Safety top priority in human trials of made-in-Vietnam COVID-19 vaccine

Friday, 2020-12-11 09:30:45
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Volunteers registered to test a locally-made COVID-19 vaccine on December 10, 2020. (Photo: NDO/Thien Lam)
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NDO – Safety of volunteers joining the human trials of a locally-made COVID-19 vaccine would be put on top priority during the testing, affirmed the organisers.

>>> Vietnam to start human trials of Covid-19 vaccine on December 10

>>> Vietnam ready to run human trials of COVID-19 vaccine

>>> Human trials of made-in-Vietnam COVID-19 vaccine to be deployed in three stages

On December 10, the Ministry of Health, the Vietnam Medical Military University and vaccine producer Nanogen Pharmaceutical Biotechnology JSC officially announced the launch of the clinical trial project of the vaccine named Nanocovax, which was researched and produced by Nanogen using recombinant protein technology.

From May 2020, the company began research and production of its COVID-19 vaccine, with its biggest advantage of creating a good immune response, high safety, less side effects and favourable storage than other vaccines (stored at 2-8C).

After the pre-clinical test on Balb/c mice, hamsters and monkeys with good results, Nanogen has applied for a license for human trials and it got an approval from the Medical Ethics Council under the Ministry of Health on December 9.

From December 10, the company cooperated with the Hanoi-based Vietnam Medical Military University (under the Ministry of Defence) to commence the testing of vaccine in humans, with the first step of selecting volunteers for the project.

It is expected that the vaccine will be tested on a three-stage clinical trial, in which Stage 1 from December 2020 to February next year on 60 people from 18-50 years old, Stage 2 from February to August 2021 on about 400-600 people aged 12-75, and Stage 3 from August 2021 to February 2022 on 1,500-3,000 people aged 12-75.

All participants will receive two doses of the vaccine intramuscularly or placebo (for phases 2 and 3). The interval between doses is 28 days. Study duration for each subject is about 56 days to assess the study goal and follow up until the 6th month from the first injection.

Ho Nhan, Chairman of the Board of Directors cum General Director of Nanogen, said that the company can produce two million doses a year and can maximise to 20-30 million doses per year during the clinical trials. The ideal capacity is 50 million doses a year.

Nanocovax vaccine produced by Nanogen with three doses of 25mcg, 50mcg and 75mcg. (Photo: Nanogen)

"This is the first vaccine in Vietnam that has completed the research process and achieved high efficiency in pre-clinical trials, promising to be the first made-in-Vietnam COVID-19 vaccine to be put on the market. We are working hard to be able to produce vaccines to meet the needs of the people as soon as possible," said Nhan.

Lieutenant General Do Quyet, Director of Vietnam Medical Military University, said that the start of the clinical trial phase of Nanocovax will open a new phase in Vietnam’s COVID-19 fight.

“We do not exchange the safety of Vietnamese people with anything else. We will make every effort not to let complications occur during the trials,” Quyet affirmed, adding that with more than 10 years of expertise in clinical trials of various vaccines, his academy has established a vaccine centre specialised in pre-clinical testing and vaccination testing in humans.

In preparation for the Nanocovax trial, the centre has prepared a 24-bed system with adequate and emergency equipment and staff ready to handle all situations during the trial, while ensuring testers to have comfortable accommodations with nutritional care.

Through online registration, 30 people have signed up to volunteer for the test injection. These people will have a physical exam to check the related indicators before participating in the trial.

Admission started yesterday and is expected to last 1-2 weeks. The first injection can be deployed after a week.

On the morning of December 10, many volunteers were present at the military medical university to register for the clinical trials. Most of them are students of several universities in Hanoi.

Dr. Nguyen Ngo Quang, Deputy Director of the Agency of Science, Technology and Training under the Ministry of Health, emphasised that phase 1 of vaccine trial is a sensitive stage. Therefore, the organisers will create the most optimal conditions for this period in terms of facilities, equipment and people.

“The Vietnam Medical Military University has established 10 specialised teams to serve the research. We have proposed the optimal monitoring plan for participants. We will spend all the best conditions on screening, examination and management of health records for them. After the injection, volunteers will be monitored for 72 hours instead of the usual 24 hours as in other vaccine trials,” said Dr. Quang.

At the launch of the clinical trial project of Nanocovax on December 10, 2020. (Photo: NDO/Thien Lam)

Explaining more about the safety of Nanocovax during the trials, Lieutenant General Quyet said that the phase 1 is mainly for testing safety, phase 2 for the immune response and phase 3 should be approved by the Ethics Council before being carried out. The director of the military medical academy also affirmed that the academy put safety first.

To protect study participants, Nanogen has purchased a VND20 billion insurance package for volunteers in the project.

It is expected that this pilot will be over by early May. This time is equivalent to the sprint of multinational corporations researching and producing vaccines in the world. The company is prepared in terms of production capacity for 30-50 million doses a year and when the pilot vaccine is approved, there will be enough vaccination output for the public.

According to a representative from Nanogen, the price of the vaccine is expected to be about VND120 thousand per dose. The company has come up with an optimal approach that can guarantee 100% COVID-19 prevention by producing nasal and eye drops vaccines, serving about 5% of the population who cannot be vaccinated, such as the elderly with underlying diseases or children under 12 years old.