Medicines regulator failed to flag Covid vaccine side effects and must be investigated, say MPs

from The Telegraph via Wayback Machine

All-party group believe MHRA were aware of heart and clotting issues in February 2021 but did not highlight the problems for several months  

The medical regulator failed to sound the alarm over Covid vaccine side effects and should be investigated, MPs have said. 

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving drugs and devices and monitors side effects caused by treatments.

But the all-party parliamentary group (APPG) on pandemic response and recovery, an influential group of MPs, has raised “serious patient safety concerns”. It has claimed that “far from protecting patients” the regulator operates in a way that “puts them at serious risk”.

Some 25 MPs across four parties have written to the health select committee asking for an urgent investigation. In reply, Steve Brine, the health committee chairman, has said an inquiry into patient safety is “very likely”. 

 

In a letter to Mr Brine, the APPG said that there was reason to believe that the MHRA had been aware of post-vaccination heart and clotting issues as early as February 2021, but did not highlight the problems for several months.

Denmark and several other European countries suspended the AstraZeneca vaccine over clotting fears in March 2021, but the MHRA only published safety advice on April 7, by which time 24 million people had been vaccinated.

The watchdog also saw a “signal” for the heart problems myocarditis and pericarditis in February 2021, but did not include the conditions in safety updates until June 2021, MPs said.

“In effect, the MHRA licences medical products as safe knowing it lacks the processes to properly monitor adverse events,” the APPG wrote.

“In the case of Covid-19 vaccines, given the comparatively novel technology and record manufacturing speed, could the MHRA have even properly scrutinised the licensing data or known the short term safety?

“Historically trust and confidence in vaccines and vaccine safety has been high in the UK, but it seems that the experience of the Covid-19 vaccines has undermined this and by association trust in the regulator and the pharmaceutical industry.

“Now more than ever a wide-reaching and in-depth review is needed.”

The group also warned that the MHRA Yellow Card reporting system – which encourages patients and doctors to flag-up medicine side effects – “grossly” underestimates complexities, and in some instances picks up just one in 180 cases of harm.

An analysis by Stockport NHS Foundation Trust found that in the North West of England, 1,058 people had been admitted to hospital with stomach bleeds caused by anticoagulant medication over five years, yet just six Yellow Card reports were made during the period.

Side effects from drugs account for one in every 16 hospital admissions in Britain, and cost the NHS more than £2 billion each year.

But trials are often too small to pick up adverse reactions, particularly when they are driven by rare genetic mutations, meaning it is vital to continue monitoring drugs in the community.

The MHRA recently said it would investigate why blood thinners were causing dangerous side effects in between two and five per cent of patients.

The APPG said it was also concerned that MHRA regulation of medicine was funded by the pharmaceutical industry and said the body had shifted from focusing on scrutiny to trying to help drugs get approved.

Dame June Raine, the chief executive of the MHRA, who announced she would be stepping down last week, has previously said the agency was transitioning from “watchdog to the enabler,” a phrase which MPs said warranted its own investigation.

Graham Stringer MP, co-chair of the APPG on pandemic response and recovery, said:

“The MHRA oversees a failing system that is slow to act, causing harm to patients and beset with conflicts of interest.

“We cannot allow it to continue. That’s why we have written to the health select committee calling for an urgent investigation into the MHRA.”

The APPG said that concerns raised directly with the MHRA had been met with “an habitually dismissive and evasive response”.

Dr June Raine, the MHRA chief executive, said: “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.”

“We are committed to enabling innovation that brings transformative medical products safely to patients.’’