HL Deb 24 March 1987 vol 486 cc153-66

5.45 p.m.

Lord Winstanley rose to ask Her Majesty's Government what progress they are making with the development and introduction of a safer whooping cough vaccine.

The noble Lord said: My Lords, I beg leave to ask the Question standing in my name on the Order Paper. As noble Lords will see, this Question is short, direct and to the point. Perhaps there are those who might say it is short to the point of being almost terse. It merely asks Her Majesty's Government what progress they are making with the development and introduction of a safer whooping cough vaccine. It is surely clear that other important questions underlie that question. Those other questions are matters of grave public importance in relation to public policy.

Since my Question refers to a safer vaccine, that necessarily appears to imply that the present vaccine is either unsafe or not safe enough. Therefore, the first additional question which I wish to put to the noble Baroness, which I am quite sure she will answer when we get to the end of the debate, is as follows. What is the Government's present estimate of the risk of vaccine-related brain damage from the use of the whooping cough vaccine which is at present used?

I have a number of figures, and I think the figure which the Government have been using recently is one in 100,000. Perhaps noble Lords might be interested in the origin of that figure. There has been an interesting series of articles in the New Scientist. In the article of 6th February headed "Whooping Cough: A Safer Vaccine?" one reads that doctors at Great Ormond Street Hospital in London reported what seemed to be a direct link in several children between brain damage and whooping cough vaccine. The article goes on to say: The Department of Health and Social Security, alarmed at this trend"— that was the trend of parents being inclined to opt not to have the whooping cough vaccine— commissioned the National Childhood Encephalopathy Study in 1976 …The DHSS was so keen to publicise the conclusions that it announced the results before the authors, Euan Ross at Charing Cross Hospital in London, and David Miller at St. Mary's Hospital, Paddington, had completed their research. It was also made clear to Ross and Miller that it they did not include an assessment of attributable risk, then one would be put in over their heads. They agreed to provide an estimate of the risk, but only in the form of a heavily qualified appendix".

Lord Ennals

My Lords, if I may intervene—

Lord Winstanley

Perhaps I may just finish the quotation. Ross and Miller concluded that there was indeed an association between vaccination and irreparable brain damage among infants. They estimated that the chances of a vaccinated child suffering brain damage were about 1 in 100,000. The Government took this figure to mean that the vaccine against whooping cough was acceptably safe". Now I give way to the noble Lord with pleasure.

Lord Ennals

My Lords, I am most grateful to the noble Lord for giving way. I just wanted to say, since I was Secretary of State at that time, that neither of the two statements that were quoted in the New Scientist on 26th February was correct. One was that the results would be published in any case, and if no figures were given, some bogus figures would be given.

Lord Winstanley

My Lords, the noble Lord was in a position to know, and, of course, noble Lords accept what he has said. I do not think it invalidates the fact that at that time the risk was put at one in 100,000.

That was not the only figure that was given. The noble Baroness will know that a report of an inquiry, commissioned and paid for by her own department and carried out by Professor Gordon Stuart, of Glasgow, came to the conclusion that the risk of brain damage was 1 in 20,000. I do not say whether that is true of whether it is untrue. But if it is true that it is 1 in 20,000, that is not a risk which can be regarded as acceptable and one should not accept it as being so. It is interesting that not much has been said about that report by Professor Gordon Stuart, which was paid for by the Department of Health but not published, I understand.

It is interesting that the February issue of Health Trends, a magazine published by the department which the noble Baroness represents, also gives a figure, though a somewhat different figure. It estimates severe irreversible damaging reactions to be 1 in 300,000. I am not entirely sure from where it gets that figure. In the bibliography at the end of that article are a series of references, and the publications indexed there are all reports which wholly agree with what the Government are now saying. But other reports by distinguished and reputable medical scientists and epidemiologists are not referred to at all in Health Trends. I would merely say in passing that it seems that the article headed "A Training Procedure for Immunisation" in the department's publication Health Trends seems to be seriously flawed from a scientific point of view. I am bound to say that were those like the noble Earl, Lord Halsbury, here to examine it, I think they would come to the same conclusion. But we are not here to discuss the merits or otherwise of the Government's publication Health Trends, so perhaps I may continue. However, at the end of the debate I should like to hear from the noble Baroness the figure which the Government accept.

It is clearly accepted that the whooping cough vaccine now in use can cause irreversible brain damage. The passing of the Vaccine Damage Payments Act is evidence of that. It was said at the time that that was a temporary measure to give some compensation to hard-hit families until the matter was looked at in depth. However, publication after publication is issued by the department which makes it clear that it accepts that brain damage sometimes occurs. At the end of the debate I should like the noble Baroness to give us the figure which the Government now adopt with regard to this vaccine.

In assessing the risk, we must weigh the risk in respect of vaccination against whooping cough against the risks in respect of the disease. That comparison must be made before we can draw any valid conclusions. What is the Government's present estimate of the risks of pertussis among the non-vaccinated and the vaccinated? That figure will give an indication of the efficacy of the vaccine at present in use.

Referring again to the publication Health Trends, regarding the training procedure for immunisation it states: Loss of confidence in the safety of pertussis vaccine has caused whooping cough epidemics to return with at least 59 deaths from pertussis in recent years.". That is not the whole story. We all know, and we in medicine have known for many years, that very young children and particularly babies are vulnerable to pertussis and are in need of protection. We know that very young children who contract whooping cough are in jeopardy. Looking at the series of articles in New Scientist of 26th February which I have already quoted, there is clear evidence that the greater majority of the deaths that have occurred from whooping cough were among the badly housed and underprivileged members of society.

The Black Report shows clearly that people living in conditions of bad housing, overcrowding and poverty in inner-city areas are underprivileged as far as concerns health. It is a tragedy that people should be living in such conditions. I hasten to say that governments of all parties are at fault. We have fallen badly behind in housing and that is a crucial factor in relation to health and infectious diseases in particular. We have fallen badly behind in housing since the 1930s when there was a major attack on the problem, and therefore governments of all complexions are involved. I hope that it will give Mr. Tebbit a little joy when I say that the Lib/Lab Pact bears a tiny proportion of the blame. We are all to blame for the fact that housing conditions are in such a state.

It is clear from the articles that of the children who died from whooping cough, the majority were living in overcrowded conditions, in bad housing and in an underprivileged environment. It seems that we could have done more for those children by improving the environment in which they lived than by giving a vaccine which could—I say only "could"—be regarded as dangerous.

I turn to the third of the specific questions which I should like to put to the noble Baroness. Could we have a safer vaccine? I refer again to the articles in New Scientist of 26th February: In Britain vaccination against whooping cough involves an injection of small doses of dead cells of the bacterium Bordetella pertussis to provoke immunity to the disease. For this reason, the vaccine is called the 'whole-cell vaccine"'. There are many influential scientists and epidemiologists who believe that the whole-cell vaccine is dangerous. The manufacturers, Wellcome, say that it is not, but they would, would they not?

What is the alternative? For at least 30 years scientists have believed that it is possible to make purer and safer vaccines against whooping cough. The way to do that is by separating from the bacterial cells those components which stimulate the immune response and so prevent the disease. Such vaccines are called acellular vaccines. They do not contain the harmful components of the whole-cell vaccines that may cause unwelcome side effects.

Britain lags behind in producing an acellular vaccine against whooping cough. However, I am informed that the Medical Research Council begins a small-scale trial with a few acellular vaccines this year. I am also told that the Wellcome Foundation, which manufactures the present whole-cell vaccine, did not have an acellular vaccine ready to take part. The Swedes have stopped using the whole-cell vaccine; the Japanese have largely stopped using them and use the acellular vaccine; and in the United States there is an increasing tendency to use the acellular vaccine rather than the whole-cell vaccine. Surely it seems reasonable that we should begin to move in that direction.

I should like the noble Baroness to accept that I am a firm believer in the principle of immunisation. As a doctor practising medicine for many years, I am aware of what happened in relation to diphtheria. The year before general immunisation against diphtheria was introduced in this country there were 72,000 cases. In the year following the introduction of immunisation the number of cases was reduced to single figures: it was as dramatic as that. I have also not forgotten that smallpox has now virtually disappeared from the world as a result of vaccination. I am therefore wholly committed to immunisation.

However, if the confidence of parents of young children is undermined in relation to one vaccine, it tends to be undermined for all. There is a danger that in hearing rumours (if they are rumours) or of the facts of the detailed figures in relation to brain damage caused by the pertussis vaccine, there are parents who will decide that a vaccine is a vaccine and that they will not have their children protected at all. That situation is very dangerous and damaging and could lead us into a perilous position. I am sure that the noble Lord. Lord Ennals, will confirm that matter because he has been wrestling with the problem for many years.

I should like to warn the noble Baroness of one matter. She will recollect that there was a time when smallpox vaccination was compulsory in Britain by Act of Parliament. One could avoid immunisation only by pleading conscientious objection. Having done that, parents could then avoid having their children vaccinated against smallpox either by their own general practitioner or by the public vaccinator. The warning to the noble Baroness is that the percentage of people vaccinated against smallpox was never as high when it was compulsory as it became once it was voluntary. There is an important lesson to he learned from that and I hope that when the Government see the figures of falling immunisation they will avoid the trap of introducing compulsion. I do not say that they will introduce it, but I say that that is a lesson which should be learned.

I am grateful to other noble Lords who will speak in respect of this matter. The noble Lord, Lord Allen of Abbeydale, who has dealt with this matter in your Lordships' house on many occasions, has gone abroad. He has asked me to say that had he not had to go abroad, he would have spoken in this debate and supported what I have said. In addition, the noble Lord, Lord Campbell of Alloway, who has also been deeply involved in the subject, has asked me to say that because of a serious family medical problem he cannot be here. Had the noble Lord been present, he also would have supported what I have said.

We need clear answers. If we cannot be satisfied that the present vaccine is sufficiently safe, then let us get a move on with getting a safer vaccine, which we have demonstrated is possible. If it is sufficiently safe, then let us he given the clear facts and the truth. I do not dream of suggesting that the noble Baroness would speak untruths to your Lordships' House. Indeed, I am sure that she would never speak an untruth to anyone. However, before I sit down I should like to ask her to hear in mind very carefully some of the words which are put into her mouth by some of the department's scientific advisers.

Lord Rea

My Lords, before the noble Lord sits down, I should like to express as a fellow professional how much I agree with all that he has said and how much I admire the way in which he has said it. The whole profession will be behind him on this issue.

6 p.m.

Lord Colwyn

My Lords, I am most grateful to the noble Lord, Lord Winstanley, for giving me the opportunity to say something about the whooping cough vaccine. He told me earlier that I would agree with every word of his speech and I concur with that thought because I do. I only saw his Unstarred Question in the Minutes this morning and I am sorry that more eminent medical Peers are not present and able to speak. However, as my youngest daughter suffered very badly after her vaccination—I hope not permanently—I felt it important to make some comments this evening. Your Lordships will also be aware of my interest in complementary medicine and the way it has affected my own professional life and my attitude to my patients.

I am grateful to Simon Mills, the herbalist, for access to an article which he wrote on the subject, but I must say that the moderate words that you will hear this evening hide some much stronger feelings on the subject which I should be reluctant to air in your Lordships' House in view of the possible resultant publicity.

From the theoretical standpoint, there can be little doubt that vaccinations are a valid prophylactic against infectious diseases. The active stimulation of the body's immunological mechanisms so that the immune response is specifically primed to counteract any subsequent infection is so well investigated in each case that the matter is largely beyond argument.

The same holds, for different reasons, for public immunisation campaigns. While it is possible to argue that many infectious diseases were declining rapidly before immunisation and antibiotics were able to affect their incidence, there can be little doubt that conditions like smallpox, poliomyelitis, measles, tetanus and whooping cough have been dramatically influenced by vaccination. It is easier to argue against the use of vaccines like whooping cough—blamed for brain damage (from DHSS figures) in almost 500 cases—when the effects of its use are compared with what happens without it, but even here the prophylactic value of the vaccination is clear.

The adverse publicity led to a fall in the uptake of the vaccine of 60 per cent. and within a year the incidence of the disease had increased nine-fold to 50,000 cases—with nine deaths in England. However, whooping cough apart, anyone who publicly supported the folly of vaccinations would have to be prepared to shoulder some of the responsibility for the increased casualties that would inevitably follow. But some real questions remain.

The problem is that blind reliance on an exogenous stimulation of the immune system for protection against infectious diseases leads attention away from those factors predisposing or precipitating the disease in the first place. It complies with the current mythology that germs are like bullets, striking down their victims in a random fashion—malevolent agents that merely need to be eliminated for disease to be eradicated.

A wider ecological perspective would support the opposite view: that germs are organisms or factors co-existing in a system of checks and balances with every other living entity; that they have to struggle for life like every other creature; that they similarly need food and shelter from adverse conditions. The body has an impressive array of defensive devices that can normally be relied on to refuse haven to the pathogenic organisms constantly around us. A close look at the incidence of each infectious disease will provide clues to the normal vital protections against it and ways in which they may be enhanced.

Most enteric innoculations including, for example, cholera, typhoid, dysentery and bacterial food poisoning are unlikely to survive exposure to the normal gastric environment. Common experience of the common cold and 'flu susceptibility suggests that many individuals can maintain resistance to a broad spectrum of rhinoviruses and other respiratory pathogens.

It is the experience of herbal practitioners, that adopting remedial strategies for improving known predisposing conditions can be very effective in treating infections and improving general resistance. Emphasis must be placed on how resistant the healthy body is to almost all infectious agents—a resistance that should be supported or enhanced rather than ignored because a vaccination has been given.

On the issue of public health, it may be asserted that concentration on immunisation campaigns can be a lucrative exercise for some, distracting from the much more important concerns of improving nutritional and social conditions widely agreed to be by far the most significant factors in the aetiology of infectious diseases.

On an individual note, we would agree that every person is a unique individual demanding unique treatment, and most of us would wish to correct individual failures of vital resistance as we encountered them, rather than relying on an arbitrary intervention. For that reason, while welcoming Lord Winstanley's plea for the development of a safer vaccine, I must caution the Government to try to avoid the acquired features of a political campaign that the whooping cough vaccine debate reached last time. If I remember correctly, the department maintained that the vaccine was good for you—so we must all have it.

The risks vary from minor reactions to brain damage and death. Most of us involved with alternative medical treatments—particularly the homeopaths —would claim that long-lasting side effects of different kinds are common following vaccination and that they go unrecognised and therefore unrecorded. I have with me figures from a study done in 1979 in the United States, under FDA sponsorship, which I think would be irresponsible of me to repeat in this House. But there seems to be a possibility that many of the children described as suffering from a learning disability or congenitally mentally retarded could have some connection with whooping cough vaccination.

The facts remain that vaccination involves an intrusion into the vital domain, a challenge to the immune system and the wider integrity of the body, whose full impact cannot be assessed. It may well be that vaccination is included in the strategy of choice, especially if environmental or other factors lead to fears for the strength of the inborn resistance, or if the patient or family is not committed to the demands of the positive approach. However, for those genuinely concerned to promote health, there are other valid strategies to choose from in any individual case.

6.8 p.m.

Lord Ennals

My Lords, I am most grateful to the noble Lord, Lord Winstanley, for opening this short debate and for giving the opportunity to the noble Lord, Lord Colwyn, to make his speech and for me to make a few remarks. Unlike both noble Lords, I am no professional. While I agreed with most of what the noble Lord, Lord Winstanley, said—except the part where I stated my disagreement—I find myself much opposed to the general approach of the noble Lord, Lord Colwyn, in the sense that it seemed to me that he was really saying that the general policy of vaccination against diseases is an intrusion into the natural immune system and that is something with which I must profoundly disagree.

If one looks at the situation not just of smallpox, as referred to by the noble Lord, Lord Winstanley, but of diphtheria, tetanus and polio, one would find that the incidence of those conditions in this country would be dramatically higher if we did not have a high level of vaccination in respect of them. Let that be, but I should like to see outside the House—and I respect the fact that the noble Lord did not reveal what he said might be frightening—the evidence on which he bases his conclusions.

I am not a professional, but pertussis vaccine and the need to find a more effective vaccine against whooping cough were crucial issues during the period when I was Secretary of State 10 or 11 years ago. There were a number of cases of vaccine damage over the years which suddenly gained a great deal of publicity, and led in particular to the formation of the Association of Vaccine Damaged Children. The media coverage of some of the sad cases—and clearly Lord Colwyn's own daughter was one of those, though I hope that whatever she suffered was not lasting—who suffered lasting damage led to great publicity. This led to an almost dramatic switch-off so far as vaccination for whooping cough was concerned.

We had to look at whether it was better or safer to have vaccination, or not to have vaccination and face the consequences of the disease. I was involved in the large national study to which the noble Lord, Lord Winstanley, referred. It was a study that started in 1976, but to achieve an outcome takes some time. You cannot just ask questions; you have to look at conclusions. The Committee on the Safety of Medicines, which advised the Secretary of State, took some time to come up with a clear statement which put the very small number of children adversely affected in the context of the serious consequences of those who suffered from the disease itself.

The study in 1976 was set up to find out whether the immunisation was really safe. The study found that most children had no ill-effects at all. The study also found that a child's chance of brain damage after a course of three whooping cough injections was very low. It was put at one in 100,000, as the noble Lord, Lord Winstanley, said. Professor Gordon Stuart, who also conducted a study, was frankly the odd man out. He was a member of the Committee on the Safety of Medicines but he was in a minority of one in the conclusions he reached, and it was an all-expert committee.

By then, however, the damage was done, in the sense that the switch-off rate among parents had been large. The proportion of children vaccinated fell alarmingly. It has taken not only the statement from the Committee on the Safety of Medicines based on the study started in 1976 to which I have referred, but also a major campaign by the department itself, carried out also with the assistance of most general practitioners, to bring the take up to what I understand is its present level of 65 per cent.

Even 65 per cent. is not very high compared with tetanus, which, in 1984—and these are the last figures I have—was 86 per cent.; poliomyelitis was 85 per cent.; diphtheria was 86 per cent.; and at that stage whooping cough was 60 per cent. That was 1984, and I think that the latest figures for whooping cough show it at 65 per cent.

The disease itself is a very serious disease. It causes long and distressing bouts of coughing and choking. They can go on for so long that the child finds it difficult to breath and becomes exhausted. The coughing often ends with the child being sick, and because food is not being kept down the child may lose weight. These fits can happen as often as 50 times a day. As the coughing goes on night and day, the parents lose sleep and the whole family suffers.

The illness itself usually lasts about three to four weeks and the coughing may go on for even longer. Severe cases of whooping cough can last for up to 12 weeks. Whooping cough can also cause convulsions, hernias, ear infections, pneumonia, bronchitis and collapsed lungs. In some cases it can cause brain damage. It was this that hit the headlines in the late 1970s. In the 10 years up to 1984, 82 children died from whooping cough in the United Kingdom.

What was quite clearly needed then was not just a statement of reassurance about a vaccine that clearly had its dangers. You weighed them up and clearly it was better to be vaccinated than not, though it has its dangers. What was needed was a vaccine so effective that all fears would be avoided as with polio, tetanus, smallpox, etc.

I have four points to put to the noble Baroness in my contribution to this brief debate. First, why is it that progress appears to be so slow? Like the noble Lord, Lord Winstanley, I was much taken by the article in New Scientist on 26th February. I have faulted part of it but there is much else that seems to have a factual basis to it.

The article said that the, American drug companies knew how to make acellular vaccines years ago". Obviously this is the difference between a whole-cell vaccine and a part-cell vaccine. I am no expert, but that is the difference. The American drug companies knew how to make acellular vaccines. The article goes on: Japanese companies have been making acellular vaccines successfully for several years now. Swedish health authorities will probably soon be using them. Pharmaceuticals companies in the US are now developing acellular vaccines on their own. In addition, scientists at Stanford University and in Sweden", are trying to manufacture these vaccines using genetic engineering.

are trying to manufacture these vaccines using genetic engineering.

I want to quote one paragraph from this particular article. By comparison, Britain lags far behind in producing an acellular vaccine against whooping cough. The Medical Research Council begins a very small-scale trial"— the noble Lord, Lord Winstanley, referred to this— with a few vaccines this year". I wonder why that is. I hope that the noble Baroness will be able to give some assurances that Britain is not lagging behind.

If there is evidence that there are better types of vaccine, why are we not promoting research and eventual development in precisely those fields? These are problems which worried me 10 years ago. There have been a number of years in which the Government could have been active in this field. If the statement that I have just quoted is true, then I want to know why it is. If it is untrue, then I should like the noble Baroness to tell me.

Thirdly, why are we still using the whole-cell vaccine as opposed to the acellular vaccine, which seems so much more effective? Has the department considered moving over—whether it is produced in Britain or not—to a vaccine that might have, and appears to have, fewer dangers?

The last point that I want to raise in the form of a question is that I recently read a report in one of the medical journals—and I have to say that I cannot trace it at the moment—which suggested that tests on a new vaccine had recently been postponed. It did not imply that the department had postponed them, but that they had been postponed. If the noble Baroness knows about this perhaps she can explain the circumstances.

If we have now a 65 per cent. take-up rate, that is too low. I do not think that it is the job of any of us to argue what I believe is abundantly clear—that it is safer for children to be vaccinated in their early months than not to be vaccinated—but it would be safer still if we could have a vaccine which leads to no significant side effects at all. Therefore, we all anxiously await the statement that the noble Baroness will make about such progress as the Government have made.

6.19 p.m.

The Parliamentary Under-Secretary of State, Department of Health and Social Security (Baroness Trumpington)

My Lords, the noble Lord's Question is timely. I welcome the opportunity of explaining the present position on the introduction of new whooping cough vaccines. I also find myself in the happy, but rather rare, position of agreeing with practically everything that the noble Lord, Lord Ennals, said. Indeed, from the depth of his experience when he was Secretary of State he kindly answered some of the questions that the noble Lord, Lord Winstanley, asked me.

I must first express my concern. It is that fears about the safety and efficacy of the present vaccine might be needlessly resurrected in the minds of parents. Immunisation against whooping cough is unquestionably a success story. The present vaccine used in this country is not old fashioned; it is highly effective in the vast majority of cases in conferring protection against the disease.

The noble Lord, Lord Winstanley, quoted various facts and figures. I think that it is he who has them wrong. Scientific research by the National Childhood Encephalopathy study has estimated that the risk of serious brain damage or death following whooping cough vaccine is about one in 300,000 injections. This equates to one in 100,000 for the complete course of three injections.

The committee on safety of medicines and the joint committee on vaccination and immunisation have examined carefully the evidence concerning the risk of brain damage following whooping cough vaccine, including the report by Professor Gordon Stewart. Incidentally, the allegations made of one in 20 were carefully examined by our expert advisory committees but were not endorsed. I think that the noble Lord, Lord Ennals, agreed with that point. They reaffirmed their advice that the benefits of whooping cough immunisation far outweigh the very small risk of serious neurological reactions.

The noble Lord, Lord Colwyn, referred to the allegations made in the United States, that its whole-cell vaccine has given rise to adverse reaction such as delayed learning. I have checked, and I have been assured that UK experience lends no credence to such allegations, despite the very careful attention given to adverse reaction to the vaccine. If evidence is produced, we will of course ask our expert advisers to examine it. However, I repeat that our present advice is that our vaccine is not prone to the reactions quoted.

Recent history speaks for itself. After the no doubt sincere but singularly ill-advised scaremongering of the 1970s, confidence in the vaccine fell, and in 1978 about 30 per cent. only of babies were immunised compared with 77 per cent. in 1974. The consequences are there to be seen in the incidence of the disease in the epidemic of 1977 to 1979. It was four times as large as that in 1974. Four years later it was again larger than any since the mid-1950s. By 1985, with confidence returning, the uptake rate had risen to about 65 per cent. I am glad to say that today's children have benefited. The epidemic from which we are now emerging has shown a reduction in cases of about 25 per cent. compared with the last one.

Lord Winstanley

My Lords; the noble Baroness referred understandably to scaremongering in past years. Will she make it absolutely clear that she does not for one moment regard attempts by families to obtain suitable compensation for what they believe to be brain damage in their children as a result of a vaccine as scaremongering?

Baroness Trumpington

My Lords, it was never compensation in the first place. It was a payment to help meet extra costs, costs over and above those that social service and other payments provided anyway. It was not compensation.

I repeat on purpose, I am glad to say that today's children have benefited. The epidemic from which we are now emerging has shown a reduction in cases of about 25 per cent. compared with the last one. Typically, a whooping cough epidemic shows two peaks of infection about 12 to 15 months apart. The good news this time is that the second peak appears largely to have been avoided.

The uptake rate of 65 per cent. is not good enough. It fails to confer the "crowd immunity" which would virtualy eradicate the disease in this country. It still leaves too many children at risk. We must therefore maintain our efforts to persuade more parents to have their babies protected.

I am grateful to the noble Lord, Lord Ennals, for his graphic description of the ill-effects of the disease. I repeat, with present tried and tested vaccines, the benefits to the children far outweigh the risks of adverse reactions. The risks to life and health from contracting the disease are infinitely greater.

The noble Lord, Lord Winstanley, spoke about the incidence of whooping cough among children living in poor housing. I would bring to the noble Lord's attention the fact that the incidence of whooping cough rose in Sweden when it ceased its vaccination programme, despite the very high standards of housing maintained in that country. The matter is not that simple. However, if there is a chance of improving the vaccine, obviously we would grasp it.

Your Lordships are far more scientifically educated than I am and can say the terrible words far more easily than I can, but the technical information that I have been given is as follows. The current vaccine is manufactured from the whole cell of the bacteria. Advances in vaccine technology over recent years have enabled scientists to identify the parts of the cell that have the antigenic properties—in lay terms, the parts that will trigger the immune system to mount its defences and to develop and manufacture vaccines based on those parts. Where this can be successfully achieved, the vaccine is in theory purer, more effective and less likely to produce unwanted side-effects.

Some years ago a committee of the Medical Research Council with wide representations of interests in vaccination advised that the UK should take this path towards developing an improved whooping cough vaccine. Our research scientists both within the pharmaceutical industry and in the public sector have a record of success in the discovery and development of new medicines which is envied throughout the world. It is therefore right that we should seek to develop a UK vaccine. This work has been based mainly at the Centre for Applied Microbiological Research at Porton Down, which I was happy to visit last week. I was most impressed by the dedication and brilliance of the scientists whom I met during a fascinating day. The Porton vaccine is now ready for testing in children as soon as the regulatory requirements on safety have been met. We have high hopes of it.

Not surprisingly, other countries have been following the same path. I agree with the noble Lord, Lord Winstanley, that it so happens that on this occasion we have not been the first past the winning post, but no delay, which I think was the word used by the noble Lord, Lord Ennals—

Lord Ennals

Does the noble Baroness know—if she does not, I do not wish to embarrass her—whether the new vaccine is a single cell vaccine or an acellular vaccine?

Baroness Trumpington

May I continue for the moment?

Lord Ennals


Baroness Trumpington

This means that we shall have the benefit of comparing the UK vaccine with others in clinical trials. The trials are certainly necessary. Much has been made of the fact that the Japanese are already using an acellular vaccine for their children. So they are. I have now answered the noble Lord's point, I think: we are talking of an acellular vaccine.

But I must point out to the noble Lord—this is extremely important when talking about the Japanese use of this vaccine—that they are starting at two years old, by which age the worst risks from the disease are past. Their vaccine still has to be fully evaluated for use at the earlier ages which we—I believe we start at three months—and others believe is a better approach.

In Sweden, France and the United States trials are already in progress and we shall watch the results with great interest. I am advised that it is too early to draw conclusions from them and certainly neither these, nor any other trials, should persuade us to rush into adopting new vaccines until they have been properly assessed. In their turn, other countries will be watching the results of our trials with great interest in order to learn from them. Safety is of course paramount, but I am advised that there is also still much to be learned from a careful comparison of the efficacy of the vaccines, which are similar in concept but differ in detail. Such learning will help us to review the pattern of vaccination, and possibly to reduce the number of injections from three to two.

Clinical trials of medicines and vaccines in this country are regulated under the Medicines Act 1968, introduced following the thalidomide tragedy. For most trials, generally involving substances of which a good deal is already known, there is now a procedure for enabling trials to start without a full dossier being submitted to our medicines division—the clinical trial exemption scheme. It was for some time assumed that the whooping cough vaccine trials might qualify for this expedited procedure. However, on studying the applications for exemptions our medicines division advised that the full clinical trial certificate procedure should be followed so that the licensing authority could first obtain the advice of the Committe on Safety of Medicines. The manufacturers were so advised.

I am sure your Lordships will agree that it is better to be safe than sorry.

Lord Graham of Edmonton

Hear, hear, my Lords.

Baroness Trumpington

Yes, my Lords. I was terribly sorry to hear of the reaction which the daughter of my noble friend Lord Colwyn suffered from the vaccine. I too very much hope that she is now well again. I should like to say that most adverse reactions reported to the Committee on the Safety of Medicines, which were 223 in all in 1986, are transitory.

All concerned with the production and the whole involvement with this vaccination process are fretful at the time needed to compile the full dossiers and refer them to the expert advisory committee. But I am equally sure that all concerned accept the need to strike that proper balance between speed and safety. When the applications are received, they will be assessed with all possible speed.

We are all hopeful that the trials will be successful and that before too long the new vaccines can be made available. I end by repeating that in the meantime there is absolutely no cause for gloom or despair. The current vaccine has a good track record and is serving our children well. Compulsory vaccination is suggested from time to time and I understand that a number of countries make school entry dependent upon immunisation against some childhood diseases. Any question of making immunisation compulsory would need very careful consideration. I am sure that my colleagues and people in my department will have listened with interest to the words of the noble Lord, Lord Winstanley.

I urge parents and others not to refuse or defer vaccinations in the hope that replacement vaccines will soon be available. There simply is no need for this and delay can be dangerous. As a mother myself, I can hardly imagine the grief of parents who lose a child, or whose child is left severely disabled, as a result of a disease which is avoidable.

House adjourned at twenty-five minutes before seven o'clock.