Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life
Vol. 74 No. 2 (2015), ORIGINAL ARTICLE
Vol. 74 No. 2 (2015)

Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life

ORIGINAL ARTICLE
https://doi.org/10.53393/rial.2015.v74.33461
Published 2016-03-28
Renata Faria de Carvalho
Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ
Simone Ferreira Teixeira Bastos
Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ
Fernando Fingola
Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Toxicologia e Farmacologia, Rio de Janeiro, RJ
Kátia Christina Leandro
Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Química, Rio de Janeiro, RJ
Catia Ines Costa
Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ
PDF

Keywords

hepatitis B vaccine
quality control
shelf life
potency
stability

How to Cite

1.
Carvalho RF de, Bastos SFT, Fingola F, Leandro KC, Costa CI. Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life. Rev Inst Adolfo Lutz [Internet]. 2016 Mar. 28 [cited 2024 Dec. 4];74(2):97-103. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/33461
ACM ACS APA ABNT Chicago Harvard IEEE MLA Turabian Vancouver

Download Citation

Endnote/Zotero/Mendeley (RIS) BibTeX

Abstract

For over 20 years, the hepatitis B (HB) vaccine has been produced by the expression of the viral gene encoding the hepatitis B surface antigen (HBsAg) in yeast. According to the data from WHO, the hepatitis B vaccines are generally stable for up to three years when stored at 2 ºC to 8 ºC. The purpose of this study was to evaluate whether the hepatitis B vaccine, at the time of their release, the quality criteria of this product were maintained seven years after the expiration date. Vaccine vials in multi-dose (10 and 05 doses) and three lots from each manufacturer (A, B and C) were analyzed. All batches were assayed for visual appearance, potency, bacterial endotoxin, thiomersal amount, aluminum hidroxyde contents and pH by means of validated tests. The nine lots evaluated seven years after the expiration date showed similar concentrations when compared to those demonstrated at the time of batches release by the National Institute for Quality Control in Health (INCQS). No significant change in the quality of the hepatitis B vaccine after the expiration date was confirmed. These data might be useful to subsidize a future evaluation for reviewing an extension of the vaccines shelf life.
https://doi.org/10.53393/rial.2015.v74.33461
PDF

References

1. Seeger C, Zoulim F, Mason WS. Hepadnaviruses. In: Fields Virology. 6ª ed. Knipe DM, Howley PM (eds). Lippincott Williams & Wilkins, PA, USA, 2013. 2185-221.

2. Zanetti AR, Van Damme P, Shouval D. The global impact of vaccination against hepatitis B: a historical overview. Vaccine.2008;26:6266-73. [DOI: 10.1016/j.vaccine.2008.09.056].

3. World Health Organization -WHO. Immunization, Vaccines and Biologicals. Hepatitis B. Geneva; 2010.

4. World Health Organization -WHO. Immunization, Vaccines and Biologicals. Hepatitis B. Geneva; 2014. [acesso 2014 Nov 20]. Disponível em: [http://www.who.int/immunization/diseases/hepatitisB/en/].

5. Decker MD. Principles of pediatric combination vaccines and practical issues related to use in clinical practice. Pediatr Infect Dis J.2001;20(11 Suppl):S10-8.

6. Decker M, Bogaerts H, Edwards K. Combination vaccines. In: Plotkin S, Orenstein W, Offit PA (eds).Vaccines. 5a ed. USA: Saunders Co; 2008. p. 1069-101.

7. Ellis RW. Development of combination vaccines. Vaccine.1999;17(13-14):1635-42. [DOI: 10.1016/S0264-410X(98)00424-1].

8. Pichichero ME. New combination vaccines. Pediatr Clin North Am.2000;47(2):407-26. [DOI: 10.1016/S0031-3955(05)70214-5].

9. World Health Organization - WHO. Requirements for Hepatitis B vaccines Made Recombinant DNA Techniques. In: WHO Expert Committee on Biological Standardization. Thirty–ninth report. Geneva, 1989, Annex 2, WHO Technical Report Series n. 786.

10. World Health Organization -WHO. Requirements for Hepatitis B vaccines Made Recombinant DNA Techniques. In: WHO Expert Committee on Biological Standardization. Forty–eighth report. Geneva, 1999, Annex 4, WHO Technical Report Series n. 889. p. 94-95. [acesso 2014 Out 20]. Disponível em: [http://apps.who.int/iris/bitstream/10665/42202/1/WHO_TRS_889.pdf ].

11. European Pharmacopoeia. Hepatitis B vaccine, 8.0, volume I, 01/2014. Strasbourg: EDQM Council of Europe.

12. U.S. Food and Drug Administration - FDA. Biological Products: general provisions. Code of Federal Regulations. Title 21, sec 600.15 -Temperatures during shipment. Washington, DC: US Government Printing Office; 2007.

13. European Directorate for the Quality of Medicines & Health Care – EDQM. EU Administrative procedure for Official Control Authority batch release: Control authority batch release of vaccines and blood products. Strasbourg: Council of Europe, 2012.

14. Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Departamento de Vigilância das Doenças Transmissíveis. Nota Técnica Conjunta n.2/2013/CGPNI/DEVEP e CGDHRV/DST-AIDS/SVS/MS. Ampliação da oferta da vacina hepatite B para a faixa etária de 30 a 49 anos em 2013. Brasília: Ministério da Saúde, 2013. [acesso 2015 Jun 11]. Disponível em: [http://www.saude.rs.gov.br/upload/1372685606_11%20Nota%20Tecnica%20N%C2%BA%20022013%20-%20vacina%20hepatite%20B%2030%20a%2049%20anos.pdf].

15. US Centers for Disease Control and Prevention - CDC. Update expanded availability of thimerosal preservative – free hepatitis B vaccine. Morb Mort Weekly Rep.2000;49(28):642-65.

16. Clapp T, Siebert P, Chen D, Braun LTJ. Vaccines with aluminum-containing adjuvants: optimizing vaccine efficacy and thermal stability. J Pharm Sci.2011;100(2):388-401. [DOI: 10.1002/jps.22284].

17. United States Pharmacopeia – USP 23 - National Formulary 19. Rockville: The United States Pharmacopeial Convention; 2000.

18. Birner J, Garnet JR. Thimerosal as a preservative in biological preparations. I. Application of polarography to the determination of thimerosal in aqueous solutions and vaccines. J Pharm Sci.1964 Oct; 53:1264-5.

19. Page JE, Waller JG. Polarographic determination of thiomersalate. Analyst.1949;74:292-6. [DOI: 10.1039/AN9497400292].

20. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline. ICH Q1A (R2): Stability Testing of New Drug Substances and Products. February 6, 2003. [acesso 2014 Out 24]. Disponível em: [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf].

21. U.S. Food and Drug Administration - FDA. Biological Products: general provisions. Code of federal regulations. Title 21, sec 600.3. Washington, DC: US Government Printing Office; 2007.

22. World Health Organization – WHO, Global Programme for Vaccines and Immunization. Thermostability of vaccines. Geneva: WHO; 1998. (Publication WHO/GPV/98.07)

23. Dobbelaer R. Collaborative study for the establishment of biological reference preparations for rDNA hepatitis B vaccine. Pharmeuropa Special Issue, BIO 1997; 2:3-18.

24. European Pharmacopeia. Method of analysis, Biological assays. Assay of hepatitis B vaccine (rDNA). General chapter 2.7.15. 5ª ed. Strasbourg, France: Council of Europe; 2005.

25. European Pharmacopeia. Statistical analysis, 8.0, volume I, 01/2014. Strasbourg: EDQM Council of Europe.

26. European Pharmacopeia. Bacterial Endotoxins, 7.0. Strasbourg: Council of Europe, 2011; p.171-5.

27. Farmacopeia Brasileira. 4 ed., parte 2, n. 5, São Paulo: Atheneu, 2004.

28. Birner J, Garnet JR. Thimerosal as a preservation in biological preparations. Application of polarography to the determination of thimerosal in aqueous solutions and vaccines. J Pharm Sci.1964;53(10):1263-5.

29. Baylor NW, Egan W, Richman P. Aluminum salts in vaccines – US perspective. Vaccine.2002;20(Suppl 3):S18-23.

30. Gupta RK. Aluminum compounds as vaccine adjuvants. Adv Drug Deliv Rev.1998;32(3):155-172.

31. Finney DJ. Chapter 4 Parallel line assays. In: Statistical Methods in Biological Assay. 3ª ed. London: Charles Griffin and Company Ltd; 1978. p. 69-104.

32. Hendriksen CFM, Garthoff B, Aggerbeck H, Bruckner L, Castle P, Cussler K et al. Alternatives to animal testing in the quality control of immunobiologicals: current status and future prospects. The report and recommendations of ECVAM workshop 4. ATLA.1994; 22:420-34.

33. Pierard I, Spelte G, Le Tallec D, Duchêne M. Consideration on a few aspects of the stability studies post licensure. Biologicals.2009;37(6):403-6. [DOI: 10.1016/j.biologicals.2009.08.011].

34. Fairweather WR, Mogg R, Bennett PS, Zhong J, Morrisey C, Schofield TL. Monitoring the stability of human vaccines. J Biopharm Stat.2003;13(3):395-413. [DOI:10.1081/BIP-120022762].

35. Schofield TL. Maintenance of vaccine stability through annual stability and comparability studies. Biologicals.2009;37(6):397-402.[DOI: 10.1016/j.biologicals.2009.08.010].

36. World Health Organization - WHO. Recommendations to Assure the Quality, Safety and Efficacy of Recombinant Hepatitis B Vaccines. Proposed replacement of: WHO Technical Report Series, Nº 786, Annex 2 and Technical Report Series, Nº 889, Annex 4. Geneva, World Health Organization, 2010. [acesso 2014 Nov 06]. Disponível em: [http://www.who.int/biologicals/HEP_B_Recomm_after_ECBS_endorsment_final].

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Copyright (c) 2016 Instituto Adolfo Lutz Journal

Downloads

Download data is not yet available.