A volunteer takes a screen test before receiving Nano Covax COVID-19 vaccine shot in the third phase of the human trials. (Photo: VNA)Hanoi (VNA) - The first 240 volunteers in the third phase of the human trials of the home-grownNano Covax COVID-19 vaccine received shots at the Vietnam Military MedicalUniversity in Hanoi on June 11.
Developed by theNanogen Pharmaceutical Biotechnology JSC, Nano Covax is Vietnam’s firstCOVID-19 vaccine candidate and was approved by authorities for clinical trials lastDecember.
According to AssociateProfessor Dr Chu Van Men, Director of the university’s Centre for ClinicalTrials and Bioequivalence, the third phase targets 13,000 people aged from18-75, with an optimal dosage of 25mcg.
Apart from theuniversity, the third phase, also the final one, will be carried out in thenorthern province of Hung Yen and the Mekong Delta provinces of Long An andTien Giang.
Following theclinical trials in Phase 2, which lasted three months, all volunteersexperienced an increase in antibody levels against the coronavirus. This is apositive sign that not only makes it possible for developers to safely speed upPhase 3 but also raises hopes that a Made-in-Vietnam vaccine will soon becomeavailable amid the growing complexity of the pandemic both locally and regionally.
As of June 11,more than 6,500 volunteers had registered for this phase, which aims to furthertest the safety and efficacy of the vaccine in humans before mass productionbegins.
AssociateProfessor Ho Anh Son, Deputy Director of the university’s Institute ofBiomedicine and Pharmacy, said a dossier will be submitted to the Government,the Ministry of Health, and the National Council for Ethics in BiomedicalResearch seeking emergency approval for conditional use in mid-September, or 42days since the first 1,000 volunteers received their second shot.
Phase 2 trials beganon February 26 involving 560 volunteers divided into four groups, with threeadministered doses of either 25mcg, 50mcg, or 75mcg and the fourth a placebo.
With this phase nowcompleted, volunteers will continue to undergo health monitoring for six monthssince the first shot to evaluate the vaccine’s ability to build immunityagainst the virus.
Many COVID-19vaccines around the world are 90 percent effective and some just 60-70 percent,Son said. With Nano Covax, all volunteers have produced immune responsesagainst COVID-19.
The study found anincrease in antibody levels in all volunteers, Son continued, and all were ingood health and no one needed drugs or emergency care. It was a veryencouraging result and the vaccine is safe for humans so far, he emphasised.
Another domesticvaccine candidate, Covivac from the Institute of Vaccines and BiologicalMedical (IVAC) in Nha Trang city, Khanh Hoa province, is preparing for Phase 1 trialdata to be reviewed by the Ministry of Health and could start Phase 2 aroundlate-June or early-July if results are deemed acceptable.
Anotherlocally-developed COVID-19 vaccine, from Vabiotech, is in pre-clinical trialson animals, while yet another from Polyvac (the Centre for Research andProduction of Vaccines and Biologicals, under the Ministry of Health) is stillunder laboratory research./.
VNA
