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Covid-19: Vaccine

Volume 809: debated on Tuesday 12 January 2021

Private Notice Question

Asked by

To ask Her Majesty’s Government what evidence they have that delaying a second dose of the Pfizer-BioNTech Covid-19 vaccine will not (1) diminish its effectiveness, or (2) cause further mutations in the virus.

My Lords, the views of the MHRA and the JCVI, based on the data submitted from extensive clinical trials, is very clear: a single dose gives very high protection from the virus 10 days after the first dose. A second vaccine dose is important to sustain that protection and extend its duration. Of course, it makes sense to vaccinate as many people as possible as quickly as possible to protect their lives and safeguard the NHS, which is why we take the approach that we have.

My Lords, today we are discussing the safety of medicines. Only moments ago, the Minister was emphasising just how important that is. Yet in delaying a second dose, the whole country is being treated as an experiment. Pfizer has said that the trial of the vaccine was on participants who received a second dose within three to four weeks. There is no data, it said, to demonstrate that protection after the first dose is sustained after 21 days. The WHO also says that there is no scientific evidence supporting the delay beyond six weeks. No other country is doing it. The UK is taking a gamble that risks fostering vaccine-resistant forms of the virus. Will the Minister mitigate the risks and ensure that a second dose is given at 21 days, until there is independent scientific advice and evidence for the delay?

My Lords, I remind the noble Baroness that Pfizer is not a regulator, nor is the WHO. Other countries are working on vaccines, but they are behind the UK in terms of authorisation and rollout. I reassure her that there is data, which is published on the internet. I tweeted a copy of it late last night, and I invite her to have a good, close look at it because it is absolutely categoric: one dose is enough.

There is a heated debate going on in the United States, as reported on CNN, over the incidence in use and registration of both the first and necessary second vaccinations with particular concern over the second, without which the first is less effective, despite what the Minister has just said. What plans do the Government have in the United Kingdom to ensure compliance with the necessary take-up of the second vaccination and the registration of both by the authorities?

The noble Lord is entirely right: the second dose is important. However, it is important not for efficacy but for durability. We have put in substantial data provisions to record every single dose into every single arm, and to put a follow-up dose into exactly those arms. We are using the NIMS system and every single vaccination is put into the GP record. They will be tracked down extremely diligently for exactly the reasons that the noble Lord describes.

My Lords, a number of scientists have expressed concerns about delaying the second dose of the Pfizer/BioNTech Covid vaccine. On the excellent Radio 4 programme “How to Vaccinate the World”, Professor Sir David Spiegelhalter said that, as the RNA technology used is new, there is less data to give confidence on spacing. But he suggested that, given a number of people have received their first dose, now is the perfect time to do a small randomised research trial on comparing those receiving their second dose at 21 days and others receiving it at 12 weeks, which would then perhaps give more confidence. Is that happening?

Who can hold a torch to Professor Spiegelhalter and his analysis of the data? Although I did not hear him, I completely welcome his comments. I reassure the noble Baroness that enormous efforts are being put into the pharmacovigilance around this vaccine. Some of this is of a clinical and scientific nature, and it takes a while to read out. We have therefore put in parallel systems to get an early read-out on exactly the kinds of questions that she has asked.

My Lords, as an interest, I can report that Lady Eccles and I have both had two Pfizer jabs, three weeks apart. At the planned rate of 2 million vaccinations a week, there will be the equivalent of 1 million people being fully vaccinated, whatever the gap. There will also be a continuing critical path through this rollout, which is complex. It may start by being vaccines, which are the limiting factor, but it could become otherwise. Can we be assured by my noble friend that the NHS is fully prepared to identify and deal with the critical path? Can we also be assured that we will get clear and full information on progress, and about the actions being taken to maintain that progress?

I congratulate my noble friend and Lady Eccles on their double vaccinations. It is one of the most heartening experiences of a pretty dreadful year to witness the rollout of this vaccination and the joy and reassurance it brings to those who have been vaccinated. I reassure my noble friend that the NHS is absolutely putting the resources in place not only to roll out the single and second vaccinations to everyone over 18 who will step up for those but also for the pharmacovigilance to ensure that any adverse effects are recorded through the Yellow Card scheme and that those records are analysed and acted upon so that any changes or tweaks, as sometimes happen, are enacted by the NHS to get the best possible outcome for as many people as possible.

My Lords, may I ask the Minister another question about evidence? When do the Government expect to have clear advice on the possible transmission risk from those who have been vaccinated? Everyone I know who has received the vaccine—they have been delighted to do so and impressed by the efficiency of the NHS—is now talking about meeting their Pfizered friends, seeing grandchildren and returning to volunteering or to your Lordships’ House. Does the Minister acknowledge that there will need to be cogent and clearly communicated advice for those who have been vaccinated, many of whom have been in virtual isolation for nearly a year?

The noble Baroness delivers tough news to her friends and to the Chamber, and I completely agree with her analysis. The frustrating truth is that, while the efficacy of the vaccine has been tested on hundreds of thousands in clinical trials, and we can lean on that data extremely well, the transmissibility of those who are immune is not yet clear. We have put in place trials and testing regimes to understand and get to the bottom of this point. But she is entirely right: it is possible, although not proven at the moment, that those who are themselves immune are not sterile but vectors of infection. Were they, for instance, to return to this Chamber, they would potentially infect those of us such as my noble friend Lord Parkinson, who is extremely young and does not qualify for the vaccine any time soon, and who could catch the virus off an octogenarian noble Lord in an instant.

The noble Baroness, Lady Hayman, raises the most important issue, which is communication and the way that the Government may allay anxiety. Something which has been put to me is that we know the risks to human health run by the creation of antibiotic resistance and the creation of mutant and resistant bacteria as a result of misuse, including inadequate doses. Can the noble Lord assure the House that immunologists are being consulted? What is their view of this risk? Anxieties are being expressed in many different ways, so there has to be better communication about this issue.

The noble Baroness is right that communication is key. We seek to explain the scientific basis of this vaccine, and a huge amount of effort has gone into what I call “O-level biology communications.” This is one of the reasons why acceptance rates appear to be—touch wood—as high as they are at nearly 90%. Had someone told me that number a few months ago, I would have happily settled for it. She is right, the escapology of this virus is just the same as it is under AMR. From very early analysis it would appear—and this is extremely conditional—that the recent variant is not escaping the vaccine or any of the therapeutics we have put in place. However, it is more performance enhancing. That is good news for the vaccine and bad news for the prospect of having a disease present in society and the world for some time to come.

My Lords, this virus is unchartered hostile territory and we can but rely on the best scientific advice. Some will say that delaying the second jab might even be advantageous and others will disagree. By delaying, debating and disagreeing we are going to put many thousands of lives at risk, lives which could have been saved by having that first jab. I am not qualified to say which is the best; I wish I was. I can only in gratitude accept the guidance of experts and that is what I will do. In doing so, I think that hundreds or thousands of extra lives will be saved by that first jab.

The noble Lord alludes to a complicated dilemma that we all feel. I welcome challenge and those who query and question the basis of our policy decisions and our science. He is right: too much false information and fake news can damage trust. We have gone about the vaccine process with an approach that is as open and transparent as it can possibly be. We have sought to engage in dialogue and answer questions where there have been any. That approach has proved to be effective and it is the one we continue with.

My husband, who is 84 years old, received his Pfizer vaccine before Christmas and his second one last week was cancelled. Is there any guarantee that, when the second jab comes, it will be the Pfizer vaccine? As I understand, there has been no research on mixing and matching these vaccines. Is there any way that the level of immunity can be tested at that three-month point?

The CMO has made it clear that he leans heavily towards having consistent vaccines, but it is not a requirement. Some of the immune response comes from antibodies which can be tested, but some of it is from T-cells, which are very difficult to test for. It is not possible to categorically say whether someone is immune. However, we have looked at ways to measure and understand more about the body’s immune response to develop our understanding in this area.

My Lords, what is the chance that, if the second Pfizer vaccine dose is delayed, the virus could become resistant to the vaccine? For what reason do Pfizer and the World Health Organization recommend three weeks between the vaccines?

The noble Baroness is right; this virus could mutate and start escaping the vaccine. That is a very real threat. The good news is that we know so much about it now, have digitally mapped it and have grown it so many times in the laboratory, that making new vaccines would be a relatively straight- forward process. It would not necessarily require the months of clinical trials that the first one did. However, be under no illusion, were this to happen it would set our vaccine deployment back considerably.

My Lords, I appreciate the necessity of getting as many people vaccinated as possible and the need therefore to be agile and flexible in making policy decisions. However, would the Minister agree with me and other Lords that it is also critical we win the battle of communications? We need to ensure that we take the public with us, with a clear understanding and a clarity of message.

The central proposition we are discussing is that it is better to double the number of people getting their first jab, even if there is a marginal decrease in the efficacy of the vaccine for a few people. That message has got through to the public and I think it enjoys tremendous public support. I acknowledge the concern that some will naturally feel about what appears to be a diminution in provision, but I am here to reassure and provide consistent scientific advice that is not the case.

My Lords, two logistical questions are raised by delaying second doses. First, given AstraZeneca’s statement yesterday about variability of manufacture, together with the increasing global demand going forward, how will the Government guarantee we have enough vaccines of the right type for all second doses at 12 weeks? Secondly, am I right that from the end of March the rate of new vaccinations will fall sharply, because we will then need 2 million doses per week just to cover the second doses?

I think the noble Lord has read too much into the AstraZeneca statement. Negotiations with AstraZeneca and provisions in manufacturing capacity are extremely well advanced. All the projections in the vaccine plan published yesterday have been bottomed out and secured with manufacturers and deployment. The Secretary of State was very clear about the objectives of 13.6 million by the end of February and the whole country by the autumn. Those are not vague reassurances; those are bottomed out and have business plans behind them.

My Lords, the time allowed for this Private Notice Question has elapsed. I apologise to the noble Baronesses, Lady Uddin and Lady Gardner of Parkes, that there was not time to take their questions.