The United States Food and Drug Administration (FDA) has announced 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 novel coronavirus (COVID-19) vaccine manufacturers. FDA notes that it 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.
To read the FDA announcement and summary of its plans to hold virtual meetings of VRBPAC, use the link below.