AstraZeneca, EU Sign Purchase Agreement for COVID-19 VaccineBy
The European Commission has signed an agreement with AstraZeneca for the purchase of up to 400 million doses of AstraZeneca’s COVID-19 vaccine. Also, AstraZeneca signed supply pacts with AMRI and Oxford Biomedica and provided an update on the clinical progression of the vaccine into Phase III trials.
The vaccine, AZD1222, was co-invented by the University of Oxford and its spinout company, Vaccitech, and licensed by AstraZeneca. The European Commission signed an agreement with AstraZeneca for the purchase of 300 million doses of the vaccine, with an option for the purchase of a further 100 million doses, to be distributed on a population-based pro-rata basis.
The contract will allow the purchase of the vaccine for all European Union member states as well as a donation to lower- and middle-income countries or the re-direction to other European countries.
The European Commission continues discussing similar agreements with other vaccine manufacturers and has concluded successful exploratory talks with Sanofi-GlaxoSmithKline, Johnson & Johnson, CureVac, and Moderna.
AstraZeneca reported this week (August 31, 2020) that it had expanded development of AZD1222 into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. The US trial is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.
Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, with trials planned to start in Japan and Russia. These trials, together with the US Phase III clinical trial, will enroll up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year (as reported on August 31, 2020), depending on the rate of infection within the clinical trial communities.
AstraZeneca says it continues to engage with governments, multilateral organizations, and partners globally to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity toward three billion doses of the vaccine.
AstraZeneca signs supply pacts with AMRI, Oxford Biomedica
Earlier this week (September 3, 2020) Albany Molecular Research, Inc. (AMRI), a contract research development and manufacturing organization, signed a supply agreement with AstraZeneca to support the manufacture of AstraZeneca’s COVID-19 vaccine candidate, AZD1222. AMRI will provide the sterile fill–finish of AZD1222 at AMRI’s drug-product manufacturing facility in Albuquerque, New Mexico. Preparations have begun at the Albuquerque facility with the potential to produce millions of doses of AZD1222 annually.
In addition, AstraZeneca also signed an 18-month supply agreement this week (September 1, 2020) with Oxford Biomedica, a gene and cell therapy company and CDMO, for the large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement.
Under the agreement, AstraZeneca will pay Oxford Biomedica £15million ($20 million) upfront as a capacity reservation fee. Subject to satisfactory scale-up of manufacturing capacity and continuation of the vaccine program, Oxford Biomedica says it expects to receive additional revenue in excess of £35million ($46 million) plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.
Under the agreement, Oxford Biomedica will reserve capacity for AstraZeneca in up to three manufacturing suites in its new 7,800-m2 commercial manufacturing center for an initial 18- month period. This new GMP facility is suitable for manufacturing viral vectored vaccines and gene-therapy vectors up to the1,000-liter scale. As part of Oxford Biomedica’s previously announced partnership with the UK’s Vaccine Manufacturing Innovation Centre, two new manufacturing suites within the company’s operations will become operational in the next two months (as reported on September 1, 2020).
This agreement builds on the supply agreement between the between the companies announced in late May (May 2020), which related exclusively to manufacture of AZD1222 at the 200-L scale and associated process development.