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FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

Posted 01 October 2021 | By Michael Mezher 

FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.
 
The committee will also meet on 26 October to discuss Pfizer's anticipated request to amend its EUA to allow for administration of its vaccine to children ages 5-11.
 
“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic. It’s critical that as many eligible individuals as possible get vaccinated as soon as possible. Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19. The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
 
Both the Moderna and J&J vaccines are currently being used under emergency use authorizations (EUAs), which could be amended to allow for booster doses. The meetings will be held on 14 October to discuss the Moderna vaccine, and on 15 October to discuss the J&J vaccine and to review data from the National Institutes of Health's National Institute of Allergy and Infectious Diseases on mixed booster doses following a primary series of one of the currently authorized vaccines.
 
While FDA is not beholden to the vote of its expert advisory committees, it often follows their recommendations.
 
The messaging surrounding the authorization and rollout of COVID-19 vaccine boosters has been both controversial and fraught, with international bodies such as the World Health Organization calling for wealthier nations to hold off on administering boosters until the vaccine is more widely available in less developed countries and mixed messaging from the Biden administration on when boosters would be available, and for whom.
 
While FDA granted full approval to the Pfizer vaccine for individuals 16 years of age and older in August, the vaccine is still being administered under an EUA to children ages 12-15 and to allow for third doses in a primary series to certain immunocompromised individuals. Last month, FDA expanded the EUA to allow for a booster dose for older individuals and certain high-risk groups after its VRBPAC committee voted 16-2 against the use of boosters for the general population.
 
Pfizer's bid to expand the use of its vaccine to children ages 5-11 comes after the company announced positive topline results from a Phase 2/3 trial that found antibody responses of children given two 10 µg doses of the vaccine were comparable to the full 30 µg doses given to 16-25 year old participants in a previous trial. The company said the lower dose was selected for safety, tolerability, and immunogenicity in the selected age group.
 
Last week, the company said it had submitted initial data from the trial to FDA ahead of a formal request to expand its EUA.
 
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Janet Woodcock.
 
FDA

 

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