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FDA Puts Novavax Flu Vaccine Trials on Hold

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

Brief:

  • Shares in Novavax fell by as much as one-fifth Wednesday morning after the company disclosed the Food and Drug Administration halted clinical testing of its combination vaccine for COVID-19 and influenza as well as of its standalone flu shots, according to a securities filing.
  • The FDA’s hold, which Novavax was informed of Friday, responds to a report last month of a serious adverse event of motor neuropathy in a participant in the company’s Phase 2 trial of the combination vaccine. The participant, who enrolled in the trial outside of the U.S., received the shot in January 2023.
  • Novavax expects an official letter from the FDA within 30 days. In the filing, the company said the hold could impact the timing of when it starts a planned Phase 3 trial of the combination and standalone flu vaccines.

Dive Insight:

Novavax was late to enter the COVID market, gaining emergency clearance in 2022 as the fourth coronavirus vaccine on the U.S. market.

The company claimed differentiation from Pfizer’s and Moderna’s mRNA vaccines as its shot was built on more traditional protein technology. Novavax also pitched its shot’s safety and ease of distribution.

But the vaccine never really caught on and slow sales forced Novavax to adjust its business plans. It laid off staff and cut spending, but still was targeted by an activist investor.

Since then, the company has banked its future on the development of combination vaccines and, earlier this year, a deal with Sanofi. The French pharmaceutical company paid $500 million upfront for rights to co-market Novavax’s COVID vaccine, and to develop combination vaccines that incorporated Sanofi’s influenza shots.

Novavax retained rights to develop its own combo vaccine, but those plans have now hit a roadblock. Previously, the company had anticipated starting a Phase 3 immunogenicity trial this quarter, which it expected would lead to data by mid-2025. Both timelines are in question if the hold continues for long.

With the stock drop Wednesday, Novavax is now worth less than $2 billion.