Approving the phase 3 trial of the COVID-19 Nano Covax vaccine on a large scale

On the afternoon of June 11, Deputy Minister of Health Tran Van Thuan informed that the Ministry of Health had officially approved the phase 3 clinical trial, Vietnam’s first COVID-19 vaccine named Nano Covax.

Illustration. At the meeting of the National Steering Committee for COVID-19 prevention and control on the afternoon of June 11, Deputy Minister of Health Tran Van Thuan informed that the Ministry of Health had officially approved the phase 3 clinical trial of the vaccine. Vietnam’s first COVID-19 room named Nano Covax. According to Deputy Minister Tran Van Thuan, the Ministry of Health has just approved the phase 3 clinical trial of Nano Covax vaccine of Nanogen Company. According to Lieutenant Colonel, Assoc. Dr. Chu Van Men – Director of the Center for Clinical Trials and Bioequivalence, Military Medical Academy, Ministry of National Defense, phase 3 injected the Nano Covax vaccine to 13,000 people and injected only a single dose group. 25 mcg and placebo injection group (with a ratio of “6 people vaccinated to 1 person injecting placebo” according to the design approved by the Ministry of Health). As for the reason for choosing the 25 mcg dose group, Assoc. Prof. Dr. Chu Van Men said that when the phase 2 trial showed that, the 3 dose levels of 25-50-75 mcg had equivalent safety and immunogenicity. undifferentiated. Therefore, in order to ensure the safety and increase the effectiveness of the number of doses of vaccine production, the National Ethical Council in Biomedical Research, the Ministry of Health decided to inject only 1 optimal dose of 25 mcg at the initial stage. this. Minister of Health Nguyen Thanh Long and Minister of National Defense Phan Van Giang asked and encouraged volunteers to test the vaccine against COVID-19 Nano Covax. Photo: PV. On June 11, the Military Medical Academy said that this unit has started to deploy the phase 3 trial injection of the COVID-19 Nano Covax vaccine for the first 19 volunteers. On the day of injection for 200 people, divided into 2 groups. Accordingly, one group injected the Nano Covax vaccine with a dose of 25mcg, the other group injected a placebo with aluminum excipients. Military medical students will inject 1,000 volunteers in the first time. According to the research outline, phase 3 will test on about 13,000 volunteers in many provinces such as Hanoi, Hung Yen, Long An, Tien Giang… At the Military Medical Academy, there are currently more than 7,000 volunteers registered to participate in the trial, of which more than 600 people have been screened and are eligible to participate. Besides, IVAC’s Covivac vaccine is also preparing to complete phase 1 trial and enter phase 2 in July 2021. Regarding the subjects of vaccination, according to Deputy Minister Tran Van Thuan, in addition to the priority subjects for COVID-19 vaccination under Resolution 21, the Ministry of Health has added workers in industrial zones and will propose more subjects working in establishments dealing in essential goods.