HCMC – The Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients on August 29 asked the HCMC-based Nanogen Pharmaceutical Biotechnology JSC to provide more data on the safety and efficacy of its Nano Covax Covid-19 vaccine before the vaccine candidate is approved for emergency use.
At a meeting held on Sunday evening, the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients and relevant agencies such as the Legal Subcommittee under the National Institute for Control of Vaccines and Biologicals, the Quality Subcommittee and the Pharmacology and Clinical Subcommittee reviewed Nanogen’s application for a certificate of circulation of the domestically developed Nano Covax Covid-19 vaccine.
The advisory council said relevant units had carefully considered the dossier. It was specifically appraised by the Legal Subcommittee twice, by the Quality Subcommittee four times and by the Pharmacology and Clinical Subcommittee three times.
After the assessment process, the council requested the company to continue to supplement and clarify some content regarding application quality and pharmacological and clinical records.
In terms of pharmacological and clinical records, the council asked Nanogen for more information about the safety, immunogenicity and prevention efficiency of Nano Covax.
The council also asked Nanogen to update data on the safety for all the people who have been vaccinated with at least one dose of Nano Covax and clearly explain any cases of serious adverse side effects.
Besides, the company needs to provide more information about the vaccine’s immunogenicity on new coronavirus strains including the Delta strain, the UK strain and others.
Regarding protection efficacy, the advisory council demanded that Nanogen coordinate with the research team to analyze and discuss the relationship between the immunogenicity of the vaccine and the protection effectiveness of at least 50% following the guidance of the World Health Organization.
The updated data should be sent to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients and the National Committee for Ethics in Biomedicine Research for a further assessment.
Nano Covax, a recombinant spike protein vaccine, is the frontrunner among Vietnamese-made Covid-19 vaccine candidates. To date it is the only home-grown Covid-19 vaccine candidate that has entered the third phase of clinical trials.
During over eight months of clinical trials, nearly 14,000 volunteers have been injected with the potential vaccine.
Some volunteers reported typical side effects such as fever, injection site soreness and nausea. Two volunteers experienced allergic reactions but they have fully recovered.
The WHO recommends that a vaccine can be approved for emergency use if it has an efficacy rate of 50% or above.
A leader of the Ministry of Health said the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients and the National Committee for Ethics in Biomedicine Research are two independent committees.
The ministry will consider giving an emergency authorization to a vaccine candidate provided that it is approved by both committees.
