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Moderna poised to seek flu shot approval after trial results

Moderna, based in Cambridge, is seeking to broaden its line of vaccines.Adam Glanzman/Bloomberg

Moderna said a reformulated version of its messenger-RNA based flu shot met its primary goals in a final-stage trial — a result that could pave the way for the company to seek regulatory approval for the vaccine.

In a trial on more than 2,400 adults, the reformulated shot produced a stronger immune response against all four strains of the influenza virus than a traditional flu vaccine, the company said in a statement Wednesday. Side effects were similar to previous trials of the vaccine. The study looked at antibody levels against the flu and didn’t directly assess efficacy in preventing disease symptoms.


Moderna shares jumped as much as 9.2 percent before closing up 3.18 percent Wednesday. The stock had declined 41 percent this year through Tuesday’s close.

‘’Our goal would be to file very quickly’' for accelerated approval in the United States, Moderna president Stephen Hoge said in an interview, without offering a specific timeline. Depending on how much additional follow-up data regulators need, Moderna’s shot could be on the market as soon as next year’s fall-winter flu season, he said.

The flu data are in line with expectations and it’s likely Moderna files for regulatory approval by year’s end, analysts from Jefferies said in a note.

Developing an influenza vaccine is important for Moderna as it seeks new sources of revenue as sales for COVID-19 shots fade amid pandemic fatigue. Moderna’s share decline this year adds urgency to its efforts.

The company is working on combination vaccines against both flu and COVID — and potentially other respiratory diseases that could reduce the number of shots needed for broad protection. In a few years, these combos should produce large annual sales, Moderna chief executive Stephane Bancel said in an interview Wednesday on Bloomberg TV.

‘’This is going to be a $15-plus billion annual sales franchise forever,’’ Bancel said. Analysts expect Moderna’s revenue to fall to about $7 billion this year.


Moderna’s mRNA flu shot was reformulated earlier this year after an initial large trial showed mixed results compared to existing vaccines. The original formulation performed well against influenza A, the most common type of flu, but fell short of showing it was as good as traditional vaccines at provoking an immune response against influenza B, a less common type.

The new results, if confirmed, indicate the reformulation worked. The company didn’t provide details of the results, which haven’t yet been published in a scientific journal. An accelerated approval would allow the shot to be approved based on the current findings while Moderna conducts a larger study to confirm that the vaccine prevents symptoms.

Besides flu and COVID, Moderna is also working on an mRNA vaccine for another virus that affects older adults, respiratory syncytial virus (RSV). Moderna said it has completed its US regulatory filing for that vaccine in older adults and expects a decision by April.

The company is behind in this vaccine race, however. Rivals Pfizer and GSK introduced adult RSV vaccines that use older technology to the United States this year.

Another potential application for Moderna’s mRNA technology is cancer vaccines. The Cambridge-based company developed a promising personalized cancer vaccine that is now in a final-stage trial for melanoma with its partner, Merck. Moderna said it plans to begin a second phase 3 trial of the vaccine in lung cancer with Merck later this year.


And earlier this week, it said it would pay as much as $1.8 billion to German biotechnology company Immatics in a broad-ranging, multiyear collaboration to develop cancer therapies using mRNA and other technologies.