BEIJING-- July 15, 2022 -- Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its COVID-19 vaccine (CoronaVac) has been approved by the Brazilian Health Regulatory Agency (Anvisa) for emergency use in children from 3 to 5 years old on 13 July. These children will receive the same dose that is already applied to minors aged 6 to 17 years and adults and there is no restriction on the application for immunosuppressed children aged 3 to 5 years.
This authorization was given under comprehensive evaluations based on analysis results from all available data on the vaccine and its use in children. Analysis relied on information submitted by the Butantan Institute, with research data from Chile, where the vaccine is already used in this age group, research results on Covid-19 vaccination in Brazil, opinions from invited medical societies, real-life evidence, and published scientific literature data.
Participants in this evaluation activity were the Brazilian Society of Pediatrics (SBP), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Pneumology and Phthisiology (SBPT), the Brazilian Society of Immunizations (SBIm), and the Brazilian Association of Collective Health (Abrasco). To assist Anvisa in evaluating the vaccine, the experts from the above institutions had access to technical materials and research data on the vaccine.
CoronaVac has been authorized for emergency use for adults in Brazil since January 17, 2021. Following, the Anvisa authorized the extension of the use of the vaccine to children and adolescents 6 to 17 years of age on January 20, 2022.
As of July 14, 2022, CoronaVac is authorized for Emergency Use for minors in 14 countries and regions, including Chile, Colombia, Ecuador, Brazil, and the countries and regions in Asia and Africa.
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