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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">safetyrisk</journal-id><journal-title-group><journal-title xml:lang="ru">Безопасность и риск фармакотерапии</journal-title><trans-title-group xml:lang="en"><trans-title>Safety and Risk of Pharmacotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2312-7821</issn><issn pub-type="epub">2619-1164</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/2312-7821-2019-7-1-6-14</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-135</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Международный мониторинг безопасности вакцин</article-title><trans-title-group xml:lang="en"><trans-title>Vaccine Safety International Monitoring</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9662-3701</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дармостукова</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Darmostukova</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>старший аналитик отдела экспертизы побочного действия МИБП Управления экспертизы безопасности лекарственных средств</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Senior Analyst ofthe Department for Evaluation of MIBPs Side Effects of the Division for Evaluation of Medicinal Products’ Safety</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">Darmostukova@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7844-7043</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Снегирева</surname><given-names>И. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Snegireva</surname><given-names>I. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>канд. мед. наук, начальник отдела экспертизы побочного действия МИБП Управления экспертизы безопасности лекарственных средств</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Cand. Sci. (Med.), Head of the Department for Evaluation of MIBPs Side Effects of the Division for Evaluation of Medicinal Products’ Safety</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">SnegirevaII@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9514-6322</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Вельц</surname><given-names>Н. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Velts</surname><given-names>N. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>канд. биол. наук, доцент, старший аналитик отдела методологии экспертного анализа Управления экспертизы безопасности лекарственных средств </p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Cand. Sci. (Biol.), Assistant Professor, Senior Analyst of the Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety</p><p>8/2 Petrovsky Blvd, Moscow 127051</p><p> </p></bio><email xlink:type="simple">Velts@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2665-796X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Казаков</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kazakov</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>канд. мед. наук, ведущий аналитик отдела методологии экспертного анализа Управления экспертизы безопасности лекарственных средств, Петровский б-р, д. 8, стр. 2, Москва, 127051;</p><p>ассистент кафедры общей и клинической фармакологии РУДН, ул. Миклухо-Маклая, д. 6, Москва, 117198</p></bio><bio xml:lang="en"><p>Cand. Sci. (Med.), Leading Analyst of the Department of Expert Analysis Methodology of the Division for Evaluation of Medicinal Products’ Safety, 8/2 Petrovsky Blvd, Moscow 127051;</p><p>Assoc. prof. of the Department of General and Clinical Pharmacology, 6 Miklukho-Maklaya St., Moscow 117198</p></bio><email xlink:type="simple">KazakovAS@expmed.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4647-977X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аляутдин</surname><given-names>Р. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Alyautdin</surname><given-names>R. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д-р мед. наук, профессор, начальник Управления экспертизы безопасности лекарственных средств</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Dr. Sci. (Med.), Professor, Head of the Division for Evaluation of Medicinal Products’ Safety</p><p>8/2 Petrovsky Blvd, Moscow 127051</p><p> </p></bio><email xlink:type="simple">Alyautdin@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products; Peoples' Friendship University of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>23</day><month>01</month><year>2019</year></pub-date><volume>7</volume><issue>1</issue><fpage>6</fpage><lpage>14</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Дармостукова М.А., Снегирева И.И., Вельц Н.Ю., Казаков А.С., Аляутдин Р.Н., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Дармостукова М.А., Снегирева И.И., Вельц Н.Ю., Казаков А.С., Аляутдин Р.Н.</copyright-holder><copyright-holder xml:lang="en">Darmostukova M.A., Snegireva I.I., Velts N.Y., Kazakov A.S., Alyautdin R.N.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.risksafety.ru/jour/article/view/135">https://www.risksafety.ru/jour/article/view/135</self-uri><abstract><p>Вопрос безопасности вакцин является важным аспектом массовой иммунизации населения, так как нежелательные реакции, возникшие после вакцинации, приводят к снижению уровня доверия к программам иммунизации. Целью работы явился анализ информации о результатах мониторинга побочных проявлений после иммунизации вакцинами, которые входят в национальные прививочные календари США, Европейского союза, Японии, Китая, Южной Кореи, Индии. Особое внимание в работе уделено к тем вакцинам, которые не включены в календарь прививок, но представлены в Российской Федерации.  Мониторинг информации в Европейском союзе, Японии и США позволил опровергнуть связь вакцинации против вируса папилломы человека с развитием аутоиммунных заболеваний. Мониторинг побочных проявлений после вакцинации ротавирусной вакциной I поколения в США, Европейском союзе и Индии позволил установить связь с развитием инвагинации кишечника и ограничить использование этой вакцины и рекомендовать вакцину II поколения. При противогриппозной вакцинации было выявлено поствакцинальное осложнение — нарколепсия, а при анализе осложнений менингококковой вакцинации — синдром Гийена–Барре. Также была проанализирована информация о различных осложнениях, связанных с вакцинацией против вирусного японского энцефалита, которая входит в национальные календари вакцинации стран Азии и Тихоокеанского региона — Китая, Индии, Японии, Южной Кореи. К основным осложнениям, зарегистрированным в Китае после введения вакцины против японского энцефалита в национальный прививочный календарь, относятся фебрильные судороги, тромбоцитопеническая пурпура, энцефалит и менингит. Проблемы безопасности вакцин, включенных в национальные календари вакцинации стран Европейского союза, США и Азиатско-Тихоокеанского региона, касаются в первую очередь вакцин, которые относительно недавно появились на фармацевтическом рынке.</p></abstract><trans-abstract xml:lang="en"><p>Vaccine safety is an important aspect of mass immunization of the population. Adverse reactions that occur following vaccination result in a decrease in public confidence. The aim of this research was to identify information on the development of adverse events after immunization with vaccines included into the national vaccination calendars of the USA, European Union (EU), Japan, China, South Korea and India. Particular attention was paid to vaccines that are not included in the vaccination calendar, but are presented in the Russian Federation. During monitoring of vaccination against human papillomavirus information in the European Union, Japan and the United States, according the possible connection with development of autoimmune diseases was refuted. Monitoring of adverse events after vaccination with rotavirus vaccine I generation in the USA, EU and India, allowed to establish a link with the development of intestine invagination and limit the use of this medicinal product in favor of vaccine II generation. After starting vaccination against influenza was detected narcolepsy as a complication of this procedure; and when analyzing the complications of meningococcal vaccination Guillain — Barre syndrome was detected. We also analyzed information on various complications associated with vaccination against Japanese viral encephalitis, which was included into the national vaccination calendar of countries in Asia and the Pacifi c region — China, India, Japan, and South Korea. The main complications registered in the PRC after the introduction of Japanese encephalitis vaccine into the national vaccination calendar included: febrile seizures, thrombocytopenic purpura, encephalitis and meningitis. The main safety concerns about vaccines included into the national vaccination calendars of EU countries, the USA and the Asia-Pacific region concern vaccines that have recently appeared on the pharmaceutical market.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>вакцины</kwd><kwd>фармаконадзор вакцин</kwd><kwd>побочные проявления после иммунизации</kwd><kwd>ПППИ</kwd><kwd>VAERS</kwd><kwd>ротавирусная вакцина</kwd><kwd>нарколепсия</kwd><kwd>вакцина против вируса папилломы человека</kwd><kwd>вакцина против вируса японского энцефалита</kwd></kwd-group><kwd-group xml:lang="en"><kwd>vaccines</kwd><kwd>vaccine pharmacovigilance</kwd><kwd>adverse events following immunization</kwd><kwd>AEFI</kwd><kwd>VAERS</kwd><kwd>rotavirus vaccine</kwd><kwd>narcolepsy</kwd><kwd>human papillomavirus vaccine</kwd><kwd>Japanese encephalitis virus vaccine</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00154-19-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590048-3).</funding-statement><funding-statement xml:lang="en">The study reported in this publication was carried out as part of a publicly funded research project No. 056-00154-19-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&amp;D public accounting No. AAAA-A18-118021590048-3).</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Авдеева ЖИ, Алпатова НА, Бондарев ВП, Волкова РА, Лонская НИ, Лебединская ЕВ и др. 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