Hanoi (VNA) –Initial results of the clinical trials of ARCT-154 show that this mRNA COVID-19vaccine is safe for healthy volunteers, an researcher said.
Phase 2 and 3a of the trialsare being carried out in Hanoi, nearby Bac Ninh province, and southern VinhLong province, engaging about 1,000 volunteers.
In Bac Ninh, the clinicaltrials have been implemented in Yen Phong district. Nearly 340 volunteers theregot the first shot of ARCT-154 as of September 29.
Reporting to a HealthMinistry delegation who visited Yen Phong on the day, Pham Thi Van Anh,Director of the Hanoi Medical University’s Centre for Clinical Pharmacology, saidthe mid-term report on the safety of ARCT-154 in Phase 1 was accepted by theHealth Ministry’s biomedical ethics council on September 20.
Initial results show thatthis vaccine is safe for healthy volunteers, she noted.
Nguyen Ngo Quang, DeputyDirector of the ministry’s Department for Science, Technology and Training,said this is a scientific study and ensures conditions necessary for nextphases to be carried out.
He added after results of thePhase 3 trials are available, the Health Ministry will make final assessmentsof ARCT-154’s protection effectiveness.
ARCT-154 is an mRNA vaccinedeveloped 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 biomedicalethics council has permitted Phase 2 and 3a of clinical trials to take place atthe same time.
Phase 3a is scheduled tofinish 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 emergencyuse authorisation for this vaccine.
ARCT-154 isthe third COVID-19 vaccine candidate put into human clinical trials in Vietnamand the first to be based on the mRNA technology./.
Phase 2 and 3a of the trialsare being carried out in Hanoi, nearby Bac Ninh province, and southern VinhLong province, engaging about 1,000 volunteers.
In Bac Ninh, the clinicaltrials have been implemented in Yen Phong district. Nearly 340 volunteers theregot the first shot of ARCT-154 as of September 29.
Reporting to a HealthMinistry delegation who visited Yen Phong on the day, Pham Thi Van Anh,Director of the Hanoi Medical University’s Centre for Clinical Pharmacology, saidthe mid-term report on the safety of ARCT-154 in Phase 1 was accepted by theHealth Ministry’s biomedical ethics council on September 20.
Initial results show thatthis vaccine is safe for healthy volunteers, she noted.
Nguyen Ngo Quang, DeputyDirector of the ministry’s Department for Science, Technology and Training,said this is a scientific study and ensures conditions necessary for nextphases to be carried out.
He added after results of thePhase 3 trials are available, the Health Ministry will make final assessmentsof ARCT-154’s protection effectiveness.
ARCT-154 is an mRNA vaccinedeveloped 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 biomedicalethics council has permitted Phase 2 and 3a of clinical trials to take place atthe same time.
Phase 3a is scheduled tofinish 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 emergencyuse authorisation for this vaccine.
ARCT-154 isthe third COVID-19 vaccine candidate put into human clinical trials in Vietnamand the first to be based on the mRNA technology./.
VNA