FDA halts Novavax trial, shares nosedive amid safety concerns
The U.S. Food and Drug Administration (FDA) has suspended Novavax's experimental combined COVID-19 and flu vaccine clinical trials. This decision followed a report from a study participant who exhibited symptoms of nervous system damage. The stock market has reacted to these developments.
The vaccine, anticipated to be groundbreaking for its dual protection against COVID-19 and the flu, may face delays. Novavax reported that last month, a participant in the mid-stage clinical trial experienced symptoms of motor neuropathy. This is a condition in which the nerve cells responsible for muscle control and movement become damaged. However, the company emphasizes that there is no certainty the vaccine caused these symptoms.
"Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible," said Robert Walker, Chief Medical Officer of Novavax, as quoted by Reuters. The company notes that studies from other vaccines on COVID-19 and the flu have shown no safety signals linked to motor neuropathy.
Novavax shares plummet
The suspension of the vaccine's clinical trials immediately impacted Novavax's stock prices. In response to the news, the company's stock price fell by about 20% to $10.13 (CAD 13.96) during morning trading. Novavax assures that it is collaborating with the FDA to resolve the issue and resume trials on both the combined vaccine and the standalone flu vaccine.
It's important to note that the COVID-19 vaccine is Novavax's only commercial product. However, the company has yet to secure a significant market share in a space dominated by earlier vaccine producers like Pfizer/BioNTech and Moderna.
Billions for Novavax
Despite current challenges, Novavax remains committed to its development plans. In May this year, the company signed a licensing agreement with Sanofi valued at at least $1.2 billion (CAD 1.65 billion). This agreement provided Novavax with essential liquidity while granting the French pharmaceutical giant a license for co-marketing Novavax's vaccine in most countries and allowing the use of the COVID-19 vaccine alongside its own flu vaccines to develop a combined vaccine.
Novavax underscores that it will continue working to resolve the current issues and aims to resume phase 3 clinical trials as soon as possible. The company hopes that its innovative approach to combined vaccines will ultimately benefit patients and strengthen its position in the pharmaceutical market.
