FDA Reveals Why It Changed End Date of Study of Heart Inflammation After COVID Vaccination

The U.S. Food and Drug Administration (FDA) Changed the End Date of a Study It Requires Pfizer The agency states that Pfizer asked for a delay and the agency is allowing it to proceed.

“The company requested an extension from FDA for completion, which the agency granted,” An FDA spokesperson spoke to The Epoch Times via email.

When the FDA approved Pfizer’s vaccine in August 2021, it said Pfizer was required to conduct postmarketing studies to evaluate the safety of the vaccine.

One of the studies was to examine subclinical myocarditis (heart inflammation) after receiving a third dose. This was in patients aged 16 to 30.

This study was due to end on June 30, 2022. Pfizer will submit a final report about the results to FDA by December 31, 2022.

After The deadline was metThe FDA The end date was quietly altered To June 30, 2023

The FDA declined comment to explain why Pfizer asked for an extension and, in any case, the reason.

“You may request any communications between FDA and the company by submitting a Freedom of Information Act request. You may also wish to contact the company directly,” According to the spokesperson of the agency.

Pfizer has not yet responded to our inquiries.

The Epoch Times submitted Freedom of Information Act requests to obtain emails and other material relating the change.

Jessica Adams, a former FDA officer who has been critical of how the issue has been handled, first disclosed that the FDA delayed the end date at Pfizer’s request.

Adams described the situation on Twitter as alarming. “I can’t think of any possible justification for this,” She wrote.

‘Public Deserves to Know’

Kim Witczak, a Drug safety advocate The man who discovered that antidepressants may increase suicide risk, was a Pfizer researcher. He believes that this is why the critical Pfizer study has been delayed.

“The public deserves to know why Pfizer was NOT able to meet their post-marketing deadline. The completion dates for post-marketing studies were established in good faith at the time of authorization. There is no excuse for this delay especially given the concerns with myocarditis,” Witczak spoke to The Epoch Times via email.

“If safety was a top priority, the FDA would have denied the request and demanded this study instead of quietly allowing the extension. Where’s the transparency the public was promised? It makes me wonder if the company doesn’t like the data they are seeing and need to figure out a way to report on the findings,” She continued. “Hopefully, the documents obtained by FOIA will shine a light on the reason.”

With regards to Zoloft, an antidepressent made by Pfizer, she noted that internal company cOrrespondence revealed in her legal case against the company over her husband’s suicide after starting to use Zoloft showed the company discussing whether to give the FDA a “simple straight-forward report” or “a complicated and confusing one” adverse reactions to Zoloft.

Pfizer was concerned over how FDA would interpret data. “do[ing] some sort of review and put[ting] our interpretation into it, and not provide them with a straight listing that they might then interpret in a manner that we believe to be not appropriate,” One message.

The case was finally settled for an undisclosed amount.

Myocarditis

Myocarditis has been occurring at higher-than-expected rates in the United States in many age groups, especially young males, following COVID-19 vaccination. It is very serious. Has been to deaths.

A connection between the Pfizer and Moderna vaccines and myocarditis wasn’t detected until after the FDA authorized them in late 2020. According to experts at the U.S. Centers for Disease Control and Prevention, the vaccines both use messenger RNA technology to cause heart inflammation.

FDA denied that the vaccine was safe at the time of approval. “assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”

“Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies,” FDA stated that six studies were available on heart inflammation, and three are for wider vaccine safety.

The one that was delayed had the earliest completion. One study has been completed but no results have been released. The final report is due Oct. 31, 2023. May 31, 2024 is the next possible end date. Others will be due in 2024 and 2025 or 2026.

‘Error’

The FDA has listed subclinical Myocarditis as one of the required studies for vaccines on its portal. “Original Projected Completion Date” of June 30, 2022. That’s false.

FDA admits it is false but does not want to remove the misleading information from its website.

“The data field, ‘Original Projected Completion Date’ was updated in error; it should reflect the date that is in the approval letter,” According to the spokesperson of the agency.

“The date will be corrected during the next routine update to the website,” According to the spokesperson.

However, the incorrect date has been updated as of February 14.

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