SINOVAC COVID-19 Vaccine Is Authorized for Emergency Use in Kids Aged 3-5 In Brazil

Rhea-AI Summary

Sinovac Biotech Ltd. (NASDAQ: SVA) announced that its COVID-19 vaccine, CoronaVac, received emergency use approval for children aged 3 to 5 from Brazil's Health Regulatory Agency (Anvisa) on July 13. The same dosage for minors 6 to 17 and adults will be used, with no restrictions for immunosuppressed children. This decision followed extensive evaluations involving data from multiple sources, including the Butantan Institute and real-life evidence from Chile. As of July 14, 2022, CoronaVac is approved for emergency use in minors across 14 countries.

Positive

• Emergency use approval for CoronaVac in children aged 3-5 in Brazil.
• Same dosage for children 3-5 as for 6-17 and adults.
• Extensive evaluations utilized data from multiple credible institutions.
• CoronaVac is approved in 14 countries for emergency use in minors.

Negative

• None.

BEIJING--(BUSINESS WIRE)-- 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.

About SIONVAC

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 and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, hepatitis A vaccine, 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) was 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220714005372/en/

Sinovac Biotech Ltd.

PR Team

pr@sinovac.com

ICR Inc.

Bill Zima

U.S.: 1-646-308-1707

william.zima@icrinc.com

Source: Sinovac Biotech Ltd.

FAQ

What recent approval did Sinovac Biotech receive for its COVID-19 vaccine, SVA?

Sinovac Biotech's COVID-19 vaccine, CoronaVac, received emergency use approval for children aged 3 to 5 in Brazil on July 13.

How does the dosage for children compare to that for adults for CoronaVac?

Children aged 3 to 5 will receive the same dosage of CoronaVac as that given to adults and minors aged 6 to 17.

In how many countries is CoronaVac authorized for emergency use in minors?

As of July 14, 2022, CoronaVac is authorized for emergency use in minors in 14 countries.

What organizations were involved in the evaluation of CoronaVac for children?

The evaluation involved expert opinions from several Brazilian pediatric and infectious disease societies.

When was the initial approval for CoronaVac in Brazil?

CoronaVac was initially approved for adult use in Brazil on January 17, 2021.