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

‘I really don’t think FDA has a leg to stand on here,’ former FDA officer says.

A medical assistant holds a tray of syringes filled with doses of Moderna COVID-19 vaccine at a vaccination site in Los Angeles on Feb. 16, 2021. Apu Gomes/AFP via Getty Images

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.

Moderna told Undark in September that it sent the results from another one of the studies, the P301 study, to the FDA.

The FDA did not deny it has received the results from the P301 study.

The Epoch Times submitted a FOIA request for the results from that study in July. It has not yet received them.

The FDA’s postmarketing database lists all three studies it directed Moderna to run on subclinical myocarditis as “ongoing.”

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.

“Neither your original request nor your appeal provided any information demonstrating that immediately prior to making your request on July 5, 2023, that the incidence of ’subclinical myocarditis’ in youth from the administration of either Pfizer’s COMIRNATY or Moderna’s SPIKEVAX vaccine products was the subject of breaking or currently unfolding news stories,” Martina Varnado, an FDA official, said in the letter rejecting the appeal.

“It shouldn’t take a FOIA request to obtain these study results that are relevant to potentially update the benefit-risk profile,” Ms. Adams told The Epoch Times via email. She added, “I really don’t think FDA has a leg to stand on here.”

The U.S. government has a pattern of withholding information on COVID-19 vaccines, including the results of autopsies conducted on people who died after receiving one. It has faced a number of lawsuits over the withholding.

With quick processing out of the question, Ms. Varnado said it would take at least two years for Ms. Adams to receive materials responsive to her request.

She said two suits have been taking up many of the FDA FOIA office resources. In those cases, judges ordered the FDA to produce records concerning the Pfizer and Moderna COVID-19 vaccines.

The U.S. Food and Drug Administration (FDA) building in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Pfizer

The FDA also directed Pfizer to carry out studies on subclinical myocarditis, but permitted the company to push back the deadline to report the results from the study with the earliest deadline. The revised deadline was set to June 30. The FDA spokeswoman suggested to The Epoch Times that the FDA has still not received the results. The agency’s database lists the current status as “delayed.”

The Epoch Times submitted FOIA requests concerning the Pfizer study in January.

The requests are “pending” at the FDA’s Center for Biologics Evaluation and Research, Ms. Kotler told The Epoch Times in an email.

“That office has a large backlog due to the many COVID vaccine related FOIA requests and litigations,” she said.

Pfizer has not responded to requests for comment.

The study in question is a prospective one aimed at examining the incidence of subclinical myocarditis in people aged 16 to 30 following receipt of a third dose of Pfizer’s vaccine.

Pfizer’s other study is not due until 2024. That study is supposed to examine the incidence of subclinical myocarditis after a second Pfizer dose in people aged 5 to 15,

Myocarditis is a known side effect of the Pfizer and Moderna shots. The FDA and the U.S. Centers for Disease Control and Prevention knew about cases in early 2021 but hid them from the public for months, an investigation from The Epoch Times found.

Only one prospective study on myocarditis has been run in the United States. It found a second dose increased the number of vascular function symptoms in adults.

Prospective papers from other countries have found high incidence rates, including two of 324 people studied in Israel.

A prospective subclinical myocarditis study conducted at a Swiss hospital, with results reported this year, discovered signs of heart injury in one of 35 workers who received Moderna’s vaccine.