FDA halts trial of Novavax COVID-flu combo shot
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The Food and Drug Administration halted Novavax's trial of a combination vaccine for COVID and influenza, as well as a standalone flu shot, after a participant suffered a serious adverse event, the company said on Wednesday.
Why it matters: It's the latest setback for the company creating alternatives to mRNA vaccines in the race to make combination shots that include protection against the flu.
Driving the news: The hold was prompted after a trial participant who received the combination vaccine reported suffering motor neuropathy, an immune disorder that affects the nerves controlling muscles.
- The Phase 2 trial was completed in July 2023 and the participant reported the condition last month.
- The company said it doesn't believe the condition was caused by its vaccine and noted data from previous COVID-19 and influenza trials "have shown no signals for motor neuropathy."
- Novavax's share price fell more than 18% on the news.
"Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible," said Robert Walker, the company's chief medical officer, in a statement.
- The clinical hold does not impact Novavax's COVID-19 vaccine.
The big picture: Pfizer and BioNTech's effort to develop a combo vaccine shot hit its own setback when it failed to meet one of its primary endpoints in a Phase 3 trial, the companies reported last month. The drugmakers said they are evaluating adjustments and next steps.
- Moderna has said it plans to seek approval for its COVID-flu shot before the end of the year.
