AQW 905/22-27

Ms Paula Bradshaw
Alliance Party
South Belfast

Tabled Date: 01/06/2022
Answered On Date: 20/07/2022
Priority Written: No

Question:
To ask the Minister of Health to outline the timescale for making Evusheld available in Northern Ireland as a treatment to prevent COVID-19.

Answer:

The drug Evusheld (tixagevimab/cilgavimab), was recently given a Conditional Marketing Authorisation for use in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). The European Medicines Agency (EMA) have also granted Evusheld a Marketing Authorisation under the Centralised Procedure for the authorisation of new medicines, and this licence applies in Northern Ireland. Evusheld is authorised to be used before being exposed to COVID-19 infection in order to prevent disease. At present there is not a supply of the drug Evusheld available in the UK.

Evusheld is being developed as a potential preventative treatment, with AstraZeneca announcing positive trial data. However, this trial took place before the emergence of the Omicron variant. The UK’s Health Security Agency (UKHSA) is carrying out further testing on the treatment’s effectiveness against the Omicron variant. The MHRA approval outlines that the duration of protection against Omicron is not yet known and a higher dose may need to be used to protect against Omicron. We therefore need an understanding of these issues before any procurement can take place.

The Department of Health and Social Care in England have asked clinical experts to advise on the most appropriate option for the Health Service in line with all available data, the public health situation and alongside the suite of other treatments available. The assessment of the most appropriate patient groups which could potentially benefit, as well as the deployment and administration process for pre-exposure prophylaxis, are being considered in parallel to inform any next steps. This is a crucial step, as we need to ascertain how it could be used and under what circumstances, to ensure that we know who could benefit the most. Any deployment would be dependent on data showing that Evusheld sufficiently neutralises Omicron variants.