China approves Sinovac's vaccine for hand, foot and mouth disease
Until last month, no vaccine existed against the virus that causes hand, foot and mouth disease (HFMD), a common infectious disease often found in children. In December 2015, the China FDA approved the first vaccine against the virus, Enterovirus 71 (EV71), made by the Institute of Medical Biology at the Chinese Academy of Medical Sciences. But competition was not far behind: the agency approved a second vaccine against the virus on Monday, this one developed by Sinovac ($SVA).
Having two vaccines against HFMD made locally is a boon for China's public health and local manufacturing sectors. While other countries in Asia have reported cases and outbreaks of HFMD, China reported far more cases in 2014 than its neighbors did: 2.7 million cases and 394 deaths, according to the World Health Organization. In contrast, Japan reported 79,000 cases and no deaths, and Singapore reported 21,400 cases and no deaths.
"EV71 vaccine is the first innovative vaccine product successfully developed and commercialized by Sinovac," said Weidong Yin, Sinovac CEO and president, in a statement. "We envision opportunities to collaborate with relevant government authorities to further test the safety and immunogenicity of the EV71 vaccine in order to provide scientific evidence of using this vaccine on a broader population."
Sinovac will manufacture the EV71 vaccine at a facility in Beijing, which is expected to produce 20 million doses annually.
The vaccine is a two-dose regimen for infants aged between 6 months and 3 years. The company expects to receive its Good Manufacturing Practices license in early 2016, after which it will immediately commence production of the EV71 vaccine, Sinovac said in the statement. It expects to have the jab on the market four to five months later.
The company plans to go through the private pay sector of the Chinese vaccine market, where it has experience selling hepatitis and flu vaccines. This strategy allows Sinovac to leverage its existing sales networks to quickly boost sales of the EV71 vaccine.
- here's the Sinovac release
- read WHO's HFMD reports here (PDF) and here (PDF)
Sinovac gets China FDA new drug, production nod for HFMD vaccine
China FDA gives manufacturing nod for EV71 hand, foot and mouth vaccine