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Learn more about Evusheld/Sipavibart:

Frequently asked questions

Here, you’ll find answers to the most common questions about Evusheld/Sipavibart, a vital monoclonal antibody treatment designed to protect immunocompromised individuals from COVID-19. Whether you’re looking for information on how Evusheld works, its availability, or eligibility criteria, this page aims to provide clear, concise, and up-to-date information to help you understand this crucial treatment option.

What are Evusheld and Monoclonal Antibodies (MABs)?

Evusheld is a combination of two long-acting antibodies (tixagevimab and cilgavimab). It’s a drug designed to protect clinically vulnerable people against COVID-19 in cases where vaccines don’t work. A good example is people who have been on the chemotherapy drug Rituximab, which causes much worse COVID-19 outcomes and also reduces vaccine efficacy. Another example is people with primary or secondary immunodeficiency. Evusheld is given prophylactically (that is: in advance) to stop people in this situation developing severe COVID-19 in the first place.

As of 2023, the efficacy of Evusheld against circulating variants has been questioned. On the one hand, in vitro results (in experiments/lab conditions) show reduced neutralisation. On the other hand, real-world studies continue to show protection.

The second version of Evusheld (Sipavibart) is currently being assessed for use by the MHRA with a view to approval for use autumn 2024/early 2025. The reason for a second version of Evusheld is to adapt it so that it is resistant to the latest variants of COVID-19, in a similar way that the vaccinations are adapted to ensure protection from the latest variants on a regular basis.

Pemgarda is also a spike protein-directed attachment inhibitor authorised for emergency use in the US only at the moment for the pre-exposure prophylaxis of COVID-19.

Who should be given MABs?

Vaccination alone does not provide sufficient protection against severe COVID-19 for individuals with weakened immune systems. For these individuals, monoclonal antibodies have long been the preferred therapeutic solution. This group includes, but is not limited to, those outlined in this document.

How can I get Evusheld/Sipavibart in the UK?

Evusheld is currently available through several private clinics in the UK, though its effectiveness against some circulating COVID-19 strains is uncertain. Once Sipavibart is assessed by the MHRA, it will also be available privately. Recognising that private access is not equitable for most people, our primary focus is on ensuring faster NHS access to these drugs. For information on the private availability of Evusheld or Sipavibart, please see this Facebook group.

Why has Evusheld not been bought on the NHS?

Evusheld was assessed by NICE in January 2023, but by the time the lengthy process concluded, it was deemed ineffective against the current COVID-19 variants. We’ve campaigned to highlight the need for shorter assessment processes to ensure drugs like Evusheld can be administered when they are most effective, similar to how vaccines are managed. Additionally, we advocate for the ability to adjust the antibodies in these treatments to match the circulating variants at any given time.

Is Evusheld needed given we now have antivirals?

Antivirals are currently only available after you have caught COVID-19. Taking Evusheld/Sipavibart would give protection against catching COVID-19, ensuring that immunocompromised patients are not put at significantly higher risk of more severe outcomes which is the risk if they catch COVID-19. If these immunocompromised patients are protected then it will ease some of the burden on the already overstretched NHS, and stop them filling much needed bed space, and offer them additional protection.

Who supports Evusheld/Sipavibart?

Many organisations, medical practitioners, charities, and MPs support the use of Evusheld/Sipavibart for immunocompromised patients.

More than 100 clinicians also called on the Government in August of 2022 to make a preventative treatment for COVID-19 available in the UK to the approximate 1.8M clinically vulnerable people who may benefit from it.

The prophylactic monoclonal antibody treatment Evusheld was approved for use in March 2022, but it was not made available on the NHS, when it was being used in 28 countries, including the United States, France and Israel.

The All Party Parliamentary Group for Vulnerable Groups to Pandemic had asked D DrLennard Lee, academic lecturer and medical oncologist at Oxford University to carry out a clinical consultation to ask clinicians how to help the people still at risk who do not have protection from vaccination.

125 clinicians responded across 17 medical specialities to the largest-known consultation in the UK, if not the world, about this new step of the pandemic response.

The consultation statement sets out the clinical benefits of making monoclonal prophylactic antibody therapies available, detailing how it helps from an individual level, to prevent infections, hospitalisation, and deaths. It also would help improve mental health and give immunocompromised people the confidence to reduce shielding. The statement also suggested it would help the broader health care system by reducing demand on the primary care, emergency services, and intensive care if there were a reduction in serious infections in immunocompromised people.

National Clinical Expert Statement

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