We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





China’s Sinovac Biotech Begins Phase 3 Trials of Coronavirus Vaccine Candidate in Brazil

By HospiMedica International staff writers
Posted on 10 Jul 2020
Print article
Image: China’s Sinovac Biotech Begins Phase 3 Trials of Coronavirus Vaccine Candidate in Brazil (Photo courtesy of Sinovac Life Sciences Co., Ltd.)
Image: China’s Sinovac Biotech Begins Phase 3 Trials of Coronavirus Vaccine Candidate in Brazil (Photo courtesy of Sinovac Life Sciences Co., Ltd.)
The Brazilian national regulatory agency, Anvisa, has granted approval to a phase 3 clinical trial to test efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co., Ltd. (Beijing, China).

Sinovac had initiated the development of an inactivated vaccine against COVID-19 named CoronaVac in January this year and was granted approval to conduct phase 1 and 2 clinical trials in China that began in April. A group of healthy adults aged 18-59 years old were vaccinated with a 0, 14 day schedule. Preliminary phase 1/2 results showed 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% seroconversion was observed in the phase 2 clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14. A Phase 2 study on elderly adults is being conducted which will be followed by child and adolescent groups. The phase 2 trial is expected to be completed at the end of 2020.

The company has partnered with several companies outside of China for phase 3 efficacy studies of CoronaVac. In Brazil, Sinovac is partnering with Instituto Butantan, a leading Brazilian producer of immunobiologic products and vaccines, which will sponsor the phase 3 vaccine trial that aims to be a pivotal study to support the licensure of the product. Anvisa’s process review included manufacturing and clinical information generated by Sinovac, and a clinical development plan and trial protocol developed by Butantan. The study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in 12 clinical sites located in several states across Brazil. The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site.

“The phase 2 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.

“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,” said Mr. Weidong Yin, Chairman, President and CEO of Sinovac.


Related Links:
Sinovac Life Sciences Co., Ltd.

Gold Member
Disposable Protective Suit For Medical Use
Disposable Protective Suit For Medical Use
Gold Member
Solid State Kv/Dose Multi-Sensor
AGMS-DM+
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Ultrasound Software
UltraExtend NX

Print article

Channels

Critical Care

view channel
Image: Researchers have developed a novel risk score for cardiovascular complications after bone marrow transplant (Photo courtesy of 123RF)

Novel Tool Predicts Cardiovascular Risks after Bone Marrow Transplantation

Every year, thousands of people undergo bone marrow transplants to potentially cure serious diseases like leukemia, lymphoma, and immune deficiency disorders. While these transplants can be lifesaving,... Read more

Surgical Techniques

view channel
Image: The Early Bird Bleed Monitoring System provides visual and audible indicators of the onset and progression of bleeding events (Photo courtesy of Saranas)

Novel Technology Monitors and Lowers Bleeding Complications in Patients Undergoing Heart Procedures

Bleeding complications at the femoral access site can significantly hamper recovery, affecting the success of procedures, patient satisfaction, and overall healthcare costs. It is crucial for surgeons... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.