Novavax on Wednesday stated the Meals and Drug Administration has put a maintain on its software for a mixture shot focusing on Covid and influenza and a standalone flu vaccine, sending the corporate’s shares down sharply. 

The biotech firm’s inventory fell almost 20% on Wednesday. The so-called medical maintain is because of a single report of nerve harm in a affected person who obtained the mix shot in a section two trial that completed in July final 12 months. 

A medical maintain is an order issued by the FDA to a producer to delay or droop a proposed medical investigation on a drug.

It’s unclear if the pause will influence Novavax’s capacity to begin and launch information on section three trials on these vaccines. Nonetheless, it seems to be a setback for the biotech firm, which is scrambling to deliver new merchandise to market as demand for its Covid vaccine plummets worldwide.

Novavax stated it was working with the FDA to resolve the medical maintain on its mixture shot and standalone flu vaccine. The corporate stated different trials of its Covid and flu pictures had not proven any security issues associated to the kind of nerve harm reported within the affected person. 

Novavax stated it doesn’t consider there’s a longtime connection that the vaccine had precipitated the nerve harm within the affected person however stated it’s working to offer extra info to the FDA. 

“Our objective is to efficiently resolve this matter and to begin our Section 3 trial as quickly as doable,” Dr. Robert Walker, Novavax’s chief medical officer, stated in a launch. 

Public well being officers see Novavax’s protein-based Covid vaccine as a precious various for individuals who do not need to take mRNA pictures from Pfizer and Moderna, which use a more recent vaccine methodology to show cells how you can make proteins that set off an immune response in opposition to Covid.

Novavax’s shot, in the meantime, fends off the virus with protein-based know-how, a decades-old methodology utilized in routine vaccinations in opposition to hepatitis B and shingles.