Live tularemia vaccine quality assessment according to test results under the mandatory certification

The results of the tests for the quality assessment of live tularemia vaccine under the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation in 2011-2015 were analyzed in the present article. There were 14 batches (of 34) which did not comply with the requirements of regulatory documents (RD) in terms of «Specific activity (percentage of live microbial cells)», «Number of cutaneous doses» and «Thermal stability». The experimental results had confirmed the irregularity of tularemia vaccine batch samples in terms of «Specific activity (percentage of live microbial cells)» which, respectively, led to differences in vaccine samples in terms of the number of cutaneous and intradermal doses. It was confirmed that FT-agar is a nutrient providing all the necessary conditions for cultivating Francisella tularensis strain. Possible causes of irregular quality of the batches released in 2011 was considered in the present article. Test results for 93 batches of tularemia vaccine manufactured in 2012-2015 shown their full compliance with the requirements of RD. Consistent quality assurance of tularemia vaccine became the basis for the possibility of choice, certification and approval of new drug batches as industrial reference standards.

Francisella tularensis, вакцина туляремийная живая, нормативная документация, специфическая активность, процент живых микробных клеток, концентрация микробных клеток, количество накожных доз, термостабильность, колониеобразующая единица, отраслевой стандартный образец, Francisella tularensis, live tularemia vaccine, regulatory documents, specific activity, percentage of live microbial cells, concentration of microbial cells, number of cutaneous doses, thermal stability, colony forming unit, growth media for cultivation and isolation of tularemia microbe (FT-agar), industry reference standard

1. Olsufiev NG, Dunaeva TN. Natural foci. Epidemiology and prevention of tularemia. Moscow; 1970 (in Russian).

2. Olsufiev NG. Taxonomy, microbiology and laboratory diagnosis of tularemia pathogen. Moscow; 1975 (in Russian).

3. Mescheryakova IS. Taxonomy, identification and immunological diagnosis of tularemia. Dr. Med. Sci [thesis]. Moscow; 1990 (in Russian).

4. Harik NS. Tularemia: epidemiology, diagnosis, and treatment. Pediatric Annals 2013; 42(7): 288–92.

5. Sjöstedt A. Tularemia: history, epidemiology, pathogen physiology, and clinical manifestations. Annals NY Acad Sci. 2007; 1105: 1–29.

6. WHO Guidelines on Tularaemia. WHO/CDS/EPR/2007.7 [Internet]. 2007 [cited 2013 Feb 12]. Available from: http://www.who.int/ csr/resources/publications/WHO_CDS_EPR_2007_7.pdf.

7. Tularemia — United States, 2001–2010. MMWR Morb Mortal Wkly Rep. 2013; 62(47): 963–6.

8. Kosilko SA, Balakhonov SV, Breneva NV, Chesnokova MV, Andaev EI, Noskov AK, et al. Epidemiological situation on zoonotic and natural-focal infectious diseases in Siberia and Far East in 2013; prognosis for 2014. Problemy osobo opasnyh infektsiy 2014; (2): 53–7 (in Russian).

9. On the status of sanitary and epidemiological welfare of the population in the Russian Federation in 2013: State Report. Moscow: Federal Service for Supervision of Consumer Rights Protection and Human Welfare; 2014. Available from: http://rospotrebnadzor.ru/bitrix/redirect.php?event1=file&event2=download&event3= gd_2013_dlya-sayta.pdf&goto=/ upload/iblock/3b8/gd_2013_dlyasayta.pdf (in Russian).

10. Pozdeev OK. Medical Microbiology. Moscow; 2004 (in Russian).

11. Guidelines «Procedure for organizing and conducting tularemia laboratory diagnostics laboratory territorial, regional and federal levels». MUK 4.2.2939–11. Moscow; 2011 (in Russian).

12. Kasina IV, Goryaev ÀÀ, Rashchepkin LI, Fadeykina OV, Nemirovskaya TI, Ustinnikova OB, et al. Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine’s specific activity and immunogenicity. Biopreparation 2015; (4): 32–8 (in Russian).