Last week the UK Government announced to the BBC they will not be buying Evusheld for vulnerable groups.
What is Evusheld?
Developed by AstraZeneca, Evusheld is a combination of two long-acting antibodies (tixagevimab and cilgavimab) that works by binding to the spike protein on the outside of the SARS-CoV-2 virus, the virus that causes COVID-19. This in turn prevents the virus from attaching to and entering human cells. In a clinical trial in adults, Evusheld was found to reduce the risk of developing symptomatic COVID-19 by 77%, with protection from the virus continuing for at least six months following a single dose.
Evusheld is authorised to be used before being exposed to the risk of COVID-19 infection in order to prevent disease (known as ‘pre-exposure prophylaxis’). It is administered as a single dose of the two medicines, tixagevimab and cilgavimab. It should be given as two injections into a muscle by a healthcare professional.
Evusheld has been approved by the MHRA for use in adults who are unlikely to mount an immune response from COVID-19 vaccination or for whom vaccination is not recommended. At present, detailed eligibility criteria for this prophylactic treatment have not been published. We anticipate that Evusheld should be offered to people on treatments which have been demonstrated to have the most significant impact on COVID-19 vaccine efficacy, such as rituximab, as well as those with known allergies preventing them from having the vaccines.
Does Evusheld work against Omicron variants?
The evidence for the MHRA to authorise Evusheld was based on clinical trials with the Delta variant. As such, there was uncertainty about whether the treatment would still be effective in protecting people against the Omicron variants.
Initial studies looking at how effective Evusheld was at preventing Omicron infection were done in-vitro (in the lab). These studies give an idea of how effective drugs like Evusheld could be, but human studies provide more certainty.
Early studies of the Omicron strain BA.2 showed that the antibodies that Evusheld is made up of (tixagevimab and cilgavimab) do still seem to work against Omicron, although it does not seem to be as effective as it was at destroying the original strain of the virus – HERE.
Further research carried out by the University of Oxford showed that Evusheld was eight-times less effective at destroying BA.4 and BA.5 compared to BA.2 – HERE.
What did the Government decide?
The Department of Health said it would not be buying doses of the Evusheld injection. This has been reported by the BBC and other news outlets, although an official statement has not yet been published on the government website. You can read the BBC News report – HERE.
Paul Howard, Chief Executive of LUPUS UK, said “This decision leaves some members of our community feeling even more abandoned and facing increased isolation and anxiety as we approach the winter months. Evusheld has been used for months now in other countries such as the US and Israel and there is a significant body of evidence showing that it can be effective in reducing the risk of severe illness and death from COVID-19 for those who are most vulnerable. This decision will mean that immunosuppressed people without adequate protection from the vaccines will often be forced to continue isolating themselves.”
What will happen next?
NICE is in the process of deciding how to evaluate the treatment for use within NHS England. Recommendations made by NICE are routinely accepted by the NHS in Wales and Northern Ireland, whilst the Scottish Medicines Consortium will usually conduct their own evaluation for NHS Scotland.
You can track the progress of the NICE evaluation HERE.
LUPUS UK completed the stakeholder registration and commented on the Draft Scope. You can see our submission, in full, HERE.
What can I do?
Contribute to LUPUS UK’s NICE submission(s)
If the NICE appraisal goes ahead, LUPUS UK will be inviting people from the lupus patient community to share their experiences and opinions as contributions for the charity’s submission. Keep watching our social media channels for ways to get involved.
Join Evusheld for the UK
Evusheld for the UK is a group of patients advocating for the availability of Evusheld in the UK. The website includes information about the group, about Evusheld, and ways for you to aid the campaign (such as writing to your MP). Learn more HERE.