The Vaccine Safety Questions No One is Asking at the Covid Inquiry

The UK Covid Inquiry started its Module 4 oral hearings about vaccines and therapeutics on January 14th 2025. Matt Hancock appeared on January 16th. He basically got off scot-free. There is a long list of hugely important questions which were not asked, either by Hugo Keith KC for the inquiry or by any of the KCs acting for the core participants.

The Perseus Group, which I represent, helpfully included a list of questions at the end of its written evidence to the inquiry covering both the Covid vaccines and medicine regulation in general. Judging by the lack of searching questions in Module 4 so far, they have either not read our evidence or are ignoring it.

So I want to highlight a few of our questions here in the faint hope that the other witnesses, notably MHRA, will not also be given a ‘Hancock-style’ easy ride when they appear before the Inquiry over the next two weeks.

Process 1 vs Process 2

When Hancock gave evidence, I was shouting at the screen, urging someone to ask him if he knew that the Pfizer, AstraZeneca and Moderna Covid vaccines which were approved for roll-out to the public (using manufacturing Process 2) were different to those used in the clinical trials (manufacturing Process 1) and that there was no safety evidence bridging the two. If you don’t believe me, read paragraphs 32-35 of our written evidence, which are based entirely on MHRA’s replies to FOIs, and my article about the issue in September 2023.

To be clear, the question is not whether MHRA was aware (it obviously was); rather, the question is did Ministers know about it prior to authorisation? If they didn’t know (and Hancock doesn’t mention it in his written evidence), alarm bells should be ringing about MHRA and the UK Vaccine Task Force (which would also have been aware about the issues associated with scaling up production); and if Ministers did know, what were they told and did they question MHRA about the safety implications, and why were neither Ministers nor MHRA transparent with the public about the issue?

To be clear, Hancock might say it was MHRA which approved the vaccines, but it was actually Lord Bethell, one of his Ministers, who signed them off even though Hancock was the Licensing Authority, accountable to Parliament under the Human Medicine Regulations.

One can only hope that the inquiry KC or core participants KCs ask MHRA and Kate Bingham about this – not just about who knew what and when, but also about the consequential safety concerns relating to RNA integrity, DNA contamination and batch inconsistency (paras 36-44 of our written evidence).

Evidence to support Covid vaccination of children

Hancock should also have been asked what changed after the public statements by him and Kate Bingham, head of the UK Vaccine Task Force in autumn 2020, that this was an “adult vaccine” because children were at negligible risk from COVID-19.

Indeed, there was also a complete lack of long term safety data, and the evidence about the effect on transmission was flimsy at best. See paragraphs 46-51 and 121 of our written evidence for details. One can only hope that the inquiry KC or core participants’ KCs ask MHRA, Kate Bingham, Chris Whitty (Chief Medical Officer) and Jenny Harries (UK Health Security Agency) about this policy ‘U-turn’ when they give their oral evidence.

The next two questions are about medicine regulation in general. I’m covering these because a) the inquiry seems so keen to focus on ‘systems and processes’ and not so much about the safety of the Covid vaccines, and b) if the inquiry is going to come up with recommendations, shouldn’t it be testing these on witnesses? So, for example:

Threshold of Safety

Why does MHRA not define a threshold of safety or the balance between benefit and risk which would lead to the withdrawal of any medicine? In all other safety-critical sectors there is a clear, documented process for assessing the absolute safety risk and tolerability of harms from use of products, and use of the ALARP principle – reducing safety risks to ‘As Low As Reasonably Practicable’. Not so in MHRA. As a result, its safety management system allows collateral damage in pursuit of benefits which are often overstated by manufacturers (particularly for new products) and poorly monitored by MHRA. See paragraphs 101-110 of our written evidence.

Independent safety audit

Unlike all other safety critical sectors, MHRA is not subject to independent safety audit (paragraph 111 of our written evidence). Why does MHRA rely on Quality Audit by the British Standards Institute instead? The two are very different: quality audit is about compliance with business processes; safety audit is primarily about the extent of products’ risks and harms. A good example to highlight the difference is that a Quality Audit would not question MHRA about the safety risks associated with having no process describing how it follows up individual Yellow Card reports (even just the fatal and serious ones) and no process for assessing causation (except in clinical trials). A safety audit would do that.

I also want to get one thing off my chest. There are growing calls for Yellow Card reporting to be made mandatory. I met the Patient Safety Commissioner (PSC) in September 2024 and she is pushing for it. I can well see the inquiry including this as a recommendation in its report. However, as I told the PSC, this won’t solve any problems in my opinion (as someone who worked for years in another safety critical sector). First, as noted above, MHRA doesn’t even investigate all of the fatal and serious Yellow Card reports it already gets. Secondly, side-effects with a temporal delay (i.e., unless you drop dead within five minutes) will tend to remain unsuspected and therefore unreported. Indeed, MHRA already has a tendency to write-off Yellow Cards as coincidental even where there is little or no temporal delay.

Finally, to end on an upbeat note, I was heartened by the debate led by Esther McVey in the House of Commons on January 16th about the MHRA. One after another, MPs stood up and spoke to MHRA’s failures in regulation of a wide range of medicines and medical devices. We certainly haven’t heard the last of that. I would simply note that the Perseus Group’s evidence is as pertinent to that as it is to the Covid Inquiry. I would urge MPs to read our evidence and ask questions. I shall certainly be pressing my own MP, Dr Simon Opher, to do exactly that. And we stand ready to present and discuss our evidence to the various All-Party Parliamentary Groups with interests involving the MHRA.

Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.