FDA approves emergency use for updated COVID-19 vaccines

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New COVID-19 vaccines are coming.

On Sept. 11, the U.S. Food and Drug Administration (FDA) announced approval and authorization of emergency use for updated COVID-19 vaccines. The new shots will “more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death,” the FDA news release said.

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

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” Marks said. “We very much encourage those who are eligible to consider getting vaccinated.”

The federal actions involve 2023-2024 vaccines made by ModernaTX Inc. and Pfizer Inc. updated to include the monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

There was not an updated delivery scheduled, but the shots are expected this fall.

“The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA announcement 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 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Sept. 12 to discuss clinical recommendations for patients.

FDA announced the following about patient particulars:

• Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months since the last dose of any COVID-19 vaccine.
• Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
• Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
• The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.