The results of the second phase of clinical research by the Pasteur Institute in Ho Chi Minh City, comparing the results of immunogenicity in the group of people injecting Nanocovax and the group having recovered from Covid-19, Nanogen estimated the protective effectiveness of the vaccine to be 90%.
On the morning of August 6, Mr. Ho Nhan, Chairman of Nanogen Company, said that this detail has been included in the fast update report on Nanocovax research results, sent to the Ministry of Health. Phase 2 clinical trial of Nanocovax vaccine began on February 26, on 560 people, divided into 4 groups including placebo injection, injection doses of 25, 50 and 75 mcg.
The report also presents a number of other analytical results that demonstrate the vaccine’s ability to prevent viruses. The vaccine was also evaluated as “initially capable of neutralizing the Delta variant” at the National Institute of Hygiene and Epidemiology, according to Mr. Nhan.
Thereby, Nanogen continued to request the Ministry of Health for an emergency license for Nanocovax.
Associate Professor, Dr. Le Van Truyen, Chairman of the Advisory Council for the issuance of circulation registration certificates of drugs and medicinal ingredients of the Ministry of Health, said that the council will work in the shortest time to propose the Minister The health department grants emergency authorization for the vaccine, when the study results are approved by the Ethics Committee. If favorable, in the fourth quarter of this year, Vietnam will have the first domestic Covid-19 vaccine.
A representative of the Military Medical Academy on the morning of August 6 also said that as of the evening of August 5, 8,500 volunteers had tested the two Nanocovax vaccines in both regions. Nanocovax phase three clinical trial was carried out on 13,000 people, in Hanoi, Hung Yen, Tien Giang, Long An. Thus, there are 4,500 people who have not received the second dose.
According to the research team’s representative, Covid-19 broke out violently in the southern provinces, so the second dose injection activity in the southern provinces was more difficult than in the North. The research team is rushing to deploy the injection, ensuring the completion of the second dose for 13,000 people by August 15.
On August 2, Deputy Health Minister Tran Van Thuan chaired a meeting to review the progress and promote the clinical trial of Nanocovax. The Ministry of Health suggested that Nanogen continue to monitor 1,000 phase 3a testers and 12,000 phase 3b testers; complete and submit phase two and initial phase three clinical study data reports by August 15. These are the necessary data for the Ethics and Licensing Board to consider an emergency license for Nanocovax. On August 4, the Ministry of Health continued to consult with experts from the World Health Organization and Korea on clinical trials and emergency licensing for vaccines.
Nanocovax, developed by Nanogen Company, is in the third phase of clinical trials on Vietnamese volunteers from the age of 18. At the end of July, Nanogen posted the results of the preclinical and phase one and two clinical trials, in manuscript form, on Biorxiv and Medrxiv. These are two online platforms that host and distribute manuscripts related to medicine, clinical and medical related fields. The presented research results help to understand more about the technology, pointing out the good points and limitations in the Nanocovax test.