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Pneumococcal Vaccine

12.58 pm

Sandra Osborne (Ayr): Over the past few months, I have been increasingly aware of an issue that affects the health and well-being of thousands of children throughout the United Kingdom. It places a significant burden on national health service resources, results in the deaths of 50 children each year and in other cases can leave parents and the caring professions struggling to cope with permanently damaged and disabled children. Yet, much of that is preventable. The issue in question is pneumococcal disease.

Many hon. Members are aware of cases of meningitis in their constituencies, the fear that outbreaks of infection can cause among parents and communities, and the devastation that it may cause. Many may not be aware that pneumococcal disease is the second greatest cause of meningitis in Britain. As a Scottish Member of Parliament, I am particularly concerned that there is a greater incidence of the disease in Scotland.

Media attention inevitably focuses on meningitis B, and overlooks the fact that although pneumococcal meningitis is not as common, it is more life threatening. Fifteen per cent. of children—one in six—who contract it die. Despite this age of rapid medical advances, that figure has, sadly, remained the same for more than 20 years. The chances of a child dying from pneumococcal meningitis are twice as high as they are for meningitis B.

When cases of meningitis are reported in the media, they are usually reported in the stark terms of a child's death, but it is important to remember that in the majority of cases children survive meningitis, although often at a high price. Those children and their families have to live with the disabling consequences of the disease for the rest of their lives.

It is obvious to my colleagues that I have a slight disability; I suffer from visual impairment. That resulted from measles at the age of three. It is a disability that people learn to cope with and adapt to and is comparatively trivial. For children who survive pneumococcal meningitis, life is not so straightforward. One in six will be brain damaged, one in seven will have epilepsy and a quarter will suffer from deafness. Overall, half the children who survive pneumococcal meningitis will be left with some form of disability, including spasticity, learning disorders and behavioural problems. Again, the record is worse than that for other forms of meningitis.

Pneumococcal disease does not cause only meningitis; it may cause a wide range of other serious and life-threatening illnesses. Every year, serious pneumococcal diseases such as meningitis, blood infections and pneumonia devastate the lives of thousands of British children and their families. Babies and young children under two are most at risk.

When discussing health topics, Mr. Winterton—

Mr. Deputy Speaker (Mr. Nicholas Winterton): Order. I am one of the four Deputy Speakers for sittings in Westminster Hall, and today's proceedings in Committee Room 10 are equivalent to those in Westminster Hall.

Sandra Osborne : I am sorry, Mr. Deputy Speaker.

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There are many facts and figures, but I want to go beyond the statistics and provide a first-hand perspective and insight into pneumococcal disease. I shall focus on two aspects: the difficulty of diagnosis and the long-term consequences of the disease for those who are lucky enough to survive.

The story of a little boy called Sam—I am very pleased that his parents are present to hear our debate today—was recently brought to my attention. Sam was only five months old when his parents became concerned because he had a cold, a temperature and was not sleeping well. One might think that those symptoms, being the normal symptoms of feeling slightly off colour, would not cause alarm bells to ring. Nevertheless, Sam's parents, ever mindful of meningitis, did not want to take any chances and took him to the local accident and emergency department where they were assured that he did not have meningitis. The following night, Sam's condition deteriorated and he had a burning temperature and bulging fontanelle. His mum and dad telephoned NHS Direct, which advised giving him paracetamol to lower his temperature. The following morning, Sam seemed better but then became worse and was again taken to the A and E. A non-specific virus was diagnosed and he was sent home.

Back at home, Sam's condition continued to deteriorate. His parents were alarmed and returned to the A and E, where Sam had a fit on arrival. That time, the doctors recognised the signs of meningitis. Sam spent the next two weeks in intensive care, fighting for his life, and a further fortnight in an isolation ward. Laboratory tests revealed that he had had pneumococcal meningitis.

Let me make one thing clear: doctors' failure to recognise Sam's condition is not an indictment of the doctors who saw him, or of the national health service. In the words of a leading expert, pneumococcal meningitis can be extremely difficult to diagnose because babies under 12 months old do not always have the classic symptoms of the disease, such as the rash that is often seen with other forms of meningitis. There is an important lesson for us all to learn from that. Pneumococcal meningitis is difficult to recognise and often, as in Sam's case, is recognised only when it is much too late. Common logic therefore dictates that, with that type of meningitis perhaps more than with any other, prevention is better than cure.

To return to Sam's story, thanks to the skill of the medical team and the antibiotics pumped into his body, Sam survived. However, as we have already heard, more than half of the children who survive pneumococcal meningitis are left disabled, and Sam was one of them. He came home paralysed down his left side, brain damaged, epileptic and profoundly deaf. Sam has, with the support of his parents and a range of specialist carers, made considerable progress. He has regained the use of his left side and, despite the meningitis having destroyed his sense of balance, now begun to walk. According to his dad, he has a great sense of humour and is full of beans. Inevitably, however, as happens with many other children affected by serious pneumococcal disease, most of Sam's disabilities will remain with him for life. That will mean the need for some care for him from his parents, family and the wider community for the rest of his life—a lifetime of care and

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support, and, for his parents, the knowledge that Sam can never lead the life that they might once have hoped for him.

Why, if pneumococcal disease is so difficult to spot and can have such devastating consequences, are we not doing something to prevent it? In a small way, we are, but in another important way, it seems that we have not quite decided. In January, the Department of Health announced that a new vaccine for pneumococcal disease, which for the first time is effective in children under three years old, should be given to the children most vulnerable to the disease. They include those with chronic heart, lung, liver or kidney disease, diabetes, sickle-cell disease and those with a poorly functioning immune system for other reasons.

The Department is to be applauded for that recommendation and for offering protection to those children. However, it is widely acknowledged that the vast majority of pneumococcal disease occurs in children who are otherwise perfectly healthy, just like Sam. Through the introduction of a routine immunisation programme, a major health gain could be won for British children. Despite that, the Department has not yet given a clear time frame for when the new vaccine will be made routinely available for all British children. That reluctance is surprising given that the Department has already conducted clinical trials on including the new vaccine in the routine childhood immunisation programme. At the moment, we have vague assertions that the possibility of an immunisation programme is actively being considered.

The disease is generally acknowledged as the commonest bacterial cause of pneumonia, which is a particularly dangerous condition in young children. Here in the UK, it is estimated that one in 200 children is hospitalised as a result of pneumococcal pneumonia before their first birthday. It is also important to recognise that the disease particularly affects older people. The pneumococcal polysaccharide vaccine could greatly benefit them, but I do not have time in this debate to pursue that further. Perhaps the Minister will comment briefly on it.

For the elderly and those in other age groups, pneumococcal pneumonia is responsible for the more serious types of pneumonia, which sometimes require surgery to resolve the damage caused and on occasion result in death. The disease does not only cause life-threatening and disabling conditions; it is a major cause of many common childhood illnesses, such as middle-ear infections. As any parent will know, such illnesses can cause considerable suffering and prove very troublesome, especially to those families who are least able to cope.

Nearly all children will have suffered a middle-ear infection by their third birthday. Although such infections can have many different causes, research shows that up to half of the cases that are bacterial in origin are due to pneumococcal disease. Moreover, severe, recurrent ear infections in children are more likely to be due to pneumococcal disease. Such infection can lead to a glue ear or a perforated eardrum—conditions that can have serious implications for a child's development, and which many families will have

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experienced. Those common diseases also impose a heavy burden on the national health service in visits to GPs and admissions to hospital.

There is growing concern about the use of antibiotics to treat conditions such as ear infections. Fears about the steady increase in antibiotic-resistant strains of bacteria—already seen in many parts of world—are very real and are now starting to become a major source of concern in this country. Recent figures from Scotland, for example, show a tripling of the rates of resistance over the past decade to both penicillin and erythromycin. The problem is twofold. First, the effectiveness of drugs vital in the line of defence against serious diseases such as meningitis is being eroded. Secondly, in an attempt to rationalise unnecessary antibiotic usage for minor viral illnesses, the more serious causes of recurrent, severe ear infections, such as those caused by pneumococcal disease, are being treated later.

A routine immunisation programme to prevent the most serious forms of pneumococcal disease would also produce additional benefits in reducing the amount of less serious pneumococcal illness commonly seen in young children. It could help score a useful win in reducing pressure on NHS beds, cutting the number of GP visits, reducing the prescription of antibiotics, and cutting demand for surgical procedures, such as the insertion of grommets in cases of glue ear.

Why does the Department of Health appear to be dragging its feet in introducing the new vaccine for all children under two, and not just those at most risk? We led the world in the introduction of a routine vaccination programme for meningitis C in 1999. Indeed, an exemplary partnership between the Department of Health, public health agencies and manufacturers allowed the immunisation programme to begin many months earlier than originally envisaged.

Judy Mallaber (Amber Valley): My hon. Friend is aware that I have tabled questions on the introduction of the pneumococcal vaccine, asking what assessment has been made of its impact in the United States and Europe on children under two, and asking when it will be introduced. Is she aware that my interest arises from the time when the former Secretary of State, my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson), allowed the meningitis C vaccine to be used in a village in my constituency before it was introduced nationally? At the time, there was complete desperation because of a series of cases of meningitis that were—and still are—completely unexplained. As my hon. Friend said, the meningitis C vaccine has been a phenomenal success nationally. We managed to introduce it a year earlier than planned, and I would like similar urgency to be given to the introduction of the pneumococcal vaccine, so that we can end the sort of desperation experienced by children in my constituency who suffered from meningitis.

Sandra Osborne : I thank my hon. Friend for her intervention. I am aware of the situation that she experienced in her constituency. We want to see an early extension of the pneumococcal vaccine. The meningitis campaign itself has been amazingly successful. Cases of meningitis C—and resultant deaths— have tumbled by a staggering 90 per cent. in just one year. However,

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despite this major public health success, no timetable has been seen set for the routine introduction of the new pneumococcal vaccine in this country.

The efficacy and safety of the new pneumococcal vaccine are not in question. The vaccine has had extensive trials in the United States and Europe. Studies have been conducted in this country by the Public Health Laboratory Service, and the Government see fit to give the vaccine to at-risk children. In addition, the new vaccine has been in routine use in the United States for two years with considerable success. There it is recommended for all children under two years of age, and it is part of the federal childhood immunisation programme.

The UK has a long-established pre-eminent global position in the promotion of public health and immunisation policy. Yet, with regard to the prevention of pneumococcal disease, there is an inexplicable lack of urgency on the part of the Department and its advisers on the Joint Committee on Vaccinations and Immunisation. Perhaps the ongoing debate about the safety of the measles, mumps and rubella vaccine has drawn the Department's attention away from the next logical step in protecting the health of the nation's children. In the media yesterday, Dr. Paul Gringas made the point that concern over MMR has set back research into autism. I wonder whether this is another parallel. Perhaps the Government consider that winning the battle against meningitis C means that we can take a rest from the continuing war against other forms of meningitis. Sam, his family and others like them would disagree.

I congratulate the Department on the chief medical officer's report, "Getting Ahead of the Curve". It points out the major health gain for the nation that routine immunisation against pneumococcal disease could produce, not only for children but for the elderly, who form another vulnerable group. The report remarks on the

"Getting Ahead of the Curve" is an insightful, forward-thinking document. However, there is a disconnection between its conclusions and the Department's resolve to act on them. The new vaccine is licensed and available, so surely the Department should act to protect our vulnerable youngsters as soon as practicably possible. Until the Department finds it timely to make its decision, its apparent procrastination and lack of commitment will continue to cost the lives of young children. Four will die each month, and many others, such as Sam, will be left with severe, permanent disabilities.

Can the Minister put on record when the Department of Health intends to introduce the new pneumococcal vaccine for all children under two as part of the routine childhood immunisation programme? An obvious first step would be to say whether the new immunisation programme is in her Department's identified spending plans for 2002-03. If it is not, she should say whether the decision rests on gaining adequate funding.

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1.18 pm

The Parliamentary Under-Secretary of State for Health (Yvette Cooper) : I congratulate my hon. Friend the Member for Ayr (Sandra Osborne) on securing a debate on this important subject. I welcome her support for the Government's vaccination programme for children. She gave us a powerful description of the dreadful impact of pneumococcal infection on children and family lives, and she made a strong case for prevention by discussing in detail the pneumococcal vaccine. I shall set out how consideration of the pneumococcal vaccine for the under-twos has progressed, and address some of her points.

As my hon. Friend said, pneumococcal infection causes a broad spectrum of disease. It is the most common cause of pneumonia, and causes meningitis and septicaemia. It is also involved in a proportion of middle-ear infections. Those diseases are serious and can be fatal. The very young and the elderly are at greatest risk. However, I shall confine my remarks to the issues that my hon. Friend raised on pneumococcal disease and the vaccine for the under-twos. Should I have time, I shall return to the issue of the elderly; if I do not, I shall happily write to her.

The peak incidence of pneumococcal disease in children is in those under two years of age, and the risk of meningitis is largely confined to children under five. In 1999, 561 invasive pneumococcal infections—meningitis or septicaemia—were reported to the Communicable Disease Surveillance Centre in children aged under five years, and there were more than 5,000 hospitalisations of children with lobar pneumonia in that age group, most of which were due to pneumococcal infection. From such hospital admissions, approximately 40 deaths are reported each year as a result of pneumococcal infection.

The data from the Public Health Laboratory Service on the level of infection is supported by a recent independent study of deaths in infants and young children due to invasive pneumococcal disease. The results of that study will be presented at the spring meeting of the Royal College of Paediatrics and Child Health in York next week. Taking into account various concerns about the data, it concluded that for the age group of one month to four years there were likely to be 43 deaths per year due to pneumococcal infection.

My hon. Friend is right about the considerable disability burden that can result from pneumococcal infection. She described it powerfully with reference to a family with which she has been in discussion. Faced with a disease such as that, we should be promoting prevention. She is also right that another major concern about pneumococcal infection is the extent to which it may be developing resistance to antibiotics, which is an additional reason to consider the role of prevention. In the UK, the use of the two main antibiotics for pneumococcal infection—penicillin and erythromycin—remains at relatively low levels, but we are monitoring that closely. In some other countries resistance is increasing, and in some cases it is already at worrying levels.

The Government have shown their commitment to introducing vaccines once their safety and efficacy are demonstrated. I know that my hon. Friend supported the meningitis C campaign, which has had an immense

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influence on saving lives. I assure her that the current position on pneumococcal vaccine is not due to a lack of commitment. Extensive work is under way, and I wish to highlight the logistics of introducing nationwide vaccine programmes. I shall set out the progress that we have made so far and the things that need to be resolved.

A new pneumococcal conjugate vaccine was licensed in the UK last year. Unlike the existing pneumococcal vaccine, it offers protection to children under two years of age. The conjugate vaccine uses the same technology that was applied to the Hib and meningococcal C conjugate vaccines, allowing younger children to develop a protective immune response and stay healthy. Unlike those vaccines, however, it is several vaccines in one. Although the existing pneumococcal vaccine contains elements of 23 strains of pneumococcus, the new conjugate vaccine prevents the development of seven strains of pneumococcus.

Work is already under way to evaluate the new vaccine's suitability for use in the UK's routine childhood immunisation programme. The work is being done by the Department of Health's vaccine evaluation consortium, which includes the Public Health Laboratory Service, the National Institute for Biological Standards and Control, the Centre for Applied Microbiology and Research and the Institute of Child Health. It is a unique collaboration of Government-funded but independent organisations and institutions. Hon. Members will be aware that it was such across-the-board collaboration that led to the very successful meningitis C campaign.

With the prospect of the introduction of an effective pneumococcal conjugate vaccine for children, the Public Health Laboratory Service enhanced its routine surveillance systems to concentrate on the most serious infections, namely those in which the bacteria reach the bloodstream. Those are infections for which the most benefit can be expected from a vaccine. One of the most important questions for surveillance is whether the vaccine provides protection against the pneumococci strains that are causing the most disease in this country. The vaccine was formulated in the United States, but prevalent serogroups of pneumococci vary from country to country. From the data that the PHLS collects, it is able to determine the proportion of invasive infections attributable to the different serotypes included in and protected by the conjugate vaccines. The proportion of serotypes currently causing invasive disease in England and Wales that would be covered by the new vaccine is 65 per cent. for all ages and 86 per cent. for those under five. That is important information.

One of the next issues to be determined is the interaction between the new vaccine and the current vaccination programme. The pneumococcal conjugate vaccine has already been introduced into the routine programme in the United States, but since the vaccine was licensed, there has been little information on its national impact, other than on the population that took part in the clinical trials. The results of those trials were highly impressive, with the almost complete disappearance of invasive pneumococcal disease caused by the strains covered by the vaccine.

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Recent population data from the Center for Disease Control suggest that there have been fewer cases—20 to 25 per cent. in children under four—of invasive pneumococcal disease since the vaccine was introduced in the USA. That does not mirror the success of the meningococcal C campaign, as a result of which the number of cases has fallen by 80 per cent. in the target groups, but it is important information nevertheless. We should remember that the vaccine protects against only seven of the most common strains of pneumococcus. However, importantly, the circumstances in which pneumococcal conjugate vaccines might be used in the UK are different from those in the United States.

The UK primary immunisation schedule is given at the ages of two, three and four months, compared with two, four and six months in the United States, where pneumococcal conjugate vaccine is given again as a booster at 12 months. We must carry out clinical trials to see whether the new vaccine is as effective at two, three and four months as it is following the United States' schedule.

Sandra Osborne : I am aware that the Minister is drawing to a conclusion, so can she can give us some idea about the time scales involved?

Yvette Cooper : I will try to give some indication of the time scale to which we are working, because many trials are already under way.

No booster doses of similar conjugate vaccines, such as Hib, are given in the UK, whereas they are given in the United States. We will have to decide whether a booster dose for pneumococcal conjugate vaccine is necessary. The addition of pneumococcal conjugate vaccines would represent a third conjugate vaccine in the UK, as meningococcal C conjugate vaccine is part of the UK but not the USA schedule. We do not know how the two conjugate vaccines interact and whether they work well when given together. That is why detailed clinical trials relevant to the UK are essential.

The Joint Committee on Vaccination and Immunisation will make the final recommendation to the Government. It has been made aware of the positive results in the USA, and has advised that the vaccine should be made available to those children under two who are at particular risk from pneumococcal disease, as my hon. Friend has said, but we need to assess additional factors and bear in mind that fitting the vaccine into the UK schedule cannot be taken for granted. All the evidence is that the more visits that parents and children have to make for vaccinations, the greater the chance that children will not complete the course.

When asked by Health Promotion England, which has already conducted a survey on pneumococcal immunisation on our behalf, parents said that they would prefer an extra injection to be given at a visit that was already scheduled, rather than scheduling a new visit. To see how a new vaccine would fit into the current schedule, it is important that the issues surrounding combinations of vaccines and their timing are properly assessed. Trials are being carried out and will be completed late this year. Studies to document the full burden of morbidity and disability attributable to pneumococcal disease in UK children are also in progress.

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Vaccine safety is an important factor. The Government will not introduce any vaccine until all the appropriate research and clinical trials have been carried out. That work will then be reviewed by the Joint Committee on Vaccination and Immunisation, which will make recommendations to the Government based on its conclusions. I assure my hon. Friend that there is no lack of commitment, but we have a responsibility to children and families to ensure that logistic, safety and efficacy issues are resolved.

There are also shortages of pneumococcal conjugate vaccine in the USA, and the full recommended schedule cannot be implemented. We need to consider supply, too. Several other countries are in the same position and are considering the impact of the vaccine on their vaccination programmes. We must recognise that there could be a big increase in the number of countries that want the vaccine to deal with their supply issues.

I shall inform my hon. Friend of progress, and give her any further information that we receive about the time scales in which the trials and the joint committee will report. I assure her, however, that we are committed to improving children's health.

Mr. Deputy Speaker : We are grateful to the Minister for her reply. We are also grateful to the right hon. Member for South-West Surrey (Virginia Bottomley) for arriving in the nick of time.

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