The Food and Drug Administration has approved a new formula for COVID-19 vaccines, which could begin being administered to Americans in the coming weeks.
The updated vaccines are being made by Moderna and Pfizer/BioNTech and are aimed at targeting the latest variants of the virus.
Last year’s bivalent COVID-19 booster is no longer authorized in the US, 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 to 11 years of age.
“Vaccination is critical to public health and provides sustained protection against the 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 meet the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. “We highly encourage those who are eligible to consider vaccination.”
The FDA said it expects new vaccines to be available “in the near future.”
While the new vaccines are authorized for most Americans, the FDA did not make any recommendations on Monday. The Centers for Disease Control and Prevention’s advisory committee on vaccination practices will meet Tuesday to issue formal recommendations on who should get the vaccine.
The FDA said the new vaccine will be available to people ages 5 and older, regardless of vaccination status. The FDA says people who have received a COVID-19 shot in the past two months will need to wait to get the updated vaccine.
People who have been previously vaccinated and are 6 months to 4 years old will be eligible for one or two shots of the updated vaccine, depending on their previous vaccination.
Unvaccinated children aged 6 months to 4 years will be eligible for the three-shot series.
“The updated vaccines are expected to provide good protection against COVID-19 from currently circulating variants,” the FDA said. “Barring the emergence of clearly more virulent variants, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.”
The FDA said it is confident that the safety and effectiveness of the vaccine outweigh the risks.
As of May 10, nearly eight months after the last bivalent vaccine was released, only 17% of the U.S. population had received the updated shot, CDC said. The vaccine received the strongest response from seniors as 43% of people above 65 years of age got the updated shot.
By comparison, 69.5% of Americans completed a two-shot series of one of the original COVID-19 vaccines.