2022-08-16| COVID-19

Despite Global Acceptance, The UK Refuses to Buy AstraZeneca’s Evusheld, Citing ‘Insufficient Data’

by Reed Slater
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After several nations like the US, Germany, France, and Canada authorized AstraZeneca’s Evusheld, an alternative COVID-19 therapy for immunocompromised individuals, the UK said it would not purchase the product due to insufficient data. The announcement comes as a blow to communities in the UK that may not be eligible for other COVID-19 prevention measures.

The Immunocompromised Community Will Not Stay Silent in the UK

The US FDA authorized Evusheld for emergency use in December last year for anyone 12 and older who is immunocompromised or cannot take other COVID-19 vaccinations due to allergic reactions or other risks. Some argue that the data is sufficient for several countries and now AstraZeneca is collecting real-world data based on these authorizations and approvals to support the use of the drug. 

Helen Rowntree, Blood Cancer UK’s director of research, services, and engagement, said, “We’re urging the government to meet with us and outline their rationale for this decision…Time and time again during the pandemic our community have felt forgotten, and this decision is yet another example of this.”

The Research to access pathway for investigational drugs for COVID-19 (Rapid C-19), a committee comprised of nine health and government bodies in the UK to advance COVID-19 drug development and authorization, advised that the UK government should not purchase the drug. The government heeded the advice but said it would meet with AstraZeneca again to discuss real-world data, which could affect consideration. AstraZeneca will submit Evusheld for a full National Institute for Health and Care Excellence (NICE) appraisal, but that process can take up to 20 months.

The decision was especially surprising because Evusheld appeared to be on track to UK use after the Medicines and Healthcare Products Regulatory Agency approved the drug for use in March to prevent COVID-19. 

Related Article: MHRA Grants Moderna’s Omicron Bivalent Vaccine Conditional Approval in UK

Evusheld’s Expanding Accumulation of Evidence

Despite the UK’s reluctance to leverage Evusheld, 32 other countries worldwide authorized the use of the drug based on AstraZeneca’s clinical data and growing pool of real-world data. 

In June, AstraZeneca released early results from its TACKLE Phase 3 trial, touting Evusheld’s effectiveness in preventing COVID-19 disease progression in vulnerable populations. The international study consisted of over 1,000 participants in the US, Europe, Latin America, and Japan. The findings demonstrated that Evusheld showed statistically significant protection from disease progression while maintaining a tolerable safety profile. 

The FDA authorized the use of Evusheld based on data that showed the drug could provide protection for up to six months after back-to-back injections. Evusheld is the only drug currently available that protects from COVID-19 and is an alternative to approved vaccines. 

AstraZeneca has not yet commented on the UK’s decision, but the company continues to market the product and gather data to support Evusheld’s efficacy and safety. As more and more data accumulates, hopefully, it will provide the push for the UK to reconsider and provide its immunocompromised communities with alternative options to fend off COVID-19. 

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