FDA authorizes Moderna, Pfizer-BioNTech Omicron booster shots

“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,” FDA Commissioner Robert Califf mentioned in a press release.

The up to date emergency use authorization means the unique formulations of the Moderna and Pfizer-BioNTech vaccines are now not licensed as booster doses for anybody 12 and older, the FDA mentioned.

Pfizer mentioned in a press release Wednesday that it plans to withdraw its supplemental biologics license utility for its unique vaccine as a booster dose for folks 16 and older and can refile for the bivalent choice. The unique vaccine will stay out there as a booster dose for teenagers ages 5-11.

Both booster shots comprise messenger RNA that codes for the spike protein of the unique SARS-CoV-2 variant, in addition to the spike protein of the Omicron variant’s BA.4 and BA.5 subvariants, that are circulating now. The boosters might be out there just for individuals who have acquired no less than a full major vaccination collection, according to a federal planning guide. The similar planning steering mentioned it expects bivalent boosters for youngsters 11 and youthful to be licensed “within a short time.”

Data dilemma: The FDA primarily based the boosters’ authorization on real-world information for present mRNA vaccines, human trial information from different bivalent shots licensed in different components of the world and information from rodent research. Some public well being specialists have argued that it’s too quickly to green-light vaccines with out security and efficacy information for folks, although the annual flu vaccine is permitted utilizing information from animal testing due to the short turnaround time wanted yearly. The flu vaccine will not be primarily based on the newer mRNA expertise nevertheless.

What’s subsequent: The Biden administration has ordered 175 million doses of the brand new boosters. Pfizer has mentioned it may well ship as much as 15 million doses of its booster by Sept. 9.

Pfizer mentioned Wednesday it plans to use for an emergency use authorization for its bivalent booster for use in children ages 5-11 in early October, and that it’s working with the FDA to organize an utility for the shot to additionally cowl infants and toddlers.