Introduction: Vaccine safety is one of the major priorities of WHO and the concerned parties, including the manufacturers, vaccine suppliers and national governments. The vaccine safety control continues after vaccine administration and the adverse reactions among the vaccinated population are strictly monitored.
Aim: The purpose of this research is to examine the adverse reactions after vaccine administration in Varna region, reported in the Regional Health Inspectorate of Varna and registered in the Executive Medicines Agency for the period from 2011 to 2017.
Materials and Methods: The data of adverse reactions after vaccine administration in Varna region reported in the Regional Health Inspection of Varna and registered in the Executive Medicines Agency and the entire country has been examined and analyzed for the period from 2011 to 2017. Epidemiologic, mathematical, statistical, graphic methods have been used to process this information.
Results: The research carried out on the reported cases of adverse reactions after vaccines administered in Varna region shows that most of the post-vaccination reactions are common and expected and are indicated in the patient information leaflet of the vaccine product. After 2011, the frequency of the annually reported cases of adverse reactions after vaccines in the Regional Health Inspectorate of Varna drops down to zero in 2014; one reported case in 2015 and one in 2017.
Conclusion: Improving the quality of control over the adverse reactions after vaccines at regional and national level will lead to enhancing the public confidence in the national immunization program and stimulating the social participation in it.
Галев, А. Ваксините – предимства и безопасност. Превантивна медицина, 2012; 1
Закон за лекарствените продукти в хуманната медицина. Обн.ДВ. бр. 31 от 13.04.2007 г., посл. изм. ДВ. бр. 12 от 13.02.2015 г.
Наредба за изм. и доп. на Наредба № 15/2005 г. за имунизациите в Република България, публ. ДВ бр. 38/12.05.2017 г.
Регламент (ЕО) № 726/2004 на Европейския парламент и на Съвета от 31.03.2004 г. за установяване на процедури на Общността за разрешаване и контрол на лекарствени продукти за хуманна и ветеринарна употреба и за създаване на Европейска агенция по лекарствата, Обн. Официален вестник на ЕС, 136/ 30.04.2004 г.
Стоименова А., М. Попова, Нежелани лекарствени реакции след ваксинации през 2017 г. по данни на ИАЛ, Доклад на ІV Експертна среща по ваксинопрофилактика, София, 23-24.02.108 г.
ECDC in collaboration with the VAESCO consortium to develop a complementary tool for vaccine safety monitoring in Europe Eurosurveillance, Volume 14, Issue 39, 01 October 2009
WHO, Vaccine and immunization Global Vaccine Action Plan (Internet) http://www.who.int/immunization/global_vaccine_action_plan/en/
WHO, Vaccine and immunization quality and safety (Internet) http://www.who.int/immunization/ quality_safety/en/,2016
WHO. Global vaccine action plan 2011-2020 (Internet). http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/
