On the afternoon of September 18, the National Ethics Committee for Biomedical Research approved the report of the phase 3 mid-term clinical trial with the Nano Covax vaccine.
Accordingly, through the evaluation, the Ethics Council determined that the vaccine (vaccine) met the requirements. Thus, this is the second time the Ethics Committee has met to evaluate the effectiveness and safety of the first Covid-19 vaccine that Vietnam researched and developed. This vaccine is currently being tested in phase 3.
Regarding this issue, on the evening of September 18, Chairman of the National Ethics Committee in Biomedical Research, Professor-Dr. Truong Viet Dung confirmed that the Nano Covax vaccine of Nanogen Company met the requirements for properties. immunogenicity and safety.
Professor Dung also added that, about the results of the meeting on September 18, the professional council will soon have official press information. In order to continue reviewing the Nano Covax vaccine, currently all records and data of this vaccine have been transferred to the Advisory Council for issuance of circulation registration certificates of drugs and medicinal ingredients (Ministry of Health), before submitting to the Ministry of Health. Health to propose a circulation registration certificate.
Currently, the Nano Covax vaccine has completed the phase 3 clinical trial, with a total of 13,000 volunteers who have received 2 doses.
Previously, to evaluate the safety and immunogenicity of the vaccine, on August 22, the National Ethics Council in Biomedical Research had a meeting to evaluate the mid-term report of phase 3a of the process. clinical trial of the Nano Covax vaccine.
At this meeting, the National Ethics Committee only evaluated the report with data collected as of August 18, and on a trial scale of 1,000 volunteers. At that time, the Ethics Council also evaluated the Nano Covax vaccine to be immunogenic against the Wuhan virus SARS-CoV-2, meeting the safety requirements (short-term); but it takes time and more research to evaluate the effect of this vaccine on Delta strains and on Alpha strains.
By August 29, in order to evaluate the immunogenicity on new strains and the sample size to evaluate the immunogenicity, it is necessary to comply with the approved research protocol, the Advisory Council issues a registration certificate to Medicines and medicinal materials have suggested Nanogen to coordinate with the research team to supplement and update the results.
In addition, based on medical data, the expert panel also recommends businesses to coordinate with the research team to analyze and discuss the protective effect, the relationship between the immunogenicity of the vaccine and the effectiveness of the vaccine. The protective effect must reach at least 50% (guideline of the World Health Organization – WHO).
Based on these requirements, over the past time, together with the Military Medical Academy, Nanogen Company has collected additional data as required, completed the mid-term report phase 3 to submit to the professional council. .
A few days ago, at a meeting on Covid-19 vaccine, Deputy Director of the Department of Science, Technology and Training (Ministry of Health), Chief of Office of the National Program for Research and Development of Vaccines Nguyen Ngo Quang, said from From now until the end of 2021, Vietnam will have at least 1 emergency licensed Covid-19 vaccine and from the beginning of 2022 will conduct domestic injection.
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