New mRNA vaccines approved for 2024-2025 season as Covid deaths soar in US
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. These vaccines, developed by ModernaTX Inc. and Pfizer Inc., target the KP.2 omicron variant strain, or FLiRT variants, of SARS-CoV-2 and offer enhanced protection against the latest circulating virus variants. The shots should be available in the next few days. Although it’s still early for the flu shot, some pharmacies are starting to offer the annual shot, and the FDA says it’s perfectly fine to get the flu shot and the new Covid vaccine on the same day.
As the number of Covid cases has risen this summer to levels that represent the largest wave in two years, the United States has led the world in Covid deaths for two months. At the end of July, the WHO record showed that the number of Covid deaths in the United States was 1.9 thousand, rising to 2.3 thousand in the 28 days leading up to August 4.
It seems telling that the FDA approved the new vaccines before the start of fall. Our government seemed to believe that Covid did not pose such a great threat to the American people and public health and that annual vaccination was all that was needed. This conclusion may have been premature, especially for those suffering from Long Covid after multiple infections, including children and adolescents.
Dr. Robert Hopkins Jr. of the National Foundation for Infectious Diseases said it would be “dangerous” to forgo vaccination.
FDA vaccine chief Dr. Peter Marks said, “We strongly recommend that everyone who is eligible get vaccinated with a current COVID-19 vaccine to have better protection against the variants currently circulating.”
The FDA’s decision follows its June recommendation to vaccine makers to update their formulas and focus on the JN.1 strain. However, given the virus’s continued evolution and the rising number of COVID-19 cases, the agency shifted its preference to the KP.2 strain. The updated Comirnaty and Spikevax vaccines are now authorized for people ages 12 and older. In contrast, Moderna and Pfizer-BioNTech’s vaccines are authorized for emergency use in children ages six months to 11 years.
“Vaccination remains an important 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.”
Important details about the updated vaccines include:
- Children aged six months to four 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 vaccination history.
- Children aged 5 to 11 years: Eligibility for a single dose of the updated Moderna or Pfizer-BioNTech vaccines, regardless of previous vaccination, provided that the dose is administered at least two months after the last dose of vaccine.
- Persons aged 12 and over: Entitlement to a single dose of the updated Comirnaty or Spikevax vaccines, administered at least two months after the last dose of vaccine.
The FDA also notes that additional doses are authorized for certain immunocompromised individuals between the ages of six months and 11 years.
The side effects of the updated vaccines are likely to be similar to those of previous mRNA vaccines against COVID-19. The FDA expects that the composition of COVID-19 vaccines will need to be reviewed annually, similar to seasonal flu vaccines, unless a significantly more contagious variant emerges.
The updated vaccines are manufactured using the same processes as previous versions that have already been administered to hundreds of millions of people in the United States, and the benefits continue to outweigh the risks.
