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

The Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

The U.S. Food and Drug Administration (FDA) changed the end date of a study it is requiring Pfizer to conduct because Pfizer requested a delay, the agency says.

"The company requested an extension from FDA for completion, which the agency granted," an FDA spokesperson told 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 meant to assess post-vaccination subclinical myocarditis, or heart inflammation, following a third dose of the vaccine in people aged 16 to 30.

That study was going to be completed on June 30, 2022, with Pfizer submitting a final report on the results to the FDA by Dec. 31, 2022.

After the deadline passed, the FDA quietly changed the end date to June 30, 2023.

The FDA declined to say whether it knows why Pfizer wanted an extension and, if so, what the rationale was.

"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," the agency spokesperson said.

Pfizer has not responded to inquiries.

The Epoch Times has submitted Freedom of Information Act requests for emails and other materials relating to 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 on Twitter described the situation as disturbing. "I can't think of any possible justification for this," she wrote.

'Public Deserves to Know'

Kim Witczak, a drug safety advocate who helped uncover that antidepressants can increase the risk of suicide, said that the reason for delaying the crucial Pfizer study needs to be released.

"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 told 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 added. "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" on adverse events after Zoloft.

Pfizer was concerned about how the FDA would interpret the data, and discussed "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," according to one message.

The case was ultimately settled for an undisclosed amount of money.

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. The condition is serious and has led to deaths.

A connection between the Pfizer and Moderna vaccines and myocarditis wasn't detected until after the FDA authorized them in late 2020. The vaccines, both of which utilize messenger RNA technology, cause the heart inflammation, according to the U.S. Centers for Disease Control and Prevention and other experts.

At the time of the vaccine approval, the FDA said it was not able to "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," the FDA said, listing six studies on heart inflammation and three for broader vaccine safety.

The one with the earliest completion date was the one that has been delayed. One study has already been completed, but results have not been released and the final report is not due until Oct. 31, 2023. The next earliest end date is May 31, 2024. Others are due in 2024, 2025, or even 2026.

'Error'

On its portal outlining the state of studies required for vaccines after authorization or approval, the FDA listed the subclinical myocarditis study as having an "Original Projected Completion Date" of June 30, 2023. That's false.

The FDA is acknowledging that it is false, but is leaving the false information up on its website for now.

"The data field, 'Original Projected Completion Date' was updated in error; it should reflect the date that is in the approval letter," the agency spokesperson said.

"The date will be corrected during the next routine update to the website," the spokesperson said.

As of Feb. 14, the wrong date is still listed.

Correction: A previous version of this article incorrectly listed the new completion date. It's June 30, 2023. The Epoch Times regrets the error.