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3.30 pm

Keith Vaz (Leicester, East) (Lab): I am most grateful to you, Mr. Deputy Speaker, for the opportunity to raise in this Chamber the case of Lachlan Fewster and the availability of the vaccine Prevenar. I am also very pleased that Scott and Maria Fewster are at Westminster today. Scott and Maria Fewster lost their only son, Lachlan, to pneumococcal meningitis in April this year. They state that his death could have been prevented if he had been inoculated with the vaccine Prevenar. Before the attack in April, like all fun-loving youngsters, Lachlan had always been full of energy. He died in hospital within hours of falling ill. Mr. and Mrs. Fewster believe that if Lachlan had received the vaccine he could still be here with us today. Losing a child is one of the most devastating things that can happen to a parent, as my wife and I know only too well, and it is Scott and Maria's commitment to raising awareness about their son's case that has convinced me to raise the issue today.

Childhood immunisation has been one of the greatest successes of modern medicine. In the last half-century, previously life-threatening and disabling diseases such as polio and diphtheria and, thanks to the success of the more recent immunisation programmes, HIB meningitis and meningitis C, have been virtually eradicated in this country. Despite that success, some serious diseases remain. Pneumococcal disease is caused by the bacterium pneumococcal pneumoniae. I apologise for my pronunciation of these words, but I am doing the best I can, considering that they are so technical. Pneumococcal infection can cause a variety of different illnesses, including life-threatening serious disease such as meningitis, pneumonia and blood poisoning. The consequences of serious pneumococcal infection in children can be devastating and potentially more severe than the consequences of other infectious diseases against which children are already routinely vaccinated. Despite the availability of effective antibiotics, serious pneumococcal diseases carry a significant risk of death or severe disability.

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. One of the most devastating forms of pneumococcal disease is meningitis, which is the second most common form of bacterial meningitis in the United Kingdom and among its most life-threatening. Media attention inevitably focuses on meningitis B, and children are immunised against meningitis C, but many parents are not even aware of the pneumococcal form of the condition. Some 15 per cent. of children, or one in six, who contract it will die. Despite 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 for meningitis B and C. As I mentioned earlier, Lachlan died within hours of contracting pneumococcal meningitis. Furthermore, children who survive infection are twice as likely to suffer long-term and severe neurological complications as children infected with other forms of meningitis. A recent analysis found that one in six children who survived pneumococcal

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meningitis subsequently suffered mental retardation; one in seven developed epilepsy or other seizure disorders; and one in four became deaf. Another recent British study showed that one in four children suffer severe to moderate disability following pneumococcal meningitis. There are many facts and figures, but I want to go beyond the statistics and provide a first-hand perspective and insight into the disease.

The story of Lachlan Fewster was recently brought to my attention when I received a letter from his parents, Scott and Maria. Mr. Fewster is the headmaster of Whitehall primary school in Evington, Leicester—the school at which my mother, Merlyn, taught for a few years when we first moved to the city.

Lachlan was aged just two years and nine months when he died of pneumococcal meningitis in April. He had recovered from the same form of meningitis in March last year after fighting the infection in hospital for nearly a fortnight. At the time, Maria and Scott were told that he had suffered no after-effects. They never dreamed that he would contract the same disease a year later and that it would claim his life.

After Lachlan's death, Scott and Maria discovered that he had been born without a spleen and, as a result, had a significantly reduced immune system. They did not know about it because Lachlan was not screened after birth and he was not considered to be at risk after his first episode of meningitis last year.

In April, the pneumococcal meningitis was stronger and Lachlan lost his fight for life just 10 hours after falling ill. Doctors could not save him, as the bacteria spread so quickly and poisoned all his organs. His parents believe that the tragedy could have been prevented if Lachlan had been given the Prevenar vaccine, which has been licensed but is not routinely available on the NHS.

The knowledge that Lachlan could still be with us haunts the family each day. With my support and that of many others, they are currently campaigning for a routine childhood pneumococcal vaccination. They launched a petition in Leicester last week, which has already received hundreds of signatures.

At present, the NHS provides the vaccine only when a child is deemed to be vulnerable to meningitis—if their immune system is weak, for example. Had Scott and Maria known of their son's reduced immune system they would have insisted that he have an inoculation, and they would have even paid for it themselves. The current price of Prevenar is £120, which would be dramatically reduced if the vaccine were routinely available.

I am glad to say that Maria is expecting a baby in January, but she wants to ensure that her new baby son or daughter is protected. Scott and Maria urge that Prevenar be routinely given to all under-twos. The Fewsters are not alone in their suffering: four children a month die from serious pneumococcal infection such as meningitis, and each time parents are outraged to find that a vaccine is available that may have saved their child.

Research from the campaign group Raising Awareness of Paediatric Pneumococcal Infection and Disease—RAPPID—found an unequivocal response from parents with regard to pneumococcal vaccination. When informed of the facts, 92 per cent. said that they

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were in favour of their children receiving the extra jabs to protect them from the devastating effects of the disease.

As I said earlier, the effects of the infection do not stop at meningitis. When the pneumococcal bacteria enter the bloodstream and multiply, a particularly life-threatening form of serious pneumococcal disease can occur. Septicaemia—blood poisoning—can also cause serious organ damage and ultimately death. The disease is also generally acknowledged as the leading cause of severe bacterial pneumonia in children under two years old and overall in any age group. Many people are not aware that babies can develop pneumonia, which is a particularly dangerous condition in young children. In the United Kingdom, it is estimated that one in 200 children are hospitalised as a result of pneumococcal pneumonia before their fifth birthday. Pneumococcal pneumonia is responsible for the most serious types of pneumonia, which sometimes require surgery to repair the damage caused and, as I said, can result in death.

There is growing concern about the use of antibiotics to treat infections, which I understand. Fears about the steady increase in antibiotic-resistant strains of bacteria already seen in many parts of the world are real and becoming a major source of concern in this country. For example, recent figures from Scotland show a tripling of the rates of resistance to penicillin and other antibiotics during the past decade. 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 uses for minor viral illnesses, the more serious causes of recurrence, such as those caused by pneumococcal diseases, 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 illnesses commonly seen in young children. It could help reduce pressure on the perennial problem of NHS beds, reducing the number of GP visits, the prescription of antibiotics and demand for surgical treatment.

The efficacy and safety profile of the pneumococcal conjugate vaccine are not in question. It has been shown to be highly effective as a vaccine, with an established safety profile generated from experience of the nearly 50 million doses administered to more than 10 million children worldwide. The vaccine has been part of the routine childhood vaccination schedule in the United States since its introduction in 2000. There, it is recommended for all children under the age of two and is part of a federal childhood immunisation programme. It has had a huge, immediate and sustained impact on serious pneumococcal disease cases, such as meningitis and septicaemia. Recent data published in the New England Journal of Medicine detailing figures compiled by the US national Centers for Disease Control and Prevention show a 69 per cent. reduction in pneumococcal diseases in children aged under two since universal use of the vaccine was introduced in 2000.

It does not stop there, as there is an added benefit to the rest of the population. Routine immunisation of children in the United States with the pneumococcal conjugate vaccine has been shown to reduce the incidence of serious pneumococcal diseases among unvaccinated children and adults, thereby extending the

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benefits to parents, carers and grandparents. In fact, just a couple of weeks ago at a conference in Cardiff on infection, the potential benefits were applied to the United Kingdom population, showing that a routine immunisation programme could save 2,000 lives a year.

The European Commission granted marketing authorisation for Prevenar in all 15 EU countries on 5 February 2001, effectively meaning that it was available for doctors in the UK. However, little use of the vaccine occurred until January 2002, when the Department of Health recommended Prevenar for infants and young children up to two years of age in groups with conditions that increase the likelihood of infection and children for whom infection is likely to have a worse prognosis. That includes infants or young children without a spleen, with sickle-cell disease, leukaemia and other malignancies, diabetes or HIV, or with respiratory, cardiac, kidney or liver impairment. However, it is widely acknowledged that the vast majority of pneumococcal disease occurs in children who are otherwise perfectly healthy and happy. Through the introduction of a routine immunisation programme, a major health gain could be won for British children.

Prevenar is also recommended for use in at-risk infants and young children in a number of other EU countries, including Denmark, Germany and Italy. Those countries are also considering the introduction of Prevenar as a routine vaccine for all infants and young children in the context of their national immunisation programmes. Other EU counties, such as France and Austria, have already implemented wider use of Prevenar. In France, recommendations for its use in at-risk children from two months to two years of age are particularly wide reaching. Within the EU, Austria has become the first country to make it available.

Government experience with implementing at-risk vaccination programmes in the United Kingdom shows them to be an inefficient way of protecting vulnerable groups and individuals, as there is no established way of measuring compliance with recommendations or associated health outcomes. So why does the Department of Health appear to be so slow in introducing the new vaccine for all children under two? That would be the best way to ensure that the most vulnerable are protected. Cases of meningitis C and resulting deaths have tumbled by a staggering 90 per cent. since the programme began. With the US experience and in the face of the facts, I ask why it has not been introduced.

On the issue of recognising universal vaccination as the most effective way to achieve protection, the Department of Health should be commended for introducing pneumococcal vaccination for all adults aged 65 and over. I have already talked about the effects on young children.

It is also recognised that cost might be a consideration with this particular vaccine. However, on inclusion in the national routine immunisation schedule, the NHS public service agreement would negotiate a contract price for Prevenar outside the basic NHS price for the Department of Health, as it does for all other routine vaccines. Furthermore, considering the widespread benefits of vaccination—not only to those immunised, but to their families and to society as a whole through

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the herd immunity observed in the US—the programme is clearly cost-effective. Ultimately, what price can we put on a baby's life or a child's damaged future?

Can the Minister put on record when the Department of Health intends to introduce the Prevenar vaccine for all children under two as part of routine immunisation? An obvious first step would be to say whether the new immunisation programme is in the Department's identifiable spending plans for 2004–05. If so, when will it be introduced? May I meet the Minister to discuss these matters?

The death of this little boy from Leicester will be with his parents, their family and friends for ever. I hope this short debate, in a small way, can prevent further deaths from happening.

3.47 pm

The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman) : I congratulate my hon. Friend the Member for Leicester, East (Keith Vaz) on securing today's debate and on his interest in this matter. My congratulations also go to Scott and Maria Fewster on trying to turn a personal tragedy into a measure to protect all children. It is a tribute to them that they have taken such an interest after what happened to their family.

The Department takes seriously the subject of how best to prevent pneumococcal infections in children. It is of great concern to us. I would be happy to meet my hon. Friend to discuss the matter further. If he contacts my office, we can arrange a meeting as soon as he likes.

We take all vaccine-preventable childhood illnesses seriously. Our vaccination programmes have been enormously successful. Nowadays in this country, we never see a child crippled by polio and wearing callipers, which was not an uncommon sight when I was a schoolboy. That is because polio has been eradicated from Europe through vaccination. Smallpox has become a disease of the past. Cases of diphtheria in children are rare, and tetanus infections in infants are also a thing of the past. We have not seen a death from acute measles in this country for 10 years.

All those diseases used to put children at risk. Immunisation has protected them from those and other preventable diseases for years, and continues to do so. An example of our commitment to childhood immunisation was the introduction of the meningitis C vaccine in November 1999. We were the first country in the world to introduce it, and it has been a huge success: cases of meningitis C in children have been reduced by 95 per cent. since the campaign began.

We were the first country to introduce that vaccine because of the collaborative work of agencies such as the Public Health Laboratory Service—now the Health Protection Agency—the National Institute for Biological Standards and Controls, and the Institute of Child Health, which form the Department's vaccine evaluation consortium. That is a unique collaboration of Government-funded, but independent, organisations and institutions. The consortium was able to carry out the studies needed to show that the vaccines were safe and effective.

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That said, the Department is very careful when considering the introduction of a new vaccine into the childhood immunisation schedule. We have to be sure that it is safe and effective in preventing disease. We must know the number of doses that children need to be protected, and at what age the doses should be given. We need to be confident that introducing a new vaccine into the childhood immunisation schedule will not interfere with the other vaccines being given.

I caution my hon. Friend against drawing on experiences in other countries; such things are not directly comparable because all countries have different immunisation regimes. We have to decide what suits our country, regardless of the risk-benefit analyses of other countries.

We also have to think of the practicalities of introducing a new vaccine into the programme, such as whether that would mean extra visits to the GP's surgery, more injections per visit, or the combination of more vaccines in one injection. Also, we must constantly check that our current vaccines are keeping levels of disease down and consider whether further booster doses will need to be added to the immunisation schedule.

It is also important to remember that not all countries offer the same vaccine programmes. For example, we offer the meningitis C vaccine to infants, but it is not routinely offered in the United States. In the United States, vaccines are offered to infants at two, four and six months of age. In the UK, we use an accelerated schedule, offering vaccines at two, three and four months. Those differences between countries' immunisation programmes depend on many factors, such as the risk of a particular disease in a specific country.

I agree with my hon. Friend that pneumococcal infection in children can be serious. The Department already recommends that the vaccine be given to children among whom pneumococcal infection is more likely to be common or more dangerous. "At risk" children include those with severe dysfunction of the spleen, asplenia, chronic renal disease, immunodeficiency or immunosuppression, chronic heart disease, chronic lung disease, diabetes mellitus, and those with a cochlear implant. We already offer protection to more vulnerable children.

In some instances, the risk factors are clear from an early age, but sadly that was not the case for Lachlan. We are already seeking advice about adding pneumococcal vaccine—and Prevenar in particular—to the routine childhood immunisation schedule. The Joint Committee on Vaccination and Immunisation gives independent expert advice on vaccination issues. It has considered the available evidence, and stated that more information and underlying evidence is needed to gain a better understanding of the impact of offering pneumococcal vaccine to children. The available evidence does not allow for an accurate prediction of the burden of disease that is vaccine-preventable.

However, the Committee is aware that the Department is funding research to find out more about the vaccine. The research is assessing the level of protection that the vaccine offers infants in the UK, the optimal schedule for the vaccine in infants, whether there is a need for a booster dose in the second year of

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life to maintain protection, and the impact of introducing the vaccine into the childhood schedule on the protection given by the other vaccines.

Those are important questions that need to be answered. We are hopeful that the studies will provide the information needed to make a clear, evidence-based decision about the vaccine, and in particular about the benefits that it would bring, the potential risks and the best schedule for giving the vaccine to infants. Some of the trials that examine the protection offered by the vaccines in the UK schedule are close to completion, and the JCVI has been kept informed of their progress.

We are also keeping a close watch on the impact of the introduction of Prevenar on children in the United States. We are especially interested to see whether there is evidence of serotype switching—where the strains of bacteria against which the vaccine protects are replaced by strains that are not vaccine-preventable. That would reduce the effectiveness of the vaccine in protecting against the disease. We also want to assess whether vaccinating children has reduced the rates of disease in older age groups, as my hon. Friend suggested.

There are many uncertainties in the evidence, especially about the amount of disease that is expected to be prevented by a vaccine in both the short and longer term. That is why, as far back as 1996, the then Public Health Laboratory Service put in place an enhanced surveillance system for pneumococcal infections.

The purpose of the enhancement has been to provide us with the best possible estimates of the disease burden to inform our economic modelling, and to serve as a baseline ahead of any introduction of a vaccine. The JCVI is kept closely informed of all the evidence as it develops.

It is important to note that the UK is not alone in awaiting further evidence before making a decision on Prevenar. Other European countries are in the same position. I believe that the US is the only country that routinely offers the vaccine as part of its childhood immunisation programme.

We cannot ignore the financial implications of introducing new immunisation programmes. Prevenar is not cheap. The price that the US Government pays for

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one dose of Prevenar is about the same as that for one dose of all the other vaccines routinely used in our childhood programme. If it were to be introduced into the routine childhood immunisation schedule in the UK, it would cost millions of pounds—probably £100 million or more to protect all children up to the age of two years.

However, I am reassured to hear from my hon. Friend that the price of Prevenar could fall dramatically if it were introduced into the national programme. I should be grateful if he would let me have any relevant information that would allow us to plan for lower prices, since we have based our estimates on the present US Government's contract price, which is already discounted from the private sector price.

We anticipate the possible use of the vaccine in the childhood immunisation programme, once we are reassured about its impact and have completed the risk-benefit analysis. However, I sound one note of caution. In the US, there have been shortages of pneumococcal conjugate vaccine, so that the full recommended schedule could not be implemented, and we would want to address that issue.

We understand the potential benefits, and that is why we are funding trials and studies on the pneumococcal conjugate vaccine's possible use in the UK. Its introduction into the childhood programme has the potential to be a positive step and, as my hon. Friend pointed out, may reduce pneumococcal disease in older unimmunised age groups, particularly where the burden of disease is high. It is also likely to reduce the quantity of antibiotics used to treat infections, which is another concern.

As soon as there is good evidence that the vaccine will deliver real benefits, provision will be made for it in the Department's spending plans. I am sure that my hon. Friend will understand the importance that the Department places on basing its decisions on immunisation issues on independent scientific advice. We take seriously our responsibility to ensure that we have the safest and most effective national childhood immunisation programme. I look forward to meeting my hon. Friend to discuss the matter further.

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