New mRNA Vaccines for 2024-2025 Season Authorized as U.S. Covid Deaths Surge
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for the 2024-2025 season. Developed by ModernaTX Inc. and Pfizer Inc., these vaccines target the Omicron variant KP.2 strain, or FLiRT variants, of SARS-CoV-2, providing enhanced protection against the latest circulating virus variants. The shots should be available in the next few days. While it is still early to get the flu shot, some pharmacies are starting to offer the yearly shot, and the FDA says it is perfectly fine to get the flu vaccine and the new Covid vaccine on the same day.
With Covid cases rising to levels making this summer’s wave the largest in two years, the United States has been leading the world in Covid deaths for two months. Late in July, WHO tracking showed that U.S. Covid deaths were 1.9K and have risen to 2.3K in the 28 days leading up to August 4.
It seems instructive that the FDA has authorized the new vaccines before the start of fall. Our government seemed to believe that Covid was not that serious of a danger to the American public and public health, and a yearly vaccine would be all that was needed. The conclusion may have been premature, especially for those suffering from Long Covid after multiple infections, including children and teens.
Dr. Robert Hopkins Jr. of the National Foundation for Infectious Diseases stated that skipping your vaccine shot is a “hazardous way to go.”
FDA vaccine chief Dr. Peter Marks said, “We strongly encourage those eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The FDA’s decision follows its June guidance to vaccine manufacturers, advising them to update their formulas to focus on the JN.1 strain. However, with the virus’s continued evolution and a rise in COVID-19 cases, the agency shifted its preference to the KP.2 strain. The updated vaccines, Comirnaty and Spikevax, are now approved for individuals aged 12 and older. In contrast, the Moderna and Pfizer-BioNTech vaccines are authorized for emergency use in children aged six months to 11 years.
“Vaccination remains a key defense against COVID-19,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet our rigorous standards for safety and effectiveness.”
Critical details about the updated vaccines include:
- Children aged six months to 4 years: Unvaccinated children can receive three doses of the Pfizer-BioNTech vaccine or two doses of the Moderna vaccine. Previously vaccinated children in this age group are eligible for one or two doses, depending on their prior vaccination history.
- Children aged 5 to 11 years: Eligible for a single dose of the updated Moderna or Pfizer-BioNTech vaccines, regardless of previous vaccination, with the dose given at least two months after their last vaccine dose.
- Individuals aged 12 and older: Eligible for a single dose of the updated Comirnaty or Spikevax vaccines, administered at least two months after their last vaccine dose.
The FDA also notes that additional doses are authorized for certain immunocompromised individuals aged six months to 11 years.
The updated vaccines’ side effects are expected to be similar to those experienced with previous mRNA COVID-19 vaccines. The FDA anticipates that the composition of COVID-19 vaccines will need to be reviewed annually, similar to seasonal influenza vaccines, unless a significantly more infectious variant emerges.
The updated vaccines are produced using the same processes as previous versions administered to hundreds of millions of people in the U.S., with benefits continuing to outweigh the risks.
