NGO Microgen implemented a unique system of quality and efficiency control of each dose of the tick-borne encephalitis vaccine
To determine the level of the main component (tick-borne encephalitis virus antigen), which determines the effectiveness of the vaccine, Russian specialists have developed and implemented an original method for assaying the antigen in the sample using ELISA and specialized computer analysis. Employed quality control method allows to maintain the antigen level of inactivated encephalitis virus from 0.6 to 3.0 ug/dose, which ensures the stability of each vaccine dose produced and ensures significantly fewer adverse events when using vaccines Encevir®.
According to NGO Microgen, the developed method has the highest accuracy of assaying the vaccine antigen and, most importantly, allows to assay the finished product, ensuring quality control of each vaccine dose.
"Introduction of an assay method for vaccine antigen allows for more strict regulation of the antigen level in one vaccine dose, which can ensure production of vaccines with improved quality and significantly fewer potential side effects", said Alexander Koltunov, Director of NGO Microgen branch in Tomsk.
The total volume of anti-tick vaccine purchased by the Russian regions from the budget is about 3.5 million doses per year, of which 2.4 million are intended for the vaccination of adults, and 1.1 million for children. At present, only NGO Microgen analyses the error in vaccine antigen assay during the production of vaccines against tick-borne encephalitis that are used for nation-wide immunization in Russia.
Since April 2015, by tick bites about 450 thousand Russians from tick bites. Among all the affected population, 1249 were infected with viral encephalitis, 120 fell ill with Crimean hemorrhagic fever, and about 3000 were diagnosed with an infectious tick-borne borreliosis.
To date, vaccination is the only effective measure to protect children and adults against tick-borne encephalitis. Every year, up to 500 ths. of adults over 18 years old are immunized with Encevir vaccine in Russia. In January this year the Tomsk branch of NGO Microgen manufactured a new vaccine for prevention of tick-borne encephalitis in children called Encevir Neo. Both vaccines are manufactured in a modern department of NGO Virion which meets all the GPM requirements.