FDA revises dates to review Pfizer/BioNTech, Moderna EUAs for COVID-19 shots
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The U.S. Food and Drug Administration (FDA) announced Monday its revised dates for the upcoming AdCom meetings to discuss the use of Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) COVID-19 vaccine in younger Americans.
Accordingly, the FDAâs Vaccines and Related Biological Products Advisory Committee (VRBPAC) is expected to meet on June 14 to review the Emergency Use Authorizations (EUA) filed by Moderna (MRNA) for its vaccine targeting those aged 6 years through 17 years.

On June 15, the group of independent experts is expected to review the EUA request made by Pfizer (PFE)/BioNTech (BNTX) for the use of its vaccine in children aged 6 months to 5 years.
The announcement followed the topline data shared by the companies for a three-dose regimen of their COVID-19 vaccine from a Phase 2/3 trial for the age group.

In April, the FDA scheduled the VRBPAC meetings for June 8, 21, and 22, subject to the submission of complete datasets by the developers.