{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T22:16:16Z","timestamp":1740176176271,"version":"3.37.3"},"reference-count":33,"publisher":"Central Research Institute for Epidemiology","issue":"5","license":[{"start":{"date-parts":[[2022,11,19]],"date-time":"2022-11-19T00:00:00Z","timestamp":1668816000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["virusjour.crie.ru"],"crossmark-restriction":false},"short-container-title":["Problems of Virology"],"abstract":"<jats:p>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.\r\nThe 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).\r\nMaterials 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.\r\nResults. 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 20192021 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.\r\nConclusion. 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.<\/jats:p>","DOI":"10.36233\/0507-4088-131","type":"journal-article","created":{"date-parts":[[2022,12,3]],"date-time":"2022-12-03T12:50:29Z","timestamp":1670071829000},"page":"414-422","update-policy":"https:\/\/doi.org\/10.36233\/0372-9311-crossmark","source":"Crossref","is-referenced-by-count":2,"title":["Quality analysis of a combined domestic vaccine for the prevention of measles, rubella and mumps"],"prefix":"10.36233","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3011-2030","authenticated-orcid":false,"given":"Anna S.","family":"Binyatova","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1606-942X","authenticated-orcid":false,"given":"Tatyana N.","family":"Unasova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0905-3630","authenticated-orcid":false,"given":"Tatyana N.","family":"Iliasova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0445-7086","authenticated-orcid":false,"given":"Karine \u0410.","family":"Sarkisyan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8473-7442","authenticated-orcid":false,"given":"Olga V.","family":"Fadeikina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2132-0962","authenticated-orcid":false,"given":"Artashes A.","family":"Movsesyants","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"22004","published-online":{"date-parts":[[2022,11,19]]},"reference":[{"doi-asserted-by":"crossref","unstructured":"Nozdracheva A.V., Semenenko T.A. The status of herd immunity to measles in Russia: A systematic review and meta-analysis of epidemiological studies. Zhurnal mikrobiologii, epidemiologii i immunobiologii. 2020; 97(5): 445\u201357. https:\/\/doi.org\/10.36233\/0372-9311-2020-97-5-7 (in Russian)","key":"ref1","DOI":"10.36233\/0372-9311-2020-97-5-7"},{"unstructured":"State report \u00abOn the state of sanitary and epidemiological welfare of the population in the Russian Federation in 2020\u00bb. Moscow; 2021. (in Russian)","key":"ref2"},{"unstructured":"Bolotovskiy V.M. Measles. In: Pokrovskiy V.I., ed. Handbook of Epidemiology and Infectious Diseases. Volume 2. Private Epidemiology [Rukovodstvo po epidemiologii i infektsionnym boleznyam. Tom 2. Chastnaya epidemiologiya]. Moscow: Meditsina; 1993: 210\u201321. (in Russian)","key":"ref3"},{"doi-asserted-by":"crossref","unstructured":"Orenstein W.A., Hinman A., Nkowane B., Olive J.M., Reingold A. Measles and Rubella Global Strategic Plan 2012\u20132020: midterm review. Vaccine. 2018; 36(Suppl. 1): A1\u201334. https:\/\/doi.org\/10.1016\/j.vaccine.2017.09.026","key":"ref4","DOI":"10.1016\/j.vaccine.2017.09.026"},{"unstructured":"About the program \u00abElimination of measles and rubella in the Russian Federation (2016-2020)\u00bb. Available at: http:\/\/25.rospotrebnadzor.ru\/rss_all\/-\/asset_publisher\/Kq6J\/content\/id\/336749 (in Russian)","key":"ref5"},{"doi-asserted-by":"crossref","unstructured":"Plemper R.K. Measles resurgence and drug development. Curr. Opin. Virol. 2020; 41: 8\u201317. https:\/\/doi.org\/10.1016\/j.coviro.2020.02.007","key":"ref6","DOI":"10.1016\/j.coviro.2020.02.007"},{"doi-asserted-by":"crossref","unstructured":"Wang H., Zhang Y., Mao N., Zhu Z., Cui A., Xu S., et al. Molecular characterization of measles viruses in China: Circulation dynamics of the endemic H1 genotype from 2011 to 2017. Plos One. 2019; 14(6): e0218782. https:\/\/doi.org\/10.1371\/journal.pone.0218782","key":"ref7","DOI":"10.1371\/journal.pone.0218782"},{"unstructured":"WHO. Worldwide measles deaths climb 50% from 2016 to 2019 claiming over 207 500 lives in 2019; 2020. Available at: https:\/\/www.who.int\/news\/item\/12-11-2020-worldwide-measles-deaths-climb-50-from-2016-to-2019-claiming-over-207-500-lives-in-2019","key":"ref8"},{"unstructured":"Sagova D.I., Medvedeva P.S., Stepanova A.V., Khalturina E.O. The relevance of the unresolved measles problem. In: XII International Student Scientific Conference Student Scientific Forum \u2013 2020 [XII Mezhdunarodnaya studencheskaya nauchnaya konferentsiya Studencheskiy nauchnyy forum \u2013 2020]. Available at: https:\/\/scienceforum.ru\/2020\/article\/2018020442 (in Russian)","key":"ref9"},{"unstructured":"WHO. COVID-19 continues to disrupt essential health services in 90% of countries; 2021. Available at: https:\/\/www.who.int\/news\/item\/23-04-2021-covid-19-continues-to-disrupt-essential-health-services-in-90-of-countries","key":"ref10"},{"unstructured":"RIA. WHO concerned about increased risk of measles outbreaks. Available at: https:\/\/ria.ru\/20211110\/kor-1758475953.html (in Russian)","key":"ref11"},{"doi-asserted-by":"crossref","unstructured":"Semenenko T.A., Nozdracheva A.V. Analysis and outlook for the development of measles epidemic situation during the Covid-19 pandemic. Epidemiologiya i vaktsinoprofilaktika. 2021; 20(5): 21\u201331. https:\/\/doi.org\/10.31631\/2073-3046-2021-20-5-21-31 (in Russian)","key":"ref12","DOI":"10.31631\/2073-3046-2021-20-5-21-31"},{"unstructured":"The program \u00abElimination of measles and rubella in the Russian Federation\u00bb (2016-2020). Available at: https:\/\/www.rospotrebnadzor.ru\/upload\/iblock\/bcf\/programma_elyuminatsii_kori_i_krasnukhi_v_rf_2016_2020_gg.pdf (in Russian)","key":"ref13"},{"unstructured":"Dutchen S. Inside Immune Amnesia. Harvard: Harvard Medical School News & Research; 2019.","key":"ref14"},{"doi-asserted-by":"crossref","unstructured":"Mina M.J., Kula T., Leng Y., Li M., de Vries R.D., Knip M., et al. Measles virus infection diminishes preexisting antibodies that offer protection from other pathogens. Science. 2019; 366(6465): 599\u2013606. https:\/\/doi.org\/10.1126\/science.aay6485","key":"ref15","DOI":"10.1126\/science.aay6485"},{"doi-asserted-by":"crossref","unstructured":"Petrova V.N., Sawatsky B., Han A.X., Laksono B.M., Walz L., Parker E., et al. Incomplete genetic reconstitution of B cell pools contributes to prolonged immunosuppression after measles. Sci. Immunol. 2019; 4(41): eaay6125. https:\/\/doi.org\/10.1126\/sciimmunol.aay6125","key":"ref16","DOI":"10.1126\/sciimmunol.aay6125"},{"unstructured":"ScienceNews. Sanders L. Measles erases the immune system\u2019s memory; 2019. Available at: https:\/\/www.sciencenews.org\/article\/measles-immune-system-memory-infection","key":"ref17"},{"unstructured":"CNN Health. Yeung J. Measles wipe immune system\u2019s memory of other illnesses, studies find. Available at: https:\/\/edition.cnn.com\/2019\/11\/01\/health\/measles-amnesia-study-intl-hnk-scli-scn\/index.html","key":"ref18"},{"unstructured":"Decree of the Government of the Russian Federation \u2116 2390-R. Strategy for the development of immunoprophylaxis of infectious diseases for the period up to 2035. Moscow; 2020. (in Russian)","key":"ref19"},{"unstructured":"Naked Science. You don\u2019t have to blush: how rubella was defeated in Russia; 2020. Available at: https:\/\/naked-science.ru\/article\/column\/krasnet-ne-pridetsya-kak-v-rossii-pobedili-krasnuhu (in Russian)","key":"ref20"},{"doi-asserted-by":"crossref","unstructured":"Semerikov V.V., Yuminova N.V., Postanogova N.O., Sofronova L.V., Kontarov N.A. Epidemic mumps in Russia: Epidemic situation, key challenges and solutions. Epidemiologiya i vaktsinoprofilaktika. 2019; 18(6): 75\u201380. https:\/\/doi.org\/10.31631\/2073-3046-2019-18-6-75-80 (in Russian)","key":"ref21","DOI":"10.31631\/2073-3046-2019-18-6-75-80"},{"doi-asserted-by":"crossref","unstructured":"Connell A.R., Connell J., Leahy T.R., Hassan J. Mumps outbreaks in vaccinated populations \u2013 is it time to re-assess the clinical efficacy of vaccines? Front. Immunol. 2020; 11: 2089. https:\/\/doi.org\/10.3389\/fimmu.2020.02089","key":"ref22","DOI":"10.3389\/fimmu.2020.02089"},{"doi-asserted-by":"crossref","unstructured":"Turaeva N.V., Frolov R.A., Tsvirkun O.V., Gerasimova A.G. Characteristics of the epidemiological situation of mumps in the world at the present stage. Epidemiologiya i vaktsinoprofilaktika. 2021; 20(2): 74\u201382. https:\/\/doi.org\/10.31631\/2073-3046-2021-20-2-74-82 (in Russian)","key":"ref23","DOI":"10.31631\/2073-3046-2021-20-2-74-82"},{"doi-asserted-by":"crossref","unstructured":"Marshall H.S., Plotkin S. The changing epidemiology of mumps in a high vaccination era. Lancet Infect. Dis. 2019; 19(2): 118\u20139. https:\/\/doi.org\/10.1016\/S1473-3099(18)30541-3","key":"ref24","DOI":"10.1016\/S1473-3099(18)30541-3"},{"doi-asserted-by":"crossref","unstructured":"Ramanathan R., Voigt E.A., Kennedy R.B., Poland G.A. Knowledge gaps persist and hinder progress in eliminating mumps. Vaccine. 2018; 36(26): 3721\u20136. https:\/\/doi.org\/10.1016\/j.vaccine.2018.05.067","key":"ref25","DOI":"10.1016\/j.vaccine.2018.05.067"},{"unstructured":"SvobodnayaPressa. Sachivko S. Caught an infection: A measles epidemic begins in Russia. Available at: https:\/\/svpressa.ru\/health\/article\/225140\/ (in Russian)","key":"ref26"},{"unstructured":"ND LP-005859-171019. VAKTRIVIR Kombinirovannaja vakcina protiv kori, krasnuhi i parotita kul\u2019tural\u2019naja zhivaja. (in Russian)","key":"ref27"},{"unstructured":"Order of the Ministry of Health of the Russian Federation \u2116 202 \u00abOn the Metrological Service of the Ministry of Health of the Russian Federation in the field of circulation of medicines for medical use\u00bb. Moscow; 2020. (in Russian)","key":"ref28"},{"unstructured":"Vaccine for the prevention of measles, mumps and rubella (live). European Pharmacopoeia; 2019.","key":"ref29"},{"unstructured":"Glantz S.A. Primer of Biostatistics. New-York: McGraw-Hill; 1994.","key":"ref30"},{"doi-asserted-by":"crossref","unstructured":"Binyatova A.S., Yunasova T.N., Sarkisyan K.A., Davydov D.S., Il\u2019yasova T.N., Movsesyants A.A. Monitoring the quality of domestic measles prevention vaccines. Epidemiologiya i vaktsinoprofilaktika. 2021; 20(2): 58\u201367. https:\/\/doi.org\/10.31631\/2073-3046-2021-20-2-58-67 (in Russian)","key":"ref31","DOI":"10.31631\/2073-3046-2021-20-2-58-67"},{"doi-asserted-by":"crossref","unstructured":"Yunasova T.N., Binyatova A.S., Fadeykina O.V., Sarkisyan K.A., Movsesyants A.A., Ignat\u2019ev G.M., et al. Analysis of the quality of national vaccine against rubella. Voprosy virusologii. 2018; 63(2): 90\u20136. https:\/\/doi.org\/10.18821\/0507-4088-2018-63-2-90-96 (in Russian)","key":"ref32","DOI":"10.18821\/0507-4088-2018-63-2-90-96"},{"unstructured":"WHO technical report series \u2116 840. Report 43; 1994. https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/39048\/WHO_TRS_840_(part1).pdf","key":"ref33"}],"container-title":["Problems of Virology"],"original-title":[],"link":[{"URL":"https:\/\/virusjour.crie.ru\/jour\/article\/viewFile\/641\/414","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/virusjour.crie.ru\/jour\/article\/viewFile\/641\/414","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,14]],"date-time":"2022-12-14T12:47:28Z","timestamp":1671022048000},"score":1,"resource":{"primary":{"URL":"https:\/\/virusjour.crie.ru\/jour\/article\/view\/641"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,19]]},"references-count":33,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2022,11,19]]}},"URL":"https:\/\/doi.org\/10.36233\/0507-4088-131","relation":{},"ISSN":["2411-2097","0507-4088"],"issn-type":[{"type":"electronic","value":"2411-2097"},{"type":"print","value":"0507-4088"}],"subject":[],"published":{"date-parts":[[2022,11,19]]}}}