Results on Enterovirus 71 for HFM Disease published in NEJM-Sinovac Biotech
Phase III clinical trial results for Enterovirus 71 vaccine, from Sinovac Biotech, for treatment of Hand, Foot and Mouth Disease, have been published online in the February 27th issue of The New England Journal of Medicine. The clinical results showed the efficacy of the vaccine against EV71-associated HFMD, or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina.
As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities. The primary endpoint was the occurrence of EV71-associated HFMD, or herpangina. The results showed the vaccine can provide protection against EV71 associated HFMD in infants and children. See: "Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China," Fengcai Zhu et al. The New England Journal of Medicine, online 27 February 2014