Sinovac’s COVID-19 Vaccine Enters Phase III Clinical Trials
CoronaVac, the COVID-19 vaccine candidate by the Chinese vaccine maker Sinovac has received approval for starting a phase-3 clinical trial in Brazil.
Sinovac said on Monday that almost 9,000 healthcare professionals working in COVID-19 specialized facilities in 12 clinical sites located in several states in Brazil will be recruited in this study.
The company added that, after ethical approval is obtained from each clinical site, the inclusion of participants is scheduled to start this month.
The study will be conducted in partnership with a leading Brazilian producer of vaccines, Instituto Butantan.
The Chairman, President, and CEO of Sinovac, Weidong Yin said in a statement, “In our mission of supplying vaccines to eliminate human diseases, and our commitment to developing vaccines for global use, we are able to move one step further with the trials, and we are pleased to advance to Phase III trials with Butantan.”
Due to the public emergency, the application for the phase-3 was fast-tracked by the Brazilian National Regulatory Agency, Anvisa.
After AstraZeneca and China National Pharmaceutical Group, Sinovac’s Covid-19 vaccine candidate has become only one of three such vaccine candidates to advance to phase-3 trial.
Moderna, the US-based pharmaceutical company is also in plans for starting a phase III trial of its Covid-19 vaccine candidate this month.
On January 28, the development of an inactivated vaccine against Covid-19 was initiated by a wholly-owned subsidiary of Sinovac Biotech Ltd., in Brazil, Sinovac Life Sciences Co., Ltd. (Sinovac LS).
In Jiangsu province of China, on April 16, the phase-1 and phase-2 trials began. In the trials, 18-59 years old healthy adults were vaccinated.
The trial demonstrated a good safety profile for the vaccine candidate as there was no serious adverse event after vaccinating a total of 743 volunteers in the trials, according to the preliminary phase I/II result.
14 days after completion of a two-dose vaccination on day 0 and day 14, over 90 percent of seroconversion was observed in phase II clinical trial.
