New evidence suggests the Centers for Disease Control and Prevention and U.S. Food and Drug Administration may have violated the Public Readiness and Emergency Preparedness Act when they withheld knowledge about myocarditis safety signals from the public and from COVID-19 vaccine fact sheets.
According to Dr. Meryl Nass, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) knew about the myocarditis safety signal in February 2021, but “hid it until they got the vaccine authorized for 12-15-year-olds in May 2021,” and then “kept pushing” the vaccine on the highest-risk groups.”
Nass said the new evidence suggests the CDC and FDA may have violated the Public Readiness and Emergency Preparedness Act (PREP Act) when they withheld knowledge about myocarditis safety signals from the public and from fact sheets included with the COVID-19 vaccines.
The new evidence includes warnings the FDA received from multiple sources, including the Israeli Ministry of Health at least as early as February 2021.
Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, this week discussed the new revelations in two Substack posts and on CHD.TV.
In an interview with The Defender, Nass said the newly discovered revelations “provide clear evidence that the agencies knew of the connection and kept it under wraps, and did not inform their advisory committees till after the vaccine was approved for the teens.”
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Brian Hooker, Ph.D., P.E., chief scientific officer for CHD and co-author of the October 2022 study that first revealed the CDC’s and FDA’s knowledge of the myocarditis safety signal in February 2021, said the new revelations suggest the actions of the two agencies were “criminal.”
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Cardiologist Dr. Peter McCullough, an outspoken critic of COVID-19 vaccines, characterized the delayed acknowledgment of myocarditis safety signals by the CDC and FDA as “astounding” and referenced the growing numbers of athletes affected by the condition after their vaccination.
McCullough told The Defender:
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By April 23, 2021, VAERS data showed the discerned level of myocarditis in young men following COVID-19 vaccination had increased to an extreme statistical level, indicating a very low likelihood that the connection between the level of myocarditis cases in this population and COVID-19 vaccination was attributable to chance.
Despite this safety signal, the FDA on May 10, 2021, expanded the EUA of the Pfizer-BioNTech COVID-19 vaccine for use in people as young as 12 years old, and the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend that all persons 12 or older get the vaccine.
According to researchers at the National Organization for Rare Disorders, myocarditis can result from infections or may result directly from a toxic effect such as a toxin or a virus. “More commonly the myocarditis is a result of the body’s immune reaction to the initial heart damage.”
Severe myocarditis can permanently damage the heart muscle, possibly causing heart failure.
Contractor alerted FDA, CDC to safety signal in February 2021
In the first of her two Substack posts, Nass wrote, “I was told that the VAERS contractor for CDC and FDA (Oracle had the contract) told the agencies there was a myocarditis adverse event signal in February 2021. This was 2 months after the Pfizer and Moderna vaccines were authorized.”
Nass referenced previous revelations by Dr. Robert Malone. Speaking at the Global COVID Summit on May 11, 2022, Malone said he had been “very actively engaged” with senior FDA personnel and William DuMouchel, Ph.D., chief statistical scientist for Oracle Health Sciences, when the COVID-19 vaccines were rolled out.
“We were talking by Zoom on a weekly or twice a week basis,” Malone said. “This is the group that first discovered the signal of the cardiotoxicity” and “absolutely did know” of such adverse events — “and did not acknowledge it.”
Nass also referred to a June 23, 2021, ACIP meeting, where during a presentation on myocarditis and pericarditis, the presenter acknowledged that in over 80% of instances, myocarditis appeared within four days of the second COVID-19 vaccine dose.
And she shared a letter that came into her possession, sent by the Israeli Ministry of Health to the European Medicines Agency on Feb. 28, 2021, “investigating a safety signal of myocarditis/peri-myocarditis in younger population (16-30 years old) following administration of Pfizer COVID-19 vaccine.”
Data provided by the CDC in February following a Freedom of Information Act request by CHD showed that on Feb. 28, 2021, the Israeli Ministry of Health also contacted the CDC with a similar request.
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According to the letter, Israeli health officials had received reports of approximately 40 such cases of myocarditis and/or pericarditis.
“Israeli media were all over the story” by April 2021, Nass said, with estimates reported at the time that “young men had a 25 times elevated risk of myocarditis after the shots.” But despite some coverage in international media, such as Reuters, “somehow the story never got legs” in the U.S.
But according to Nass, “The CDC and FDA … managed to keep the story under wraps, denying any vaccine problems at an advisory committee meeting.” This continued until the FDA’s May 10, 2021, granting of EUA for the Pfizer-BioNTech COVID-19 vaccine for adolescents.
It took an additional six weeks for public health agencies to acknowledge the myocarditis safety signal.
[…]CDC data full of discrepancies
In her analysis of the June 23, 2021 ACIP meeting, Nass referenced a presentation by the CDC’s Dr. Tom Shimabukuro, showing that as of June 11, 2021, over two million males between the ages of 12 and 17 had received two doses of an mRNA COVID-19 vaccine, with 128 “observed” cases of myocarditis identified in this population.
According to Nass, the reason such a relatively low number of myocarditis cases was observed at this time in this population was that COVID-19 vaccines had been authorized for 12-15-year-olds for only 32 days before the data cutoff — and in those 32 days, adolescents would have had to receive both doses, develop myocarditis symptoms and have filed, or had someone file on their behalf, a VAERS report.
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She also referenced a separate June 10, 2021, talk by Shimabukuro to the FDA’s vaccine advisory committee (VRBPAC), where preliminary safety data — including myocarditis cases recorded through May 31, 2021 — from VAERS, V-Safe and VSD (Vaccine Safety Datalink) were discussed.
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Nevertheless, “people under age 25 comprised only 8.8% of the second doses received, but were 52.5% of the myocarditis cases reported,” Nass said, adding that this age group was six times more likely to be diagnosed with myocarditis than the overall population.
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Another potential discrepancy from the data presented at the June 10, 2021, meeting pertained to adverse events reported within 21 days of either dose of the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines.
According to Nass, the data presented indicated that all of the “prespecified outcome events” — as the adverse events were referred to — were “unassociated statistically with COVID vaccines.”
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Nass suggested that such an outcome was not possible. According to Nass, the data presented at the meeting indicated that “people given other vaccines were more likely to get myocarditis than those who got a COVID vaccine.”
However, Nass noted that “the only other vaccines that commonly cause myocarditis are smallpox and monkeypox, and neither was being given to civilians at the time.”
Another possible discrepancy from the June 10, 2021, meeting pertained to statistics presented that showed “only 22 cases of diagnosed myocarditis in 16-39 year old enrollees in the VSD. Eighteen occurred after the second dose. Fourteen were in those who received Moderna.”
According to Nass, this data was “strange,” because “Even though 11 episodes of myocarditis occurred after the second Moderna dose, there is a claim that the adjusted rate ratio (ARR) is ‘non-estimable.’ Yet Dr. Shimabukuro estimated the ARR for Pfizer’s first dose when there was only one myocarditis case.”
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Nass also noted that the Department of Health and Human Services (HHS), the parent agency of both the CDC and the FDA, holds patents in Moderna’s COVID-19 vaccine.
Even with such potential discrepancies in the data, Nass wrote that the information presented at the June 10, 2021, VRBPAC meeting made it “clear that even by May 29, the second dose caused over five times as many myocarditis cases as the first dose. For both brands,” adding that “This cannot be a random event.”
In Hooker and Jablonowski’s October 2022 study, VAERS data was referenced, which showed 24,371 reports of myocarditis and pericarditis between Dec. 14, 2020, and Oct. 14, 2022. Of these, 1,333 reports occurred among 12- to 17-year-olds.
This was despite the fact that the CDC uses a narrowed case definition of “myocarditis” that excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
VAERS has historically been shown to report only 1% of actual vaccine adverse events.
‘I would call it a criminal coverup’
According to Nass, “the CDC worked to cover its derriere regarding the myocarditis ‘signal’ — I would call it a criminal coverup — regarding the data it was sitting on, and other data it was misrepresenting.”
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Via https://childrenshealthdefense.org/defender/fda-cdc-covid-vaccine-myocarditis-safety-signal/
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