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Vietnam begins clinical trials of COVID-19 vaccine based on tech transfer from US

Vietnam begins clinical trials of COVID-19 vaccine based on tech transfer from US

Sunday, August 15, 2021, 16:03 GMT+7
Vietnam begins clinical trials of COVID-19 vaccine based on tech transfer from US
This image shows a woman ready to receive a COVID-19 vaccine shot in Vietnam. Photo: Quang Dinh / Tuoi Tre

Vietnam’s Hanoi Medical University on Sunday kicked off the first phase of clinical trials of a COVID-19 vaccine developed by Arcturus Therapeutics, a U.S. firm that has transferred the vaccine technology to a Vietnamese company.

The vaccine, ARCT-154, will undergo the three-phase trials in Vietnam following the technology transfer from Arcturus to Vinbiocare Biotechnology JSC (Vinbiocare), a company under the Southeast Asian country’s leading private conglomerate Vingroup.

The first trial phase will enlist 100 volunteers, while 300 and 20,600 people will participate in the second and third stages, respectively.

The first-phase volunteers began to receive the first shots at the university’s Clinical Testing Center on Sunday.

Volunteers must be healthy adults aged 18 to 59, have no underlying medical conditions or history of SARS, MERS, or COVID-19.

They are also required not to take any medications on a regular basis and have yet to be vaccinated against COVID-19.

ARCT-154 is a self-amplifying mRNA vaccine designed to act against various coronavirus variants, including the highly contagious Delta, according to the vaccine developer.

The Ministry of Health approved the clinical trials of the ARCT-154 in Vietnam when it had entered clinical trials in the U.S., Singapore, and other countries.

In the past clinical trials, the vaccine yielded satisfactory seroconversion rates and met the requirements on safety and tolerability.

Upon completion of the trials in Vietnam, Vinbiocare will submit the results to the ministry for approval for emergency use of the vaccine in the country in December.

Vinbiocare is building a factory capable of producing 200 million ARCT-154 doses per year in Hanoi’s Hoa Lac Hi-Tech Park at a cost of over US$200 million.

The first batch of the vaccine is expected to be made available in early 2022.

ARCT-154 is the third COVID-19 vaccine to have entered clinical trials in Vietnam and the first to be developed with mRNA technology.

The first COVID-19 vaccine tested on humans is Nano Covax, developed domestically by Ho Chi Minh City-based Nanogen Pharmaceutical Biotechnology JSC based on recombinant DNA/protein technology.

Nano Covax is in late-stage clinical trials after results from the first two phases showed that all volunteers developed antibodies against the novel coronavirus.

State President Nguyen Xuan Phuc has asked health authorities to promptly authorize Nano Covax to make the first Vietnamese vaccine available soon.

The second vaccine, Covivac, made by Vietnam’s Institute of Vaccines and Medical Biologicals, is expected to begin phase-three testing in September.

The country is accelerating immunization to drive back the COVID-19 spread, with the numbers of people receiving the first and second shots topping 12.5 million and 1.2 million, the health ministry reported on Saturday evening.

Vietnam has targeted to secure 150 million doses of vaccines to inoculate two-thirds of its 98-million population to reach herd immunity, said the ministry.

However, the country has so far obtained only over 20.5 million doses from different sources, including the COVAX Facility, contractual purchases, and donations.

Since the pandemic hit the country in early 2020, Vietnam has recorded 265,464 COVID-19 cases, including 5,437 deaths, ranking 80th and 69th in terms of infection and fatality rates among 222 countries and territories in the world, according to the health ministry.

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Vinh Tho / Tuoi Tre News


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