This is a tale about the U.K. drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), and its consultation with its independent safety adviser, the Commission on Human Medicines, and two of its subcommittees – the Pharmacovigilance Expert Advisory Group (PEAG) and the COVID-19 Vaccines Benefit Risk Expert Working Group (VBR-WG). I know that sounds a bit tedious and forensic but bear with me. It reveals that the MHRA is at it again, redacting vaccine safety data without a proper reason and trying to avoid revealing further safety data.
In February 2021, MHRA announced four strands of its “proactive vigilance” to monitor the safety of the Covid vaccine rollout.
One of those strands was new: the MHRA’s Yellow Card Vaccine Monitor (YCVM) programme. A proactive programme, working closely with the NHS, where a random selection of Covid vaccinees would be invited to register (before vaccination and therefore before the onset of any side-effects) for follow-up at set intervals to ask whether any adverse reaction had occurred. As someone who had a senior role in a safety critical sector for over 20 years, that proactive programme seemed like a very sensible thing to do – not least to overcome the massive under-reporting of side-effects to MHRA’s main Yellow Card system, the lack of medium and long term safety data from the rushed Covid vaccine trials, and to try address concerns in the Cumberlege Report that the MHRA does not listen to patients. In the event, 30,000 people registered by mid 2021.
Having seen no trace of the YCVM programme since its announcement, I recently decided to ask for a copy MHRA’s latest report about it. MHRA very helpfully sent me a copy of its report dated August 2021 to the Commission on Human Medicines (CHM) Pharmacovigilance Expert Advisory Group (PEAG). It contains comparisons of the ethnic, gender and age profiles and top side-effects between the proactive YCVM programme and its wider but passive Yellow Card scheme, but no details about the frequency or severity of the side-effects.
Call me cynical but I suspect that’s all they wanted me to believe is the purpose of the YCVM programme. Unfortunately for MHRA, the report also included vaccine safety data presented the previous month (July 2021) to a different group – the CHM’s COVID-19 Vaccines Benefit Risk Expert Working Group (VBR-WG). The safety data from the YCVM programme related to Covid vaccines in pregnancy and breastfeeding (para 25) and about menstrual disorders (para 27) with the data reproduced at Appendices 2 and 3.
So, for its reply to my FOI request to be true – that the August 2021 report to the PEAG was the most recent about its YCVM programme – the MHRA must not have presented any further safety data from the YCVM to the VBR-WG subsequent to July 2021.
I therefore did a bit of digging. I found the minutes of the CHM PEAG August 2021 meeting with MHRA about the report. And it’s true, the PEAG has not subsequently discussed the YCVM programme. However, I could not find any minutes of the VBR-WG. Imagine my surprise when I found MHRA’s reply to FOI 22/592: that the VBR-WG is “not a permanent body and minutes are not published”.
I cannot believe that MHRA did not make any subsequent presentations to the VBR-EWG, its independent safety adviser, about Covid vaccine safety data from the YCVM, not least because the benefit-risk balance associated with the Covid vaccines has changed so markedly since the vaccine rollout began. The AstraZeneca Covid vaccine has been as good as withdrawn and there are eligibility criteria for the other Covid vaccines. So I have pointed all this out to MHRA and requested that it conducts an Internal Review about how my FOI request was handled.
There was another concerning aspect. Some data in Appendix 2 of the August 2021 paper were redacted, namely the number of YCVM reporters with ongoing problems from Covid vaccine side-effects. The reason the MHRA gave was “to maintain patient confidentiality”. This appears to be an entirely specious argument. Numbers in a table are, by definition, anonymous. Rather than just trot out ‘patient confidentiality’, MHRA needs to explain how not redacting a number would compromise patient confidentiality. That was also part of my requested Internal Review.
Finally, those who have stayed with me so far will have spotted one glaring loose end – that the minutes of the CHM’s COVID-19 Vaccines Benefit Risk Expert Working Group, which the MHRA uses as an independent safety adviser, are not published. Regardless of the YCVM programme, it is inevitable that the CHM reviewed the evidence for continuing the vaccine roll-out as COVID-19 reduced in lethality and safety risks emerged over time. This is not the transparency the public deserves or was promised. The CHM is not a Public Body so it is not subject to the Freedom of Information Act. Someone in authority needs to demand that the minutes of this pivotal meeting are published. Perhaps an MP would like to ask a Parliamentary Question.
Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.