COVID-19 Frequently asked questions

Last updated December 2021

 

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 Oxford1 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.2

Complementing our vaccines approach, we also quickly mobilised research efforts to advance the development of a coronavirus-neutralising long-acting antibody (LAAB) combination 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?

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the recent Emergency Use Listing granted by the World Health Organization this accelerates the pathway to access in up to 142 countries through the COVAX Facility.

AstraZeneca is committed to broad and equitable supply of the vaccine at no profit during the period of the pandemic. We continue to identify and forge partnerships to develop a number of supply chains around the world.

We are deeply committed to the safety of our participants and to maintaining the highest standards of conduct across all our clinical trials.

What is the status of the long-acting antibody (LAAB) development?

AstraZeneca was granted an emergency use authorisation (EUA) for the LAAB by the US Food and Drug Administration (FDA) in December 2021. Rolling reviews are ongoing in other regions.

Clinical development of the long-acting antibody (LAAB) combination is ongoing, assessing efficacy and safety as a potential prevention and treatment in up to 9,000 participants globally across a range of ages and diverse racial, ethnic and geographic groups.3-8

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.9-14

Earlier in 2021, AstraZeneca announced high-level results from Phase III trials in pre- and post-exposure prophylaxis and outpatient treatment.

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. 

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.

Is the AstraZeneca Vaccine available for private purchase?

Our current focus is delivering on our substantial global commitments to governments and international health organizations, as quickly as possible to help end the pandemic; as such there is currently no private sector supply, sale or distribution of the vaccine.

If someone offers private vaccines, it is likely counterfeit, so should be refused and reported to local health authorities.


References

1. AstraZeneca PLC. AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine. Available at: https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html  [Last Accessed: December 2021]

2. AstraZeneca PLC. AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit. Available at: https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-to-supply-europe-with-up-to-400-million-doses-of-oxford-universitys-vaccine-at-no-profit.html. [Last accessed: December 2021]

3. Clinicaltrials.gov. Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT). [Online]. Available at: https://clinicaltrials.gov/ct2/show//NCT04625725. [Last accessed: December 2021].

4. Clinicaltrials.gov. Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults (STORM CHASER). [Online]. Available at: https://clinicaltrials.gov/ct2/show//NCT04625972. [Last accessed: December 2021].

5. Clinicaltrials.gov. Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults (TACKLE). [Online]. Available at: https://clinicaltrials.gov/ct2/show//NCT04723394. [Last accessed: December 2021].

6. Clinicaltrials.gov. ACTIV-2: A Study for Outpatients With COVID-19. [Online]. Available at: https://clinicaltrials.gov/ct2/show//NCT04518410. [Last accessed: December 2021].

7. Clinicaltrials.gov. ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO). [Online]. Available at: https://clinicaltrials.gov/ct2/show//NCT04501978. [Last accessed: December 2021].

8. Clinicaltrials.gov. Trial of Treatments for COVID-19 in Hospitalized Adults (DisCoVeRy). [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT04315948. [Last accessed: December 2021]

9. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013; 57 (12): 6147-53.

10. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Antimicrob Agents Chemother. 2017;61(3): e01714-16.

11. Yu XQ, et al. Safety, tolerability, and pharmacokinetics of MEDI4893, an investigational, extended-half-life, anti-staphylococcus aureus alpha-toxin human monoclonal antibody, in healthy adults. Antimicrob Agents Chemother. 2016; 61 (1): e01020-16.

12. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants. Pediatr Infect Dis J. 2018;37(9): 886-892.

13. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548

14. Loo Y-M, et al. AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans. medRxiv. Cold Spring Harbor Laboratory Press; 2021 [preprint] Available from: https://www.medrxiv.org/content/10.1101/2021.08.30.21262666v1. [Last accessed: December 2021].


Veeva ID: Z4-40262 
Date of Preparation: December 2021