epidemiologyЭпидемиология и ВакцинопрофилактикаEpidemiology and Vaccinal Prevention2073-30462619-0494«Numicom» LLC10.31631/2073-3046-2016-15-6-62-69epidemiology-217Research ArticleВАКЦИНОПРОФИЛАКТИКАVACCINAL PREVENTIONБезопасность комбинированных вакцин с цельноклеточным коклюшным компонентомSafety of Combination Vaccines with Whole Cell Pertussis ComponentПерелыгинаО. В.PerelyginaO. V.noemail@neicon.ruАлексееваИ. А.AlekseevaI. A.iaalex@list.ruФГБУ «Научный центр экспертизы средств медицинского применения»РоссияFederal State Budgetary Institution «Scientific Center on Expertise of Medicinal Application Products» of the Ministry of Healthcare of the Russian FederationRussian Federation2016201220161566269Copyright © Перелыгина О.В., Алексеева И.А., 20162016Перелыгина О.В., Алексеева И.А.Perelygina O.V., Alekseeva I.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.epidemvac.ru/jour/article/view/217

Рассматривается безопасность отечественных комбинированных препаратов (АКДС, Бубо-Кок), содержащих цельноклеточную коклюшную вакцину. АКДС и Бубо-Кок вакцины по безопасности отвечают требованиям ВОЗ, ЕФ и более жестким, в ряде случаев, требованиям отечественной нормативной документации. Так, при оценке специфической безопасности коклюшной вакцины и полноты обезвреживания дифтерийного и столбнячного токсинов, лабораторным животным вводят значительно большие дозы испытуемых препаратов по сравнению с требованиями ВОЗ и ЕФ. В отличие от ВОЗ и ЕФ в отечественной НД есть жесткие требования к количественному содержанию в вакцине неадсорбированных анатоксинов. По сравнению с зарубежными аналогами, отечественные вакцины несут значительно меньшую антигенную нагрузку, что обусловливает их невысокую реактогенность, в то же время они обладают требуемой иммуногенной активностью.

We consider the safety of domestic products combined (DTP, Bubo Kok) containing whole-cell pertussis vaccine. DTP and Bubo Kok safety vaccines meet WHO requirements, EF and more rigid in some cases, the requirements of Russian regulatory documents. Thus, in assessing the safety of specific pertussis vaccine and complete neutralization of diphtheria and tetanus toxins, are administered to laboratory animals much larger doses of test products in comparison with the requirements of the WHO and the EP. In contrast to the WHO and the EP in the domestic requirements have stringent requirements for quantitative content in the non-adsorbed toxoids vaccine. Compared with foreign counterparts, domestic vaccines are significantly less anti-genetic load, that is responsible for their low reactivity, at the same time they possess the desired immunogenic activity.

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