SINOVAC's COVID-19 Vaccine Obtains the Official Pharmaceutical Product Registration in Hong Kong

December 20, 2022, Hong Kong -- 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 fully registered in Hong Kong under the Pharmacy and Poisons Ordinance Cap 138, on December 16, 2022. It is one of the first COVID-19 vaccines approved for such official registration in Hong Kong.


According to the latest approval from the Government of the Hong Kong Special Administrative Region (HKSAR) of the People's Republic of China, CoronaVac®, can be supplied to registered medical practitioners and institutions for both private and public markets. CoronaVac® can be used as a fully registered pharmaceutical product for children aged 3 and above.


On 2 Aug 2022, the Secretary for Health of HKSAR of China has approved the lowering of the minimum age for receiving CoronaVac® from 3 years to 6 months old for "off-label use", marking the only inactivated COVID-19 vaccine approved to use for children as young as 6 months old in the world.


To date, SINOVAC has delivered 9.46 million doses of CoronaVac® to Hong Kong and more than 8.7 million of doses have been administrated locally. With more than 2.9 billion doses shipped globally, CoronaVac® has been approved for use in more than 60 countries and regions worldwide, of which, more than a dozen country governmental health authorities in the Asia, Latin America, and Africa regions have approved vaccine use in children.


Last month, CoronaVac® was also validated by the World Health Organization ("WHO") for extended use in children as young as three years old under the Emergency Use Listing ("EUL") Procedure. This is the youngest age that the WHO has validated for EUL of COVID-19 vaccines in the world thus far.





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 under "Category 1 Preventative Biological Products" and 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






Sinovac Biotech Ltd.


PR Team