Infectious Disease

FDA authorizes updated COVID-19 booster vaccines

August 31, 2022

2 min read

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Califf and Marks report no relevant financial disclosures.

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The FDA on Wednesday authorized bivalent COVID-19 booster vaccines from Moderna and Pfizer-BioNTech for emergency use in the United States.

The vaccines target both the original strain and omicron variant of SARS-CoV-2. The FDA said it will refer to the vaccines as “updated boosters.”

COVID vaccine draw

The FDA has authorized updated omicron-specific COVID-19 boosters from Moderna and Pfizer-BioNTech. Source: Adobe Stock.

“The FDA has extensive experience with strain changes for annual influenza vaccines,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”

Both messenger RNA vaccines combine the companies’ original vaccines with another component targeting the omicron BA.4 and BA.5 subvariants, which the FDA noted are expected to circulate this fall.

According to the latest tracking data published by the CDC, BA.4 and BA.5 account for all but 0.2% of new infections in the US

An FDA advisory committee voted in favor of adding omicron to COVID-19 booster compositions in late June.

According to the FDA, the decision to authorize the updated boosters was based on available evidence, including safety and effectiveness data for each of the monovalent mRNA vaccines, safety and immunogenicity data from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from Omicron variant BA.1 lineage, and nonclinical data collected using a bivalent COVID-19 vaccine containing an mRNA component of the original strain and an mRNA component in common between the BA.4 and BA.5 lineages of the omicron variant.

Under the updated EUA, people aged 12 years or older are eligible to receive the Pfizer-BioNTech booster and adults aged 18 years or older are eligible for the Moderna booster, as long as it has been at least 2 months since they completed their primary series or received their most recent booster shot.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes of COVID-19,” FDA Commissioner Robert M. Califf, MD, said in the release. “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 CDC’s vaccine advisory group is scheduled to meet and vote on the updated boosters on Thursday. A CDC recommendation will follow the vote.

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