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Vietnam will screen 3 volunteers before giving injections to the remaining 57 people. All the time it will last almost 2 months.
This afternoon, the National Council of Ethics in Biobiomedical Research met to evaluate and approve the research file of the Phase 1-2 clinical trial for the Covid-19 vaccine produced by the Nanogen company.
Starting tomorrow (December 10), the Academy of Military Medicine will begin recruiting volunteers for the phase 1 clinical trial.
The National Council of Ethics in Biomedical Research adopted 60 healthy volunteers between the ages of 18 and 50 who participated in early-stage clinical trials.
60 people will be divided into 3 groups, injecting 3 doses of vaccine of 25 mcg, 50 mcg and 75 mcg, respectively.
The Nanogen Covid-19 vaccine, dubbed Nanocovax, will begin human testing on December 17.
All subjects participating in the phase 1 study will receive 2 intramuscular injections of vaccine, the interval between 2 injections is 28 days.
To ensure safety, after the selection of volunteers, starting on December 17, the team will vaccinate the first three volunteers with a dose of 25 mcg.
After a 72-hour follow-up, if there are no abnormal results, the study will continue injecting with the remaining 57 volunteers.
The study period per participant was 56 days, however, all volunteers were followed up to the sixth month from the first nose.
Mr. Nguyen Ngo Quang, Deputy Director of the Department of Science and Technology of the Ministry of Health, added that the volunteers who participate in the phase 1 clinical trials should be those who have never had Covid-19 and who do not suffer from chronic diseases. calculated, not allergic. Target groups such as prisoners, pregnant women, disabled people, economically dependent people will not be able to participate.
The Health Ministry said it will send a mission to monitor the entire clinical trial process to ensure the absolute safety of the volunteers involved.
The Nanogen company said that, while implementing phase 1, the team will always implement the pillows of phase 2-3, it is expected that by the end of April 2021 the clinical trial can be completed and from May there. can be produced for immunization.
Thuy Hanh
Covid-19 vaccine in Ho Chi Minh City before the test
40 volunteers received a Covid-19 vaccine test on December 10. Nanogen is considering sales prices of no more than VND 500,000 per dose.