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Wednesday, June 29th, 2022

FDA to meet on authorizing COVID-19 boosters, child vaccines

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According to an announcement from the United States Food and Drug Administration (FDA) last week, two upcoming meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be held next week to address the newest COVID-19 vaccine data.

These meetings will be livestreamed on October 14 and 15, during which time members will discuss the potential use of booster doses of both the Moderna and Janssen/J&J COVID-19 vaccines for patients at least 18 years old. A separate meeting has been scheduled for October 26, at which time the committee will address the use of the Pfizer vaccine among children between 5 and 11 years old. The latter was initiated due to anticipation of a formal request from Pfizer to amend its existing emergency use authorization to allow the vaccine’s use on this age group.

“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,” Dr. Janet Woodcock, Acting FDA Commissioner, said.

At next week’s meetings, the FDA advisors will discuss and hear presentations of the available data on booster usage by those who took a different vaccine course in their original series. These will include only the three authorized or approved COVID-19 vaccines, and time will be given to the National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to address heterologous use of booster doses.

“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “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.”

These will be open hearings, and accordingly, background materials for the VRBPAC meetings will be made available to the public before each meeting. During them, the public will be able to comment.