FDA Authorizes Updated COVID Boosters to Target Newest Variants

Aug. 31, 2022 –The FDA on Wednesday granted emergency use authorization to Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna.

The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.

If you’ve been waiting to get a variant-specific booster shot, you may be in luck as early as next week.

The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specific designed to protect against the most recent Omicron variants, BA.4 and BA.5.

The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.

As of August 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, CDC data show.

The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.

This is a developing story. Please check back for updates.