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CDC recommends high-dose flu vaccines for seniors
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.
Is a single dose of HPV vaccine enough?
In an April press release, the Strategic Advisory Group of Experts on Immunization (SAGE) of the World Health Organization (WHO) reported the findings of their review concerning the efficacy of various dose schedules for human papillomavirus (HPV). “A single-dose HPV vaccine delivers solid protection against HPV, the virus that causes cervical cancer, that is comparable to 2-dose schedules,” according to SAGE.
This statement comes on the heels of an article published in the November 2021 issue of Lancet Oncology about a study in India. It found that a single dose of the vaccine provides protection against persistent infection from HPV 16 and 18 similar to that provided by two or three doses.
Will this new information lead French authorities to change their recommendations? What do French specialists think? At the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases (SFCPCV), Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, shared his thoughts.
With respect to the Indian study, Dr. Canlorbe pointed out that while its findings would need “to be confirmed by other studies,” they were, nonetheless,
India and France
During the congress press conference, he went on to say that, at this stage, the findings “cannot be extrapolated” to France. This is because the country’s situation is different. HPV vaccination coverage is low; estimates put it at 23.7%, placing the country 28th out of 31 in Europe.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
In addition, he drew attention to several limitations of the Indian study. Initially, the team had planned to enroll 20,000 participants. In the end, there were around 17,000, and these were allocated to three cohorts: single-dose, two-dose, and three-dose. Furthermore, the primary objective, which had initially been focused on precancerous and cancerous lesions, was revised. The new aim was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years postvaccination. In about 90% of cases, the HPV infection went away spontaneously in 2 years without inducing lesions. Finally, the participants were women in India; therefore, the results cannot necessarily be generalized to the French population.
“This information has to be confirmed. However, as far as I know, there are no new studies going on at the moment. The Indian study, on the other hand, is still in progress,” said Dr. Canlorbe.
“In France, I think that for the time being we should stick to the studies that are currently available, which have demonstrated the efficacy and safety of two or three doses,” he concluded. In support of this approach, he cited a study on the effects of the national HPV vaccination program in England; there, the vaccination coverage is 80%.
This program was associated with a 95% risk reduction for precancerous lesions and an 87% reduction in the number of cancers, confirming the good results already achieved by Sweden and Australia.
In his comments on the WHO’s stance (which differs from that of the French experts), Jean-Luc Mergui, MD, gynecologist in the department of colposcopy and hysteroscopy at Pitié-Salpêtrière, and former president of the SFCPCV, offered an eloquent comparison: “The WHO also recommends 6 months of breastfeeding as a method of contraception, but this isn’t what’s recommended in France, for the risk of getting pregnant nevertheless remains.”
Indian study highlights
Partha Basu, MD, PhD, of the International Agency for Research on Cancer (IARC) in Lyon, France, and colleagues compared vaccine efficacy of a single dose of Gardasil (HPV 9-valent vaccine, recombinant) to that of two and three doses in protecting against persistent HPV 16 and HPV 18 infection at 10 years postvaccination.
According to the protocol, the plan was to recruit 20,000 unmarried girls, aged 10-18 years, from across India. Recruitment was initiated in September 2009. However, in response to seven unexplained deaths reported in another ongoing HPV vaccination demonstration program in the country, the Indian government issued a notification in April 2010 to stop further recruitment and HPV vaccination in all clinical trials. At this point, Dr. Basu and his team had recruited 17,729 eligible girls.
After suspension of recruitment and vaccination, their randomized trial was converted to a longitudinal, prospective, cohort study by default.
Vaccinated participants were followed up over a median duration of 9 years. In all, 4,348 participants had three doses, 4,980 had two doses (at 0 and 6 months), and 4,949 had a single dose. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Participants were invited to an annual cervical cancer screening once they reached age 25 years and were married.
A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and HPV 18, the genotypes responsible for nearly 70% of cervical cancers, compared with that provided by two or three doses. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% (95% confidence interval [CI], 85.0-99.9) in the single-dose default cohort (2,135 women assessed), 93.1% (95% CI, 77.3-99.8) in the two-dose cohort (1,452 women assessed), and 93.3% (95% CI, 77.5-99.7) in three-dose recipients (1,460 women assessed).
Dr. Canlorbe reported no relevant financial relationships regarding the content of this article.
This article was translated from the Medscape French edition. An English version appeared on Medscape.com.
In an April press release, the Strategic Advisory Group of Experts on Immunization (SAGE) of the World Health Organization (WHO) reported the findings of their review concerning the efficacy of various dose schedules for human papillomavirus (HPV). “A single-dose HPV vaccine delivers solid protection against HPV, the virus that causes cervical cancer, that is comparable to 2-dose schedules,” according to SAGE.
This statement comes on the heels of an article published in the November 2021 issue of Lancet Oncology about a study in India. It found that a single dose of the vaccine provides protection against persistent infection from HPV 16 and 18 similar to that provided by two or three doses.
Will this new information lead French authorities to change their recommendations? What do French specialists think? At the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases (SFCPCV), Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, shared his thoughts.
With respect to the Indian study, Dr. Canlorbe pointed out that while its findings would need “to be confirmed by other studies,” they were, nonetheless,
India and France
During the congress press conference, he went on to say that, at this stage, the findings “cannot be extrapolated” to France. This is because the country’s situation is different. HPV vaccination coverage is low; estimates put it at 23.7%, placing the country 28th out of 31 in Europe.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
In addition, he drew attention to several limitations of the Indian study. Initially, the team had planned to enroll 20,000 participants. In the end, there were around 17,000, and these were allocated to three cohorts: single-dose, two-dose, and three-dose. Furthermore, the primary objective, which had initially been focused on precancerous and cancerous lesions, was revised. The new aim was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years postvaccination. In about 90% of cases, the HPV infection went away spontaneously in 2 years without inducing lesions. Finally, the participants were women in India; therefore, the results cannot necessarily be generalized to the French population.
“This information has to be confirmed. However, as far as I know, there are no new studies going on at the moment. The Indian study, on the other hand, is still in progress,” said Dr. Canlorbe.
“In France, I think that for the time being we should stick to the studies that are currently available, which have demonstrated the efficacy and safety of two or three doses,” he concluded. In support of this approach, he cited a study on the effects of the national HPV vaccination program in England; there, the vaccination coverage is 80%.
This program was associated with a 95% risk reduction for precancerous lesions and an 87% reduction in the number of cancers, confirming the good results already achieved by Sweden and Australia.
In his comments on the WHO’s stance (which differs from that of the French experts), Jean-Luc Mergui, MD, gynecologist in the department of colposcopy and hysteroscopy at Pitié-Salpêtrière, and former president of the SFCPCV, offered an eloquent comparison: “The WHO also recommends 6 months of breastfeeding as a method of contraception, but this isn’t what’s recommended in France, for the risk of getting pregnant nevertheless remains.”
Indian study highlights
Partha Basu, MD, PhD, of the International Agency for Research on Cancer (IARC) in Lyon, France, and colleagues compared vaccine efficacy of a single dose of Gardasil (HPV 9-valent vaccine, recombinant) to that of two and three doses in protecting against persistent HPV 16 and HPV 18 infection at 10 years postvaccination.
According to the protocol, the plan was to recruit 20,000 unmarried girls, aged 10-18 years, from across India. Recruitment was initiated in September 2009. However, in response to seven unexplained deaths reported in another ongoing HPV vaccination demonstration program in the country, the Indian government issued a notification in April 2010 to stop further recruitment and HPV vaccination in all clinical trials. At this point, Dr. Basu and his team had recruited 17,729 eligible girls.
After suspension of recruitment and vaccination, their randomized trial was converted to a longitudinal, prospective, cohort study by default.
Vaccinated participants were followed up over a median duration of 9 years. In all, 4,348 participants had three doses, 4,980 had two doses (at 0 and 6 months), and 4,949 had a single dose. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Participants were invited to an annual cervical cancer screening once they reached age 25 years and were married.
A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and HPV 18, the genotypes responsible for nearly 70% of cervical cancers, compared with that provided by two or three doses. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% (95% confidence interval [CI], 85.0-99.9) in the single-dose default cohort (2,135 women assessed), 93.1% (95% CI, 77.3-99.8) in the two-dose cohort (1,452 women assessed), and 93.3% (95% CI, 77.5-99.7) in three-dose recipients (1,460 women assessed).
Dr. Canlorbe reported no relevant financial relationships regarding the content of this article.
This article was translated from the Medscape French edition. An English version appeared on Medscape.com.
In an April press release, the Strategic Advisory Group of Experts on Immunization (SAGE) of the World Health Organization (WHO) reported the findings of their review concerning the efficacy of various dose schedules for human papillomavirus (HPV). “A single-dose HPV vaccine delivers solid protection against HPV, the virus that causes cervical cancer, that is comparable to 2-dose schedules,” according to SAGE.
This statement comes on the heels of an article published in the November 2021 issue of Lancet Oncology about a study in India. It found that a single dose of the vaccine provides protection against persistent infection from HPV 16 and 18 similar to that provided by two or three doses.
Will this new information lead French authorities to change their recommendations? What do French specialists think? At the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases (SFCPCV), Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, shared his thoughts.
With respect to the Indian study, Dr. Canlorbe pointed out that while its findings would need “to be confirmed by other studies,” they were, nonetheless,
India and France
During the congress press conference, he went on to say that, at this stage, the findings “cannot be extrapolated” to France. This is because the country’s situation is different. HPV vaccination coverage is low; estimates put it at 23.7%, placing the country 28th out of 31 in Europe.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
In addition, he drew attention to several limitations of the Indian study. Initially, the team had planned to enroll 20,000 participants. In the end, there were around 17,000, and these were allocated to three cohorts: single-dose, two-dose, and three-dose. Furthermore, the primary objective, which had initially been focused on precancerous and cancerous lesions, was revised. The new aim was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years postvaccination. In about 90% of cases, the HPV infection went away spontaneously in 2 years without inducing lesions. Finally, the participants were women in India; therefore, the results cannot necessarily be generalized to the French population.
“This information has to be confirmed. However, as far as I know, there are no new studies going on at the moment. The Indian study, on the other hand, is still in progress,” said Dr. Canlorbe.
“In France, I think that for the time being we should stick to the studies that are currently available, which have demonstrated the efficacy and safety of two or three doses,” he concluded. In support of this approach, he cited a study on the effects of the national HPV vaccination program in England; there, the vaccination coverage is 80%.
This program was associated with a 95% risk reduction for precancerous lesions and an 87% reduction in the number of cancers, confirming the good results already achieved by Sweden and Australia.
In his comments on the WHO’s stance (which differs from that of the French experts), Jean-Luc Mergui, MD, gynecologist in the department of colposcopy and hysteroscopy at Pitié-Salpêtrière, and former president of the SFCPCV, offered an eloquent comparison: “The WHO also recommends 6 months of breastfeeding as a method of contraception, but this isn’t what’s recommended in France, for the risk of getting pregnant nevertheless remains.”
Indian study highlights
Partha Basu, MD, PhD, of the International Agency for Research on Cancer (IARC) in Lyon, France, and colleagues compared vaccine efficacy of a single dose of Gardasil (HPV 9-valent vaccine, recombinant) to that of two and three doses in protecting against persistent HPV 16 and HPV 18 infection at 10 years postvaccination.
According to the protocol, the plan was to recruit 20,000 unmarried girls, aged 10-18 years, from across India. Recruitment was initiated in September 2009. However, in response to seven unexplained deaths reported in another ongoing HPV vaccination demonstration program in the country, the Indian government issued a notification in April 2010 to stop further recruitment and HPV vaccination in all clinical trials. At this point, Dr. Basu and his team had recruited 17,729 eligible girls.
After suspension of recruitment and vaccination, their randomized trial was converted to a longitudinal, prospective, cohort study by default.
Vaccinated participants were followed up over a median duration of 9 years. In all, 4,348 participants had three doses, 4,980 had two doses (at 0 and 6 months), and 4,949 had a single dose. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Participants were invited to an annual cervical cancer screening once they reached age 25 years and were married.
A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and HPV 18, the genotypes responsible for nearly 70% of cervical cancers, compared with that provided by two or three doses. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% (95% confidence interval [CI], 85.0-99.9) in the single-dose default cohort (2,135 women assessed), 93.1% (95% CI, 77.3-99.8) in the two-dose cohort (1,452 women assessed), and 93.3% (95% CI, 77.5-99.7) in three-dose recipients (1,460 women assessed).
Dr. Canlorbe reported no relevant financial relationships regarding the content of this article.
This article was translated from the Medscape French edition. An English version appeared on Medscape.com.
Study confirms increased CVT with AstraZeneca COVID vaccine
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
Pfizer plans a vaccine to target all coronaviruses
Ask the sibling of any celebrity and they’ll tell you they don’t get anywhere near the same attention. The same is true for coronaviruses – the one that causes COVID-19 has been in the spotlight for more than 2 years now, while the others at the moment circulate in relative obscurity.
With the knowledge that any of the other coronaviruses could pose a serious future threat, Pfizer and its partner BioNTech announced plans on June 29 to develop a vaccine that will work against SARS-CoV-2 (the virus that causes COVID-19) and the entire class, or family, of related coronaviruses.
Trials in people of this “pan-coronavirus” vaccine are scheduled to start this fall, Reuters reported.
“I applaud the sentiment that is long overdue,” said Eric Topol, MD, when asked to comment. “It is crucial that we get ahead of the virus, and the best way is to develop pan-betacoronavirus vaccines that are variant-proof.”
“We had potential to get them into clinical trials many months ago, but this is the first sign it may happen,” said Dr. Topol, executive vice president of Scripps Research and editor-in-chief for Medscape, WebMD’s sister site for health care professionals.
SARS-CoV-2 is not the first troublemaker in the coronavirus family. SARS, a coronavirus that causes acute respiratory syndrome, emerged in late 2002. A decade later, officials sounded the alarm about the coronavirus behind Middle East respiratory syndrome (MERS).
The coronavirus family is large, but only seven coronavirus types can infect humans, the CDC reports. Most cause mild to moderate upper respiratory tract infections, although some people can get pneumonia or bronchiolitis.
Unless you’re a virologist, immunologist, or public health official, you may be unaware that coronaviruses are one of the causes of the common cold, for example.
A version of this article first appeared on WebMD.com.
Ask the sibling of any celebrity and they’ll tell you they don’t get anywhere near the same attention. The same is true for coronaviruses – the one that causes COVID-19 has been in the spotlight for more than 2 years now, while the others at the moment circulate in relative obscurity.
With the knowledge that any of the other coronaviruses could pose a serious future threat, Pfizer and its partner BioNTech announced plans on June 29 to develop a vaccine that will work against SARS-CoV-2 (the virus that causes COVID-19) and the entire class, or family, of related coronaviruses.
Trials in people of this “pan-coronavirus” vaccine are scheduled to start this fall, Reuters reported.
“I applaud the sentiment that is long overdue,” said Eric Topol, MD, when asked to comment. “It is crucial that we get ahead of the virus, and the best way is to develop pan-betacoronavirus vaccines that are variant-proof.”
“We had potential to get them into clinical trials many months ago, but this is the first sign it may happen,” said Dr. Topol, executive vice president of Scripps Research and editor-in-chief for Medscape, WebMD’s sister site for health care professionals.
SARS-CoV-2 is not the first troublemaker in the coronavirus family. SARS, a coronavirus that causes acute respiratory syndrome, emerged in late 2002. A decade later, officials sounded the alarm about the coronavirus behind Middle East respiratory syndrome (MERS).
The coronavirus family is large, but only seven coronavirus types can infect humans, the CDC reports. Most cause mild to moderate upper respiratory tract infections, although some people can get pneumonia or bronchiolitis.
Unless you’re a virologist, immunologist, or public health official, you may be unaware that coronaviruses are one of the causes of the common cold, for example.
A version of this article first appeared on WebMD.com.
Ask the sibling of any celebrity and they’ll tell you they don’t get anywhere near the same attention. The same is true for coronaviruses – the one that causes COVID-19 has been in the spotlight for more than 2 years now, while the others at the moment circulate in relative obscurity.
With the knowledge that any of the other coronaviruses could pose a serious future threat, Pfizer and its partner BioNTech announced plans on June 29 to develop a vaccine that will work against SARS-CoV-2 (the virus that causes COVID-19) and the entire class, or family, of related coronaviruses.
Trials in people of this “pan-coronavirus” vaccine are scheduled to start this fall, Reuters reported.
“I applaud the sentiment that is long overdue,” said Eric Topol, MD, when asked to comment. “It is crucial that we get ahead of the virus, and the best way is to develop pan-betacoronavirus vaccines that are variant-proof.”
“We had potential to get them into clinical trials many months ago, but this is the first sign it may happen,” said Dr. Topol, executive vice president of Scripps Research and editor-in-chief for Medscape, WebMD’s sister site for health care professionals.
SARS-CoV-2 is not the first troublemaker in the coronavirus family. SARS, a coronavirus that causes acute respiratory syndrome, emerged in late 2002. A decade later, officials sounded the alarm about the coronavirus behind Middle East respiratory syndrome (MERS).
The coronavirus family is large, but only seven coronavirus types can infect humans, the CDC reports. Most cause mild to moderate upper respiratory tract infections, although some people can get pneumonia or bronchiolitis.
Unless you’re a virologist, immunologist, or public health official, you may be unaware that coronaviruses are one of the causes of the common cold, for example.
A version of this article first appeared on WebMD.com.
More evidence the flu vaccine may guard against Alzheimer’s
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings – that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years – adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, of the University of Texas, Houston, said in an interview.
The new findings support earlier work by the same researchers that also suggested a protective effect of flu vaccination on dementia risk.
The latest study was published online in the Journal of Alzheimer’s Disease.
40% lower risk
Prior studies have found a lower risk of dementia of any etiology following influenza vaccination in selected populations, including veterans and patients with serious chronic health conditions.
However, the effect of influenza vaccination on AD risk in a general cohort of older U.S. adults has not been characterized.
Dr. Bukhbinder and colleagues used claims data to create a propensity-matched cohort of 935,887 influenza-vaccinated adults and a like number of unvaccinated adults aged 65 and older.
The median age of the persons in the matched sample was 73.7 years, and 57% were women. All were free of dementia during the 6-year look-back study period.
During median follow-up of 46 months, 47,889 (5.1%) flu-vaccinated adults and 79,630 (8.5%) unvaccinated adults developed AD.
The risk of AD was 40% lower in the vaccinated group (relative risk, 0.60; 95% confidence interval, 0.59-0.61). The absolute risk reduction was 0.034 (95% CI, 0.033-0.035), corresponding to a number needed to treat of 29.4.
Mechanism unclear
“Our study does not address the mechanism(s) underlying the apparent effect of influenza vaccination on Alzheimer’s risk, but we look forward to future research investigating this important question,” Dr. Bukhbinder said.
“One possible mechanism is that, by helping to prevent or mitigate infection with the flu virus and the systemic inflammation that follows such an infection, the flu vaccine helps to decrease the systemic inflammation that may have otherwise occurred,” he explained.
It’s also possible that influenza vaccination may trigger non–influenza-specific changes in the immune system that help to reduce the damage caused by AD pathology, including amyloid plaques and neurofibrillary tangles, he said.
“For example, the influenza vaccine may alter the brain’s immune cells such that they are better at clearing Alzheimer’s pathologies, an effect that has been seen in mice, or it may reprogram these immune cells to respond to Alzheimer’s pathologies in ways that are less likely to damage nearby healthy brain cells, or it may do both,” Dr. Bukhbinder noted.
Alzheimer’s expert weighs in
Heather M. Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this study “suggests that flu vaccination may be valuable for maintaining cognition and memory as we age. This is even more relevant today in the COVID-19 environment.
“It is too early to tell if getting flu vaccine, on its own, can reduce risk of Alzheimer’s. More research is needed to understand the biological mechanisms behind the results in this study,” Dr. Snyder said in an interview.
“For example, it is possible that people who are getting vaccinated also take better care of their health in other ways, and these things add up to lower risk of Alzheimer’s and other dementias,” she noted.
“It is also possible that there are issues related to unequal access and/or vaccine hesitancy and how this may influence the study population and the research results,” Dr. Snyder said.
The study had no specific funding. Dr. Bukhbinder and Dr. Snyder disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ALZHEIMER’S DISEASE
White House expands access to monkeypox vaccines
The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.
“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”
As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.
Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:
- People who have had close physical contact with someone diagnosed with monkeypox.
- People with a sexual partner diagnosed with monkeypox.
- Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.
The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”
The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.
At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.
“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”
A version of this article first appeared on Medscape.com.
The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.
“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”
As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.
Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:
- People who have had close physical contact with someone diagnosed with monkeypox.
- People with a sexual partner diagnosed with monkeypox.
- Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.
The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”
The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.
At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.
“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”
A version of this article first appeared on Medscape.com.
The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.
“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”
As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.
Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:
- People who have had close physical contact with someone diagnosed with monkeypox.
- People with a sexual partner diagnosed with monkeypox.
- Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.
The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”
The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.
At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.
“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”
A version of this article first appeared on Medscape.com.
FDA panel backs adding Omicron component to COVID boosters
A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.
The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.
In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.
New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
Double-duty vaccine
In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.
Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.
“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
Limited data
Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.
Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.
“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“
Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.
Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.
Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.
“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.
Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.
“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.
A version of this article first appeared on Medscape.com.
A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.
The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.
In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.
New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
Double-duty vaccine
In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.
Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.
“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
Limited data
Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.
Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.
“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“
Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.
Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.
Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.
“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.
Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.
“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.
A version of this article first appeared on Medscape.com.
A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.
The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.
In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.
New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
Double-duty vaccine
In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.
Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.
“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
Limited data
Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.
Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.
“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“
Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.
Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.
Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.
“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.
Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.
“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.
A version of this article first appeared on Medscape.com.
COVID subvariants could cause ‘substantial’ summer cases
As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.
Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.
“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.
Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.
As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.
“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.
Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.
“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”
At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.
“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.
So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.
He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.
“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.
“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”
A version of this article first appeared on WebMD.com.
As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.
Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.
“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.
Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.
As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.
“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.
Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.
“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”
At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.
“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.
So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.
He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.
“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.
“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”
A version of this article first appeared on WebMD.com.
As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.
Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.
“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.
Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.
As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.
“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.
Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.
“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”
At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.
“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.
So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.
He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.
“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.
“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”
A version of this article first appeared on WebMD.com.
Provider recommendation key to boosting teen HPV vaccines
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
FROM PEDIATRICS
HPV vaccination with Cervarix ‘unmasks’ cervical lesions from non-vax strains
Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.
However,
An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.
The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.
After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.
The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.
Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.
The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.
The findings were published online in The Lancet Oncology.
The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.
This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
Highlighting a need for caution
The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.
He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.
The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).
There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.
There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.
“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.
These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.
“There might be a little problem if we stop too early,” he said.
Study details
During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.
In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.
There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.
Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.
There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.
Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.
The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.
A version of this article first appeared on Medscape.com.
Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.
However,
An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.
The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.
After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.
The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.
Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.
The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.
The findings were published online in The Lancet Oncology.
The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.
This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
Highlighting a need for caution
The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.
He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.
The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).
There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.
There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.
“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.
These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.
“There might be a little problem if we stop too early,” he said.
Study details
During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.
In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.
There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.
Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.
There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.
Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.
The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.
A version of this article first appeared on Medscape.com.
Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.
However,
An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.
The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.
After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.
The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.
Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.
The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.
The findings were published online in The Lancet Oncology.
The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.
This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
Highlighting a need for caution
The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.
He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.
The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).
There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.
There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.
“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.
These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.
“There might be a little problem if we stop too early,” he said.
Study details
During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.
In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.
There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.
Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.
There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.
Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.
The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.
A version of this article first appeared on Medscape.com.
FROM THE LANCET ONCOLOGY