AstraZeneca to supply Canada with 100,000 doses of Evusheld, a long-acting antibody combination for the prevention of COVID-19
February 23, 2022, 11:30 am
MISSISSAUGA, ON, Feb. 23, 2022 /CNW/ - AstraZeneca Canada has signed an agreement with the Government of Canada for the supply of 100,000 doses of Evusheld (tixagevimab co-packaged with cilgavimab), its long-acting antibody (LAAB) combination for the prevention (pre-exposure prophylaxis) of COVID-19 in those patient populations who require additional protection.
Doses will be delivered in 2022, should Evusheld (the proposed trade name for AZD7442), receive regulatory approval from Health Canada.
[Evusheld is being cloned by $37.6 million grant from DARPA will leverage AstraZeneca's monoclonal antibody and INOVIO's DNA-encoded monoclonal antibody (dMAb®).
COVID-19 dMAbs offer a cost-effective treatment option, are fast to administer to subjects, and can be quickly manufactured and scaled up compared to traditional recombinant monoclonal antibody-based therapies
- dMAbs do not require cold chain transport/storage, and the overall approach can be applied beyond COVID-19 for any pathogen or disease that can be treated by recombinant monoclonal antibody-based therapies.]
In November 2021, AstraZeneca Canada announced it had initiated a rolling review New Drug Submission with Health Canada for the authorization of Evusheld. If granted, Evusheld would be the first LAAB combination to receive Health Canada authorization for COVID-19 prevention.
"Thousands of Canadians remain at serious risk for COVID-19 because they are unable to mount an adequate response to a vaccine due to an underlying health condition or medication they take that compromises their immune system," said Kiersten Combs, President of AstraZeneca Canada. "We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have an easily-administered, long-lasting option, which we hope will soon be available to offer protection to immune-compromised populations against COVID-19 in Canada."
Approximately 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.1,2 Additionally, more than 40% of those hospitalized with breakthrough COVID-19 infections after vaccination are immune-compromised.3,4 This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions, including multiple sclerosis and rheumatoid arthritis.5-9 Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution that is an important factor in the emergence of variants.
In August 2021, AstraZeneca announced high-level results of the primary analysis from the PROVENT pre-exposure prophylaxis trial, which showed Evusheld reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. Importantly, the trial population included people with co-morbidities and who may need additional protection from SARS-CoV-2 infection. Greater than 75% of participants in PROVENT presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination. Further data of the ongoing PROVENT trial announced in November 2021 demonstrated the long-term benefits with an 83% reduction in the risk of developing symptomatic COVID-19 compared to placebo at a median of 6 months follow-up.
Multiple independent pseudovirus and authentic 'live' virus studies show that Evusheld retains neutralizing activity against the Omicron variant and all other tested variants of concern to date.
About Evusheld
Evusheld is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein11 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies;12-15 data from the Phase III PROVENT trial show protection lasting at least six months, with the Phase I trial showing high monoclonal antibody titres for at least nine months.
AstraZeneca to supply the US government with an additional one million doses of EVUSHELDTM long-acting antibody combination for the prevention of COVID-19
PUBLISHED
14 February 2022
Builds on initial US government agreement, now totalling 1.7 million doses
Only antibody therapy authorized in the US for pre-exposure prophylaxis of COVID-19 in people who are immunocompromised
AstraZeneca today announced the US Department of Health and Human Services has finalized its agreement to purchase an additional one million doses of EVUSHELDTM (150mg of tixagevimab co-packaged with 150mg of cilgavimab), a long-acting antibody combination for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised populations.
This agreement includes the 500,000 additional dose purchase announced by the US government on January 12, 2022 and follows the government’s initial agreement for the purchase of 700,000 doses of EVUSHELD which are already being administered at sites around the US, for a total of 1.7 million doses. The US government has indicated that it plans to distribute these additional doses to states and territories at no cost.
Multiple independent live and pseudovirus studies showed that EVUSHELD retains neutralizing activity against the Omicron variant and all tested SARS-CoV-2 variants of concern to date.1-4 By combining two particularly potent antibodies with different and complementary activities against the virus, EVUSHELD was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants.
EVUSHELD received Emergency Use Authorization (EUA) in the US on December 8, 2021 for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine.
