A medical worker is preparing to give the shot off Nano Covax on one of the first three volunteers on Thursday morning in Ha Noi. VNA/VNS Photo
The Vietnamese health ministry on August 2 asked Ho Chi Minh City-based biopharmaceutical company Nanogen, developer of the Covid-19 vaccine Nano Covax, to submit results of Phase II and initial Phase III trials to be reviewed for emergency approval.
Deputy minister Tran Van Thuan, leader of the ministry’s special task force on clinical trials and development of Covid-19 vaccines, made the request during a progress meeting with experts, as the country deals with a severe fourth wave of infections while vaccine supply is still limited amid a global shortage.
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The meeting included leaders of the ministry’s Department of Science and Technology-Training, the Military Medical Academy, the National Institute of Hygiene and Epidemiology, and the Pasteur Institute in Ho Chi Minh City and was held to review the current progress and find ways to facilitate the clinical trials and push for reports on data of phases I, II, III (a, b) of the Nano Covax vaccine.
Phase III trials are being conducted with 13,000 volunteers, divided into two parts, IIIa with 1,000 people and IIIb with 12,000 people.
The 13,000 first doses in Phase III have been administered, with the second dose expected to be completed before mid-August, according to the company.
Surrogate virus neutralisation tests (sVNT) for the 1,000 people involved in Phase IIIa, revealed 100 per cent production of neutralising antibodies at levels higher than 30 per cent, but further monitoring is needed.
In tandem with applying for conditional approval for emergency use, Nanogen is also requesting the ministry to consider Phase IIIc trials, which would involve 500,000 to one million volunteers. Trials of the vaccine on children 12-18 years old would be conducted once the full approval is obtained.
Deputy minister Thuan said the ministry is anticipating the domestically researched and manufactured Covid-19 vaccine will help protect the health and lives of the Vietnamese people, be more proactive in vaccine rollout and reduce dependency on foreign vaccine imports.
“The good news is the [Nano Covax] vaccine seems to be safe and can elicit high level of [SARS-CoV-2] neutralising antibodies,” he said. “But we have not yet had enough data on the protective properties of the vaccine, more time and more study are needed.”
The ministry has purportedly always supported and created the most favourable conditions for companies and individuals to participate in the production of Covid-19 vaccines, having mobilised many industry-leading scientists in the country to participate in the assessment of vaccines.
The health official wants Nanogen to submit a report on research results for Phase II and initial Phase III, so that the National Ethics Committee in Biomedical Research can start evaluation for emergency approval for Nano Covax.
VIET NAM NEWS/ASIA NEWS NETWORK
