Published: May 25, 2023 | Dr. Michael Nevradakis, Ph.D.

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.

New evidence suggesting public health officials knew early in 2021 that COVID-19 vaccines posed a heightened risk of myocarditis in young men — but withheld that information from the public — raises questions about whether federal health agencies violated any laws.

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.

Kim Mack Rosenberg, acting outside general counsel for CHD, told The Defender:

“As more and more information becomes publicly available, it becomes ever clearer that claims that EUA [Emergency Use Authorization] vaccines were safe and effective ring hollow, at best.

“While the PREP Act purposefully creates challenges to suing the parties responsible for this debacle, Children’s Health Defense continues to pursue possible ways to seek justice for those injured and betrayed.”

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.”

Hooker told The Defender:

“The paper I published with Dr. Karl Jablonowski makes it clear that the CDC knew about the myocarditis signal at least as early as Feb. 19, 2021 — when the signal became significant on VAERS [Vaccine Adverse Event Reporting System].  This is when the vaccination rate in the U.S. was about 8%.

“Despite mounting evidence from multiple sources that this was a huge problem, the CDC chose to hide this signal until they finally, quietly posted a new website suggesting there might be a myocarditis signal on May 27, 2021. At that point, the vaccination rate had risen to about 50%.

“CDC let 42% of the U.S. population get vaccinated, knowing full well that mRNA vaccines were causing myocarditis, which is criminal.”

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:

“What is even more astounding is that professional sports leagues — for example, the National Football League — mandated (starting August 2021) the heart-damaging COVID-19 vaccines after the CDC/FDA warning in June 2021.

“The cardiology position papers before COVID-19 clearly warned that exercise during active myocarditis is strictly prohibited because it can trigger a cardiac arrest. Once the vaccines were mandated, none of the teams took adequate safety measures for the players.”

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.

“We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine,” the letter stated. “We would like to discuss the issue with a relevant expert at CDC.”

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.

“Having then pushed COVID vaccine clinics for kids in a major way, the agencies finally admitted there was a danger signal about 6 weeks later, on June 23, 2021, at the ACIP meeting,” where “stunning” data were revealed, according to Nass.

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.

“It is curious that CDC did not separate the 12-15-year-olds from the 16-17-year-olds who were authorized to receive the vaccine six months earlier (on December 11, 2020 for the Pfizer shot),” Nass said.

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.

Nass observed a discrepancy in the data, writing:

“The data were collected through May 31, 2021. There were only two [myocarditis] cases in 12-15-year-olds because there was not enough time for that age group to get their second shot: it was authorized for them on May 10, and they had to wait three weeks for the second dose. Three weeks later was May 31, the data cut-off.

“So, there should have been no myocarditis reports from the 12-15 year age group, because not enough time had elapsed for them to legally receive a second dose. Yet his chart claims 134,000 second doses had been administered by May 31.”

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.

Nass also observed that out of 12 million people who were enrolled in the VSD database, one-third of vaccinated 16-17-year-olds did not return to receive a second dose of the COVID-19 vaccine.

“Presumably most had a troublesome adverse reaction,” Nass wrote.

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.”

“Not even one of the adverse events the CDC thought were most likely associated with COVID vaccines had generated a safety signal by May 29, 2021 in the VSD. Or so the CDC claimed,” Nass said.

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.”

“I think they did not want us to see the ARR for myocarditis associated with Moderna’s second dose, because it would have been sky-high,” Nass wrote, noting that studies have shown that “the Moderna vaccine is much more strongly associated with myocarditis than the Pfizer vaccine.”

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.”

According to Nass, potential negligence on the part of federal public health agencies also extends to the fact sheets that are included with the COVID-19 vaccines.

“The fact sheets that substitute for informed consent, and are required to be given to all vaccine recipients, should have been updated with this warning immediately, according to the PREP Act. It requires that significant known risks be disclosed. I’d call heart damage and the risk of sudden death significant,” Nass wrote.

This was despite what the FDA described in the June 10, 2021, presentation as “the most intensive vaccine safety monitoring in U.S. history.”

For Nass, this delay in reporting the myocarditis safety signals may potentially be legally actionable, as “Willful misconduct is clearly demonstrated.”

“I think an adolescent who received the Pfizer or Moderna COVID vaccine in May or before June 23, 2021, and developed myocarditis would have a very interesting lawsuit,” Nass said, adding:

“The PREP Act requires that in lieu of informed consent, recipients must be given a fact sheet and it must disclose all significant risks. It did not, until months after myocarditis was known to be a risk. The risks were not told to the advisory committees either, in a timely way.

“The numbers appear to have been played with, or the method of assessing risk. With discovery, we will get even more information on how the statistics were fudged.”

However, challenging the PREP Act is a difficult proposition, said Nass:

“To bring a PREP Act lawsuit, you need to show willful misconduct and get the Secretary [of HHS] to okay a lawsuit. This is a bar to litigation higher than anything else in U.S. law.

“I was hopeful that with this level of evidence, the misconduct is blatant enough that the Secretary would be drawn in to say okay or refuse — and publicity could be obtained about that refusal.”

Other legal experts who spoke to The Defender agreed and also noted that fact sheet requirements have frequently not been honored, with many COVID-19 vaccine recipients not having been provided the information at the time of vaccination.

As early as October 2021, Sweden’s Public Health Agency paused Moderna’s COVID-19 vaccine for people born 1991 and later, “as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated,” according to Reuters.

At around the same time, Finland’s public health authorities also paused the vaccine in young people.

And in November 2022, Sweden paused the Novavax COVID-19 vaccine for those under 30, due to an increased risk of myocarditis and pericarditis.

Novavax received EUA from the FDA despite “Multiple events of myocarditis/pericarditis” recorded during clinical trials.

Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”

The original article can be viewed here

Note: The views expressed on vinceiori.org are not necessarily those of Vince Iori, Vince’s Blog, or Vince Iori Live.

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