Children's 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.
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.
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