In a significant move to bolster public health, the U.S. Food and Drug Administration (FDA) announced the approval and emergency use authorization of updated mRNA COVID-19 vaccines for the 2024-2025 season. These vaccines, developed by ModernaTX Inc. and Pfizer Inc., are designed to more effectively target the Omicron KP.2 variant of SARS-CoV-2, a strain currently responsible for a significant portion of COVID-19 cases.
A Tailored Response to an Evolving Threat
The FDA’s decision to update the mRNA vaccines comes after extensive research and monitoring of the virus’s evolution. In June, the FDA advised vaccine manufacturers to focus on a monovalent formula, specifically targeting the JN.1 lineage. However, with the rapid rise in cases linked to the KP.2 strain, the agency adjusted its recommendation to focus on this more prevalent variant.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” emphasized Dr. Peter Marks, 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 from previous exposure and vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
Who Can Get the Updated Vaccines?
The updated vaccines, branded as Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna), cater to a wide age range:
- For Children 6 Months to 4 Years: Unvaccinated children are eligible for three doses of the Pfizer-BioNTech vaccine or two doses of the Moderna vaccine. If already vaccinated, these children may receive one or two additional doses, depending on their prior vaccination history.
- For Children 5 to 11 Years: Regardless of vaccination status, children in this age group can receive a single dose of either the Moderna or Pfizer-BioNTech vaccine. Previously vaccinated children must wait at least two months since their last dose.
- For Individuals 12 Years and Older: This group can receive a single dose of the updated Comirnaty or Spikevax vaccine, with a minimum two-month gap since their last COVID-19 vaccine.
- For Immunocompromised Individuals: Additional doses are available for certain immunocompromised children aged 6 months to 11 years, as outlined in the fact sheets provided with the vaccines.
The FDA assures the public that side effects from the updated vaccines are expected to be similar to those experienced with previous mRNA vaccines. These include mild reactions such as soreness at the injection site, fatigue, and low-grade fever.
Looking Ahead: Annual Assessments and Beyond
As the FDA continues to monitor the evolution of SARS-CoV-2, there is an expectation that the composition of COVID-19 vaccines will need to be reviewed annually, much like the process for seasonal influenza vaccines. However, unless a more infectious variant emerges, the current vaccines are anticipated to provide robust protection against the variants currently circulating.
