FDA Puts a Pause on Novavax's Combined COVID and Influenza Vaccine

FDA Puts a Pause on Novavax’s Combined COVID and Influenza Vaccine

The FDA has implemented a clinical hold on the investigational new drug (IND) application for Novavax’s combination vaccine targeting COVID-19 and influenza, in addition to a separate standalone influenza vaccine candidate. This hold, however, does not impact the independent COVID-19 vaccine.

This regulatory action stems from a reported serious adverse event involving a participant located outside the U.S., who was involved in a phase 2 trial for the combination vaccine that concluded in July 2023.

The individual who received the vaccine in January 2023 began experiencing symptoms of motor neuropathy in September of this year. This incident prompted the FDA to pause the vaccine’s development to determine if there might be a connection between the reported adverse event and the vaccine candidate.

Robert Walker, Novavax’s Chief Scientific Officer, expressed that the company has no evidence to suggest that the vaccine caused the adverse event. Previously run clinical trials assessing the combination COVID-19 and influenza vaccine did not reveal any other cases of motor neuropathy.

“We are collaborating closely with the FDA to provide essential information that could clarify this observation and aid in lifting the clinical hold,” commented Walker. “It’s critical to emphasize that safety remains our highest priority, and despite not establishing a causal link, we are dedicated to swiftly addressing further information requests from the FDA. Our objective is to resolve this situation promptly and to initiate our phase 3 trial at the earliest opportunity.”

The outcomes from the completed phase 2 trial of both the combination vaccine and the standalone influenza vaccine have been encouraging. Notably, the response elicited by the influenza vaccine candidate was substantially superior compared to Novartis’ Fluad and Sanofi’s Fluzone, which are both available on the market.

Novavax intended to commence a phase 3 trial for its combination and standalone influenza vaccine later this year, but this schedule may be impacted by the FDA’s clinical hold.

This development arrives amid the company’s strategy to slash annual expenditures and research and development costs by over 50%, which includes two rounds of layoffs that reduced its global workforce by around 30% at the start of the year.