Esther McVey

I do not believe that the MHRA has taken such action. We are probably still waiting for it. Hopefully, that will come out. People are also either not getting compensation quickly enough or not receiving compensation that is commensurate with the illness and damage caused to them. It is worth noting what happened when The Daily Telegraph reported on the potential causal link between the AstraZeneca vaccine and blood clots in March 2021. The journalist who wrote the story received a threatening call from the MHRA warning that The Telegraph would be banned from future briefings and press notices if it did not soften the news—an extremely defensive approach for an agency whose No. 1 strategic objective is to maintain public trust through transparency and proactive communication. Does that sound like an agency that is doing its best to maintain public trust, let alone patient safety? It is clear that the system does not work. We have good evidence that suspected adverse reactions are under-reported, but what about the ones that are reported? We know from freedom of information requests that the MHRA does not have a process for investigating and following up individual yellow card reports. We know that the retrieval of follow-up information from the yellow card database still requires manual extraction and that only 54% of deaths reported as possibly linked to exposure to one of the covid-19 vaccines were followed up by the MHRA. That is extremely worrying or, as Matt Hancock infamously described it in a 2021 WhatsApp message, “shonky”. The chief medical officer, Chris Whitty, replied to that message by saying that the system “needs to get better”. Another long-standing problem with the MHRA is its lack of transparency. Take FOIs to the agency as an example. Between 2008 and 2017, only 41% of requests were successful. In 2021, 76% were answered outside the 20-working-day statutory response time. A culture of delay and secrecy has emerged, and MHRA’s behaviour around the Commission on Human Medicines meetings for the covid-19 vaccine benefit risk expert working group show that beyond any doubt. Minutes of the meetings were published just last month, four years after they took place—why the delay? They are stuffed full of redactions that leave us with many more questions than answers, particularly as to why the new vaccines were continually described as safe and effective. In the meeting on 18 November 2020, the expert working group asks if Pfizer was “required to respond to the 36 questions asked by MHRA”. In response, the MHRA confirmed that “there is no formal obligation to reply”. Why is there no formal obligation to reply? Surely it is essential, when making such an important decision as to whether to allow a new vaccine to be rolled out to the nation, to have those replies. The minutes do not specify the 36 questions. Indeed, they do not appear to have been mentioned again. I asked a written question last week to see whether, in the spirit of openness and transparency, the MHRA would publish those questions and any answers received from Pfizer. The response was that the MHRA does not intend to publish those questions or any subsequent responses. Why not? Is this not a matter of public interest? Those issues were not resolved before the MHRA gave the green light to start the vaccination of the nation. Particularly worrying is the issue of lymphopenia, where blood does not have enough white blood cells, which was reported in phase 1 of the trials and then went away—not because they fixed the problem, but because testing for the condition was not conducted in phases 2 or 3. In summary, the failure to act on the weaknesses of the MHRA will lead only to more harm and further damage to the public’s trust in the pharmaceuticals agency and those tasked with regulating it. My hope is that the debate will help bring those wide-ranging issues further to light and focus the Minister’s mind on finding solutions. I will end on the words of Dr Tom Jefferson of the University of Oxford: “You cannot support both secrecy and vaccination. Requesting data is not a sign of being against drugs or vaccines; it shows that you favour transparency. Those who try to keep data confidential and criticise those who ask for evidence are anti an evidence-based approach. How can you have informed consent if you do not know precisely what is happening?”