Nano Covax’s clinal trial dossier meets requirements

The dossier of the home-grown vaccine candidate Nano Covax’s clinical trials has basically met the requirements, according to an assessment of the National Ethics Council for Biomedical Research.

Nanogen's Nano Covax vaccine has entered late-stage trials.
Nanogen's Nano Covax vaccine has entered late-stage trials.

The statement was made following a meeting of the council on September 18.

Earlier, the council asked the producer Nanogen to provide more data on the vaccine’s safety on all volunteers who had been given at least one dose, its generation of immune response, as well as an explanation of serious adverse incidents.

With regards to immunogenicity, the report is updated with data on the immune response to new variants, such as the now prevalent Delta variant.

Based on medical literature data, Nano Covax has an efficacy rate of at least 50% as recommended by the World Health Organisation.

Vietnam’s Ministry of Health aims to authorise at least one domestic COVID-19 vaccine in 2021, but the authorisation must be based on scientific and transparent evidence to be considered by the drug licensing council.

As vaccines are products with effect on the entire community, they need to undergo careful and thorough examination in order to evaluate short-term and long-term safety, the stability of the immune response, and especially its protection effectiveness.