The FDA said no. Then it said yes. And Moderna shareholders are having a very good Wednesday because of it.
Shares of the biotech company surged more than 6% after Moderna announced that the Food and Drug Administration reversed its earlier decision and agreed to review the company’s experimental mRNA flu vaccine, mRNA-1010. Just last week, the FDA had refused to even accept the application for review — citing the lack of a comparison study with a vaccine currently used by older adults. The reversal came after Moderna made what the company called “concessions,” though the specifics remain vague.
This is not just about a flu shot. This is about Moderna’s entire survival strategy. The company has been burning cash since the COVID vaccine boom faded, and its path to profitability runs directly through a combination COVID-flu jab that would use the same mRNA platform. Getting the standalone flu vaccine approved is the prerequisite for that combo product. Without it, Moderna’s target of breaking even by 2028 starts looking a lot more ambitious.
The FDA has set a decision date of August 5, which means Moderna could potentially have the vaccine available for the upcoming influenza season. CEO Stéphane Bancel was quick to frame it as a win for consumers: “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
Moderna’s mRNA platform is the real story here. If the flu shot gets approved, it validates the technology beyond COVID — opening the door for mRNA-based vaccines targeting RSV, cancer, and a dozen other conditions in the company’s pipeline. The flu vaccine is essentially the proof of concept that mRNA is not a one-trick pandemic pony.
The stock had been trading near 52-week lows before today’s pop, reflecting deep skepticism about the company’s post-COVID future. But if the FDA gives the green light in August, the narrative changes fast. Moderna would go from “company that peaked during COVID” to “company that built a platform for the next generation of vaccines.” That is a fundamentally different investment thesis — and the kind of pivot that makes biotech stocks dangerous to bet against.