In response to the company’s petition for approval of the vaccine for emergency use, the Ministry officially said that any vaccine must undergo clinical trials on human in three phases.
Moreover, before being used for emergency purpose, any vaccine must prove its safety, great immunogenicity, and vaccine efficacy and effectiveness.
Nguyen Ngo Quang, deputy head of the Administration of Science Technology and Training under the ministry, said that while the vaccine produced by Nanogen has undergone two phases of clinical trials and showed great immunogenicity, the sample size was still too small to fully establish its protective effects.
Presently, Nano Covax vaccine has entered its second phase of human trials on hundreds of volunteers. So far, it has just experimented
on 1,000 volunteers in the third phase while according to the Ministry, the clinical trial’s third phase must be carried out on 20,000 to 50,000 volunteers.
In addition, after the second injection of the trial, immunization experts need around 36, 45, 56 days to evaluate the vaccine after injection. In order to assess the vaccine’s immunogenicity and efficiency and effectiveness, experts need at least two months to carry out a proper evaluation of the vaccine.
Up to now, Vietnam has approved four Covid-19 vaccines including Comirnaty of Pfizer, A2D1222 of AstraZeneca, Sputnik-V of Gamalaya, Vero-Cell of Sinopharm for emergency use in the fight against Covid-19.