Sinovac's EV71 vaccine effective against HFMD

Sinovac Biotech, Ltd., announced Phase III clinical trial results on Wednesday for its proprietary enterovirus 71 vaccine, which demonstrated 94.8 percent efficacy among infants and young children.

The study, which was meant to measure the efficacy of the vaccine against EV71-associated hand, foot and mouth disease or herpangina, was published in the Thursday edition of The New England Journal of Medicine. The vaccine demonstrated an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated HFMD or herpangina.

Sinovac's vaccine also demonstrated a 100 percent efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of deaths from the infection.

According to the National Health and Family Planning Commission of China, there were more than nine million cases of HFMD reported between 2008 and 2013. There were approximately 2,700 fatalities from the infections, more than 90 percent of which were caused by EV71 infection.

"The successful development of the EV71 vaccine is an exciting achievement by Sinovac, as it will provide an effective tool to protect infants and young children against EV71 associated HFMD, especially at the level of severe cases and potential fatalities," Fengcai Zhu, the lead author of the study, said.

Weidong Yin, the chairman, president and CEO of Sinovac, said there is no commercialized vaccine available for EV71.

"We are pleased to see that our vaccine is able to provide protection to infants and children against the EV71-associated HFMD," Yin said. "Sinovac is well prepared for the commercialization of this much needed vaccine. Once the regulatory approval is granted, we will be able to contribute to the overall control and prevention of this devastating disease."