The Results of Re-certification of Reference Standard Sample Used for the Examination of Quality Smallpox Vaccines

The article presents the results of research quality of drugs for the prevention of smallpox during the period from 2007 to 2015 years, where the reference standard uses industry standard of activity, specificity (identification) and necrotic activity of smallpox vaccine, on indicators: «Specific activity», «The antigenic activity» and «Specific safety». Described research methods, presented results and statistical analysis of the results. The article also provided the results of the regular re-certification of reference standard sample activity, specificity (identification) and necrotic activity smallpox vaccine OOO 42-28-113-12 (ОСО), held in 2015. Branch reference preparation for the determination of activity, specificity and necrotic activity of the smallpox vaccine was re-certified with the « specific activity» assigned value of 4,9 ± 2,7 х 10⁸ pfu/ml. Other certified characteristics were also confirmed. The criteria «Specific activity» and «Specificity (identification)» were determined using chorioallantoic membrane of 12-days-old chicken embryos and compared against the First International reference preparation of the smallpox vaccine. The re-certification of the branch reference preparation for the determination of activity, specificity (identification) and necrotic activity of the smallpox vaccine (42-28-113-12) confirmed the possibility of its further use. The shelf-life before the next re-certification is 3 years.

пострегистрационная оценка препарата, вакцина оспенная живая, ОспаВир, Postmarketing evaluation of the quality of drugs, Smallpox vaccine, live, OspaVir. Smallpox vaccine is inactivated, industry standard of activity, specificity and necrotic activity smallpox vaccine, specific activity, testing of vaccines for the prevention of smallpox

1. Scientific review of variola virus research, 1999–2010 gg. WHO/HSE/GAR/BDP/2010.3. Dekabr’ 2010 g.

2. Fenner F., Henderson D.A., Arita I. et al. Smallpox and its eradication. Geneva: World Health Organization. 1988.

3. Maksjutov R.A., Gavrilova E.V., Shhelkunov S.N. Development of modern smallpox vaccines. Voprosy virusologii. [Problems of Virology]. 2011; 56 (6): 4 – 8 (in Russian).

4. Perekrest V.V., Movsesyants A.A., Mukhacheva A.V., Shevtsov V.A., Shvedov D.V., Borisevich I.V. Preparations for specific prevention of smallpox, registered in the Russian Federation. BIOpreparati. [BIOpreparations]. 2013; 2: 4 – 13.

5. Mukhacheva A.V., Perekrest V.V., Movsesyants A.A., Sargsyan K.A., Fadeykina O.V. et al. The results of re-certification of the Industry standard sample activity, specificity and necrotic activity of smallpox vaccine. BIOpreparati. [BIOpreparations]. 2013; 4: 34 – 40.

6. Borisevich I.V. Petukhov V.G., Movsesyants A.A., Volkova R.A., Fadeykina O.V. Ustinnikova O.B. et al. The standard samples for quality control of medical immunobiological preparations. Abstracts of the All-Russia scientific-practical conference «Vaccinology 2010. Immunobiological means of prevention, diagnosis and treatment of infectious diseases». Moscow: 2010: 27 – 28.

7. WHO Expert Committee on biological standardization. Recommendations for the preparation, characterization and establishment of international and other bioilogical reference standards. – Geneva, 2004; WHO Technical Report Series 932, annex 2; 73 – 131, 137.

8. WHO International Standard The 1st International Standard for Smallpox Vaccine NIBSC code: SMV Instructions for use (Version 4.0, Dated 18/03/2008).

9. The certificate on the industry standard patеnt of activity, specificity and necrotic activity of smallpox vaccine (CCA 42 - 28 - 113 - 07).

10. Officinal item of Company P N 001141/01 on drug «Smallpox vaccine live (smallpox vaccine), lyophilisate for solution for intradermal and epidermal scarification application together with the solvent».

11. Officinal item of Company P N 001038/01 on drug «TEOVak (smallpox vaccine embryonic live)», divisible tablets coated shell.

12. Registration number LSR-005198/08 on drug «OspaVir. Smallpox vaccine, inactivated, lyophilisates for solution for subcutaneous administration».

13. Instructions for use. «Industry standard pattern of activity, specificity and necrotic activity of smallpox vaccine (CCA 42 - 28- 113- 12). Moscow; 2012. Scientific Center for Expertise of Medical Products of Russian Ministry of Healthcare.