AstraZeneca announced Thursday that it received support of up to $1.2 billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of at least 300 million doses of the University of Oxford's COVID-19 vaccine starting as early as October. As part of the agreement, the development programme for the recombinant adenovirus vaccine, formerly known as ChAdOx1 nCoV-19 and now dubbed AZD1222, will include a Phase III study in the US with 30,000 participants and a paediatric trial.
Commenting on the deal, US Department of Health and Human Services Secretary Alex Azar said "this contract with AstraZeneca is a major milestone in Operation Warp Speed's work toward a safe, effective, widely available vaccine by 2021." Last week, the US government formally unveiled the framework and leadership for Operation Warp Speed, which aims to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. Specifically, the project hopes to have "substantial quantities" of a safe and effective vaccine available in the US by January 2021.
The BARDA deal follows a recent agreement with the UK government to support development of AZD1222, under which AstraZeneca will supply 30 million doses of the vaccine to the UK by September. Chief executive Pascal Soriot remarked "we would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available."
Deals for 400 million doses
AstraZeneca said it has concluded the first agreements for at least 400 million doses of AZD1222 and has so far secured total manufacturing capacity for 1 billion doses, with deliveries beginning in September. The drugmaker indicated that it hopes to conclude additional agreements supported by several parallel supply chains, which will further boost capacity "over the next months to ensure the delivery of a globally accessible vaccine."
Meanwhile, the company is also engaging with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organization, for the "fair allocation and distribution" of the vaccine around the world. In addition, AstraZeneca is in discussions with governments to increase access, and is also holding talks with the Serum Institute of India as well as other possible partners to ramp up production and distribution.
Last month, a Phase I/II trial of AZD1222 enrolled its first patients, with the aim of recruiting over 1000 healthy volunteers aged 18 to 55 years across several study centres in southern England. At the time, Soriot suggested "by June, July we will already have a very good idea of the direction of travel in terms of its potential efficacy." AstraZeneca said Thursday that while "the vaccine may not work…[it] is committed to progressing the clinical programme with speed and scaling up manufacturing at risk."
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