Sinovac Biotech announced the China National Medical Products Administration (NMPA) has approved and issued a Product license for the Company’s varicella vaccine to prevent the varicella-zoster virus in children from 1 to 12 years old.
“The approval of our varicella vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population,” Weidong Yin, Chairman, President and CEO of Sinovac, said. “This is the first vaccine product approved by the Chinese government after the issuance and implementation of the Vaccine Management Law in China. Our ability to continue to gain approval for our products since the government issued the Vaccine Management Law and implemented stringent management of the vaccine industry is a testament to the strength of our operations and the quality of our products. Moreover, with approximately 40 countries including varicella vaccines in their government sponsored national immunization programs, we have a positive outlook in our ability to provide varicella vaccines to markets outside of China and generate additional sources of growth.”
Varicella, commonly known as “chickenpox,” is a highly contagious infectious disease caused by the varicella-zoster virus. The disease is spread by direct contact or through respiratory droplets. It is characterized by the appearance on the skin and mucous membranes of successive crops of lesions that are easily broken and become scabbed. Varicella usually affects children and is relatively benign, but complications may arise in the form of pneumonia and encephalitis. After infection, the virus may be reactivated and develop into herpes zoster, commonly known as “shingles,” in older adults.
Sinovac’s Varicella Vaccine is derived from Oka strain and performed in the Company’s proprietary Human Diploid Cell. Sinovac completed pre-clinical studies of a human vaccine against varicella and was approved to conduct human clinical trials in October 2015. A phase I clinical trial was conducted and completed in 2016. A phase III efficacy study conducted among 6000 subjects in 2017 shows the protection rate of the vaccine is 87.1%, which was published in Clinical Microbiology and Infection.
