Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the changes proposed in his Department’s consultation on changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines, how long the proposed temporary authorisation of the supply of an unlicensed vaccine is planned to last.

The preferred route to enable deployment of a new vaccine for COVID-19 is through the usual marketing authorisation (product licensing) process. If a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and efficacy, becomes available, we will seek to license that vaccine through the usual route. Any temporary authorisation of the supply of an unlicensed vaccine would be by exception and the timing of this would depend on the public health need.