatology.

According to Dr. Connolly, the researchers launched their study to better understand the effect of two-dose SARS-CoV-2 messenger RNA vaccinations authorized for emergency use by the Food and Drug Administration (Pfizer and Moderna vaccines) on immunosuppressed patients. As she noted, patients with RMDs were largely excluded from vaccine trials, and “studies have shown that some patients with RMDs are hesitant about vaccination due to the lack of safety data.”

Some data about this patient population have started to appear. A study published July 21 in Lancet Rheumatology found that patients with systemic lupus erythematosus (SLE) reported few flares within a median of 3 days after receiving one or two doses of various COVID-19 vaccines. Side effects were common but were mainly mild or moderate.

For the new study, researchers surveyed 1,377 patients with RMDs who’d received two vaccination doses between December 2020 and April 2021. The patients had a median age of 47, 92% were female, and 10% were non-White. The patients had a variety of RMDs, including inflammatory arthritis (47%), SLE (20%), overlap connective tissue disease (20%), and Sjögren’s syndrome and myositis (each 5%).



A total of 11% said they’d experienced a flare that required treatment, but none were severe. In comparison, 56% of patients said they had experienced a flare of their RMD in the 6 months prior to their first vaccine dose. Several groups had a greater likelihood of flares, including those who’d had COVID-19 previously (adjusted incidence rate ratio [IRR], 2.09; P = .02). “COVID-19 can cause both acute and delayed inflammatory syndromes through activation of the immune system,” Dr. Connolly said. “Vaccination possibly triggered further activation of the immune system resulting in disease flare. This is an area that warrants further research.”

Patients who took combination immunomodulatory therapy were also more likely to flare after vaccination (IRR, 1.95; P < .001). And patients were more likely to report flares after vaccination if they experienced a flare in the 6 months preceding vaccination (IRR, 2.36; P < .001). “This may suggest more active disease at baseline,” Dr. Connolly said. “It is difficult to differentiate whether these patients would have experienced flare even without the vaccine.”

A number of factors didn’t appear to affect the likelihood of flares: gender, age, ethnicity, type of RMD, and type of vaccine.

Local and systemic side effects were frequently reported, including injection site pain (87% and 86% after first and second doses, respectively) and fatigue (60% and 80%, respectively). As is common among people receiving COVID-19 vaccines, side effects were more frequent after the second dose.

As for future research, “we are evaluating the long-term safety and efficacy of the COVID-19 vaccines in patients with RMDs,” study coauthor Julie J. Paik, MD, assistant professor of medicine at Johns Hopkins, said in an interview. “We are also evaluating the impact of changes in immunosuppression around vaccination.”

Dr. Julie J. Paik

The study was funded by the Ben-Dov family and grants from several institutes of the National Institutes of Health. Dr. Connolly and Dr. Paik reported no relevant disclosures. Other study authors reported various financial relationships with pharmaceutical companies.

Double-dose vaccination against SARS-CoV-2 in patients with rheumatic and musculoskeletal diseases (RMDs) doesn’t appear to boost the risk of flares, a new study shows. The risk of adverse effects after vaccination is high, just as it is in the general population, but no patients experienced allergic reactions.

Dr. Caoilfhionn Connolly

“Our findings suggest that COVID-19 vaccines are safe in patients with rheumatic and musculoskeletal diseases. Overall, rates of flare are low and mild, while local and systemic reactions should be anticipated,” lead author Caoilfhionn Connolly, MD, MSc, a rheumatology fellow at Johns Hopkins University, Baltimore, said in an interview. “Many of our patients are at increased risk of severe infection and or complications from COVID-19. It has been shown that patients with RMDs are more willing to reconsider vaccination if it is recommended by a physician, and these data should help inform these critical discussions.”

The study appeared Aug. 4 in Arthritis & Rheumatology.

According to Dr. Connolly, the researchers launched their study to better understand the effect of two-dose SARS-CoV-2 messenger RNA vaccinations authorized for emergency use by the Food and Drug Administration (Pfizer and Moderna vaccines) on immunosuppressed patients. As she noted, patients with RMDs were largely excluded from vaccine trials, and “studies have shown that some patients with RMDs are hesitant about vaccination due to the lack of safety data.”

Some data about this patient population have started to appear. A study published July 21 in Lancet Rheumatology found that patients with systemic lupus erythematosus (SLE) reported few flares within a median of 3 days after receiving one or two doses of various COVID-19 vaccines. Side effects were common but were mainly mild or moderate.

For the new study, researchers surveyed 1,377 patients with RMDs who’d received two vaccination doses between December 2020 and April 2021. The patients had a median age of 47, 92% were female, and 10% were non-White. The patients had a variety of RMDs, including inflammatory arthritis (47%), SLE (20%), overlap connective tissue disease (20%), and Sjögren’s syndrome and myositis (each 5%).



A total of 11% said they’d experienced a flare that required treatment, but none were severe. In comparison, 56% of patients said they had experienced a flare of their RMD in the 6 months prior to their first vaccine dose. Several groups had a greater likelihood of flares, including those who’d had COVID-19 previously (adjusted incidence rate ratio [IRR], 2.09; P = .02). “COVID-19 can cause both acute and delayed inflammatory syndromes through activation of the immune system,” Dr. Connolly said. “Vaccination possibly triggered further activation of the immune system resulting in disease flare. This is an area that warrants further research.”

Patients who took combination immunomodulatory therapy were also more likely to flare after vaccination (IRR, 1.95; P < .001). And patients were more likely to report flares after vaccination if they experienced a flare in the 6 months preceding vaccination (IRR, 2.36; P < .001). “This may suggest more active disease at baseline,” Dr. Connolly said. “It is difficult to differentiate whether these patients would have experienced flare even without the vaccine.”

A number of factors didn’t appear to affect the likelihood of flares: gender, age, ethnicity, type of RMD, and type of vaccine.

Local and systemic side effects were frequently reported, including injection site pain (87% and 86% after first and second doses, respectively) and fatigue (60% and 80%, respectively). As is common among people receiving COVID-19 vaccines, side effects were more frequent after the second dose.

As for future research, “we are evaluating the long-term safety and efficacy of the COVID-19 vaccines in patients with RMDs,” study coauthor Julie J. Paik, MD, assistant professor of medicine at Johns Hopkins, said in an interview. “We are also evaluating the impact of changes in immunosuppression around vaccination.”

Dr. Julie J. Paik

The study was funded by the Ben-Dov family and grants from several institutes of the National Institutes of Health. Dr. Connolly and Dr. Paik reported no relevant disclosures. Other study authors reported various financial relationships with pharmaceutical companies.

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