FDA Asks Sarepta to Halt Gene Therapy After Three Deaths

Agency's "safety first" approach to Elevidys muscular dystrophy therapy contrasts with its clemency to the Moderna and Pfizer vaccine Cosa Nostra.

Sarepta Therapeutics is in hot water with the FDA and its stock has been hammered after three deaths were reportedly linked to its Elevidys muscular dystrophy gene therapy. As reported by Bloomberg:

Two teenage boys died of acute liver failure in recent months after taking Elevidys. They were being treated for Duchenne muscular dystrophy and weren’t able to walk because of the muscle-wasting disease. Separately, the company said Friday that a 51-year-old patient died of acute liver failure last month in an early-stage trial of a gene therapy to treat limb-girdle muscular dystrophy.

FDA leaders met with Sarepta, the agency said in a statement, and requested it voluntarily stop all shipments of the drug, which is its biggest product. “The company refused to do so,” the agency said.

This morning comes the news that the Children's Hospital Los Angeles (CHLA) has announced it will halt the use of Elevidys, further pressuring the stock, which was already at a nine-year low.

The FDA’s response to Sarepta’s trouble with Elevidys starkly contrasts with its breathtaking leniency with Moderna and Pfizer in the matter of their COVID-19 mRNA gene therapy injections that have been misleadingly categorized as “vaccines.”

On August 1, 2022, thoughtful and attentive cardiologists were stunned by the publication of a report that two teenage boys had died within the first week after receiving the second Pfizer-BioNTech COVID-19 dose. Autopsies confirmed that both had died of vaccine-induced myocarditis.

As we note in Chapter 26 of our book Vaccines: Mythology, Ideology, and Reality:

As of April 25, 2025, 19,403 American deaths have been reported to the Vaccine Adverse Event Reporting System (VAERS), mostly by healthcare professionals who believe these deaths are vaccine related. Approximately 1,134 deaths on the day of vaccination have been reported, and 1,266 on the day after vaccination. A study published in 2010 by principal investigator Lazarus Ross, MBBS, MPH for Harvard Pilgrim Health Care, Inc. found that “fewer than 1 percent of vaccine adverse events are reported” to VAERS. Using the far more conservative estimate of 3.3 percent, or a 1 in 30 under-reporting factor, 19,403 yields a nationwide estimate of 582,090 US vaccine deaths.

Sarepta is not a vaccine producer. Its Elevidys therapy is categorized as a pharmaceutical product without the special liability protection granted to substances categorized as “vaccines.”

What is happening to Sarepta is evidence that companies such as Moderna and Pfizer—i.e., companies that have availed themselves with the mystical appellation of “Vaccine Producers”—have obtained a unique status in human affairs akin to an ancient and powerful religious institution.

Vaccine Producers have also succeeded in placing innumerable “friends” in federal agencies—including the DoD, CIA, and HHS—whose entrenched power supersedes the executive power of HHS Secretary Robert F. Kennedy, Jr.

The Sicilian Mafia calls itself the “Cosa Nostra,” which translates into English as “This Thing of Ours”—a sardonic and veiled reference to a secretive power structure erected over centuries that has proven remarkably immune to the reform efforts of honest law officers. Dedicated cops and prosecutors come and go and many die violently, but “This Thing of Ours” remains.

Vaccines: Mythology, Ideology, and Reality will be published on July 29. Please click on the cover image below to see the book’s Amazon product page and consider ordering a copy.