Novavax shares plunge as company says FDA pauses two shots | Wilnesh News

Novavax The U.S. Food and Drug Administration said on Wednesday it had suspended applications for a combination COVID-19 and flu vaccine as well as a stand-alone flu vaccine, sending the company’s shares sharply lower.

The biotech company’s shares fell nearly 20% on Wednesday. The so-called clinical hold was due to a single report of nerve damage in a patient who received the combination shot in a phase 2 trial that ended last July.

A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend clinical studies of a proposed drug.

It’s unclear whether the pause will affect Novavax’s ability to launch and release data from Phase 3 trials of these vaccines. Still, it appears to be a setback for the biotech, which is scrambling to bring new products to market as global demand for COVID-19 vaccines plummets.

Novavax said it is working with the FDA to resolve clinical holds on its combination vaccine and standalone flu vaccine. The company said other trials of its COVID-19 and flu vaccines did not show any safety issues related to the type of nerve damage reported by patients.

Novavax said it does not believe there is a definite link between the vaccine and nerve damage in patients, but said it is working to provide more information to the FDA.

“Our goal is to successfully resolve this issue and begin our Phase 3 trial as soon as possible,” Dr. Robert Walker, Novavax’s chief medical officer, said in a press release.

Public health officials consider Novavax’s protein-based Covid vaccine a valuable alternative for people who don’t want to take the mRNA shot Pfizer and modernwhich uses a newer vaccine approach to teach cells how to make proteins that trigger an immune response against the coronavirus.

Novavax’s vaccine, meanwhile, uses protein-based technology to protect against the virus, a decades-old approach used in routine hepatitis B and shingles vaccinations.