USA: Coronavirus Cure Astra Zeneca Begins Phase III Clinical Trial for Covid-19 Vaccine in USA
Led by Astra Zeneca, the phase III clinical trial for the Covid-19 vaccine AZD1222 has begun in the USA across all adult age groups. The trial is recruiting up to 30,000 adults in the age group of 18 and above to evaluate the safety, efficacy and immunogenicity of the vaccine.
USA – AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.
The US trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (Barda), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (Niaid), part of the U.S. National Institutes of Health, and led by Astra Zeneca. The Niaid-supported Covid-19 Prevention Network (Co VPN) will participate in the trial.
Mene Pangalos, Executive Vice President, Bio Pharmaceuticals R&D, said: “We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with Barda and Niaid to accelerate the development of this vaccine. Should clinical trials demonstrate the vaccine protects against Covid-19 disease and 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 AZD1222 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 vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia. These trials, 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.
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed AZD1222 was tolerated and generated robust immune responses against the Sars-Cov-2 virus in all evaluated participants.
Astra Zeneca continues to engage with governments, multilateral organisations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.
The company recently issued a commitment to the highest safety standards and to broad and equitable access, reiterating its core values to ‘follow the science’ and ‘put patients first’.