References

vedomostiregmed

Регуляторные исследования и экспертиза лекарственных средств

Regulatory Research and Medicine Evaluation

3034-30623034-3453

Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)

vedomostiregmed-98

Research Article

Методология экспертизы средств медицинского применения

METHODOLOGY OF EXPERT EVALUATION OF MEDICINES

Современные подходы к взаимозаменяемости вакцин

Modern approaches to vaccines interchangeability

Снегирева

И. И.

Snegireva

I. I.

noemail@neicon.ru

Затолочина

К. Э.

Zatolochina

K. E.

noemail@neicon.ru

Дармостукова

М. А.

Darmostukova

M. A.

noemail@neicon.ru

Аляутдин

Р. Н.

Alyautdin

R. N.

noemail@neicon.ru

Романов

Б. К.

Romanov

B. K.

noemail@neicon.ru

Научный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation

2016

13022018

0438

2018

Снегирева И.И., Затолочина К.Э., Дармостукова М.А., Аляутдин Р.Н., Романов Б.К.

Snegireva I.I., Zatolochina K.E., Darmostukova M.A., Alyautdin R.N., Romanov B.K.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.vedomostincesmp.ru/jour/article/view/98

Результаты научных исследований допускают возможность замены препаратов вакцин при их использовании в соответствии с рекомендуемым графиком введения и дозировкой, указанной производителем. Контрольно-регуляторные органы многих стран издают рекомендации о том, как следует поступать в случае необходимости замены вакцины на аналогичную. Однако в России отсутствуют какие-либо специальные нормативные положения, касающиеся взаимозаменяемости вакцин. Необходимо определить понятие «взаимозаменяемость» для вакцин как «заменяемость» и распространить его на возможность продолжения курса прививок у конкретного лица препаратом другого производителя и возможность применения вакцин аналогичного назначения, выпускаемых разными производителями.

Research findings demonstrate the possibility of replacing the vaccines, when used in accordance with the recommended dosage and administration schedule specified by the manufacturer. Control and regulatory authorities in many countries publish recommendations on how to proceed in case of the need to replace a vaccine with a similar one. However, in Russia there are no special normative documents regulating interchangeability of vaccines. It is necessary to define the concept of «interchangeability» of a vaccine as «changeability» and extend it to the possibility of continuing immunization course in a specific patient using a drug from a different manufacturer and the possibility of using vaccines with similar therapeutic indications produced by various manufacturers.

взаимозаменяемостьвакцинаанатоксиниммунобиологический препаратвакцинацияinterchangeabilityvaccinetoxoidimmunobiological productsvaccination

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