FDA News Release
Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
- For Immediate Release:
On May 23, the FDA revised the dates of the upcoming Vaccines and Related Biological Products Advisory Committee meetings due to new data from sponsors and expected submissions of emergency use authorization (EUA) requests. The new dates are as follows:
- June 14 will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna’s EUA request for 6 years through 17 years of age.
- June 15 will be the new meeting date for the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
Today, the U.S. Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
It is important to note that the dates below are tentative as none of the submissions are complete. The agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly and anticipates convening the following VRBPAC meetings:
- On June 7, FDA intends to convene VRBPAC to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.
- On June 8, 21 and 22, the FDA has held dates for the VRBPAC to meet to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations. As the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request.
- On June 28, the FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for Fall 2022. This meeting is a follow-up to the April 6 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to further meet public health needs.
“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research. “We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public. The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed.”
Once the meeting dates are finalized, the FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days before each meeting.
The agency is also prepared to schedule additional VRBPAC meetings as needed should additional complete EUA requests be submitted that warrant discussion with the FDA’s advisors.
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 meetings on the agency’s YouTube channel; the meetings will also be webcast from the FDA website.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs