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[PRINCIPLES OF MONITORING OF ADVERSE EVENTS AFTER VACCINATION IN RUSSIAN FEDERATION AND THE WORLD].

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    Russian adverse event registration differs from global standards. The Russian Federation only records specific post-vaccinal complications, unlike WHO recommendations for all post-vaccination events within one month.

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    Area of Science:

    • Public Health
    • Vaccinology
    • Regulatory Science

    Background:

    • Discrepancies exist in terminology for post-vaccination conditions between Russia and other countries.
    • Current Russian regulations focus on registering only specific post-vaccinal complications.

    Purpose of the Study:

    • To analyze and compare the Russian Federation's adverse event registration system with international standards, particularly WHO recommendations.
    • To highlight differences in the scope of registered post-vaccination events.

    Main Methods:

    • Comparative analysis of regulatory documents within the Russian Federation.
    • Review of international adverse event registration systems, including WHO guidelines.
    • Examination of definitions and criteria for adverse event registration post-vaccination.

    Main Results:

    • The Russian Federation's system, guided by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, registers limited conditions termed 'post-vaccinal complications'.
    • International practices and WHO recommendations advocate for registering all adverse events occurring within one month post-vaccination.

    Conclusions:

    • A significant divergence exists between Russian and international approaches to registering post-vaccination adverse events.
    • Adopting a broader registration scope, aligned with WHO, could improve the detection of vaccine-event interconnections.