News of the U.S. Food and Drug Administration’s refusal to review Moderna’s mRNA-based flu vaccine spread quickly among participants at Phacilitate’s Advanced Therapies Week in San Diego. The decision comes as advanced therapies, including mRNA technologies, are seeing increasing adoption globally.
Roberta Duncan, former chief strategy officer at Arcturus Therapeutics and board vice-chair of the Alliance for mRNA Medicines (AMM), commented during a panel moderated by BioSpace: “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.” She added, “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. 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 FDA’s recent refusal-to-file (RTF) letter for Moderna’s mRNA-1010 flu vaccine follows other setbacks for companies working with this technology. In August 2025, the Department of Health and Human Services canceled 22 mRNA programs under its Biomedical Advanced Research and Development Authority, affecting firms such as Moderna, Pfizer, Sanofi, and AstraZeneca.
State-level initiatives have also emerged. For example, South Carolina lawmakers have proposed a bill that would ban synthetic mRNA-based products for preventing communicable diseases and penalize healthcare providers who administer them. AMM representatives recently visited state legislators to argue against this measure.
In response to the FDA's action on February 12, AMM Executive Director Clay Alspach said: “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,” adding that “FDA seems to have arbitrarily moved the goal post to avoid even evaluating the data on its merits.”
Moderna has responded by shifting its business strategy away from late-stage vaccine studies in the United States. At last month’s World Economic Forum in Davos, CEO Stéphane Bancel stated: “You cannot make a return on investment if you don’t have access to the U.S. market,” according to Bloomberg News.
Other pharmaceutical companies are watching developments closely. While Pfizer has not made major pipeline changes following recent federal actions regarding mRNA technology, CEO Albert Bourla criticized Health Secretary Robert F. Kennedy Jr.’s stance on vaccines at Davos as “anti-science,” saying there was an almost religious fervor behind it.
Amid these U.S.-based challenges for advanced therapies developers like Moderna and others such as Capricor Therapeutics, uniQure and Biohaven—who have cited unclear FDA guidance—global regulators appear more receptive.
Duncan noted during Tuesday’s panel: “We can no longer treat multinational access as a luxury. It is a requirement.” Michael Meyers of H.C. Wainwright added that diversifying portfolios across regions such as Europe or Asia-Pacific may reduce risk compared with relying solely on the U.S.
Moderna awaits regulatory decisions for its flu shot candidate mRNA-1010 in Canada, Australia and Europe; these markets could see product availability by 2027–2028 while timing for a potential U.S. launch remains uncertain. On February 10th, Moderna announced an agreement with Mexico involving supply of respiratory vaccines and collaboration on local research aligned with Mexican health priorities. Bancel said: “We are proud to support Mexico in its mission to strengthen national health security.”
Executives from other biotechnology firms described smoother experiences abroad compared with current conditions at home. Samar Mohanty of Nanoscope Therapeutics highlighted positive engagement with Japan's Ministry of Health during their drug approval process earlier this year; Duncan recalled similar constructive feedback from Japanese authorities during development of Arcturus/CSL's ARCT-154 COVID-19 vaccine.
By contrast Vlad Coric of Biohaven described less productive interactions with FDA after his company received a rejection last November for troriluzole—a treatment targeting spinocerebellar ataxia—saying: “We’re trying to work with the FDA... We have not seen the constructive collaboration with us but we will keep at it.”
Alspach warned that these shifts could impact American competitiveness: “Discriminatory decision-making against a proven technology threatens to chill investment, stall innovation, and weaken American leadership in biotechnology,” he said.“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?’”
BioSpace served as media partner for Phacilitate’s Advanced Therapies Week held February 9–12 at San Diego Convention Center.
