The U.S. Food and Drug Administration (FDA) has reversed its previous decision and will now review Moderna’s application for its mRNA-based influenza vaccine, a development that lifted the vaccine maker’s stock price and offers a potential new weapon in the fight against seasonal flu. The reversal comes after Moderna proposed changes to its regulatory approach following an initial rejection of the application just last week. Moderna’s stock rose more than 3% in pre-market trading on Wednesday, February 18, 2026, following the announcement.
The FDA’s initial decision not to review the vaccine application had been a surprise to many in the industry, raising questions about the future of mRNA technology in preventative medicine. The agency had initially stated that Moderna’s trial design did not reflect the “best-available standard of care,” specifically regarding the comparator vaccine used in the study. Now, the FDA will consider Moderna’s revised approach, which seeks full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, along with a post-marketing study focused on older adults.
FDA Initially Rejected Application Over Trial Design
The initial rejection, revealed last week, centered on the control group used in Moderna’s Phase 3 trial. According to a letter from the FDA, the agency found that the standard-dose influenza vaccines, including Fluarix made by GlaxoSmithKline, used for comparison in the trial did “not reflect the best-available standard of care.” Ars Technica reported that the decision was made by political appointee Vinay Prasad, overruling agency scientists and a career official.
Moderna responded by holding a formal meeting (Type A) with the FDA to discuss a revised regulatory pathway. “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, Moderna’s CEO, in a statement. The company is now aiming for potential availability of the vaccine later this year, pending final approval.
mRNA Technology and Shifting Health Policy
The development comes at a time of shifting national health policy, particularly regarding mRNA vaccines. The success of mRNA technology in combating COVID-19, credited with saving millions of lives, is now navigating a landscape influenced by Health Secretary Robert F. Kennedy Jr., a long-time critic of mRNA vaccines. NBC News notes this context as potentially influencing the regulatory process.
The FDA is expected to make a final decision on Moderna’s mRNA-1010 flu vaccine candidate by August 5, 2026, according to the company. The agency indicated it will maintain its rigorous standards throughout the review and potential licensure stages, as it does with all pharmaceutical products. CNN reported that the FDA’s initial rejection did not raise any safety or efficacy concerns.
What’s Next for Moderna’s Flu Vaccine
The FDA’s acceptance of the revised application marks a significant step forward for Moderna’s flu vaccine program. The company is now focused on providing the FDA with the necessary data to support approval for both the 50-64 and 65+ age groups. The post-marketing study in older adults will be crucial in further evaluating the vaccine’s effectiveness and safety in this vulnerable population. CBS News confirmed the FDA’s notification to Moderna regarding the application review.
The potential availability of an mRNA flu vaccine could offer a new option for protecting against influenza, particularly for seniors. The mRNA technology allows for faster development and production compared to traditional flu vaccines, potentially enabling a more rapid response to evolving flu strains. CBC News also reported on the reversal.
Looking ahead, the FDA’s decision in August will be a key moment for Moderna and for the future of mRNA vaccines beyond COVID-19. The outcome will likely influence the development and regulatory pathways for other mRNA-based vaccines targeting a range of infectious diseases.
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Disclaimer: This article provides informational content and should not be considered medical or professional advice. Consult with a qualified healthcare provider for any health concerns or before making any decisions related to your health or treatment.
