Deputy Health Minister Do Xuan Tuyen answered the press about the “fate” of the “made in Vietnam” vaccine at the government’s press conference on the evening of April 4, from the beginning when the epidemic broke out in Vietnam. , the Ministry of Health has directed and recommended the scientific research units and agencies to participate in the production of vaccines.
So far, Vietnam has 3 candidates for the Covid-19 vaccine: Nanocovax from Nanogen Pharmaceutical Biotechnology Joint Stock Company; Covivac studied by Nha Trang Institute of Vaccines and Medical Biologicals (IVAC); and technology transfer vaccine ARCT-154.
|Vice Minister of Health Do Xuan Tuyen|
In particular, the Nanocovax vaccine studied 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) and the Council. Consultancy on the issuance of registration certificates of drugs and medicinal ingredients from the Ministry of Health to evaluate.
Accordingly, by reviewing the dossier, this vaccine candidate still has some data from the Advisory Board for the Granting of Registration Certificates of Drugs and Medicinal Ingredients, which he recommends Nanogen to supplement.
The deputy health minister said Nanogen is currently collecting data and supplementing it where necessary. After that, the councils will continue to meet in accordance with the research protocol and, if appropriate, the Advisory Council for the issuance of registration certificates for medicines and medicinal ingredients will submit a license for this vaccine to the Ministry of Health.
IVAC’s Covivac vaccine has been evaluated on the interim results of Phase 1 clinical trials and is in Phase 2 trials. This vaccine is in the process of finalizing protocol and documentation for Phase 3 clinical trials.
With the ARCT-154 vaccine, Mr. Tuyen, is this the vaccine that technology has been given by the US? This vaccine has been evaluated midway through 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 phase. When the vaccine research units supplement the files at the request of the Ethics Council and the Licensing Advisory Council. “Based on the assessment of these two councils, if the conditions are met, the Ministry of Health will issue a permit,” the deputy health minister said.
According to Deputy Minister Do Xuan Tuyen, the vaccine is a biological product that is injected into the human body, so it requires a very high safety rating, including an assessment of immediate side effects and long-term effects. We will not allow vaccines without adequate research and evaluation.