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FDA Won’t ‘Rubber-Stamp’ Pfizer mRNA Flu Vaccine Without Better Safety Data

By Michael Nevradakis, Ph.D. | The Defender | December 15, 2025

The U.S. Food and Drug Administration (FDA) likely won’t approve Pfizer’s mRNA flu vaccine unless the drugmaker produces data proving the product is safe for seniors, according to FDA Commissioner Marty Makary.

Makary told Fox News last month that the data from Pfizer’s recently completed Phase 3 clinical trial showed that adults 65 and older were at higher risk of several serious adverse events, including kidney failure and acute respiratory failure.

“We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial,” Makary said. “It makes a mockery of science if we’re just going to rubber-stamp things with no data.”

Makary said the shot “failed in seniors” and the trial data “showed zero benefit” from the vaccine.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said Makary’s comments signal a change in the way the FDA evaluates clinical trial data for vaccines.

“Makary’s FDA threw out the rubber stamp,” Jablonowski said. “The FDA, under different leadership, may have brushed off the lack of efficacy and Pfizer’s concerning safety data. A future administration may resurrect the rubber stamp. For the time being, this is Makary’s FDA.”

Last month, Pfizer published the results of its clinical trial in the New England Journal of Medicine (NEJM). However, the published results included data only for participants between 18 and 64. Data for participants 65 and older, published only on ClinicalTrials.gov, drew criticism from some scientists.

That data showed that elderly trial participants who received the mRNA vaccine had a significantly higher rate of death and several serious adverse events, including cancer, compared to participants who received the conventional non-mRNA flu shot.

This contrasts with Pfizer’s claims that the vaccine delivered “statistically superior efficacy” compared to the conventional flu shot, and that the frequency of serious adverse events was “similar” across the mRNA and non-mRNA groups.

“The disposition of the kidney and lung issues associated with the mRNA shot was concerning,” Jablonowski said.

Some experts noted that even among the 18-64 age group, adverse events were higher among trial participants who received the mRNA shot.

The only mention of the trial data for people 65 and over in the NEJM came in an accompanying editorial, which noted that this age group faces “the highest risk of hospitalization or death” from the flu.

Dr. Meryl Nass, a former internist and founder of Door to Freedom, said she was encouraged by Makary’s remarks. She said the FDA is legally required to license only those drugs that are proven to be safe and effective.

“This mandate is at least 70 years old,” Nass said. “What Makary is saying is already mandated by Congress. But the FDA has chosen to ignore that mandate due to politics, and Congress has failed to enforce it. Makary is actually obeying the law for the first time in decades regarding flu shots.”

Makary: annual mRNA vaccination ‘not based on science’

Makary told Fox News that past administrations rubber-stamped vaccine approvals even when safety data was questionable.

“That was the MO in the Biden administration with the eternal COVID booster approvals for young healthy kids,” Makary said.

The current administration will adopt a different approach to vaccine approvals, especially for children, Makary said.

“Recommending that a 6-year-old girl get another 70 mRNA COVID shots, one each year for the rest of her life, is not based on science,” Makary said.

Makary’s remarks came days after the release of a leaked memo in which Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said changes are coming to the framework for evaluating flu vaccines.

“We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. We will re-appraise safety and be honest in vaccine labels,” Prasad wrote in that memo.

Dr. Robert W. Malone, a member of ACIP and the committee’s influenza workgroup, told The Epoch Times that Prasad’s memo means “the entire influenza vaccine, annual vaccination enterprise is now subject to major disruption.”

In May, COVID-19 vaccine manufacturer Moderna withdrew its application for FDA approval of a combination mRNA flu and COVID-19 vaccine, after the FDA requested more clinical trials.

In June, the CDC’s vaccine advisers voted to stop recommending flu shots that contain thimerosal — a mercury-based preservative linked to neurodevelopmental disorders, including autism.

‘No one has figured out’ how to make mRNA shots safe

Makary’s statements came amid growing questions about the safety, efficacy and necessity of existing non-mRNA flu vaccines and waning uptake of the shots.

A Cleveland Clinic study published in April found that people who received the flu vaccine were 27% more likely to get the flu than those who didn’t.

Another study, published that month in JAMA Network Open, found that flu vaccines, whether given alone or in conjunction with COVID-19 shots, caused women to have longer menstrual cycles.

Endpoints News reported last month that public demand for flu vaccines is stalling and that “the general consensus among vaccine makers for Covid-19, flu and RSV is that dampening demand has shrunk sales.” Data from Eurostat indicate a decline in flu vaccine uptake in the European Union.

Research into mRNA-related platforms is also facing growing scrutiny. In August, the U.S. Department of Health and Human Services cancelled nearly $500 million in funding for mRNA vaccine research.

“With regard to mRNA injections, no one has figured out how to make them safe,” Nass said. “mRNA shots provide an unknown dose, and they can be ‘the gift that keeps on giving,’ because we don’t know how to shut off the production of mRNA-coded proteins. We probably never will.”

Nass added that while FDA rules require that a specific dose be established for every drug, “somehow this rule has never applied to mRNA vaccines.”

“I believe the mRNA platform is irrevocably flawed for this reason alone, although there are other toxicities involved that also make the platform problematic,” Nass said.

A growing number of scientists have called for the suspension or withdrawal of the administration of mRNA vaccines and products.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

December 20, 2025 - Posted by aletho | Corruption, Science and Pseudo-Science | CDC, European Union, FDA, United States