November 18, 2022, Jakarta -- Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its inactivated Enterovirus Type 71 (EV71) vaccine, Inlive®, has been authorized for children between the ages of 6 months to three-years-old, by Indonesia's Food and Drug Authority (FDA) on Thursday, November 17th, 2022.
This is the first vaccine approved in Indonesia to protect from hand, foot and mouth diseases (HFMD), as well as Inlive®'s first received overseas authorization.
HFMD is a common and usually mild childhood disease; however, HFMD caused by EV71 has shown higher acute fatal incidence as well as neurologic involvement.
There have been a number of outbreaks of HFMD caused by EV71 in the Asia-Pacific region since 1997. In 2016, a HFMD outbreak occurred in Banjarmasin, South Kalimantan, Indonesia. There is no identified treatment for enterovirus infections.
A study conducted from 2008 to 2012 showed that EV71 was the causative agent of mild HFMD cases occurring across the Indonesian archipelago, according to a review published by Wiley in April 2022.
SINOVAC's Inlive® was launched in 2016. A Phase III clinical study shows that the vaccine provides 100% protection against EV71 associated hospitalization and 94.6% protection against EV71-associated HFMD.
In China, Inlive® usage has been expanded in children aged six to seventy-one months old since 2021, to provide protection for more children.
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company's website at www.sinovac.com.
Sinovac Biotech Ltd.