Until recently Rubella has been a wide spread infection. Thanks to vaccination against rubella, taking part in the global elimination program of “manageable infections” of WHO and adoption of the program “Elimination of measles and rubella in Russian Federation” the morbidity index of rubella has reached the sporadic level. One of the determining conditions of rubella elimination is application of high-quality vaccines that satisfy international standards. In Russian Federation, foreign rubella vaccines certified in our country were used for several years. In 2008, the commercial production of domestic vaccine began. It is widely known that the required quality of immunobiological medications is achieved using adequate production conditions and standard technological process. That is why during the production of domestic rubella vaccine, all the rules and requirements of Russian regulatory authorities and international recommendations are followed. In this article, a retrospective analysis of domestic vaccine against rubella according to laboratory options of quality in 2012-2017 is given. The results of the analysis show that the medication demonstrates stable high quality that is indicative of secure production technologies.
Currently, the identity of measles, mumps and rubella virus vaccines is determined during certification testing by a labour-consuming, lengthy and costly neutralisation test using cell cultures. The identity of the virus contained in such vaccines is established based on neutralisation of cytopathic effect of viruses in sensitive RK-13 and Vero cell cultures using a specific immune serum. An urgent challenge is to simplify and reduce the cost of controlling the identity of commercial batches of measles, mumps and rubella vaccines using polymerase chain reaction (PCR) tests. The aim of the study was to determine the possibility of viral ribonucleic acid (RNA) detection in these vaccines using reagent kits from different manufacturers for detection of measles, mumps and rubella viruses in clinical material by real-time reverse transcription-PCR (RT-PCR). The article presents the results of the study, which assessed the possibility of using the real-time RT-PCR for testing the identity of measles, mumps and rubella viruses in vaccines. The authors of the study analysed domestically produced and foreign reagent kits intended for detection of measles, mumps and rubella viruses in clinical material. All the studied reagent kits were able to detect RNAs of the above-mentioned viruses in vaccine products. All the reagent kits demonstrated high specificity and could be used to confirm the identity of the measles, mumps and rubella viruses in all the studied vaccines. Commercial domestic reagent kits can be used to determine the identity of rubella vaccines by RT-PCR. However, it is advisable to develop domestic reagent kits for checking the identity of measles and mumps vaccines by RT-PCR. The acceptability of the test results was assessed using the industry reference standards of measles, mumps and rubella viruses activity with certified stable activity values.
Relevance. The need to increase vaccination coverage in order to eliminate measles in Russia and increase public confidence in vaccination requires constant monitoring of the quality of vaccines used for measles prevention. Aim. Analysis of laboratory quality parameters of commercial series of vaccines for measles prevention produced by JSC NPO Microgen, issued from 2015 to 2020, in comparison with the series issued in the period from 2002 to 2009. Materials and methods. The object of the study was a live measles culture vaccine and a live mumps-measles culture vaccine produced by JSC «NPO «Microgen». The quality analysis of vaccines was carried out according to the consolidated production and control protocols of 422 series of measles vaccine and 855 series of mumps-measles vaccine issued in 2015-2020, and 1043 series of measles vaccine and 902 series of mumpsmeasles vaccine issued in 2002-2009. Results and discussion. It is shown that the quality of the studied vaccines is stable during 16 years of monitoring. The sensitizing properties of both vaccines significantly decreased during the last 6 years of follow-up due to a decrease in the residual content of the antibiotic in the vaccination dose to less than the detection limit, as well as due to the low content of heterogeneous protein (bovine serum albumin). Conclusion. The quality of domestic vaccines for the prevention of measles and mumps meets who requirements; it is characterized by stability over 16 years of follow-up and minimal sensitizing properties. Information about the quality of domestic vaccines for the prevention of measles is an important argument for countering the antivaccination movement, which is a global problem and is recognized by who as one of the most important threats to the health of the world's population.
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