Nanocovax approved by National Biomedical Research Ethics Council
Results from the phase 3a clinical trial of the domestically-produced COVID-19 vaccine Nanocovax on more than 1,000 volunteers have been adopted by the National Biomedical Research Ethics Council (NBREC).
This comes after a local research team working on developing Nanocovax unveiled the promising outcomes of the mid-term phase 3a clinical trials on August 22.
The clinical trials of phase 3a involved the participation of 1,004 volunteers based in both Hanoi and Long An.
According to the preliminary evaluation of the NBREC, the domestically-developed vaccine fully meets all safety and immunogenicity requirements.
After receiving approval from the council, the dossier and research data of the Nanocovax vaccine will now be transferred to the Advisory Council for issuance of a registration certificate for circulation of drugs and medicinal ingredients. This is being done in order for the Ministry of Health (MoH) to consider a decision about granting a conditional emergency license for the Nanocovax vaccine.
The time to issue a registration certificate for an eligible vaccine typically happens within 20 days. However, if the Nanocovax vaccine is able to meet all requirements, then the licensing period may be shorter and may even take less than a week.
Nanocovax represents the first locally-produced COVID-19 vaccine and is being produced by the Nanogen Pharmaceutical Biotechnology Joint Stock Company in collaboration with the Military Medical Academy on recombinant DNA/protein technology. It is currently in the process of phase three trials, one of 15 vaccines against COVID-19 being produced globally in this stage.
According to Dr. Nguyen Vu Hong An, head of Nanogen's Quality Control Department, the company initially began research on the Nanocovax vaccine in March, 2020.
In July, 2020, the company completed everything related to the preclinical period and has since finalised procedures, trial phases, and clinical testing according to the standards of the Ministry of Health, along with conducting trial injections on humans.
According to the MoH, once the Vietnamese Nanocovax COVID-19 vaccine meets the standards and is granted a licence, the World Health Organisation (WHO) will consider including it in the COVAX programme.
In response to a proposal made by Nanogen regarding dispatching a task force to assist it in handling related administrative procedures, Minister of Health Nguyen Thanh Long said that he would streamline administrative procedures. Moving forward, the only focus will be on resolving professional issues so that the Nanocovax vaccine can be licensed as soon as possible.
