In a major development, UK based AstraZeneca has begun its Phase 3 clinical trial evaluating an investigational vaccine for the covid-19 disease. The trial will be conducted among 30,000 volunteers at 80 sites in the United States to see the effects of the vaccine candidate.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are providing funding to back the trial.
“Safe and effective vaccines will be essential to meet the global need for widespread protection against COVID-19,” said NIAID Director Anthony S. Fauci, M.D. “Positive results from preclinical research led by NIH scientists supported the rapid development of this vaccine candidate, which has also showed promise in early-stage clinical trials.”
The vaccine developed by AstraZeneca in collaboration with University of Oxford is leading the race towards a successful vaccine. In addition to the US trials, a final stage trial of immunisation will also be conducted in the UK and is expected to produce preliminary results next month.
The trial had been delayed for several days due to political pressure, perhaps becaue US regulators planned to grant an emergency use autorization on the basis of trial in the Europe, Palm Beach Post reported last week.
Volunteers 18 years and older are eligible to participate in the trial. However, they must inform their consent to participate. Participants will be closely monitored, particularly after injections, for safety.
Investigators will evaluate participants after daily vaccination and will ask them to monitor symptoms after returning home as well.
