(VOVWORLD) - Made-in-Vietnam COVID vaccine Nano Covax is deemed to be safe in the short term and able to elicit immune responses based on reports of phase 3 trials, according to a statement issued on Sunday by the National Ethics Council in Biomedical Research under the Ministry of Health.
 (Photo: VNA) |
The council met on Saturday to look into the result of mid-term phase 3 trials of the vaccine developed by Nanogen Pharmaceutical Biotechnology JSC.
The council’s statement stressed that to date they haven’t had the data to “directly" evaluate the protective efficacy, or the ability of a vaccine to prevent infection or symptomatic infections, saying further study is needed for assessment of this "most important criteria to determine the vaccine's quality."
The currently available estimation of Nano Covax’s protective efficacy extrapolated from its immunogenicity, or the level of antibodies in the vaccinated, however, has “enough scientific grounds” for the council to send the vaccine documents to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients for reviews.
Regarding the proposal to grant Nano Covax conditional approval for emergency use, the council said they reached ‘consensus’ in the use of mid-term phase 3 trials for the drugs advisory body to deliberate.
Currently, 13,000 volunteers in phase 3 trials of Nano Covax, which is set to wrap up by 2022 February, have been given the second shots of the vaccine.
Under the latest guidelines from the Health Ministry, domestically developed COVID-19 vaccines could be authorised for emergency use if they prove to be safe and effective in mid-term phase 3 findings, with further monitoring required even after obtaining such approval.