Diving overview:
Novavax shares rose Wednesday after the company disclosed that the Food and Drug Administration had halted clinical trials of its COVID-19 combination vaccine and standalone influenza shot, according to a securities filing. It fell by up to a fifth in the morning. The FDA hold that Novavax was made aware of on Friday was in response to a report last month that participants in a Phase 2 trial of the company’s combination vaccine experienced a serious adverse event: motor neuron impairment. The participants, who enrolled in the trial outside the United States, received the vaccine in January 2023. Novavax expects to receive a formal letter from the FDA within 30 days. The company said in its filing that the hold could impact the timing of the start of planned Phase 3 trials for combination and single influenza vaccines.
Dive Insight:
Novavax was late to enter the coronavirus market, becoming the fourth coronavirus vaccine on the U.S. market to receive emergency authorization in 2022.
The company claimed that its vaccine differentiates itself from Pfizer and Moderna’s mRNA vaccines because it is built on more traditional protein technology. Novavax also touted shot safety and ease of delivery.
But the vaccine never really caught on, and weak sales forced Novavax to adjust its business plans. It laid off employees and cut spending, but it still became a target for activist investors.
Since then, the company has bet its future on developing a combination vaccine and signing a deal with Sanofi earlier this year. The French drugmaker paid $500 million upfront for the rights to co-market Novavax’s coronavirus vaccine and develop a combination vaccine that incorporates Sanofi’s flu shot.
Novavax had retained the rights to develop its own combination vaccine, but its plans have now hit a roadblock. The company previously expected to begin a Phase 3 immunogenicity study this quarter, with data available by mid-2025. If the hold lasts for an extended period of time, both schedules become questionable.
With Wednesday’s share price drop, Novavax is now worth less than $2 billion.
