HÀ NỘI — The research ethics committee has accepted the results from Nano Covax's phase 3a clinical trials involving about 1,000 volunteers, opening up the pathway for the homegrown COVID-19 vaccine to obtain an emergency use licence, according to local media on Friday.
After obtaining the green light from the National Committee for Ethics in Biomedicine Research, the documents will be forwarded to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients under the Ministry of Health, who will review the case and issue a licence for use of the vaccine in an emergency epidemic situation.
It’s reported that the experts are reviewing the documents and no date for a meeting has been fixed.
Existing policies dictate that 20 days after the receiving of full documents and feedback from advisory bodies (with WHO guidelines taken into account) for a vaccine circulation request, the director of the Drug Administration would grant a registration certificate for use of the vaccine.
Last week, the ethics committee convened to assess the mid-term result reports of safety and immunogenicity of the vaccine developed by HCM City-based Nanogen Biopharmaceuticals.
Nanogen is still conducting phase 3 trials with a total of 13,000 adult volunteers, but according to the latest guidelines from the health ministry, the vaccine could be given the emergency licence once the ethics committee approved the mid-term report.
A thousand volunteers in the 3a phase have been given the required two doses.
Some reported typical side effects like pain at the injection site, itchiness, nausea, light fever after receiving the vaccine. Two suffered from shock reactions but have completely recovered.
Data from the second phase trials showed that the vaccine is 96.5 per cent effective in neutralising live coronavirus at the 42nd day (14 days after injection of second dose).
The geometric mean concentration (GMC) of the antibody among the injected volunteers evaluated by PRNT50 tests on Wuhan strain is at 63.5, while GMC for those given placebo is at five.
On day 42, the seroconversion rate reached 99.2 per cent.
As COVID-19 case numbers surge in Việt Nam’s fourth wave of infections, many provinces have also asked to participate in the trials of Nano Covax but the health ministry didn’t agree, citing doability, safety and ethics concerns.
Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine, followed by COVIVAC from the Institute of Vaccines and Biologic Medical and mRNA vaccine ARCT-154 (by Arcturus and VinBioCare) just starting phase 2 trials.
Nanogen said the price of each shot will be at VNĐ120,000 (US$5.2) and could produce 100 million doses this year.
Deputy Prime Minister Vũ Đức Đam, deputy head of the National Steering Committee for COVID-19 Prevention and Control, has received two shots of Nano Covax as part of its phase 2 trials. — VNS