Nanogen asked to provide more data of homegrown Nano Covax

Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced vaccine. (Photo: VNA)

Hanoi (VNA) – has been asked to
provide more data for consideration before a registration certificate of conditional
circulation for its can be granted.

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 percent (according
to the guidance of the World Health Organization).

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./.