FDA halts Novavax's vaccine trials after safety scare
The U.S. Food and Drug Administration (FDA) has suspended Novavax's experimental combined COVID-19 and flu vaccine clinical trials. This decision followed reports of a participant's symptoms of nervous system damage, and the stock market has reacted to these reports.
3:33 PM EDT, October 16, 2024
The vaccine, expected to be groundbreaking due to its simultaneous protection against COVID and flu, may face delays. Novavax disclosed that a participant in the mid-stage clinical trial experienced symptoms of motor neuropathy last month. This condition involves damage to the nerve cells responsible for muscle control and movement. However, the company emphasizes that no certainty exists that the vaccine caused these symptoms.
"Our goal is to resolve this issue successfully and start the phase three trial as soon as possible," said Robert Walker, Chief Medical Officer of Novavax, as quoted by Reuters. The company notes that other COVID-19 and flu vaccine studies have shown no safety signals linked to motor neuropathy.
Novavax shares plummet
News of the suspension had an immediate impact on Novavax's stock prices. Following the announcement, the company's stock price dropped by about 20% to $10.13 during morning trading. Novavax assures that it is working with the FDA to resolve the issue and resume trials for both the combined vaccine and the standalone flu vaccine.
It's worth noting that the COVID-19 vaccine is Novavax's only commercial product. However, the company has struggled to gain a significant market share in a space dominated by earlier vaccine producers like Pfizer/BioNTech and Moderna.
Billions for Novavax
Despite current challenges, Novavax is not giving up on its development plans. The company signed a licensing agreement with Sanofi in May of this year worth at least $1.2 billion. This agreement provided Novavax with necessary liquidity, while granting the French pharmaceutical giant a license for co-marketing Novavax's vaccine in most countries and the opportunity to use the COVID-19 vaccine alongside its flu vaccines in developing a combined vaccine.
Novavax emphasizes that it will continue to work on resolving the current issues and aims to resume phase 3 clinical trials as quickly as possible. The company hopes that its innovative approach to combined vaccines will ultimately benefit patients and strengthen its position in the pharmaceutical market.
