Covivac vaccine clinical trial begins
HÀ NỘI — A second Vietnamese COVID-19 vaccine entered the first phase of clinical trials on Monday morning.
Six volunteers were injected with the Covivac vaccine, researched and produced by the Institute of Vaccines and Medical Biologicals (IVAC), at the Hà Nội Medical University.
Dương Hữu Thái, director of the IVAC, said the research project for the Covivac vaccine under the Ministry of Health began in May last year on the basis of co-operation with universities, research institutes and international production organisations.
Phase one will be implemented at the Hà Nội Medical University, with 120 healthy volunteers aged 18-59 participating. Volunteers in the study will receive two injections 28 days apart.
After the first injection, the volunteers will be medically monitored for 24 hours at the Centre for Clinical Pharmacology at the Hà Nội Medical University.
After the second injection, the volunteers will be monitored for four hours.
Phase two will be conducted at the Vũ Thư District Medical Centre in the northern province of Thái Bình. Volunteers participating in the study at this stage will include 300 healthy people, aged 18-75, of which those age 60-75 will account for about one third.
Forty-three days after phase one, if results are good, the optimal dose level will move to phase two research.
The Covivac vaccine is a liquid vaccine with or without adjuvants, without preservatives, with the production technology of Newcastle vector vaccine, based on production technology on chicken eggs with embryos. This technology is also used to produce seasonal flu vaccines in Việt Nam.
Director Thái said preclinical studies in India, the US and Việt Nam so far had shown safety and effectiveness. The Covivac vaccine antibody also protects against a variant of the SARS-CoV-2 virus from the UK and South Africa.
After seven months of research, from May to December last year, the IVAC has successfully produced three consecutive batches on a large scale, from 50,000 to 100,000 doses per batch. According to calculations, each dose of the vaccine will not cost more than VNĐ60,000 (US$2.6).
Covivac is the second COVID-19 vaccine in Việt Nam to conduct clinical trials.
Previously, the Nano Covax vaccine of the Nanogen Company has started phase two of its trial.
During the trial vaccination of Covivac on Monday morning, six volunteers received the first shot. Professor Trần Văn Thuấn, Deputy Minister of Health said the clinical trial of the vaccine was an important milestone of the COVID-19 vaccine research and production process.
“I suggest the implementing units strictly follow the procedures and techniques for implementing vaccine clinical trials and closely monitor volunteers after vaccination. The Ministry of Health will direct, oversee the entire research implementation process and review the results of the mid-term phase one trial to approve the implementation of phase two to ensure the safety of the volunteers,” he said. — VNS