SINOVAC COVID-19 Vaccine Approved for Use in Children Above 6 months of Age in Hong Kong

Rhea-AI Summary

Sinovac Biotech Ltd. (NASDAQ: SVA) has received approval from the Hong Kong Health Bureau for its COVID-19 vaccine, CoronaVac, for children aged 6 months to 3 years. This vaccine will adhere to a three-dose schedule, with no restrictions for immunosuppressed children. The vaccine has previously been authorized for minors and adults aged over 3 years since February 15, 2022, and is approved in 14 countries across Latin America, Asia, and Africa. The phase III clinical studies indicate a good safety profile and immunogenicity for the target age group.

Positive

• Approval of CoronaVac for children aged 6 months to 3 years enhances market reach.
• Good safety and immunogenicity profile reported from phase III clinical studies.

Negative

• Limited to Hong Kong market for this age group; global approval not yet indicated.

BEIJING--(BUSINESS WIRE)-- Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that based on related clinical trials and studies of vaccination for local children and adolescents, the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China has approved the Company’s COVID-19 vaccine (CoronaVac), intended for children aged 6 months to 3 years.

The vaccination schedule for this age group follows the same vaccination schedule of older children. Three doses of vaccines will be used for children aged six months to under three years of age, with the first two doses given 28 days apart followed by a third dose at least 3 months after the second dose, and there is no restriction on the application for immunosuppressed children.

The Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases under the Centre for Health Protection of the Department of Health, joined by the Chief Executive's expert advisory panel, issued the consensus interim recommendations on the use of COVID-19 vaccines for children aged 6 months or above in Hong Kong on August 1, 2022.

SINOVAC initiated its COVID-19 vaccine (CoronaVac) phase III clinical studies among children aged 6 months to 17 years since 2021. Preliminary results show the vaccine has a good safety and immunogenicity profile, with no severe adverse reaction reported 6 months after two doses of vaccination among children aged 6 months to 35 months.

CoronaVac has been authorized for emergency use for minors and adults above 3 years old in Hong Kong since February 15, 2022. As of August 2022, CoronaVac has been approved for use in minors in 14 countries in Latin America that include Chile, Colombia, Ecuador, Brazil, as well as in other countries in the Asia and Africa regions.

About SINOVAC

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/20220803005368/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 Ltd. receive for its COVID-19 vaccine, CoronaVac?

Sinovac Biotech Ltd. received approval from the Hong Kong Health Bureau for CoronaVac for children aged 6 months to 3 years.

What is the vaccination schedule for CoronaVac approved for young children?

The schedule for children aged 6 months to 3 years includes three doses: the first two doses 28 days apart and a third dose at least 3 months after the second dose.

When was CoronaVac approved for emergency use in Hong Kong?

CoronaVac was approved for emergency use for minors and adults above 3 years old in Hong Kong on February 15, 2022.

In how many countries is CoronaVac approved for minors?

As of August 2022, CoronaVac has been approved for use in minors in 14 countries across Latin America, Asia, and Africa.

What are the results of Sinovac's clinical trials for CoronaVac in young children?

Preliminary results from phase III clinical studies indicate a good safety and immunogenicity profile with no severe adverse reactions reported 6 months after two doses.