Chinese HFMD vaccine impresses in Phase III

Things happen quickly when China coordinates the cogs of its state infrastructure. One year ago a state-funded vaccine for one cause of hand, foot and mouth disease (HFMD) reported Phase I data. Phase II results followed in January, and now Phase III data has arrived.

The latest phase of the whirlwind development of a enterovirus 71 (EV71) vaccine was reported in The Lancet. EV71 is one cause of HFMD, a disease that has killed more than 2,000 people over the past decade. China began tracking HFMD more closely in 2008, and two years later it documented 1.8 million cases and more than 900 deaths. Concern about EV71 and HFMD led to China's National Major Infectious Disease Program funding development of a vaccine.

Results from the vaccine have impressed at each stage of development, culminating in Phase III data from 10,000 children showing it offered 90% efficacy against EV71-associated HFMD. EV71 is also associated with other diseases--such as aseptic meningitis or encephalitis--and the shot was 80% effective at preventing these cases. Adverse events were comparable to the placebo group. With safety and efficacy clearly demonstrated, thoughts have turned to how to use the vaccine.

"The next step is to assess the appropriateness of including an EV71 vaccine in China's national immunization programme, including a cost-effectiveness analysis," Australian scientists wrote in a comment piece in The Lancet. Importantly, none of the children who received the vaccine were admitted to the hospital, suggesting the shot can help reduce EV71-associated healthcare costs. As EV71 has a relatively low morbidity and mortality, a potential drop in hospitalizations is important when considering the vaccine's value.  

While the Phase III trial was a success, some limitations of the vaccine may restrict its use. The study team looked at one year of HFMD cases and found EV71 was linked to a small portion of the incidents. Consequently, the authors caution that widespread vaccination may fail to bring HFMD under control.

- here's the abstract
- read Reuters' take