The clinical trial phase 2 of Nano Covax vaccine (vaccine researched and developed by Nanogen Company) was conducted on 560 people divided into 4 groups, injected with 3 doses of 25mcg, 50mcg and 75mcg Nano Covax vaccine in the same group. placebo injection. However, to nose 2, there were 554 testers because 6 people were withdrawn from the list for objective reasons.
Results showed that all 3 doses ensure safety. 100% of people injected with 3 above doses are immunized at different levels.
Regarding the antibody index to neutralize the virus (the ability to destroy the invading virus after vaccination), the 25mcg dose level reached the highest with over 90% at 14 days after the second injection (ie 42 days after the first injection). The remaining 2 doses were approximately 25 mcg, but the difference was not statistically significant.
Completed the test of vaccine COVID-19 ‘made in Vietnam’ phase 2.
It is expected that on April 27, the research team will report to the Biomedical Ethics Council of the Ministry of Health, and at the same time propose a plan to implement phase 3 research (according to the report, the clinical trial is expected to begin. phase 3 from 5/5 to).
In phase 3, the research team will report to the Ministry of Health, suggest testing on a large group of volunteers from 10,000 to 15,000 people both in Vietnam and abroad. In this stage, only one effective dose level is used, 25 mcg, each person injects 2 doses 28 days apart. All these proposals will be submitted to the panel for review.
Vaccine for prevention COVID-19 Nano Covax started testing in humans from December 17, 2020, now has completed phase 2, preparing to move to phase 3, which is the final stage of testing before the vaccine is released. school.
For Nano Covax vaccine, after the end of the phase 1 clinical trial, 100% of the injected people were safe, produced antibodies with high concentrations, had good protective effects and tested effectively on variables. new variant of SARS-CoV-2 virus like the one found in the UK
Previously, at the Standing meeting of the National Steering Committee for the prevention and control of outbreaks of COVID-19, a representative of the Ministry of Health said that Nano Covax vaccine will be studied for phase 3 from May to September 2021 and accepted. the result is around September 2021.
Based on the results of phase 1 and phase 2 testing up to now, all experts are optimistic that if it is favorable, even at the end of the third quarter of 2021, phase 3 will be completed. for vaccine COVID-19 Nano Covax, to shorten to 3 months compared to the previous expected plan.
Of the 554 volunteers, the Military Medical Academy conducted a 2-phase test of the second phase of the COVID-19 Nano Covax vaccine for 278 people, the Pasteur Institute of Ho Chi Minh City injected 276 people in Ben Luc district, Long An province. ; complete 100% of the 2nd test injections of this period.
In clinical trial phase 2 of this vaccine has expanded to the elderly and the underlying medical condition. Currently, 108 elderly people have been injected with clinical trial phase 2, of which the highest is 76 years old. After injecting 2 phase 2 of the COVID-19 Nano Covax vaccine, the volunteers had symptoms such as low-grade fever, injection site pain, muscle pain, joint pain, fatigue … but quickly disappeared, no intervention needed. medical.