Washington, D.C., February 12, 2026 — Alliance for mRNA Medicines Executive Director Clay Alspach released the following statement following reports that the U.S. Food and Drug Administration declined to review an application for an innovative mRNA flu vaccine, overruling review staff who wanted to review the application:
“The Alliance for mRNA Medicines is deeply concerned by reports that the FDA has refused to review a potential new mRNA flu vaccine— over the apparent objections of the agency’s own review staff. An editorial by the Wall Street Journal sums it up: ‘This is arbitrary government at its worst.’
“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. FDA seems to have arbitrarily moved the goal post to avoid even evaluating the data on its merits.
“This action is part of a disturbing pattern of heightened skepticism and scrutiny toward mRNA technology. This and other recent policy decisions undermine a revolutionary platform that’s demonstrating its potential to save the lives of patients with cancer, rare genetic conditions, and infectious diseases.
“Discriminatory decision-making against a proven technology threatens to chill investment, stall innovation, and weaken American leadership in biotechnology. 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?’
“Patients benefit most when breakthrough technologies are evaluated through rigorous, transparent, and consistent scientific standards. We urge policymakers to ensure that oversight remains grounded in evidence and that the promise of mRNA medicine is not sidelined by shifting or opaque regulatory decisions.”
Alliance for mRNA Medicines (AMM)
The Alliance for mRNA Medicines (AMM) is the leading global organization dedicated to advancing and advocating for mRNA and next generation encoding RNA therapeutics and vaccines for the benefit of patients, public health, and society. Our mission is to propel the future of mRNA medicine, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists, and other key stakeholders. Learn more at https://mrnamedicines.org
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