FDA halts Novavax trials after nerve damage report prompts concern
The US 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 experienced nervous system damage symptoms. The stock market has responded to these developments.
The vaccine, which was expected to be innovative due to its simultaneous action against COVID and flu, may face delays. Novavax revealed that a participant in the mid-stage clinical trial reported symptoms of motor neuropathy last month. This condition involves damage to the nerve cells responsible for muscle control and movement. However, the company stresses that it is not certain whether 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 highlights that studies of other vaccines for COVID-19 and flu have shown no safety issues related to motor neuropathy.
Novavax shares plummet
The news of the suspension of the vaccine's clinical trials had an immediate impact on Novavax's share prices. Following this announcement, the company's share price fell by about 20% to £8.16 during morning trading. Novavax assures it is working with the FDA to resolve the issue and resume trials on both the combined vaccine and the standalone flu vaccine.
It is important to note that the COVID-19 vaccine is Novavax's only commercial product. However, the company has not managed to capture a significant market share in a space dominated by earlier vaccine producers such as Pfizer/BioNTech and Moderna.
Billions for Novavax
Despite current challenges, Novavax is not abandoning its development plans. In May of this year, the company signed a licensing agreement with Sanofi worth at least £990 million. This agreement provided Novavax with necessary liquidity, while granting the French pharmaceutical giant a licence to co-market Novavax's vaccine in most countries and use the COVID-19 vaccine alongside its own flu vaccines to develop a combined vaccine.
Novavax emphasises that it will continue to work on resolving the current issues and aims to resume phase three clinical trials as soon as possible. The company hopes its innovative approach to combined vaccines will ultimately benefit patients and strengthen its position in the pharmaceutical market.
