Covid-19 Vaccines: Safety

Danny Kruger Excerpts

Monday 24th October 2022 Westminster Hall

[Danny Kruger (Devizes) (Con)]

My hon. Friend talks about the independence of the MHRA, and I very much hope he is right about that. Is he aware that it is overwhelmingly funded by the pharmaceutical companies that it regulates? Does he have any concerns about the objectivity of its work?

[Elliot Colburn]

No, I see nothing to concern me about the independence of the MHRA. Indeed, I saw a group of anti-vax protesters outside the House today, holding up signs saying, “Vaccines kill,” and, “Would you not believe that pharmaceutical companies kill?” It seems a bit of a strange business model for a pharmaceutical company to kill off everyone it is trying to administer a vaccine to. I have seen absolutely nothing to concern me that the MHRA has any problems with independence.

For previous vaccines, we have had to wait for a full package and for each stage to be finished before moving on to the next stage. That is one of the reasons that the covid-19 vaccine was developed at such speed; corners were not cut, but the model was changed.

Pfizer and BioNTech fed the MHRA data to be assessed even before the final clinical submission in November 2020. Once it was submitted, scientific and clinical experts robustly and thoroughly reviewed it with scientific rigour, looking at all aspects, including the laboratory studies, the clinical trials and more. That included assessing the level of protection the product provides and how long that protection is provided for, as well as its safety, stability and how it needs to be stored.

On top of that, the MHRA has a range of experts inspecting the sites used across the whole lifecycle of the vaccine, from its initial development in a lab to its manufacture and distribution once approved. The inspectors work to legislation that incorporates internationally recognised clinical standards. The MHRA seeks advice from the Commission on Human Medicines, the Government’s independent advisory body, which critically assesses the data before advising the UK Government on the safety, quality and effectiveness of any potential vaccine.

I wish I could delve deeper into the specifics of how and why vaccines work, but we would be here all night and I do not want to duplicate the work that has been done in other debates. Nevertheless, I hope I have managed to demonstrate succinctly the rigorous scientific testing that occurs prior to a vaccine being distributed in the UK. However, the main premise of much of the literature that has been distributed about the impact of the covid-19 vaccine and the nationwide roll-out needs to be looked into. As part of its statutory functions, the MHRA continually monitors the use of vaccines to ensure that their benefits continue to outweigh any risks. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected events.

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[Elliot Colburn]

I am very sorry to hear of the case of my hon. Friend’s constituent, and I agree that we need to look at compensation and measures when things go wrong. No vaccine is without risk. No medicine is without risk, but that is the balance that we must weigh up when making decisions about our own health.

Let me return to the safety and efficacy of the vaccine, and how that is monitored. The core of this work is individuals self-reporting any adverse effects post vaccination, and active surveillance of particular groups of adverse events. That is well known as the yellow card scheme. I recently met representatives of the MHRA to be briefed on its vaccine safety surveillance strategy, which has four main pillars, the first of which is enhanced passive surveillance through observed versus expected analysis. The MHRA performs enhanced statistical analysis on data generated through the yellow card scheme to evaluate observed versus expected event reports in order to determine whether more events are occurring after vaccination than might be expected ordinarily. That assists the MHRA to identify when and where vaccine-related side effects are signalled.

Secondly, the MHRA conducts rapid cycle analysis and ecological analysis to supplement the yellow card scheme, which relies on direct reporting. The MHRA also analyses anonymised electronic healthcare records, particularly by way of the clinical practice research datalink Aurum dataset, which captures data from 13 million registered GP patients in the UK. It will track a range of theoretical side effects in order to detect safety signals. The MHRA also performs ecological analysis to monitor trends in high priority vaccination population cohorts—for example, increased trends among the elderly.

Thirdly, the agency performs targeted active monitoring; it has developed a new, voluntary follow-up platform for a randomly selected group of those vaccinated through the NHS. The group is contacted at set intervals to determine the frequency and severity of any vaccine side effects. Finally, there are formal epidemiological studies. The above methods detect signals and patterns but do not necessarily confirm vaccine causation. As such, where necessary, formal epidemiological studies are undertaken to solidify causal links.

As of 28 September 2022, in the UK, 173,381 yellow cards had been reported for Pfizer-BioNTech; 246,393 for AstraZeneca; 42,437 for Moderna; 14 for Novavax; and 1,848 for vaccines where the brand was not specified. For Pfizer, AstraZeneca and Moderna, the reporting rate is about two to five yellow cards per 1,000 doses administered.

The use of the yellow card scheme has been used as an example of why vaccines do not work, but it is important to note that the scheme is a self-reporting system. It cannot be used to prove a causal link between reported symptoms and potential damage caused. The reported reaction could have occurred regardless of the vaccine, or the person reporting could have no knowledge of the relationship between that symptom and the vaccine; it may have occurred even if the person had not been vaccinated altogether. I could get on the phone to the yellow card scheme right now and say that I have a side effect from a vaccine—I could completely make it up. The scheme has no verification process.

[Danny Kruger]

I think my hon. Friend is suggesting that the yellow card scheme numbers exaggerate the potential negative effect of the vaccines. Is he aware that the independent MHRA suggests that vaccine injuries have been under-reported by one in 10, meaning that there may be 10 times more vaccine-related injuries than the yellow card scheme reports? Surely, if there is an exaggeration, it is in the opposition direction from the one that he is suggesting.

[Elliot Colburn]

I am aware of that, but the point I am making is that the yellow card scheme is not a determining factor of damage done by the vaccine; there is no way to prove a causal link, as the reported reaction could have happened anyway. The worldwide awareness of covid, its blanket media coverage over multiple years, and the impact it has had on all our lives, are bound to have led to an increase in reports from previous vaccine roll-outs. Most reports relate to injection site reactions, including a sore arm and generalised symptoms, such as flu-like symptoms, illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles or rapid heartbeat. Generally, those reactions are not associated with more serious illness and likely reflect an expected, normal immune response to vaccines.

There have been some occurrences of inflammatory heart conditions following a covid-19 vaccination, but fortunately they are incredibly rare. For Pfizer, the suspected myocarditis reporting rate is 12 reports per 1 million doses. For suspected pericarditis, including viral pericarditis and infective pericarditis, the overall reporting rate is eight reports per 1 million doses. For Moderna, that is 42 per million, and for AstraZeneca four per million.

The events reported are typically mild, with individuals usually recovering within a short time, following standard treatment and rest. The benefits of the vaccines in protecting against covid-19 and the serious complications associated with it far outweigh any currently known side effects. I understand that one of the biggest concerns about vaccine safety is the potential influence on excess deaths. Of course, the excess mortality rates have increased. However, there is no evidence to prove a causal relationship between a spike in excess deaths and covid-19. I am not clinically trained, so I do not wish to preach in this debate, but multiple drivers could have caused the spike, including the impact of missed and delayed diagnoses earlier in the pandemic, and the long-term impact of covid-19 on people who contracted it; and that has been confirmed to me by the MHRA.

In one study this year, researchers estimated how often covid-19 leads to cardiovascular problems. They found that people who had the disease faced a substantially increased risk for 20 cardiovascular conditions in the year after infection with coronavirus. Researchers say that such complications can happen even in people who seem to have completely recovered from a mild infection. With millions—perhaps even billions—of people having been infected with the virus, clinicians are wondering whether the pandemic will be followed by a cardiovascular aftershock. Again, I am not clinically trained, but I wanted to touch on that point to provide some food for thought, because I understand that the issues around excess mortality rates are of extreme importance.

Easily the biggest elephant in the room while discussing the safety of the covid-19 vaccine and a potential inquiry into its safety is that the Government have already announced a public inquiry into their handling of the covid-19 pandemic as a whole. Since the Government responded to the petition, the terms of reference for the UK covid-19 public inquiry have been published by the Cabinet Office. One of the inquiry’s aims is to examine

“The response of the health and care sector across the UK…including the development, delivery and impact of therapeutics and vaccines”.

The first preliminary hearing of module 1 of the inquiry took place just a few weeks ago, with the second due to take place next Monday. The inquiry will further announce modules in 2023 that are expected to cover both system and impact issues, including vaccines, therapeutics and antiviral treatment. I would be grateful if the Minister could shed a bit more light on the aim of the content of the modules that will be investigating the vaccines, and if she could provide more details on how others can contribute towards the process, including those who signed the petition.

I will bring my comments to a close because other Members wish to contribute. I appreciate that for some people the question of whether the covid-19 vaccine is safe is still up in the air, and I understand that my comments may not easily persuade them otherwise. However, we know that vaccines are the best way to protect against covid-19 and they have already saved tens of thousands of lives. I hope that I can offer some reassurance to those who are unsure about this matter that the right steps were taken to ensure that vaccines were safe prior to roll-out, and that vaccines continue to be monitored for their safety and effectiveness. I hope that they can also be reassured by the Minister’s remarks that the Government are including an extensive investigation into the vaccine as part of their covid-19 public inquiry, and that separate investigation is not necessary.

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[Danny Kruger (Devizes) (Con)]

It is a pleasure to serve under your chairmanship, Sir Roger.

I am grateful to my hon. Friend the Member for Carshalton and Wallington (Elliot Colburn), who gave a very good defence of the vaccine programme and of the Medicines and Healthcare products Regulatory Agency. I respect that, but I regret his response to my hon. Friend the Member for Christchurch (Sir Christopher Chope), who raised the point about medical expertise that casts some doubt on the vaccines. My hon. Friend the Member for Carshalton and Wallington chose to smear all opponents of the vaccine programme. Of course there are lunatics out there who make absurd and outrageous claims, but there are many reasonable and respectable people who have anxieties about the vaccine programme, particularly people who have suffered as a result of the programme and their families.

I am a member of the all-party parliamentary group on covid-19 vaccine damage, which my hon. Friend the Member for Christchurch chairs. The APPG looks at vaccine injuries, and we had what I think was our first meeting last week in a Committee room in Portcullis House. I am afraid there were only a tiny handful of colleagues there, but well over a hundred members of the public attended, which is not the usual story for an APPG. I felt somewhat ashamed, on behalf of Parliament, that that was the first time that those members of the public—including families of the bereaved, who are themselves injured citizens—had had the opportunity to be in a room with members of this House, but I am very pleased that we are having this debate, and particularly pleased that there is an opportunity for members of the public to hear from the Minister on this topic.

I should say to members of the public who are watching that we have in Westminster Hall today a very good Minister, the Under-Secretary of State for Health and Social Care, my hon. Friend the Member for Sleaford and North Hykeham (Dr Johnson), who is genuinely committed to health, including public health, and she showed a real interest in this topic and in the effect of covid policies when she was a Back-Bench MP.

Although many questions about our covid response need to be answered, the UK is by no means the worst offender. We are not Canada, New Zealand or China—places where Governments think they can exterminate covid by depriving their population of the most basic civil liberties. However, I am afraid that we still have many questions to ask ourselves, and even much to be ashamed of. I put on record that in hindsight I am particularly ashamed of my vote to dismiss care workers who did not want to receive the vaccine. I very much hope that the 40,000 care workers who lost their jobs can be reinstated, and indeed compensated. A group of us—including, I think, the Minister—held out against compulsory vaccination of health workers when that was proposed by the Government last winter. I think that resistance turned the tide, to a degree, on Government policy, and we emerged from the lockdowns more quickly than we might otherwise have done, yet we still have a policy of mass vaccination, which I want to query on behalf of constituents who have written to me about it.

My query starts with a simple point. In October 2020, when preparations were being made for the vaccine roll-out, Kate Bingham, the head of the vaccines agency, said:

“There’s going to be no vaccination of people under 18. It’s an adult-only vaccine, for people over 50, focusing on health workers and care home workers and the vulnerable.”

Why was vaccination extended to the whole population? I do not think we have ever had a completely satisfactory answer to that question. I ask it again, because my concern is that extending the vaccination programme became an operation in public persuasion—an operation in which dissent was unhelpful or even immoral, and an operation that justified the suppression and even vilification of those who raised concerns.

[Andrew Bridgen (North West Leicestershire) (Con)]

I thank my hon. Friend for giving way. Unlike any other vaccine, the covid vaccine was given to people who had natural immunity because they had provably contracted the virus. Why were those people vaccinated?

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[Danny Kruger]

My hon. Friend is absolutely right. The best vaccine against covid is covid, and many people were naturally immune. There are questions to be asked about the effects of vaccination on the immune system.

My hon. Friend the Member for Carshalton and Wallington made an understandable point about the importance of resisting misinformation. As I mentioned, there are certainly many crazy theories out there to which we need not give credence. If we are talking about a programme of vaccinating the population, it is important that the public are persuaded to do what the Government want them to do, so I understand why the Government should have a public health information campaign. However, it is an essential principle of medical ethics that people must be able to give informed consent before any treatment, and I worry about whether we can say that consent was fully informed in all cases.

Throughout, there has been misinformation in favour of the vaccine. I would not say that was deliberate; it was possibly accidental. We can tell that with hindsight. Perhaps the most egregious example was the claim that the vaccine is 95% effective; as was mentioned earlier, Dr Malhotra presented on this to the APPG last week. That figure refers simply to the relative risk, instead of the actual or absolute reduction in risk to an individual. The absolute risk reduction is really less than 1%.

There was also the widespread claim that the vaccine stops transmission, so people should take the jab to protect other people. We were all told that; we all believed that for many months. Last month, we heard from Pfizer that its vaccine was never tested to see whether it would stop transmission. Despite that, we had the notorious claim by Professor Chris Whitty that even though the vaccine brought no benefit to children, children should be vaccinated to protect wider society. I am all for thinking about society, not the individual, but that, again, feels like a profound break with medical ethics. A lot of people are asking what the vaccine does to children and young people, and Professor Whitty is right that the benefit to healthy children seems to be essentially nil.

There are genuine questions to be asked. I have not verified these questions; I merely ask them on behalf of my constituents. How do we explain the increase in the rates of myocarditis, heart attacks and excess deaths among young people? Indeed, across the general population, it is plausible, though not definitive, that the vaccine is responsible for more harms than we know about. As I said in my intervention, we know from the yellow card scheme that up to one in 200 hundred people vaccinated report an adverse reaction. That is bad enough in itself, but we also know that adverse effects are significantly under-reported through the yellow card scheme. Based on the MHRA’s research, there may be as many as 10 times more serious adverse reactions than the yellow card system shows.

[Apsana Begum (Poplar and Limehouse) (Lab)]

Does the hon. Gentleman agree that it is important for the Minister to explain how people who say they have experienced damage from the vaccine can ensure that they are heard? There is the yellow card scheme, the module in the public inquiry, and people can apply for vaccine damage compensation, but there need to be more meaningful ways through which people can be engaged with on their experiences of damage.

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[Danny Kruger]

I am grateful to the hon. Lady—I absolutely agree. This is a very important moment in which the Minister can hear from Members speaking on behalf of their constituents. I encourage far greater engagement with citizens who have suffered from vaccine damage, or even lost loved ones to it.

There may be innocent explanations for the rather terrifying facts I have mentioned; I very much hope there are. If these are conspiracy theories, we need them to be comprehensively and courteously debunked.

To close, I have four questions for the Minister. First, will she review the vaccination of children? Children have strong naturally acquired immunity, and the chance of death from covid for a healthy child is one in 2 million. I believe we should follow other countries, such as Denmark, and stop vaccinating children altogether. I invite the Minister to review that aspect of the policy.

Secondly, will the Minister make representations in Government, and to Baroness Hallett, on broadening the terms of reference for her inquiry, so that they explicitly include the efficacy and safety of the vaccines? I hear what my hon. Friend the Member for Carshalton and Wallington says, and he is absolutely right: the inquiry terms of reference include mention of the vaccination programme and its effects. He may well be right that that is sufficient, and that the review will properly consider the topics that we are discussing. I hope so, but that needs to be made more explicit; I invite the Minister to comment on that.

[Sir Christopher Chope]

I wrote to Baroness Hallett, asking her to ensure that the terms of reference specifically covered the safety and impact of vaccines. As a result of representations, not just from me but from others, the terms of reference were amended to make it quite clear that vaccines, their impact and the potential damage done by them are included.

[Danny Kruger]

I am grateful for that clarification. It causes me concern to hear that it took my hon. Friend’s representations to ensure that the inquiry will consider the effect of the vaccines. We need to go further and talk about efficacy and safety, not just impact. We need to be explicit about what questions we want answers to. These issues need to be covered directly. We need the public inquiry to consider these matters, because of the compromised nature of medical regulation in our country. I mentioned that the MHRA is funded by the pharmaceutical companies that produce the drugs and vaccines that it regulates. There might be some universe in which that makes sense, but this is not it. I do not think that is right.

Thirdly, we need to do a lot more for the injured and bereaved, as the hon. Member for Poplar and Limehouse (Apsana Begum) said. I agree with all the recommendations of my hon. Friend the Member for Christchurch, and we will hear from him shortly on what needs to be done to raise the threshold for compensation for the injured, and the speed of payouts. I agree with him that we need clinics for people with adverse reactions, just as we do for people with long covid.

Finally, we need to change the power imbalance. I am sorry, on behalf of Parliament, that this is the first proper debate that we have had on this subject. I regret that victims and families have had to struggle so hard to get engagement of the system. I hope that the Minister agrees to meet some of the people here, and other representatives of families affected by the vaccines, for a proper exchange of information and ideas, and I hope that she will request that Dame June Raine of the MHRA meets them, rather than ignoring letters for months.

A new Government take over this week. I hope that the Minister, who was appointed only recently, will stay in post, and that we can start a new chapter in the story of covid. No more remote power telling people what to do. Let us put truth and justice back into public life, and restore trust in the experts on whom we rely.

[Several hon. Members rose—]