Oral Poliovirus Vaccine (OPV) Manufacturing in Iran over Five Decades: from tOPV to bOPV and Future Planned Cessation

Document Type : Review Article

Authors

1 Department of Human Viral Vaccines, Razi Vaccine and Serum Research Institute (RVSRI), Agricultural Research, Education, and Extension Organization (AREEO), Karaj, Iran

2 Department of Human Viral Vaccines, Razi Vaccine and Serum Research Institute (RVSRI), Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

10.32592/ARI.2025.80.SpecialIssue.21

Abstract

By the early 1970s, there were no manufacturers in Iran producing oral poliovirus vaccine (OPV). The only domestic OPV was produced by the Razi Vaccine and Serum Research Institute (RVSRI) in 1974 after receiving the Sabin seeds on 5 January 1973. The quality of six vaccine lots derived from them was deemed satisfactory after re-evaluation by two WHO reference laboratories. Then, the RVSRI OPV produced using human diploid cell (HDC) substrate was manufactured at a scale sufficient to meet nearly all domestic consumption. Vaccine lots that passed control tests were released lot by lot by the national regulatory authority after reviewing the summary protocol and selected independent testing. Following the global switch plan from trivalent OPV (tOPV) to bivalent OPV (bOPV) which protects against type 1 and 3, the RVSRI started manufacturing bOPV in 2014. In 2016, the tOPV was entirely replaced by the bOPV in Iran.
For over 50 years, from 1974 to the present, more than 600 million doses of OPV, including both tOPV and bOPV, produced by RVSRI have been approved by the national regulatory authorities and utilized in Iran. Wild poliovirus was eradicated from Iran during this period. Although Iran shares borders with two polio-endemic countries, Pakistan and Afghanistan, there have been no recorded outbreaks of poliomyelitis in Iran for several years. This may be attributed to a sufficient level of herd immunity. Over 50 years of experience in Iran has shown that this vaccine is safe and efficient, and no increased incidence of adverse events following immunization (AEFI) was observed in Iranian OPV recipients. Without a doubt, in the post-eradication era, safe polio vaccines such as Sabin inactivated poliovirus vaccine (sIPV) and/or Virus-Like Particle (VLP) will completely replace OPV in Iran''s national immunization program. This change aligns with the global movement to cease the use of OPV to finalize the risks associated with vaccine-derived polioviruses (VDPVs) and vaccine-associated paralytic poliomyelitis (VAPP).

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Main Subjects

References

  1. Racaniello V. Picornaviridae: The viruses and their replication. 2001
  2. Coyne CB, Oberste MS, Pallansch MA. Enteroviruses: polioviruses, coxsackieviruses, echoviruses, and newer enteroviruses. Fields virology: emerging viruses. 2017;7:86-128
  3. Racaniello VR. One hundred years of poliovirus pathogenesis. Virology. 2006;344(1):9-16
  4. Enders JF, Weller TH, Robbins FC. Cultivation of the Lansing strain of poliomyelitis virus in cultures of various human embryonic tissues. Science. 1949;109(2822):85-7
  5. Duchene M, Peetermans J, D′ HONDT E, Harford N, Fabry L, Stephenne J. Production of poliovirus vaccines: past, present, and future. Viral immunology. 1990;3(4):243-72
  6. Chumakov M, Voroshilova M, Antsupova A, Boiko V, Blinova M, Rodin V. Live enterovirus vaccines for emergency non-specific prevention of mass respiratory diseases during autumn-winter outbreaks of influenza and other acute respiratory diseases. Zh Mikrobiol Epidemiol Immunobiol. 1992;11:37-40
  7. Habibzadeh F, Sajadi MM, Chumakov K, Yadollahie M, Kottilil S, Simi A, et al. COVID-19 infection among women in Iran exposed vs unexposed to children who received attenuated poliovirus used in oral polio vaccine. JAMA Network Open. 2021;4(11):e2135044-e
  8. Geiger K. Progress toward poliomyelitis eradication—worldwide, January 2022–December 2023. MMWR Morbidity and Mortality Weekly Report. 2024;73
  9. Nategh R, Naficy K, Shahriary M. Mass trivalent oral polio vaccination in primary school age children in Teheran. 1970
  10. Kazemi B, Nourmand A, Ziai M. Paralytic Poliomyelitis Before and After Mass Vaccination: A Record of Clinical and Demographic Experiences in Southern Iran. Clinical pediatrics. 1972;11(12):698-700
  11. Mirchamsy H, Shafyi A, Ahourai P, Bahrami S, Kamali M, Razavi J, et al. Experience with production and control of attenuated poliovirus (Subinstrains) in human diploid cells. Archives of Razi Institute. 1978;30(1):39-50
  12. Standardization WECoB. Requirements for poliomyelitis vaccine (oral). World Health Organization, Technical Report Series no 486: WHO Geneva; 1972. p. 20-58.
  13. MlRCHAMSY H, Shafyi A. The expanded programme in immunization against measles and poliomyelitis, Iran''s Experience. Archives of Razi Institute. 1984;34(1):1-8
  14. Zahraei SM, Marandi A, Sadrizadeh B, Gouya MM, Rezaei P, Vazirian P, et al. Role of National Immunization Technical Advisory Group on improvement of immunization programmes in the Islamic Republic of Iran. Vaccine. 2010;28:A35-A8
  15. Zahraei SM, Eshrati B, Gouya MM. Is there still an immunity gap in high-level national immunization coverage, Iran? Archives of Iranian medicine. 2014;17(10):698
  16. Zahraei S, Sadrizadeh B, GOUYA MM. Eradication of poliomyelitis in Iran, a historical perspective. 2009
  17. Zahraei SM, Izadi S, Gouya MM, Shahri SMH, Mohammadi M. Immunization coverage of children aged 24-35 months in the Islamic Republic of Iran: a national cluster coverage survey. Eastern Mediterranean Health Journal. 2022;28(2):121-9
  18. Orenstein WA, Offit PA, Edwards KM, Plotkin SA. Plotkin''s Vaccines, E-Book: Elsevier Health Sciences; 2022.
  19. Part A. Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated).
  20. Wood D, Macadam A. Laboratory tests for live attenuated poliovirus vaccines. Biologicals. 1997;25(1):3-15
  21. Keshavarz M, Shafiee A, Rasekhi M, Abdeshah M, Mohammadi A, Tariqi G, et al. Development of Indirect Immunofluorescence Technique for the Identification of MRC5 Working Seed Cell. Archives of Razi Institute. 2018;73(1)
  22. Mirchamsy H, Shafyi S, Bahrami S, Kamali M, Nazari P, Mahinpour M. Improvement in the yield of oral poliovirus vaccine (Sabin strains) produced in human diploid cells. Developments in Biological Standardization. 1978;41:183-5
  23. Agol V, Drozdov S, Ivannikova T, Kolesnikova M, Korolev M, Tolskaya E. Restricted growth of attenuated poliovirus strains in cultured cells of a human neuroblastoma. Journal of virology. 1989;63(9):4034-8
  24. Alirezaie B, Taqavian M, Aghaiypour K, Esna‐Ashari F, Shafyi A. Phenotypic and genomic analysis of serotype 3 sabin poliovirus vaccine produced in MRC‐5 Cell substrate. Journal of medical virology. 2011;83(5):897-903
  25. Prikazsky V, Leroux-Roels G, Van Damme P, Safary A, Colau B, Duchene M. Comparative pre-clinical and clinical experience with oral polio vaccine produced on MRC-5 cells or on primary monkey kidney cells. Vaccine. 2005;23(33):4219-27
  26. Pagano JS. Attenuated poliovirus vaccines grown in human diploid cell strains for the immunization of infants. The Journal of Pediatrics. 1966;68(2):189-98
  27. Ikic D. Recent information on poliomyelitis vaccine, live, oral, prepared in human diploid cell strain system. Proc 9th Int Cong Permanent Sect Microbiol Standard Int Ass Microbiol Soc, Lisbon: Prog Immunobiol Stand. 1965;2:305-10
  28. Hayflick L, Plotkin SA, Norton TW, Koprowski H. Preparation of poliovirus vaccines in a human fetal diploid cell strain. American Journal of Epidemiology. 1962;75(2):240-58
  29. Mirchamsy H, Shafyi A, Mahinpour M, Nazari P. Stabilizing effect of magnesium chloride and sucrose on Sabin live polio vaccine. Developments in biological standardization. 1978;41:255-7
  30. Moussavi T, Sadrizadeh B, Zahraei M, Nategh R, Nadim A. POLIO ERADICATION IN IRAN (REPORT). 2012
  31. Mirchamsy H, Shafyi A, Sassani A. Efficacy of oral poliovaccine made in human diploid cells. Archives of Razi Institute. 1981;32(1):1-14
  32. Gholizadeh M, Salarilak S, Roustaei M, Soleymanjahi H. Assessment Of Antibody Level Of Antmruses Of Poliomyelitis Types I, Ii, Iii In Children Under 5 Years Of West-Azarbaijan After Holding Of The 3rd National Immunization Days (Nids) Program In Iran. 2001
  33. Izadi S, Shahmahmoodi S, Zahraei S, Dorostkar F, Majdzadeh R. Risk of polio reintroduction to border regions of Islamic Republic of Iran: seroprevalence study of children with at least 5 doses of oral polio vaccine. East Mediterr Heal J. 2014;20:287-94
  34. Lago PM, Bravo JR, Andrus JK, Comellas M, Galindo M, de Quadros CA, et al. Lessons from Cuba: mass campaign administration of trivalent oral poliovirus vaccine and seroprevalence of poliovirus neutralizing antibodies. Bulletin of the World Health Organization. 1994;72(2):221
  35. Dömök I, Balayan M, Fayinka O, Škrtić N, Soneji A, Harland P. Factors affecting the efficacy of live poliovirus vaccine in warm climates: efficacy of type 1 Sabin vaccine administered together with antihuman gamma-globulin horse serum to breast-fed and artificially fed infants in Uganda. Bulletin of the World Health Organization. 1974;51(4):333
  36. Franklin G, Robertson M. A Mass Vaccination Campaign against Poliomyelitis using the Sabin Oral Vaccine. 1965
  37. Lee L, Lim K, Tye C. Prevention of poliomyelitis in Singapore by live vaccine. British medical journal. 1964;1(5390):1077
  38. Moriniere BJ, van Loon FP, Rhodes PH, Patriarca P, Klein-Zabban M-L, Herrington J, et al. Immunogenicity of a supplemental dose of oral versus inactivated poliovirus vaccine. The Lancet. 1993;341(8860):1545-50
  39. Patriarca PA, Wright PF, John TJ. Factors affecting the immunogenicity of oral poliovirus vaccine in developing countries. Reviews of infectious diseases. 1991;13(5):926-39
  40. Weldon WC, Oberste MS, Pallansch MA. Standardized methods for detection of poliovirus antibodies. Poliovirus: methods and protocols: Springer; 2016. p. 145-76.
  41. Mohanty MC, Nalavade UP, Deshpande JM. Serum IgG and IgA levels in polio and non-polio acute flaccid paralysis cases in western Uttar Pradesh, India. Indian pediatrics. 2015;52(3):220-2
  42. Buisman A-M, Abbink F, Schepp RM, Sonsma JA, Herremans T, Kimman TG. Preexisting poliovirus-specific IgA in the circulation correlates with protection against virus excretion in the elderly. The Journal of infectious diseases. 2008;197(5):698-706
  43. Connor R, Brickley E, Wieland-Alter W, Ackerman M, Weiner J, Modlin J. Mucosal immunity to poliovirus. Mucosal Immunol. 2022; 15 (1): 1–9.
  44. Nejati A, Tabatabaei SM, Mahmoudi S, Zahraei SM, Tabatabaie H, Razaghi M, et al. Environmental surveillance of poliovirus and non-polio enteroviruses in Iran, 2017–2023: First report of imported wild poliovirus type 1 since 2000. Food and Environmental Virology. 2024;16(3):391-7
  45. Gao J, Kang G, Hu R, Zhang L, Yu J, Wang Z, et al. Adverse events following immunization with bivalent oral poliovirus vaccine in Jiangsu, China. British journal of clinical pharmacology. 2021;87(12):4831-8
  46. Platt LR, Estívariz CF, Sutter RW. Vaccine-associated paralytic poliomyelitis: a review of the epidemiology and estimation of the global burden. The Journal of infectious diseases. 2014;210(suppl_1):S380-S9
  47. Cáceres VM, Sutter RW. Sabin monovalent oral polio vaccines: review of past experiences and their potential use after polio eradication. Clinical Infectious Diseases. 2001;33(4):531-41
  48. Khetsuriani N, Prevots DR, Quick L, Elder ME, Pallansch M, Kew O, et al. Persistence of vaccine-derived polioviruses among immunodeficient persons with vaccine-associated paralytic poliomyelitis. The Journal of infectious diseases. 2003;188(12):1845-52
  49. Shaghaghi M, Shahmahmoodi S, Abolhassani H, Soleyman-Jahi S, Parvaneh L, Mahmoudi S, et al. Vaccine-derived polioviruses and children with primary immunodeficiency, Iran, 1995–2014. Emerging infectious diseases. 2016;22(10):1712
  50. Shaghaghi M, Shahmahmoodi S, Nili A, Abolhassani H, Madani SP, Nejati A, et al. Vaccine-derived poliovirus infection among patients with primary immunodeficiency and effect of patient screening on disease outcomes, Iran. Emerging Infectious Diseases. 2019;25(11):2005
  51. Shahmahmoodi S, Parvaneh N, Burns C, Asghar H, Mamishi S, Tabatabaie H, et al. Isolation of a type 3 vaccine-derived poliovirus (VDPV) from an Iranian child with X-linked agammaglobulinemia. Virus research. 2008;137(1):168-72
  52. Parvaneh N, Shahmahmoudi S, Tabatabai H, Zahraei M, Mousavi T, Esteghamati A-R, et al. Vaccine-associated paralytic poliomyelitis in a patient with MHC class II deficiency. Journal of clinical virology. 2007;39(2):145-8
  53. Rahimi P, Tabatabaie H, Gouya MM, Zahraie M, Mahmudi M, Ziaie A, et al. Characterization of mutations in the VP1 region of Sabin strain type 1 polioviruses isolated from vaccine-associated paralytic poliomyelitis cases in Iran. Journal of clinical virology. 2007;39(4):304-7
  54. Mamishi S, Shahmahmoudi S, Tabatabaie H, Teimourian S, Pourakbari B, Gheisari Y, et al. Novel BTK mutation presenting with vaccine-associated paralytic poliomyelitis. European journal of pediatrics. 2008;167(11):1335-8
  55. Naeini AE, Ghazavi M, Moghim S, Sabaghi A, Fadaei R. Acute flaccid paralysis surveillance: a 6 years study, Isfahan, Iran. Advanced biomedical research. 2015;4(1):99
  56. Taherkhani R, Farshadpour F, Ravanbod MR. Vaccine-associated paralytic poliomyelitis in a patient with acute lymphocytic leukemia. Journal of NeuroVirology. 2018;24(3):372-5
  57. Taherkhani R, Farshadpour F. Pediatric case with vaccine-related poliovirus infection: A case report. World Journal of Clinical Pediatrics. 2021;10(5):106
  58. Macklin G. Update on immunodeficiency-associated vaccine-derived polioviruses—Worldwide, July 2018–December 2019. MMWR Morbidity and mortality weekly report. 2020;69
Archives of Razi Institute
Volume 80, Special Issue - Serial Number 1
Special Issue_ 100th Anniversary
2025
Pages 21-29

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