Evusheld (pre-exposure prophylaxis (prevention) against COVID-19)

Evusheld is pre-exposure prophylaxis (prevention measure) against COVID-19.

It was provisionally approved, on 24 Feb 2022, by the Therapeutic Goods Administration (TGA) for use in people who are at risk of infection but have not yet been exposed to the virus (known as pre-exposure prevention of COVID-19).

Evusheld is made up of two long-acting monoclonal antibodies, tixagevimab and cilgavimab. These antibodies bind to the spike protein of the SARS-CoV-2 virus at two different sites to stop the virus from entering the body’s cells and causing infection.

Unlike a vaccine, which takes time to train the body’s immune system to respond to a virus, antibodies like Evusheld mimic or enhance the body’s natural immune response to identify and attack the SARS-CoV-2. (ref: https://www.astrazeneca.com.au/media/press-releases/2022/astrazenecas-evusheld.html)

EVUSHELD has been granted provisional approval for the (pre-exposure) prevention of COVID-19 in people aged 12 years and older weighing at least 40 kg:
-who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or
-for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component.

Eligibility also varies depending on state. At 4 July 2022, the information was as follows, although restrictions have been changing rapidly

People receiving:

• anti-CD20 therapies (Ocrevus, Kesimpta) can access Evusheld in all states except ACT, NT and Tasmania, although Tasmanian restrictions may soon be changing.
• S1P treatments (Gilenya, Mayzent, Zeposia) can access Evusheld in NSW, VIC, WA and SA
• corticosteroids (prednisone) can access Evusheld in NSW.

For further information on access in individual States see “How do I access Evusheld”

Categories of medicines or treatments are considered to induce moderate to severe immunocompromise include:
– B- or T-cell depleting medicines
o This includes the following disease-modifying therapies for MS: Ocrevus (ocrelizumab), Lemtrada (alemtuzumab), Gilenya (fingolimod),  Mayzent (Siponimod). 

– Stem cell transplant
o including autologous haematopoietic stem cell transplant for MS, or AHSCT.

A person is also considered to have moderate to severe immunocompromise, if they do not show a response to COVID-19 vaccination (that is, they are negative for COVID antibodies on blood testing, or “seronegative”) after the 3 rd primary dose of vaccine.

You will need to contact your doctor for local access to Evusheld. Evusheld is a prescription only (S4) medicine which requires a prescription from an authorised prescriber. This medicine is being supplied by the Australian Government to all state and territory governments through the National Medical Stockpile (NMS), a strategic reserve of drugs, vaccines, antidotes and personal protective equipment for use in national health emergencies. The National Medical Stockpile (NMS) distributes approved COVID-19 treatments.

To access supplies of Evusheld, healthcare professionals need to contact their relevant state or territory health department (local health department) about their supply arrangements. (Reference: Dept of Health advice to health care professionals)
(Reference: https://www.health.gov.au/initiatives-and-programs/national-medical-stockpile).

For further State-specific information please see links below:

The Australian Federal Government has secured a number of treatment courses of EVUSHELD from AstraZeneca. These doses will be provided to eligible patients at no cost, although there may be costs of administration of the injections in private medical practices and other private healthcare settings. Please contact your provider for more details.

As of 27 January 2023, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that Evusheld not be placed on the Pharmaceutical Benefits Scheme (PBS) at this time, however, this might be revised in the future. Access will remain through current schemes.

No. Pre-exposure prevention with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. COVID-19 vaccination provides additional protection compared to Evusheld. It activates 2 arms of the immune system: humoral immunity (or antibodies to SARS-CoV-2 virus) and cellular immunity (or T cells to specifically fight SARS-CoV-2 infection). Evusheld increases the level of protective antibodies against the SARS-CoV-2 virus, but does not activate the T cell arm of the immune system against SARS-CoV-2. Recent studies in people with MS on immune-depleting therapy, have shown that vaccination does successfully activate T cells against SARS-CoV-2 in this group. In addition, while their antibody response to vaccination can be greatly reduced, there can still be some level of priming of this response by vaccination, even if they test “seronegative” for antibodies to SARS-CoV-2. It is currently recommended that everyone over the age of 5 years should be vaccinated against COVID-19, including people with MS. See here for more details: https://www.msaustralia.org.au/covid-19-vaccination-guidance-for-people-with-ms-2022/

EVUSHELD is administered as two separate, sequential, injections of the long-acting monoclonal antibodies, tixagevimab and cilgavimab. 

These are administered intramuscularly at different injection sites (one in each gluteal muscle).

The answer to this is not known yet. EVUSHELD was designed to be long-lasting in the body. The effectiveness of EVUSHELD was assessed in a clinical trial (called the PROVENT Phase III pre-exposure prevention trial).

This study showed that EVUSHELD significantly reduced the risk of developing symptomatic COVID-19, and that protection from the virus continued for at least six
months. Further information on the length of the protective effect (ie whether it lasts longer than 6 months) will come from data currently being collected, which will be provided to the TGA by the sponsor, Astra Zeneca.

The TGA is currently evaluating treatment of COVID-19 as another indication for Evusheld, but this is still under review. 

For more information on Evusheld, see the TGA’s Consumer Medicine Information
(https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-01157-1)

TGA Media release:
https://www.tga.gov.au/media-release/tga-provisionally-approves-astrazenecas-combination-therapy-tixagevimab-and-cilgavimab-evusheld-pre-exposure- prevention-prophylaxis-covid-19
TGA Product information:
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?penAgent&id=CP-2022-PI-011561&d=20220624172310101
Australian Government Department of Health, Evusheld Fact Sheet for Health Professionals
https://www.health.gov.au/resources/publications/evusheld-fact-sheet-for-health-professionals
Australian Government Department of Health, Treating your patients.
https://www.health.gov.au/health-alerts/covid-19/treatments/treating-your-patients