The medicines regulator the MHRA failed to sound the alarm over Covid vaccine side-effects and should be investigated, a cross party groups of MPs has said. Sarah Knapton in the Telegraph has more.
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 7th, 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 U.K., 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.
Dame June Raine, the Chief Executive of the MHRA, who announced she would be stepping down last week, said in 2022 the agency was transitioning from being a “watchdog” to an “enabler”, a phrase which MPs said warranted its own investigation.
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