What is Evusheld? How is it different from other treatments?
Evusheld is a preventative (or prophylactic) treatment that protects from Covid-19. It’s distinct from other treatments, because it’s taken before someone becomes ill with Covid. It helps to prevent infection from happening in the first place – but if someone who’s taken Evusheld still becomes ill with Covid, it also reduces the chances of them becoming seriously ill. It can help to protect people whose weakened immune systems haven’t responded well to the vaccines by giving them the antibodies they can’t produce themselves; for this reason, Evusheld is called a ‘monoclonal antibody treatment.’ It is made up of two monoclonal antibodies: tixagevimab and cilgavimab.
Other Covid treatments are already used in the NHS, which help to reduce the chances of being hospitalised or dying and help to clear the virus out quickly. They’re called ‘post-exposure’ treatments, and are an important way to protect the immunocompromised after they’ve become infected .
Yet the system through which these Covid treatments are delivered hasn’t been reliable. Only around 17% of people who become infected with Covid and are referred for treatment actually receive it. In some instances, this is because someone doesn’t have symptoms, but we also know there are systemic issues in how these treatments are being delivered that mean that some people just can’t access them. Relying, then, on treatments given only after becoming infected with Covid is a terrifying prospect for people who are at very high risk of hospitalisation, and death.
Despite these treatments, many people with weakened immune systems are still at higher risk of poor outcomes and death from Covid. People with blood cancer, for example, are 12 times more likely to die from Covid than the general population, according to an analysis of ONS data by Blood Cancer UK. In people with a kidney transplant, the relative risk increased from 7 times higher than the general population in the first wave of Covid in 2020, to 26 times higher in the third wave in 2021. An analysis of intensive care data shows that, while only 1 in 134 of the population is immunocompromised, 1 in 11 of all people admitted to the ICU for Covid were immunocompromised, in the first half of this year.
Further, the likelihood of receiving these treatments after being infected with Covid is related to several factors including whether they live in a deprived area, their ethnicity, and which region they live in. To reduce their risk, the immunocompromised need a safe, effective treatment that aims to prevent them becoming infected in the first place.
Why don’t we have Evusheld yet?
Evusheld has been rolled out in 33 countries, including the United States, Canada, Japan, and France. Most of these countries have measured the impact and effectiveness of Evusheld to monitor whether it works against new variants. The latest real-world data, published as a pre-print (undergoing peer-review) on July 29 and collected in Israel during the Omicron BA.1 and BA.2 waves, shows that immunocompromised people who took Evusheld were half as likely to become infected with Covid, and 92% less likely to be hospitalised and/or die.
Although Evusheld was approved for use in the UK on 17 March 2022 by the Medicines and Healthcare Products Regulatory Agency (MHRA), the Government hasn’t bought any doses for use by the NHS. The Westminster Government’s rationale for this is that there isn’t enough evidence of Evusheld’s effectiveness against the Omicron subvariants. While the main clinical trials testing Evusheld were conducted against the Delta variant of the virus, newer research has shown that it’s still effective against Omicron BA.1 and BA.2, but less effective against Omicron BA.4 and BA.5. For more information on Evusheld’s effectiveness against the Omicron variants, see this blog post by Blood Cancer UK.
It’s impossible to say whether Evusheld will be more or less effective against future variants, because we can’t predict how the virus will mutate. This is the same for all monoclonal antibody treatments, including sotrovimab, which is used in the NHS to treat Covid after you’ve been infected. The Covid vaccines are even more susceptible to reduced effectiveness against new variants than Evusheld or sotrovimab, because they target a part of the virus that has mutated considerably over the course of the pandemic. However, the Government has rightly continued to purchase vaccines.
We believe Evusheld should be bought by the Government, because it still has the ability to prevent Covid and can help to fight against the virus when someone comes into contact with it. It’s needed for those people whose immune systems aren’t responding adequately to the vaccines. There are robust safeguards in place in the UK to ensure that drugs such as these are monitored for effectiveness in light of new variants – as is the case for sotrovimab. Evusheld should be bought, rolled out, and monitored accordingly when new variants arise.
What’s going on with Evusheld now?
In July, the National Institute for Health and Care Excellence (NICE) launched an appraisal of Evusheld. This is an evaluation of its clinical and cost-effectiveness. Covid vaccines and other Covid treatments are normally rolled out before they’re fully appraised by NICE, via a pathway called RAPID C-19. This is because the individual and public health need for these treatments is considered greater and more urgent than the need to determine how cost-effective they are. If the vaccines had undergone NICE appraisals before they were rolled out, for instance, they would have been delayed, typically for around one year.
In August, the Government announced that, based on advice from the RAPID C-19 Oversight Group and independent experts, it would wait until Evusheld had been appraised by NICE before deciding whether to make it available. This is unusual for Covid treatments: it’s the first time this has happened since the start of the pandemic. The NICE appraisal won’t be complete until the end of May 2023. For immunocompromised people who haven’t mounted an adequate response to the Covid vaccines, this means they may have very little protection against Covid this winter, and must rely on post-exposure Covid treatments after they become infected.
The immunocompromised urgently need a safe and effective treatment to help prevent them from getting infected with Covid, and from the severe outcomes associated with the disease. The Government should buy Evusheld and make it available on the NHS in time for winter, to help protect those who can’t rely on vaccines and post-exposure treatments alone.
- Learn more about Evusheld
- Help Us Campaign
- Support for Shielders
- Charity Letter and Clinical Consultation
Who are the 500,000 immunocompromised people in the UK?
There are 505,081 people on NHS England’s list of people who they consider severely immunosuppressed. In Wales and Scotland, this is 103,992 and 85,208 respectively (according to their spring booster eligibility lists). Unfortunately, this information isn’t publicly available for Northern Ireland. In total, there are therefore at least 694,281 people who are classified as immunocompromised in the UK for the purposes of determining their eligibility for additional vaccine doses. This number changes often, however, and each nation has different criteria that they use to decide whether someone is immunocompromised, or ‘severely’ immunocompromised. For that reason, we stick to the 500,000 number so as not to inadvertently overstate the number of people with weakened immune systems who remain at high risk from Covid.
Are any of the 500,000 immunocompromised protected by Covid vaccines?
Yes – people who are considered immunocompromised have a wide range of different health conditions, or are taking certain medical treatments, that weaken their immune system in different ways. Depending on various factors, some people are more protected by the Covid vaccines than others. There has been a great deal of research conducted among people with blood cancer, for example (of whom there are almost 280,000 in the UK) that shows that someone’s particular condition and cancer treatment impacts how their immune system responds to the vaccines.
The immune system has two key components related to B cells and T cells. Research suggests that B cells produce antibodies that help protect against and fight off infection, and T cells help protect against becoming seriously ill. While antibodies wane relatively quickly, T cells provide more durable protection – which lasts longer – and also protects against a broader range of Covid variants. Even though spikes in Covid cases are usually caused by new variants, T cells can provide some protection against those new variants despite not encountering them previously. It’s much easier to measure antibodies than it is to measure T cell activity, so while some immunocompromised people can get antibody tests, the results of these tests still won’t indicate to them exactly how protected they are against Covid. T cell tests do exist, but they tend to be expensive and are mostly available privately. There’s also uncertainty as to their accuracy.
Immunocompromised people, for example people with primary and secondary immunodeficiency, may have a condition that means their T cells aren’t able to protect them. They may also be on medication (such as cancer treatment) that depletes their B cells. Some might also have genetic conditions, such as primary immunodeficiency disorders, where their B cells aren’t able to produce antibodies to protect them properly. Others may have had a transplant (such as a solid organ or stem cell transplant) that renders them immunocompromised. Some people have very weak immune systems, while others’ are somewhat weakened. Many of them are still at risk from Covid despite being vaccinated. Among the unvaccinated, people who are immunocompromised only make up 2.4% of ICU admissions. Among people who’ve had three or more vaccine doses, this is 27.7%, reflecting that their risk is still high, while people with strong immune systems have a lower risk from Covid after being vaccinated.
People with weakened immune systems need more vaccine doses than others to increase their chances of producing antibodies or a T cell response. Some people are able to produce antibodies after 4 or 5 vaccine doses – but others haven’t produced any at all. This is why it’s important for people to keep getting multiple Covid vaccine doses, but also why there are some people who remain at very high risk from Covid, and need a treatment like Evusheld to protect them from infection, severe illness, and death.
What is the Government’s argument for not making Evusheld available?
A group of charities have been corresponding with the Secretary of State for Health and Social Care on Evusheld since August. Their letters are a useful way to understand both sides of the argument, and you can read them below. In summary, the Government is relying on lab-based data because they’ve dismissed the existing real-world evidence due to concerns about the methodologies used in some of the studies. On the other hand, we disagree with their stated reasons, and believe their dismissal of this evidence is out of step with standard practice among regulators like the MHRA.
- 23 August 2022 letter from charities to Steve Barclay MP (the previous Secretary of State for Health)
- 05 September 2022 letter from Steve Barclay MP to charities
- 21 September 2022 letter from Blood Cancer UK to Therese Coffey MP (the current Secretary of State for Health)
Further, the patient-led campaign group, Evusheld for the UK, has also been corresponding with the government. Their letters offer similar rebuttals.
- Evusheld for the UK. 2022. ‘Response Letter to the New Secretary of State for Health’. 20 September 2022.
- Evusheld for the UK. 2022. ‘Response to DHSC Shelving Plans for Evusheld in Winter 2022’. 12 August 2022.
- Evusheld for the UK. 2022. ‘Department of Health Plans to Deny Lifesaving Treatment to Vulnerable Patients’. 10 August 2022.
- Evusheld for the UK. 2022. ‘UK “Outlier” in Not Protecting 500,000+ Vulnerable Patients with New Lifesaving Drug. AstraZeneca Denies Government Claims of Further Testing’. 21 June 2022.