by Brenda Baletti, Ph.D., Childrens Health Defense:
Dr. Meryl Nass told The Defender there have been other recent drug trials in which participants suffered serious adverse events similar to the one reported by Novavax — yet the trials were allowed to continue, and the drugs were approved.
The U.S. Food and Drug Administration (FDA) halted Novavax’s trial of its experimental COVID-19-flu combination vaccine and its standalone flu shot after a trial participant reported nerve damage, the company said today.
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The patient received the COVID-flu shot in January 2023 during Phase 2 trials for the drug. However, Novavax said it didn’t receive the report showing the participant had developed motor neuropathy — a disease affecting the nerves that control muscles — until last month.
In response, the FDA put a clinical hold on Novavax’s COVID-flu Phase 3 trial, which was set to begin this month, and on its flu vaccine trials. The company finished its Phase 2 trial last year.
In a press release, Novavax said the data from previous COVID-19 and flu trials showed no safety signals for motor neuropathy.
The company said it did not believe there was sufficient evidence to show the neuropathy was causally linked to its vaccine. “We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold,” Novavax’s Chief Medical Officer Robert Walker said.
Novavax’s share price immediately plummeted about 20% in early trading. The company is struggling financially, FierceBiotech reported, having begun 2024 with a second round of layoffs that reduced its workforce by around 30%. Its growth plans are largely based on these two vaccines.
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