Novavax can move forward with a trial for its combined Covid-19 and influenza vaccine after regulators lifted a clinical hold.
The Gaithersburg, Md., vaccine developer said Monday that the U.S. Food and Drug Administration had removed the clinical hold on its investigational new drug application for its combined vaccine and its standalone flu vaccine candidates.
Regulators can place clinical holds on trials if there is concern about a risk of illness or injury to study participants, as well as other issues.
Novavax shares were up 11% to $9.89 in recent trading. The stock has risen almost 86% this year.
The hold was put in place last month after a study participant who had received the combination vaccine experienced a serious adverse event. Novavax said that it provided additional information about the adverse event to the FDA, leading to the conclusion that the event was not related to the vaccine.
The company said it would be working to start a Phase 3 trial of the vaccines as soon as possible.
Novavax said the event, which was initially reported as motor neuropathy, was determined to have been amyotrophic lateral sclerosis, or ALS. ALS is not known to be immune-mediated or associated with vaccination, the company said.
Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, Sanofi will have the sole right to use Novavax's existing Covid-19 vaccine in combination with its own flu vaccine.
The company will also rake in double-digit percentage royalties on sales of the combined vaccine.
Major vaccine developers, including Moderna and Pfizer, are racing to bring a combined Covid-flu vaccine to market. Some analysts are hoping that the new products will boost companies' revenue as they face slipping uptake of newer Covid-19 vaccines, which generated booming results during the pandemic.
Pfizer, which is developing the novel vaccine with BioNTech, has reported mixed results for the combined shot. Meanwhile, Moderna said last week that it plans to file for FDA approval of its own combo vaccine by the end of the year.