Breaking News: FDA Puts Hold on Novavax’s Covid-Flu Vaccine Application
In a surprising move, the Food and Drug Administration (FDA) has put a hold on Novavax’s application for a combination shot targeting Covid-19 and influenza, as well as a stand-alone flu vaccine. This decision has sent the biotech company’s shares plummeting nearly 20% in a single day.
A Single Report of Nerve Damage Sparks Concern
The FDA’s clinical hold is a result of a single report of nerve damage in a patient who received the combination shot in a phase two trial that concluded in July last year. While it’s unclear whether this pause will impact Novavax’s ability to start and release data on phase three trials, it’s undoubtedly a setback for the company.
Novavax Scrambles to Resolve the Issue
Novavax is working closely with the FDA to resolve the clinical hold on its combination shot and stand-alone flu vaccine. The company claims that other trials of its Covid and flu shots have not shown any safety concerns related to the type of nerve damage reported in the patient. However, Novavax acknowledges that it needs to provide more information to the FDA to establish a clear connection between the vaccine and the reported nerve damage.
A Valuable Alternative to mRNA Shots
Public health officials see Novavax’s protein-based Covid vaccine as a valuable alternative for people who don’t want to take mRNA shots from Pfizer and Moderna. Novavax’s shot uses a decades-old method of protein-based technology, similar to routine vaccinations against hepatitis B and shingles.
What’s Next for Novavax?
Novavax’s chief medical officer, Dr. Robert Walker, stated that the company’s goal is to successfully resolve this matter and start its Phase 3 trial as soon as possible. As the biotech company navigates this setback, investors and healthcare professionals alike will be watching closely to see how this development unfolds.
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