Examination of Witnesses (Questions 60-79)|
30 NOVEMBER 2005
Q60 Bob Spink: Is there anything
that the Government could be doing now, irrespective of cost,
to shorten that timescale?
Dr Hay: In the immediate term
what we have to focus on is the vaccines that we can use at the
present time. In the longer timescale this fits in with the MRC's
support for further work on different types of vaccines which
may well shorten the lead time in terms of manufacturing a vaccine.
Q61 Adam Afriyie: Is there anything
that you would like to ask the Government to do now that would
assist you in that process? Is there any barrier to anything you
would like to do from a scientific point of view?
Dr Hay: What people want to do
at the moment is to do clinical trials with the vaccines that
have been prepared, to determine the most appropriate formulations
of that vaccine and to get a suitable immune response such that
we know that when it is used it will be effective. This involves
investigating the use of different adjuvant, for example, to increase
the potency of the vaccine such that we can use as little as possible
of the actual vaccine in one particular immunization.
Q62 Bob Spink: Is it any use getting
stuck into the general antivirals, will they help to reduce morbidity
and mortality rates? Should I be looking for an antiviral?
Dr Hay: Until we have the vaccines
the antivirals are all we have really got. The focus has been
on one single antiviral, Tamiflu, although there is another drug
licensed but it is not currently available.
Chairman: We will come on to this later.
Q63 Dr Harris: The question is not
what we would like to do in terms of trials. The question that
Dr Spink asked was what should the Government be doing now that
would enable us to have the right capacity and to shorten the
time? Everyone knows we want to do clinical trials to get the
right adjuvants and all that. We are seeking to scrutinise Government.
Is there anything out there? I can suggest some things and you
can say yes or no, but I thought you might have some off the top
of your head that should be being done now.
Dr Hay: As far as I know the Department
of Health has already been in discussions with manufacturing companies
to agree the production of sufficient vaccines for the whole population.
Q64 Dr Harris: What about building
up capacity? Vaccine manufacturers have said that they need to
have more contracts for the seasonal flu vaccine in order that
they do not build factories which are just not feasible for them
economically. Even if the cost-effectiveness is not as it should
be, should we not be increasing the amount of seasonal vaccine
we supply in Europe and in this country?
Dr Hay: That is correct. That
is the logical situation to have, it makes common sense. The companies
are not going to increase their manufacturing capability over
and above that which they use to manufacture the vaccine they
Q65 Dr Harris: So there is something
that the Government should be doing. Your advice would be that
in this country and across Europe we should be ordering more seasonal
flu vaccine to build up capacity.
Dr Hay: Certainly encouraging
the use of the vaccine would help us in the event of a pandemic.
Q66 Bob Spink: Should we also be
developing a `library' of vaccine strains? Would that help?
Dr Hay: There has been a certain
amount done on this in terms of choosing those viruses that are
most likely to cause a pandemic and a number of strains have been
prepared and this is on-going work, some of it being coordinated
by the WHO and some of it being initiated by the European Union.
Q67 Bob Spink: The UK is known to
be a world leader in the development of influenza virus vaccines
and so on. Is our expertise being provided to the rest of the
world? Is it being properly harnessed and used?
Dr Hay: The efforts in terms of
the preparation of vaccine seeds and the information for those
vaccine seeds is a role which the NIBSC play along with ourselves
at the international level together with the WHO and the viruses
chosen are agreed by the WHO group.
Q68 Bob Spink: What about the methods
of vaccine production? We are still stuck in the old steam age
using eggs. Should we be moving to DNA or to cell culture technologies?
Dr Hay: DNA is a different type
of vaccine. To move to cell culture is a move which has been gathering
momentum over the last few years. There was reluctance by manufacturers
to invest the amount of money required, but more and more are
doing so and this is quite a logical progression.
Q69 Chairman: What research is the
MRC doing in this area?
Dr Hay: This is more an issue
for the manufacturing companies themselves.
Q70 Dr Harris: Is there not a role
for Governmentbecause there is not a market at the momentto
really push on this? I am not hugely keen on research being driven
by Government, but a pandemic seems to be a reasonable excuse
compared to some other things. Should they not be pushing much
more investment, offering incentives for industry and partnerships
for research into alternative vaccine methods of manufacture?
Dr Hay: There have been a number
of coordinated meetings
Q71 Dr Harris: I would like a yes
or no answer. Should the Government be doing more than it is doing
at the moment?
Dr Hay: It is necessary for governments
to collaborate with the manufacturing industry in improving the
potential to provide a flu vaccine.
Q72 Dr Harris: Is the Government
doing what you have just suggested needs to be done sufficiently
at the moment, yes or no?
Dr Hay: I do not know enough of
the detail to judge on one particular government. There is quite
a lot of effort between governments and the manufacturing industry
in this area. It is considered to be a very serious situation.
Q73 Chairman: We would like to get
an answer from you and the panel to that specific question.
Professor Blakemore: I am not
in a position to comment on exactly that point. I do not have
facts about how much interaction there is specifically between
Government and industry on cell based culture. What I can say
is that cell based culture techniques will certainly be one of
the areas that will be highlighted in the call for research proposals
in the MRC scheme. I would not want to give the impression that
this country is lagging behind the entire world in thinking about
cell based culture. I had a meeting with Elias Zerhouni, who is
the Director of NIH in Washington, just three weeks ago and it
is very much at the top of his mind because he feels that it needs
to be pushed and developed, and it will be on the agenda for that
meeting that I mentioned in Beijing in three weeks' time for heads
of international research organisations. It has the potential
to replace egg based techniques for vaccine production. Egg based
techniques, although it sounds terribly antiquated, have stood
the test of time and served us very well. They are the best means
available at the moment for developing vaccines.
Q74 Bob Spink: The egg based technique
may be justifiable, but we are talking about avian flu and eggs
may become in shorter supply than they are now. We are looking
at perhaps the Government's order of 120 million doses and you
need one egg for every dose. Should we not be looking at different
Professor Blakemore: I think perhaps
Andrew is the best person to answer this question.
Professor McMichael: We want to
keep it out of the chickens in this country and that may not threaten
the supply of eggs in the short term. I think in the meeting we
are having next week this very issue will come up. Where the MRC
is putting more funds into research this will enable us to look
at proposals like this that are not the kind of `sexy' proposals
that we would normally look at that are very high quality, exciting
science. This is an important issue that to some extent is a bit
boring, but it is incredibly important and this might be something
that, if suitable proposals come in, the MRC would look at and
Q75 Dr Harris: On vaccines, given
the problems of getting enough capacityand that is relying
on industry to feel there is a current market, but it is less
worried than the Government is about a pandemic fluis there
a role for the Government to set up a publicly funded manufacturing
facility that is there and available even if there is no commercial
business case for it and that can be used when necessary?
Dr Hay: I think they are unlikely
to do that.
Q76 Bob Spink: Would you like them
Dr Hay: I think we have quite
a clear understanding of the relative roles of the public health
services and the manufacturing
Q77 Chairman: With respect, we do
not get that impression at all. We get the impression, if I am
honest, that it is being left to the market and that if there
was a pandemic there would be a real problem in terms of getting
vaccines quickly enough to people because there is no capacity,
you have no intentions of investing in research and the Government
is just basically going to have a wait and see policy.
Dr Hay: That is not true. We interact
with the vaccine manufacturers twice a year when the WHO makes
recommendations. There is dialogue between the manufacturers in
terms of vaccine production, with our side in terms of the strains
and just how this process works and problems that occur on both
sides, so there is an ongoing dialogue regarding this. In terms
of the provision of vaccine for this country in the event of a
pandemic, I thought the Department of Health already was securing
the availability of the 120 million doses so why would it need
to build its own plant for that?
Dr Iddon: The previous Committee looked
at chemical and biological warfare both with a visit to America
and to places like Porton Down and others in this country. We
came to the conclusion that if there was a serious risk from biological
warfare in this country we ought to have a public capacity and
that that public capacity may be based at Porton Down so that
we could step up production when industry were lacking in filling
the gap. That is a comment rather than a question.
Q78 Dr Harris: Dr Hay, you are saying
that the Government has got a sleeping order for 125 million doses
assuming that it is efficacious at one dose per injection and
you do not need to increase the amount in there and that we will
not suddenly find that we are outbid by another country that does
this or we can sue while we are all not getting our vaccine. What
I have not had an answer to, Professor Blakemore, is this question
of whether you think the Government should be putting more money
in to research into alternative vaccine approaches and manufacturing
Professor Blakemore: I would always
be very happy for the Government to put more money into research
and the MRC could certainly use more. As we have shown in the
plan to invest £10 million, which is a significant amount
of money, within existing resources we do have the capacity to
respond to new scientific situations even within present capacity.
I would like to comment on the proposal that Government ought
to be establishing a public facility for vaccine production. If
we had some massive enterprise, presumably a large investment
of public funds
Chairman: We are not suggesting that.
The question was whether you think that there should be.
Q79 Mr Newmark: Is the Government
doing enough given that we are facing a potential pandemic?
Professor Blakemore: I think one
could rehearse exactly the same arguments for pharmaceuticals
production. The pharmaceuticals industry, despite some of the
criticisms of it, has actually served us very well in producing
drugs. I think industry is responding responsibly to the present
circumstances. We know that there have been discussions going
on between governments and international agencies, with vaccine
producers and indeed with pharmaceutical companies that produce
antivirals about how they can gear up their production, divert
productivity, subcontract it to other generic producers and so
on. I think this is a rather good example of governments working
with industry in a potentially world threatening situation.
Mr Newmark: We are facing a potential
pandemic. We do not necessarily want to rely totally on the market
because the market rarely delivers what is needed in a pandemic.
Given that situation, does Professor Blakemore believe that the
Government is genuinely doing enough?