Pfizer-BioNTech and Moderna’s Covid boosters to be authorized around Labor Day by FDA
Most likely, the FDA will approve the updated versions of Pfizer-BioNTech and Moderna’s Covid boosters around Labor Day.
As part of its fall booster campaign, the Biden administration is prepared to deliver the updated booster vaccines to both teens and adults.
The so-called bivalent vaccines of both Pfizer and Moderna target the BA.4 and BA.5 omicron subvariants in addition to the original coronavirus strain in a single dose. According to data from the Centers for Disease Control and Prevention, BA.5 causes over 90% of all new cases of Covid in the United States.
Moderna is seeking authorization for all adults, while Pfizer is seeking authorization for those aged 12 and older.
The FDA does not plan to meet with its advisory committee, the Vaccines and Related Biological Products Advisory Committee, before the authorization.
The FDA’s approval will not be the last stage before the distribution of the vaccines. The CDC must also give its approval; the agency will convene its advisory committee, the Advisory Committee on Immunization Practices, on September 1 and 2 to discuss COVID boosters.
Dr. Rochelle Walensky, director of the CDC, might approve the updated boosters immediately after the two-day meeting. One person said that vaccinations with the new shots might begin as early as the day following the national holiday.
However, this plan is not official and might change.
The federal government thinks that by adapting vaccinations to better match circulating strains, the efficiency of the doses would be enhanced and maybe immunity would remain longer.
Both Pfizer and Moderna submitted information about the efficacy of the BA.4/BA.5 booster shot in animal research. However, human studies have not yet been conducted.
Some independent experts disagree with the decision to move forward without full data from studies on humans. They say that the new shots have not shown that they are better than the Pfizer and Moderna vaccines that are already authorized.
Other experts have acknowledged Pfizer and Moderna’s exceptional pace in developing the new boosters. The spread of BA.5 throughout the United States didn’t start until early June.