Updated mRNA COVID-19 vaccines get FDA approval: Here’s what you need to know

The U.S. Food and Drug Administration (FDA) has approved the exploit of two updated mRNA COVID-19 vaccines that target currently circulating strains of the virus, as cases surged this summer.

The updated COVID-19 vaccines from Pfizer-BioNTech and Moderna target the current KP.2 strain of the SARS-CoV-2 virus, a descendant of the highly contagious JN.1 subvariant of the Omicron virus. The vaccines will be available to consumers within a week.

“Vaccination continues to be the cornerstone of preventing COVID-19. These updated vaccines meet the agency’s demanding, science-based standards for safety, efficacy, and manufacturing quality. Given the waning immunity of the population due to prior exposure to the virus and prior vaccination, we strongly encourage eligible individuals to consider receiving the updated COVID-19 vaccine to provide greater protection against the variants currently circulating,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. press release.

Who is eligible for vaccination?

Unvaccinated people 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 people in the same age group can receive one or two doses of the updated vaccine, depending on their vaccination history.

For children ages 5 to 11, the FDA recommends a single dose of the updated Moderna or Pfizer-BioNTech vaccine regardless of their vaccination status. However, if they have previously been vaccinated against COVID-19, the updated vaccine should be given at least 2 months after their last shot. People 12 years and older can receive a single dose of the updated Comirnaty or Spikevax vaccine. If they have been previously vaccinated, the shot can be given at least 2 months after their last shot.

Additional doses are available for some immunocompromised individuals aged 6 months to 11 years, according to information in the Moderna and Pfizer vaccine package inserts.

What to expect?

According to the U.S. Centers for Disease Control and Prevention (CDC), KP.3.1.1 is the dominant SARS-CoV-2 variant among the JN.1-derived variants currently co-circulating in the United States. It is expected to account for 31% to 43% of cases by August 17.

“The updated vaccines are expected to provide protection against COVID-19 caused by currently circulating variants,” the FDA said. It anticipates that the updated mRNA COVID-19 vaccines may have similar side effects to those seen with previous mRNA vaccines, as described in the prescribing information or fact sheets.