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Sinovac Approved to Start Phase III Trial of COVID-19 Vaccine in Brazil
Sinovac Life Science (NSDQ: SVA), a Beijing vaccine company, has been approved to start a 9,000 person Phase III trial of its inactivated COVID-19 vaccine in Brazil. The trial, which will be conducted by Sinovac's Brazilian partner, Instituto Butantan, will enroll healthcare workers to provide a faster read of the vaccine's efficacy, though Sinovac did not disclose the proposed length of the trial. Sinovac said it has partnered with other ex-China companies to conduct additional Phase III efficacy tests.
In the ongoing China Phase II trial, 743 healthy volunteers were enrolled. The vaccine produced a 90% seroconversion 14 days after completion of a two-dose vaccination at day 0 and day 14. A Phase II study on elderly adults is being conducted, which will be followed by child and adolescent groups. The Phase II trial is expected to be completed at the end of 2020.
The Brazil trial will be conducted at twelve clinical sites located in several states. Once ethical approval is obtained from each clinical site, the trial will begin enrolling patients. Butantan makes immunobiologic products and vaccines.
On July 3, 2020, the Brazilian National Regulatory Agency, Anvisa, issued its approval after two weeks of review. Anvisa is a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and qualified as a full functional regulatory agency for the World Health Organization prequalification process.
"The Phase III clinical trial approval is a demonstration that the Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide," said Dr. Dimas Covas, Director of Instituto Butantan.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, added “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.”
Sinovac provided the following timeline of CoronaVac ,its COVID-19 vaccine:
• On January 28th, 2020, Sinovac started development of the vaccine. Preclinical study results were published in the peer-reviewed academic journal Science.
• On April 13th, 2020 China's NMPA granted approval for Phase I and II clinical trials in China.
• The trials started on April 16, 2020 in Jiangsu Province, enrolling healthy adults aged 18-59 years old. They were vaccinated with a 0, 14 day schedule.
• Preliminary Phase I/II results were reported on June 15, 2020. There were no serious adverse events after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate.
Sinovac Life Science is a new name for the company, which focuses on human vaccines. It is a wholly owned subsidiary of Sinovac Biotech (Hong Kong) Limited.
See our other articles on Sinovac.