UK Health Regulator Failed to Warn About COVID-19 Vaccine Side Effects, Claim MPs

Dame June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency, during a media briefing in Downing Street, London, on Sept. 13, 2021. (Hannah McKay/PA)

A cross-party group of MPs has claimed the UK’s drug safety regulator failed to mention in 2021 that the COVID-19 vaccines carry risks of myocarditis and pericarditis.

On Feb. 22, the All-Party Parliamentary Group (APPG) on Pandemic Response and Recovery published a letter it had sent in December to the Health and Social Care Committee raising serious concerns about the Medicines and Healthcare products Regulatory Agency (MHRA) and patient safety.

The letter, which was addressed to Conservative MP Steve Brine, said that there “is reason to believe the MHRA was aware of a signal for post-vaccination myocarditis and pericarditis in February 2021.”

It said, however, that it “failed to mention myocarditis or pericarditis in safety updates in April, May and June, only alerting the public on June 25, supposedly ‘following a thorough review of extremely rare reports of myocarditis and pericarditis after COVID-19 vaccination.’”

It added that they know from Freedom of Information (FOI) requests cited in a previous letter that the MHRA “does not have a process for the investigation and follow up of individual Yellow Card reports and cannot and does not effectively monitor them.”

It said that further FOI requests indicate that, in the intervening two-and-a-half years since knowing of post-vaccination myocarditis and pericarditis, the MHRA “has not undertaken any such formal epidemiological studies or instructed Pfizer and Moderna to carry any out.”

Related Stories

MPs Call For Investigation Into MHRA Over Safety Failings And ‘Needless Deaths’

2/14/2024

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

10/26/2023

The letter said that the examples seem to “characterise the regulator’s safety monitoring activity, casting a further dark shadow over the MHRA’s approach to patient safety.”

‘Needless Deaths’

The letter also claimed that in 2021 The Telegraph received “a threatening phone call from a senior official at the MHRA warning that it would be banned from future briefings and press notice” if it did not “soften the news” regarding an article implying a causal link between the AstraZeneca COVID-19 vaccine and blood clots.

The MPs said that it seems the MHRA “is more concerned with putting itself, and perhaps the pharmaceutical industry, first. Protecting itself, one might say, rather than protecting and ensuring patient safety.”

The Epoch Times has not been able to independently verify that the MHRA threatened The Telegraph.

An MHRA spokesman told The Epoch Times by email that it is looking into the claims.

Earlier in February, the APPG also raised serious concerns in another letter about the MHRA and patient safety, accusing it of causing “needless deaths” and highlighting its apparent conflicts of interest with the pharmaceutical industry.

It singled out Dame June Raine, chief executive of the MHRA, for criticism, saying that she “boasted” of the agency’s transition from “the watchdog to the enabler,” which they said ”does little to quell suspicions of conflicts and the implications for patient safety.”

Warnings

Last October The Epoch Times reported that MHRA detected a signal for post-vaccination myocarditis and pericarditis four months before telling the public.

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.

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

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

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

‘Patient Safety Is Embedded Firmly Into Law’

A spokesman for the MHRA provided The Epoch Times with the exact statement from Dame June, which was previously published when the first letter from the APPG was reported on. It did not address any of the specific claims raised in the second letter.

Dame June said that the MHRA is “committed to enabling innovation that brings transformative medical products safely to patients.’’

“We have made significant steps to put patients at the heart of all our work.

“These include incorporating patient views and lived experience into our safety reviews; involving patients in the early stages of planning medicines development and building a new responsive reporting system for patients to tell us about any adverse incidents. We have also led on legislative changes to strengthen surveillance for medical devices and medicines, meaning patient safety is embedded firmly into law.

“Our progress so far in making changes based on meaningful patient involvement gives us a solid base to build upon as we continue on this important journey.”

The Epoch Times contacted the Health and Social Care Committee, Pfizer, and Moderna for comment.