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FDA blasted for 'misleading' mRNA COVID vaccine labels as 'sudden death' research mounts

Even FDA-funded research acknowledges "safety signal" for serious heart inflammation in 12-17 year-olds. Agency ignores federal law by demanding proven "causality," medical researchers claim.

Published: July 4, 2023 9:57pm

Updated: July 5, 2023 12:32pm

Researchers around the world continue documenting potentially severe side effects from COVID-19 mRNA vaccines in certain demographics, but the Food and Drug Administration refuses to label them or even tell recipients the shots can't stop transmission of an increasingly immune-evasive virus.

Autopsies and reviews of medical records revealed a much higher incidence of Pfizer and Moderna vaccine-associated heart deaths than officially categorized in South Korean, Japanese and Qatari government registries, particularly in younger people at lower risk from COVID. That echoes a German autopsy study of healthy people who died within 20 days of jabs.

An FDA-funded study in the Journal of the American Medical Association Pediatrics on May 22 also found a "safety signal" for myocarditis and pericarditis — forms of serious heart inflammation — following vaccination in 12-17 year-olds. It was based on "near-real-time monitoring using commercial claims databases" for more than 3 million children ages 5-17 who took Pfizer's vaccine.

Three weeks earlier, the Nature journal NPJ Vaccines published a Taiwanese study that found a much higher risk of "all forms of retinal vascular occlusion" — visual impairment — among vaccinated populations both 12 weeks and two years later, with "no disparity … between brand and dose" among mRNA vaccines.

The South Korean study, published in the European Society of Cardiology's journal, found 61% more vaccine-related myocarditis deaths following autopsies than recorded in the country's vaccine injury registry, all under age 45.

It drew attention from prominent medical researchers who unsuccessfully petitioned the FDA to require vaccine makers to add myriad notices to labels, including the weakness of evidence that they stop transmission or death and likelihood of resulting heart inflammation.

Those researchers castigated the FDA in a Hill op-ed last month, calling the mRNA vaccine labels "obsolete, misleading and out of touch with regulators" in Japan and Europe, where "heavy menstrual bleeding" is listed as a potential adverse reaction.

The South Korean study, published after the petition was rejected, adds to the "multiple autopsy studies on lethal vaccination-associated myocarditis" they highlighted to argue for adding "sudden death" to labels.

"Whatever one thought of the initial shots, people are now getting boosted indefinitely with little reliable information about scientific developments," wrote University of Maryland pharmacy faculty Linda Wastila and Peter Doshi, who is also senior editor of the British Medical Journal, and Kim Witczak, consumer representative on the FDA's advisory committee for new drugs.

By requiring proven "causality" to add mandatory warnings to mRNA vaccines, the agency is ignoring federal law that only requires "some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event" and explicitly rejects "definitively established" causality as the standard, they wrote.

The Qatari study, published in Nature Communications, reviewed all 138 recorded deaths within 30 days of vaccination in that country from Jan. 1, 2021 to June 12, 2022, using a "modified" World Health Organization algorithm. The median age was 55, 82% men and only 22% Qatari nationals. (The rich Persian Gulf country is highly reliant on foreign labor.)

Eight deaths were deemed "high probability" of association with vaccination — within five days of jabs — involving sudden cardiac death in people with "no known risk factors for cardiac disease." Seven of those were under age 50. Another 15 deaths were deemed "intermediate probability," 11 of them also sudden cardiac death and 10 under age 50, six to 15 days after vaccination. All were heart-related: sudden cardiac death or myocardial infarction.

"Since time of death from the time of last vaccination is an arbitrary measure of association," the researchers also used a second "time cut-off," finding twice as many vaccine-associated deaths: high probability for 29 deaths with no known risk factors within 15 days of jabs, and intermediate for 19 between 16-30 days. 

Under this second measurement, more than a third of deaths within 30 days of jabs were more than likely vaccine-related.

Previous research from Qatar found bivalent booster efficacy goes negative as soon as 2 months after inoculation in 5-11 year-olds, making reinfection more likely than if they hadn't been boosted.

The Japanese study, published in Elsevier's Legal Medicine, had an even more narrow range for determining vaccine-associated deaths: within seven days of jabs. Medical examiners performed autopsies on 54 patients, with a mean age of 68 and 63% men, 70% of whom received the fully licensed Pfizer Comirnaty, 11% Moderna Spikevax and the rest not known.

While only seven had evidence of vaccine association — five "possible" and two "unlikely" — myocarditis killed the youngest recipients, ages 24 and 39 (both Spikevax), and cerebral hemorrhage killed a 52-year-old (vaccine unknown) whose only known condition was stomach pain. Another 39-year-old Spikevax recipient died of unknown causes "but slight lymphocyte and macrophage infiltration in the interstitial space of myocardium was observed." All were men.

The Japanese and Qatari studies have received little attention since they were published in late 2022 and early 2023, former New York Times drug industry reporter Alex Berenson wrote in his newsletter last week.

He's especially concerned by the latter, which suggests mRNA vaccines carry a 1-in-50,000 risk of sudden cardiac death for "healthy young adults" and thus "several thousand sudden deaths from mRNAs within weeks - in people at almost no risk from Covid."

The FDA gave Just the News a lengthy statement and background Wednesday following a Monday request for its response to the foreign research and criticism of the basis for its rejection of new warning labels.

The "safety and effectiveness of the mRNA COVID-19 vaccines ... are fully supported by the available scientific data" and getting every recommended booster, which the agency calls "staying up to date ... is the best way to reduce the risks of death and serious illness or hospitalization from COVID-19." It did not make distinctions based on age or risk level from COVID.

That said, safety monitoring systems have found "several health problems potentially associated with vaccination" including heart inflammation following both mRNA and traditional Novavax vaccines, and the FDA added a warning to the fact sheet "as soon as " it became aware of "reasonable evidence of a causal association" specifically for mRNA vaccines.

"The chance of having this occur is very low," the agency emphasized. It has updated the warning over time "based on the data that have accrued" to, for example, convey "risk information based on age and sex," and testified on the subject in public hearings.

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