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.