Nanogen Biopharmaceuticals and the research team behind Việt Nam’s home-grown COVID-19 vaccine Nano Covax, have been asked to provide more data before an emergency use licence can be granted.
A volunteer receives a Nano Covax vaccine as part of human trials on August 27.
The request was made by the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients after a meeting held late Sunday evening.
The council said in a press released they and relevant units had carefully considered the application, adding that the dossier had been appraised by the Legal Subcommittee under the National Institute for Control of Vaccines and Biologicals twice; by the Quality Subcommittee four times, and by the Pharmacology and Clinical Subcommittee three times.
The Advisory Council acknowledged the results obtained for the application for a certificate of circulation of the Nano Covax vaccine which had been appraised by the expert subcommittees, and accepted by the Ethics Council. At the same time, the Advisory Council requested the company continue to supplement and clarify some content regarding application quality and pharmacological and clinical records.
Regarding pharmacological and clinical records, the council asked for more information regarding safety, immunogenicity and protection effect.
Specifically, the enterprise needs to add and update data on safety for all subjects who have been vaccinated with at least one dose of the vaccine up to the present time and clearly explain the cases of serious adverse events (SAE).
The council also asked for more data according to the latest amendment protocol approved by the Ethics Committee, including: assessment of immunogenicity on new strains (for example Delta strain, UK strain, and others) and sample size for immunogenicity assessment should be carried out in accordance with the approved research protocol.
Regarding the protection effect, it is required that the enterprise coordinate with the research team to analyse and discuss the relationship between the immunogenicity of the vaccine and the protection effectiveness of at least 50 per cent (according to the guidance of the World Health Organization).
Last week, the results from Nano Covax's phase 3a clinical trials involving about 1,000 volunteers were given the green light from the National Committee for Ethics in Biomedicine Research.
Some volunteers 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.
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.
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.
In its statement issued on August 28, the National Committee for Ethics in Biomedical Research affirmed that the homegrown COVID-19 vaccine meets safety requirements.