×

Ethics Council: ‘Nanocovax vaccine meets safety requirements’

Ethics Council: 'Nanocovax vaccine meets safety requirements' 6

Ethics Council: ‘Nanocovax vaccine meets safety requirements’

Accordingly, representatives of the Nanocovax vaccine research team have submitted data on mid-term results of phase three clinical trials as of September 2, updated on September 17.

Specifically, Nanocovax meets the short-term safety requirements, based on data reporting mid-term phase three clinical trial results to date.

Vaccines are also immunogenic.

Antibodies are a component of the immune system, in which IgG antibodies appear in the blood and extracellular fluid, helping to protect the body from infection.

Quantitative antibody testing, neutralizing antibody evaluation, and neutralizing antibody evaluation on live virus using PRNT are important criteria to evaluate the immunogenicity of the vaccine.

Regarding protective effectiveness, currently `the vaccine does not have data to directly evaluate based on the number of Covid-19 cases in clinical research`.

Medical staff prepare to test inject the Nanocovax vaccine at Ben Luc District Medical Center, Long An, in February. Photo: Quynh Tran

From here, the Ethics Council agreed to allow the use of clinical trial research results up to the time of mid-term evaluation of phase 3 results, sending them to the Standing Advisory Council to issue drug registration certificates and raw materials.

On the evening of September 18, after the Ethics Council’s second meeting to evaluate the Nanocovax vaccine dossier on the same afternoon, Professor Truong Viet Dung, Chairman of the Ethics Council, told VnExpress that the results were `basically satisfactory.`

After this meeting, according to order, the Nanocovax clinical trial research results continue to be sent to the Advisory Council for drug registration and medicinal ingredients for consideration and emergency licensing.

Nanocovax is a Covid-19 vaccine researched and developed by Nanogen Company, a course of two doses administered 28 days apart.

Currently, Nanogen is collaborating with the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City to test the third phase of the vaccine.

Post Comment