FDA/CDC

FDA authorizes updated COVID boosters to target newest variants


 

The Food and Drug Administration today 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.

The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically 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 Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention 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. A version of this article first appeared on WebMD.com.

Recommended Reading

Regular physical activity may fight infection, illness from COVID: Study
MDedge Infectious Disease
Children and COVID: New cases fall again, ED rates rebound for some
MDedge Infectious Disease
Pfizer seeks approval for updated COVID booster
MDedge Infectious Disease
Metformin fails as early COVID-19 treatment but shows potential
MDedge Infectious Disease
COVID to blame as U.S. life expectancy falls
MDedge Infectious Disease
COVID-19 vaccine safe in patients with heart failure
MDedge Infectious Disease
Paxlovid reduces risk of COVID death by 79% in older adults
MDedge Infectious Disease
Autoimmune disease patients’ waxing, waning response to COVID vaccination studied in-depth
MDedge Infectious Disease
How do you live with COVID? One doctor’s personal experience
MDedge Infectious Disease
Children and COVID: New cases increase; hospital admissions could follow
MDedge Infectious Disease