Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine. (Photo: VNA) Therequest was made by the Advisory Council for the Registration of Circulation ofDrugs and Medicinal Ingredients after a meeting held on August 29.
Ina press release, the council said it and relevant units had carefully consideredthe application, adding that the dossier had been appraised by the LegalSubcommittee twice; by the Quality Subcommittee four times,and by the Pharmacology and Clinical Subcommittee three times.
The AdvisoryCouncil acknowledged the results obtained for the application for a registrationcertificate of circulation of the Nano Covax vaccine which had been appraisedby the expert subcommittees, and accepted by the Ethics Council. Atthe same time, the Advisory Council requested the company continue tosupplement and clarify some content regarding application qualityand pharmacological and clinical records.
Regardingpharmacological and clinical records, the council asked for moreinformation regarding safety, immunogenicity and protection effect.
Specifically,the company needs to add and update data on safety for allsubjects who have been vaccinated with at least one dose of the vaccine up tothe present time and clearly explain the cases of serious adverse events (SAE).
The councilalso asked for more data according to the latest amendment protocolapproved by the Ethics Committee, including: assessment of immunogenicity onnew strains (for example Delta strain, UK strain, and others) and sample sizefor immunogenicity assessment should be carried out in accordance with theapproved research protocol.
Regardingthe protection effect, it isrequired that the enterprise coordinate with the research teamto analyse and discuss the relationship between the immunogenicity of thevaccine and the protection effectiveness of at least 50 percent (accordingto the guidance of the World Health Organization).
NanoCovax, a recombinant spike protein vaccine, is the forerunner in the race fordomestically produced COVID-19 vaccine, followed by COVIVAC from the Instituteof Vaccines and Biologic Medical and mRNA vaccine ARCT-154 (byArcturus and VinBioCare) just starting phase 2 trials./.
VNA
