KUALA LUMPUR – Phase 3 of the Covid-19 vaccine clinical trials are cleared to start today in nine hospitals, involving 3,000 adult volunteers, said the Health Ministry.
In a statement today, the ministry said the trials are sponsored by the Institute of Medical Biology Chinese Academy of Medical Sciences, and will be overseen by the Clinical Research Institute, where half of the volunteers will receive two doses of inactive vaccines, while the rest get two doses of a placebo.
It added that the placebo is a product that is similar to a vaccine but does not contain the SARS-CoV-2 antigen.
“Vaccine and placebo recipients will get two doses on the upper arm in a 14-day interval. They have to come for six visits in two months, and a follow-up 13 months later.”
Even after receiving more than 7,000 calls from interested members of the public, the ministry said volunteer recruitment is still open to ensure that the trials have 3,000 participants who fit the bill and are able to commit for 13 months.
The Phase 3 trials were approved by the ministry via the Medical Review and Ethics Committee on December 14, and the National Pharmaceutical Regulatory Agency on January 8.
The research vaccines arrived on January 23, and will be sent to the respective hospitals from today. The first batch of volunteers is expected to start receiving the shot by the end of this month or early February.
The Institute of Medical Biology Chinese Academy of Medical Sciences has carried out Phases 1 and 2 trials in China, while Phase 3 trials will also be carried out in Brazil.
China has at least five vaccines, developed by Sinovac, Sinopharm, CanSino Biologics and the Chinese Academy of Medical Sciences, in late-stage trials. – The Vibes, January 27, 2021
