Question to the Department of Health and Social Care:

To ask His Majesty's Government why the Medicines and Healthcare products Regulatory Agency claimed in their 6 September letter to Gemma Peters, Chief Executive of Blood Cancer UK, that there is ongoing uncertainty about whether the results from the PROVENT study on Evusheld shed light on clinical effectiveness, given this study supported their decision to approve single and double doses of Evusheld in the UK in March.

Evusheld received a conditional marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022, following trials conducted during the non-Omicron variant wave of the COVID-19 pandemic. The PROVENT study provided data on effectiveness of Evusheld against the alpha, beta, delta and epsilon variants. It was noted that there was a lack of data regarding the dose and the efficacy against the Omicron variant, which was the prevalent circulating strain of the virus at the time of the approval. This was reflected in the summary of the product characteristics of Evusheld approved by the MHRA.

As with all newly authorised medicines, a Risk Management Plan (RMP) has been developed to ensure that Evusheld is used as safely as possible. The RMP details the risks, how these risks can be minimised, any uncertainties and how more information will be obtained.