§ Norman BakerTo ask the Secretary of State for Health which health authorities inoculated children with Wellcome's Trivax vaccines that came from(a) batch 3741 and (b) batch 3732; how many children were so vaccinated; how many adverse reactions were reported in respect of each batch, including fatalities; if he will take steps to trace those who have been inoculated with vaccines from these batches; and if he will make a statement. [5695]
§ Yvette Cooper[holding answer 20 July 2001]: I apologise to the hon. Member for the delay in responding to this question. I refer the hon. Member to the reply that my right hon. Friend the Secretary of State gave my hon. Friend the Member for Blackpool, North and Fleetwood (Mrs. Humble) on 5 March 2002, Official Report, column 192W.
Batches 3741 and 3732 of Diphtheria, Tetanus and Pertussis (DTP) vaccine are believed to have been manufactured and distributed in Eire in the late 1960s and early 1970s. At that time DTP vaccine was not provided by the Department but was either purchased by local health authorities or obtained by general practitioners (GPs) from local retail pharmacists. Thus, information on whether batches 3741 and 3732 were supplied to United Kingdom doctors is not held centrally. Should such vaccines have been issued, the only information on who might have received them will depend on GPs or local health authority clinics maintaining records that will be now over 30-years-old. The Department has asked the then manufacturer's present owners, GlaxoSmithKline, to investigate their records. The National Institute for Biological Standards and Control has also been asked to investigate whether they tested these vaccines.
Extensive investigation of the safety of pertussis vaccines was undertaken during the 1970s and early 1980s following negative publicity about brain damage following pertussis immunisation. In 1981 a major report was published by the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation which investigated pertussis vaccine, including suspected adverse 824W reactions to the vaccine. The report of this investigation was published in 1981 ("Whooping Cough", HMSO, ISBN 011 3207646) and advises on page 47 that
From 1964 onwards, all vaccines used in the UK also conformed to World Health Organisation standards of preparation and potency".The Yellow Card database has been interrogated for reports of suspected adverse reactions to the vaccine batches 3714 and 3723 which were available between 1968 and 1971. No such reports have been identified. For reports received in the late 1960s and early 1970s, full data are not available for all reports. For those reports where full information is available, the batch number of the suspected vaccine is not always provided. The Yellow Card used at that time did not specifically ask reporters to provide information on batch numbers. The Yellow Card used currently asks specifically for information on batch and since 1992, where this information has been provided by the reporter, there has been full electronic capture of this information on the database.
Investigation of reports of suspected adverse reactions following pertussis containing vaccines (principally DTP vaccine) reveals no rise in reactions during the period when, if they were used in the UK, batches 3741 and 3732 might have been given (late 1960s and early 1970s) (see table).
Breakdown of reports of suspected adverse reactions Year Number of reports received 1964 92 1965 69 1966 42 1967 63 1968 40 1969 44 1970 36 1971 44 1972 37 1973 19 1974 37 1975 15 1976 46 1977 127 1978 143 1979 168 1980 209 Note:
Suspected adverse reaction reports for pertussis containing vaccine collected via the Committee on Safety of Medicine's Yellow Card Scheme
These figures represent suspected adverse reactions associated with single and multi-component pertussiscontaining vaccines. It should be noted that a report of a suspected adverse reaction does not necessarily mean that it was caused by the vaccine. Many vaccines are administered in combination and in these circumstances it may be difficult to ascribe the cause of the reaction to an individual vaccine.
Adverse reporting rates are influenced by many factors, including the extent of use of a drug or vaccine and any publicity about the vaccine.
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