FDA Freezes COVID-Flu Combo Vaccine Trial

The U.S. Food and Drug Administration has put a trial of Novavax’s COVID-influenza and its standalone flu vaccines on hold after a participant who took the combination shot reported nerve damage, the company said.

Novavax said a participant enrolled in a mid-stage study of the combination vaccine last month reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement. The person was given the vaccine in January last year.

The company in May had signed a deal worth at least $1.2 billion with Sanofi to co-sell Novavax’s vaccine in most countries and use the COVID shot along with its own flu vaccines to develop a combination shot. 

Sanofi said the clinical hold has “nothing to do with” its partnership with Novavax. Outside of the agreement, the companies can individually develop their own flu-COVID vaccines and other products, it said in an e-mailed statement.