The U.S. Food and Drug Administration (FDA) announced Wednesday that the agency greenlighted the redesigned COVID-19 booster shots developed by Pfizer / BioNTech and Moderna.
Accordingly, the agency has amended emergency use authorizations (EUA) issued for the vaccine developers allowing the use of their bivalent vaccines targeting Omicron BA.4 and BA.5 subvariants as a single booster dose at least two months after the primary or booster vaccination.
While Pfizer (PFE)/BioNTech (BNTX) vaccine is indicated for those aged 12 years and above, FDA has permitted Moderna’s (MRNA) vaccine for individuals aged 18 and older.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” the head of the FDA, Dr. Robert Califf said.
The authorization comes ahead of a key meeting convened by the Centers for Disease Control and Prevention (CDC) in which an independent panel of advisors will vote on the vaccines this week before their U.S. rollout can begin.