HC Deb 20 March 1997 vol 292 cc804-8W
Mr. Llew Smith

To ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Southwark and Bermondsey (Mr. Hughes) of 12 March,Official Report, column 263, if he will list for each of the nine measles, mumps and rubella vaccines for which the product licence has been cancelled, the date on which the product licence was granted; whether the licensing of the vaccine was on the advice of the Committee on Safety of Medicines; on what date each cancellation took place; what safety concerns had been identified for each vaccine by the Medicines Control Agency; and under whose direction the licence was withdrawn. [21303]

Mr. Malone

With reference to the dates of granting of the nine measles, mumps, and rubella vaccines I refer the hon. Member to the reply I gave the hon. Member for Southwark and Bermondsey (Mr. Hughes) on 12 March, at column263. Information regarding the cancellation of product licences is commercially confidential. The recommendation of the Committee on Safety of Medicines are confidential.

I refer the hon. Member to the replies given on 6 November 1995, Official Report columns 607–11, which discuss the replacement of the Urabe strain of MMR vaccine with the current strain.

Mr. Smith

To ask the Secretary of State for Health on what dates the Medicines Control Agency first raised safety concerns regarding mumps, measles and rubella vaccines containing Urabe strain of mumps vaccine with the manufacturers of Pluserix-MMR and Immravac; and if he will make a statement. [21164]

Mr. Malone

I refer the hon. Member to the replies given on 6 November 1995 at columns607–11 which discuss the replacement of the Urabe strain of MMR vaccine with the current strain. Discussions between the Licensing Authority and marketing authorisation holder are confidential.

Mr. Smith

To ask the Secretary of State for Health (1) what assessment of the safety of mumps, measles and rubella vaccine was made by the Joint Committee on Vaccination prior to its 1988 recommendation for a vaccination programme; when the Committee on Safety of Medicines considered that assessment; and if he will make a statement; [21168]

(2) on what date the Joint Committee on Vaccination advised the introduction of a vaccination programme using combined mumps, measles and rubella vaccines; if he will list the members of the committee on the date on which the recommendation was made; if he will publish the committee's advice; which Ministers instructed that the committee's advice should be implemented; and if he will make a statement; [21267]

(3) what factors led his Department to announce on 1 September 1988 that a vaccination programme using combined mumps, measles and rubella vaccines would commence in October 1988; and if he will make a statement. [21167]

Mr. Horam

The joint committee on vaccination and immunisation decided at its meeting of 7 November 1986 to recommend to Ministers that a combined measles, mumps and rubella vaccine be introduced into the United Kingdom childhood immunisation programme as a replacement for single antigen measles vaccine. This recommendation was made following consideration of the experience of several other countries which had successfully used MMR vaccine for a number of years.

The JCVI recommended that MMR vaccine be introduced to: provide protection against measles, mumps and rubella; stimulate an increase in the uptake of measles vaccine; and augment the schoolgirl rubella immunisation programme with the aim of eliminating congenital rubella syndrome. The elimination of measles and congenital rubella syndrome were targets set by the WHO European region in its "Health for all by the year 2000" programme.

Before the introduction of MMR vaccine, the JCVI gave careful consideration to available information from Finland, Sweden and the USA on the safety, efficacy and efficiency of the vaccine and from trials conducted by the Public Health Laboratory Service communicable disease surveillance centre in about 10,000 immunised United Kingdom children. It is not the responsibility of the Committee on the Safety of Medicines to consider assessments made by the JCVI.

The Government's agreement in principle to this change was announced by Baroness Trumpington on 7 April 1987 and the change was confirmed in an announcement by my right hon. Friend the Leader of the House on 17 December 1987. Work on the implementation of the recommendation was guided by a working party established by the Department under the chairmanship of Sir John Badenoch, chairman of the JCVI.

The recommendations of the JCVI, as endorsed by Ministers, are made available in the publication "Immunisation Against Infectious Disease" copies of which are in the Library of the House. A list of the recommendations and statements concerning immunisation against measles, mumps and rubella is included in the answer to the question from the hon. Member for Southwark and Bermondsey at column 265.

The membership of the joint committee on vaccination and immunisation at April 1988 was as follows: Chairman: Sir John Badenoch. Members: Professor J. E. Banatvala; Dr. M. F. H. Bush; Professor A. G. M. Campbell; Dr. K. M. Citron; Professor J. G. Collee; Professor A. M. Geddes; Dr. D. G. Grahame Smith; Professor P. Grob; Dr. P. F. Grundy; Professor D. Hull; Dr. I. Jones; Professor J. K. Knowelden; Professor H. P. Lambert; Professor R. J. Levinsky; Dr. A. J. McFarlane; Professor D. L. Miller; Dr. J. Noble; Professor C. Peckham; Mrs. D. Roden; Dr. D. Reid; Dr. G. Schild; Dr. J. Selkon; Dr. J. W. G. Smith; Professor R. W. Smithells.

Mr. Smith

To ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Southwark and Bermondsey (Mr. Hughes) of 12 March,Official Report, column 263, if the Pluserix MMR vaccine was recommended for approval by the Committee on Safety of Medicines; and if he will make a statement. [21302]

Mr. Malone

Marketing authorisations are granted by the Licensing Authority. When appropriate, the advice of the Committee on Safety of Medicines is sought. However, the recommendations of the committee are confidential.

Mr. Smith

To ask the Secretary of State for Health if he will list the dates on which the Committee on Safety of Medicines and its sub-committees have considered the safety of measles and rubella vaccines since 1 January 1992; and if he will make a statement. [21166]

Mr. Malone

The safety of measles and rubella vaccines was considered by either the Committee on Safety of Medicines or its sub-committee on the following dates: 23 September 1992, 2 May 1995, 3 October 1995, 26 October 1995 and 31 October 1995.

Mr. Smith

To ask the Secretary of State for Health what assessments of the safety of(a) mumps, measles and rubella vaccines and (b) measles and rubella vaccines have been made by the joint committee on vaccination since 1 January 1988; if he will publish those assessments; and if he will make a statement. [21171]

Mr. Horam

The joint committee on vaccination and immunisation regularly receives information on reported adverse events, including yellow card reports from the Medicines Control Agency, as well as published papers on safety and other expert advice. When considering the place of any vaccine in the UK immunisation programme very careful consideration is given to the likely risks and benefits of each vaccine. JCVI's recommendations for the United Kingdom programme reflect is assessment of this. The introduction of MMR vaccine in 1988, the measles/rubella campaign in the winter of 1994–95, and the introduction of a second dose of MMR in 1996 were all recommended after looking at the safety of the vaccines concerned. Since January 1988, the committee has considered the matter of MMR vaccine, or its component vaccines, at each of the 18 meetings it has held.

The recommendations of the committee, as endorsed by Ministers, are made available in the publication "Immunisation Against Infectious Disease", copies of which are in the Library.

Mr. Smith

To ask the Secretary of State for Health when a product licence was granted to Immravax; when the product was withdrawn; on whose authority; and if he will make a statement. [21169]

Mr. Malone

I refer the hon. Member to the reply I gave the hon. Member for Southwark and Bermondsey (Mr. Hughes) on 12 March 1997 at column263. Marketing authorisations are granted by the Licensing Authority. Information regarding the withdrawal of a product is commercially confidential.

Mr. Smith

To ask the Secretary of State for Health if he will list the products which had a product licence on 2 September 1988 for the prevention of mumps, measles and rubella, and the dates of the granting of those product licences; and if he will make a statement. [21268]

Mr. Malone

The available information listing the vaccines for the prevention of mumps, measles and rubella on 2 September 1988 is as follows:

Product name Date of grant
Pluserix MMR vaccine 17 June 1988
M-M-R-II 17 August 1972