Sinovac’s COVID-19 Vaccine Gets Nod for Phase-3 Trial

Sinovac, gets approval for starting the phase-3 trial of CoronaVac. In phase I and II trials, CorornaVac has demonstrated a good safety profile for the vaccine candidate and no serious adverse events were reported.

Sinovac, the Chinese vaccine maker received a nod for commencing the phase-3 trial of its COVID-19 vaccine candidate, CoronaVac, in Brazil.

This study will recruit nearly 9,000 healthcare professionals working in CPVID-19 specialized facilities in 12 clinical sites located in several states in Brazil, according to Sinovac.

Coronavirus
Coronaviruses infect animals, humans, and birds. Human coronaviruses, such as SARS, MERS, and 2019-nCoV cause respiratory distress and even death. The S protein is the infectious agent of the virus.

‘Phase III vaccine trials will allow in taking the commitment to develop vaccines forward, and to fulfill the mission of supplying enough vaccines to eliminate human diseases.’

The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site, the company added.

The study will be conducted in partnership with Instituto Butantan, a leading Brazilian producer of vaccines.

"We are pleased to advance to Phase III trials with Butantan, which will allow us one step further to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases," Weidong Yin, Chairman, President and CEO of Sinovac, said in a statement.

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The Brazilian National Regulatory Agency, Anvisa, fast-tracked the application for the phase-3 trial due to the public health emergency.

Sinovac's Covid-19 vaccine candidate has become only one of three such vaccine candidates to advance to phase-3 trial after AstraZeneca and China National Pharmaceutical Group.

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The US-based Moderna is also planning to start a phase-3 trial of its Covid-19 vaccine candidate this month.

Sinovac Life Sciences Co., Ltd. (Sinovac LS), a wholly owned subsidiary of Sinovac Biotech Ltd., in Brazil initiated the development of an inactivated vaccine against Covid-19 on January 28.

The phase-1 and phase-2 trials commenced on April 16 in Jiangsu province of China.

A group of healthy adults aged 18-59 years old were vaccinated in the trials.

According to the preliminary phase I/II results, there was no serious adverse event after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate.

Over 90 percent seroconversion was observed in the phase II clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14.

Source-IANS