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FDA Refused To Release Vaccine Myocarditis Results?!

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Did the FDA refuse to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine?!

Take a look at the viral claim, and find out what the facts really are!

 

Claim : FDA Refused To Release Vaccine Myocarditis Results!

People are sharing an article by The Epoch Times which claims or suggests that the US FDA is refusing to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine!

Here is an excerpt of The Epoch Times article. Feel free to skip to the next section for the facts:

FDA Has Results of Subclinical Myocarditis Studies, but Won’t Release Them Yet

The U.S. Food and Drug Administration (FDA) has received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but is refusing to release them to the public—at least for now.

FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis, or heart inflammation without symptoms, after COVID-19 booster vaccination. One study, mRNA-1273-P204, would examine the incidence of subclinical myocarditis in children aged 6 months through 11 years. Another, mRNA-1273-P203, would examine the incidence in adolescents aged 12 years through 17 years. The third, mRNA-1273-P301, would examine the incidence in adults.

Moderna has shared the results of the P203 study with the FDA, an FDA spokeswoman told The Epoch Times in an email. But she declined to provide them. To obtain the results, she said, The Epoch Times would need to request them under the Freedom of Information Act (FOIA).

“The FDA doesn’t post PMR/PMC study reports,” she said, using acronyms for postmarketing requirements and postmarketing commitments, or requirements and commitments pharmaceutical companies make when receiving FDA clearance for their products. “They may be requested under FOIA.”

The spokeswoman did not disclose why the FDA doesn’t release the results absent a FOIA request. Moderna has not responded to requests for comment. The Epoch Times has submitted a FOIA request for the results but has not yet received them.

Jessica Adams, a former FDA officer, asked for the P301 study results in July. She requested quick processing because, according to cardiologists, subclinical myocarditis can result in serious problems. She cited a recent study that discovered some sudden deaths in South Korea were caused by myocarditis, even though no inflammation was detected until autopsy.

The matter “represents an urgent and imminent threat to young people who may be mandated to take this vaccine,” Ms. Adams told the FDA.

A number of U.S. colleges have required COVID-19 vaccination for attendance. Some are requiring the newest version of the shots from Moderna, Pfizer, and Novavax, even though they were authorized with human data from just 50 people.

The FDA rejected the bid for quick processing.

“You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual,” Sarah Kotler, an FDA FOIA official, told Ms. Adams. “Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged federal government activity.”

An appeal was also turned down.

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No Evidence FDA Refused To Release Vaccine Myocarditis Results

In this article, I will go through some of their points, and show you what the facts really are!

Fact #1 : Moderna Studies Started In 2020-2021

First, let me start by pointing out that the three Moderna studies mentioned in The Epoch Times article did not begin in 2022. Rather, they started in 2020 / 2021:

Fact #2 : FDA Did Not Order Those Studies In 2022

The Epoch Times article claimed that “FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis“, and provided this FDA document (PDF download as evidence.

If you actually look at the FDA document, titled Summary Basis for Regulatory Action, you’ll realise that it tells a completely different story:

  • it stated that the Review Committee recommended the approval of the Moderna SPIKEVAX mRNA vaccine for COVID-19
  • it mentioned the P203, P204, and P301 studies which were already running by then.
  • it stated that Moderna requested the deferment of three paediatric studies, including P203 and P204.
  • it stated that the FDA approved Moderna’s request to defer the paediatric studies in December 2021.

To address requirements of the Pediatric Research Equity Act, the Applicant submitted a request for deferral of the following studies in pediatric individuals ˂18 years of age because the mRNA-1273 vaccine would be ready for approval for use in adults before such studies could be completed. The deferred studies are:

  • Deferred pediatric study P203 to evaluate the safety and effectiveness of mRNA-1273 vaccine in children 12 years through 17 years of age
  • Deferred pediatric study P204 to evaluate the safety and effectiveness of mRNA-1273 vaccine in children 6 months to <12 years of age
  • Deferred pediatric study to evaluate the safety and effectiveness of mRNA-1273 vaccine in infants <6 months of age

The deferral request and pediatric plans were accepted without revisions by the FDA Pediatric Review Committee on December 14, 2021.

To be clear – the P203, P204, and P301 studies were already running in 2021 – long before the FDA released that PDF.

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Fact #3 : FDA Has PMR/PMC Website

The FDA requires manufacturers of certain drug products (including vaccines) to conduct postmarket studies and clinical trials to assess for possible serious risks associated with those drugs / vaccines.

Referred to as postmarket requirements (PMRs) and postmarket commitments (PMCs), these studies are conducted after the approval of the drugs / vaccines.

You can actually look up PMR / PMC studies on the FDA website (link). Here are the results of the three Moderna trials mentioned in the article:

  • mRNA-1273-P203 : Final report submitted to FDA on 13 January 2023
  • mRNA-1273-P204 : Study is ongoing
  • mRNA-1273-P301 : Study is ongoing

Fact #4 : PMR / PMC Report May Be Requested

Even though the FDA regularly releases information about PMR / PMC studies, it does not release the actual data or results. This is not just for COVID-19 vaccines. This policy extends to all PMR / PMC studies.

As an FDA spokesperson explained to The Epoch Times, those reports may be requested through a FOIA (Freedom of Information Act) request.

The FDA doesn’t post PMR/PMC study reports. They may be requested under FOIA.

You may wondering why the FDA cannot publicly release PMR / PMC study results. That’s because those documents may contain classified information, personal information, confidential business details, or even trade secrets.

Anyone can make a FOIA request for these reports, but the FDA must first go through the reports, and redact information that are exempt from disclosure under FOIA, before they can be released.

Recommended : Why Adverse Events of Special Interest Are NOT Side Effects!

FDA Refused To Release Vaccine Myocarditis Results?!

Fact #5 : FOIA Delays Due To Excessive Requests

Ironically, a key reason why the FDA cannot expedite FOIA requests for those three Moderna studies is because it was compelled by US District Judge Mark Pittman to expedite the processing of some 329,000 pages of documents requested by PHMPT looking into the Pfizer COVID-19 vaccine!

That decision came after the PHMPT demanded that the FDA release all those documents within 108 days. Now that the FDA is compelled to focus on processing those documents, it has far less resources to process other FOIA requests.

Fact #6 : No Evidence Of Vaccine Subclinical Myocarditis

While the article appears to suggest that the Moderna P203 study results may prove that the Moderna mRNA vaccine causes subclinical myocarditis, it offers no proof of that. The article only points out that:

  • Moderna submitted its final report on the P203 study to the FDA
  • The Epoch Times requested for the Moderna report
  • The FDA told The Epoch Times to file an FOIA request
  • The Epoch Times filed its FOIA request in July 2023
  • The Epoch Times has not received the report as of 11 October 2023

Jessica Adams, who requested the P301 study results in July 2023, was told by the FDA that it would take “at least two years” for her to receive the results.

The Epoch Times article actually mentioned this, so there is no reason to believe that its P203 request made in the same month would be released anytime soon.

To be clear – there is not even a hint of smoke, because none of them actually have access to any of the three Moderna study results – two of which are still ongoing!

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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