COVID-19 Frequently asked questions
Last updated 8 December 2020
How is AstraZeneca responding to the COVID-19 global pandemic?
AstraZeneca is responding to the COVID-19 global pandemic in a manner consistent with our values: to follow the science, put patients first and do the right thing.
We continue to support the global effort to fight the pandemic, collaborating with scientists, governments and multilateral organisations, to accelerate efforts to advance the development of potential medicines to prevent or treat the infection, to boost diagnostic testing and to help protect healthcare workers on the frontline.
We joined forces with the University of Oxford to bring together its world-class expertise in vaccinology with our global development and manufacturing capabilities. We have accelerated development and rapidly mobilised a global supply chain to supply the potential vaccine broadly and equitably across the globe, when approvals are granted, and at no profit during the pandemic.
Complementing our vaccines approach, we also quickly mobilised research efforts to advance the development of a coronavirus-neutralising long-acting antibody combination (LAAB) for the potential prevention and treatment of COVID-19.
We continue to ensure the supply and quality of our medicines to patients and to safeguard the health and wellbeing of all our employees. We have also provided our expertise in science and technology to international health authorities, such as the World Health Organization (WHO) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
What is the status of vaccine development?
We have a landmark collaboration with the University of Oxford for the development of their potential vaccine. We have rapidly accelerated our clinical trial programme around the world with accelerated timelines to investigate the potential vaccine in different age groups, diverse racial and geographic groups.
- Interim analysis of the Phase III program conducted by Oxford University with AZD1222 was published in The Lancet on 8 December. The results demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 more than 14 days after the second vaccination and that it protects against severe disease and hospitalisation more than 21 days after the first vaccination. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.
- An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring more than 14 days after receiving two doses of the vaccine. Additional cases are expected to accrue and future analyses will determine the duration of protection.
- No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
- AstraZeneca has begun the submission of the clinical data to regulators around the world that have a framework in place for emergency use or conditional approval.We will also seek an Emergency Use Listing from the World Health Organization for acceleration of the pathway to access in low-income countries.
- Rolling reviews of data have been implemented by many regulatory authorities to flexibly progress the assessment of promising vaccines, such as AZD1222. This approach may reduce the time taken from the filing of final data to approval as much of the data will already have been reviewed. We will continue to work with regulatory agencies to bring this vaccine to people as quickly as possible
If approval for use is received from regulators, AstraZeneca is committed to broad and equitable supply of the vaccine at no profit during the period of the pandemic, and we are working tirelessly towards the goal of achieving this at an unprecedented pace. We continue to identify and forge partnerships to develop a number of supply chains around the world.
What is the status of the long-acting antibody (LAAB) development?
We are progressing a long-acting antibody (LAAB) combination into late-stage trials for the potential prevention and treatment of COVID-19. Discovered by Vanderbilt University and licensed to AstraZeneca in June 2020, the antibodies were optimised by AstraZeneca with half-life extension and Fc Receptor binding reduction. In a recent Nature publication, the LAAB was shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.
How is AstraZeneca ensuring the continuity of its supply of medicines?
Our medicines supply chain is robust and we have business continuity plans in place to ensure that patients continue to receive their medicines. We have not had, and do not anticipate, any disruption to supply.
Have ongoing or new clinical trials been stopped or put on hold?
As a science-led biopharmaceutical company, our ongoing clinical research is crucial to the development of innovative new medicines and we have taken appropriate measures to ensure continuity and mitigate any impact to our research and development programmes. We have focused on ensuring the continued safety of patients in all our ongoing clinical trials, while activating continuity plans in order to minimise trial disruption from the pandemic.
Our mitigation strategies include home-based treatment and monitoring options, moving patient recruitment to less-affected regions, and planning for accelerated recruitment once the pandemic has receded. As always, our highest priority is to protect the safety and wellbeing of employees and the patients involved in our clinical trials.
Is AstraZeneca developing diagnostic tests for COVID-19?
We are providing our world class scientific and technical expertise to help boost COVID-19 testing. We are accelerating the development of our diagnostic testing capabilities to scale-up screening, and we are collaborating with governments on existing screening programmes to supplement testing.
In the UK, we formed a collaboration with the University of Cambridge and GSK to support the government’s national effort to boost COVID-19 testing. The new testing facility was operational in just five weeks – a task which would usually take six months and is testament to the strength of both the UK’s life sciences sector and the life sciences cluster in Cambridge.
What philanthropic initiatives has AstraZeneca supported for the pandemic?
We donated nine million face masks to support healthcare workers around the world as they respond to the COVID-19 global pandemic. We partnered with the World Economic Forum’s COVID-19 Action Platform, created with the support of the World Health Organisation (WHO), to identify countries in greatest need and inform the direction of our donation. The nine million masks included a mixture of both surgical and N95 masks, depending on country requirements.
In direct response to the COVID-19 global pandemic, we have also donated US$1 million to our Young Health Programme and emergency response partners for the work they are doing to support the needs of children, youth and vulnerable populations in low- and middle-income countries around the world. This is aligned to our global philanthropic focus on young people and the prevention of non-communicable diseases.
Veeva ID: Z4-29567
Date of preparation: December 2020