Answering the press about the “fate” of the “made in Vietnam” vaccine at the Government press conference on the evening of April 4, Deputy Minister of Health Do Xuan Tuyen said that right from the beginning when the epidemic broke out in Vietnam. , the Ministry of Health has directed and recommended scientific research units and agencies to participate in vaccine production.
Up to now, Vietnam has 3 candidates for Covid-19 vaccine: Nanocovax of Nanogen Pharmaceutical Biotechnology Joint Stock Company; Covivac researched by Nha Trang Institute of Vaccines and Medical Biologicals (IVAC); and technology transfer vaccine ARCT-154.
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| Deputy Minister of Health Do Xuan Tuyen |
In particular, the Nanocovax vaccine researched by Nanogen has progressed to phase 3 clinical trial evaluation. This vaccine has been approved by the National Ethical Council in Biomedical Research (Ethics Council) as well as the Council. Consultancy on issuance of registration certificates of drugs and medicinal ingredients of the Ministry of Health meeting to evaluate.
Accordingly, through reviewing the dossier, this vaccine candidate still has some data from the Advisory Council for granting registration certificates of drugs and medicinal ingredients, which he recommends Nanogen to supplement.
The Deputy Health Minister said that Nanogen is currently gathering and supplementing data as required. After that, according to the research protocol, the councils continue to meet and, if eligible, the Advisory Council for granting registration certificates of drugs and medicinal ingredients will submit to the Ministry of Health for a license for this vaccine.
IVAC’s Covivac vaccine has been evaluated midterm results of phase 1 clinical trials and is in phase 2 studies. This vaccine is in the process of finalizing the protocol and documentation for phase 3 clinical trials.
With the ARCT-154 vaccine, Mr. Tuyen said, this is the vaccine received technology transfer from the US. This vaccine has been evaluated mid-term phase 2 and is implementing phase 3, which has been tested on 1,000 volunteers.
“All three candidates for Vietnam’s Covid-19 vaccine are in the clinical trial stage. When the vaccine research units complete the dossiers at the request of the Ethics Council and the Licensing Advisory Council. , on the basis of the assessment of these two councils, if conditions are met, the Ministry of Health will issue a license,” said the Deputy Health Minister.
According to Deputy Minister Do Xuan Tuyen, the vaccine is a biological product injected into the human body, so it requires a very high safety assessment, including an assessment of immediate adverse events and long-term effects. We will not authorize vaccines without adequate research and evaluation.
Source: qdnd.vn
Source: Vietnam Insider