Institute of Vaccines and Medical Biologicals (IVAC) has just said that the unit has been implementing a clinical trial of Covivac vaccine in human phase 1.
Covivac vaccine is prepared by using chicken egg with embryos by IVAC.
This is the second Covid-19 vaccine in Vietnam to clinical trials on human. The clinical trial unit is the Center for Clinical Pharmacology, Hanoi Medical University and National Institute of Hygiene and Epidemiology.
In phase 1, there will be 120 volunteers, aged between 18 and 59, participating in the trial. These volunteers will receive 2 injections/0.5ml (vaccine or placebo injection) 28 days apart and will be given a physical exam 8 times in 12 months, taking blood samples 7 times to assess health status and measure antibody after injecting. Phase 1 is expected to end in June. If the results are good, Phase 2 will be launched from July to October.
Phase 2 will be implemented in Thai Binh province with about 300 volunteers. Phase 3 will be implemented by the end of 2021, depending on the situation of the disease; it can be carried out domestically or overseas. According to the process developed by IVAC, if the 3 phases of clinical trials on humans go smoothly, it is expected that in the first quarter of 2022, Covivac vaccine will be brought to the market at the price not exceeding 60,000 VND/dose.
It is known that Covivac vaccine is prepared by IVAC by using chicken egg with embryo technology, in liquid with or without adjuvants, without preservatives. This is the technology used by IVAC to produce a variety of vaccines, including influenza vaccines that are being circulated in the market. After 7 months of research (from May to December 2020), IVAC produced 3 batches with a scale from 50,000 to 100,000 doses/ lot. Results of preclinical studies on toxicity, immune response, and protective effects on experimental animals in India, the United States and Vietnam have shown safety and efficiency. Preclinical reviews showed that vaccines response good immune, safe, and effective to protect against a variant of SARS-CoV-2 virus from UK and South African.
MY HAU