A nurse prepares a flu shot at Huntington Village Pediatrics in Huntington, New York, December 8, 2021.
Steve Pfost | News day | Getty Images
Modern said Wednesday that its experimental mRNA-based flu vaccine produced a stronger immune response against four strains of the virus than a currently available flu vaccine in a late-stage trial, paving the way for approval in the UNITED STATES.
Moderna shares rose 4% in premarket trading Wednesday following the announcement.
The results come as Moderna attempts to strengthen its pipeline and become a company known for much more than its blockbuster mRNA Covid vaccine, which won more approvals from U.S. regulators this week. Moderna expects its Covid vaccine – its only commercially available product – as well as its flu shot and other experimental respiratory vaccines to generate up to $15 billion in sales by 2027.
Wednesday’s results also come as a sigh of relief for Moderna after the company pushed back its experimental flu vaccine program to April. After the initial vaccine formulation did not accumulate enough data to determine its effectiveness, the company reformulated the vaccine.
This seemed to pay off in the latest phase three trial. Moderna compared the flu vaccine, called mRNA-1010, to a seasonal flu vaccine currently approved by GlaxoSmithKline called Fluarix.
An interim analysis of the trial found that mRNA-1010 produced higher antibody levels for all four strains of influenza recommended by the World Health Organization – two each of influenza A and B – compared to Fluarix. Moderna’s flu vaccine also generated higher seroconversion rates, which refers to the development of specific antibodies against a virus.
Moderna said the safety results of the trial were similar to previous ones, in which muscle aches, headaches, fatigue, pain and swelling were the most common side effects of mRNA -1010.
Also Wednesday, Moderna announced the end of a separate phase three trial of the first version of its flu vaccine. This study did not generate enough cases to provide efficacy data.
Meanwhile, Moderna said Wednesday that it expects a decision from the Food and Drug Administration on its mRNA respiratory syncytial virus vaccine in adults 60 and older by April. The FDA approved RSV vaccines for seniors from Pfizer and GSK in May.
“Our mRNA platform works,” Stéphane Bancel, CEO of Moderna, said in a statement. “With today’s positive results for Phase 3 of influenza, as well as previous results for Covid and RSV, we are now three of three to advance respiratory disease programs towards positive phase data 3.”
The company will host a virtual event on Wednesday at 1 p.m. ET to discuss research and development updates with investors.