Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to implement the decision of the International Coalition of Medicines Regulatory Authorities not to require the use of animal disease models to test the effectiveness of potential vaccines for the SARS-CoV-2 virus before they proceed to human clinical trials.

Assessors from the Medicines and Healthcare products Regulatory Agency (MHRA) took a lead part in the meeting of the International Coalition of Medicines Regulatory Authorities, held on 18 March 2020, where participants acknowledged that the extent of non-clinical data to support proceeding to First Time in Human (FTIH) clinical trials for a candidate COVID-19 vaccine depends on the vaccine construct, the supportive data available for the construct, and data from closely related products. It was generally agreed that if a platform technology utilised to manufacture a licensed vaccine or other investigational vaccines is well characterised, it is possible to use toxicology data and clinical data accrued with other products using the same platform to support FTIH clinical trials for a SARS-CoV-2 vaccine candidate. However, it was also agreed that data from animal disease models would be required to support Phase II clinical trials. This is the policy that the MHRA had already implemented for other candidate vaccines for various diseases.