Russian Journal of Infection and ImmunityRussian Journal of Infection and ImmunityИнфекция и иммунитет2220-76192313-7398SPb RAACI1562810.15789/2220-7619-SEF-15628ORIGINAL ARTICLESОРИГИНАЛЬНЫЕ СТАТЬИResearch ArticleSide effects following administration of the Gam-COVID-Vac in MontenegroПобочные эффекты при применении Гам-КОВИД-Вак в ЧерногорииDabanovicVeraДабановичВера
Montenegro

DSc (Medicine)

д.м.н.

vera.dabanovic@montefarm.co.mePharmacy Institution of Montenegro “Montefarm” Podgorica, MontenegroУчреждения здравоохранения Аптеки Черногории "Монтефарм"1311202325122023136115011601908202327102023Copyright ©; 2023, Dabanovic V.Copyright ©; 2023, Дабанович В.2023Dabanovic V.Дабанович В.https://creativecommons.org/licenses/by/4.0https://iimmun.ru/iimm/article/view/15628

Introduction. In Montenegro, vaccination against COVID-19 infection began with the use of Gam-COVID-Vac, which was not approved for emergency use before the end of clinical trials, by the Food and Drug Administration and the European Medicines Agency. Therefore, it is necessary to emphasize the adverse effects.

Materials and methods. For the purpose of this study, there were collected data from national adverse events reporting form for Gam-COVID-Vac obtained from the Health Institution Pharmacy of Montenegro — Montefarm, as the holder of permits for these vaccines. Results. For the period March 1, 2021 to February 13, 2022, after administration of 16 756 doses of vaccine Gam-COVID, a total of 220 case reports, or 716 adverse effects were recorded. The mean age of vaccinated individuals who reported adverse effects was 40.79±11.35 years. Totally, 79.55% females versus 20.45% males reported side effects post-vaccination. The most common adverse reaction was pyrexia (79.55%). Other very common adverse effects were as follows: injection site pain (38.18%), headache (33.18%), myalgia (32.27%), malaise (31.82%), fever (30.45%), arthralgia (22.73%) as well as swelling and redness at the site of application (15.91%). Less common adverse effects were nausea, pain in extremity, diarrhea, dizziness, fatigue, sore throat and labial herpes. Serious adverse effects were recorded in 8 cases including tinnitus, thrombophlebitis, hypotension, chest pain, palpitations and peripheral cyanosis related to specific comorbidities.

Conclusions. After the administration of Gam-COVID vaccine, the population in Montenegro experienced mild to moderate adverse effects, with rare serious transient adverse effects related to specific comorbidities. The data presented here on investigating Gam-COVID-Vac caccine verified good safety profile and high tolerability evidenced by the statistics analysis as lacked COVID-19-associated hospitalizations or deaths.

Введение. В Черногории вакцинация против инфекции COVID-19 началась с использования Гам-КОВИД-Вак, который не был одобрен для экстренного использования до окончания клинических испытаний со стороны Управления по санитарному надзору за качеством пищевых продуктов и медикаментов и Европейского агентства по лекарственным средствам. Поэтому необходимо подчеркнуть побочные эффекты.

Материалы и методы. Данные для целей настоящего исследования были собраны из национальной формы сообщения о нежелательных явлениях для Гам-КОВИД-Вак, полученной от Учреждения здравоохранения Аптеки Черногории — Монтефарм как носителя разрешения на эти вакцины.

Результаты. За период с 1 марта 2021 г. по 13 февраля 2022 г. после применения 16 756 доз вакцины Gam-COVID было всего зарегистрировано 220 случаев, то есть 716 побочных эффектов. Средний возраст вакцинированных, сообщивших о нежелательных явлениях, составил 40,79±11,35 лет. В общей сложности 79.55% женщин по сравнению с 20,45% мужчин сообщили о побочных эффектах после вакцинации. Наиболее частой побочной реакцией была температурная (79,55%). Другими очень частыми побочными эффектами были: боль в месте инъекции (38,18%), головная боль (33,18%), миалгия (32,27%), недомогание (31,82%), лихорадка (30,45%), артралгия (22,73%), отек и покраснение в месте введения (15,91%). Менее распространенными побочными эффектами были тошнота, боль в конечностях, диарея, головокружение, утомляемость, боль в горле и herpes labialis. Серьезные побочные эффекты — шум в ушах, тромбофлебит, гипотония, боль в груди, учащенное сердцебиение и периферический цианоз — были зафиксированы в 8 случаях. Все они были связаны с наличием сопутствующих заболеваний.

Выводы. После введения вакцины Гам-KОВИД у населения Черногории наблюдались побочные эффекты легкой и средней степени тяжести с редкими серьезными эффектами преходящего характера, которые были связаны с определенными сопутствующими заболеваниями. По результатам данного исследования вакцина Гам-KОВИД подтвердила хороший профиль безопасности и высокую переносимость, о чем свидетельствует статистический анализ с отсутствием госпитализаций и летальных случаев.

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