Moderna flu vaccine shows promising phase three trial results

Moderna on Wednesday said its experimental mRNA-based flu vaccine produced a stronger immune response against 4 strains of the virus than a currently available flu vaccine in a late-stage trial, clearing the best way for a path to approval within the U.S. 

Shares of Moderna rose 4% in premarket trading Wednesday following the announcement.

The outcomes come as Moderna tries to beef up its pipeline and turn out to be an organization known for greater than its blockbuster mRNA Covid vaccine, which won more approvals from U.S. regulators this week. Moderna expects its Covid shot – its only commercially available product – together with its flu jab, and other experimental respiratory vaccines to make as much as $15 billion in sales by 2027.

Wednesday’s results are also a sigh of relief for Moderna after the corporate pushed back its experimental flu shot program in April. An initial vaccine formula didn’t accumulate enough data to find out its efficacy, so the corporate reformulated the shot. 

That appeared to repay in the most recent phase three trial. Moderna compared the flu vaccine, dubbed mRNA-1010, to a currently approved seasonal flu vaccine from GlaxoSmithKline called Fluarix. 

An interim evaluation of the trial found that mRNA-1010 produced higher antibody levels for all 4 influenza strains really helpful by the World Health Organization – two each for influenza A and B – in comparison with Fluarix. Moderna’s flu shot also generated higher seroconversion rates, which refers back to the development of specific antibodies against a virus.

Moderna said the protection findings were similar within the trial to previous ones, which found muscle pain, headache, fatigue, pain and swelling as essentially the most common unwanted effects of mRNA-1010. 

Also on Wednesday, Moderna said it’s ending a separate phase three trial on the primary version of its flu vaccine. That study didn’t generate enough cases to offer efficacy data. 

Meanwhile, Moderna on Wednesday said it expects a call from the Food and Drug Administration 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 platform is working,” Moderna CEO Stephane Bancel said in a press release. “With today’s positive phase 3 flu results, together with previous ends in Covid and RSV, we at the moment are three for 3 on advancing respiratory disease programs to positive phase 3 data.”

The corporate will hold a virtual event at 1 p.m. ET on Wednesday to debate research and development updates with investors.