Response to DHSC Open Consultation: Changes to Human Medicine Regulations to support the rollout of COVID-19 Vaccines

We are writing in response to the UK Government consultation in respect of the proposals to modify the Human Medicine Regulations 2012 (“the Regulations”) in order to support the rollout of a COVID-19 vaccine. This is a submission to the consultation on behalf of a group of specialists drawn from different disciplines setting out our views on the proposed changes. Under the proposed modification of the Regulations, the envisaged scenario is that if there is a compelling case on public health grounds for using a vaccine before it is given a product licence, the Joint Committee on Vaccination and Immunisation may take the step of advising the UK government to use a tested, unlicensed vaccine/s against COVID-19. This would be a highly unusual step to take, and we have concerns about any UK Government decision to resort to the supply of an unlicensed medicinal product in this manner and the public health messaging that is thereby relayed. This is particularly the case in respect of one or several vaccines which have been developed under a fast-track procedure, potentially based on innovative technology, and which is to be used on such a wide scale to the general population.