#UK AstraZeneca scales to billion doses of coronavirus vaccine buoyed by $1bn US windfall

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AstraZeneca is scaling manufacturing capability of a new Oxford University COVID-19 vaccine to one billion doses to supply countries worldwide at no profit during the pandemic.

The Cambridge business wants to ensure a vaccine is available across the planet – not just the UK – and its altruism has today been rewarded with a $1 billion windfall from a US power player.

The investment has come from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in September.

That development programme includes a Phase III clinical trial with 30,000 participants plus a paediatric trial.

AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.

Only a week ago the company was targeting 100 million doses of the vaccine but the landscape has changed dramatically and ambitions have been ramped accordingly.

The first agreements are now to supply at least 400 million doses and the company reveals it has total capacity sourced for one billion doses through 2020 and into 2021 and continues to seek opportunities to further scale capacity.

AstraZeneca says it is advancing its ongoing response to address the unprecedented challenges of COVID-19 and collaborating with a number of countries and multilateral organisations to make the Oxford vaccine widely accessible around the world in an equitable manner.

It has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine.  

The company is also engaging with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO), for the fair allocation and distribution of the vaccine across borders. 

AstraZeneca is also in discussions with governments around the world to increase access and talking to the Serum Institute of India and other potential partners to increase production and distribution.

CEO Pascal Soriot said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. 

“We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. 

“We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.”

AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing 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 centre at Oxford University for pandemic preparedness research.

A Phase I/II clinical trial of the vaccine began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. 

Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. 

AstraZeneca’s comprehensive pandemic response also includes rapid mobilisation of its global research efforts to discover novel coronavirus-neutralising 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. 

The company has also quickly moved into testing of new and existing medicines to treat the infection, including CALAVI and ACCORD trials underway for Calquence (acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.

AstraZeneca said the scale-up to a billion doses was not anticipated to have any significant impact on its financial guidance for 2020; expenses to progress the vaccine are anticipated to be offset by funding from governments.

from Business Weekly https://ift.tt/3e5XouP

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