FDA tightens use of Pfizer, Moderna and Novavax COVID-19 vaccines

The US Food and Drug Administration (FDA) has revoked its emergency COVID-19 vaccine approvals, handing out three revised mandates that mainly restrict use to those deemed ‘high risk’.

The regulator’s marketing authorisations for Pfizer/BioNTech’s Comirnaty, Moderna’s Spikevax and mNexspike, and Novavax’s Nuvaxovid were announced by Human and Health Services (HHS) Secretary Robert F Kennedy (RFK Jr) in a post on X.

Comirnaty was approved for individuals aged five to 64 who are at increased risk for severe COVID as well as for adults aged 65 and older with a supplemental Biologics License Application (sBLA).

Pfizer said it would immediately begin shipping a Comirnaty formulation that closely matches the circulating strain of the virus by targeting the SARS-CoV-2 sub-lineage LP.8.1.

Moderna’s vaccines were also approved for the LP.8.1 variant, with a wider licence for Spikevax that allows it to be used by individuals six months to 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID, as well as all adults 65 years of age and older.

The biotech company’s mNexspike vaccine received a more restrictive approval for  individuals aged 12 to 64 years at high risk for severe outcomes from COVID, and all adults aged 65 and older.

Like Pfizer, Moderna will move quickly to make its COVID vaccines available in the US and expects them to be distributed in the next few days.

Stéphane Bancel, Chief Executive Officer of Moderna, said: “Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to four million outpatient visits and nearly half of a million hospitalisations last year.

“We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season.”

Finally, Novavax‘s Nuvaxovid – commercialisation of which is being led by its partner Sanofi – was handed the same restrictive approval as mNexspike, with an sBLA for those aged 12 and older who are at high risk from the virus and then all adults aged 65 and over.

Although RFK Jr said in a post on X that “these vaccines are available for all patients who choose them after consulting with their doctors”, the approvals do not specifically cover people who are pregnant or aged under five or those without an underlying condition across the wider general population.