FDA approves new COVID shots - with same restrictions as last year

The FDA issued approvals for Pfizer and Moderna's 2026 COVID-19 vaccines on Thursday, but is recommending them for the same reduced patient population as last year: all patients 65 and over as well as younger patients with at least one condition that increases COVID risk.

The new shots target the XFG variant of COVID that is currently circulating. Pfizer's Comirnaty will be available for patients ages 5 and up with at least one underlying condition, while Moderna's Spikevax starts at 6 months for that higher-risk population and mNexspike starts at age 12.

"COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the U.S. last year alone," Moderna CEO Stéphane Bancel said in a statement. "Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season."

Pfizer said it would begin shipping immediately, while Moderna said doses would be available in the coming days.

Last year the FDA stoked controversy by narrowing the recommendations for who should get the vaccine; prior to that it was recommended for nearly everyone, making it easy to obtain at doctor's offices and pharmacies. The new rules have made access more difficult, especially given that the CDC's ACIP panel that normally makes vaccine recommendations is currently in legal limbo.

Those recommendations affect what vaccines are covered by private insurance and by the Vaccines for Children programme. Last year confusion reigned and vaccine availability varied greatly depending on what state a patient lived in, with some blue states doing an end-run around the FDA and CDC to make sure vaccines remained available to all.

Moderna's Spikeva has already been approved in Europe, South Korea, Singapore, Switzerland, and the United Kingdom, while mNexSpike has been approved in Japan, according to the company. Pfizer's vaccine (developed with BioNTech) got EU approval back in July.