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FDA Plans to Approve Omicron-Targeting Booster Vaccines

Pfizer-BioNTech and Moderna have developed new booster shots optimized for Omicron. They could be approved as soon as Labor Day.

The Food and Drug Administration (FDA) will likely authorize new Pfizer-BioNTech and Moderna vaccine boosters, updated to combat the emerging COVID-19 variants.

Both mRNA vaccine manufacturers submitted their bivalent booster vaccine candidates to the FDA for Emergency Use Authorization (EUA). The Moderna and Pfizer-BioNTech bivalent boosters are both designed to target the Omicron BA.4/BA.5 and original wild-type COVID-19 strains.

As COVID-19 mutates, it has become more resistant to the vaccines intended to combat its earliest iteration. Additionally, the COVID-19 vaccines naturally wane over time. The highly infectious BA.5 variant is now responsible for an estimated 90% of COVID-19 cases in the United States. This has motivated Pfizer-BioNTech and Moderna to rapidly produce “new and improved” boosters; the BA.5 variant only emerged in June 2022.

Moderna’s EUA seeks approval to administer the updated booster to adults 18 years and older. Pfizer-BioNTech filed their EUA for persons 12 years and older.

Notably, the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) is not expected to convene and offer a recommendation on the EUAs. If the FDA authorizes these boosters, as the agency is expected to do, the decision will then go to the US Centers for Disease Control and Prevention (CDC).

The CDC’s Advisory Committee on Immunization Practices (ACIP) will convene on September 1 and 2, after which CDC Director Rochelle Walensky, MD, MPH, must sign off on the updated boosters.

Pfizer-BioNTech and Moderna have presented positive data of these new boosters in animal models, human studies have not been completed.

If Walensky does approve the new Omicron boosters after next week’s meeting, the shots could be rolled out within a couple days of Labor Day.