The vaccine is made from inactivated enterovirus 71 (EV71), another major cause for HFMD aside from the widely known coxackievirus. Sinovac aims to start the production at the end of January, after its vaccine facility, which is located in Changping in suburb Beijing, receives good manufacturing practice certification. The annual capacity is expected to reach 20 million vials.
“Preclinical and clinical studies showed great efficacy and safety of our EV71 vaccine. It targets children between 6-month old and 3-year old, covering a huge market in China” Yang Guang, Sinovac investor relations director, told Biopharma-reporter.
Thanks to China’s newly eased birth control policy, which allows a family to have up to two children, Sinovac estimates that around 17 million children will receive the EV71 vaccine each year.
EV71 is a “category II” vaccine in China, meaning the cost is paid by the receivers. Yang said the price tag for EV71 vaccine will be higher than CNY85($12.9).
Founded in 2001 and listed in Nasdaq, Sinovac is a subsidiary of Sinobioway, a Beijing-based company focusing on the biotech industry. Sinovac is experienced in vaccine development and manufacturing. Its major products include Anflu (inactivated influenza vaccine), Panflu (inactivated H1N1 influenza A vaccine) and Healive (inactivated hepatitis A vaccine).
“Thanks to our experiences, we were able to overcome many challenges during the EV71 vaccine development, including strain selection and optimization, as well as virus inactivation and purification,” Yang said.
To ensure safety during manufacturing, Yang said Sinovac established internal standards, which are stricter than the GMP standards.
“We have various quality control checklists to ensure quality and safety,” he added.
Vaccines in China
China’s vaccine industry was shadowed by a quality scandal in late 2013, when 17 infants were reported dead after being vaccinated using hepatitis B vaccine from a Shenzhen-based major vaccine producer Biokangtai.
While China is certainly a major market for the EV71 vaccine, Sinovac is also eyeing on other regions with high incidence of HFMD.
“We plan to export the vaccine to other countries, especially to the countries in Asia Pacific. Young children in many countries in the region such as Australia, Malaysia, Singapore and Taiwan are threatened by HFMD,” Yang said.