FDA approves COVID-19 vaccines for the 2024-2025 season

The U.S. Food and Drug Administration today approved new COVID-19 vaccines for adults and children for the 2024-2025 season.

The FDA approved the Comirnaty vaccine, a vaccine for adults, for BioNTech.

The agency gave approval for the Pfizer-BioNTech vaccine, a vaccine for children ages 6 months through 11 years, jointly to Pfizer and BioNTech.

“This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals and clinics across the U.S. beginning in the coming days, Pfizer said.

The FDA also gave Moderna approval for its Spikevax COVID vaccine for adults and a COVID vaccine formula for children ages 6 months through 11 months.

“Moderna’s updated vaccine is expected to be available in the coming days,” the company said.

Related: Novavax strikes $1.2B deal with Sanofi to develop COVID-flu combo vaccine

Information about pricing was not immediately available.

Pfizer generated about $12.5 billion from the sale of COVID vaccines and other COVID products in 2023, and Moderna reported $6.7 billion in 2023 COVID vaccine sales.

Fully funded employer health plans and self-insured employer-sponsored health plans that are not exempt from Affordable Care Act preventive services benefits through grandfathering must cover the vaccinations free from cost-sharing for the patients.

The process: The FDA actually allowed the use of the vaccines through a two-step process: It provided official approval for use of the vaccines, and it granted the vaccines emergency use authorizations.

One controversy was over which COVID-19 variant to focus on in the vaccine.

The FDA originally was going to ask vaccine makers to aim for the JN.1 lineage in the FLiRT variant family, and that’s what European health agencies have required, according to Moderna.

The FDA ended up deciding to ask vaccine makers to aim for the KP.2 offshoot of the JN.1 lineage, rather than the JN.1 lineage itself.

The backdrop: The FDA approved the vaccines as the U.S. Centers for Disease Control and Prevention’s new, limited COVID data tracker website is showing that the current COVID surge may be comparable to the long, quiet surge that hit the United States starting around July 2023 and ended only in April.

The CDC has stopped posting the comprehensive, county-by-county COVID reports it published when COVID emergency funding was available.

The health agencies that continue to report data to the CDC say about 2.4% of the emergency room visits recorded in the week ending Aug. 10 were for people who turned out to have positive COVID deaths.

About 1.9% of the people who died in the week ending Aug. 10 died from COVID.

Emergency room use by people with COVID was also about 2% for working-age people, or people ages 18 through 64.

The overall U.S. death rate is still about 5% to 10% higher than it was before the COVID pandemic started, at least in part because of the direct effects of COVID and the impact of COVID on use of routine health care and the operations of the health care system.