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Oral Poliovirus Vaccine (OPV) Manufacturing in Iran over Five Decades: from tOPV to bOPV and Future Planned Cessation | ||
| Archives of Razi Institute | ||
| مقالات آماده انتشار، پذیرفته شده، انتشار آنلاین از تاریخ 08 شهریور 1404 اصل مقاله (432.33 K) | ||
| نوع مقاله: Review Article | ||
| شناسه دیجیتال (DOI): 10.22092/ari.2025.370018.3735 | ||
| نویسندگان | ||
| Behnam Alirezaie1؛ Ashraf Mohammadi* 2 | ||
| 1Department of Human Viral Vaccines, Razi Vaccine and Serum Research Institute (RVSRI), Agricultural Research, Education, and Extension Organization (AREEO), Karaj, Iran | ||
| 2Department of Human Viral Vaccines, Razi Vaccine and Serum Research Institute (RVSRI), Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran | ||
| چکیده | ||
| 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). | ||
| کلیدواژه‌ها | ||
| Poliovirus؛ OPV؛ Iran؛ Vaccine | ||
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