The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
News of the FDA’s refusal to review Moderna’s mRNA-based flu vaccine rippled through a drafty San Diego convention center last Tuesday as participants at Phacilitate’s Advanced Therapies Week reacted in real time to what appeared to be another U.S.-based slight to the life-saving technology. This latest FDA action also comes amid a rapidly growing global footprint for advanced therapies.
“What we’re seeing in the U.S. are the policy threats that are impacting not only mRNA-enabling technologies, but all the adjacent technologies in advancement as well,” Roberta Duncan, former chief strategy officer at Arcturus Therapeutics, said during a panel discussion moderated by BioSpace.
While Duncan, who is also board vice-chair of the Alliance for mRNA Medicines (AMM), was clear that she was not “necessarily” speaking about the regulatory space, the warning was particularly apposite on Feb. 10.
“I just want to remind everyone that while we’re seeing these headwinds in mRNA, any technology where the science is being challenged is a gateway for all technology to be challenged,” she continued. “The battlefront is on mRNA right now in certain areas, and we’re going to continue to take that head on, but it is not in a vacuum.”
The mRNA Battlefield
While mRNA was the basis of the COVID-19 vaccines that resulted from Operation Warp Speed during President Donald Trump’s first term, the technology has faced threats since the beginning of the second Trump administration. In August 2025, the Department of Health and Human Services (HHS) axed 22 mRNA programs under the Biomedical Advanced Research and Development Authority, affecting companies like Moderna, Pfizer, Sanofi, AstraZeneca and more.
There are also state-based initiatives seeking to squelch the technology. A bill being proposed in South Carolina would prohibit the administration of synthetic mRNA-based products for preventing communicable diseases, with penalties for healthcare providers. AAM recently visited the state legislature to speak against this bill, Duncan said.
In a statement on Feb. 12, AMM Executive Director Clay Alspach called the FDA’s decision to issue a refusal-to-file (RTF) letter for Moderna’s mRNA-1010 “over the apparent objections of the agency’s own review staff . . . part of a disturbing pattern.
“While regulatory scrutiny is vital, decisions that appear to override established review processes undermine confidence in the agency’s work and the innovative treatments and vaccines it ultimately approves,” Alspach continued. FDA seems to have arbitrarily moved the goal post to avoid even evaluating the data on its merits.” Indeed, companies including Moderna, Capricor Therapeutics, uniQure and Biohaven, have been sent reeling this past year by conflicting and unclear FDA guidance.
Even before the RTF, Moderna responded to the U.S. government’s anti-mRNA stance with a key pipeline decision. Last month at the World Economic Forum in Davos, Switzerland, CEO Stéphane Bancel said the company will no longer invest in late-stage vaccine studies in the U.S. “You cannot make a return on investment if you don’t have access to the U.S. market,” Bancel told Bloomberg News at the time.
Whether Moderna is a canary in the coal mine for the biopharma industry remains to be seen. Pfizer, maker of BioNTech-partnered mRNA-based COVID-19 vaccine Comirnaty, has not announced any key pipeline shifts in response to the Trump administration’s rhetoric and actions around mRNA. However, CEO Albert Bourla did have some strong words for Health Secretary Robert F. Kennedy Jr. at the World Economic Forum, calling his rhetoric and policies on vaccines “anti-science,” adding that “there’s almost like a religion there.”
Global Regulators on Board
This U.S. backlash against mRNA is occurring during a shift toward the globalization of advanced therapies, experts on Tuesday’s panel agreed. “We can no longer treat multinational access as a luxury,” Duncan said. “It is a requirement.”
And with the situation in the U.S. becoming more and more uncertain, priorities are shifting. “We think areas like Europe broadly, [Asia-Pacific], suggests that companies’ portfolios should be diversified where country risk, regional risk, is lessened than, perhaps, as compared to the U.S,” Michael Meyers, head of M&A and Strategic Advisory Services at H.C. Wainwright, said during the panel.
Indeed, Moderna is awaiting regulatory decisions for mRNA-1010 in Canada, Australia and Europe, the company disclosed on its a fourth quarter earnings call on Friday. These shots could be available for the 2027–2028 flu season, while timing of a potential U.S. market debut is now uncertain. Also on Feb. 10, Moderna announced an agreement with Mexico in which it would supply the country with its respiratory vaccines and collaborate on local clinical research and development programs in line with Mexico’s health priorities. “We are proud to support Mexico in its mission to strengthen national health security,” Bancel said in a statement accompanying the press release.
Moderna is not alone in looking outside the U.S. In these and other countries, such as Japan, sponsors are finding smoother waters to sail. “I never had such regulatory interaction, where almost every alternate day they were giving feedback through emails, not formal meetings and stuff,” Samar Mohanty, president & chief scientific officer at Nanoscope Therapeutics, said of Japan’s Ministry of Health, Labour and Welfare (MHLW), which in January granted Sakigake and orphan drug designations to the company’s lead asset for inherited retinal diseases.
Duncan too had a positive interaction with Japan’s Pharmaceuticals and Medical Devices Agency during the approval process for Arcturus and CSL’s ARCT-154, the world’s first self-amplifying mRNA COVID-19 vaccine. She recalled “continuous engagement, continuous feedback that allowed us to really progress approval there rather quickly.”
Juxtapose this with recent comments from Vlad Coric, CEO of Biohaven, which in November 2025 was hit with an FDA rejection for troriluzole, a glutamate modulator in development for the rare disease spinocerebellar ataxia.
“We’re trying to work with the FDA, and we’re engaged in that,” Coric told Fierce Biotech last week. “We have not seen the constructive collaboration with us but we will keep at it.”
For now, though, AMM’s Alspach reiterated the concern that the shifting risk profile in the U.S. around mRNA serves to undermine the country’s long-held edge in biomedical innovation.
“Discriminatory decision-making against a proven technology threatens to chill investment, stall innovation, and weaken American leadership in biotechnology,” he said in his statement. “These misguided policies are already driving research away from the United States and hurting American manufacturing jobs. As the Wall Street Journal asked: ‘Is the White House paying attention?’”
Editor’s note: BioSpace is a media partner of Phacilitate’s Advanced Therapies Week, held Feb. 9–12 at the San Diego Convention Center.
