Mr. SmithTo ask the Secretary of State for Health which measles, mumps and rubella vaccines, supplied by which companies, were withdrawn from use in 1992; and for what reasons. [41066]
§ Mr. Sackville[holding answer 2 November 1995]: The two vaccines were manufactured by SmithKline Beecham and Merieux. As to the reasons for the discontinuation of their use, I refer the hon. Member to the reply I gave him on 6 November, Official Report, column 607–11.
Mr. SmithTo ask the Secretary of State for Health what plans he has to dispose of measles vaccine surplus to the 1994–95 campaign. [41019]
§ Mr. SackvilleSurplus measles-rubella vaccines arising from overprovision of diluent has already been returned to manufacturers for which my Department has received reimbursement as credit; a small stock is being held against future requirements.
Mr. SmithTo ask the Secretary of State for Health what information he possesses as to the reason for MMR vaccines being withdrawn in Japan. [41023]
§ Mr. Sackville[holding answer 2 November 1995]: Urabe-based MMR vaccines have been withdrawn from use in Japan only recently, for the same reasons that they were replaced in this country three years ago. The reason for replacement was restricted to the rate of adverse reactions in the mumps vaccine component.
Mr. SmithTo ask the Secretary of State for Health what information his Department holds as to the shelf life of the vaccines used in the campaign conducted since November 1994 to vaccinate against measles and rubella. [41024]
§ Mr. Sackville[holding answer 2 November 1995]: The shelf lives of the vaccines used in the measles-rubella immunisation campaign were all two years. The expiry dates of the batches were either 30 or 31 July 1996, 30 August 1996 or 30 September 1996.
Mr. SmithTo ask the Secretary of State for Health what studies have been conducted by his Department into the effects of the modification of natural immunologic response by vaccines in relation to the increase in autoimmune diseases. [41028]
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§ Mr. Sackville[holding answer 2 November 1995]: I will write to the hon. Member.
Mr. SmithTo ask the Secretary of State for Health which companies were chosen as suppliers of the measles-rubella vaccine in the recent countrywide campaign; and for what reasons. [41018]
§ Mr. Sackville[holding answer 2 November 1995]: All possible manufacturers were approached. Only SmithKline Beecham and Merieux were in a position to supply—both were awarded contracts.
Mr. SmithTo ask the Secretary of State for Health what assessment his Department has made of the likelihood of the adverse reactions to the administration of both MR and MMR vaccines, in regard to the under-reporting of thrombocytopenic purpura. [41017]
§ Mr. Sackville[holding answer 2 November 1995]: The Public Health Laboratory Service has recently published a review on an advanced technique for surveillance of adverse reactions. New information was established on the association between idiopathic thrombocytopenic purpura and MMR immunisation. This related to primary immunisation and was of little relevance to the measles-rubella campaign because there was a far lower probability of susceptibility to rubella in children of the campaign age than in those immunised with MMR at 12 to 15 months.
Mr. SmithTo ask the Secretary of State for Health what assessment his Department has made of the problems occurring in the passive surveillance procedures adopted in the United Kingdom to monitor adverse effects of vaccinations. [41031]
§ Mr. Sackville[holding answer 2 November 1995]: Doctors are aware that suspected adverse reactions to vaccines should be reported through the United Kingdom's adverse drug reactions reporting scheme. It is more likely that acute and serious adverse reactions are reported. The United Kingdom's reporting scheme has successfully detected rare unrecognised hazards with vaccines and other medicines and the scheme receives widespread support from doctors. The limitations of the scheme are well recognised but it is the best scheme currently available for the routine surveillance of adverse reactions to vaccines throughout the UK.
Mr. SmithTo ask the Secretary of State for Health if he will set out each consideration which led his Department to initiate a country-wide vaccination campaign against measles and rubella jointly in November 1994. [41061]
§ Mr. Sackville[holding answer 2 November 1995]: The key consideration was to protect children against a predicted epidemic of measles. The background is given in the chief medical officer/chief nursing officer letters issued in July and September 1994, copies of which are available in the Library; other supportive information has been published in:
Babad H.R., Noakes D. J., Gay N.J., Miller E., Morgan-Capner P., Anderson R. M.,Predicting the impact of measles vaccination in England and Wales; model validation and analysis of policy options.Epidemiol Infect 1995; 114: 319–344.Gay N. J. Hesketh L. M., Morgan-Capper P., Miller E.977WInterpretation of serological surveillance data for measles using mathematical models: implications for vaccine strategy.Epidemiol InfectRamsay M., Gay N. J. Miller E., Rush M., White J., Morgan-Capper P.et al.The epidemiology of measles in England and Wales; rationale for the 1994 national vaccination campaign.CDR Review1994: 4: R141–146.Christine P.Measles in ScotlandCommun Dis Envir Hith Scot 1994; 28(41): 3–8For further relevant scientific papers I refer the hon. Member to the reply I gave him on 6 November, Official Report, columns 607–11.
Mr. SmithTo ask the Secretary of State for Health what considerations led to the decision not to include on the consent form given to parents for children being vaccinated against rubella information on the possibility that it might lead to some increase in arthritis. [41033]
§ Mr. Sackville[holding answer 2 November 1995]: In preparing the leaflet for parents careful evaluation was given to all side effects. The risk of arthritis in the age group covered by the measles-rubella campaign was considered not to warrant inclusion as the risk is in older women.
Mr. SmithTo ask the Secretary of State for Health what assessment he has made of the claims in a journal which has been sent to him regarding information to parents and professionals in respect of the recent MMR campaign. [40885]
§ Mr. SackvilleThe information for parents was produced after careful consideration of all relevant information and was pre-tested with parents and young people. Extensive information on adverse reactions was provided to all doctors and other health professionals involved in the campaign. The author appears not to have considered all the relevant information in making his claims.
Mr. SmithTo ask the Secretary of State for Health what studies have been(a) conducted and (b) sponsored by his Department into the causes and development of measles encephalitis in children. [41021]
§ Mr. Sackville[holding answer 2 November 1995]: Two studies on the rate of acute encephalitis associated with measles infections have been conducted by the Public Health Laboratory Service, and deaths from measles encephalitis were reviewed by the PHLS in 1985. In addition, detailed information on cases on late-onset encephalitis following measles infection subacute sclerosing panencephalitis is collected by the PHLS, and a comprehensive report from this surveillance scheme was published in 1992.
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- Miller DL. Frequency of complications of measles, 1963. BMJ 1964; 2: 75–78
- Miller CL. Severity of notified measles. BMJ 1978. 1: 1255–54
- Miller CL. Deaths from measles in England and Wales, 1970–83. BMJ 1985; 290: 433–34.
- Miller C, Farrington CP, Harbert K. The epidemiology of subacute sclerosing panencephalitis in England and Wales, 1970–89. Int J Epidemiol 1992; 21: 988–1006.
Mr. SmithTo ask the Secretary of State for Health how many cases of(a) mumps and (b) rubella occurred in each year since 1985; and what assessment he has made of the reliability of the data. [41026]
§ Mr. Sackville[holding answer 2 November 1995]: Since 1985, the most reliable source of data on mumps and rubella incidence is reports of confirmed infections to the Communicable Disease Surveillance Centre from laboratories in England, Wales and Northern Ireland. Cases thus confirmed therefore represent true infections. Laboratory investigation is not performed in all suspected cases, however, and therefore these figures may under-estimate the total number of mumps and rubella infections. Since 1988, statutory notifications of mumps and rubella have been collected at the Office of Population Censuses and Surveys. In a Public Health Laboratory Service study of the accuracy of notification, laboratory confirmation of rubella cases was attempted in 18 districts between 1991 and 1993. Only 29 per cent, of rubella were confirmed by laboratory testing. No formal study of mumps notifications has taken place but, as part of the PHLS saliva diagnosis scheme, we have confirmed only 3.3 per cent. of mumps cases notified this year. This data suggest that notifications substantially over-estimate the incidence of these infections.
Reports to Communicable Disease Surveillance Centre of confirmed infection from laboratories in England, Wales and Northern Ireland 1985–1995 Year Mumps Rubella 1985 360 828 1986 547 2,069 1987 688 1,887 1988 428 1,031 1989 265 760 1990 94 705 1991 52 249 1992 49 201 1993 37 1,625 1994 47 310 1995 (to week 42) 44 752
Mr. SmithTo ask the Secretary of State for Health how many yellow card reports covering measles, mumps and rubella have been registered by the Medicines Control Agency identifying cases of possible vaccine damage, in each month since 1992. [41022]
§ Mr. Sackville[holding answer 2 November 1995]: The number of yellow card reports of adverse reactions related to measles, mumps and rubella vaccine for each month since 1992 is shown in the table.
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1992 1993 1994 1995 January 8 8 6 10 February 11 16 3 16 March 15 13 13 15 April 12 10 5 11 May 15 15 14 12 June 17 11 7 15 July 15 8 7 4 August 7 12 13 11 September 44 10 9 4 October 27 9 15 — November 22 8 19 — December 9 5 20 — The report of a suspected adverse reaction does not necessarily mean the vaccine was responsible.
Mr. SmithTo ask the Secretary of State for Health what consideration was given to the conclusions in the communicable disease report, volume 4, review number 7 of 24 June 1994, as to the need for a mass campaign against rubella before the decision to institute a measles and rubella campaign in November 1994 was taken. [41032]
§ Mr. Sackville[holding answer 2 November 1995]: The results of the summary of districts in England and Wales were consistent with the decision to include rubella vaccine in the immunisation campaign of November 1994. The article identified current policy at that time but also stated that there are no contradictions to a second vaccination in girls. The article did not address the issue of rubella immunisation in boys.
Mr. SmithTo ask the Secretary of State for Health what considerations he has given to including decisions not to include details of each of the known side effects of immunisation in the booklet "Measles: Why every child in school needs to be protected from measles this autumn"; and if he will make a statement. [41020]
§ Mr. Sackville[holding answer 2 November 1995]: The content of the measles booklet was underpinned by research by the Health Education Authority among parents to establish what information they regarded as most important. This research showed that parents were unaware of the seriousness of measles. The final leaflet reflected parents information priorities about the need for measles and rubella immunisation. Side effects from measles rubella vaccine are rare but the more common ones are covered in the booklet. Doctors and other health care workers were given more detailed information on the full range of possible adverse reactions. Parents were advised to discuss any further concerns with their family doctor.
Mr. SmithTo ask the Secretary of State for Health what assessment has been made of the policy implications of the scientific article on measles, mumps, rubella and varicella, a copy of which has been sent to him. [40884]
§ Mr. SackvilleThe scientific article inThe Lancet—volume 345, 4 March 1995— a copy of which is in the Library, has been considered by the Department of Health, and the Joint Committee on Vaccination and Immunisation, and its importance is acknowledged. It describes a valuable technique for investigating more serious adverse reactions—that is, those likely to lead to hospital admission. Wider evaluation of the technique would be appropriate. The policy implication of the article is that active surveillance reveals a higher than previously reported risk of thrombocytopaenia and a fourfold reduction of risk of febrile convulsions after the change in the immunisation schedule that we implemented in 1990. The article has no relevance to varicella, for which there is no UK licensed vaccine.
Mr. SmithTo ask the Secretary of State for Health what assessment has been made of the incidence of measles in 1994–95 among unimmunised 17-year-olds. [41062]
§ Mr. Sackville[holding answer 2 November 1995]: During 1994, there were 19 confirmed cases of measles infection in 17-year-old children—all of whom were unimmunised—reported to the Public Health Laboratory 980W Service. So far in 1995, there have been only five confirmed cases and all of these cases occurred in unimmunised people.
Mr. SmithTo ask the Secretary of State for Health what recent representations his Department has received from the Association of Parents of Vaccine Damaged Children. [41068]
§ Mr. Sackville[holding answer 2 November 1995]: A number of letters have been received concerning the measles-rubella campaign and the childhood immunisation programme in general.
Mr. SmithTo ask the Secretary of State for Health what mechanism exists for parents who have lost confidence in their general practitioner to pass on confidential information concerning the suspected deleterious effects of measles immunisation vaccinations on their children. [41006]
§ Mr. SackvilleDoctors are asked to report adverse reactions when, based on their clinical judgment, there is a likelihood of the reported event being related to the administration of the vaccine. We believe that there was good compliance with standard reporting procedures during the course of the campaign. It is open to parents to make representations on specific issues of concern to them to their local family health services authority through the complaints procedures.
Mr. SmithTo ask the Secretary of State for Health what guidance is issued to doctors, nurses and other medical service professionals in regard to the level of information that they are expected give parents on potentially adverse effects of immunisation against measles. [41069]
§ Mr. Sackville[holding answer 2 November 1995]: Health service professionals are given extensive information on possible adverse reactions to vaccines. The United Kingdom Health Departments' "memorandum", Immunisation against Infectious Disease, published by Her Majesty's Stationery Office, provides information on adverse reactions. In addition, for the measles-rubella immunisation campaign the chief medical officer's letters of July, September and October 1994 covered adverse reactions in some detail and included an information booklet for health care professionals.
Mr. SmithTo ask the Secretary of State for Health what tests are conducted on children before immunisation against measles to establish their existing levels of blood antibodies. [41029]
§ Mr. Sackville[holding answer 2 November 1995]: None. The European advisory group on immunisation of the World Health Organisation has specifically advised against testing of blood for antibodies because of potential unreliability of information obtained and the impractical scale of the exercise. This practice is not known to be routinely undertaken in any country in the world.
Mr. SmithTo ask the Secretary of State for Health how many updates have been prepared and circulated by the chief medical officer, the chief nursing officer and the chief pharmacist on the national measles-rubella immunisation campaign since December 1994; and if he will place copies in the Library. [41025]
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§ Mr. Sackville[holding answer 2 November 1995]: There has been one joint communication from the chief medical officer, the chief nursing officer and the chief pharmacist on the measles-rubella immunisation campaign since December 1994. This was a letter dated 19 December 1994: "Update on National Measles-Rubella Immunisation Campaign". A brief article also appeared in CMO's update 6, dated July 1995: "Success of measles/rubella immunisation campaign". Both letters are available in the Library.
Mr. SmithTo ask the Secretary of State for Health (1) what papers or research reports have been prepared or sponsored by his Department on adverse reactions to immunisation against measles; [41030]
(2) what studies have been (a) conducted and (b) published by the United Kingdom Public Health Laboratory Service on investigation into the effects of measles-mumps-rubella-immunisation inoculation on convulsions amongst recipient children. [41060]
§ Mr. Sackville[holding answer 2 November 1995]: Extensive studies of measles vaccine were conducted by the Medical Research Council before the introduction of measles vaccine in 1968. Two reports from these studies summarised the incidence of adverse events. Subsequently, a study of symptoms following measles vaccination was conducted by the Public Health Laboratory Service in a large number of children between 1970 and 1980.
Before the introduction of MMR vaccine in 1988, studies were conducted by the Public Health Laboratory Service to measure the rate of adverse events, including convulsions, associated with the vaccine. The study involved over 10,000 children in three district health authorities in the United Kingdom. In 1993, a pilot study to evaluate new methods for monitoring adverse events following vaccination, including MMR vaccine, was conducted.
This involved linking computerised hospital admissions data to child health vaccination records in five districts of England and Wales.
Measles Vaccine Committee. Vaccination against measles: a clinical trials of measles given alone and live vaccine preceded by killed vaccine. BMJ 1966; 1: 441–6. Measles Vaccine Committee. Vaccination against measles: a study of clinical reactions and serological responses of young children. BMJ 1965; 1: 817–23.Miller C. Surveillance after measles vaccination in children. Practitioner 1982; 226: 535–7.Miller C, Miller E, Rowe K, et al. Surveillance of symptoms following MMR vaccine in children. Practitioner 1989; 223: 69–72.Farrington P, Pugh S, Colvile A et al. A new method for active surveillance from diphtheria/tetanus pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 567–9.
Mr. SmithTo ask the Secretary of State for Health when the decision was taken, and on what basis, to place a notification for competitive tender in theOfficial Journal of the European Communities for the vaccines to be used in the immunisation campaign initiated in November 1994 against measles and rubella. [41067]
§ Mr. Sackville[holding answer 2 November 1995]: The normal procedures of the European Communities public procurements directives did not allow sufficient time for manufacture of vaccines. Therefore, no notification for competitive tender was placed in the Official Journal of 982W the European Communities for the vaccines used in the measles rubella immunisation campaign, but contracts were placed using a negotiated procedure as specified in Statutory Instrument 2679 of 1991.
Mr. SmithTo ask the Secretary of State for Health when his predecessor was first involved in internal discussions with his chief medical officer and departmental experts on immunology, on the immunology campaign against measles and rubella launched last year. [41063]
§ Mr. Sackville[holding answer 2 November 1995]: Ministers were informed in April 1994 of the Joint Committee on Vaccination and Immunisation's recommendation that a measles-rubella campaign should be undertaken. This recommendation was considered by Ministers and an announcement made on 28 July 1994.
Mr. SmithTo ask the Secretary of State for Health what inter-departmental discussions at(a) ministerial and (b) official level have been held since 1993 on the measles-rubella immunisation campaign. [41065]
§ Mr. Sackville[holding answer 2 November 1995]: Discussions took place as required.
Mr. SmithTo ask the Secretary of State for Health what procedures have been adopted to monitor suspected adverse reactions to the measles-rubella immunisation campaign since November 1994; and what it has cost to date to conduct the monitoring. [41027]
§ Mr. Sackville[holding answer 2 November 1995]: Before the start of the campaign with measles rubella vaccine the Medicines Control Agency agreed that all reports of suspected adverse reactions would be handled with the highest priority. Spontaneous reports using the yellow card system were classified and entered on to the MCA database within 24 hours of receipt and evaluated by a doctor within 36 hours. Requests for further information were made for serious adverse reactions if inadequate information had been provided on the yellow card. The cost of monitoring MR vaccine cannot be estimated because surveillance was part of the normal MCA procedures for monitoring all licensed medicines in the United Kingdom.
Mr. SmithTo ask the Secretary of State for Health when officials in his Department first established internal discussions on the departmental immunisation campaign against measles and rubella. [41064]
§ Mr. Sackville[holding answer 2 November 1995]: The situation was evaluated in 1992. Development work on strategies was undertaken in 1993. This work was under the stewardship of the United Kingdom Health Departments' external independent expert committee—the Joint Committee on Vaccination and Immunisation.