Особенности и проблемы регистрации и применения препаратов для профилактики COVID-19 в период пандемии

В конце 2019 г. в городе Ухань (провинция Хубэй) в Китае началась вспышка новой коронавирусной инфекции COVID-19, которая переросла в пандемию. В кратчайшие сроки, в том числе отечественными производителями, были разработаны вакцины для профилактики COVID-19 и проведена вакцинация населения. В условиях пандемии ускоренная регистрация вакцин является одним из важных факторов, сокращающих срок их выведения на рынок в целях массовой вакцинации. Опыт быстрой разработки и внедрения вакцинных препаратов в рутинную практику важен не только для управления текущей пандемией, но и окажется ценным в случае будущих пандемий, вероятность которых крайне высока. Цель работы – анализ основных проблем оценки безопасности и эффективности вакцин для профилактики COVID-19 при их регистрации и широком применении в условиях пандемии и продолжающейся эволюции вируса SARS-CoV-2. Учитывая скорость разработки и внедрения в практику здравоохранения вакцин для профилактики COVID-19 в условиях пандемии, в процессе их применения был выявлен ряд проблем, которые требуют дальнейшего исследования. Проведенный анализ показал, что к числу наиболее важных проблем относятся необходимость ускоренной оценки безопасности и иммуногенности новых вакцин; отсутствие иммунологических маркеров эффективности; снижение антительного иммунитета с течением времени и, соответственно, необходимость определения параметров ревакцинации и вакцинации переболевших; появление мутантных вариантов SARS-CoV-2. Отмечено, что одним из важных аспектов является разработка рекомендаций по смене штаммового состава в зарегистрированных вакцинах для профилактики COVID-19. Сделан вывод о том, что в условиях пандемии в эволюции вируса определенную роль играет уровень популяционного иммунитета, в том числе сформировавшийся в результате вакцинации. Регулярная ревакцинация может иметь существенное значение при вероятном переходе COVID-19 к модели сезонного заболевания.

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