Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Government has considered introducing an accelerated regulatory and approval pathway for new vaccines and immunisations, particularly for diseases where an effective vaccine does not yet exist.

There are no current plans to introduce alternative accelerated approval pathways specific to vaccines and immunisations. At present, where accelerated approval of a vaccine is necessary, a medicine can be assessed for temporary authorisation under Regulation 174. This permits the supply of vaccine batches based on the safety, quality and efficacy data submitted by the applicant to the Medicines and Healthcare products Regulatory Agency (MHRA). This authorisation is not a marketing authorisation and only applies to supply within the United Kingdom of Great Britain and Northern Ireland.

Apart from Regulation 174, there are other regulatory routes in place for new medicines and vaccines. These regulatory routes may include (Conditional) Marketing Authorizations as well as Innovative Licensing and Access Pathway and Access Consortium approval procedures.

The Conditional Marketing Authorisation (CMA) route is particularly suited to vaccines for prevention of serious infectious diseases where no vaccine exists currently. This route allows for the possibility of authorisation earlier in the development pathway, before confirmatory data are available. New vaccines would be eligible for the accelerated, 150 day, assessment procedure.