Vietnam to consider emergency licensing of first homegrown COVID-19 vaccine

Theo NDO 05:34 03/08/2021 - Brand name drugs
The Ministry of Health will consider the emergency license for the country’s first homegrown COVID-19 vaccine, named Nanocovax, later this month.
A volunteer is injected with a dose of Nanocovax in the second phase of human trials in late February 2021. (Photo: NDO/Ha Nam)
A volunteer is injected with a dose of Nanocovax in the second phase of human trials in late February 2021. (Photo: NDO/Ha Nam)

 

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.

Continuous reading

Health ministry official caught in Covid test kit scam

Health ministry official caught in Covid test kit scam

Brand name drugs - 26/05/2022

Health ministry official caught in Covid test kit scam

Vietnam to import Covid-19 antibody drug Evusheld

Vietnam to import Covid-19 antibody drug Evusheld

Brand name drugs - 11/03/2022

Vietnam to import Covid-19 antibody drug Evusheld

Guidelines on using newly approved COVID-19 vaccines to be issued soon

Guidelines on using newly approved COVID-19 vaccines to be issued soon

Brand name drugs - 27/09/2021

Guidelines on using newly approved COVID-19 vaccines to be issued soon

Vaccination considered “golden key” for COVID-19 control

Vaccination considered “golden key” for COVID-19 control

Brand name drugs - 24/09/2021

Vaccination considered “golden key” for COVID-19 control

Nano Covax COVID-19 vaccine candidate to be assessed by Indian institute

Nano Covax COVID-19 vaccine candidate to be assessed by Indian institute

Brand name drugs - 24/09/2021

Nano Covax COVID-19 vaccine candidate to be assessed by Indian institute

Bảng thống kê bệnh nhân nhiễm bệnh nCoV các quốc gia trên thế giới