biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2020-20-4-228-244biopreparat-311Research ArticleОБЗОРЫREVIEWSМеждународные и отечественные нормативные рекомендации к разработке и регистрации вакцин против COVID-19 в условиях пандемииRussian and International Regulatory Recommendations for the Development and Marketing Authorisation of COVID-19 Vaccines in the Context of the Pandemichttps://orcid.org/0000-0001-6269-0201СолдатовА. 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/0000-0002-9377-1378АвдееваЖ. И.AvdeevaZh. I.

Авдеева Жанна Ильдаровна, д-р мед. наук, проф.,

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

Zhanna I. Avdeeva, Dr. Sci. (Med.), Professor,

8/2 Petrovsky Blvd, Moscow 127051

Avdeeva@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.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/0000-0001-6472-6386МосягинВ. Д.MosyaginV. D.

Мосягин Вячеслав Дмитриевич, д-р мед. наук, проф.,

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

Vyacheslav D. Mosyagin, Dr. Sci. (Med.), Professor,

8/2 Petrovsky Blvd, Moscow 127051

mosiagin@expmed.ruhttps://orcid.org/0000-0003-3637-7179ИвановВ. Б.IvanovV. B.

Иванов Вячеслав Борисович, д-р мед. наук, проф.,

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

Vyacheslav B. Ivanov, Dr. Sci. (Med.), Professor,

8/2 Petrovsky Blvd, Moscow 127051

Ivanov@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

diyarl@ya.ruhttps://orcid.org/0000-0001-6269-0201ХантимироваЛ. М.KhantimirovaL. M.

Хантимирова Лейсан Маратовна, канд. биол. наук.,

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

Leysan M. Khantimirova. Cand. Sci. (Biol.),

8/2 Petrovsky Blvd, Moscow 127051

Khantimirova@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 ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal Products I. M. Sechenov First Moscow State Medical UniversityRussian Federation202030112020204228244Copyright © Солдатов А.А., Авдеева Ж.И., Бондарев В.П., Меркулов В.А., Мосягин В.Д., Иванов В.Б., Горенков Д.В., Хантимирова Л.М., 20202020Солдатов А.А., Авдеева Ж.И., Бондарев В.П., Меркулов В.А., Мосягин В.Д., Иванов В.Б., Горенков Д.В., Хантимирова Л.М.Soldatov A.A., Avdeeva Z.I., Bondarev V.P., Merkulov V.A., Mosyagin V.D., Ivanov V.B., Gorenkov D.V., Khantimirova L.M.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/311

Развитие пандемии COVID-19 инициировало исследования по разработке вакцин против этой коронавирусной инфекции. ВОЗ и национальные регуляторные органы многих стран подготовили руководства, позволяющие ускорить разработку и регистрацию вакцин против COVID-19. Цель работы — анализ международных и отечественных регуляторных рекомендаций к разработке и ускоренной регистрации вакцин для профилактики коронавирусной инфекции COVID-19 в условиях пандемии, а также обобщение предварительных опубликованных результатов первых этапов доклинических и клинических исследований. В работе рассмотрены подходы к процедуре ускоренной регистрации лекарственных средств в условиях пандемии в Российской Федерации, ЕС и США. Представлены регуляторные требования к качеству, доклиническим и клиническим исследованиям вакцин для профилактики COVID-19. Описаны первые результаты разработки вакцин против COVID-19. Показано, что, согласно регуляторным документам указанных стран, возможно ускорение регистрационного процесса за счет сокращения сроков экспертизы качества, эффективности и безопасности вакцины. Также возможна так называемая регистрация на условиях, при этом вакцина может быть зарегистрирована на основании неполных доклинических и клинических исследований при условии, что после регистрации все исследования будут выполнены в полном объеме. Представлены обобщенные результаты клинических исследований вакцин против COVID-19. Единичные опубликованные предварительные результаты первых этапов клинических исследований вакцин против COVID-19 продемонстрировали их хорошую переносимость, безопасность и иммуногенность. При исследовании вакцин на основе аденовируса установлено, что до исследования практически у половины добровольцев определялись высокие титры антител к аденовирусу, что сопровождалось более мягким развитием побочных реакций и низкой иммуногенностью. При этом у лиц старшей возрастной группы (45–60 лет) иммунный ответ был слабее, чем в группе лиц младше 45 лет. Результаты анализа нормативных требований, регламентирующих разработку и регистрацию вакцин против COVID-19 в условиях пандемии, а также международных и национальных нормативных подходов для разработки и регистрации вакцин могут послужить основой при разработке отечественных требований для вакцины против COVID-19 в условиях пандемии.

The progress of the COVID-19 pandemic initiated research to develop vaccines against this novel coronavirus infection. The WHO and national regulatory authorities in many countries have elaborated guidelines to speed up the development and authorisation of COVID-19 vaccines. The aim of the study was to analyse international and Russian regulatory recommendations for the development and fast-track approval of COVID-19 vaccines in the context of the pandemic, as well as to summarise the preliminary published results of the first stages of preclinical and clinical studies. The paper analyses approaches to fast-track approval of medicines in the face of the pandemic in Russia, the European Union, and the United States. It summarises regulatory requirements for the quality of COVID-19 vaccines, as well as for preclinical, and clinical studies. It describes the first results of COVID-19 vaccine development. The analysed regulatory documents allow for accelerated authorisation due to reduction of time spent on evaluation of vaccine quality, safety, and efficacy. Another option is the so-called conditional marketing authorisation when a vaccine is registered based on incomplete preclinical and clinical data provided that all the studies will be completed after the vaccine authorisation. The paper summarises the results of clinical trials of COVID-19 vaccines. The few published preliminary results of the first phases of COVID-19 vaccine clinical trials demonstrate the vaccines’ good tolerability, safety, and immunogenicity. Evaluation of adenovirusbased vaccines showed that almost half of the volunteers had had high antibody titers to adenovirus before the study, which resulted in milder adverse reactions and low immunogenicity. In addition, the immune response was weaker in the older group of subjects (45–60 years) as compared to the subjects younger than 45 years. The results of the analysis of regulatory requirements for the development and marketing authorisation of COVID-19 vaccines in the context of the pandemic, as well as of national and international regulatory approaches to vaccine development and authorisation can be used as a basis for the development of Russian requirements for COVID-19 vaccines in the context of the pandemic.

пандемия COVID-19вакцинывирус SARS-CoV-2нормативные требованияускоренная регистрация вакцинрегистрация вакцин против COVID-19COVID-19 pandemicvaccinesSARS-CoV-2 virusregulatory requirementsfast-track approval of vaccinesCOVID-19 vaccine authorisationРабота выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00003-20-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590046-9).The study reported in this publication was carried out as part of a publicity funded research project No. 056-00003-20-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590046-9).ReferencesГоренков ДВ, Хантимирова ЛМ, Шевцов ВА, Рукавишников АВ, Меркулов ВА, Олефир ЮВ. Вспышка нового инфекционного заболевания COVID-19: β-коронавирусы как угроза глобальному здравоохранению. БИОпрепараты. 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The authors declare that there are no conflicts of interest present.