biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2022-22-4-361-381biopreparat-465Research ArticleСтатьиОсобенности и проблемы регистрации и применения препаратов для профилактики COVID-19 в период пандемииAspects and issues of marketing authorisation and use of medicinal products for COVID-19 prevention during the pandemichttps://orcid.org/0000-0001-6624-2692СолдатовА. А.SoldatovA. A.

Солдатов Александр Алексеевич, д-р мед. наук. 

Петровский б-р, д. 8, стр. 2, Москва, 127051

Aleksandr A. Soldatov, Dr. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051

Soldatov@expmed.ruhttps://orcid.org/0000-0003-0940-8080ГоренковД. В.GorenkovD. V.

Горенков Дмитрий Витальевич

Петровский б-р, д. 8, стр. 2, Москва, 127051

Dmitry V. Gorenkov

8/2 Petrovsky Blvd, Moscow 127051

gorenkov@expmed.ruhttps://orcid.org/0000-0003-4891-973XМеркуловВ. А.MerkulovV. A.

Меркулов Вадим Анатольевич, д-р мед. наук. проф.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Трубецкая ул., д. 8, стр. 2, Москва, 119991

Vadim A. Merkulov, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051

8/2 Trubetskaya St., Moscow 119991

Merkulov@expmed.ruhttps://orcid.org/0000-0001-6472-6386БондаревВ. П.BondarevV. P.

Бондарев Владимир Петрович, д-р мед. наук. проф.

Петровский б-р, д. 8, стр. 2, Москва, 127051

Vladimir P. Bondarev, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051

Bondarev@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202230112022224Разработка биологических лекарственных препаратов для профилактики, диагностики и лечения COVID-19361381Copyright © Солдатов А.А., Горенков Д.В., Меркулов В.А., Бондарев В.П., 20222022Солдатов А.А., Горенков Д.В., Меркулов В.А., Бондарев В.П.Soldatov A.A., Gorenkov D.V., Merkulov V.A., Bondarev V.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/465

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.

At the end of 2019, an outbreak of a new coronavirus began in the city of Wuhan (Hubei Province) in the People's Republic of China. The outbreak turned into a pandemic. In the shortest possible time, national and international manufacturers developed preventive COVID-19 vaccines, and the population was vaccinated. During pandemics, accelerated approval of vaccines is an important factor that shortens the time to market with the aim of mass vaccination. The experience of rapidly developing and introducing vaccines into routine practice is not only important for managing the current pandemic, but also valuable in case of extremely likely future ones. The aim of this study was to analyse the main issues associated with assessing the safety and efficacy of vaccines for COVID-19 prevention during their registration and widespread use amid the pandemic and ongoing SARS-CoV-2 evolution. The vaccines for COVID-19 prevention were developed and introduced into healthcare practice very rapidly and under the circumstances of the pandemic, and the use of these vaccines has surfaced a number of concerns requiring further research. The most important issues identified in the performed analysis include, but are not limited to the need for accelerated assessment of the safety and immunogenicity of new vaccines; the lack of immune correlates of protection against SARS-CoV-2; the waning of antibody immunity over time, motivating the need to determine revaccination and post-recovery vaccination timelines; and the emergence of mutant SARS-CoV-2 variants. One of noteworthy aspects is the need to develop recommendations for updating the strain composition of registered COVID-19 vaccines. According to the conclusions, the level of herd immunity, including vaccine-induced protection, plays a certain role in virus evolution during the pandemic. If COVID-19 becomes seasonal, which is a probable scenario, regular revaccination can be essential.

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The authors declare that there are no conflicts of interest present.