Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer- BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
The U.S. Food and Drug Administration is announcing a virtual meeting
of its Vaccines
and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to
discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech
COVID-19 Vaccine for use in children 6 months through 4 years of age.
“Having a safe
and effective vaccine available for children in this age group is a priority for the agency and
we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge.
Furthermore, children are not small
adults. Because they’re still growing and developing, these vaccines must be evaluated in
well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D. "In the meantime, the best way to
protect children, including when they are at school or daycare, is to practice social distancing and masking by public health
recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose
when eligible.”
The FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for use in
children 5 through 11 years of age in October
2021 and recently authorized the use of a single booster dose in
individuals 12 through 15 years of age and older. As of Dec. 19, 2021,
according to the Centers
for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations
have been given to kids 5 through 11 years of age, which is about one-third of
the approximately 24 million U.S. kids this age in the U.S. There are
approximately 23 million children less than 5 years of age in the U.S. “The need for a safe and effective vaccine
for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable
rise in the number of
hospitalizations in young children with severe disease, and the possibility that future variants could
cause severe disease in those who are unvaccinated,”
said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “As we
have done for other COVID-19 vaccine authorizations,
this meeting will help ensure that the public has a clear understanding of the data and information
the FDA will evaluate as it considers whether
to authorize the vaccine. We are committed to a transparent process, which will include input from our external
advisors.”
The FDA intends to make background material available to the
public, including the meeting agenda and committee roster, no later than two
business days before the meeting.
In general, advisory committees include a Chair, members with
scientific, medical, and public health expertise, and a consumer and industry
representative.
The FDA intends to Livestream the VRBPAC meeting on the agency’s YouTube channel; the meeting will also be a webcast from the FDA website.
Related
Information
Vaccines
and Related Biological Products Advisory Committee