Nanogen asked to provide more data of homegrown Nano Covax
Nanogen Pharmaceutical Biotechnology JSC has been asked to provide more data for consideration before a registration certificate of conditional circulation for its Nano Covax can be granted.
Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine. (Photo: VNA)
Hanoi (VNA) - Nanogen Pharmaceutical Biotechnology JSC has been asked toprovide more data for consideration before a registration certificate of conditionalcirculation for its Nano Covax can be granted.
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./.
The vaccine market in Vietnam - a tropical country with a hot and humid climate - is forecast to be large and has a high growth rate in the coming years, health experts said.
The National Committee for Ethics in Biomedical Research under the Ministry of Health (MoH) has agreed that the mid-term results from Nano Covax's phase 3 clinical trials will be submitted to the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients for considering the issuance of a registration certificate for the conditional circulation of the vaccine.
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In 2024, Vietnam achieved 99% coverage for the first dose of the diphtheria, tetanus and pertussis vaccine, up from 80% in 2023. Immunisation coverage in the country has not only rebounded to the high levels seen before the COVID-19 pandemic but has now surpassed the rates recorded in 2019.
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The Hanoi ceremony highlighted efforts to ensure all citizens, especially women and youth, can access accurate information and healthcare services to make informed reproductive choices.
After such a long time, the law has revealed many limitations, prompting the Ministry of Health (MoH) to gather opinions to amend the law to give more chances to thousands of patients every year.
Currently, cardiovascular specialists from the 108 Military Central Hospital are working alongside a team of Prof.Dr. Jan D. Schmitto, Deputy Director of MHH’s Department of Cardiac, Thoracic, Transplantation and Vascular Surgery on clinical trials for MCS devices, implanted in heart failure patients either as a bridge to transplantation or as permanent treatment.
The centre not only serves residents living on the island, but also receives tens of thousands of visitors every year, according to Assoc Prof Dr Tang Chi Thuong, Director of the HCM CIty Department of Health.
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During the COVID-19 pandemic in 2020, the Ministry of Health swiftly launched a telemedicine programme, connecting more than 1,000 medical establishments nationwide. The model, which remains in operation, has benefited tens of thousands of patients, including foreign nationals.
After more than three weeks of intensive treatment, the patient's pneumonia improved, breathing stabilised, sedation was reduced, and the breathing tube was removed. He is now conscious, able to eat orally, and in recovery.
Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced COVID-19 vaccine. (Photo: VNA) 
