Considerations for developing an immunization strategy with enterovirus 71 vaccine

Abstract

Enterovirus 71 (EV71) is a common pathogen for hand, foot, and mouth disease (HFMD), which has significant morbidity and mortality, and for which children aged 6-59 months age are at highest risk. Due to lack of effective treatment options, control of EV71 epidemics has mainly focused on development of EV71 vaccines. Clinical trials have been completed on 3 EV71 vaccines, with trial results demonstrating good vaccine efficacy and safety. When EV71 vaccine is approved by China's national regulatory authority, an evidence-based strategy should be developed to optimize impact and safety. An immunization strategy for EV71 vaccine should consider several factors, including the target population age group, the number of doses for primary immunization, the need for a booster dose, concomitant administration of other vaccines, economic value, program capacity and logistics, and public acceptance. Once EV71 vaccines are in use, vaccine effectiveness and safety must be monitored in large populations, and the epidemiology of HFMD must be evaluated to assure a match between vaccination strategy and epidemiology. Evaluation in China is especially important because there are no other EV71 vaccines globally.

Is a multivalent hand, foot, and mouth disease vaccine feasible?

“…The annual economic burden of EV-A71-associated HFMD amounts to US$161-323 million per year. 194 This figure is still optimistic since it does not take into account the fact that the number of annual EV-A71 cases is likely underestimated, or the number of HFMD cases caused by other enteroviruses, or the costs linked to sequelae and fatalities. Clinical trials have revealed that the administration of 400 units (1 mg) dose of EV-A71 vaccine twice achieved efficacy.…”

“…195 Another recent study reports that immunization with an EV-A71 vaccine would be cost-effective if vaccination costs were US$75 per dose for 90% efficacy. 194 With this profit margin and the new emerging vaccine markets in the Asia-Pacific region, the global vaccine companies should become interested in manufacturing monovalent, bivalent and ultimately multivalent HFMD vaccines.…”

Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial

“…39 However, in both arms the rate of adverse events was dramatically lower following booster injections, 40,41 as has been previously reported for other vaccines. 39,42 The Cochrane-Armitage analysis showed that in the vaccine group age was associated with the occurrence of adverse effects. In general, solicited adverse reactions were more frequent in younger patients, including fever, diarrhea, ANV, IDF, redness, swelling, and induration.…”

Condition and Prospects of Development of Vaccines for Specific Prevention of Enterovirus (Nonpolio) Infection

“…Краткое описание 3-й фазы испытаний и трех вакцин, полученных разными производителями Китая [38], представлены в таблице 1.…”