FDA Approves Updated mRNA COVID-19 Vaccines

On August 22, the U.S. Food and Drug Administration (FDA) approved and granted emergency use authorization for updated mRNA COVID-19 vaccines to include a single component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.

The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.

The FDA's actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines for 2024-2025 is the KP.2 strain, if feasible.

"Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants."

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

What You Need to Know

Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax. For those previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine.

Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets.

The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.