Further data on Nano Covax vaccine’s protective efficacy needed
The National Ethics Committee in Biomedical Research under the Ministry of Health has requested additional reports on the protective efficacy of the homegrown candidate COVID-19 vaccine Nano Covax, requiring that they should be submitted before 3pm on December 22 for review.
Hanoi (VNA) - The National Ethics Committee inBiomedical Research under the Ministry o♉f Health has requested additionalreports on the protective efficacy of the homegrown꧅ candidate COVID-19 vaccine Nano Covax, requiring that they should be submitted before 3pm on December 22 for review.
The ministry announced on December 20 that onDecember 16, the committee convened a meeting reviewing supplementary reports on the mid-term outcomes of the phase 3trial of Nano Covax as of November 30.
Accordingly, it concluded that Nano Covax met safetyrequirements based on data of the additional reports. It also met requirements on immunityproduction in accordance with the ministry’s professional guidelines.
However, more data on its efficaಞcy🐬 are needed, the National Ethics Committee in Biomedical Research said.
Nano Covax, a recombinant spike proteinvaccine, is the forerunner in the race for domestically produced COVID-19vaccine, followed by COVIVAC from the Institute of Vaccines and BiologicMedical and mRNA vaccine ARCT-154 (by Arcturus and VinBioCare) juststarting phase 2 trials.
Developed by the Nanogen PharmaceuticalBiotechnology JSC based on recombinant DNA/protein technology, Nano Covax wentthrough the first-phase trial from December 18, 2020 and the second phase fromFebruary 26, 2021. The third phase started on June 11, 2021.
Results from the first💫 two trial phases showedthat all volunteers developed antibodies against the coronavirus SARS-CoV-2./.
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.
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.
Nanogen Pharmaceutical Biotechnology JSC was asked to provide more information regarding safety, immunogenicity, and protection effects before a registration certificate of circulation for its Nano Covax can be granted, Deputy Minister of Health Tran Van Thuan has said.
The National Ethics Committee in Biomedical Research under the Ministry of Health on September 19 issued a press statement on its conclusions of a meeting one day earlier during which it looked into the mid-term phase 3 trial’s results of homegrown COVID-19 vaccine Nano Covax.
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Illustrative image (Photo: Nanogen) 
