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Chinese vaccine manufacturer Sinovac has been licensed to launch phase 3 clinical trials of its COVID-19 product, CoronaVac, in Brazil
Chinese vaccine producer Sinovac has obtained clearance from its COVID-19 vaccine product, CoronaVac, in Brazil, to launch phase 3 clinical trials.
The research would employ about 9,000 healthcare practitioners employed in specialist facilities at CPVID-19 in 12 clinical sites based in many Brazilian states, Sinovac said Monday.
Participant participation is expected to begin this month after every trial location has received ethical clearance, the organization said.
The study is being carried out in partnership with Instituto Butantan, a leading Brazilian vaccine producer.
"We are pleased to advance to Phase III trials with Butantan which will allow us to take a further move towards our commitment to developing vaccines for global use and towards our goal to provide vaccines to eradicate human diseases," said Weidong Yin, Chairman, President and CEO of Sinovac.
Thanks to the public safety situation, the Brazilian National Regulatory Agency, Anvisa, has fast-tracked the proposal for the phase-3 study.
Following AstraZeneca and the China National Pharmaceutical Group, Sinovac's Covid-19 vaccine candidate has been just one of three such vaccine candidates to progress to phase-3 studies.
The US-based Moderna is also planning to launch this month a phase-3 trial of their Covid-19 candidate for the vaccine.
Sinovac Life Sciences Co. , Ltd. (Sinovac LS), a wholly-owned company of Sinovac Biotech Ltd., started producing an inactivated Covid-19 vaccine in Brazil on January 28th.
Phase-1 and Phase-2 trials began in China's Jiangsu province on April 16.
For the studies a sample of stable individuals between the ages of 18 and 59 is vaccinated. Due to the findings of the provisional step I / II, after vaccinating a total of 743 participants in the experiments, there was no significant adverse incident that indicated a strong health profile for the applicant for the vaccine.
In phase II clinical trial, more than 90 percent seroconversion was observed 14 days after a two-dose vaccination was completed on day 0 and day 14.