Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what pre-clinical animal testing was conducted prior to reaching the clinical vaccine trial stage for AHEAD-MERIT (BNT113).

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that all medicines and vaccines, including cancer vaccines, meet appropriate standards of safety, quality and efficacy before they are approved for use in humans.

Non-clinical (also known as pre-clinical) studies for therapeutic cancer vaccines are performed in compliance with applicable International Council for Harmonisation guidance, the WHO guideline on Non-clinical Evaluation of Vaccines. Such studies must be conducted in compliance with the principles of Good Laboratory Practice and in accordance with the United Kingdom’s strict animal welfare legislation, including the Animals (Scientific Procedures) Act 1986, which requires that the use of animals in research is justified and that alternatives are considered wherever possible.

The MHRA is not able to share confidential information on pre-clinical studies. A clinical trial may only proceed once the MHRA is satisfied that the data supports a reasonable expectation of safety and potential therapeutic benefit to participants.