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.
The Parliamentary Under-Secretary of State, Department of Health
and Social Care () (Con)
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.
(CB) [V]
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?
(Con)
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.
(Lab)
[V]
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?
(Con)
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.
(LD)
[V]
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?
(Con)
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.
(Con)
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?
(Con)
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.
(CB) [V]
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?
(Con)
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 , 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.
(Lab)
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.
(Con)
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.
(LD) [V]
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.
(Con)
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.
(Con)
[V]
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?
(Con)
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.
(CB) [V]
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?
(Con)
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.
(Con)
[V]
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.
(Con)
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.
(CB)
[V]
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?
(Con)
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.
