URGENT AUTHORIZATION FOR NANOCOVAX VACCINE HAS NOT BEEN APPROVED DUE TO LACK OF DATA

This morning, August 29,  the Ministry of Health  held a meeting to consider  emergency licensing of the NanoCovax vaccine . According to initial information, the research team was asked to add some data.

Already 13,000 people volunteered to participate in the experiment (vaccination) Nanocovax

According  to the Ministry of Health , up to now, Nanocovax of Nanogen Company is  Vietnam's first Covid-19 vaccine to  deploy phase 3 clinical trial (TNLS), with 13,000 participants, ages 18 and older. , including the elderly group,  people with underlying diseases .

Accordingly, phase 3 was tested on 13,000 people, divided into 2 small phases (3a: 1,000 people and 3b: 12,000 people).

According to the research team, the Nanocovax vaccine meets the requirements for safety and immunogenicity.

Before the meeting, all dossiers and data of phase 3a clinical trial were transferred by the Ethics Council to the Advisory Council for issuance of circulation registration certificates of drugs and medicinal ingredients of the Ministry of Health for consideration for urgent licensing. conditional.

According to the latest guidance, in the decisive Circular 11/2021, creating opportunities for vaccines in the country, stated in "Regulations on clinical data in the application for registration of circulation of vaccines": vaccines The domestically produced Covid -19 prevention  team is conducting a clinical trial, but the results of the phase 3 mid-term evaluation of the safety and protective effectiveness of the vaccine are based on data on the immunogenicity of the vaccine. is used to consider granting a conditional marketing authorization.

It will be based on the advice of the Ethics Council and the Licensing Council, with reference to the guidelines or recommendations of the World Health  Organization .