Raising concerns about the MHRA (part two)

Steve Brine MP
Health and Social Care Committee,
House of Commons,
London, SW1A 0AA

Letter by email

SENT: 11 December 2023

Dear Steve,

Thank you for your reply to our email of 24 October raising serious concerns about the MHRA’s approach to patient safety.

Since we wrote, more examples have come to light of the disarray which seems to characterise the regulator’s safety monitoring activity, casting a further dark shadow over the MHRA’s approach to patient safety. I am taking this opportunity to bring them to your attention. Perhaps you would be good enough to share this correspondence with Dame Jane Dacre for the Committee’s Independent Expert panel to consider along with the contents of our earlier letter.

There is reason to believe the MHRA was aware of a signal for post-vaccination myocarditis and pericarditis in February 2021. However, 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". Except we know from FOIA requests cited in the previous letter 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.

Yet in the response to FOI 23/707, asking for disclosure of formal epidemiological studies the MHRA has undertaken in accordance with its proactive vigilance for COVID-19 vaccines, or which it has instructed Pfizer and Moderna to carry out, to test the association between Covid vaccines and myocarditis and pericarditis, indicates 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.

This is despite them being necessary, and the one method of the four strands of its proactive pharmacovigilance, that can confirm and quantify whether a safety signal is in fact a side effect. Instead the requester was directed to the Risk Management Plans for each manufacturer on the European Medicines Agency (EMA) website, suggesting the MHRA still abrogates responsibility to the EMA under the European Commission Decision Reliance Procedure (ECDRP). An added concern given we believe there are considerable gaps in Post-Authorisation Safety Studies (PASS), a condition of authorisation for all the Covid vaccines and vital to monitoring safety.

The Daily Telegraph has now revealed that in March 2021, when it published an article implying a causal link between the AstraZeneca Covid-19 vaccine and blot clots, they “received a threatening phone call from a senior official at the MHRA warning that The Telegraph would be banned from future briefings and press notices if we did not soften the news”. An extraordinary reaction, and from a senior official, in the wake of the IMMDS review's findings. Not one you might expect from a drug safety regulator that has learnt lessons, was genuine in its response to the review’s recommendations or puts patients first in everything it does. Indeed, 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.

I appreciate the challenge the Health and Social Care Committee would likely encounter with such an investigation, however we are faced with a wholly unsatisfactory set of serious safety compromises which the MHRA appears to be doing little to fix.

I will look forward to updates on any further developments.


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