China-based Sinovac has announced receiving pre-qualification (PQ) status from the World Health Organization (WHO) for its varicella vaccine, marking the first of its kind in China to achieve this recognition. This follows previous PQs granted to Sinovac’s inactivated hepatitis A vaccine and Sabin strain inactivated polio vaccine, as well as the inclusion of its COVID-19 vaccine CoronaVac on the WHO’s Emergency Use List (EUL).
Vaccine Profile
Sinovac’s varicella vaccine is produced by inoculating the varicella-zoster virus attenuated strain (international Oka strain) into SV-1 human diploid cells independently developed by Sinovac. The virus is harvested using pure physical technology with core patents and is freeze-dried with a stabilizer. The results of a Phase III clinical study showed that the antibody positive conversion rate in children aged 1-12 years after vaccination was 97.1%. The vaccine demonstrated a protective effect of 87.1% against confirmed varicella cases, 89.2% against breakthrough varicella cases, and 100% against moderate and severe varicella cases, with good safety.
Market Context
Fineline Info & Tech data indicates that Sinovac’s varicella vaccine was approved in China in December 2019. Other companies with approved varicella vaccines in China include GlaxoSmithKline, the Beijing Institute of Biological Products, and the Chengdu Institute of Biological Products. The WHO pre-qualification underscores Sinovac’s commitment to meeting global health standards and expanding access to essential vaccines.-Fineline Info & Tech
