Novavax Stock Surges
Novavax Stock Surges has lifted its clinical hold on Novavax’s late-stage trial for its COVID-19 and influenza combination vaccine, as well as its standalone flu vaccine. Novavax (NASDAQ: NVAX) announced the news on Monday, resulting in a 13% increase in the company’s stock in premarket trading.
Initial Hold Due to Participant’s Health Concern
Last month, Novavax paused the trial after a participant who received the combination vaccine reported symptoms resembling motor neuropathy, a condition affecting the nerves that control muscle movement. Novavax later provided additional data to the FDA, indicating that the participant’s symptoms were likely due to amyotrophic lateral sclerosis (ALS), a neurological disorder impacting nerve cells in the brain and spinal cord.
No Link Found Between Vaccine and Symptoms
Novavax emphasized that assessments showed no connection between the reported symptoms and its vaccine. “We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package,” said Robert Walker, Chief Medical Officer of Novavax.
The information we provided supported our assessment that the serious adverse event was not related to our vaccine. We plan to begin our Phase 3 trial as soon as possible.
Impact of FDA’s Hold on Novavax Shares
A clinical hold is an FDA measure that instructs a drug manufacturer to delay or stop a planned clinical study. Last month’s hold triggered a noticeable drop in Novavax’s stock, though the company remained firm in its belief that there was no confirmed link between its vaccine and the patient’s symptoms.
Novavax’s Vaccine Approach as a Key Alternative
Public health officials see Novavax’s protein-based COVID-19 vaccine as a valuable option for individuals hesitant to receive mRNA vaccines like those from Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA). Unlike mRNA vaccines, which use cell-based protein production to trigger an immune response, Novavax relies on protein-based technology, a time-tested method previously used for vaccines against diseases such as hepatitis B and shingles.
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