Amid uncertainty over how the Trump administration would approach mRNA COVID-19 vaccines for the upcoming respiratory virus season, the FDA has approved updated shots from Pfizer and Moderna.
But rather than granting the broad endorsements the vaccines previously held, the administration is restricting their use in many age groups to include only people with underlying health conditions.
The new version of Pfizer and BioNTech's Comirnaty is designed to target the LP.8.1 sublineage of the SARS-CoV-2 virus, the partners said in an Aug. 27 press release. In addition, Moderna has secured new regulatory nods for the LP.8.1-tailored versions of its Spikevax and mNEXSPIKE.
For people ages 5 years through 64 years, the new Comirnaty approval mandates that recipients have at least one underlying condition that puts them at a high risk of severe outcomes from COVID. Additionally, the FDA has approved the shot's use in all individuals age 65 and older.
It's not clear what exactly constitutes as an underlying condition for a person to be eligible for a COVID shot. High-risk conditions for severe COVID include asthma, cancer, chronic kidney disease, diabetes and many others, according to the Centers for Disease Control and Prevention (CDC).
Pfizer and BioNTech said they plan to begin distributing their updated shot "immediately" in order to "ensure robust supply and rapid access" across the country.
Similar restrictions apply for Moderna's Spikevax, which is approved for use in babies as young as six months. For people under 64 years, the FDA is requiring individuals have at least one underlying condition to be eligible to receive the vaccine. The updated version of Spikevax is approved for all people 65 and older, Moderna said in a release.
As for Moderna's newer mNEXSPIKE, the vaccine is approved to be used in people as young as 12 years. Americans 64 and younger must have at least one underlying condition to be eligible.
Besides the mRNA approvals, Novavax's protein-based vaccine carries the same stipulations around underlying conditions and is approved for people 12 years and older, according to a release from the company. Anyone 65 years and older can get the vaccine.
Novavax plans to "work with our partner Sanofi to provide access to a protein-based, non-mRNA COVID-19 vaccine" this fall, CEO John Jacobs said in a statement.
Before the FDA approvals, a report in Axios pointed out that the nation’s plan for COVID boosters was extremely uncertain as cases surge in the West and schools begin to reopen.
Plus, with Robert F. Kennedy Jr. at the helm of the Department of Health and Human Services and leaders of the FDA pledging a stricter approach to COVID-19 vaccines going forward, the approvals weren't viewed as a sure thing. Suspicions about the Trump administration's plans only intensified earlier this week after several news outlets reported on Monday hat the administration may be planning to “ban” COVID-19 vaccines in the coming months.
Alongside the approvals, RFK Jr. laid out the administration's regulatory approach to COVID-19 vaccines in an Aug. 27 post on X. He said the framework delivers "science, safety and common sense" and will enable continued access for vulnerable people who want vaccines.
In addition to granting the approvals, the FDA revoked prior Emergency Use Authorizations (EUAs) for COVID-19 vaccines, Kennedy explained on X. This means that Pfizer and BioNTech’s vaccine is now only endorsed for children 5 years and older. The move is a confirmation of reporting and warnings earlier this month that Pfizer and BioNTech might lose their EUA, making it more difficult to vaccinate young children this fall.
The FDA is also requiring COVID-19 vaccine manufacturers to conduct several new trials, STAT News points out. Pfizer and BioNTech are expected to run a study of their shot in adults ages 50 to 64 years without underlying conditions, with final results due in 2027.
Editor's note: This article is being updated as more information becomes available.