Breaking News: FDA Puts Hold on Novavax’s Combination Shot
A recent setback for Novavax has sent shockwaves through the biotech industry. The Food and Drug Administration (FDA) has placed a hold on Novavax’s application for a combination shot targeting both Covid and influenza, as well as a stand-alone flu vaccine. This decision has caused Novavax’s stock to plummet nearly 20%.
The FDA’s action was prompted by a single report of nerve damage in a patient who had received the combination shot in a phase two trial that concluded last year. This clinical hold is a serious step taken by the FDA to delay or suspend a proposed clinical investigation on a drug.
While Novavax is currently working with the FDA to address this issue, the company is facing uncertainty about the impact this hold will have on its phase three trials for these vaccines. Despite this setback, Novavax remains committed to resolving the clinical hold and moving forward with its research and development efforts.
Novavax’s protein-based Covid vaccine has been seen as a valuable alternative for individuals who are hesitant to receive mRNA vaccines from Pfizer and Moderna. Unlike these newer vaccine technologies, Novavax’s shot utilizes protein-based technology, which has been used for decades in routine vaccinations against diseases like hepatitis B and shingles.
As experts in the biotech industry, we at Extreme Investor Network are closely monitoring this situation and will provide updates as they become available. Stay tuned for more insights and analysis on this developing story.