Clinical Trials & Research News

AstraZeneca Inks Deals to Supply 400M Doses of a COVID-19 Vaccine

The deals also secured total manufacturing capacity for 1 billion doses of the University of Oxford’s COVID-19 vaccine.

COVID-19 Vaccine

Source: Thinkstock

By Samantha McGrail

- AstraZeneca recently announced that it is enhancing its response to the current pandemic and collaborating with multiple countries and organizations to make the University of Oxford’s COVID-19 vaccine widely accessible. 

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The pharmaceutical multinational company finalized its license agreement with Oxford University for the recombinant adenovirus vaccine, known as AZD1222. 

The vaccine follows the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group, AstraZeneca stated. The company agreed to support the establishment of a joint research center at Oxford University for pandemic preparedness research.

AstraZeneca will provide at least 400 million doses of the vaccine and has already secured total manufacturing capacity for one billion doses. 

The first deliveries will begin in September 2020. 

“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,” Pascal Soriot, chief executive officer at AstraZeneca said in the announcement.

“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 and governments around the world will expand capacity further over the next months to ensure the delivery and increased access of a global vaccine.  

The US Biomedical Advanced Research and Development Authority (BARDA) gave $1 billion for the development, production, and delivery of the vaccine. The development program includes a Phase III clinical trial with 30,000 participants and a pediatric trial, AstraZeneca said. 

BARDA has been on the frontlines of the COVID-19 pandemic since the beginning and has continuously supported vaccine research and development efforts. Last month, the organization gave $483 million to Moderna to bolster vaccine development using the company’s mRNA vaccine candidate.

The BARDA funding will support the late-stage clinical development programs and boost mRNA-1273 manufacturing in 2020.

Moderna will hire nearly 150 new team members in the US this year to accelerate the scale-up. This includes a boost in its skilled manufacturing staff to expand capacity from two shifts per day, five days per week to three shifts per day, seven days per week.

A Phase 3 clinical trial could begin in fall 2020, but this decision is subject to data from the previous two studies.

Currently, AstraZeneca is in conversation with international organizations including 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 AZD1222 around the world. 

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 yearacross southern England. 

Research data from the trial is expected shortly and would lead to late-stage trials in a number of countries if positive, AstraZeneca said. 

AstraZeneca’s detailed pandemic response also includes rapid mobilization of global research efforts to discover novel coronavirus-neutralizing antibodies to prevent and treat progression of the COVID-19 disease.

The company stated that the aim is to reach clinical trials in the next three to five months. 

Additionally, AstraZeneca recently moved into testing for new and existing medicines to treat the COVID-19, including CALAVI and ACCORD trials underway for CAlquence (acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in infected patients, the company said.