The FDA initially refused to review Moderna’s experimental mRNA flu vaccine due to concerns over trial design but reversed its decision days later after a high-priority meeting. Moderna proposed splitting its application by age groups full approval for adults 50-64 and accelerated approval for seniors 65+, contingent on post-marketing studies.
Critics argue the FDA’s sudden reversal bypasses rigorous safety protocols, especially for vulnerable seniors, while Moderna defends its trial design, claiming the FDA previously approved it. The agency had objected to Moderna using a standard-dose flu vaccine comparator instead of the high-dose version recommended for older adults.
Sources suggest President Trump pressured FDA Commissioner Dr. Marty Makary to expedite the review, though the White House denied involvement. Meanwhile, HHS Secretary Robert F. Kennedy Jr., a vocal mRNA skeptic, has overseen stricter mRNA vaccine regulations, including warning labels and rescinded blanket COVID-19 recommendations.
Moderna’s stock surged 6% after the FDA’s reversal, signaling investor optimism, despite unresolved scrutiny. Critics, including HHS, accuse Moderna of exposing elderly participants to “substandard” care, while Moderna insists regulators had approved the study design over a year prior.
The controversy highlights ongoing tensions between rapid medical innovation and long-term safety, mirroring debates from the COVID-19 vaccine emergency approvals. Observers question whether corporate lobbying and political influence are undermining regulatory rigor.
The Food and Drug Administration (FDA) has agreed to review Moderna’s experimental mRNA flu vaccine, just days after initially refusing to consider the application.
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