FDA ends emergency COVID authorisations, issues narrow approvals

In a post on X, HHS Secretary Robert F Kennedy Jr announced the end of emergency use authorisations for COVID-19 vaccines, while sharing that Moderna and Pfizer's updated 2025 shots are now approved - but only for patients over 65 or at higher risk because of another condition.

"The emergency use authorisations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," Kennedy wrote. "FDA has now issued marketing authorisation for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors."

The Novavax approval - with its restrictions - was announced back in May. Pfizer and Moderna confirmed the approval of their new formulations, which target the LP.8.1 variant of the virus, in press releases, saying the shots would be available soon. 

"Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalisations last year," Stéphane Bancel, chief executive officer of Moderna, said in a statement. "We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season."

The Moderna approval covers both Spikevax and mNEXSPIKE for individuals from six months of age through 64 years if they have an underlying condition, and for all adults 65 and over.

Notably, the Pfizer approval covers those with an underlying condition starting at age five. Under the emergency use authorisation, the shot was routinely given to children six months and up, so this narrow approval is likely to result in fewer available shots for young children.

Consistent with policy announced back in May, the shots are also not approved by default for pregnant women.

While Kennedy avowed that shots would be available to "all patients who choose them", the reality is that the narrow FDA approval, combined with similarly narrow recommendations likely forthcoming from the Secretary's reconstituted Advisory Committee on Immunisation Practices (ACIP), will likely result in limited availability for patients who will have to schedule a doctor's visit to get the shot, rather than having access at their pharmacy, and whose insurance may not pay for the shot without the ACIP recommendation.

In his social media post, Kennedy said these actions were in fulfilment of four promises he made: to end COVID mandates, to keep vaccines available to people who want them, to demand placebo-controlled trials from companies, and to end the COVID emergency. 

It's worth noting, however, that Kennedy also promised to "do nothing […] that makes it difficult or discourages people from taking vaccines" at two Senate confirmation hearings before taking on his current role.