OPV Cessation – GPEI
OPV Cessation

Why OPV cessation?

Oral polio vaccine (OPV) is extremely safe and effective at protecting children against lifelong polio paralysis.  Over the past ten years, more than 10 billion doses of OPV have been given to nearly three billion children worldwide. More than 16 million cases of polio have been prevented, and the disease has been reduced by more than 99%.  It is the appropriate vaccine through which to achieve global polio eradication.

OPV contains attenuated (weakened) polioviruses.  On extremely rare occasions, use of OPV can result in cases of polio due to vaccine-associated paralytic polio (VAPP) and circulating vaccine-derived polioviruses (cVDPVs).  For this reason, the global eradication of polio requires the cessation of all OPV in routine immunization, as soon as possible after the eradication of wild poliovirus (WPV) transmission.

Phased approach to OPV cessation – trivalent OPV to bivalent OPV switch

Historically, OPV has been available in different formulations:

  • Trivalent OPV – containing type 1, 2 and 3 serotypes
  • Bivalent OPV – containing type 1 and 3 serotypes
  • Monovalent OPV – containing one serotype (ie type 1, 2 or 3)

A mix of all three formulations was being used to eradicate polio during supplementary immunization activities (SIAs).  However, only trivalent OPV was used in routine immunization programmes.  Bivalent OPV was exclusively used during SIAs to more rapidly interrupt the transmission of WPV1 and 3 – the only remaining WPV strains in circulation.  WPV2 has been eradicated since 1999.

With the transmission of WPV2 already successfully interrupted, the only cases of type 2 paralytic polio were being caused by the type 2 serotype component in trivalent OPV.  Over 90% of cVDPV cases were due to the type 2 component, which was also responsible for up to 38% of VAPP cases (approx. 200 cases per year worldwide).

The switch

In April 2016 a switch was implemented from trivalent OPV to bivalent OPV in routine immunization programmes.

Following WPV1 and WPV3 eradication, use of all OPV in routine immunizations will be stopped.

GPEI Statement on Independent Switch Evaluation Report

The Global Polio Eradication Initiative (GPEI) welcomes the expert evaluation of the 2016 global “switch” from the use of trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) in polio eradication efforts. The GPEI commissioned this evaluation to gain a better understanding of the conditions and challenges associated with the switch and its outcome; GPEI will use the learnings to inform the planning that is underway for the eventual cessation of all OPV use, as part of a broad Post-Certification Strategy. We accept the report’s findings of shortcomings in the implementation of the mitigation measures before and after the switch that resulted in an increase in cases and outbreaks.

With the goal of preventing all disease and transmission from type 2 poliovirus, the decision to withdraw type 2-containing OPVs globally was made based on the best available evidence at the time, including guidance from the Strategic Advisory Group of Experts on immunization (SAGE) and endorsement by World Health Assembly (WHA) resolution.

Despite careful evaluation of the risk of variant polio outbreaks, population immunity in some places proved lower than estimated. As a result, outbreaks, particularly in parts of Africa and Asia, grew and spread more than anticipated, which required using type 2 monovalent OPV (mOPV2) to respond. Meanwhile, supply constraints on both inactivated polio vaccine (IPV) and mOPV2 further reduced the scope of responses needed to decisively stop these outbreaks. In addition, sub-optimal quality of the outbreak response campaigns led to continuation of transmission and the emergence of new variant strains.

To ensure successful cessation of all OPVs following eradication of wild poliovirus, the GPEI is applying the lessons from this evaluation.  These lessons have informed the policy framework, triggers and principles of risk tiering for OPV cessation, which have been endorsed by SAGE.  For example, the programme will enhance efforts in historically hard-to-reach places to increase vaccination coverage before OPV cessation. Higher levels of baseline immunity will be a major OPV-cessation success factor.

At the time of the switch, the GPEI established an OPV2 cessation risk task team to monitor and mitigate evolving threats. Since the switch, GPEI partners and affected countries have taken important steps to ensure that any trace of poliovirus transmission is detected quickly, and outbreak responses are fast and effective. These steps are making a positive difference: cases of type 2 variant polio have fallen by approximately 60% from a peak in 2020 to those reported in 2023, and they continue to decline in 2024. However, the remaining presence of variant poliovirus transmission in many places underscores the threat that polio will continue to pose until all transmission is stopped for good.

The GPEI leadership is continuing to engage closely with affected countries to ensure commitments to high-quality outbreak responses, including through stronger engagement of communities. Through its partnership with Gavi, the Vaccine Alliance, the GPEI gives increased focus to strengthening routine immunization, ensuring adequacy of IPV supply and adding a second dose to the essential immunization schedule, which is helping to lay the groundwork for a lasting end to polio.

An innovative tool has been available to address variant poliovirus since 2021 — novel oral polio vaccine type 2 (nOPV2), with over 1.2 billion doses administered to children in 42 countries around the world. Use of nOPV2 helps countries to respond to outbreaks with reduced risk of seeding new variant emergences. Further work to bolster nOPV2 vaccine supply, improve outbreak response time through faster detection and testing, and closing immunity gaps to prepare for OPV cessation will help to achieve and sustain eradication.

Download the expert evaluation report.