Official results for the second phase are expected to be reported to the Ministry of Health on April 27.
Vietnam has completed the second phase of human trial of Nanocovax's Covid-19 vaccine, which has proven immunogenic on all volunteers, according to researchers at Vietnam Military Medical University.
Initial results showed all 556 volunteers, who got injected with the 25, 50 and 75 microgram vaccine doses in groups, produced immunogenicity.
All the volunteers are now in stable condition. They will have blood tests for antibody on the 28th, 34th, 42nd day, and after 3 months and 6 months from the first shot.
Official results for the second phase are expected to be reported to the Ministry of Health on April 27. Upon completion of human trials, Nanocovax is expected to seek emergency approval for community distribution.
A volunteer participated in the second phase trial of Nanocovax vaccine at the Military Medical Academy in Hanoi. Photo: VGP |
Researchers said they would use the result produced by the lowest 25 microgram dosage group as the proposed optimal dose for use in Nanocovax’s third phase of human trials, expected to start from May 5 to late June, involving over 1,000 volunteers.
In the third phase, 10,000-15,000 people, including volunteers in countries such as India, Hungary and Bangladesh, will join the trial.
In this phase, the Ethics Council in Biomedical Research will decide on whether to immediately administer this vaccine to Vietnamese people in high-risk groups such as anti-pandemic forces and employees at airports and flight attendants. The decision will be made on the results of the second phase clinical trials.
Nanocovax vaccine of Nanogen is Vietnam’s first Covid-19 vaccine in clinical trial. Trial of phase 1 took place from December 17, 2020 to February 7, 2021.
Vietnam expects to complete clinical trial of Nanocovax vaccine by the end of this year so that it can start large-scale production and widespread use by early 2022.
Vietnam is currently developing four domestic Covid-19 vaccines: Nanocovax by Nanogen, Covivac by the Institute of Vaccines and Medical Biologicals (IVAC), and two others by the Vaccine and Biological Production Company No. 1 (Vabiotech) and the Center for Research and Production of Vaccines and Biologicals.
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