The US Food and Drug Administration (FDA) has approved updated mRNA vaccines from Moderna and Pfizer/BioNTech that protect against Covid-19, despite a broader policy shift shunning the modality in the US.
Moderna has scored approvals for updated formulas to its Spikevax vaccine and new vaccine mNEXSPIKE, while Pfizer and BioNTech have received an updated approval for Comirnaty. The supplemental biologics licence applications (sBLA) cover changes in the vaccines that target the LP.8.1 sublineage of the SARS-CoV-2 virus.
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The LP.8.1 sublineage is currently a dominant variant of the virus and is the preferred target of vaccines for use beginning in autumn 2025, as per guidance from the FDA.
Comirnaty has been licensed for adults aged 65 and above, as well as individuals aged five to 64 years with at least one underlying condition that puts them at high risk for severe outcomes from Covid-19.
Moderna’s Spikevax has a broader range. The jab is approved for babies from as young as six months of age. Within the six-month to 64-year age range, individuals must have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19 to take the vaccine. Patients aged 65 and above are eligible.
Moderna’s mNEXSPIKE, which was only approved in the US in June 2025, is licensed for patients aged at least 12 years. Those aged 64 years and younger must have at least one underlying condition to be eligible. As with Spikevax, all those aged 65 years and older can be administered with the vaccine.
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By GlobalDataPfizer and BioNTech said they will immediately begin shipping their vaccine, with it expected to be available in pharmacies, hospitals, and clinics across the US “in the coming days”.
Moderna also said its updated vaccines “are expected to be available in the coming days”.
William Blair analysts said in a research note: “We see today’s outcome as the FDA maintaining autonomy and data-driven science decisions on vaccine approvability, important for industry integrity as a whole, regardless of any negative political sentiment.”
The FDA approvals come amid a testing time for mRNA technology in the US. US health secretary Robert F Kennedy (RFK) Jr cut $500m worth of mRNA funding earlier this month. This amounted to the termination of 22 mRNA vaccine development initiatives, impacting many big pharma companies and smaller biotechs. RFK Jr has long held a negative opinion of mRNA vaccines, maintaining that they hold more risks than benefits.
The cuts to mRNA funding are part of a wider shift in the US away from vaccines more generally, given RFK Jr’s anti-vax views. Regulatory shifts include the overhaul of a committee that licenses vaccines in the US with controversial experts, while another example is the restriction of Covid-19 booster shots to the elderly.
