The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a third dose in individuals who face a high risk of infection or developing severe COVID-19. Those groups include people at least 65 and those aged 18 to 64 with a high risk of developing severe COVID-19.
The EUA also covers individuals aged 18 to 64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”
According to Acting Commissioner Dr. Janet Woodcock, the EUA will apply to “health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others.”
The latter recommendation deviates somewhat from those presented at the most recent Vaccines and Related Biological Products Advisory Committee (VRBAC) meeting, which recommended boosters to those with high occupational risk to the virus, including medical workers.
On August 23, FDA approved the primary series of the PfizerBioNTech vaccine for those 16 and older.
Two days later, the FDA submitted to amend their biologics license application to allow for a single booster dose six months after administering the second dose.
Containing 30 µg of mRNA, the booster doses will be identical to those used for the first and second injections.
Moderna has decided to use a 50-µg dose for its booster. Its first and second doses contain 100 µg of mRNA.