Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will publish the toxicology non-clinical studies for zapomeran, also called Kostaive, mRNA covid-19 vaccine following its approval for adults by the Medicines and Healthcare products Regulatory Agency.

Whilst the Medicines and Healthcare products Regulatory Agency (MHRA) does not publish non-clinical studies, in line with Section 64 of the Human Medicines Regulations 2012, the MHRA has published a public assessment report (PAR) for Kostaive. This PAR includes the MHRA’s assessment of the non-clinical data submitted. This PAR is accessible to the public on the MHRA’s products website at the following link:

https://mhraproducts4853.blob.core.windows.net/docs/0e710f66d3e04b6346f668178c02524de9248f57

This product was authorised via the International Recognition Procedure ‘Route B’ process, with the European Medicines Agency (EMA) acting as the reference regulator. Further information on the EMA’s assessment of Kostaive, including its own PAR, is accessible to the public on the EMA’s website at the following link:

https://www.ema.europa.eu/en/medicines/human/EPAR/kostaive