Novavax drops 10% after Moderna, Inc.'s experimental combination COVID and flu vaccine triggered better immune responses than stand-alone shots currently on the market, according to clinical trial data the company released Monday.
The late-stage trial compared the investigational combo shot mRNA-1083 against the Sanofi SA flu vaccine Fluzone HD and Moderna's Spikevax COVID vaccine in adults 65 and older. For patients age 50 to 64, the trial compared the combination vaccine against GlaxoSmithKline PLC 's Fluarix flu vaccine and Spikevax.
In both age groups, the two-in-one shot prompted higher immune responses against three flu strains as well as COVID, Moderna said.
Analysts and pharmaceutical companies are looking to combination shots to help improve vaccine uptake and expand the respiratory-vaccine market. Looking at the most recent vaccination season, nearly half of U.S. adults were vaccinated against the flu as of early June, but less than a quarter were vaccinated against COVID, according to the Centers for Disease Control and Prevention.
Pfizer and BioNTech SE are also working on a combined COVID and flu vaccine that is currently in Phase 3 trials, and Sanofi and Novavax last month announced a deal that includes development of new flu and COVID combination vaccines.
"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Moderna CEO Stephane Bancel said in a statement.
In addition to the consumer convenience factor, healthcare providers, retailers and pharmacies may find the combined shot is "just easier to administer - one shot and you're done," Moderna Chief Financial Officer Jamey Mock told MarketWatch. "And hopefully it reduces the overall cost for them, because it should save time."
The trial results bode well for other combination shots in Moderna's pipeline, Mock said, by helping to address a couple of questions that were hanging over the experimental vaccines. One concern was whether both antigens in a combination shot could be made to stimulate an immune response at the same time, given that they could potentially interfere with each other. "Clearly, we were able to do that," Mock said.
The second concern was whether packing two vaccines into one shot could lead to safety or tolerability issues, Mock said. "We don't see that" in the Phase 3 trial results, he said. Side effects of the combination shot included injection-site pain, fatigue, muscle pain and headache, Moderna said, but those issues generally appeared consistent with the stand-alone vaccines currently on the market.
Moderna's combined flu and COVID shot includes components of its experimental seasonal flu vaccine mRNA-1010 and its next-generation COVID vaccine candidate mRNA-1283. Moderna in March released late-stage trial results showing that its next-generation COVID vaccine produced better immune results than its original Spikevax shot.
It's not yet clear whether those two components of the combined shot would need individual regulatory approval before mRNA-1083 can be approved, Mock said, adding that Moderna hopes it may be able to launch the combined vaccine sometime next year. The Food and Drug Administration last year gave Moderna's combined COVID and flu vaccine fast-track designation, which is designed to speed up the review of drugs that treat serious conditions and fill an unmet medical need.