§ Motion made, and Question proposed, That this House do now adjourn.—[Dan Norris.]
7.13 pm§ Dr. Ian Gibson (Norwich, North)Vaccines have changed the lives of children and their parents by reducing the risk of contracting crippling childhood diseases. Experience with smallpox and polio provides clear evidence of that, and shows that vaccines can be a most effective means of controlling serious infective disease in human populations. That observation is especially important in the context of the developing world where treatment of diseases such as tuberculosis, AIDS and many parasitic diseases by conventional chemotherapeutic means, when they exist, is impractical or even impossible for reasons of infrastructure and logistics. In those cases, preventive public health measures, including immunisation, must be the way to reduce the disease burden.
The market for vaccines has, in the past, been regarded as insufficiently profitable by the larger pharmaceutical companies. In the UK, there has been a progressive contraction of conventional vaccine production since the 1980s. Vaccines were seen as low-value products. In the UK, the main producer of conventional vaccines was Evans, which is now part of Powderject. During the 1990s, there was a resurgence of interest in vaccine development and production, fuelled by the availability of recombinant DNA technology to produce clean antigens. This development has resulted in the creation of some effective vaccines for infectious diseases that are difficult to treat and have a high morbidity or mortality attached to them—hepatitis and meningitis, for example. These vaccines are regarded as high-value products. In the UK, GlaxoSmithKline is a major company player, although a number of smaller biotech-based companies are also active in this area.
Among the most promising new developments in vaccinology is the development of "naked DNA" vaccines—a stretch of DNA from pathogens containing the genes coding key antigenic components. The idea is that when this material is injected into the skin, it is taken up by host cells, which then make the antigen in situ. This forms a depot of antigen, which provides a continuous immunological stimulus.
A second development, pioneered by Powderject, is the formulation of the antigen-vaccine in powder form. This is introduced into the subject by means of a high-pressure air jet. This transdermal route is known to produce an immune response at least as good as the conventional, needle-based intradermal injection. It is painless, and, being in the form of a powder rather than the more conventional liquid, it is more stable in adverse conditions.
There is a particular problem in the case of diseases such as smallpox that have been eradicated, or diseases such as anthrax that do not normally present a serious risk to human populations, but which can be used for bioterrorism. As the need for vaccines for such diseases disappeared or diminished, the incentive for maintaining a vaccine manufacturing facility for them also diminished. There has therefore been a rundown in manufacturing capacity. 1027 With the present bioterrorism threat, there is now concern that sufficient vaccine stocks will not be available to protect military or civilian populations. There is now only limited commercial production capacity for smallpox and anthrax vaccines. Smallpox has been eliminated, so the availability of the vaccine has become scarce. Limited stocks are held by the World Health Organisation and by some national Governments.
As these diseases have either gone or become uncommon, the development of novel vaccines is either difficult or impossible. There are no large populations of susceptible, at-risk people in which clinical trials to prove safety and efficacy can be carried out. It would be unacceptable to carry out challenge studies on such vaccines using normal subjects. The individuals would be put at risk, and there would be a serious risk of the pathogen escaping into the general population. Such vaccines can be tested only by examining immunised subjects for the presence of certain markers of immunity.
To meet the present threat, reliance must be placed on running up the old manufacturing methods as quickly as possible. There are few companies worldwide with the appropriate plant and expertise to hand. Powderject has been awarded the UK Government contract to produce the smallpox vaccine. However, it does not have the technology in-house, and is having to go to a Danish company—Bavarian Nordic—for the technology and supply of the vaccine. It will then have to develop the plant and methodology in-house to produce it. This will be the case for any other company or organisation that takes on such manufacture de novo.
Acambis would appear to have been involved in smallpox vaccine production in recent years under contract to the US Government. The US vaccine is based on a different strain of organism from that used in the UK. I do not know whether the differences between the strains are significant in terms of levels of efficacy, as I am not aware of any head-to-head comparison of the two vaccines having been undertaken when smallpox was a serious health risk. Both vaccines were obviously effective, however, in providing populations with some measure of protection. I look forward to hearing from the Minister which vaccine strain has been used in Britain, and whether it was the more effective. There were several forms of TB vaccine in use in the 1950s: one form gave good protection in the UK but not in the US, and vice versa.
The only UK capacity that I know of for the production of anthrax vaccine is at the Centre for Applied Microbiological Research at Porton Down, which has upgraded its production facilities recently. It still uses a process based on older technology, however. There might also be other research and development enterprises going on elsewhere. I would imagine that in the next few months there will be a great deal of activity, given 11 September, the anthrax outbreak and the other scares in the United States.
The problem of large-scale production of old vaccines against defunct or rare disease organisms has been highlighted by recent events. They have provided effective bio-weapons for use by terrorist regimes, and can be produced on a large scale for such purposes as a very low-tech enterprise. The Government should take 1028 responsibility, and ensure that the country has the capacity to respond rapidly to such threats. It should not be left to the whim of industries, which by and large do not act as charities and will want due reward.
Other organisms could be used by bioterrorists—for example, plague and the ebola virus, which could have a devastating effect on an unprotected population. It could, I think, be argued that the Government should establish its own vaccine production organisation, capable of ensuring effective and timely responses to biological threats.
Vaccination has always entailed the problem of convincing the public that no risk is attached. There is no such thing as a risk-free world or technology, and when scientists and politicians stand up and imply that there is no risk, they are likely to be disbelieved. All the arguments need to be put on the table.
Sir Paul Nurse, a recent Nobel laureate from this country, expressed his views on the politics of scientific evidence not long ago. He said that
there is no doubt that what the Government is saying is true on MMR and that the evidence that it's accepted and safe is very good. Like all things, and in science in particular, you can't be certain of everything and there will be a small risk. In MMR the adverse risk seems to be very, very low to almost non-existent. I think the point is that they"—politicians—need to communicate the evidence. This is where there is a dumbing down. I think they are really frightened to talk about science because politicians come from a different background. They are not happy with it and they are used to having to deal with certainties—and science doesn't deal with certainties.Submitting a study to a scientific process rather than to partially informed opinion is crucial to the determination of whether a vaccine actually causes a given reaction. If undertaken carelessly or without scientific rigour the study results will be inconclusive at best, may result in the inappropriate withdrawal from use of a valuable vaccine, or at worst may result in a population's exposure to a dangerous vaccine.
In the United States there are controversies about the safety of vaccines. The US has addressed the problem by establishing an immunisation safety review committee—a multi-disciplinary committee with members whose expertise is in epidemiology, biostatistics, paediatrics, public health, immunology, neurology, infectious disease, risk perception, genetics, ethics, health communication and other subjects.
The committee helps to communicate to the public the state of knowledge regarding any particular immunisation safety concern. It produces reports, and has so far been able to convince the public of the uncertainties surrounding any new vaccine coming on to the market. It has recommended to the US Department of Health the creation of a panel to examine parents' perceptions of the risks and benefits to develop better communication tools to them and their doctors. I suggest to the Minister that the Government might follow that example, and address the fears of those caught in doubt or dilemma over the MMR vaccine. Such people may be worried by the unexplained rise in the number of diagnosed cases of autism, although no link has been proven scientifically.
Where will we draw the line on vaccination policies in future? How many shots will an individual need for nations to feel protected? If we expose our immune systems to too many toxins, especially in a very short 1029 time span, there may be deleterious effects—as has been implied in the context of Gulf war syndrome. Given increasingly visible scientific developments, the vaccination scenario for the future may be very different from the current one. New delivery systems for vaccination shots may prove more effective by mimicking natural infection mechanisms. An example is the aerosol delivery of the measles vaccine.
The more we know about the nature of the human genome, the more we start to realise the existence of genetic differences between individuals. That may not just translate into a susceptibility to certain illness such as cardiovascular disorders; it could indicate resistance to certain infections. The future might well hold tailor-made provisions for vaccination, with a profile-adjusted individual vaccination plan that could prevent any possible detrimental effects linked to immune reactions.
Although individuals ask for 100 per cent. security in everything, they realise that it may not be achievable. Governments who play that card and win public confidence by covering up uncertainty and playing the "safe politics" game run great risks. The consequences of such reductionist approaches in political and social debate may yet come to haunt us. The public need to know the risks, and to feel empowered to act accordingly.
I have tried to raise some of the issues to which the subject of vaccination gives rise. Given that biotechnology is coming on-stream at a great rate, and that many diseases are appearing in certain countries for the first time, I believe that there will be an explosion in research and development into new vaccines. It is time for a review of, for example, the relationship between global warming and the new diseases. We need to examine the new vaccines, and our approach should consider how best to protect our population further.
§ The Parliamentary Under-Secretary of State for Health (Yvette Cooper)I congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson) on securing this debate, and on choosing a subject that is of immense importance to the health and lives of people across the country. My hon. Friend is right to say that we should not underestimate the impact on public health of immunisation programmes such as the NHS programme. Immense improvements have been made not through treatment but through vaccination—a fact that is of worldwide significance.
It is because of the immunisation programme that the incidence of childhood disease in this country has fallen to its lowest ever levels, greatly reducing morbidity and mortality from such diseases. In 1940, before vaccination was introduced, there were over 46.000 cases of diphtheria. Recent data show that, some 60 years later, the annual number of cases has reduced to single figures. In 1940, there were over 400,000 cases of measles, but recent data show that the rate is now less than 200 cases per year. In the same year, there were over 50,000 cases of pertussis—whooping cough—but recent data show that there are now less than 3,000 cases per year.
In 1989, when monitoring began, there were more than 24,000 cases of rubella. The most recent figures show a rate of less than 100 cases a year. Here, the most important issue is the prevention of congenital rubella syndrome. As a result of measles, mumps and rubella 1030 vaccination in young children, there were no such cases in England and Wales between 1997 and 1999. Childhood vaccination has repeatedly been demonstrated as cost-effective—indeed, even cost-saving—and the World Bank has identified it as one of the most cost-effective health strategies.
My hon. Friend is right to say that vaccination is a rapidly moving field. Recent developments in this country include the introduction of meningococcal C conjugate vaccine. Before its introduction, there was an increase in the number of notifications of, and laboratory-confirmed cases of, meningococcal disease, and a relatively greater increase in cases of disease caused by group C infection, particularly in older teenagers. In the light of that increase, the UK took a leading role in developing a new meningococcal C conjugate vaccine, and was the first country in the world to introduce it.
In 1994, the Department of Health funded an accelerated research programme to evaluate the safety and efficacy of the new vaccine. It involved collaboration with the Public Health Laboratory Service, the National Institute for Biological Standards and Control, the institute of child health, and the Centre for Applied Microbiology and Research. My hon. Friend referred to that centre, and I shall discuss it later. That is an interesting example of work carried out in partnership with vaccine manufacturers such as those that he mentioned. They have the capacity to respond and to adapt, and were keen to work with the Department on developing a new programme.
The meningitis C campaign, which was introduced to offer the vaccine to everyone under the age of 18, has been extended to include older age groups. The programme has been completed, and has had a dramatic effect on all immunised age groups, resulting in the near disappearance of meningitis C disease in people under the age of 20. The incidence of serogroup C disease in targeted age groups fell by more than 80 per cent., and the number of deaths among the under-20s decreased from 78 in 1998-99 to 11 in 2000-01. The provisional data for the last year show that we have not had a laboratory-confirmed case of meningitis C in infants under one year of age since the beginning of December last year. From July 2001 to date, there have been only five cases of meningitis C in the 15 to 17-year-old age group, whereas we saw 73 cases in the same period three years ago. Those are recent examples of the huge impact of developments in vaccination programmes. We have also seen developments in flu vaccines.
My hon. Friend the Member for Norwich, North mentioned issues for the future and the progress that needs to be made. He will know that the chief medical officer has recently published a report entitled "Getting Ahead of the Curve: A Strategy for Combating Infectious Diseases", and a key aspect of future policy is continuing to secure the benefits of safe and effective vaccines in future. Other aspects include influenza and pneumococcal vaccine; coverage in childhood immunisation programmes; the examination and introduction of new vaccines; and research and investment, including international research to develop a new vaccine against HIV.
My hon. Friend asks what more can be done. He raised issues connected with the Centre for Applied Microbiology and Research—CAMR—and what role the Government could play in ensuring strategic capacity for 1031 the manufacture of vaccines. It is rarely likely for it to be sensible or economic for the Government to manufacture the vaccines that we might need for a population of 50 million, with the problems of patents, property rights and licence fees. Vaccine production can be achieved most economically for markets bigger than the UK, so it is not a worthwhile use of resources for the Government to manufacture vaccines directly. However, we can work in partnership to great effect, as we have done with three vaccine manufacturers to develop the meningococcal C conjugate vaccine.
CAMR is a special health authority, funded by the Department of Health and located alongside the Ministry of Defence establishment at Porton Down. As part of its work CAMR undertakes small-scale vaccine manufacture and research. Current work includes the manufacture of anthrax vaccine under a five-year contract for the Ministry of Defence. My hon. Friend was right to refer to the importance of such work. There was no commercial producer of that vaccine because there was only a limited demand for it and it was not considered to be commercially profitable. However, in the UK there has been a long-standing demand for that vaccine for military personnel and therefore CAMR took on its development and production, albeit on a relatively small scale, in order to meet the Ministry of Defence need.
The vaccine was not available in the United States, but since 11 September and the anthrax releases there, substantial demand has been generated and the vaccine is now being produced commercially. Where there is a military need, which is usually a low-volume need, or a requirement for capacity to respond rapidly, there remains a need for the Government to fund research and development for vaccines. We may also need to respond, as we have in the past with anthrax, to demand for vaccines. Before 11 September, my right hon. Friend the Secretary of State for Health agreed to the establishment of a strategic response capability at CAMR, which is part of its long-term development.
My hon. Friend raised several issues related to bioterrorism and our response to it. He will know that the planned response to any terrorist attack is co-ordinated between several Government Departments and agencies and facilitated by the civil contingency secretariat in the Cabinet Office. The Department of Health has issued guidance to regional and health authority directors covering the planning of the health service response to any deliberate release of biological and chemical agents and has issued guidance to regional directors of public health on mass decontamination and related matters. Further guidance has been issued to health authorities on the procedures to be followed in the event of the covert or overt release of smallpox, anthrax, plague, botulism or unknown biological or chemical agents.
In October last year, the Public Health Laboratory Service also issued guidelines for action in the event of a deliberate release of smallpox. It is important that we have the right preparation and planning in place. That work is ongoing and has been part of the Department's activity for a long time.
As part of its contingency planning since 1988, the Department has reviewed its stocks and supplies of medical countermeasures. Additional stockpiles of appropriate antibiotics and other medical countermeasures 1032 have been put in place, as have additional stocks of smallpox vaccine for use in the event of a bioterrorist attack.
My hon. Friend the Member for Norwich, North will be aware that my right hon. Friend the Minister of State has set out, in answers to parliamentary questions, many of the decisions taken in this connection, including the decision about the strain of vaccine. Advice about that decision was taken from across Government, especially from the Joint Committee on Vaccination and Immunisation. That is an important body, providing well-established independent expertise for the Department. It regularly reviews UK epidemiological evidence on disease and progress on vaccine development. It also has the important function of horizon scanning, so that priorities can be set against the assessments of disease burdens and the predicted pace of new vaccines.
My hon. Friend referred to matters to do with communication, and the importance of providing people with accurate information. I agree that people need more information, and that they want it to be clear and comprehensible. When complex scientific matters are involved, that is often not a simple task. It is an important challenge, and we must accept that people increasingly want information in which they would not have been interested, and would not have expected, 20 or 30 years ago. That information is now very much part of current expectations of the health service.
My hon. Friend mentioned MMR. Parents have understandably been worried about media stories over the past few months. The Department has conducted extensive research to find out parents' concerns, and to determine what sort of information they want. It is important that we answer the questions that people want to ask, and that we respond to their concerns in this area.
§ Dr. GibsonIs the uptake of the triple jab rising or falling? If it is falling, what is the likelihood that the trend might be reversed?
§ Yvette CooperThe latest figures from the PHLS show that there was a dip in the level of MMR uptake among 16-month-olds between December and March. Interestingly, however, uptake in that age group showed an increase in April. The figures are available on the PHLS website.
It is important that we continue to respond to people's concerns about MMR. That is why we have sent out new and substantial parent packs to GP surgeries and to NHS Direct. They provide more extensive information to respond to parents' queries and questions, and give more information about scientific research.
The packs include statements from various independent bodies, because, in matters such as this, we must not rely solely on advice from the Department's experts. We need to turn to independent bodies such as the World Health Organisation, the Royal College of Paediatrics and Child Health, the Royal College of General Practitioners and many other organisations in this country and around the world. They have all advised us that MMR is the safest way to immunise children against what are very serious diseases. It is important to tell people the full facts about MMR, including the views of all the independent experts, and the single jabs. They have a right to have all the information. 1033 Vaccination policy is difficult, especially when the immunisation programme has been successful in largely eradicating a disease. Many younger people have no experience of the diseases that we are talking about, so the huge impact of the immunisation programme can be underestimated. That applies to many programmes across the board.
§ Dr. GibsonWill the Minister say whether there has been any increase in measles outbreaks in this country since the controversy arose? She gave me the figures for the triple MMR uptake, but is there any evidence in relation to a measles epidemic?
§ Yvette CooperThere has not been a measles epidemic in this country, although there have been isolated outbreaks in various areas. The experience in Ireland is that isolated outbreaks can occur, and we need to take them seriously. The PHLS said today that the majority of parents are still having their children immunised with the MMR vaccine, but we must continue to take the issue extremely seriously and ensure that parents get the information they need.
My hon. Friend spoke about looking to the future, whether in the areas of new technology, the human genome project or research. He is right that there are all kinds of exciting possibilities, with different technology 1034 and research coming to bear. There is extensive research into HIV and other diseases, but we do not know what the long-term possibilities will be. We must ensure that the system can respond rapidly to developments in technology and in progress.
The experience of the meningitis C vaccine has been a powerful testimony to the capacity of the NHS in particular to respond rapidly to a new vaccine that is proven to be effective and have a big impact. This country was one of the first to introduce a meningitis C programme right across the childhood population. That is an immense tribute to those working in the NHS, in both primary care and schools. It is a testimony to the partnerships that the NHS has with the various companies involved and its capacity to deliver immunisation programmes. This is not simply a research or a technology issue: it is also a health service issue because, ultimately, immunisation programmes have to be delivered.
My hon. Friend has raised a series of important points. I congratulate him again on securing this debate. This is an area in which I hope we will see further positive developments. We have had much to be thankful for, not simply over the past few years but over the past 40, 50 or 60 years.
§ Question put and agreed to.
§ Adjourned accordingly at seventeen minutes to Eight o'clock.