AstraZeneca’s Evusheld™ (Tixagevimab and Cilgavimab) Granted Provisional Approval For Pre-Exposure Prophylaxis (Prevention) Of COVID-19 In Australia’s Most At-Risk

Evusheld (formerly AZD7442) is a long-acting antibody (LAAB) combination for the prevention of symptomatic COVID-19 before exposure in those who are unlikely to be protected by a COVID-19 vaccine,1-3 and those for whom vaccination is not recommended.

  • Evusheld (tixagevimab co-packaged with cilgavimab), AstraZeneca’s long-acting antibody (LAAB) combinationgranted provisional approval by Australia’s Therapeutic Goods Administration (TGA) for use against COVID-19.1,4,5
  • Long-acting antibodies a new option in the fight against COVID-19: Antibodies like Evusheld mimic the body’s natural immune response to identify and attack specific disease-causing organismsto prevent the disease from entering the body’s cells and causing infection.7-11
  • Most at-risk in the community and those who are unlikely to be protected from COVID-19 by vaccination now have an option to protect against this infectious virus: This includes people from 12 years and older who are immunocompromised, due to underlying health conditions or people requiring medication that supresses the immune system such as medicines used to treat blood cancer and following organ transplant.7-11

FRIDAY, 25 FEBRUARY 2022 (SYDNEY): AstraZeneca is pleased to announce that Evusheld has been granted provisional approval in Australia by the Therapeutic Goods Administration for the pre-exposure prophylaxis (prevention) of COVID-19 in adolescents and adults aged 12 years and older.1

Vaccination is an important tool in reducing the risk of serious illness and hospitalisation from COVID-19, however, not everyone who receives a vaccine can produce an immune response that will protect them from COVID-19.7-11 An estimated 2% of the global population are considered at increased risk of serious illness from COVID-19 due to an inability to develop an adequate response to a COVID-19 vaccine.12,13 This includes people who are immunocompromised due to underlying health conditions, or who are taking immunosuppressive drugs for medical conditions such as blood cancers, active chemotherapy, dialysis, organ transplant and primary immune deficiency.7-11

More than 40% of those hospitalised with COVID-19, despite being fully vaccinated, are people who are immunocompromised.14-16 Dr Paul Griffin, Director of Infectious Diseases at the Mater Health Services and Associate Professor at The University of Queensland,said vulnerable populations may need an additional layer of protection.

“This virus has shown us time and time again how challenging it is to control, particularly in recent times with the emergence and widespread transmission of the highly infectious Omicron variant.”

“We are extremely fortunate to have a number of safe and highly effective vaccine options that work tremendously well at protecting the majority of people. However, there are individuals who are unable to respond adequately to vaccination alone and therefore are at greater risk of infection. Evusheld represents another step forward in our ability to combat this virus by providing these people an option to add another layer of protection for those most at risk.”

Evusheld is a combination of two long-acting monoclonal antibodies (mAbs), tixagevimab and cilgavimab, administered as two intramuscular injections.2,3 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 coronavirus.The antibodies work by binding to the spike protein of the SARS-CoV-2 virus at two different sites. By attaching to the spike protein, the medicine is expected to stop the virus from entering the body's cells and causing infection.17-19

Evusheld may also offer protection for those who are unable to receive vaccination, for example those with allergies or other intolerance of the vaccines.3, 20-21 However, Evusheld is not intended to be used as a substitute for vaccination against COVID-19.22

Liz Chatwin, Country President, AstraZeneca Australia & New Zealand, said: “We are so proud to continue to play a leading role in the fight against the COVID-19 pandemic, both at home in Australia and around the world. The approval of Evusheld brings welcome news for those immunocompromised and vulnerable population groups who may have not received adequate protection against COVID-19 to date. We look forward to working with the Australian Government on ensuring those eligible have access to Evusheld.

Agreements are in place around the world for the supply of Evusheld in 2022 including in Australia and North America, within the EU and in the Middle East.

Evusheld builds on AstraZeneca’s global response to COVID-19 and the company’s commitment to playing a leading role in safe-guarding the health of all those in the community.

The most common side effects associated with Evusheld include pain, bruising of the skin, soreness or swelling, at the injection site. More serious side effects include difficulty breathing, swelling of the face, lips, tongue or throat, severe itching of the skin, which may indicate an allergic reaction following the administration of monoclonal antibodies. Cardiac (heart) and blood clot events may present as a side effect, but this may not necessarily be related to the administration of Evusheld. Individuals with a history of severe hypersensitivity reactions, including anaphylaxis, to the active substances, bleeding disorders and cardiac events should not receive Evusheld.

For more information on Evusheld, visit the Therapeutic Goods Administration at https://www.tga.gov.au/ or speak to your healthcare practitioner about your eligibility.

REFERENCES:

  1. Therapeutic Goods Administration. TGA grants provisional determination to AstraZeneca Pty Ltd for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (EVUSHELD). Available at: https://www.tga.gov.au/media-release/tga-grants-provisional-determination-astrazeneca-pty-ltd-covid-19-prophylaxis-and-treatment-tixagevimab-and-cilgavimab-evusheld. [Last accessed: February 2022].
  2. AstraZeneca news release. AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html. [Last accessed: February 2022].
  3. AstraZeneca news release. AZD7442 reduced risk of developing severe COVID-19 or death in patients with mild-to-moderate COVID-19 in TACKLE Phase III treatment trial. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html. [Last accessed: February 2022].
  4. Dejnirattisai W, et al. Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Available from: https://www.biorxiv.org/content/10.1101/2021.12.03.471045v2. [Last accessed: February 2022].
  5. VanBlargan LA, et al. An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by 2 several therapeutic monoclonal antibodies. Available from: https://www.biorxiv.org/content/10.1101/2021.12.15.472828v1.full.pdf. [Last accessed: February 2022].
  6. Lloyd E, Gandhi T, Petty L. Monoclonal antibodies for COVID-19. JAMA. 2021; 325(10):1015. doi:10.1001/jama.2021.1225. 
  7. Centers for Disease Control and Prevention. Altered immunocompetence. General Best Practice Guideline for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. [Online]. Available at: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html [Last accessed: December 2021].
  8. Boyarsky BJ, et al. Immunogenicity of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients. JAMA. [Internet] 2021; 325 (17):1784-1786. Available at: https://jamanetwork.com/journals/jama/fullarticle/2777685. [Last accessed: December 2021].
  9. Rabinowich L, et al. Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients, Journal of Hepatology. [Internet] 2021. Available at: doi: https://doi.org/10.1016/j.jhep.2021.04.020. [Last accessed: December 2021].
  10. Deepak P, et al. Glucocorticoids and B cell depleting agents substantially impair immunogenicity of mRNA vaccines to SARS-CoV-2. medRxiv. [Preprint] 2021. PMID: 33851176; PMCID: PMC8043473. Available at: https://doi.org/10.1101/2021.04.05.21254656. [Last accessed: December 2021].
  11. Simon D, et al. SARS-CoV-2 vaccination responses in untreated, conventionally treated and anticytokine-treated patients with immune-mediated inflammatory diseases. Ann Rheum Dis. 2021. Available at: https://ard.bmj.com/content/early/2021/05/05/annrheumdis-2021-220461. [Last accessed: December 2021].
  12. Oliver, S MD. Data and clinical considerations for additional doses in immunocompromised people. ACIP Meeting July 22, 2021. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf [Last accessed: December 2021] 
  13. AstraZeneca Data on File (REF-129335).
  14. Harpaz et al. Prevalence of immunosuppression among US adults, 2013. JAMA. 2016 Dec 20;316(23):2547-2548. Available at: https://doi.org/10.1001/jama.2016.16477 [Last accessed: December 2021].
  15. Tenforde MW, et al. Effectiveness of SARS-CoV-2 mRNA vaccines for preventing Covid-19 hospitalizations in the United States. medRxiv. [Preprint] 2021; Available at: doi: https://doi.org/10.1101/2021.07.08.21259776. [Last accessed: December 2021].
  16. Brosh-Nissimov T, et al. BNT162b2 vaccine breakthrough: clinical characteristics of 152 fully vaccinated hospitalized COVID-19 patients in Israel. Clin Microbiol Infect. 2021; Available at: https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(21)00367-0/fulltext.
  17. AstraZeneca news release. COVID-19 long-acting antibody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials. Available at: https://www.astrazeneca.com/media-centre/press-releases/2020/covid-19-long-acting-antibody-laab-combination-azd7442-rapidly-advances-into-phase-iii-clinical-trials.html. [Last accessed: February 2022].
  18. Zost, S.J., et al. Potently neutralizing and protective human antibodies against SARS-CoV-2. Nature; 2020. 584: 443–449. Doi: https://doi.org/10.1038/s41586-020-2548-6  

AU-12838 | February 2022