§ Paul FlynnTo ask the Secretary of State for Health what assessment he has made of the possible(a) side effects, (b) benefits and (c) risks of prescribing the pneumococcal vaccine Prevenar to children who are not identified as at high risk of paediatric pneumococcal disease. [55821]
§ Ms BlearsPrevenar was authorised by the European Commission in February 2001 for active immunisation of infants and children from two months of age to two years of age against invasive disease (including bacteraemia, sepsis, meningitis, bacteraemic pneumonia) caused by the streptococus pneumoniae serotypes contained in the vaccine. An assessment of the possible risks and benefits of the vaccine for this indication was considered by the Committee for Proprietary Medicinal Products, the advisory body to the European Agency for the Evaluation of Medicinal Products (EMEA) prior to licensing. The at-risk groups were not distinguished. The current product information lists known side effects.
1077WStudies to document the full burden of morbidity attributable to pneumococcal disease in the United Kingdom's children and to evaluate the vaccine's suitability for use in the routine childhood immunisation programme are also in progress by the Department's vaccine evaluation consortium.
In January 2002, the Joint Committee on Vaccination and Immunisation, which advises the Department on national immunisation policy, recommended that the small number of children under two years who are at particular risk from pneumococcal disease, who would be recommended to receive polysaccharide vaccine if they were over two years, should now receive the new pneumococcal conjugate vaccine (Prevenar).