Peer-reviewed primary analysis of Phase III trials with AstraZeneca’s Covid-19 vaccine published

Baar, 22 February 2021 - Results of the primary analysis of the Phase III programme conducted by Oxford University with AstraZeneca’s Covid-19 vaccine, peer-reviewed and published in The Lancet on Friday, 19 February 2021, confirmed the effectiveness of AstraZeneca's Covid-19 vaccine at preventing COVID-19 (76% / 82%). No severe cases and no hospitalisations more than 22 days after the first dose were reported. 


Results demonstrated vaccine efficacy of 76% (CI: 59% to 86%) after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82% (CI: 63%, 92%).

The primary analysis for efficacy was based on 17,177 participants accruing 332 symptomatic cases from the Phase III UK (COV002), Brazil (COV003) and South Africa (COV005) trials led by Oxford University and AstraZeneca.

Data will continue to be analysed and shared with regulators around the world to support their ongoing rolling reviews for emergency supply or conditional approval during the health crisis. In Switzerland, AstraZeneca’s COVID-19 vaccine is not yet authorized, while it has been granted Emergency Use Listing by the World Health Organization for active immunisation to prevent COVID-19 in individuals 18 years of age and older recently, enabling an accelerated pathway to vaccine availability in low-income countries.

The vaccine can be stored, transported and handled at normal refrigerated conditions (two to eight degrees Celsius) for at least six months and administered within existing healthcare settings.

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

COV002

COV002 is a single-blinded, multi-centre, randomised, controlled Phase II/III trial assessing the safety, efficacy and immunogenicity of AstraZeneca’s COVID-19 vaccine in 12,390 participants in the UK. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants receive one or two intramuscular doses of a half dose (~2.5 x1010 viral particles) or full dose (~5x1010 viral particles) of AstraZeneca’s COVID-19 vaccine or comparator, meningococcal vaccine MenACWY. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR. In addition, weekly swabbing are done for detection of infection and assessment of vaccine efficacy against infection.

COV003

COV003 is a single-blinded, multi-centre, randomised, controlled Phase III trial assessing the safety, efficacy, and immunogenicity of AstraZeneca’s COVID-19 vaccine in 10,300 participants in Brazil. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants are randomised to receive two intramuscular doses of a full dose (~5x1010 viral particles) of AstraZeneca’s COVID-19 vaccine or comparator, meningococcal vaccine MenACWY as first dose and a saline placebo as second dose. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR.

COV005

COV005 is a blinded, multi-centre, randomised, controlled Phase I/II trial assessing the safety, efficacy, and immunogenicity of AstraZeneca’s COVID-19 vaccine in 2,070 participants in South Africa. Trial participants are aged 18-65 years, who are living with or without HIV, are randomised to receive two intramuscular doses of AstraZeneca’s COVID-19 vaccine at 5-7.5 x1010 viral particles or saline placebo. Participants had blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Regular COVID-19 PCR testing is performed up to one year post-vaccination.

AstraZeneca’s COVID-19 vaccine

AstraZeneca’s COVID-19 Vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.

Please find more information about the vaccine at our COVID-19 information hub.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca in Switzerland

AstraZeneca has 120 employees who are responsible for coordinating business operations in Switzerland. Our site in Baar is also the headquarters of the Europe & Canada Commercial Regional Team and the Europe & International Oncology Team, which employ a further 40 staff in Switzerland. Our primary therapeutic areas are Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. To meet our climate goals ahead of schedule, we are working tirelessly to further reduce CO2 emissions and waste. As part of our Ambition Zero Carbon strategy, we are transitioning to a carbon-free business operation by taking steps to reduce and ultimately eliminate greenhouse gas emissions. In 2020, AstraZeneca Switzerland was recognized by its employees for the third time as an outstanding employer, and was awarded the external “Great place to work®” certification.

Find out more: astrazeneca.ch

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AstraZeneca Switzerland Media Department

Tel. +41 (0) 41 725 75 75; angelika.maerz@astrazeneca.com

Dr. Angelika März, Corporate Affairs Lead


CH-3710, 02/2021
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