The National Ethics Committee in Biomedical Research under the Ministry of Health (MoH) approves the clinical trial results of the phase 3 of Nanocovax.
The conclusion was made by the National Ethics Committee in Biomedical Research under the Ministry of Health (MoH) in a meeting on assessment of the clinical trial results of the phase 3 mid-term of Nanocovax based on the study result conducted by September 2.
The study reported that Nanocovax vaccine shows an immune response, based on results of anti-SARS-CoV-2 IgG antibody concentration test in 924 samples at the 42nd day after first shot; the live virus neutralization assay in 761 samples at the 42nd day after first shot; the plaque reduction neutralization test (PRNT) using 107 samples with the original Wuhan strain, 41 samples with Delta variant, 39 samples with Alpha variant 42 days after the first jab.
Notably, there are no data for the direct evaluation of the Nanocovax vaccine’s protective efficacy based on the number of people infected with Covid-19 after getting the shots in the clinical trial.
The National Ethics Committee in Biomedical Research agreed on using results of the phase 3 mid-term clinical trial to submit to the MoH’s Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients.
Besides, the Nanogen Pharmaceutical Biotechnology Joint Stock Company and the Nanocovax vaccine research group have been asked to complete reports and the approved clinical trial process by March, 2022 as well as update study results for submission to the Boards of professionals and management units.