Moderna's mRNA flu vaccine showed abysmal efficacy in preventing hospitalization. It also showed a higher risk of adverse events, including death, compared with a non-mRNA standard-dose flu vaccine, according to a reanalysis of the FDA's clinical data. The authors of the reanalysis, including Dr. Peter McCullough and Nicolas Hulscher, urged U.S. Health Secretary Robert F. Kennedy Jr. to halt distribution of the shots.

Moderna's mRNA flu vaccine should be immediately withdrawn from the market due to the shot's huge risks and small benefits, according to a reanalysis of the U.S. Food and Drug Administration's (FDA) own data on the vaccine's risk-benefit profile.

The authors — cardiologist Dr. Peter McCullough, epidemiologist Nicolas Hulscher and natural medicine physician John Catanzaro, Ph.D. — on Wednesday published their results on the preprint server Zenodo.

They reanalyzed clinical data on the safety and efficacy of Moderna's mFLUSIVA (mRNA-1010) flu vaccine from an FDA briefing document that the FDA's vaccine committee reviewed at its June 18 meeting. During that meeting, the committee unanimously voted to endorse Moderna's mRNA flu vaccine for people 50 and older.

The briefing document, which reported results from safety and efficacy studies conducted by Moderna, was prepared by the FDA's Division of Clinical and Toxicology Review, part of the agency's Office of Vaccines Research and Review.

According to the reanalysis by McCullough's team, Moderna's mRNA flu vaccine showed abysmal efficacy in preventing hospitalization. It also showed a higher risk of adverse events, including death, compared with a non-mRNA standard-dose flu vaccine

For example, their analysis of data from one of the shot's main trials revealed that, to prevent a single hospitalization, 5,017 adults had to receive the mRNA flu vaccine, the authors said.

Meanwhile, the mRNA shot had roughly 1,454 additional solicited adverse reactions, 233 additional Grade 3 systemic reactions severe enough to prevent normal daily activity, and approximately two excess unexplained deaths, compared to the non-mRNA shot.

Additionally, neither of the two main trials for the mRNA shot used a placebo or looked at whether the shot prevented flu-related deaths.

According to the report, "A vaccine licensed in large part to prevent severe influenza outcomes was never tested against influenza death; no influenza-mortality endpoint appears anywhere in its development program."

The authors sent a letter about their findings to U.S. Health Secretary Robert F. Kennedy Jr., calling on him to remove the shot from the market.