Covid-19 Vaccines: Safety

Elliot Colburn Excerpts
Monday 24th October 2022

(1 year, 4 months ago)

Westminster Hall
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Elliot Colburn Portrait Elliot Colburn (Carshalton and Wallington) (Con)
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I beg to move,

That this House has considered e-petition 602171, relating to the safety of covid-19 vaccines.

It is a pleasure to serve under your chairmanship, Sir Roger. On behalf of the Petitions Committee, I will read out the prayer of the petition, which states:

“There has been a significant increase in heart attacks and related health issues since the rollout of the Covid-19 vaccines…This needs immediate and full scientific investigation to establish if there is any possible link with the Covid-19 vaccination rollout.

It is the duty of the Government to ensure that the prescribed medical interventions of its response to Coronavirus are safe. We believe that the recent and increasing volume of data relating to cardiovascular problems since the Covid-19 vaccine rollout began is…enough…to warrant a full Public Inquiry.”

The petition has amassed over 107,000 signatures, including signatories from my own Carshalton and Wallington constituency. I put on record my gratitude to the Petitions Committee Clerks and the team behind the scenes for organising today’s debate, and particularly to the Medicines and Healthcare products Regulatory Agency—the MHRA —which recently briefed me on its vaccine safety surveillance strategy. Throughout my speech, I will point out why I do not think that the Government should launch a public inquiry into vaccine safety; it would be a waste of taxpayers’ money, and is not necessary for reasons that I will discuss.

The covid-19 vaccine has been the subject of four previous e-petitions debates in Westminster Hall, and of many other parliamentary debates, many questions and much Committee work since the pandemic hit. It is worth remembering that, for the first 26 months of the pandemic, over 178,000 people across the UK died within 28 days of a positive covid-19 test. It remains my position that vaccination is the single most effective way to reduce deaths and severe illness from covid-19.

More than 53 million people in the UK have received at least their first covid-19 vaccine, and I put on record my thanks to the amazing staff and volunteers who contributed to that gargantuan operation, which was a shining example of effective national collaboration. I would go so far as to say that, in the public inquiry into covid, the Government should look at how the vaccine roll-out was such a success, how we can learn from that success and how we can apply those lessons in future circumstances.

Christopher Chope Portrait Sir Christopher Chope (Christchurch) (Con)
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My hon. Friend has obviously done a lot of preparation for the debate. Did part of that preparation include looking at Oracle Films’ “Safe and Effective: A Second Opinion”, which was produced about a month ago and has already had more than 1 million views online? Most people think it highly persuasive.

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Elliot Colburn Portrait Elliot Colburn
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I have not seen that publication, although I have read a lot of the significant amounts of material that have been shoved through my constituency office door by a large number of anti-vax protesters, who have flyposted my office on no less than a dozen occasions, and intimidated my 18-year-old apprentice and the people who live above my constituency office. Given that the content of that literature includes climate change denial, moon landing denial and so on, I am inclined to ignore it completely.

It is impossible to vaccinate every person in the country, nor should vaccines be thrust upon people without their consent. People have a right to know what is put in their bodies, and have the autonomy to decide whether to have a vaccination. It is therefore the job of the state to ensure not only that vaccines are safe for use and continually reviewed, but that knowledge of why they are safe and effective is communicated well to our constituents.

With that in mind, I will briefly outline the steps taken to review the safety of covid-19 vaccines before the roll-out, and the continuous monitoring of vaccine safety. All vaccines must be tested through a series of clinical trials to establish their efficacy and safety, and must have a product licence before they can be made available for widespread use in humans.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Starting in 2020, a dedicated team of MHRA scientists and clinicians carried out a rigorous, detailed scientific review of all the available data in the development of covid-19 vaccines, including from laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and it considered the conditions for the vaccine’s safe supply and distribution.

In early June 2020, the MHRA set up an independent expert working group to begin some of the most important safety work. In August 2020, a second working group was formed with different expertise, this time to advise the MHRA on the benefits and risks of the vaccines in development. The groups were formed of 48 experts from outside the MHRA, including virologists, epidemiologists, immunologists and toxicologists.

In September 2020, the MHRA started preparing laboratories for independent batch testing of the vaccine. Although the vaccine manufacturers carried out their own comprehensive testing regimes on the batches of products they produced, it is vital that tests focusing on safety and quality are conducted independently too. In the UK, the independent testing is performed by the National Institute for Biological Standards and Control, which is part of the MHRA. Before any batch testing can reach the public, the NIBSC must conduct a rigorous assessment to check that it is consistent with characteristics derived from results from batches previously shown to be safe, and from effective clinical trials or routine clinical use. That work began in November 2020.

The covid-19 vaccines were developed in a co-ordinated way that allowed some stages of the assessment processes to happen in parallel, which enabled the producers and regulators to condense the time normally needed. That rolling review allowed the MHRA to review data as it became available from ongoing studies, rather than waiting.

Danny Kruger Portrait Danny Kruger (Devizes) (Con)
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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 Portrait Elliot Colburn
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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.

Richard Holden Portrait Mr Richard Holden (North West Durham) (Con)
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My hon. Friend is making a good speech. My constituent Gareth Eve lost his wife Lisa Shaw when she was only 44, as a result of the AstraZeneca vaccine. He is not an anti-vaxxer. Although the debate is on the broad issue, does my hon. Friend agree that matters such as how families get compensation could be dealt with much better, even if he does not agree with a full public inquiry into the entire body of the issue? So many families, including that of my constituent, have been left waiting for that support for a very long time.

Roger Gale Portrait Sir Roger Gale (in the Chair)
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Order. I appreciate that hon. Members wish to represent their constituents, but interventions must be interventions and not speeches.

Elliot Colburn Portrait Elliot Colburn
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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 Portrait Danny Kruger
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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 Portrait Elliot Colburn
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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.

None Portrait Several hon. Members rose—
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Elliot Colburn Portrait Elliot Colburn
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It is unusual to be in this place and be lambasted by colleagues, but I make no apology for looking out for the health and wellbeing of my constituents. I completely agree with the sentiments raised throughout the course of the debate. We have to do more, and I urge the Minister to look into what more we can do for those who are adversely affected. I will not apologise for not allowing that to be a gateway that allows vaccine misinformation to come into the mainstream.

Some people have said that the debate is overdue. I hastened to remind colleagues in my opening remarks that there have been four of these Petitions Committee debates, let alone the Backbench Business debates and private colleagues who have come forward to ask for debates. This is not overdue; it has happened plenty of times. We have given a lot of parliamentary time to this. Yes, there is more that we can and must do for those who suffer harm, but it is worth reiterating that the system for approving and monitoring vaccines is robust, the inquiry exists already and vaccines are a great British success story. It was a Brit who discovered vaccines in the way that we know them today, and they have been effective in tackling a range of illnesses that would previously have been life-threatening or very dangerous indeed. The proof is that they work, they are saving lives and they protect us and others. I join the Minister in urging people to come forward for their vaccines this winter, to help to protect themselves and others and ensure the strain on our NHS is as minimal as possible.

Question put and agreed to.

Resolved,

That this House has considered e-petition 602171, relating to the safety of covid-19 vaccines.