>>> Additional 12,000 volunteers get second Nano Covax vaccine shots in third trial phase
On August 2, Prof. Tran Van Thuan, Deputy Health Minister cum Head of the Special Working Group on clinical trial research and development of COVID-19 vaccines, chaired an online meeting with experts and research units to discuss acceleration of Nanocovax’s human trials.
Currently, Nanocovax, developed by Nanogen Pharmaceutical Biotechnology JSC, is in phase 3 of testing on a group of 13,000 volunteers across four provinces, divided into two smaller phases (phase 3a with 1,000 people and 3b with 12,000).
The results of blood sample analysis on the 42nd day after injection of 1,000 volunteers in phase 3a showed that 100% of them had surrogate neutralising antibodies at above the 30% threshold, while 99.2% possessed high seroconversion rates.
Nanogen requested that the Ministry of Health and the Government soon grant a conditional emergency use license for its vaccine, while recommending the ministry and the Ethics Council to consider implementing the phase 3c on 500,000 - 1 million volunteers.
In the case that the vaccine is urgently approved, the study can be extended to children aged 12-18.
Deputy Health Minister Thuan affirmed that his ministry is looking forward to having a domestically produced vaccine to protect Vietnamese people, helping to reduce the dependence on imported vaccines.
“There is good news that the vaccine is safe and has relatively high immunogenicity. However, we do not have data for sure on how protective the vaccine is, so we need more time," said Thuan.
He emphasised that the Ministry of Health always supports and creates the most favourable conditions for companies and individuals to participate in the production of COVID-19 vaccines. The ministry has mobilised leading scientists to participate in the assessment, research and appraisal process.
The Ministry of Health recommended Nanogen to send a report on phase 2 research data and initial phase 3 results to the ministry before August 15, from which the Ethics and Licensing Council will consider the licensing in the state of emergency.
