Britain’s medicines regulator has been accused of failing to sound the alarm over Covid jab side effects, despite allegedly knowing of heart risks for months before warnings were issued.
A cross-party group of MPs and peers called for an urgent investigation to be held into The Medicines and Healthcare products Regulatory Agency (MHRA).
They claim the agency’s apparent lack of action put Brits at ‘serious risk’.
Members of the All-Party Parliamentary Group (AAPG) on Pandemic Response and Recovery said ‘there is reason to believe’ the MHRA knew about post Covid vaccine complications myocarditis and pericarditis in February 2021.
However, in a letter to the Government’s Health and Social Care Committee, they said it was only several months later, in June, that the MHRA alerted the public.
The AAPG letter, penned by its co-chair Graham Stringer the Labour MP for Blackley and Broughton, called for an urgent investigation to be held into The Medicines and Healthcare products Regulatory Agency (MHRA) over an apparent lack of action on Covid jabs despite knowing of risks for months before issuing official warnings
Myocarditis and pericarditis are both cardiovascular complications involving the inflammation of tissues in or surrounding the heart, respectively.
Although extremely rare, both conditions have been linked to Covid jabs, particularly the mRNA versions made by Pfizer and Moderna.
Experts insist the vaccines are still safe, despite the risk.
Steve Brine, the health committee chairman, replied to the group’s letter by saying an inquiry into patient safety is ‘very likely’, The Telegraph reported.
The AAPG letter, penned by its co-chair Graham Stringer the Labour MP for Blackley and Broughton, cites emails seemingly written by the EU medicines regulator, the European Medicines Agency, in March 2021.
These emails, shared by far-right news organisation The Epoch Times, discuss prior conversations with the MHRA about myocarditis cases following Covid jabs.
This, the APPG claims, stands in contrast to the MHRA only alerting the public about the potential risk on June 25, several months later.
The letter also highlights how despite the MHRA stating in February 2021 of plans for ‘proactive vigilance’ on Covid vaccine safety, Freedom of Information (FOI) requests revealed the regulator hasn’t performed, or requested Pfizer and Moderna to perform, studies testing the link between the jabs and myocarditis and pericarditis.
In a separate letter, sent earlier this month, the AAPG stated they had ‘serious patient safety concerns’ regarding the MHRA’s actions, or lack thereof, overall.
Signed by 25 MPs and peers, they claimed that instead of ‘protecting patients’. the regulator was operating in a way that ‘puts them at serious risk’.
The APPG also cited reports from the MHRA’s safety alert system of Brits suffering vaccine-induced blood clots after receiving an AstraZeneca jab on February 7, 2021.
MP Steve Brine, the health committee chairman, replying to the group’s letter said an inquiry into patient safety is ‘very likely’
Myocarditis and pericarditis are both cardiovascular complications involving the inflammation of tissues in or surrounding the heart respectively
The MPs and peers contrasted this with Denmark and other European nations, which suspended the vaccine in March.
The MHRA only published a warning on April 7, and only withdrew the AstraZeneca jab for the under-40s in May.
This, the AAPG noted, only came after ‘further needless deaths, such as that of BBC radio reporter Lisa Shaw who received her first dose of the AZ vaccine on April 29’.
It also cited an FOI which found the MHRA had only followed up 54 per cent of deaths related to Covid jabs reported via its Yellow Card system and that, by its own admission, ‘the MHRA cannot and does not effectively monitor Yellow Card reports’.
Yellow Card reports can be made by members of the public and medics and the report of an event following the use of a medicine doesn’t necessarily mean the two are linked.
The most recent AAPG letter reads: ‘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 MPs claimed the issues identified with a lack of ongoing proactive safety monitoring of drugs in Britain weren’t unique to Covid jabs.
It cited an example where an NHS trust in the North West of England found 1,058 bleed related emergency admissions were a side effect of taking an anticoagulant medication, yet only six Yellow Card reports were made by the Trust in that time.
Adverse reactions to medications are behind one in every 16 hospital admissions in Britain, the Government says, with studies estimating the cost to the NHS is over £2billion each year.
While strict medical safety trials identify most of the potential risks of drugs, some inevitably slip through the net.
Some can involve specific and rare genetic mutations among a tiny fraction of patients that can be missed.
As such, experts say it is vital to continue monitoring drugs for safety once they start being used in the community.
Responding to the APPG’s letter, Dr June Raine, the outgoing chief of the MHRA, 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.’
The MHRA also stated it recovers operational costs from the pharmaceuticals sector, a practice it said was common with its international equivalents.
It also defended its ‘proactive and continuous monitoring strategy’ for Covid vaccines stating it took action when safety concerns were identified.
The AAPHG said it was also commenced by the extent the MHRA was funded by the fees it charged to the pharmaceutical industry, and comments from its outgoing chief executive chair Dame June Raine, of the agency’s transition from ‘the watchdog to the enabler.’
The MHRA also said it regularly communicated its position on myocarditis through its regulars reports and its position was determined by all the available evidence, not by one single source.
While safety concerns have been spotted with Covid vaccines, experts insist that, on the whole, they are safe to use for the majority of the population.
This is because many of the side effects, like myocarditis and pericarditis, are rare, usually mild and resolve on their own with no long-term complications.
Experts also highlight that in many cases a Covid infection carries a higher risk of causing myocarditis and pericarditis than the jab, justifying its use.
Anti-vaxxers claims that myocarditis and pericarditis have led to wave of sudden deaths is not substantiated by evidence, experts say.
For blood clots related to the AstraZeneca jab, the situation is a bit more complex.
The complication vaccine-induced immune thrombocytopenia and thrombosis (VITT) is believed to be responsible for the death of 81 Brits and disability and injury of more.
It relates to a rare side effect where the vaccine causes the body to confuse components of the blood for the Covid virus leading to clots forming.
Such reactions usually start about five days after being jabbed and are estimated to occur in about one in 10,000 jabs.
When the risk was discovered risk/benefit ratio for the jab was re-calculated.
It was eventually restricted to only older Brits, who were deemed to be at greatest risk of Covid, while younger Brits, who had less to fear from an infection, were told not to have it.
AstraZeneca’s jab has not been included in the latest Covid jab rollouts with health officials opting to use the mRNA versions instead.
Some Brits who lost family members to the jab, as well survivors who were disabled or injured, are currently seeking legal action claiming it was ‘defective’.
Covid jabs have also been credited with helping end the series of paralysing national lockdowns that both ground the UK economy to a halt and frayed its social fabric.
