Authored by Zachary Stieber via The Epoch Times (emphasis ours),
Pfizer’s experimental influenza vaccine will not receive approval absent new data proving that it protects seniors against the flu, the commissioner of the Food and Drug Administration suggested in a new interview.
The messenger ribonucleic acid (mRNA) shot “failed in seniors,” Dr. Marty Makary, the FDA commissioner, said during an appearance on Nov. 29 on Fox News.
“The trial showed zero benefit,” he said.
“We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial. It makes a mockery of science if we’re just going to rubber-stamp things with no data.”
Pfizer’s media team did not respond to a request for comment.
The experimental mRNA shot performed better in a trial than an already-approved vaccine from a different company among healthy people aged 18 to 64, researchers with Pfizer and other organizations said in a recent paper published by the New England Journal of Medicine (NEJM).
The researchers did not mention that among vaccinated seniors, or people aged 65 and older, in the same trial, 0.5 percent suffered influenza-like illness and had laboratory-confirmed influenza cases. That was the same percentage as recipients of a licensed vaccine.
Many more seniors—68.7 percent—reported adverse reactions within seven days of Pfizer vaccination compared with just 25.8 percent of recipients of the existing vaccine, the results also showed.
The results from the seniors in the trial were posted to ClinicalTrials.gov earlier this year and highlighted following publication of the paper by independent journalists and members of the panel that advises the Centers for Disease Control and Prevention on vaccines, including Retsef Levi, a professor at the Massachusetts Institute of Technology.
“I find this to be a major integrity failure in the peer-review process. The NEJM editorial board should provide a clear explanation how this failure has occurred and … require the authors to correct the current articles and report on the entire results of the trial,” Levi told The Epoch Times in an email.
“The study authors are best able to answer your question,” a spokesperson for the journal told The Epoch Times in an email when asked why the results for seniors were not included in the paper.
The study’s corresponding author, who works for Pfizer, did not return an inquiry.
Makary’s comments came after Dr. Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research, wrote in a memorandum that officials will be revising the current framework for influenza vaccines, which he called “an evidence-based catastrophe of low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.” He indicated that more details would be forthcoming after internal conversations.
The current framework features annual approvals of updated shots that target strains projected to circulate.
The FDA says on its website on a page updated in 2024 that FDA-approved flu vaccines “are safe and effective.” Officials with the Centers for Disease Control and Prevention estimate that the vaccines’ effectiveness against influenza since 2009 have ranged from 19 percent to 60 percent.
Prasad also said that for most new vaccines, officials will be requiring randomized trials that provide evidence of efficacy based on clinical endpoints, which can include prevention of disease.
Dr. Robert Malone, who leads the CDC advisory panel’s influenza workgroup, told The Epoch Times that the memo means “the entire influenza vaccine, annual vaccination enterprise is now subject to major disruption.”
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