Influenza Vaccine, mRNA(Moderna)

The US FDA has approved updated 2026-2027 formulations of both Spikevax and mNexspike (COVID-19 Vaccine, mRNA) from Cambridge, Massachusetts-based Moderna (Nasdaq: MRNA), covering the JN.1-lineage XFG subvariant of SARS-CoV-2. The approvals, via supplemental Biologics License Applications (sBLA), extend Moderna's annual COVID-19 vaccine update cycle into the 2026-2027 respiratory season, with the company reporting that COVID-19 was responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the US in the prior year. The updated Spikevax formula is approved for all adults ≥65 and people aged 5–64 with at least one underlying high-risk condition. Mnexspike — Moderna's next-generation mRNA COVID-19 vaccine — carries a narrower age indication, covering individuals aged 12 through 64 at high risk, plus all adults 65 and older. Both formulations were updated per FDA guidance specifying a monovalent JN.1-lineage XFG subvariant composition. Both vaccines use lipid nanoparticle-delivered mRNA, but differ in their antigen design. Spikevax encodes the full-length SARS-CoV-2 spike protein, while mNexspike uses Moderna's next-generation construct encoding linked receptor-binding and N-terminal domains of spike. The press release did not report specific immunogenicity or tolerability data for the XFG formulations. The 2026-2027 Spikevax formula had already received approval in Europe, South Korea, Singapore, Switzerland, and the United Kingdom ahead of the US decision; the mNexspike XFG formulation had been approved in Japan. This international rollout reflects the established annual strain-update regulatory pathway. Moderna's broader mRNA platform has gained further regulatory traction in 2026, with mFlusiva becoming the first mRNA influenza vaccine approved in the US, and the European Committee for Medicinal Products for Human Use (CHMP) recommending approval of mCombriax, a combined mRNA flu-COVID vaccine. Pfizer and BioNTech's Comirnaty XFG received FDA approval on the same date for adults aged 65 and older and people aged 5–64 with at least one underlying condition placing them at high risk for severe COVID-19. Novavax's protein-based Nuvaxovid remains the principal non-mRNA alternative in the US. Spot something wrong? Report an issue with this article

Moderna notched a hard-fought regulatory win earlier this month when the Food and Drug Administration approved mFlusiva for adults aged 50 and older, making it the first approved mRNA flu vaccine in the U.S. The agency used the accelerated approval pathway for those 65 and older, meaning continued approval for the older group could depend on a confirmatory trial.The approval came after months of back-and-forth with the agency, which issued a refusal-to-file letter in February and initially declined to review Modernas application. But snagging the FDA OK will likely be just the first hurdle Moderna faces as it brings the vaccine to market.In a phase 3 trial of adults 50 and above, mFlusiva demonstrated 26.6% relative vaccine efficacy compared with a standard-dose flu jab. Its messenger-RNA platform can produce vax doses faster than conventional vaccines. Still, the new shot carries a lot of baggage, including mRNA skepticism, Modernas past tussles with the FDA and a political environment thats often unfriendly to vaccines in general.However, the big plus or minus could be the timing of annual flu vaccine strain selection, according toMyles Minter, a biotech research analyst at William Blair.Currently, annual flu vaccine strains are chosen six to nine months ahead of flu season. With mRNA vaccines faster production, flu vaccine strain selection could theoretically be delayed until two months before flu season, boosting the odds of pinpointing that seasons circulating strains.You could theoretically make multiple different vaccines throughout one season if you wanted to, Minter said.From there, vaccine efficacy would also theoretically increase because of the closer strain match, he said. Moderna President Stephen Hoge touted this edge for mFlusiva in an investor relations video on the companys website.Then again, that advantage might be moot. If the World Health Organization and FDA dont adjust their current strain selection process, then it doesnt matter what Moderna does and how fast they can make a vaccine because the recommendation for the strain is uniform and you have to make it against that, Minter said. It basically takes away that advantage.To leverage that edge, Moderna will need to push for a framework shift among global regulators. Those authorities would need to believe there is an advantage in doing so to protect the people better against seasonal influenza, according to Minter.Navigating flu market challengesEven without the benefit of later strain selection, mFlusiva outperformed a standard-dose flu vaccine in a Phase 3 trial. But Moderna still has other hurdles to work around. As with any newly launched vaccine, market traction will largely hinge on regulatory recommendations and list versus net price. Moderna also faces flu-specific challenges, such as the fact that consumers dont typically get to choose which vaccine they receive.Although Moderna expects mFlusiva to reach select retailers in a few weeks, analysts dont expect it to generate meaningful revenue in the short term because the company already missed this seasons contracting cycle. But mFlusiva revenue could pick up down the road.In terms of changing the top-line revenue trajectory for the company, youre probably going to see an impact of this U.S. FDA flu vaccine approval starting in 2027, Minter said. Longer term, I think the value of this product is severalfold.The firm projects mFlusiva revenue will hit $131 million in 2027 and then cross the blockbuster threshold with peak sales of $1.1 billion annually, about one-fifth of the current market, he said.Regulatory and market hurdles aside, infectious disease experts view mFlusiva as a game changer, Minter said.If theres good adoption, I think itll change the fundamental aspects of how we vaccinate against seasonal influenza, he said.More precise and nimble strain selection could boost flu vaccine efficacy, which could, in turn, increase vaccination rates that remain low.If we can close that gap and become more accurate at doing it, we should drive that effectiveness up. And if its a more effective product in theory, that uptake number would go up, Minter said.mFlusivas approval could also restart regulatory momentum for Modernas flu and COVID-19 combo vaccine in the U.S. Earlier this year, European regulators approved the combo shot, but the FDA hit the brakes on its review and asked Moderna for additional Phase 3 efficacy data on the flu component.Now, the question is: Does this approval in flu alone open up the regulatory door again? Minter said. That could be something interesting. '