Quality analysis of a combined domestic vaccine for the prevention of measles, rubella and mumps
- 作者: Binyatova A.S.1, Unasova T.N.1, Iliasova T.N.1, Sarkisyan K.А.1, Fadeikina O.V.1, Movsesyants A.A.1
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隶属关系:
- Scientific Center for Examination of Medical Devices
- 期: 卷 67, 编号 5 (2022)
- 页面: 414-422
- 栏目: ORIGINAL RESEARCH
- URL: https://journals.rcsi.science/0507-4088/article/view/118239
- DOI: https://doi.org/10.36233/0507-4088-131
- ID: 118239
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Introduction. The need to maintain a high level of vaccination coverage against measles, rubella and mumps in conditions of an increased risk of outbreaks of infections due to violations of vaccination tactics associated with the pandemic of coronavirus infection and due to the unfavorable epidemic situation in neighboring countries determines the advisability of using a combined vaccine for the simultaneous prevention of these three socially significant infections.
The aim of the study: to analyze the quality of commercial series of a new domestic combined cultured live vaccine against measles, rubella and mumps (MRM) throughout the entire time of its manufacturing according to all specification indicators in regulatory documentation (RD).
Materials and methods. The object of the study was the combined cultured live vaccine against measles, rubella and mumps. The analysis of the quality of the drug was carried out according to 86 consolidated production protocols of manufactured series, as well as according to the results of control of these series in the Testing Center for Quality Expertise of the Federal State Budgetary Institution NCESMP of the Ministry of Health of the Russian Federation.
Results. It is shown that the quality of the combined drug for the prevention of measles, rubella and mumps corresponds to the RD in all studied indicators. The drug does not contain an antibiotic. Bovine serum albumin, which is a technological impurity, is detected in quantities more than 5 times lower than the established norm. A comparison of the specific activity of the viral components of new combined domestic vaccine and the components of the bivalent vaccine against measles and mumps produced by the company in 2019–2021 showed that the spread of the activity values of the viral components in the new drug and in the series of mumps-measles vaccine was minimal, which allowed us to make a conclusion about the stability of the production technology.
Conclusion. The quality of the new domestic combined vaccine for the prevention of measles, rubella and mumps meets WHO requirements. The results of the conducted studies indicate the stability of production and the standard quality of the drug. The use of a combined vaccine against three significant infections will ensure the necessary level of vaccination coverage in the population. Information about the results of studies can help reduce the number of vaccination refusal.
作者简介
Anna Binyatova
Scientific Center for Examination of Medical Devices
编辑信件的主要联系方式.
Email: Binyatova@expmed.ru
ORCID iD: 0000-0003-3011-2030
SPIN 代码: 3818-9089
1st Professional Category Expert of the Laboratory of Viral Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
俄罗斯联邦, 127051, MoscowTatyana Unasova
Scientific Center for Examination of Medical Devices
Email: Unasova@expmed.ru
ORCID iD: 0000-0002-1606-942X
SPIN 代码: 7746-0839
Candidate of Biol. Sciences, Chief Expert of the Laboratory of Viral Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
俄罗斯联邦, 127051, MoscowTatyana Iliasova
Scientific Center for Examination of Medical Devices
Email: Iliasova@expmed.ru
ORCID iD: 0000-0002-0905-3630
SPIN 代码: 4455-6821
Leading Еxpert of the Laboratory of Viral Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
俄罗斯联邦, 127051, MoscowKarine Sarkisyan
Scientific Center for Examination of Medical Devices
Email: Sarkisyan@expmed.ru
ORCID iD: 0000-0003-0445-7086
SPIN 代码: 3433-9485
Candidate of Med. Sciences, Head of the Laboratory of Viral Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
俄罗斯联邦, 127051, MoscowOlga Fadeikina
Scientific Center for Examination of Medical Devices
Email: Fadeikina@expmed.ru
ORCID iD: 0000-0002-8473-7442
SPIN 代码: 3262-9749
Candidate of Biol. Sciences, chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
俄罗斯联邦, 127051, MoscowArtashes Movsesyants
Scientific Center for Examination of Medical Devices
Email: movsesyants@expmed.ru
ORCID iD: 0000-0003-2132-0962
SPIN 代码: 4144-6278
Doctor of Medical Sciences, Professor, Head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
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