Trial progress of two Covid-19 vaccines in Vietnam

Associate Professor, Dr. Vu Dinh Them, Director of the Center for Clinical Trial, National Institute of Hygiene and Epidemiology, said that 6 people who injected the second dose of Covivac were monitored 4 hours after injection, went home this afternoon. There have been no unusual reactions in this group. This is the first group of six people to receive two doses of Covivac vaccines. They gave the first dose on March 15.

Covivac, researched and developed by the Institute of Vaccine and Medical Biologicals (Ivac), is conducting a first stage clinical trial on 120 people in Hanoi. This phase is to determine the safety and part of the immunogenicity of the vaccine. There are 5 experimental groups with different dose levels, including 3 groups of vaccines without adjuvants, testing doses 1, 3 and 10 mcg; a test group of 1 mcg dose mixed with adjuvants; a group of 20 people injected a placebo with sterile saline to compare with the vaccination group.

Regarding the first-dose injection progress, currently 96 people have injected, while 24 people are expected to inject on April 16-17. In particular, some volunteers had mild side effects such as soreness at the injection site, muscle fatigue, and low fever. These side effects go away just a few hours after the injection.

Trial progress of two Covid-19 vaccines in Vietnam

Volunteer vaccination Covivac at Hanoi Medical University. Photo: Thao Huong.

With Nanocovax, 554 people received two doses of the vaccine, 6 people in Long An asked to withdraw, not to get the second dose because of work reasons. The injections are completed by April 8.

Nanocovax, researched by Nanogen Company, is conducting a second phase clinical trial on 560 people in Hanoi and Long An. At this stage, the team evaluated the safety and immune response of three doses of vaccine 25, 50, and 75 mcg. In which, 108 people over 60 years old participated in the trial, some people with mild background diseases, two politicians including Deputy Prime Minister Vu Duc Dam and Deputy Minister of Science and Technology Pham Cong Tac.

According to Associate Professor, Dr. Chu Van Men, Director of the Center for Clinical Trial and Bioequivalence, Military Medical Academy, the team noted that the post-injection side effects were very mild after injection, such as swelling of the injection site, muscle and joint pain, but these reactions go away quickly after rest. All volunteers returned home to self-monitor their health. They will receive a blood sample for immunization assessment on 28, 35, 42, 3 months and 6 months after the first dose. From there, the team chose the dose level with the best immunogenicity for inclusion in the third phase of the trial.

It is expected that the vaccine team will file a report ending phase two of clinical trials by the end of April, early May. The Military Medical Academy is cooperating with Nanogen, Pasteur Institute ho Chi Minh City and the Ministry of Health to develop the outline of clinical trial phase 3, which is expected to start from August 2021 to February 2022. This period, over 1,500 to 3,000 people aged 12 to 75 continue to evaluate the immunity and protective effectivenessity of the vaccine.

Nanocovax is the first Covid-19 vaccine in Vietnam for human testing. Covivac is the second Covid-19 vaccine from Vietnam to be tested in humans.

As of April 12, Vietnam has injected Covid-19 AstraZeneca vaccine for more than 58,000 people, all of which are in the priority group on the front line against Covid-19. Up to now, Vietnam has had two rounds of receiving AstraZeneca vaccine, of which more than 117,000 doses were received through VNVC at the end of February and is currently inoculation; The second round of more than 800,000 doses, provided by the United Nations Covax mechanism, is being distributed by the Ministry of Health to 63 provinces and cities to organize injections for priority groups.

Source: ndh.vn – Translated by fintel.vn

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