The U.S. Food and Drug Administration (FDA) approved updated mRNA COVID-19 vaccines manufactured by Pfizer and Moderna which target the currently dominant Omicron variant KP.2 strain of SARS-CoV-2, the agency announced Thursday.
The new shots are recommended for all people ages 6 months and older. However, according to the FDA, the new vaccines remain under emergency use authorization (EUA) for people between ages 6 months and 11 years.
According to NBC News, the new vaccines could be available within days.
The vaccines were approved even though their clinical trial data have not been released. Manufacturers claim that “testing in animals shows the shots trigger neutralizing antibodies,” The Epoch Times reported.
According to MedPageToday, the new vaccines “are manufactured using a similar process as previous formulas of these vaccines” and “the FDA assessed manufacturing and nonclinical data” in its approval process.
NBC News quoted a Pfizer spokesperson who said the data the company submitted to the FDA indicates a “substantially improved” immune response against the currently circulating COVID-19 variants.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement, “Vaccination continues to be the cornerstone of COVID-19 prevention.”
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Marks said.
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