Novavax Stock Dips After FDA Halts Development of COVID and Flu Vaccine Options

Novavax Stock Dips After FDA Halts Development of COVID and Flu Vaccine Options

On Wednesday, shares of Novavax experienced a decline of 16% as the FDA imposed a clinical hold on its investigational combination COVID-19/influenza vaccine as well as its individual influenza vaccine following the report of a serious adverse event involving a trial participant.

According to Novavax, the standalone COVID-19 vaccine—its only product currently available in the U.S.—is unaffected by the FDA’s hold, as it competes against major players like Pfizer/BioNTech and Moderna.

In a concise press announcement, Novavax disclosed that the hold was a result of an incident involving a serious adverse event of motor neuropathy in a Phase II trial participant located outside the United States. They emphasized that the adverse event has not been directly linked to the vaccine candidates under evaluation. The Phase II study concluded in June 2023, and the company had moved forward with filing for a Phase III study before receiving the adverse event report last month. Furthermore, Novavax noted that no instances of motor neuropathy occurred throughout the Phase II trial.

“We are in close collaboration with the FDA to share the required information that will clarify this situation and help lift the clinical hold,” stated Robert Walker, Novavax’s chief medical officer. “Our objective is to resolve this issue promptly and initiate our Phase III trial as soon as feasible.”

Motor neuropathy is a rare immune-mediated disorder that leads to muscular weakness in the arms and legs. Earlier cases of this adverse event have been reported by some individuals who received various COVID-19 vaccines, including the Pfizer/BioNTech vaccine; however, there has been no established connection between the complication and vaccination.

Novavax faced challenges while bringing its COVID-19 vaccine to the market, securing an emergency use authorization significantly later than its counterparts Pfizer/BioNTech and Moderna. Nevertheless, Novavax’s vaccine presented a different alternative to mRNA technology, garnering a dedicated following among those seeking a third option during the pandemic.