Question to the Department of Health and Social Care:

To ask Her Majesty's Government how the risks and benefits of new vaccinations are assessed; and who is responsible for that assessment.

All new vaccines that are to be marketed in the United Kingdom require a Marketing Authorisation issued either by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK national competent authority, or by the European Commission.

Applications for Marketing Authorisations for any new medicine, including vaccines, must contain data on the quality, safety and efficacy of the medicinal product. In the case of vaccines, information on the safety and immunogenicity of the antigenic components of the candidate vaccine in the target population must be provided. These data are assessed by MHRA and, where applicable, the European Medicines Agency. This information is fully evaluated to establish the efficacy and safety of the medicinal product, and to ensure that the balance of the expected benefits and potential risks is favourable. Safety evaluation of vaccines continues in the post-licensing period and throughout the life-cycle of the product.

An independent external review of the authorisation of new medicines, including vaccines, is provided by the Commission on Human Medicines and its Expert Advisory Groups, which advises the MHRA and Ministers on the safety, efficacy and quality of medicinal products. The members of the Commission are appointed by Ministers.

The Joint Committee on Vaccination and Immunisation (JCVI), another independent expert advisory committee and statutory body, advises the Government on matters relating to vaccination and immunisation. The JCVI advises the Government on all changes to the national vaccination programme, including on the introduction of new vaccines. The JCVI reviews evidence on the potential health benefits and the safety of vaccines when developing its advice. The JCVI keeps all UK vaccination programmes under review, including regular updates from the MHRA on vaccine associated adverse events reported in the UK.