Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Prescription Medicines Code of Practice Authority case rulings with reference (a) AUTH/3815/8/23 and (b) 3886/3/24 on Moderna’s NextCOVE trial in children, if he will make an assessment of the potential impact of those rulings on the nature of his Department's future work with that company on mRNA (i) research and (ii) development.

The Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority, and the Research Ethics Committee (REC) review and approve clinical trials on the basis of the benefits and risks, in line with the UK Clinical Trials regulatory (UK CTR) framework.

The safety of those participating in clinical trials is the MHRA’s first priority, and our oversight of trial conduct is informed by the trial’s sponsor efficiently notifying us of safety issues during the conduct of their trial.

Sponsors and investigators involved in the conduct of clinical trials are expected to have robust processes to ensure compliance with The Medicines for Human Use (Clinical Trials) Regulations, which includes compliance with the provision and use of documentation that has been approved for use by a REC.

Where doubts about the safety, conduct, or scientific validity of a clinical trial are identified, the MHRA may take action, in line with the UK CTR, which could include requiring changes to be made to the trial protocol, or suspension or termination of a trial.