Pharmaceutical giants expressed optimism that new influenza vaccines will be released this year, despite approval concerns.
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Published February 18, 2026
The federal agency responsible for regulating pharmaceutical products in the United States has announced it will review an application for a flu vaccine from pharmaceutical giant Moderna, a week after the company rejected the application in an unusual move.
Moderna announced Wednesday that the Food and Drug Administration (FDA) has accepted an amended application seeking full approval of its new influenza vaccine for patients ages 50 to 64 and expedited approval for patients 65 and older.
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“Pending FDA approval, we look forward to making our influenza vaccine available later this year so older Americans have another option to protect themselves from the flu,” CEO Stéphane Bancel said in a statement.
He also expressed gratitude for the FDA’s “involvement” in this issue.
The FDA’s decision to accept Moderna’s application marked an abrupt shift from its previous position. On February 10, Moderna announced that the FDA had rejected its application for review of its new influenza vaccine. For the elderly.
The announcement raised concerns in the pharmaceutical industry about how new vaccines would be received under U.S. President Donald Trump, who has rescinded certain vaccine guidelines.
Some Trump officials, particularly Health and Human Services Secretary Robert F. Kennedy Jr., also spread false information. Claims about vaccine safety.
At the time, Moderna said the agency’s refusal was “inconsistent with previous written communications” with the FDA.
Bancel said in a statement that the decision “did not identify any concerns regarding the safety or efficacy of our products” and “does not advance our shared goal of strengthening America’s leadership in the development of innovative medicines.”
The agency’s refusal to consider the company’s application was an unprecedented move.
In a “application denial” letter rejecting the initial application, Vinay Prasad, the FDA’s director of vaccines, argued that Moderna should have included a higher-dose brand as a comparator during the trial process.
Moderna conducted a 40,000-person clinical trial in adults 50 and older and concluded that its new vaccine is more effective than the standard vaccine.
The company publicly responded that the FDA recommended that approach itself when approving the study.
As a compromise, Moderna agreed to conduct another study on a new influenza vaccine once it becomes available. FDA aims to issue a decision on the amended application by August 5th.
The flu vaccine, made using mRNA technology, has been a frequent target of criticism for President Kennedy, who has promoted anti-vaccine views and replaced experts at the Department of Health and Human Services with individuals who share Kennedy’s skepticism.
Last June, Kennedy canceled nearly $500 million in federal research grants and contracts for mRNA vaccine research.
