AstraZeneca Begins Phase 3 Trial of COVID-19 Vaccine and Expands Supply Agreement with Oxford Biomedica

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia. These trials, together with the US Phase 3 clinical trial will enroll up to 50,000 participants globally. The US trial, called D8110C00001, will be conducted at centers across the country and recruit up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centers outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.

Participants are being randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.

“We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. “Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”

Separately, AstraZeneca and Oxford Biomedica plc (Oxford, UK) have signed an 18 month supply agreement under a three year Master Supply and Development Agreement for the large-scale commercial manufacture of AZD1222. This agreement builds on the supply agreement between the companies announced in May that related exclusively to manufacture of AZD1222 at 200L scale and associated process development. The companies could extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement.

Under the terms of the agreement, AstraZeneca will pay Oxford Biomedica GBP 15 million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine program, Oxford Biomedica expects to receive additional revenue in excess of GBP 35 million plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021. As part of the agreement, Oxford Biomedica will reserve capacity for AstraZeneca in up to three manufacturing suites in the Group’s new commercial manufacturing centre, Oxbox, for an initial 18 month period. The new GMP facility is suitable for manufacturing viral vectored vaccines and gene therapy vectors up to 1,000 liter scale.

“We have been working hard with AstraZeneca and other partners to establish GMP manufacturing of AZD1222 at scale, and we are therefore very pleased to extend our current partnership to include large-scale manufacturing of the vaccine candidate, AZD1222,” said John Dawson, Chief Executive Officer of Oxford Biomedica. “Our previously announced partnership with the UK’s Vaccine Manufacturing Innovation Centre (VMIC) has supported our ability to make additional facilities available for this supply agreement. We look forward to continuing to work with AstraZeneca to rapidly contribute to the global effort to support the large-scale manufacturing of AZD1222 to ensure that the vaccine candidate is available if and when it is approved by Regulatory Authorities.”

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