‘Do not expand Nanocovax vaccine trial’ – VnExpress

Responding to the proposal of piloting the Nanocovax vaccine by the provinces of Khanh Hoa and Binh Duong, the Ministry of Health said that it “has not yet approved to expand the research area in the third phase”.

In a response letter on August 14, the Ministry of Health “supported the expansion of the clinical trial area of ​​the Nanocovax vaccine in terms of policy”. The expanded criteria are to ensure safety, science and feasibility; compliance with research ethics; research dossiers must be developed by the research team; The National Biomedical Research Ethics Council appraises and approves it, then submits it to the Ministry of Health for approval.

However, according to the Ministry of Health, the response of the clinical trial units Nanocovax is to continue implementing according to the approved research protocol, not to expand the location of the third phase clinical trial to ensure Ensure the progress of the mid-term report and complete the research against the approved plan. Nanogen also agreed not to expand the test due to the complicated disease situation making it difficult to deploy on a large scale.

“Based on comments from Nanogen Company and vaccine research units, the Ministry of Health has not temporarily approved the expansion of the research area for phase three clinical trials with the Nanocovax vaccine in the current period,” the company said. response text.

The Ministry of Health also emphasized that “it is forbidden to use vaccines that are in the process of testing for pilot or commercial purposes”.

Previously, on August 2 and 3, the two provinces of Khanh Hoa and Binh Duong sent documents to the Ministry of Health, proposing to pilot the Nanocovax vaccine as soon as possible. Khanh Hoa province leader said “want to contribute to put Nanocovax into service soon”; Binh Duong province’s leaders wished to “promote the prevention and control of Covid-19, control the epidemic, and prevent outbreaks on a large scale”.

Nanocovax is a Covid-19 vaccine researched and developed by Nanogen Company and put into clinical trials from December 17, 2020. Two units cooperate in vaccine research, including the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City. Currently, the vaccine is in phase three clinical trials on 13,000 people, divided into two small phases, including 3a trials on 1,000 people, 3b trials on 12,000 people, using a placebo as a control. The results of the evaluation of phase 3a and stages one and two are the basis for experts to consider the urgent licensing proposal for Nanocovax, according to the Ministry of Health on July 22.

The appraisal meeting of phase 3a, scheduled for August 15, has been postponed. According to a representative of the Ministry of Health, the reason is that research units including the Military Medical Academy, the Pasteur Institute in Ho Chi Minh City and Nanogen have just submitted the results of phase 3a to the Ministry of Health and the Ethics Council in biomedical research. National School.

Experts are expected to hold an appraisal meeting this week.

Vaccine Nanocovax is researched and manufactured by Nanogen company. Photo: Quynh Tran



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