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<article article-type="review-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">microbe</journal-id><journal-title-group><journal-title xml:lang="ru">Проблемы особо опасных инфекций</journal-title><trans-title-group xml:lang="en"><trans-title>Problems of Particularly Dangerous Infections</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0370-1069</issn><issn pub-type="epub">2658-719X</issn><publisher><publisher-name>Russian Research Anti-Plague Institute “Microbe”</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21055/0370-1069-2025-4-6-16</article-id><article-id custom-type="elpub" pub-id-type="custom">microbe-2243</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>Анализ опыта повышения безопасности применения противооспенных вакцинных препаратов</article-title><trans-title-group xml:lang="en"><trans-title>Analysis of the Experience of Improving the Safety of Anti-Smallpox Vaccines</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6742-3919</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Борисевич</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Borisevich</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Борисевич Сергей Владимирович, </p><p>141306, Сергиев Посад-6, ул. Октябрьская, 11</p></bio><bio xml:lang="en"><p>Sergey V. Borisevich, </p><p>11, Oktyabrskaya St., Sergiev Posad-6, 141306</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0002-6347-3476</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Махлай</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Makhlay</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>141306, Сергиев Посад-6, ул. Октябрьская, 11</p></bio><bio xml:lang="en"><p>11, Oktyabrskaya St., Sergiev Posad-6, 141306</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-3058-6706</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Подкуйко</surname><given-names>В. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Podkuiko</surname><given-names>V. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>141306, Сергиев Посад-6, ул. Октябрьская, 11</p></bio><bio xml:lang="en"><p>11, Oktyabrskaya St., Sergiev Posad-6, 141306</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9946-6553</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Терентьев</surname><given-names>А. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Terent’ev</surname><given-names>A. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>141306, Сергиев Посад-6, ул. Октябрьская, 11</p></bio><bio xml:lang="en"><p>11, Oktyabrskaya St., Sergiev Posad-6, 141306</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6686-320X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хмелев</surname><given-names>А. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Khmelev</surname><given-names>A. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>141306, Сергиев Посад-6, ул. Октябрьская, 11</p></bio><bio xml:lang="en"><p>11, Oktyabrskaya St., Sergiev Posad-6, 141306</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-4026-6466</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Поярков</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Poyarkov</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119160, Москва, Фрунзенская наб., 22/2</p></bio><bio xml:lang="en"><p>22/2, Frunzenskaya Embankment, Moscow, 119160</p></bio><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ «48 Центральный научно-исследовательский институт» Министерства обороны Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>48th Central Research Institute of the Ministry of Defense of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Управление начальника войск радиационной, химической и биологической защиты Вооруженных Сил Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Department of the Chief of Radiation, Chemical and Biological Protection Troops of the Armed Forces of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>14</day><month>01</month><year>2026</year></pub-date><volume>0</volume><issue>4</issue><fpage>6</fpage><lpage>16</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Борисевич С.В., Махлай А.А., Подкуйко В.Н., Терентьев А.И., Хмелев А.Л., Поярков А.Ю., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Борисевич С.В., Махлай А.А., Подкуйко В.Н., Терентьев А.И., Хмелев А.Л., Поярков А.Ю.</copyright-holder><copyright-holder xml:lang="en">Borisevich S.V., Makhlay A.A., Podkuiko V.N., Terent’ev A.I., Khmelev A.L., Poyarkov A.Y.</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://journal.microbe.ru/jour/article/view/2243">https://journal.microbe.ru/jour/article/view/2243</self-uri><abstract><p>Эпидемиологическая опасность ортопоксвирусов и побочное действие применяемых живых вакцин растут, повышая требования к безопасности вакцинации.</p><p>Целью данного обзора был анализ направлений повышения безопасности оспенных вакцин. Биотехнологическое совершенствование дермовакцин не увеличило безопасность до допустимого уровня и вызвало введение большого количества ограничений, противопоказаний, а в конечном итоге – запрет их применения. При совершенствовании парентеральных вакцин доминирует биотехнологическое направление повышения безопасности, которое вкупе с иммунологической коррекцией метода вакцинации (двухэтапный метод вакцинации в России или многократная иммунизация за рубежом) способствовало достижению допустимых требований безопасности у третьего поколения оспенных вакцин. Неудачи биотехнологического совершенствования дермовакцин обусловили интенсификацию исследований по разработке пероральных вакцин третьего поколения типа ТЭОВак, отвечающих принципам безопасности и эффективности, и дальнейшее развитие иммунологического направления повышения безопасности вакцинации. Реализация иммунологического направления совершенствования безопасности противооспенных вакцин осуществлялась за счет разработки пероральных мукозальных вакцин и двухэтапного метода вакцинации. Еще одной проблемой специфической профилактики оспы является высокий риск развития осложнений вакцинации. Двухэтапный или двукратный метод вакцинации эпидемически эффективными живыми вакцинами составляет универсальное направление купирования таких осложнений. В США для купирования осложнений создан запас гомологичного иммуноглобулина и выпускаются химиопрепараты, в РФ в настоящее время лицензирован единственный препарат НИОХ-14, делаются попытки компенсировать отсутствие гомологичного иммуноглобулина гетерологичным очищенным препаратом. Таким образом, для России наиболее действенным и перспективным направлением повышения безопасности оспенных вакцин является иммунологическое: разработка современного перорального способа иммунизации, мукозальных вакцин и двухэтапного метода вакцинации. За рубежом доминирует биотехнологическое направление совершенствования парентеральных оспенных вакцин, которое дополняется иммунологическим.</p></abstract><trans-abstract xml:lang="en"><p>The epidemiological hazard of orthopoxviruses and the side effects of the used live vaccines are growing, raising the safety requirements for vaccination.</p><p>The aim of this review was to analyze ways to improve the safety of smallpox vaccines. Biotechnological improvement of dermovaccines did not enhance safety to an acceptable level and caused the introduction of a large number of restrictions, contraindications, and eventually a ban on their use. The improvement of parenteral vaccines is dominated by the biotechnological trends of safety increment, which, combined with the immunological correction of the vaccination method (two-stage vaccination in Russia or multiple immunization abroad), contributed to achieving acceptable safety requirements for the third generation of smallpox vaccines. The failures of biotechnological improvement of dermovaccines led to the intensification of research on the development of third-generation oral vaccines of the TEOVac type, meeting the principles of safety and effectiveness, and further development of the immunological aspect of higher vaccination safety. The implementation of the immunological course for improving the safety of anti-smallpox vaccines was carried out through the development of oral mucosal vaccines and a two-stage vaccination method. Another problem with the specific prevention of smallpox is the high risk of complications after vaccination. A two-stage or two-fold method of vaccination with epidemiologically effective live vaccines is a universal solution for the relief of such complications. In the USA, a supply of homologous immunoglobulin has been created and chemotherapy drugs are being produced to relieve complications; in the Russian Federation, only the NIOX‑14 drug is currently licensed, and attempts are being made to compensate for the absence of homologous immunoglobulin with a heterologous purified drug. Thus, for Russia, the most effective and promising area for improving the safety of smallpox vaccines is immunological one: the development of a modern oral method of immunization, mucosal vaccines and a two-stage vaccination method. Abroad, the biotechnological trends in improvement of parenteral smallpox vaccines dominate, which is complemented by the immunological one.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>безопасность оспенных вакцин</kwd><kwd>биотехнологическое и иммунологическое направления совершенствования</kwd><kwd>мукозальное оспопрививание</kwd><kwd>двухэтапный метод вакцинации</kwd><kwd>купирование поствакцинальных осложнений</kwd><kwd>патогенные для человека ортопоксвирусы</kwd></kwd-group><kwd-group xml:lang="en"><kwd>safety of smallpox vaccines</kwd><kwd>biotechnological and immunological aspects of improvement</kwd><kwd>mucosal vaccination</kwd><kwd>two-stage vaccination method</kwd><kwd>relief of post-vaccination complications</kwd><kwd>orthopoxviruses pathogenic for humans</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Onishchenko G.G., Semenov B.F., Zverev V.V. 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