Updated COVID vaccines: FDA announces emergency approval and authorization

The U.S. Food and Drug Administration (FDA) announced on Monday that it has approved and authorized updated versions of mRNA COVID-19 vaccines for emergency use.

The updated vaccines, which are manufactured by Pfizer and Moderna, are “formulated to more closely target currently circulating variants,” particularly the Omicron variant XBB.1.5.

The vaccines have also been formulated to “provide better protection against serious consequences of COVID-19, including hospitalization and death,” according to a news release from the agency.

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Anyone 5 years of age and older can receive a single dose of the updated vaccine as long as it is administered at least two months after their last COVID shot, the FDA stated.

Children between 6 months and 4 years of age who have previously received a COVID vaccine can get one or two doses of an updated vaccine, depending on the timing and details of their previous doses.

Unvaccinated children between 6 months and 4 years of age can receive three doses of the updated Pfizer vaccine or two doses of the updated Moderna vaccine, per the FDA.

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

“We very much encourage those who are eligible to consider getting vaccinated.”

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality,” he continued. 

“We very much encourage those who are eligible to consider getting vaccinated.”

Regarding the safety of the updated COVID vaccine, the FDA stated that “the benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood, as these vaccines have been administered to hundreds of millions of people in the United States.”

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The agency also noted that although “serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”

With Monday’s announcement, “the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States,” the FDA said.

It is expected that the updated vaccines will be available in the “near future,” the agency stated. The manufacturers have announced a timeline of this fall for availability.

The U.S. Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices plans to meet on Tuesday to discuss “clinical recommendations” for the updated vaccine, along with guidance for high-risk groups.