A coddle prepares a flu shot at Huntington Village Pediatrics, in Huntington, New York on December 8, 2021.
Steve Pfost | Newsday | Getty Mental pictures
Moderna on Wednesday said its experimental mRNA-based flu vaccine produced a stronger immune response against four family backgrounds of the virus than a currently available flu vaccine in a late-stage trial, clearing the way for a path to approval in the U.S.
Shares of Moderna thrive 4% in premarket trading Wednesday following the announcement.
The results come as Moderna tries to beef up its pipeline and suit a company known for more than its blockbuster mRNA Covid vaccine, which won more approvals from U.S. regulators this week. Moderna foresees its Covid shot – its only commercially available product – along with its flu jab, and other experimental respiratory vaccines to swipe up to $15 billion in sales by 2027.
Wednesday’s results are also a sigh of relief for Moderna after the company pushed away its experimental flu shot program in April. An initial vaccine formula didn’t accumulate enough data to determine its efficacy, so the troop reformulated the shot.
That appeared to pay off in the latest phase three trial. Moderna compared the flu vaccine, dubbed mRNA-1010, to a currently approved seasonal flu vaccine from GlaxoSmithKline called Fluarix.
An interim critique of the trial found that mRNA-1010 produced higher antibody levels for all four influenza strains recommended by the Smashing Health Organization – two each for influenza A and B – compared to Fluarix. Moderna’s flu shot also generated higher seroconversion rates, which refers to the maturity of specific antibodies against a virus.
Moderna said the safety findings were similar in the trial to previous songs, which found muscle pain, headache, fatigue, pain and swelling as the most common side effects of mRNA-1010.
Also on Wednesday, Moderna maintained it is ending a separate phase three trial on the first version of its flu vaccine. That study did not generate enough covers to provide efficacy data.
Meanwhile, Moderna on Wednesday said it expects a decision from the Food and Drug Supplying on its mRNA vaccine for respiratory syncytial virus in adults 60 and older by April. The FDA approved RSV vaccines for older adults from Pfizer and GSK in May.
“Our mRNA podium is working,” Moderna CEO Stephane Bancel said in a press release. “With today’s positive phase 3 flu results, along with above-mentioned results in Covid and RSV, we are now three for three on advancing respiratory disease programs to positive phase 3 data.”
The company wishes hold a virtual event at 1 p.m. ET on Wednesday to discuss research and development updates with investors.