{"id":12858219,"date":"2026-02-18T19:31:04","date_gmt":"2026-02-19T00:31:04","guid":{"rendered":"https:\/\/www.philstockworld.com\/?p=12858219"},"modified":"2026-02-18T19:32:29","modified_gmt":"2026-02-19T00:32:29","slug":"fdas-abrupt-flip-flop-on-modernas-mrna-flu-shot-highlights-growing-risks-to-drug-makers-of-investing-in-vaccines","status":"publish","type":"post","link":"https:\/\/www.philstockworld.com\/2026\/02\/18\/fdas-abrupt-flip-flop-on-modernas-mrna-flu-shot-highlights-growing-risks-to-drug-makers-of-investing-in-vaccines\/","title":{"rendered":"FDA\u2019s abrupt flip-flop on Moderna\u2019s mRNA flu shot highlights growing risks to drug-makers of investing in\u00a0vaccines"},"content":{"rendered":"

FDA\u2019s abrupt flip-flop<\/span> on Moderna\u2019s mRNA flu shot highlights growing risks to drug-makers<\/span> of investing in\u00a0vaccines<\/h2>\n
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Federal health officials have raised safety concerns about mRNA vaccines, although they have provided no credible data on health risks. NurPhoto via Getty Images<\/a><\/span><\/figcaption><\/figure>\n<\/div>\n
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By Ana Santos Rutschman<\/a>, Villanova University<\/a><\/em><\/div>\n
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The Food and Drug Administration\u2019s decision, made public on Feb. 10, 2026, to not review an application<\/a> to approve Moderna\u2019s proposed mRNA-based flu vaccine<\/a> set off a firestorm of criticism from public health experts<\/a>.<\/p>\n

But just a week later, on Feb. 18, the FDA backtracked on its decision<\/a>, saying that it will indeed review the vaccine, potentially in time for its approval for the 2025-26 flu season. The decision sent Moderna\u2019s stocks soaring<\/a> in a rebound from the earlier decision<\/a>.<\/p>\n

Even before the FDA\u2019s decision to reject the application, Moderna and other drugmakers were beginning to pare back investments in vaccines due to concerns about the approval process. As a law professor who studies vaccine policy<\/a>, I believe the FDA\u2019s abrupt shift is unlikely to assuage those concerns.<\/p>\n

What happens now that the FDA is willing to review the application?<\/h2>\n

The FDA said it will review the vaccine for use by people age 50 to 64 under the standard review pathaway<\/a>, which is how it evaluates most drugs.<\/p>\n

In declining the application originally, the FDA claimed<\/a> that Moderna did not conduct an \u201cadequate and well-controlled\u201d study because it had not compared patients receiving its vaccine with patients receiving what the agency claimed to be \u201cthe best-available standard of care.\u201d The agency\u2019s decision to review it now is effectively a reversal of that position, which was not based on any legal standard<\/a> .<\/p>\n

For people age 65 and older, the FDA said it will now review the vaccine through a long-standing program called \u201caccelerated approval<\/a>,\u201d which is used to more quickly review drugs that \u201ctreat serious conditions\u201d and \u201cfill an unmet medical need<\/a>,\u201d and that show promise.<\/p>\n