A member (not wanting to be named) of the Nanocovax vaccine research team told VnExpress this news on the afternoon of August 27.
According to the process, after being approved by the National Council of Ethics in Biomedical Research (hereinafter referred to as the Ethics Council), the Nanocovax vaccine dossier is transferred to the Advisory Council for issuance of drug circulation registration certificate.
The representative of the Advisory Council for issuance of circulation registration certificates for drugs and medicinal ingredients also said that experts are studying the dossier, and there is no meeting schedule to consider licensing the Nanocovax vaccine.
According to instructions from the Ministry of Health, the vaccine can be licensed within 20 days from the time the company representative submits complete registration documents for circulation to the Drug Administration of Vietnam.
Nanocovax is a Covid-19 vaccine researched and developed by Nanogen Company, currently the most promising vaccine candidate in the country.
In early August, Nanogen sent an official dispatch to the Ministry of Health, updating Nanocovax research results in clinical research phases one and two.
Previously, on July 22, a representative of the Ministry of Health said that the records of clinical research results of phases one and two, and the mid-term results of phase 3a `are the basis for considering a proposal for emergency licensing for
The vaccine has three phases of clinical trials.
Phase three started on June 11, on 13,000 people, evaluating the safety, immunogenicity and protective effectiveness of the vaccine.
The trial was blinded, meaning researchers and volunteers did not know who received the vaccine and who received the placebo.
Nanocovax vaccine at Nanogen Company’s factory in Ho Chi Minh City.