Sanofi-Novavax deal in jeopardy as FDA halts vaccine approval

​Dr Sara Brenner, the FDA's principal deputy commissioner, has paused the approval process for Novavax's Covid-19 vaccine by requesting additional data.
Source: Novavax.
Source: Novavax.

This intervention coincides with the dismissal of Dr Peter Marks, FDA's top vaccine chief, by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and the placement of Marks's deputy on administrative leave. The FDA had an 1 April 2025 deadline to license the Novavax vaccine for individuals aged 12 and up, but this decision has now been delayed.

Novavax's vaccine, which differs from Pfizer and Moderna's mRNA products, currently holds only emergency use authorisation and relies on a public health law for liability protections.

Full approval is crucial for Novavax to proceed with a $175m partnership deal with Sanofi, set to commence in the 2025-2026 virus season. The FDA has not publicly commented on the delay, as its press office has faced cuts.


 
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