Эффективность и безопасность вакцин для профилактики ротавирусной инфекции

Ротавирусная инфекция вызывает острый гастроэнтерит и является одной из основных причин приводящей к смерти от тяжелой дегидратирующей диареи у детей младше 5 лет во всем мире. Живые аттенуированные ротавирусные вакцины являются единственным средством профилактики тяжелых форм заболевания. Цель работы — анализ двадцатилетнего опыта иммунопрофилактики ротавирусной инфекции в мире. Представлены результаты анализа эффективности и безопасности при долговременном применении вакцин Rotarix® (Бельгия) и RotaTeq® (США) против ротавирусной инфекции в государствах Европейского региона ВОЗ, Европейского Союза (ЕС) и других стран. Рассмотрены вопросы разработки корреляционных показателей иммунной защиты вакцин, а также экспертная оценка эффективности и безопасности новых вакцин Rotavac® и Rotasiil® (Индия) в клинических исследованиях. Проведен анализ мирового опыта их применения в странах, в которых детская смертность от диареи не регистрируется. Обобщены результаты клинических исследований по применению новых вакцин, преквалифицированных ВОЗ в 2018 г., в регионах, в которых регистрируется высокая детская смертность от диареи. Обоснована целесообразность массовой вакцинации. Установлено, что вакцинация не только уменьшает количество случаев госпитализаций иммунизированных детей, но и обеспечивает формирование популяционного иммунитета. Вакцины Rotarix® и RotaTeq® разрешены к применению или включены в национальные календари профилактических прививок многих стран, но вакцинация в большинстве государств не является обязательной. Охват вакцинацией в странах ЕС — 24 %. Для снижения имеющегося риска предназначены альтернативные схемы вакцинации живыми аттенуированными вакцинами на основе штаммов, выделенных от новорожденных детей, а также парентеральными ротавирусными вакцинами, которые не способны к размножению в кишечнике. Сделан вывод о том, что внедрение живых ротавирусных вакцин в календарь профилактических прививок должно сопровождаться изучением частоты возникновения инвагинации тонкого кишечника до и после введения массовой иммунизации и проведением мероприятий по активному фармаконадзору.

ротавирусная инфекция, живые аттенуированные вакцины, нереплицирующиеся вакцины, эффективность и безопасность вакцин, инвагинация, популяционный иммунитет

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