§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the Committee on Safety of Medicines has assessed the similarities and differences between the. Japanese acellular whooping cough vaccine and the development in vaccines made but not exploited by United States compaines in the 1960s;
(2) whether the Committee on Safety of Medicines has taken any steps to evaluate the difference in safety and 665W efficacy between the whole whooping cough vaccine used by the National Health Service and the acellular vaccine used in other countries;
(3) if he will request the Committee on Safety of Medicines to examine the relevance to current research of the evidence that has recently been produced in courts in the United States regarding attempts by American companies in the 1960s to produce a safe whooping cough vaccine; and if he will make a statement;
(4) whether the Committee of Safety on Medicines is liaising with the Swedish health uthorities in their assessment of the efficacy and safety of the Japanese acellular whooping cough vaccine following tests with the vaccine on very young Swedish children; and if he will make a statement;
(5) if he will ensure that the Committee on Safety of Medicines, after the Swedish tests on the Japanese whooping cough vaccine are completed, will immediately assess whether there should be a British test with a view to using the vaccine in Britain, and if he will make a statement.
§ Mr. NewtonConsideration by the Committee on Safety of Medicines of data relating to acellular pertussis vaccines will take place only in the context of applications for clinical trial certificates under Section 31 of the medicines Act 1968. The Committee will take account of all the evidence available to it in deciding what advice to tender to the licensing authority.
§ Mr. Ashleyasked the Secretary of State for Social Services if there is any mechanism whereby the Committee on Safety of Medicines is kept informed of the evidence given in American whooping cough court cases which are won by the plaintiff or are settled out of court in favour of the plaintiff; and if he will make a statement.
§ Mr. NewtonNo. The Committee on Safety of Medicines would, however, consider any scientific evidence affecting the safety, quality or efficacy of a medicinal product currently on the market or in connection with an application for a product licence.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) which companies have provided whooping cough vaccine for the National Health Service;
(2) if he will list the American manufacturers of whooping cough vaccine which have supplied any such vaccine to the National Health Service; and if he will make a statement.
§ Mr. NewtonWhooping cough vaccine for use in the National Health Service is purchased, under central supply arrangements, from the Wellcome Foundation Ltd. No American manufactured vaccine has been used in the NHS.
§ Mr. Ashleyasked the Secretary of State for Social Services what consultation there has been with the Japanese health authorities regarding their use of the acellular whooping cough vaccine.
§ Mr. NewtonThe Department has not been in direct touch with the Japanese health authorities, but officials have attended international meetings and noted papers published in English language journals. The United States Public Health Service arranged a tour of Japan to monitor vaccine development, production and usage. The report on that visit was made freely available to the Medical666W Research Council's subcommittee on whooping cough vaccines, which is part of the Committee on the Development of Vaccines and Immunisation Procedures.
§ Mr. Ashleyasked the Secretary of State for Social Services whether there have been any discussions between the manufacturers of the whooping cough vaccine used in Britain and his Department regarding the court cases that families of vaccine-damaged children are bringing to seek compensation; and if he will make a statement.
§ Mr. NewtonIn 1985 Wellcome discussed with officials the role of the Department in legal proceedings relating to whooping cough vaccines. Discussions have since been held with the solicitors acting for the manufacturer about the use to be made in the Loveday case currently before the High Court of documents obtained by the manufacturer from the Committee on Safety of Medicines and the Department as a result of an application for discovery of documents in the earlier Kinnear case.
§ Mr. Ashleyasked the Secretary of State for Social Services if the Committee on Safety of Medicines has made any study of the incidence of whooping cough, and, in particular, hospitalisation and deaths resulting from whooping cough, in those countries which have stopped advising parents to have their children vaccinated; and if he will make a statement.
§ Mr. NewtonNo. However, in considering an application for a licence for whooping cough vaccine, the Committee on Safety of Medicines would take account of all available scientific evidence on the incidence and effects of whooping cough.
§ Mr. Ashleyasked the Secretary of State for Social Services what information he has as to whether the nature of the whole cell whooping cough vaccine used in Britain differs significantly from the whole cell vaccines used in the United States; and if he will make a statement.
§ Mr. NewtonThe only significant difference between the whole cell vaccines used in the United Kingdom and in the United States of America is that the latter has a higher potency than the former. The vaccine used in this country conforms to the World Health Organisation standard.
§ Mr. Ashleyasked the Secretary of State for Social Services what criticisms have been made to his Department of the conclusions of the National Childhood Encephalophy Study about the statistical chances of a child suffering brain damage following whooping cough vaccination; who made the criticisms; and what alternative probabilities they suggested.
§ Mr. NewtonThe principal criticisms of the Study's conclusions have been made by Professor G. C. Stewart in theBritish Medical Journal and at a World Health Organisation conference in Geneva in 1984. Professor Stewart's conclusion was that the estimated risk from vaccination was greater than the 1 in 100,000 three dose courses reached by the study.
The joint committee on vaccination and immunisation has studied these criticisms and does not accept Professor Stewart's calculations on the risks from whooping cough vaccination or from the disease itself. The joint committee remains firmly convinced that the benefits of whooping cough vaccination far outweigh the risks, and that, with 667W due attention to contra-indications, whooping cough vaccination should continue to he recommended as part of the basic course for childhood immunisation.