AstraZeneca Enters into $750-M Pact for COVID-19 Vaccine MfgBy
AstraZeneca has formed pacts with three organizations to supply 1.3 billion doses of an investigational COVID-19 vaccine candidate, which includes a $750-million deal for the supply of 300 million doses.
In the first pact, AstraZeneca has formed a $750-million agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, and Gavi, a public–private global health partnership, to support the manufacturing, procurement, and distribution of 300 million doses of the University of Oxford’s recombinant adenovirus COVID-19 vaccine, AZD1222, with delivery starting by the end of this year (2020). In late April (April 2020), the University of Oxford announced a partnership with AstraZeneca for the development and potential large-scale distribution of the COVID-19 vaccine candidate.
The agreement with CEPI and Gavi also represents the first advanced market commitment through the Access to COVID-19 Tools (ACT) Accelerator, a global mechanism co-chaired by the Bill & Melinda Gates Foundation and the World Health Organization (WHO). This mechanism will work to ensure the fair allocation and distribution of the vaccine globally, including in low- and middle-income nations. CEPI will lead development and manufacturing, and Gavi will lead the procurement within the global mechanism.
Under the deal, CEPI will invest a total of up to $383 million in the partnership to support the technical transfer of vaccine-production technology to manufacturing sites predominantly in Europe to create additional manufacturing capacity for the vaccine. It will also purchase manufacturing materials and reserve manufacturing slots to secure a total 300 million doses of the vaccine.
AstraZeneca and CEPI’s ACT Accelerator partner, Gavi, have entered into a memorandum of understanding that envisages procuring the vaccine produced under the CEPI agreement for distribution by the COVID-19 Vaccine Global Access Facility, an instrument of the vaccines pillar of the ACT Accelerator within which CEPI works in partnership with Gavi and WHO. AstraZeneca will supply the vaccine to the COVID-19 Vaccine Global Access Facility on a no-profit basis during the pandemic. In a separate development, Gavi has launched the Gavi Advance Market Commitment for COVID-19 Vaccines (Gavi Covax AMC), a new financing instrument aimed at incentivizing vaccine manufacturers to produce sufficient quantities of eventual COVID-19 vaccines and to ensure access for developing countries. The Gavi Covax AMC is being launched with an initial goal of raising $2 billion; enough for Gavi-supported countries to immunize healthcare workers as well as high-risk individuals and create a flexible buffer of doses to be deployed where needed most.
AZD1222 has progressed into late-stage Phase II/III clinical trials in more than 10,000 people from across the UK. If the vaccine is proven to be safe and effective, the first doses to be produced under the CEPI/Gavi agreement are anticipated to be available in early 2021. Vaccines will be released on a rolling basis as production is completed, and the full quota of 300 million doses is expected to be available by July 2021.
This agreement builds upon CEPI’s initial seed funding for this vaccine candidate, which supported the University of Oxford to manufacture clinical trial materials, in addition to funding preclinical studies of AZD1222 at Australia’s Commonwealth Scientific and Industrial Research Organization.
In a separate pact, AstraZeneca has formed a licensing agreement with the Serum Institute of India, a vaccines company based in Pune, India and part of the Cyrus Poonawalla Group, to supply one billion doses for low- and middle-income countries, with a commitment to provide 400 million before the end of 2020.
AstraZeneca says it is building a number of supply chains in parallel globally to support global access at no-profit during the pandemic and has so far secured manufacturing capacity for two billion doses of the vaccine.
AstraZeneca recently agreed to supply 400 million doses to the US and UK after reaching a license agreement with Oxford University for its recombinant adenovirus vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222. Last month (May 2020), AstraZeneca announced it had been awarded more than $1 billion from the Biomedical Advanced Research and Development Authority, part of the office of Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for the development, production and delivery of the University of Oxford’s COVID-19 vaccine, starting in the fall (fall 2020).