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Vietnam to start clinical trials of mRNA COVID-19 vaccine

The Hanoi Medical University will on August 15 start the first phase of clinical trials of COVID-19 vaccine ARCT-154, a mRNA vaccine developed by US company Arcturus Therapeutics, Inc, which transferred the technology to a company in Vietnam.
According to the ministry, ARCT-154 is a self-amplifying mRNA vaccine designed to act against coronavirus variants, including the Delta.

The clinical trials will be carried out in three phases with the participation of 21,000 volunteers, including 100 in phase one, 300 in phase two and 20,600 in phase three.

On August 2, the MoH approved a proposal on human clinical trials of the ARCT-154 vaccine. The vaccine's production technology was bought by VinBioCare Biotechnology JSC, a subsidy of Vietnam's leading multisectoral conglomerate Vingroup.

VinBioCare has begun construction of a vaccine production facility in Hanoi’s Hoa Lac Hi-Tech Park with total investment of more than 200 million USD. The facility has a designed capacity of 200 million doses per year.

The installation of equipment for the facility is expected to be completed in November.

After completing the three-phase human clinical trial, VinBioCare said it would send the results to the ministry for approval for emergency use across the country in December. The first batch of vaccines is expected to be available in early 2022.

ARCT-154 is the third COVID-19 vaccine put into human clinical trials in Vietnam and the first developed with mRNA technology.

The first COVID-19 vaccine tested on humans is Nanocovax, a product of Nanogen Pharmaceutical Biotechnology JSC based on recombinant DNA/protein technology. The vaccine has gone through three phases of the clinical trials with more than 13,620 volunteers. Results from the first two trial phases showed that all volunteers developed antibodies against SARS-CoV-2.

The second vaccine, Covivac, developed by the Institute of Vaccines and Medical Biologicals (IVAC), is expected to enter phase three in September 2021./.