Sinovac vaccine meets goal in late-stage trial
Sinovac's experimental vaccine caused an immune response to the infection in 95.4 percent of vaccinated subjects. The late-stage trial tested two doses of the HFMD vaccine in 10,000 healthy infants and adverse events only occurred in 2.2 percent of test subjects. The adverse events were not considered to be related to the vaccine, Reuters reports.
Sinovac plans to finalize the clinical report as a part of its documents to be filed with the People's Republic of China's State Food and Drug Administration.
Raghuram Selvaraju, an analyst with Aegis Capital, said the vaccine is expected to be approved by the end of the first quarter of 2014 and launched by the middle of 2014.
"There are usually 2 million cases (of HFMD) reported in China every year and a vaccination program would cover at least 10 million people," Selvaraju said, according to Reuters.
Sinovac said it completed its facility to manufacture the vaccine, which is ready for inspection by the SFDA.
HFMD is caused by enterovirus 71 and typically affects infants and children. The disease is spread through direct contact with the feces, saliva or mucus of an infected person, Reuters reports.