2024-10-18 17:17:00
The trial of Novavax’s combined anti-Covid and influenza vaccine ends up on standby. The company itself announced this, explaining that the US Food and Drug Administration (Fda) has decided to place a ‘clinical suspension’ on its application for the combined Covid-flu vaccine candidate and for the single flu vaccine candidate.
The regulatory body decision (act that is issued to delay or suspend a proposed clinical trial on a drug) is due, Novavax informed, to a spontaneous report of a serious adverse eventa motor neuropathy, in a single participant in the phase 2 trial of the combined vaccine, outside the United States. The person had received the vaccine in January 2023. The trial ended in July and the participant reported the adverse event in September.
“We are working closely with the FDA to provide the necessary information that will allow us to better understand this observation and resolve the clinical suspension,” assured Robert Walker, Chief Medical Officer of Novavax. “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to comply with the FDA’s requests.” Our goal is to resolve” and “start our phase 3 study as soon as possible.” The company also states that data from previous Novavax studies on Covid and influenza showed no signs of motor neuropathy.
In the meantime, the news of the suspension, as reported by the international media, caused the company’s shares to collapse on Wednesday, which fell by almost 20% that day, we read on ‘CNBC’. All while the company’s anti-Covid vaccine isn’t taking off, it’s also seeing a drop in demand around the world.
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