Government Response

The Government responded to this petition on Wednesday 25th May 2022

The Government recognises the concerns of immunocompromised people, and is actively exploring all available evidence on Evusheld in order to make decisions around its use in the UK.

Thank you for raising the important issue of therapeutic options for immunocompromised patients.

The Government has made neutralising monoclonal antibodies and antiviral drugs available to those at highest risk of severe COVID-19, including patients with immunosuppression. These treatments are taken after developing symptoms and clinical trial evidence shows that they are effective reducing mortality. Further information on these treatments is available here: https://www.nhs.uk/conditions/coronavirus-covid-19/treatments-for-coronavirus/.

We recognise that many people are also interested in prophylactic treatments that could potentially reduce the risk of COVID-19 infection and are keen for the Government to secure Evusheld (a prophylactic antibody therapy manufactured by AstraZeneca).

We are assessing all the available evidence for Evusheld, so we can make a decision on whether it should become available to UK patients.

We need to be confident that any therapeutics in use in the UK are sufficiently effective against the currently circulating variants. Evusheld is a neutralising monoclonal antibody, and this type of treatment can be made less effective by new variants due to the way in which the drug binds to the virus. In August 2021, Ronapreve, a neutralising antibody, received conditional Marketing Authorisation for both prophylaxis (prevention) and treatment of COVID-19 in the UK. After being used by the NHS between September and December 2021, it had to be withdrawn from clinical policies because it was not effective against the Omicron variant.

The conditional Marketing Approval of Evusheld by the Medicines and Healthcare products Regulatory Agency (MHRA) approves the product for use in Great Britain. However, the MHRA has highlighted that the efficacy of Evusheld against the Omicron variant is not yet fully understood. The MHRA noted that against some SARS COV2 variants (including Omicron variants) a higher dose might be required, and the duration of protection that would be provided to patients is unknown.

The evidence considered by the MHRA is summarised here: https://www.gov.uk/government/publications/regulatory-approval-of-evusheld-tixagevimabcilgavimab/summary-of-product-characteristics-for-evusheld?msclkid=afe12767cf7611ecabe3a0cc919b8794.

It is very important that we answer these questions before taking a decision on procuring Evusheld, so that we know what level and duration of protection it would provide if it were made available in the UK.

The UK Health Security Agency (UKHSA) has been carrying out further testing on the treatment’s effectiveness against the Omicron variant. These results will help inform any decisions on next steps for this treatment.

We are working in parallel to understand who could benefit the most from pre-exposure prophylaxis. The new Therapeutics Clinical Review Panel is providing advice on the most appropriate patient cohorts for new COVID-19 therapeutics, including preventive treatments such as Evusheld. This will help with determining who could benefit from such treatments if they are found to be sufficiently effective, and under what circumstances. Final clinical policies and eligibility would be determined by the NHS and Devolved Administrations.

Department of Health and Social Care