AstraZeneca has received over $1 billion from the United States government, via BARDA investment, to support development and production of the Oxford University vaccine it has embraced as the candidate to go to market with great intentions of assurance involving the broad and equitable supply of the vaccine throughout the world at no profit during the pandemic. In light of recent controversial news associated with the Oxford vaccine, are there any implications for this deal?
TrialSite News rundown of this latest update.
AstraZeneca has centered its COVID-19 pandemic response on the Oxford University drug known as ChAdOx1. With big objectives, it must collaborate with a number of countries and multilateral organizations to make the Oxford vaccine widely accessible worldwide in an equitable manner—a noble goal.
The UK drug company completed the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses thus far. It plans its first deliveries in September 2020. It must negotiate and finalize further agreements supported by several parallel supply chains—thus expanding capacity further over the next months to support the ability to deliver worldwide.
AZ/Oxford Deal for ChAdOx1
AstreaZeneca has teamed with Oxford and the UK Government to support the Oxford University vaccine. AstraZeneca has now finalized its license agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows 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 Oxford University for pandemic preparedness research.
Phase I/II Clinical Trial
The company, along with Oxford, commenced a Phase I/II clinical trial of ChAdOx1—now referred to as AZD1222—in April. They will assess the safety, immunogenicity, and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centers in southern England. The study data should be available soon. If positive, the sponsor will progress with late-stage trials in a number of countries. Interestingly, in a recent press release, the UK drug company commented, “AstraZeneca recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.
AstraZeneca COVID-19 Clinical Trials Program
The company’s comprehensive pandemic response includes rapid mobilization of AstraZeneca’s global research efforts to discover novel coronavirus-neutralizing antibodies to prevent and treat the progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the company has quickly moved into the testing of new and existing medicines to treat the infection, including CALAVI and ACCORD trials underway for Calquence (acalabrutinib) and the DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.
Does the Vaccine Work in Monkeys?
TrialSite News recently introduced somewhat disturbing data points that a former Harvard professor, Dr. William Haseltine, wrote an article in Forbes questioning why the study would continue when it was revealed—based on data uploaded to the preprint server BioRxiv, that in a preclinical study several monkeys that were exposed to the SARS-CoV-2 virus remained infected after administration of the Oxford vaccine. This observation appears to be fact based on the researcher’s response.
$1 Billion from the US Government
Recently, the US Biomedical Advanced Research and Development Authority (BARDA) inked a deal with AstraZeneca totaling over $1 billion for the development, production, and delivery of the vaccine starting in the fall of 2020. This money helps cover the cost of a Phase III clinical trial with 30,000 participants and a pediatric trial.
Partnerships with NGOs
Moreover, the company continues to engage with non-governmental organizations (NGOs) such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the World Health Organization (WHO) for the fair allocation and distribution of the vaccine worldwide.
Partnerships with Other Governments & National Focused Entities
Additionally, the UK-based company must collaborate with multiple governments worldwide to further access for residents of specific counties. Moreover, the company must formalize arrangements with certain national focused non-profits or companies such as the Serum Institute of India and other potential partners to increase production and distribution.
AstraZeneca has stepped up admirably to take on enormous responsibility and effort, raising over a billion dollars from the US government alone in a quest to ensure wide-spread, equitable, and economical vaccine access during the pandemic. A complex, large-scale drug development, commercialization, and distribution endeavor, AstraZeneca is well-suited for this kind of activity. But the recent observations in the primate data raises some questions. Hopefully, this was but a blip in history and the vaccine moves forward and works. The world needs it.