Regulator Didn’t Tell Public About Post COVID-19 Vaccination Myocarditis for Four Months

The MHRA said it needed to assess data from multiple sources before adding warnings to COVID shots.

A file photo shows a worker preparing a COVID-19 vaccine. Liam McBurney/PA Media

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) detected a signal for post-vaccination myocarditis and pericarditis four months before telling the public, emails show.

According to emails, the MHRA detected a safety signal for heart inflammation after COVID-19 vaccination in early 2021, but did not tell the public about the issue for nearly four months until June 25, 2021, when it added warnings to the labels for the Pfizer and Moderna shots.

In response, MRHA said that chose that time after it had “all available evidence, including that received from international regulators, rather than using any one source in isolation.”

Myocarditis or Pericarditis

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.

The MHRA did not mention myocarditis or pericarditis in safety updates in April 2021, May 2021, or June 2021.

In its July 2021 update, it advised vaccinated people to “seek immediate medical attention should they experience new onset of chest pain, shortness of breath, or symptoms of disturbance of cardiac rhythm.”

This was “following a thorough review of extremely rare reports of myocarditis and pericarditis after COVID-19 vaccination.”

“These events are extremely rare and tend to be mild when they do occur,” it said.

The NHS started administering vaccinations for COVID-19 in England on Dec. 8, 2020. By June 20, 2021, 86.3 percent of the population aged 25 and over had been vaccinated with at least one dose.

‘Chance Finding’

The information came from FOI emails from Dr. Georgy Genov, the head of the European Medicines Agency (EMA) Pharmacovigilance Office.

He was warned by Israel on Feb. 28, 2021, of around 40 post-vaccination cases of myocarditis, a form of heart inflammation, according to the emails.

On March 1, he wrote that “we are monitoring closely cases of myocarditis (triggered for Comirnaty as we have more reports) and already had a discussion with MRHA.”

It was claimed that the signal was a “chance finding.”

The emails were obtained through a freedom of information request by “Benedikt,” who was hospitalised on March 29, 2021, with myocarditis after receiving his second Pfizer COVID-19 vaccination.

Benedikt, a consultant, asked that his last name not be used due to a fear of professional repercussions.

One Source in Isolation

MHRA indicated it did detect a signal, but it needed to assess data from multiple sources.

“Myocarditis was one of a number of adverse events of special interest that the MHRA and other global regulators have monitored since the start of C-19 vaccinations in line with our COVID-19 surveillance strategy,” the MHRA told The Epoch Times in an email.

“This included monitoring of Yellow Card data reported to the MHRA, data recorded in electronic health care records and evidence generated through independent studies,” it said.

“With any such regular repeated analysis, there is an increased possibility of chance findings which do not reflect true associations, and therefore, it is important that data from multiple sources are assessed,” it added.

The regulator said it decided how to communicate with the public based on “all available evidence, including that received from international regulators, rather than using any one source in isolation.”

Failing to Warn People

Dr. Clare Craig, a consultant pathologist who has carried out extensive research into COVID-19 with HART, told The Epoch Times that it “is so outrageous.”

HART is an organisation that was set up to share concerns about policy and guidance recommendations relating to the COVID-19 pandemic.

Dr. Craig has repeatedly called for the strengthing surveillance of post-COVID vaccine injury.

“We were being attacked for saying there was an issue, and they were failing to warn people who had no possibility of any personal benefit—so the harm would have had to outweigh the risk,” she said.

Pfizer and Moderna did not respond to requests for comment on their early approach to myocarditis after COVID-19 vaccination in an earlier article.