Trial enrolling up to 30,000 adults to assess safety, efficacy and
immunogenicity of the vaccine for the prevention of COVID-19
Development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19.1
The trial is funded by US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are proud to be collaborating with NIAID to accelerate the development of the potential vaccine. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and it is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
Trial centres across the US are recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centres outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.
Participants are being randomised to receive two doses of either the potential vaccine or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the potential vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of the potential vaccine is progressing globally with late-stage Phase II/III trials ongoing in the UK and Brazil, a Phase I/II trial in South Africa and planned trials in Japan and Russia. These, together with the US Phase III clinical trial will enrol up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
AstraZeneca has a core value to ‘follow the science’ and adheres to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance. The Company’s submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world.
The Company also has a core value to ‘put patients first’ and will continue to work with governments, multilateral organisations and partners around the world towards broad and equitable global access to the vaccine, should clinical trials prove successful. Recent announcements with Japan, China, Latin America and Brazil takes the global supply capacity towards three billion doses of the vaccine.
Pascal Soriot, Chief Executive Officer said “In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work. We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVID-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around the world.”
1. Clinicaltrials.gov. A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19. [Online] Available at: https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746&draw=2&rank=1. Last accessed: August 2020.
Veeva ID: Z4-26431
Date of preparation: September 2020