FDA authorizes COVID-19 variant booster shots

The U.S. Federal Food and Drug Administration (FDA) has amended its emergency use authorizations (EUAs) to include updated booster shots targeting the BA.4 and BA.5 COVID-19 subvariants.

The FDA specifically updated the EUAs of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for bivalent formulations of the vaccines for a single booster dose at least two months following a primary or booster vaccination. The Moderna booster is authorized for individuals 18 years and older, while the Pfizer-BioNTech booster is authorized for individuals 12 and older. 

The FDA’s authorization was expected this week as the Omicron subvariants of the virus have continued to spread across the U.S. According to the Centers for Disease Control and Prevention (CDC), the U.S. is currently reporting more than 82,000 daily new cases of COVID-19 and 387 new deaths daily. 

"The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert M. Califf, MD, said in a statement. “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.”

The new authorization also comes as Moderna has launched lawsuits against PFizer and BioNTech for allegedly infringing on its mRNA patents for their COVID-19 vaccine. Though, notably, Moderna is not seeking for cessation of the sale of the Pfizer-BioNTech vaccines. By more specifically targeting COVID-19 variants, which may be more contagious, through boosters, scientists hope to better protect individuals.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

The new booster shots could become available to the public as soon as next week.

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