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Pfizer’s mRNA Flu Vaccine Faces FDA Scrutiny After clinical Trial Failure in Elderly
The U.S. Food and Drug Administration is unlikely to approve Pfizer’s experimental mRNA influenza vaccine without further data demonstrating it’s effectiveness in older adults, following reports that the vaccine showed no efficacy in clinical trials for this population.
the concerns were publicly voiced by FDA Commissioner Dr. Marty Macari in a recent interview with Fox news on November 29th, where he stated, “This vaccine failed in clinical trials in the elderly population,” and emphasized, “The test results showed no efficacy at all.” Dr. Macari underscored the agency’s commitment to scientific rigor, asserting, “We cannot unconditionally approve a new product that is ineffective and failed in clinical trials. If we only give formal approval without any data, it is a mockery of science.”
Did you know? – The FDA is unlikely to approve Pfizer’s mRNA flu vaccine without more data. Trials showed no efficacy in older adults. The agency prioritizes scientific rigor.
While the mRNA vaccine demonstrated better performance than existing approved vaccines in trials involving healthy adults aged 18 to 64, a critical omission of detailed results for individuals 65 and older from the published research in the New England Journal of Medicine (NEJM) has ignited controversy. Researchers failed to disclose that 0.5% of the vaccinated elderly group experienced flu-like symptoms, with confirmed cases of influenza thru laboratory testing – a rate consistent with the currently approved vaccine group.
Pro tip: – The NEJM omitted elderly trial data. 0.5% of vaccinated elderly had flu-like symptoms, matching existing vaccines. This omission raised ethical concerns.
Further raising concerns, a significantly higher proportion – 68.7% – of elderly participants receiving the Pfizer vaccine reported adverse reactions within seven days of vaccination, compared to 25.8% in the existing vaccine group. Thes clinical results, initially made public on ClinicalTrials.gov earlier this year, have drawn renewed attention from independant journalists and members of the Centers for Disease Control and Prevention (CDC) advisory commitee.
Reader question: – Why were adverse reactions higher in the pfizer vaccine group? 68.7% of elderly participants reported reactions, compared to 25.8% in the existing vaccine group.
“This is a major ethical failure in the expert review process,” stated Professor Recep Levy of the Massachusetts Institute of technology (MIT) in a written interview with The epoch Times. He called on the NEJM editorial board to explain the omission and demand full disclosure of the clinical trial results through a revision of the published paper.
When The Epoch Times inquired about the missing elderly data, NEJM responded via email, stating that “The study authors are the ones who can best answer that question.” Attempts to reach the Pfizer researcher leading the study for comment were unsuccessful.
The FDA’s scrutiny follows an internal memo from Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), announcing a complete review of the current influenza vaccine approval system. Dr. Prasad characterized the existing system as “a disaster created by uncertain vaccine efficacy based on low-quality evidence, poor surrogate marker testing, and inadequate case-control studies.” He indicated that detailed policy changes are forthcoming after internal discussions.
Did you know? – The FDA is reviewing the flu vaccine approval system. Dr. Prasad calls the current system a “disaster.” Policy changes are expected after internal discussions.
Currently, the FDA approves updated flu vaccines annually, targeting predicted prevalent virus strains. The agency’s website,
