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FDA approves updated COVID-19 vaccines for this fall

The updated vaccines are intended to target newer variants of COVID-19 and are expected to available "in the near future."
FDA approves updated COVID-19 boosters for this fall
Posted at 2:05 PM, Sep 11, 2023

The Food and Drug Administration has approved a new formula for COVID-19 vaccines, which could start to be administered to Americans in the coming weeks. 

The updated vaccines are being made by Moderna and Pfizer/BioNTech and are intended to target more recent variants of the virus. 

Last year's bivalent COVID-19 booster is no longer authorized in the U.S., the FDA said. 

The updated mRNA vaccines are approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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.”

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The FDA said it expects the new vaccines to be available "in the near future."

While the new vaccines are authorized for the vast majority of Americans, the FDA did not make any recommendations on Monday. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Tuesday to issue formal recommendations on who should get the vaccine. 

The FDA said the new vaccine will be available to those ages 5 and up regardless of vaccination status. The FDA says those who have received a COVID-19 shot in the last two months will need to wait to get the updated vaccine.

Those previously vaccinated who are ages 6 months to 4 years will be eligible for one or two shots of the updated vaccine, depending on their prior vaccine.

Unvaccinated children ages 6 months to 4 years will be eligible for a three-shot series. 

"The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants," the FDA said. "Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine."

The FDA said it is confident the safety and effectiveness of the vaccine outweighs the risks. 

As of May 10, some eight months after the previous bivalent vaccine was released, only 17% of the U.S. population got the updated shot, the CDC said. The vaccine got its strongest response from seniors as 43% of those over age 65 got the updated shot. 

By comparison, 69.5% of Americans completed the two-shot series of one of the original COVID-19 vaccines.

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