It is expected that next week, Vietnam will start the phase 3 trial of the Nanocovax vaccine with about 13,000 volunteers.
The Ethics Committee of the Ministry of Health has just met to consider and approve the decision to allow the implementation of phase 3 clinical research of the Covid-19 vaccine Nanocovax.
A source from the Ministry of Health said that the council basically agreed to study the multi-center phase 3, but the research unit needs to complete the dossier this week and submit it to the Ministry of Health for approval before signing. deployment.
In phase 3, Nanocovax vaccine will be tested in multi-centers at domestic facilities with about 13,000 volunteers. In the North, there are Military Medical Academy and Hung Yen, in the South, there is the Pasteur Institute in Ho Chi Minh City. Ho Chi Minh City and Long An participated.
Phase 3 will be divided into several small phases, will first inject 800 registered volunteers, then continue to recruit more.
Ms. N. is one of the first 3 volunteers to participate in the Nanocovax vaccine trial. Photo: Thuy Hanh
The optimal dose chosen for stage 3 is 25mcg. Through the study, all 3 dose groups of 25mcg, 50mcg and 75mcg produced equivalent immunity. Due to the equal effectiveness, the Ethics Committee chose the lowest dose to produce and save raw materials.
Phase 2 trial of Nancocovax vaccine has been completed since April 8, however, the follow-up will last for 1 year. It is currently in the mid-term evaluation phase but the research results are very positive, the vaccine is very immunogenic and is effective with both British and South African variants. The effect with the Indian variant will continue to be studied in phase 3.
If favorable, by the end of September, the phase 3 trial will be completed, then Vietnam can produce the first Covid-19 vaccine.
According to studies in the world, the immune response level of volunteers is well assessed when producing antibodies 4 times higher than normal, in some cases 20 times more.
However, in fact with Nanocovax, 35 days after the first injection, the amount of antibodies on some volunteers increased to more than 60 times, after 3 months it was still 34 times. This is a very impressive number.
Nanocovax vaccine produced by Nanogen company is based on recombinant protein technology. Phase 1 clinical trial started from December 17, 2020, to April 8 ended phase 2 on 554 volunteers, including 108 elderly people.
In phase 2, volunteers were divided into 4 groups, injected with 3 doses of 25mcg, 50mcg, 75mcg and the other group received a placebo.
Phase 2 results show that, all 3 doses are safe, 100% of the injectors generate immunity at different levels.
In particular, the virus neutralizing antibody index (ability to kill SARS-CoV-2 virus) after 2 weeks of injection of the 2nd dose in the 25mcg dose group gave the highest results, with over 90%, 2 groups of 50mcg and 75mcg doses for results are not significantly lower.
Nanocovax is Vietnam's first Covid-19 vaccine in clinical trials. The second vaccine in the country to participate in the "race" is Covivac of IVAC company, which has completed the first phase of vaccination.
Project Nanocovax may receive hundreds of millions of dollars in funding
According to a reliable source, the Nanocovax project received funding up to hundreds of millions of dollars from a private domestic corporation. This grant is intended to accelerate the final stage of internal vaccine testing for approval for general use.
At the same time, the production system, supplies and equipment are urgently investing in order to supply a sufficient number of vaccines, supplementing with the imported vaccine quantity. The big purpose of this funding program is to complete the vaccination program against Covid-19 for Vietnamese people right in 2021.
Sponsors and domestic vaccine research and production units hope that the Nanocovax project will contribute to Vietnam's economic opening, continuing to be a bright spot in the world map for Covid-19 prevention and control. A safe destination for investment, tourism, trade and all travel and exchange needs of people and visitors.