AstraZeneca Expands Global Phase III Trial of COVID-19 Vaccine AZD1222, Aims to Enroll Over 50,000 Volunteers Including 30,000 in the U.S.
AstraZeneca
Biopharmaceutical Manufacturer
Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, provides a comprehensive, systematic approach to the development and procurement of necessary vaccines, drugs, therapeutics, and diagnostic tools for public health medical emergencies.
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that constitute the National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services. NIAID’s mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases. NIAID operates “intramural” laboratories in Maryland and Montana and funds research conducted by scientists at institutions across the United States and around the world.
On the evening of September 1, AstraZeneca announced its COVID-19 candidateVaccinePhase III of AZD1222Clinical Trialswill expand to the United States, making it the third product to undergo clinical trials in the U.S.COVID-19Candidate vaccine. The project, designated D8110C00001, is funded by the U.S. Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
Currently, AstraZeneca is recruiting nearly 30,000 adults aged 18 and older for a clinical trial, including both healthy individuals and those with stable underlying medical conditions, representing diverse ethnicities and geographic regions. Reportedly, the volunteer cohort also includes people living with HIV and individuals at higher risk of SARS-CoV-2 infection. In this clinical trial, participants will be randomized into either the vaccine group or the control group, with all receiving two injections administered four weeks apart.
AstraZeneca stated that the company plans to recruit more than 50,000 volunteers globally for the trial. In addition to the 30,000 volunteers in the United States, it will also launch volunteer recruitment in Latin America, Asia, Europe, and Africa.
As part of its plan, AstraZeneca has reached supply agreements with Russia, South Korea, Japan, China, Latin America, and Brazil to ensure a global vaccine supply of 3 billion doses. In June, AstraZeneca announced plans to produce 2 billion doses of the COVID-19 vaccine, with 400 million doses allocated to the United States and the United Kingdom, and 1 billion doses allocated to low- and middle-income countries.
AZD1222 was jointly developed by AstraZeneca and the University of Oxford. Trial results previously published in The Lancet showed that among 1,077 volunteers in early-phase clinical trials, the vaccine did not cause any serious side effects, indicating its safety; it elicited antibody and T-cell immune responses, with the strongest responses observed in individuals who received two doses, demonstrating its efficacy.
This article is sourced from EO Intelligence, an original piece by author Lin Yiling. For reprinting or collaboration, please click hereReprint Notice, unauthorized reposting will be subject to legal action.