New COVID Vaccines Force Bivalents Out

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COVID vaccines will have a new formulation this year, according to a decision announced today by the US Food and Drug Administration that will focus efforts on circulating variants. The move pushes last year's bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older. And the new options are being developed using a similar process as previous formulations, according to the FDA.

Targeting Circulating Variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

"This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants," according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit to risk profile is well understood as they move forward with new formulations.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

Timing the Effort

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet tomorrow to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older people.

Manufacturers have publicly announced that updated vaccines will be ready this fall and the FDA says it anticipates the updated vaccines will be available soon.

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Cite this: New COVID Vaccines Force Bivalents Out - Medscape - Sep 11, 2023.

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