FDA Places Clinical Hold on Novavax’s COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates Due to Rare Adverse Event

Clinical Hold:
The FDA has placed a clinical hold on Novavax's COVID-19-Influenza combination and stand-alone influenza vaccine candidates due to a reported case of motor neuropathy in a Phase 2 trial participant outside the U.S..

Adverse Event:
The participant received the vaccine in January 2023 and reported the serious adverse event (SAE) of motor neuropathy in September 2024.

Impact on Shares:
Novavax shares fell by approximately 16% following the announcement of the clinical hold.

Safety Priority:
Novavax emphasized that safety is their top priority and they are working closely with the FDA to provide necessary information to resolve the clinical hold and start the Phase 3 trial as soon as possible.

No Impact on COVID-19 Vaccine:
The clinical hold does not affect Novavax's COVID-19 vaccine, which is currently available on the U.S. market.

Motor Neuropathy:
Motor neuropathy is a rare, acquired immune-mediated disorder that causes muscle weakness of the arms and legs. While cases have been reported in individuals who received other COVID-19 vaccines, there is no established link to vaccination.