US Gov’t Awards AstraZeneca $1 Bn for COVID-19 Vaccine CandidateBy
AstraZeneca has been awarded more than $1 billion from the Biomedical Advanced Research and Development Authority (BARDA), 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). The development program includes a Phase III clinical trial with 30,000 participants and a pediatric trial.
AstraZeneca has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries this September (September 2020). AstraZeneca says it aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months (as reported on May 21, 2020) to ensure the delivery of a globally accessible vaccine.
In addition, the company is engaging with international organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on accelerating vaccines for pandemics, GAVI, a public–private global health partnership, and the World Health Organization for the fair allocation and distribution of the vaccine. AstraZeneca says it is also in discussions with governments around the world to increase access and is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.
AstraZeneca recently joined forces with the UK Government to support the University of Oxford’s COVID-19 vaccine and has progressed in its efforts to expand access. The company says it will supply the UK starting in September (September 2020).
AstraZeneca also finalized its license agreement with the University of Oxford for the recombinant adenovirus vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, following the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research center at the University of Oxford for pandemic preparedness research.
A Phase I/II clinical trial of AZD1222 began last month (April 2020) to assess immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centers in southern England. Data from the trial are expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca says it recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.
AZD1222 was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.
AstraZeneca says its pandemic response also includes mobilization of AstraZeneca’s research efforts to discover novel coronavirus-neutralizing antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, AstraZeneca has moved into testing of new and existing medicines to treat the infection, including trials for Calquence (acalabrutinib) a drug to treat mantle cell lymphoma and chronic lymphocytic leukemia, and a trial for Farxiga (dapagliflozin), a drug to treat Type II diabetes, in COVID-19 patients.