§ Mr. BakerTo ask the Secretary of State for Health, pursuant to his answer of 24 May 2000,Official Report, column 506W, (1) what are the benefits and risks that are considered and constantly reviewed for each individual vaccination; [124762]
(2) what are the serious adverse reactions to vaccination; and how rare they are. [124761]
186W
§ Yvette Cooper[holding answer 7 June 2000]: The benefits of vaccination are the prevention of illness and death from infectious diseases. These benefits are assessed from clinical trials and epidemiological studies, prior to authorisation for clinical use. Following the introduction of a vaccine, there is ongoing monitoring of disease incidence rates and, where appropriate, outcomes.
The risks of immunisation to the individual are those of adverse reactions from the vaccine. These risks are evaluated both before and after authorisation using a range of data sources including clinical trials, spontaneous adverse reaction reports from health professionals, epidemiological studies and the published scientific literature.
The Department publishes full information on the benefits and serious adverse reactions to vaccination in the book 'Immunisation against infectious disease', copies of which are available in the Library. Vaccine-associated paralytic polio is the only serious reaction where evidence supports the suggestion of a causal association and there are demonstrated long-term consequences; this occurs in one out of approximately every million immunisations.
The authorised Summary of Product Characteristics for each product contains important prescribing information on individual vaccines and possible undesirable effects. These are available in the Compendium of Data Sheets and Summaries of Product Characteristics published by the Association of the British Pharmaceutical Industry. The Summary is updated throughout the lifetime of the product, as new information becomes available.