Covid-19 Vaccine

Bill Wiggin Excerpts

Tuesday 10th November 2020 Westminster Hall

[Bill Wiggin (North Herefordshire) (Con)]

I beg to move,

That this House has considered covid-19 vaccine.

Is locking down the nation the only way of combatting covid-19? Whatever suggestions emerge from this debate, we must continue to protect the vulnerable and at-risk individuals. I was briefed by three leading vaccine manufacturers to discuss their work in the fight against this disease. Following those calls, I wanted to have this debate to see what can be done to accelerate the licensing and deployment of vaccines, and the immediate extension of vaccine and therapeutic trials, and how we can ensure that people can take up these vaccines when they are approved.

According to the Department of Health and Social Care website, the Government’s preferred route to enable deployment of the vaccine remains through the usual licensing routes available. It goes on to say that temporary licensing can occur only in “exceptional circumstances.” The recent report of the Tony Blair Institute for Global Change has been helpful in bringing further attention to this issue. It highlights four ways to avoid further lockdowns, of which two are of interest: expanding the trial of therapeutic drugs and shortening the process for approving vaccines. The report is helpful, although it has its limits, and I believe that we can go further and do better, first, by seeking volunteers to extend trials on a larger scale and to those who are most at risk.

We do not really know what scientists and the pharmaceutical industry can accomplish, and there are ethical and responsibility issues that we need to address, but at the moment the risk/reward ratio is out of kilter and we need to do far more to address the possibilities. There are 258 candidate vaccines worldwide, around 50 of which are in clinical testing and 11 in the final regulatory approvals process. Between the three candidates that I mentioned, the Government have forward purchased a total of 190 million doses. The most publicised of these are the joint enterprises between, first, AstraZeneca and Oxford University, widely seen as the most advanced in the world, and secondly, Pfizer and BioNTech, also much publicised after their promising announcement yesterday. The third is Valneva. All three companies emphasise the support and help that the Government have given them. Let us not make another massive communications error by failing to remind the people that these decisions by the Government have helped provide stability and confidence, which have accelerated the whole testing process.

None of the vaccines is the same and all three are unique in their approach. AstraZeneca and Oxford are pursuing an active vaccine. That type of vaccine uses a weaker and smaller amount of the virus to create immunity in the body. Examples of active vaccines are those for MMR––measles, mumps and rubella––and yellow fever. The former provides immunity for the rest of an individual’s life, but it is not known whether that would be the case with covid-19. Valneva is pursuing an inactive vaccine, using a killed version of the germ that causes the disease. Such vaccines are less able than active vaccines to provide immunity for life; typical examples are the flu jab and the rabies injection. Pfizer and BioNTech are pioneering an mRNA vaccine. This is a relatively new type of vaccine that uses a short segment of genetic material to make a harmless version of a target protein or immunogen. This activates an immune response and generates antibodies that fight off the virus.

The development of vaccines is typically a long and drawn-out process, but in response to the pandemic, the Government have helped to speed it up. There are usually three phases. The first involves producing a small amount of vaccine for use in a controlled study with a small number of healthy adults. Tests are performed on participants, half of whom are given the vaccine, the other half a placebo. This ascertains whether the vaccine generates the expected immune response and if it is safe. This stage usually takes only one or two years, yet all that has been passed by all three vaccine candidates already. Scientists at this time will work to provide the data, and a deal will be made with manufacturers to produce whatever amount is required.

Phase 2 sees the data from phase 1 scrutinised to determine whether those who received the vaccine had any adverse reactions. Again, this phase can take up to two years, yet it has already been completed by all three candidates. A larger group of people—several hundred—will then be given the vaccine to broaden the data set. Until that phase is over, scientists and patients will not know who has received the vaccine and who has had the placebo. That prevents the data being deliberately altered and manipulated. At the same time, work will continue to define the manufacturing methods and ensure consistency in the process.

Phase 3, the final phase, will include tens of thousands of study participants who represent a similar demographic to the population, including important factors such as age and ethnicity. As is the case with other phases, the scientists, the patients and those collecting the samples or checking the results do not know who has received the vaccine and who has received the placebo. Getting to phase 3 demonstrates a confidence in the safety, efficiency and efficacy of the vaccine candidate.

During this accelerated process, independent regulators have continued to monitor the trials, as they would with any other vaccine. Safety and accountability have not been compromised or relaxed in any way. As I call for a further acceleration of this process, I do not wish to see those standards dropped. Instead, we need better and faster collaboration between Governments and regulators internationally, because at the end of phase 3 the regulator will investigate the data and decide whether the vaccine candidate is effective enough for mass production.

Several factors affect the effectiveness of a vaccine. For example, the higher the number of patients in the trial who test positive and require medical assistance, the more data manufacturers and regulators have to use. This is referred to as “an event” and it allows scientists and regulators to determine and prove the efficiency or efficacy of the vaccine—in other words, how likely it is to be effective. The more events that occur within the placebo patients, the more it helps scientists come to their final conclusions on how well the vaccine is working. In statistical figures, one hopes to achieve a p-value or confidence quantifier lower than 0.5. That would mean there is a lower than 5% chance that the figures in the test are wrong, giving the scientists 95% assuredness that the test results are reliable and the vaccine is effective. I hope that in a matter of weeks it will be announced that the phase 3 trials have been completed, and then the regulators will study the data before pronouncing whether the vaccine is fit for the public.

The problem is that different regulators around the world have different demands and requirements. This is plainly an area where we can assist the manufacturers, by ensuring that the process is accepted as safe globally and that the different demands, which delay the final outcome, can be agreed by the experts and the approvals process can become smoother.

The pandemic reminds us that we are all people with the same biological make-up, and to defeat the virus we need to unite rather than specialise. Of course, the sooner we can vaccinate those most at risk—the elderly, care workers and frontline staff—the sooner we can begin to rebuild the country and the economy. When the common flu or influenza arrived, it was very likely to result in death. Nowadays, we give those most vulnerable in our society a flu jab to ensure that they remain safe, and we can beat covid-19 in the same way. By reaching phase 3, these vaccines are deemed to be safe.

The question of how effective the vaccine is remains unanswered, but that should not deter us from getting on with vaccinating more people. For example, yesterday’s announcement by Pfizer was a promising step forward on this front. Normally, scientists strive for 70% to 80% efficiency, meaning the vaccine is 70% to 80% effective in reducing the likelihood of contracting the virus. Therefore, even if it was lower, say 40%, we should still look at beginning the roll-out, because 40% could be the difference between life and death for thousands of people. That is why the existing Human Medicines Regulations 2012 contain a provision, regulation 174, that enables the temporary authorisation of the supply of an unlicensed medicine in response to a public health emergency.

With over 200 vaccines in development worldwide and 50 clinical trials, 11 of which are in final phase 3 trials, the Government could look at incorporating as many of those candidates as possible into further trials. We could also have more of the public participating in trials, and not only healthy people but volunteers—they must be volunteers—who are vulnerable and at risk. The Pfizer and BioNTech candidate is already incredibly close to completion, with footage of its full-flowing production line shown in the media only a couple of weeks ago, and yesterday we had the announcement that the safety monitors had found no problems and that it was 90% effective. Now we have to wait for the final data, but the Government could apply the same parameters for therapeutics and their wider use.

Therapeutics are medicines that help people who already have the disease, treatments that are improving to help reduce the fatalities from covid-19, and we have learned a lot about them since March. They are typically used when someone has a disease for which they have been hospitalised. They can both relieve pain and fight back against the virus, reducing its effect on patients. For disease treatment, therapeutics are generally in the form of a drug, and there is substantial evidence to suggest that the use of therapeutics when administered can alter and halt the spread of the virus. Vaccines help prevent people from catching the virus, but therapeutics work for those who already have it. The fear of overwhelming the NHS with covid cases prompted our Prime Minister to lock us down again, but therapeutics can prevent the NHS from being overwhelmed and keep people off ventilators.

Therapeutics come in a variety of forms, and the type being trialled for covid-19 is antibody treatment, of which there are three types: single monoclonals; cocktails of monoclonals, which most covid-19 trials are using; and polyclonals, such as plasma. Only four have so far been approved worldwide, and the only one currently approved in the UK is dexamethasone. Eli Lilly, an American company, is proving to be close with two separate antibody treatments, LY-CoV016 and LY-CoV555, the latter of which is being tested in America as a preventative therapy for residents in care homes.

Another therapeutic is Regeneron, which President Trump famously claimed cured him of his own bout of covid-19, and AstraZeneca is in phase 3 trials for its candidate, AZD7442. The UK Government have agreed to an unspecified amount of the AZ candidate. Pfizer also has advanced therapeutic trials under way, being developed in Sandwich in Kent, and 50 of these trials are going on worldwide. I think the Government could reach out to manufacturers currently in trials and look to extend the trial in this country as soon as possible. Therapeutics could significantly reduce the number of deaths, and these trials could be extended to those who are on ventilators or on oxygen, working not only with regulators but with medical bodies to agree on the ethical stance of compassionate use.

Therapeutics have another huge advantage: their cost. A treatment course of dexamethasone can cost as little as £5. Those courses are largely available and work well with the rapid testing trials that are going on in Liverpool, bridging the gap until the vaccine is approved. I have written to the Prime Minister and the Health Secretary, urging them to extent trials of vaccines for those people who are at risk. During my call with AstraZeneca, I asked, “What more could we do to test safe medicines for people who fear for their lives, who at the moment can do nothing but hope?” I expected to be told that nothing more could be done, but instead AstraZeneca’s team suggested that we ask them for suggestions on what they think they could do. I have faithfully passed on that request, because I think that, for all of us, this stems from the need to save lives.

Of course, I understand that people are concerned about the new vaccines. However, despite the social media opportunities, less time should be spent on the anti-vaxxers and more on those who want to protect their parents and grandparents. Given the guidance from the Joint Committee on Vaccination and Immunisation, the current advice is that vaccines will be administered not to children but to adults, starting with the most elderly and working down to the over-50s.

Detractors and anti-vaxxers believe that vaccines can be unsafe, and it is true that vaccines can run the risk of causing side effects in some people, just like driving a car or riding a bike can pose risks—nothing in life comes without a degree of risk. Those people want to wait for the one-in-a-million or even the one-in-10-million event to occur before we deploy. Those arguing against rushing the vaccine cite examples such as the H1N1 swine flu vaccine. Those shots reportedly caused Guillain-Barre syndrome paralysis in 6.2 people per 10 million who received the vaccine. If we cast our minds back to that pandemic, 284,000 people died of swine flu globally. Undoubtedly, the vaccine did more to halt the spread of the virus as opposed to the damage it caused. Indeed, as outlined in a 2010 article in Neurology Reviews, GBS was associated with the seasonal flu shot at a rate of 10.6 cases per 10 million doses. That did not stop more than 14 million people from receiving a flu vaccine last year alone without incident.

There must be a balance in this argument between covid-19 and the risk to the 194 people who were killed by it in the UK yesterday—eight people every hour. This virus has killed over 49,000 people in this country alone. There is untold damage to people’s wellbeing, mental health, livelihoods and the economy. Unemployment is rising and small businesses are closing. Social isolation inflicts vast damage, particularly on the old and the poor, but if someone is vaccinated, the likelihood of their dying from this disease is significantly reduced. Vaccination could also prevent people from passing the disease on, often unknowingly, to those they love, such as parents or grandparents. The Government and the World Health Organisation should address not just how we vaccinate, and the therapeutic trials and approvals; in addition, lessons need to be learned and procedures changed.

The suffering and death of so many people can be reduced, with collaboration and a reduction in bureaucracy. There must be a balance, weighing up the positives against the risks. The World Economic Forum gauges that coronavirus has cost at least $8 trillion globally, and possibly as much as $16 trillion, and the cost is only increasing. There is a way out and I hope that the Government in this country and Governments abroad, the manufacturers, scientists, medical professionals and regulators will all work together to strive for a final resolution and a better way of addressing the threat of viruses in the future.

--- Later in debate ---

[Bill Wiggin]

I hoped I had been clearer that I was not calling for a curtailment of any of the safety steps. However, with eight people dying every hour, delay has consequences too. What is not acceptable is that the standards for safety in the UK may be slightly different from the standards around the rest of the world. I was asking for a coming together so that we can have that agreed consensus on safety.

[Neale Hanvey]

I thank the hon. Member for that helpful clarification. I certainly hope that there would be a concordance of agreement to ensure not only that similar standards are followed, but that research can be worked on across all countries that have the capacity to do so.

I will make some progress. In our collective hope that there is indeed light at the end of the tunnel, the darkness of our shared journey through this pandemic must not be allowed to obscure our important public duty to act in good faith and with financial probity. That responsibility is not only of value in and of itself; we must do that out of respect for the many who did not make it through and who succumbed to covid-19, and in memory of those key workers who did so for the most selfless of reasons.

I want to refer to comments made by the hon. Member for Strangford (Jim Shannon). I agree with him that this has been a long, dark six months; it has been incredibly difficult. There is a need to feel optimistic, but it almost feels too good to be true. We hope that we will see this through, but again, I urge patience so that we can move forward collectively.

We must not emerge from this dark period with an “at any cost” attitude. We must ensure that the burden was shared equally and we acted together. In the spirit of co-operation alluded to by the hon. Member for Henley (John Howell), during Prime Minister’s questions on 18 March I asked a question about scientific support and I concluded:

“Does he agree that the prize on this occasion must be the victory and not patents and profits?”

In response the Prime Minister stated:

“I endorse completely the sentiment that the hon. Gentleman has just expressed about the need to do this collectively.”

And he concluded that

“everybody is working together on the very issues that the hon. Gentleman raised.”—[Official Report, 18 March 2020; Vol. 673, c. 1001.]

With regard to the spirit of togetherness, it is deeply concerning that we repeatedly hear of cronyism at the heart of this Government, particularly in relation to their less than rigorous approach to appointments and procurement. This morning on the BBC’s “Today” programme, the Secretary of State was challenged about the costs surrounding the vaccine taskforce’s work and its processes. Rightly or wrongly, the appointment of Kate Bingham has proven controversial, and there are no doubt questions to be asked about the absence of any clear recruitment process. However, when she appeared before the Health and Social Care Committee last week, I was very impressed by her performance. She has a very real command of the work that she has been leading, and the relevance and depth of her skillset were clearly in tune with the demands of such a position. However, that does not negate the Government’s or, indeed, any appointee’s responsibility to act ethically and in good faith and, most importantly, to transparently account for their actions.

Concerns about passing on company names that the Government favoured in the pursuit of a vaccine is not a matter for me to pass any judgment on, but they do need to be scrutinised fully. The most recent concerns, set out in The Guardian this morning, are also significant. In simple terms, how can a job be considered unpaid when the postholder holds a position of influence or control in the process of awarding a £49 million investment in a company that they remain a managing partner of? That Ms Bingham is married to a Treasury Minister should have set off the ethical alarm bells well in advance of the matter appearing in the media.

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[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

Thank you, Mr Dowd. I will try to be concise. We have covered an awful lot of ground, and to give my hon. Friend the Member for North Herefordshire (Bill Wiggin) his two minutes—

[Bill Wiggin]

I don’t need two minutes; just tell us everything.

[Jo Churchill]

Right—bless you!

It is a pleasure to serve under your chairmanship, Mr Dowd. I congratulate my hon. Friend the Member for North Herefordshire on securing this debate—and on such a timely day, as the hon. Member for Nottingham North (Alex Norris) said. It is almost as if my hon. Friend had planned it. I agree wholeheartedly with his comment that we must continue to protect the vulnerable as a priority. I also agree with much of what he said about making sure that we are moving at pace, while never sacrificing safety or efficacy, to drive forward and make sure, in therapeutics and particularly in vaccines, that we are delivering as fast as we can.

Many of those doing the work are involved not only in vaccine development but in vaccine manufacture. That means that they are ready to deploy once regulatory approval has been received. But the process has to be properly and ethically done, and people have to be secure in the knowledge that the vaccine is safe.

As everybody has mentioned, yesterday’s news excited us. However, as my hon. Friend the Member for Henley (John Howell) mentioned, there is not a golden bullet. We need to carry on with the non-pharmaceutical interventions and with driving down the R number, as we are doing. But we have had good news, and we can all afford a little moderated optimism to give ourselves a little bit of cheer. It is promising progress that takes us one step closer to finding a vaccine and, as has been much mentioned in this debate, to helping protect millions of people across the world as well as in the UK.

We need to make the vaccine clinically safe. We know that it will not by itself bring the pandemic to an end, but an assured vaccine would be a huge step forward towards resuming a normal way of life. After clean water, vaccination is the single most effective public health intervention. As my hon. Friend the Member for North Herefordshire said, the benefits are enormous. Working with the Department for Digital, Culture, Media and Sport and social media platforms, we are making sure that the message of vaccination hesitancy is worked on. We are doing that across Government and, more broadly, across companies. This is a national effort, and we have to work together to make sure that we give the right message that gives people confidence.

There is enormous collaboration across science, medicine, industry and government, here and internationally, to find a safe vaccine. Our aim of rapidly developing a mass-produced vaccine means that we are striving to do something that has never been done before. Progress is being made at an extraordinary pace.

My hon. Friend the Member for North Herefordshire took me back to my degrees by mentioning p-numbers and statistical significance, and as he said, although access to the vaccine should be given as quickly as possible, we must ensure that it is safe. I congratulate the vaccine taskforce, which has been mentioned, on its hard work leading the UK’s effort to find and manufacture a vaccine. It has successfully secured early access to 350 million doses through agreements with six separate vaccine developers.

My hon. Friend spoke of several of the vaccines, but not all of them. We have four different types: the Oxford-AstraZeneca vaccine, which is in phase 3 trials; the BioNTech-Pfizer mNRA vaccine, about which we had the excellent phase 3 trials news yesterday; and inactivated whole virus vaccines and protein adjuvant vaccines, which are all in phase 1, 2 or pre-clinical trials. The vaccine taskforce makes a call on those most likely to be effective, because we need a rational approach. The vaccine candidates are all in different stages, and extraordinary progress is being made with the phase 3 clinical trials underway in the UK, the USA, India, Brazil and South Africa. I reassure all hon. Members that the Government are prioritising developing, acquiring and deploying vaccines as soon as they are safely available.

The NHS covid-19 vaccine research registry has been developed in partnership with NHS Digital to help facilitate the rapid recruitment of large numbers of people into further trials over the coming months, so that an effective vaccine for coronavirus could potentially be found. It is important that we spread the net and encourage as many people of both genders and from as many different backgrounds as possible to take part, because we know that there is often a degree of over-representation in clinical trials in certain areas. I know that my hon. Friend is particularly interested in ensuring that we do not dismiss any potential vaccines, but he also said that he is very interested in seeing things sped up, so that bench to patient is much quicker. I could not agree more.

Experts from the NHS, academia and the private sector have worked closely with us to explore and establish human challenge trials in the UK, backed by more than £33 million-worth of investment. The studies offer a chance to accelerate the development of promising covid-19 vaccines in a safe and controlled environment. They are being considered by regulators and ethics committees and, if approved, would start in January with results expected by May 2021. Almost £20 million more is being made available to scale up capabilities to process blood samples from clinical trials.

We have invested significantly through UK Research and Innovation to provide unique capability for process, development and scale up. Once an effective vaccine is ready, we must be able to manufacture it at an unmatched and hitherto unseen speed. We will then move on to deployment. I am running out of time, but I am sure that the usual routes will give us a chance to talk about that deployment and other pertinent issues at another date.

The global co-operation was mentioned by several hon. Members. Globally accessible vaccines, treatments and tests are needed for all of us. No single country holds the key; it is a worldwide pandemic, and we are stronger when working together. The UK has taken a strong role in global leadership and in collaborating with other countries. Our commitment to international collaboration is clear, and we were proud to work through multilaterals—such as the G7 and G20, and with the WHO and other international partners, including industry —to agree collaborative approaches to supporting vaccine development, manufacturing scale-up and future distribution to meet domestic and international needs, including for the world’s poorest countries, which touches on points that were made earlier.

I thank scientists and clinicians around the world for their remarkable efforts in working at pace to develop covid-19 vaccines. I thank my hon. Friend for securing this debate. The vaccine will not be a silver bullet—we have to keep trying—but it will be one of the several tools that help our fight against the virus and allow us to have a more normal way of life.

Question put and agreed to.

Resolved,

That this House has considered covid-19 vaccine.