On September 20, a representative of the Licensing Advisory Council said that he had not received the acceptance record of the Nanocovax vaccine from the Ethics Council and other updated documents.
According to the Ministry of Health’s Instructions for registration of circulation of Covid-19 vaccines in emergencies dated August 19, domestically produced vaccines need to have mid-term evaluation results of phase three clinical trials for safety.
Specifically in the case of Nanocovax, the documentation requirements according to instructions from the Ministry of Health have been met by the manufacturer.
Therefore, on September 18, the Ethics Council held a meeting to evaluate the mid-term report of phase three, evaluating the vaccine’s safety and immunogenicity, but there was no data to directly evaluate the protective effect and agreed.
Thus, the Nanocovax vaccine has one more approval step before the emergency licensing door, but this possibility is still open because the Advisory Council may `not approve` and continue to request the manufacturer to supplement documents.
If approved, the Advisory Council will propose to the Ministry of Health to grant an emergency license to Nanocovax.
Nanocovax is a Covid-19 vaccine researched and developed by Nanogen Company.
Currently, Nanogen is collaborating with the Military Medical Academy and Pasteur Institute in Ho Chi Minh City to test the third phase of the vaccine, including 2 phases: 3a on 1,000 people and 3b on 12,000 people, the test dose is 25 mcg.
Covid-19 vaccine Nanocovax is researched and produced by Nanogen company.