§ Mr. RuaneTo ask the Secretary of State for Health what steps he is taking to monitor safety of childhood vaccinations; and if he will make a statement. [122158]
§ Yvette Cooper[holding answer 15 May 2000]: The Post-Licensing Division of the Medicines Control Agency (MCA) is responsible for monitoring the safety of all marketed medicines, including vaccines, licensed in the United Kingdom. Prior to licensing, all vaccines are thoroughly tested for safety, efficacy and quality. A manufacturer must demonstrate that the vaccine is safe and effective in preventing disease and that it is manufactured to appropriate standards before a Product Licence is given.
Suspected adverse reactions to vaccines, and other medicines, can be reported through the yellow card (YC) scheme by doctors, dentists, coroners, and pharmacists. In addition, vaccine manufacturers must submit details of all reports of suspected adverse drug reactions that are of a serious nature to the MCA. Reports received through the YC scheme and from companies are entered onto a specialised computer system called ADROIT (Adverse Drug Reactions On-line Information Tracking). This system allows rapid processing and detailed analysis of reports. Information collected through this system provides additional information on recognised reactions and can act as an early warning system for the identification of previously unrecognised reactions.
The YC scheme is well established and has been shown to be effective in identifying previously unrecognised adverse reactions. It is the key system for nation-wide surveillance in all age groups and can provide signals for very rare adverse events. The number and pattern of reports are regularly reviewed, and appropriate action initiated if there is indication of a problem.
Information from the YC scheme, together with information from other sources including published papers, large controlled trials, epidemiological studies, record linkage studies and screening of general practitioners and hospital databases provides comprehensive monitoring of the safety of childhood vaccines.
The question of vaccine safety is one that we take very seriously and is of the utmost importance. The benefits and risks of vaccination are always carefully considered and kept under constant review. Serious adverse reactions to vaccines are very rare. Reported suspected adverse reactions are carefully monitored both by the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation, independent expert groups which advise the UK health departments. Information on 508W safety issues is considered in detail by the MCA and the Department and by its independent expert advisers on a regular basis.
The National Institute for Biological Standards and Control tests each batch of vaccine for potency, safety and purity before it is issued for use. Only batches that reach the required standard are released for use. No vaccine is issued in the UK unless it passes the highest standards for quality. As a result, the childhood immunisation programme remains the safest way for parents to protect their children against disease.
§ Mr. BakerTo ask the Secretary of State for Health what advice parents are given about the side-effects of the Meningitis C vaccine; whether the vaccine carries a risk of brain-damage or death; and whether all risks are made clear before parental consent is requested. [122913]
§ Yvette Cooper[holding answer 19 May 2000]: A leaflet for parents—"Meningitis C. Reduce the risk. Your guide to the new meningitis C vaccine"—provides information on the possible side effects of the meningococcal Group C conjugate vaccine. The consent form for the meningococcal Group C immunisation tells parents to "Make sure you have read and understood the leaflet". It goes on to advise "Before you fill in the rest of the form, please make sure you have read this leaflet carefully" and then explicitly draws attention to "the possible side effects of the immunisation (read page 6)". Brain damage and death are not recognised risks.
About 26 million copies of the parents' leaflet have been printed and it has been mailed to general practitioners' surgeries, pharmacies and schools for every parent to receive and also made widely available though high street pharmacies and post offices. Copies of the leaflet and the consent form are available in the Library.