The Ministry of Health on the evening of August 2 said it had approved the clinical trial protocol for the ARCT-154 vaccine against Covid-19, and is expected to begin testing on August 8 at Hanoi Medical University.
The ARCT-154 vaccine was purchased by VinGroup, through its member VinBioCare Biotechnology Joint Stock Company, from Arcturus Therapeutics, Inc., USA. This is a vaccine developed on mRNA technology to prevent Covid-19.
The ARCT-154 vaccine will be tested in all 3 phases 1, 2, 3 in Vietnam, on volunteers aged 18 and over, in which:
Phase 1, carried out at Hanoi Medical University, tested on 100 volunteers.
Phase 2, testing on 300 volunteers at trial organizations and in the community in the provinces implementing the study.
Phase 3, tested on 20,600 volunteers, including phase 3a (600 volunteers) and 3b (20,000 volunteers).
The Ministry of Health has not announced the expected time to complete these three trial phases.
Thus, this is Vietnam’s third Covid-19 vaccine to be clinically tested on humans. The first vaccine is Nanocovax of Nanogen Company, which is in the third phase of testing, and is in the process of applying for an emergency license from the Ministry of Health. The second vaccine is Covivac of the Institute of Vaccines and Medical Biologicals (IVAC), which is in phase two trials.
Another vaccine piloted for pipe processing in Vietnam is Russia’s Sputnik, with the first batch sent to Russia for quality control.
VinGroup will invest in building a vaccine factory at Hoa Lac Hi-Tech Park, Hanoi. The total investment capital of the factory is more than 200 million USD; capacity 200 million doses per year. Currently, VinBioCare has signed contracts to purchase machinery and equipment, expected to move back to Vietnam in September. The construction of the factory has also been basically completed, the installation of equipment is expected to be completed in November.
In a press release issued in the afternoon of the same day, VinGroup said that according to the schedule, in August, VinBioCare coordinated with the Department of Science, Technology and Training of the Ministry of Health to bring the vaccine into phase 3 clinical trials with a scale of 20,000 people. In December, it is expected to complete the dossier and send it to the Ministry of Health for a conditional emergency license for use in Vietnam. The first batch of vaccines will be shipped in early 2022.
Arcturus Therapeutics is a research and development unit for Covid-19 vaccines based on mRNA technology – one of the most advanced technologies in the world today.
The value of the technology transfer contract was not disclosed.
By agreement, Arcturus exclusive transfer of technology to produce a vaccine against Covid-19 named VBC-COV19-154, based on the invention of the ARCT-154 vaccine. This vaccine is capable of protecting against dangerous new strains such as Delta (India), Alpha (UK), Beta (South Africa), Gamma (Brazil)…
At the same time, Arcturus transferred to VinBioCare the production process, including: Technology know-how; Training, transferring, practicing and testing products; Supplying input materials according to Arcturus’s proprietary technology. Delivery is expected from the beginning of August.
VinBioCare is also licensed by Arcturus to manufacture all of its other Covid-19 vaccines such as ARCT-021 (1 dose) and future vaccines to serve disease prevention in Vietnam.