Important points
The Food and Drug Administration has placed Novavax’s combined COVID-19 and influenza vaccine and stand-alone influenza vaccination on clinical hold due to safety concerns. The move came after one patient who received the combination vaccine reported nerve damage. The company said it is cooperating with authorities. FDA will resolve the issue and obtain the information the company needs to proceed with its inspection.
Novavax (NVAX) stock rose Wednesday after the Food and Drug Administration (FDA) approved the biotech company’s experimental COVID-19 and influenza vaccine combination and standalone flu shot studies. The drug plunged by nearly 20% after it was discontinued following reports of nerve damage in one patient who took it. injection.
The company said the FDA had “spontaneously reported a serious adverse event (SAE) of motor neuropathy in one non-U.S. CIC Phase 2 trial participant who received the vaccine in January 2023.” The company announced that it has placed this treatment on clinical hold.
Novovax does not believe ‘causality has been established’
Dr. Robert Walker, Novavax’s chief medical officer, said the company does not believe “causality has been established,” but that “we need the information needed to better understand this finding and resolve the clinical hold.” “We are working closely with the FDA to provide this.” . Walker added that Novavax’s goal is to begin Phase 3 trials “as soon as possible.”
The company noted that its current COVID-19 vaccines are not affected by the FDA action.
Despite today’s decline, Novavax stock has more than doubled this year.
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