Updated COVID mRNA Vaccines Get FDA Approval: Here's What To Know
The U.S. Food and Drug Administration (FDA) has approved the use of two updated COVID-19 mRNA vaccines, targeting the currently circulating virus strains, amid rising cases this summer.
The updated COVID shots from Pfizer-BioNTech and Moderna target the current KP.2 strain of SARS-CoV-2, a descendant of the highly contagious Omicron subvariant JN.1. The jabs will be available to consumers within a week.
"Vaccination continues to be the cornerstone of COVID-19 prevention. These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given the 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," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.
Who is eligible for the vaccine?
Unvaccinated individuals aged 6 months to 4 years can receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the Moderna vaccine. Previously vaccinated individuals in the same age group may receive one or two doses of the updated vaccine based on their vaccination history.
For children aged 5 to 11, the FDA recommends getting a single dose of the updated Moderna or Pfizer-BioNTech vaccine regardless of their vaccination status. However, if previously vaccinated against COVID-19, the updated vaccine must be administered at least 2 months after the last shot. Those aged 12 and older can receive a single dose of the updated Comirnaty or Spikevax vaccine. If they are previously vaccinated, the shot may be given at least 2 months after the last shot.
Additional doses are available for certain immunocompromised individuals aged 6 months to 11 years, as detailed in the vaccine fact sheets of both Moderna and Pfizer.
What to expect?
According to the U.S. Centers for Disease Control and Prevention (CDC), KP.3.1.1 is the predominant SARS-CoV-2 variant among the currently co-circulating JN.1-derived variants in the United States, expected to account for between 31% and 43% of cases by Aug. 17.
"The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants," the FDA stated. It anticipates that the updated mRNA COVID-19 vaccines might have similar side effects to those seen with previous mRNA vaccines, as outlined in the prescribing information or fact sheets.