A medical worker administers the ARCT-154 vaccine to a volunteer on August 15 (Photo: VNA) Phase 2 and 3a of the trials are being carried out in Hanoi, nearby Bac Ninh province, and southern Vinh Long province, engaging about 1,000 volunteers.
In Bac Ninh, the clinical trials have been implemented in Yen Phong district. Nearly 340 volunteers there got the first shot of ARCT-154 as of September 29.
Reporting to a Health Ministry delegation who visited Yen Phong on the day, Pham Thi Van Anh, Director of the Hanoi Medical University’s Centre for Clinical Pharmacology, said the mid-term report on the safety of ARCT-154 in Phase 1 was accepted by the Health Ministry’s biomedical ethics council on September 20.
Initial results show that this vaccine is safe for healthy volunteers, she noted.
Nguyen Ngo Quang, Deputy Director of the ministry’s Department for Science, Technology and Training, said this is a scientific study and ensures conditions necessary for next phases to be carried out.
He added after results of the Phase 3 trials are available, the Health Ministry will make final assessments of ARCT-154’s protection effectiveness.
ARCT-154 is an mRNA vaccine developed basing on the ARCT-021 vaccine, whose research results in Phase 1, 2, and 3 have been reported in the US and Singapore. Given this, the biomedical ethics council has permitted Phase 2 and 3a of clinical trials to take place at the same time.
Phase 3a is scheduled to finish on November 24, and results will be reported on December 30, Quang said, noting that if good results are obtained, the research team will seek emergency use authorisation for this vaccine.
ARCT-154 is the third COVID-19 vaccine candidate put into human clinical trials in Vietnam and the first to be based on the mRNA technology./.
VNA
