Monovalent Oral Polio Vaccine Research Articles

Use of a fractional dose of inactivated polio vaccine (fIPV) to increase IPV coverage among children under 5 years of age in Somalia

BackgroundGlobal efforts reduced incidence of polio cases from 350,000 in 1988 to 22 cases in 2022 globally. There have been no wild poliovirus (WPV) cases seen in Somalia since August 2014. However, in 2017, there was a surge in the number of cases of circulating vaccine-derived poliovirus type 2 (cVDPV2), even with different intervention responses using monovalent oral polio vaccine type 2 (mOPV2). This study aimed to assess the use of fractional inactivated polio vaccine (fIPV), a smaller dose of the polio vaccine, equal to 1/5 of a standard dose, as an innovative polio vaccination delivery model, and identify the main opportunities for and challenges to the use of fIPV in the future for vaccinations.MethodsThe study used two designs: a quasi-experimental design used to pilot fIPV in five districts and a cross-sectional study using both quantitative and qualitative approaches to collect primary data. A simple random sampling method was used to select 2 out of the 5 pilot districts for household surveys to study 768 participants. Key informant interviews and focus-group discussions were used to collect data from key frontline health workers and health/immunization officials involved in the campaigns. Secondary data from the pilot campaigns were analysed, such as administrative pilot data, lot quality assurance sampling (LQAS) and post-campaign communication assessments.ResultsA total of 131,789 children aged 4–59 months were included for the pilot. Among these, 126,659 (96.1%) and 126,063 (95.6%) children were vaccinated in rounds 1 and 2, respectively. Out of the 768 households assessed, 99.9% had their children vaccinated. Nearly half of the few children who were not vaccinated were reported to be due to the parent of the child not being at home (48%). Ninety-seven percent of the qualitative study interviewees were satisfied with fIPV injection and recommended its use for routine immunization.ConclusionsThe study findings are promising in the use of fIPV in mass campaigns to realize better coverage and global polio eradication. fIPV will potentially be used by policymakers in the design of polio eradication campaigns that integrate the fIPV vaccine into routine or supplementary immunization.

Outbreak Response to Circulating Vaccine-Derived Poliovirus in Three Northern Regions of Ghana, 2019.

Background: Circulating Vaccine-Derived Poliovirus Type 2 (cVDPV2) was isolated in sewage and later in stool samples from children with acute flaccid paralysis (AFP) in northern Ghana. Method: A multidisciplinary and multisectoral team investigated this outbreak and reported on epidemiological and laboratory investigations. Sewage/wastewater samples were collected from the environment, while stool samples were collected from AFP/contact children under 5 years of age. The samples were processed for virus isolation, and positive isolates were sequenced. We also conducted a descriptive investigation involving a review of records, active case search, and Monovalent Oral Polio Vaccine 2 campaigns. Additionally, we interviewed caregivers about the vaccination status of their children, as well as their knowledge on polio prevention. Water quality, sanitation, hygiene practices, and health-seeking behaviours were also assessed. Results: A total of 18 cVDPV2 were confirmed in the three regions of Ghana during the outbreak in 2019-2020. All strains were genetically linked to a Nigerian cVDPV2 strain NIE-KWS-KSB-18-006HC29 that circulated in 2018. Evaluation of the surveillance system shows that officers have good knowledge of AFP and know how to collect samples, package them, and ship them to the laboratory. Few communities had access to potable water. Open defecation was common, and the water supply, sanitation, and hygiene practices of the communities were poor. Conclusion: The cVDPV2 outbreak represents the first time cVDPV2 has circulated in the country since Ghana embarked on the polio eradication program in 1996. However, with quality mOPV2 mop-up campaigns, a nationwide IPV catch-up campaign coupled with enhanced surveillance measures, transmission was interrupted.

A circulating vaccine-derived poliovirus type 2 outbreak in a chronic conflict setting: a descriptive epidemiological study in South Sudan – 2020 to 2021

BackgroundIn this study, we describe the epidemiological profile of an outbreak of the circulating Vaccine Derived Polio Virus type 2 in South Sudan from 2020 to 2021.MethodWe conducted a retrospective descriptive epidemiological study using data from the national polio/AFP surveillance database, the outbreak investigation reports, and the vaccination coverage survey databases stored at the national level.ResultsBetween September 2020 and April 2021, 59 cases of the circulating virus were confirmed in the country, with 50 cases in 2020 and 9 cases in 2021. More cases were males (56%) under five (93%). The median age of the cases was 23.4 ± 11.9 months, ranging from 1 to 84 months. All states, with 28 out of the 80 counties, reported at least one case. Most of the cases (44, 75%) were reported from five states, namely Warrap (31%), Western Bahr el Ghazal (12%), Unity (12%), Central Equatoria (10%), and Jonglei (10%). Four counties accounted for 45.8% of the cases; these are Gogrial West with 12 (20%), Jur River with 5 (8.5%), Tonj North with 5 (8.5%), and Juba with 5 (8.5%) cases.The immunization history of the confirmed cases indicated that 14 (24%) of the affected children had never received any doses of oral polio or injectable vaccines either from routine or during supplemental immunization before the onset of paralysis, 17 (28.8%) had received 1 to 2 doses, while 28 (47.5%) had received 3 or more doses (Fig. 4). Two immunization campaigns and a mop-up were conducted with monovalent Oral Polio Vaccine type 2 in response to the outbreak, with administrative coverage of 91.1%, 99.1%, and 97% for the first, second, and mop-up rounds, respectively.ConclusionThe emergence of the circulating vaccine-derived poliovirus outbreak in South Sudan was due to low population immunity, highlighting the need to improve the country’s routine and polio immunization campaign coverage.

The impact of surveillance and other factors on detection of emergent and circulating vaccine derived polioviruses.

Background: Circulating vaccine derived poliovirus (cVDPV) outbreaks remain a threat to polio eradication. To reduce cases of polio from cVDPV of serotype 2, the serotype 2 component of the vaccine has been removed from the global vaccine supply, but outbreaks of cVDPV2 have continued. The objective of this work is to understand the factors associated with later detection in order to improve detection of these unwanted events. Methods: The number of nucleotide differences between each cVDPV outbreak and the oral polio vaccine (OPV) strain was used to approximate the time from emergence to detection. Only independent emergences were included in the analysis. Variables such as serotype, surveillance quality, and World Health Organization (WHO) region were tested in a negative binomial regression model to ascertain whether these variables were associated with higher nucleotide differences upon detection. Results: In total, 74 outbreaks were analysed from 24 countries between 2004-2019. For serotype 1 (n=10), the median time from seeding until outbreak detection was572 (95% uncertainty interval (UI) 279-2016), for serotype 2 (n=59), 276 (95% UI 172-765) days, and for serotype 3 (n=5), 472 (95% UI 392-603) days. Significant improvement in the time to detection was found with increasing surveillance of non-polio acute flaccid paralysis (AFP) and adequate stool collection. Conclusions: cVDPVs remain a risk; all WHO regions have reported at least one VDPV outbreak since the first outbreak in 2000 and outbreak response campaigns using monovalent OPV type 2 risk seeding future outbreaks. Maintaining surveillance for poliomyelitis after local elimination is essential to quickly respond to both emergence of VDPVs and potential importations as low-quality AFP surveillance causes outbreaks to continue undetected. Considerable variation in the time between emergence and detection of VDPVs were apparent, and other than surveillance quality and inclusion of environmental surveillance,the reasons for this remain unclear.

The impact of surveillance and other factors on detection of emergent and circulating vaccine derived polioviruses

Background: Circulating vaccine derived poliovirus (cVDPV) outbreaks remain a threat to polio eradication. To reduce cases of polio from cVDPV of serotype 2, the serotype 2 component of the vaccine has been removed from the global vaccine supply, but outbreaks of cVDPV2 have continued. The objective of this work is to understand the factors associated with later detection in order to improve detection of these unwanted events. Methods: The number of nucleotide differences between each cVDPV outbreak and the oral polio vaccine (OPV) strain was used to approximate the time from emergence to detection. Only independent emergences were included in the analysis. Variables such as serotype, surveillance quality, and World Health Organization (WHO) region were tested in a negative binomial regression model to ascertain whether these variables were associated with higher nucleotide differences upon detection. Results: In total, 74 outbreaks were analysed from 24 countries between 2004-2019. For serotype 1 (n=10), the median time from seeding until outbreak detection was 284 (95% uncertainty interval (UI) 284-2008) days, for serotype 2 (n=59), 276 (95% UI 172-765) days, and for serotype 3 (n=5), 472 (95% UI 392-603) days. Significant improvement in the time to detection was found with increasing surveillance of non-polio acute flaccid paralysis (AFP) and adequate stool collection. Conclusions: cVDPVs remain a risk; all WHO regions have reported at least one VDPV outbreak since the first outbreak in 2000 and outbreak response campaigns using monovalent OPV type 2 risk seeding future outbreaks. Maintaining surveillance for poliomyelitis after local elimination is essential to quickly respond to both emergence of VDPVs and potential importations as low-quality AFP surveillance causes outbreaks to continue undetected. Considerable variation in the time between emergence and detection of VDPVs were apparent, and other than surveillance quality and inclusion of environmental surveillance, the reasons for this remain unclear.

The impact of surveillance and other factors on detection of emergent and circulating vaccine derived polioviruses

Background: Circulating vaccine derived poliovirus (cVDPV) outbreaks remain a threat to polio eradication. To reduce cases of polio from cVDPV of serotype 2, the serotype 2 component of the vaccine has been removed from the global vaccine supply, but outbreaks of cVDPV2 have continued. The objective of this work is to understand the factors associated with later detection in order to improve detection of these unwanted events. Methods: The number of nucleotide differences between each cVDPV outbreak and the oral polio vaccine (OPV) strain was used to approximate the time from emergence to detection. Only independent emergences were included in the analysis. Variables such as serotype, surveillance quality, and World Health Organization (WHO) region were tested in a negative binomial regression model to ascertain whether these variables were associated with higher nucleotide differences upon detection. Results: In total, 74 outbreaks were analysed from 24 countries between 2004-2019. For serotype 1 (n=10), the median time from seeding until outbreak detection was 284 (95% uncertainty interval (UI) 284-2008) days, for serotype 2 (n=59), 276 (95% UI 172-765) days, and for serotype 3 (n=5), 472 (95% UI 392-603) days. Significant improvement in the time to detection was found with increasing surveillance of non-polio acute flaccid paralysis (AFP) and adequate stool collection. Conclusions: cVDPVs remain a risk; all WHO regions have reported at least one VDPV outbreak since the first outbreak in 2000 and outbreak response campaigns using monovalent OPV type 2 risk seeding future outbreaks. Maintaining surveillance for poliomyelitis after local elimination is essential to quickly respond to both emergence of VDPVs and potential importations as low-quality AFP surveillance causes outbreaks to continue undetected. Considerable variation in the time between emergence and detection of VDPVs were apparent, and other than surveillance quality and inclusion of environmental surveillance, the reasons for this remain unclear.

Intradermal fractional-dose inactivated polio vaccine (fIPV) adjuvanted with double mutant Enterotoxigenic Escherichia coli heat labile toxin (dmLT) is well-tolerated and augments a systemic immune response to all three poliovirus serotypes in a randomized placebo-controlled trial

Eradication of poliomyelitis globally is constrained by fecal shedding of live polioviruses, both wild-type and vaccine-derived strains, into the environment. Although inactivated polio vaccines (IPV) effectively protect the recipient from clinical poliomyelitis, fecal shedding of live virus still occurs following infection with either wildtype or vaccine-derived strains of poliovirus. In the drive to eliminate the last cases of polio globally, improvements in both oral polio vaccines (OPV) (to prevent reversion to virulence) and injectable polio vaccines (to improve mucosal immunity and prevent viral shedding) are underway. The E. coli labile toxin with two or “double” attenuating mutations (dmLT) may boost immunologic responses to IPV, including at mucosal sites. We performed a double-blinded phase I controlled clinical trial to evaluate safety, tolerability, as well as systemic and mucosal immunogenicity of IPV adjuvanted with dmLT, given as a fractional (1/5th) dose intradermally (fIPV-dmLT). Twenty-nine volunteers with no past exposure to OPV were randomized to a single dose of fIPV-dmLT or fIPV alone. fIPV-dmLT was well tolerated, although three subjects had mild but persistent induration and hyperpigmentation at the injection site. A ≥ 4-fold rise in serotype-specific neutralizing antibody (SNA) titers to all three serotypes was seen in 84% of subjects receiving fIPV-dmLT vs. 50% of volunteers receiving IPV alone. SNA titers were higher in the dmLT-adjuvanted group, but only differences in serotype 1 were significant. Mucosal immune responses, as measured by polio serotype specific fecal IgA were minimal in both groups and differences were not seen. fIPV-dmLT may offer a benefit over IPV alone. Beyond NAB responses protecting the individual, studies demonstrating the ability of fIPV-dmLT to prevent viral shedding are necessary. Studies employing controlled human infection models, using monovalent OPV post-vaccine are ongoing. Studies specifically in children may also be necessary and additional biomarkers of mucosal immune responses in this population are needed.Clinicaltrials.gov Identifer: NCT03922061.

Polio Supplementary Immunization Activities During COVID-19 Pandemic: Experience from Penampang District, Sabah, Malaysia.

Background:Polio Supplementary Immunization Activities (SIAs) were carried out in the State of Sabah in response to the Vaccine Derived Poliovirus outbreak declared in December 2019. Prior to this, Malaysia had been polio-free over the past 27 years. This paper reported on the successful implementation of SIAs in the district of Penampang, Sabah, adapting (vaccine administration) to the COVID-19 pandemic.Methods:A series of meticulous planning, healthcare staff training, advocacy, and community engagement activities were conducted by the Penampang District Health Office. Bivalent Oral Polio Vaccine (bOPV) and monovalent Oral Polio Vaccine were administered over the period of 1 year via these methods: house to house, drive-through, static, and mobile posts. The targeted group was 22 096 children aged 13 years and below.Results:Polio SIAs in Penampang managed to achieve more than 90% coverage for both bOPV and mOPV. The overall vaccine wastage was reported to be 1.63%. No major adverse reaction was reported.Conclusion:High vaccine uptake during Polio SIAs in Penampang was attributed to good inter-agency collaboration, community engagement, intensified health promotion activities, and drive-through vaccination campaign.

Immunity and field efficacy of type 2-containing polio vaccines after cessation of trivalent oral polio vaccine: A population-based serological study in Pakistan

BackgroundIn Pakistan and other countries using oral polio vaccine (OPV), immunity to type 2 poliovirus is now maintained by a single dose of inactivated polio vaccine (IPV) in routine immunization, supplemented in outbreak settings by monovalent OPV type 2 (mOPV2) and IPV. While well-studied in clinical trials, population protection against poliovirus type 2 achieved in routine and outbreak settings is generally unknown. MethodsWe conducted two phases of a population-based serological survey of 7940 children aged 6–11 months old, between November 2016 and October 2017 from 13 polio high-risk locations in Pakistan. ResultsType 2 seroprevalence was 50% among children born after trivalent OPV (tOPV) withdrawal (April 2016), with heterogeneity across survey areas. Supplementary immunization activities (SIAs) with mOPV2 followed by IPV improved population immunity, varying from 89% in Pishin to 64% in Killa Abdullah, with little observed marginal benefit of subsequent campaigns. In the other high-risk districts surveyed, a single SIA with IPV was conducted and appeared to improve immunity to 57% in Karachi to 84% in Khyber. ConclusionsOur study documents declining population immunity following trivalent OPV withdrawal in Pakistan, and wide heterogeneity in the population impact of supplementary immunization campaigns. Differences between areas, attributable to vaccination campaign coverage, were far more important for type 2 humoral immunity than the number of vaccination campaigns or vaccines used. This emphasizes the importance of immunization campaign coverage for type 2 outbreak response in the final stages of polio eradication. Given the declining type 2 immunity in new birth cohorts it is also recommended that 2 or more doses of IPV should be introduced in the routine immunization program of Pakistan.

Polio Eradication in Nigeria and India: A Systematic Review of Challenges and Successes

Background: The global eradication of polio is considered an emergency and an unaccomplished task until completely eliminated. Vaccinating children against the polio virus confers immunity on them and breaks the transmission of the polio virus. Afghanistan, Nigeria and Pakistan remain the only three countries in the world that have not eliminated polio. The aims of this paper were to: (1) to identify the factors that impact the failure to eliminate polio from Nigeria and (2) determine the factors that led to the successful elimination of polio from India.
 Methodology: A systematic literature review was carried out to meet the above research objectives.
 Methods: Four electronic databases were searched (Cochrane Library, Medline, PubMed and Google Scholar) and articles that fulfilled the inclusion and exclusion criteria were selected and critically appraised.
 Results: In all, 98 articles were retrieved. After selection based on our selection criteria, fourteen studies were identified and included in the study. These were 5 systematic reviews: 3 cross-sectional studies, 3 mixed methods studies, 2 case-control studies and one quantitative (survey) study. In all, seven themes were identified from the review of the articles. Four themes were identified from the factors associated with the failure to eliminate polio from Nigeria: (1) Failure of the oral polio vaccine (OPV); (2) Institutional and geographical failures in vaccine programs; (3) Program and campaign management limitations; and (4) Vaccine refusal. Similarly, three themes were identified from the factors that contributed to the elimination of polio from India: (1) Replacement of the trivalent OPV with the monovalent and bivalent OPVs; (2) Implementation of intensive social mobilization strategies; and (3) Effective program micro planning and campaign management.
 Conclusion: Based on the findings from the literature review, we highlight areas where Nigeria can learn from India in its quest to eliminate polio. These factors can form the basis for future theoretical and policy reforms in the fight against polio not only in Nigeria but in countries where it remains endemic. Further research should compare the success of polio eradication in other countries.
 Key words: • Polio • Immunization • Nigeria • India • Pakistan • Eradication • Systematic review
 
 Copyright © 2019 Bulama and Goodman-Brown. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Intestinal antibody responses to a live oral poliovirus vaccine challenge among adults previously immunized with inactivated polio vaccine in Sweden

BackgroundOur understanding of the acquisition of intestinal mucosal immunity and the control of poliovirus replication and transmission in later life is still emerging.MethodsAs part of a 2011 randomised, blinded, placebo-controlled...

Intestinal Immunity to Poliovirus Following Sequential Trivalent Inactivated Polio Vaccine/Bivalent Oral Polio Vaccine and Trivalent Inactivated Polio Vaccine–only Immunization Schedules: Analysis of an Open-label, Randomized, Controlled Trial in Chilean Infants

BackgroundIdentifying polio vaccine regimens that can elicit robust intestinal mucosal immunity and interrupt viral transmission is a key priority of the polio endgame.MethodsIn a 2013 Chilean clinical trial (NCT01841671) of trivalent inactivated polio vaccine (IPV) and bivalent oral polio vaccine (bOPV; targeting types 1 and 3), infants were randomized to receive IPV-bOPV-bOPV, IPV-IPV-bOPV, or IPV-IPV-IPV at 8, 16, and 24 weeks of age and challenged with monovalent oral polio vaccine type 2 (mOPV2) at 28 weeks. Using fecal samples collected from 152 participants, we investigated the extent to which IPV-bOPV and IPV-only immunization schedules induced intestinal neutralizing activity and immunoglobulin A against polio types 1 and 2.ResultsOverall, 37% of infants in the IPV-bOPV groups and 26% in the IPV-only arm had detectable type 2–specific stool neutralization after the primary vaccine series. In contrast, 1 challenge dose of mOPV2 induced brisk intestinal immune responses in all vaccine groups, and significant rises in type 2–specific stool neutralization titers (P < .0001) and immunoglobulin A concentrations (P < 0.0001) were measured 2 weeks after the challenge. In subsidiary analyses, duration of breastfeeding also appeared to be associated with the magnitude of polio-specific mucosal immune parameters measured in infant fecal samples.ConclusionsTaken together, these results underscore the concept that mucosal and systemic immune responses to polio are separate in their induction, functionality, and potential impacts on transmission and, specifically, provide evidence that primary vaccine regimens lacking homologous live vaccine components are likely to induce only modest, type-specific intestinal immunity.

Wild Poliovirus Importation, Central African Republic1

Wild Poliovirus Importation, Central African Republic1

Poliovirus eradication

Poliovirus eradication

Feasibility of Quantitative Environmental Surveillance in Poliovirus Eradication Strategies

The progress of the Global Polio Eradication Initiative is monitored by acute flaccid paralysis (AFP) surveillance supplemented with environmental surveillance in selected areas. To assess the sensitivity of environmental surveillance, stools from (re)vaccinated elderly persons with a low seroprevalence and from wastewater were concurrently collected and analyzed in the Netherlands over a prolonged period of time. A total number of 228 healthy individuals with different levels of immunity were challenged with monovalent oral polio vaccine serotype 1 or 3. Poliovirus concentrations were determined by the titration of fecal suspensions on poliovirus-sensitive L20B cells and of sewage concentrates by L20B monolayer plaque assay. Almost half of the individuals (45%) shed poliovirus on day 3 after challenge, which peaked (57%) on day 8 with an average poliovirus excretion of 1.3 × 10(5) TCID(50) per g of feces and gradually decreased to less than 5% on day 42. The virus concentrations in sewage peaked on days 6 to 8 at approximately 100 PFU per liter, remained high until day 14, and subsequently decreased to less than 10 PFU per liter on day 29. The estimated poliovirus concentration in sewage approximated the measured initial virus excretion in feces, within 1 log(10) variation, resulting in a sensitivity of detection of 100 infected but mostly asymptomatic individuals in tens of thousands of individuals. An additional second peak observed in sewage may indicate secondary transmission missed by enterovirus or AFP surveillance in patients. This enables the detection of circulating poliovirus by environmental surveillance, supporting its feasibility as an early warning system.

Polio Eradication in India

The Global Polio Eradication Initiative gained a great success in India in the last one year, especially on the epidemiology of type 1 wild poliovirus (WPV), by the intensive use of monovalent oral polio vaccine (OPV) type 1. However, failure to completely interrupt the transmission of type 1 and persistence of type 3 WPV in western Uttar Pradesh and Bihar are still causes of concern. The year 2010 was very crucial for polio eradication in India; as good control over transmission of type 1 wild polio virus was achieved. While mOPV1 is a sharper tool against WPV1, bOPV seems to be adequate against WPV3; hence there may not be any more need for mOPV3. Thus, the key to success lies in intelligent and imaginative use of the three OPVs, i.e. mOPV1, bOPV and tOPV, against WPV types 1 and 3, and circulating vaccine derived polio virus types 1, 2 and 3. Serious consideration should be given to a contingency plan to the use of inactivated polio vaccine or non OPV in endemic areas.

Path to polio eradication in India: A major milestone

The global polio eradication initiative was established in 1988 by the World Health Organization to achieve eradication of wild polioviruses (WPVs) by the year 2000. More than a decade later India achieved a major milestone when in 2012 it crossed one full year without any WPV detection. India’s achievement is positive encouragement for GPEI and a sign of hope that global eradication is achievable. Technically the absence of WPV for three years in the face of high quality surveillance is necessary for global acceptance of elimination. However the quality of India’s surveillance is exemplary as supported by the evidence of improved antibody prevalence in infants. Several agencies contributed to this success – GPEI Immunization Division of the Ministry of Health Uttar Pratesh and Bihar State Governments district personnel health workers and families. Success can be attributed to several factors including sustained intensive vaccination programs diligence in finding and vaccinating children of migrant families and the use of monovalent and bivalent oral polio vaccines (OPVs). In guiding India’s future plans for action concerns about complacency and transmission must be kept in mind. The risk of undetected WPV circulation is especially important when targeting migrant mobile and underserved communities. Though a globally firm strategy for the immediate post-WPV eradiation phase has not been finalized options are currently being discussed and debated. The GPEI has been exploring ways to reduce the cost of inactivated poliovirus vaccine after which the government must be prepared to introduce to achieve high coverage after the elimination of WPVs in India.

Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad

This study is the first systematic documentation of the potency of monovalent oral polio vaccine type 3 (mOPV3) kept at ambient temperatures during a polio immunization campaign in Chad. During the study test vials were exposed to temperatures of up to 47.1 °C, and kept outside of the 2–8 °C range for a maximum of 86.9 hours. Post-campaign laboratory testing confirmed that the test vials were still potent, and in conformity with the defined release specifications. Further, the Vaccine Vial Monitors performed as expected, giving an early warning indication of when cumulative exposure to heat reached levels that may have negatively affected the vaccine's potency. This study provides proof-of-concept evidence that certain types of OPV remain potent and thus can be kept, for limited periods of time, as well as administered at ambient temperatures.

Paralytic Poliomyelitis Associated With Sabin Monovalent and Bivalent Oral Polio Vaccines in Hungary

Historical records of patients with vaccine-associated paralytic poliomyelitis (VAPP) in Hungary during 1961-1981 were reviewed to assess the risk of VAPP after oral polio vaccine (OPV) administration. A confirmed VAPP case was defined as a diagnosis of paralytic poliomyelitis and residual paralysis at 60 days in a patient with an epidemiologic link to the vaccine. Archived poliovirus isolates were retested using polymerase chain reaction and sequencing of the viral protein 1 capsid region. This review confirmed 46 of 47 cases previously reported as VAPP. Three cases originally linked to monovalent OPV (mOPV) 3 and one case linked to mOPV1 presented after administration of bivalent OPV 1 + 3 (bOPV). The adjusted VAPP risk per million doses administered was 0.18 for mOPV1 (2 cases/11.13 million doses), 2.96 for mOPV3 (32 cases/10.81 million doses), and 12.82 for bOPV (5 cases/390,000 doses). Absence of protection from immunization with inactivated poliovirus vaccine or exposure to OPV virus from routine immunization and recent injections could explain the higher relative risk of VAPP in Hungarian children. In polio-endemic areas in which mOPV3 and bOPV are needed to achieve eradication, the higher risk of VAPP would be offset by the high risk of paralysis due to wild poliovirus and higher per-dose efficacy of mOPV3 and bOPV compared with trivalent OPV.

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