A new vaccine to protect children against the Hand, Foot and Mouth Disease (HFMD)-causing virus enterovirus 71 (EV71) has been developed in China. HFMD is common in the Asia-Pacific region, and serious cases of the viral disease can lead to potentially fatal meningitis and encephalitis. Currently, there's no effective vaccine against the disease that recently infected 35,000 people in an outbreak in China in June 2012, but trial data published in The Lancet shows the new inactivated alum-adjuvant EV71 vaccine, made by Beijing Vigoo Biological, to offer 90% protection against the virus. The vaccine also provided 80.4% protection against EV71-associated disease for at least 12 months. However, the vaccine does not protect against coxsackievirus A16 – the most common cause of the disease in the US (CDC). It's also not known whether the vaccine also works on other regionally specific strains of EV71 outside of mainland China.
The trial enrolled over 10,000 children aged 6-35 months at four sites in China. "This multicenter randomized controlled trial done in China is a notable advance in protection against EV71," Nigel Crawford and Steve Graham, paediatricians at the Murdoch Childrens Research Institute in Melbourne, wrote in an accompanying commentary. "The major effect of this vaccine will be to reduce hospital admissions."
Beijing Vigoo Biological's vaccine is up against another EV71 vaccine, made by Sinovac Biotech, that has also undergone phase III testing in China. Fengcai Zhu, Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, presented Phase III top-line results of the Sinovac EV71 vaccine at this year's World Vaccine Congress & Expo USA 2013 (press release).
Also in the pipeline is an EV71 vaccine that Takeda acquired following their recent acquisition of Inviragen. Dr Joseph Santangelo, Chief Operating Officer, InViragen, presented at the World Vaccine Congress 2012 in Washington on the development of EV71 vaccines. You can watch his presentation below:
If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Asia 2013, 17-20 June 2013, Singapore. There will be a presentation on âHand, Foot, and Mouth Disease: Overcoming challenges of conducting clinical studies for HFMD vaccine' from Shanshan Samantha Dong, Sinovac Biotech.