FDA Authorizes Use of Updated COVID-19 Vaccines

Via a recent news release, the U.S. Food and Drug Administration (FDA) has announced its authorization of updated COVID-19 vaccines, aimed to help individuals avoid hospitalizations and death from currently circulating variants of the virus.

The FDA’s actions are specifically in regard to mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc. for 2023–2024, which have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

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

Here’s some of what you need to know about the updated vaccines:

• The updated vaccines are approved for use by individuals 12 years of age and older. They are also authorized under emergency use for individuals 6 months through 11 years of age.
• 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 2 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.
• Individuals who receive an updated mRNA COVID-19 vaccine could experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.

In the press release, the FDA stated its confident in the safety and effectiveness of the updated vaccines, saying that the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.

The manufacturers have publicly announced that the updated vaccines would be ready this fall. As part of the FDA’s actions, the previous bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

For more information on the updated vaccines, visit the FDA website.