|Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine. (Photo: VNA)|
The request was made by the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients after a meeting held on August 29.
In a press release, the council said it and relevant units had carefully considered the application, adding that the dossier had been appraised by the Legal Subcommittee 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 registration 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 company 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% (according to the guidance of the World Health Organisation).
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.