Sat Mar 23, 2024 11:33 pm by globalturbo
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.
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.
MORE HERE: https://justthenews.com/government/federal-agencies/fda-blasted-misleading-mrna-covid-vaccine-labels-sudden-death-research
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.
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.
MORE HERE: https://justthenews.com/government/federal-agencies/fda-blasted-misleading-mrna-covid-vaccine-labels-sudden-death-research
