§ Mr. Llew Smith
To ask the Secretary of State for Health what arrangements exist for the long-term safety monitoring of MMR vaccines. 
§ Ms Jowell
Before measles, mumps and rubella (MMR) vaccination was introduced into the United Kingdom immunisation programme in 1988, there was extensive experience of its use in many other industrialised countries. The United States had been using MMR routinely since the early 1970s and around 100 million doses have been administered. By the time a two dose programme was introduced in the UK, in 1996, there was extensive experience of two dose programmes in many other countries. For example, a two dose programme of MMR in place in Finland since 1982 has 537W led to the elimination of these diseases from that country. The vaccine was reported to have an excellent safety record.
In the UK the Medicines Control Agency (MCA) collects information from many different sources to monitor the safety of all medicines, including vaccines, in clinical practice worldwide. Spontaneous reports of suspected adverse drug reactions are submitted to the Committee on Safety of Medicines (CSM) and MCA by doctors, pharmacists, coroners and dentists under the voluntary 'yellow card' scheme in the UK. There is a statutory requirement for pharmaceutical companies to report reactions to their products on a world-wide basis. Companies also provide regular safety updates for their products to the MCA. The number and pattern of suspected adverse reactions reports from all data sources are regularly reviewed, and appropriate action initiated if there is any indication of a safety hazard. The safety of vaccines is carefully monitored both by the CSM and the Joint Committee on Vaccination and Immunisation which advise UK Health Ministers.
§ Ms Jowell
The Public Health Laboratory Service is investigating adverse events associated with immunisation in children under two years of age, using hospital admissions data and child health immunisation records. Pilot studies in single districts have been published and copies of this paper have been placed in the Library. Their latest work, using regional data, will shortly be submitted for publication. Unfortunately, the results from studies using general practitioners' records do not so far suggest that this will be a useful source of data for identifying adverse reactions to vaccines.
§ Mr. Smith
To ask the Secretary of State for Health if he will set out the criteria used for the testing of vaccines for immunogenicity and reactogenicity; what discussions his Department has had with the National Institute for Biological Standards and Control over the product licensing of vaccines; and when he next plans to meet the Joint Committee on Vaccination and Immunisation to discuss the administration of the MMR vaccine. 
§ Ms Jowell
Before a new vaccine is licensed in the United Kingdom all of the information on its safety, quality and efficacy is evaluated by the Government's Medicines Control Agency and by the Committee on Safety of Medicines (CSM), an independent advisory committee. For a vaccine this will include assessment of clinical trials investigating the immunogenicity and reactogenicity of the product. There are no specific criteria laid out for the clinical testing of vaccines and each application for licensing by the MCA is taken on a case by case basis, depending on the type of vaccine.
The National Institute for Biological Standards and Control (NIBSC), as a European Official Medicines Control Laboratory, carries out the batch release testing for certain biologicals, including vaccines, which is required as a condition of the European or United Kingdom licence granted for the product in question. Such testing is aimed at assessing the purity and potency of each batch of the product against specifications defined in 538W the product licence. NIBSC also reviews manufacturing protocols as part of the evaluation of batch release. NIBSC also provides expert advice on vaccines and some of its staff are members of the biologicals sub-committee of the Committee on Safety of Medicines. The Director of the NIBSC is a member of the Joint Committee on Vaccination and Immunisation (JCVI); any concerns NIBSC may have would be brought to the attention of that committee.
We have no plans to meet the JCVI, but, as with all vaccines, the JCVI will keep the benefits and risks of MMR vaccination under review. We have asked to be kept informed of any developments.