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[Experience with the use of pharmacopoeial reference material for the activity of measles vaccine]

A S Binyatova1, T N Yunasova1, R A Volkova1

  • 1Scientific Centre for Expert Evaluation of Medicinal Products.

Voprosy Virusologii
|December 29, 2023
PubMed
Abstract

Insights

This study confirms the stable activity of the measles vaccine pharmacopoeial reference material (PRM). This ensures accurate measurement of measles virus in vaccines, supporting effective disease prevention efforts.

Area of Science:

  • Immunology
  • Virology
  • Pharmacology

Context:

  • Rising global measles incidence necessitates robust vaccine quality control.
  • Ensuring measles vaccine efficacy is a key public health policy objective.

Purpose:

  • To evaluate the utility of a pharmacopoeial reference material (PRM) for quantifying measles vaccine activity.
  • To assess the specific activity of measles virus in vaccines used for measles prevention in the Russian Federation.

Summary:

  • The study analyzed a measles vaccine PRM (series 10) to determine measles virus specific activity in various vaccines.
  • Results from 2021-2022 showed measles virus titers in the PRM consistently met certified values and acceptance criteria.
  • The PRM demonstrated stable activity, supporting the accuracy of measles virus titer determination and vaccine monitoring.

Impact:

  • Confirms the reliability of the PRM for measles vaccine quality assessment.
  • Validates the methodology for monitoring measles virus specific activity in vaccine production.
  • Contributes to ensuring the availability of high-quality measles vaccines for public health protection.
Keywords:
controlmeasles vaccinespharmacopoeial reference materialqualityresults acceptance criteriasystem suitability criteria

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