Environmental Surveillance for Risk Assessment in the Context of a Phase 2 Clinical Trial of Type 2 Novel Oral Polio Vaccine in Panama

Environmental surveillance was recommended for risk mitigation in a novel oral polio vaccine-2 (nOPV2) clinical trial (M5-ABMG) to monitor excretion, potential circulation, and loss of attenuation of the two nOPV2 candidates. The nOPV2 candidates were developed to address the risk of poliovirus (PV) type 2 circulating vaccine-derived poliovirus (cVDPV) as part of the global eradication strategy. Between November 2018 and January 2020, an environmental surveillance study for the clinical trial was conducted in parallel to the M5-ABMG clinical trial at five locations in Panama. The collection sites were located upstream from local treatment plant inlets, to capture the excreta from trial participants and their community. Laboratory analyses of 49 environmental samples were conducted using the two-phase separation method. Novel OPV2 strains were not detected in sewage samples collected during the study period. However, six samples were positive for Sabin-like type 3 PV, two samples were positive for Sabin-like type 1 PV, and non-polio enteroviruses NPEVs were detected in 27 samples. One of the nOPV2 candidates has been granted Emergency Use Listing by the World Health Organization and initial use started in March 2021. This environmental surveillance study provided valuable risk mitigation information to support the Emergency Use Listing application.

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The polio endgame: rationale behind the change in immunisation

Archives of Disease in Childhood ◽

10.1136/archdischild-2016-311171 ◽

2017 ◽

Vol 102 (4) ◽

pp. 362-365 ◽

Cited By ~ 3

Author(s):

Julie Garon ◽

Manish Patel

Keyword(s):

Scale Up ◽

Oral Polio Vaccine ◽

Polio Eradication ◽

World Health ◽

Routine Immunisation ◽

Wild Poliovirus ◽

Polio Vaccine ◽

Global Coordination ◽

Eradicate Polio

The decades long effort to eradicate polio is nearing the final stages and oral polio vaccine (OPV) is much to thank for this success. As cases of wild poliovirus continue to dwindle, cases of paralysis associated with OPV itself have become a concern. As type-2 poliovirus (one of three) has been certified eradicated and a large proportion of OPV-related paralysis is caused by the type-2 component of OPV, the World Health Assembly endorsed the phased withdrawal of OPV and the introduction of inactivated polio vaccine (IPV) into routine immunisation schedules as a crucial step in the polio endgame plan. The rapid pace of IPV scale-up and uptake required adequate supply, planning, advocacy, training and operational readiness. Similarly, the synchronised switch from trivalent OPV (all three types) to bivalent OPV (types 1 and 3) involved an unprecedented level of global coordination and country commitment. The important shift in vaccination policy seen through global IPV introduction and OPV withdrawal represents an historical milestone reached in the polio eradication effort.

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Australian National Enterovirus Reference Laboratory annual report, 2015

Communicable Diseases Intelligence ◽

10.33321/cdi.2020.44.24 ◽

2020 ◽

Vol 44 ◽

Author(s):

Jason A Roberts ◽

Linda K Hobday ◽

Aishah Ibrahim ◽

Thomas Aitken ◽

Bruce R Thorley

Keyword(s):

Surveillance System ◽

Oral Polio Vaccine ◽

World Health ◽

Surveillance Program ◽

Reference Laboratory ◽

Poliovirus Type ◽

Wild Poliovirus ◽

Polio Vaccine ◽

Clinical Surveillance

Australia conducts surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years as recommended by the World Health Organization (WHO) as the main method to monitor its polio-free status. Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2015, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.2 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Two non-polio enteroviruses, enterovirus A71 and coxsackievirus B3, were identified from clinical specimens collected from AFP cases. Australia complements the clinical surveillance program with enterovirus and environmental surveillance for poliovirus. Two Sabin-like polioviruses were isolated from sewage collected in Melbourne in 2015, which would have been imported from a country that uses the oral polio vaccine. The global eradication of wild poliovirus type 2 was certified in 2015 and Sabin poliovirus type 2 will be withdrawn from oral polio vaccine in April 2016. Laboratory containment of all remaining wild and vaccine strains of poliovirus type 2 will occur in 2016 and the National Enterovirus Reference Laboratory was designated as a polio essential facility. Globally, in 2015, 74 cases of polio were reported, only in the two remaining countries endemic for wild poliovirus: Afghanistan and Pakistan. This is the lowest number reported since the global polio eradication program was initiated.

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Inferring Numbers of Wild Poliovirus Excretors Using Quantitative Environmental Surveillance

Vaccines ◽

10.3390/vaccines9080870 ◽

2021 ◽

Vol 9 (8) ◽

pp. 870

Author(s):

Yuri Perepliotchikov ◽

Tomer Ziv-Baran ◽

Musa Hindiyeh ◽

Yossi Manor ◽

Danit Sofer ◽

...

Keyword(s):

Oral Polio Vaccine ◽

Turnaround Time ◽

Quantitative Detection ◽

Environmental Surveillance ◽

Wild Poliovirus ◽

Polio Vaccine ◽

Kinetic Information ◽

Using Data ◽

Number Of Individuals

Response to and monitoring of viral outbreaks can be efficiently focused when rapid, quantitative, kinetic information provides the location and the number of infected individuals. Environmental surveillance traditionally provides information on location of populations with contagious, infected individuals since infectious poliovirus is excreted whether infections are asymptomatic or symptomatic. Here, we describe development of rapid (1 week turnaround time, TAT), quantitative RT-PCR of poliovirus RNA extracted directly from concentrated environmental surveillance samples to infer the number of infected individuals excreting poliovirus. The quantitation method was validated using data from vaccination with bivalent oral polio vaccine (bOPV). The method was then applied to infer the weekly number of excreters in a large, sustained, asymptomatic outbreak of wild type 1 poliovirus in Israel (2013) in a population where >90% of the individuals received three doses of inactivated polio vaccine (IPV). Evidence-based intervention strategies were based on the short TAT for direct quantitative detection. Furthermore, a TAT shorter than the duration of poliovirus excretion allowed resampling of infected individuals. Finally, the method documented absence of infections after successful intervention of the asymptomatic outbreak. The methodologies described here can be applied to outbreaks of other excreted viruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), where there are (1) significant numbers of asymptomatic infections; (2) long incubation times during which infectious virus is excreted; and (3) limited resources, facilities, and manpower that restrict the number of individuals who can be tested and re-tested.

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Evaluating cessation of the type 2 oral polio vaccine by modeling pre- and post-cessation detection rates

Vaccine ◽

10.1016/j.vaccine.2017.08.048 ◽

2017 ◽

Vol 35 (42) ◽

pp. 5674-5681 ◽

Cited By ~ 9

Author(s):

Steve J. Kroiss ◽

Michael Famulare ◽

Hil Lyons ◽

Kevin A. McCarthy ◽

Laina D. Mercer ◽

...

Keyword(s):

Oral Polio Vaccine ◽

Detection Rates ◽

Polio Vaccine

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Factors associated with the utilization of inactivated polio vaccine among children aged 12 to 23 months in Kalungu District, Uganda

Health Policy and Planning ◽

10.1093/heapol/czaa099 ◽

2020 ◽

Vol 35 (Supplement_1) ◽

pp. i30-i37

Author(s):

Mirembe Rachel Faith ◽

Babirye Juliet ◽

Nathan Tumuhamye ◽

Tumwebaze Mathias ◽

Emma Sacks

Keyword(s):

Health Care Providers ◽

Health Workers ◽

Oral Polio Vaccine ◽

Systematic Sampling ◽

Care Providers ◽

Cross Sectional ◽

Inactivated Polio Vaccine ◽

Factors Associated ◽

Polio Vaccine ◽

Eradication Strategy

Abstract Uganda officially introduced the inactivated polio vaccine (IPV) in May 2016 as part of the polio eradication strategy and integrated it into its routine immunization programme in addition to the oral polio vaccine. The current coverage stands at 60% as of July 2017. We therefore aimed to determine factors associated with the uptake of IPV among children in Kalungu District so as to inform the implementation of the vaccine policy. A community-based cross-sectional study was conducted among caregivers of 406 eligible children aged 12–23 months through multi-stage systematic sampling and a standardized semi-structured questionnaire. Nine key informant interviews were conducted through purposive selection of health care providers and members of Village Health Teams (VHTs) based on their expertize. Modified Poisson regression and thematic content analysis were used to determine factors significant to IPV uptake among children. 71% of sampled children aged 12–23 months had received IPV in Kalungu District. The survey found that being encouraged by health workers and VHTs was significant to children’s uptake of IPV (Adjusted PR 1.24, 95% CI; 1.22–3.47). Distance to the immunization point (Adjusted PR 0.32,95% CI; 0.16–0.62) and caregiver’s education level (Adjusted PR 1.16,95% CI; 1.05–2.22) were also associated with IPV uptake. Qualitative findings from health workers and VHT members further confirmed the perception that distance to the immunization post was important, and VHTs also stated that being encouraged by health workers was critical to IPV uptake. The current prevalence of IPV uptake among children aged 12–23 months in Kalungu is 71%, higher than the last reported national coverage (60%), though still below the recommended national coverage of 95%. Efforts should be focused on sensitization of caregivers through health workers and VHTs. Immunization outreach should be strengthened so as to bring services closer to patients.

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The risk of type 2 oral polio vaccine use in post-cessation outbreak response

BMC Medicine ◽

10.1186/s12916-017-0937-y ◽

2017 ◽

Vol 15 (1) ◽

Cited By ~ 13

Author(s):

Kevin A. McCarthy ◽

Guillaume Chabot-Couture ◽

Michael Famulare ◽

Hil M. Lyons ◽

Laina D. Mercer

Keyword(s):

Oral Polio Vaccine ◽

Outbreak Response ◽

Polio Vaccine

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Post-polio eradication: vaccination strategies and options for India

Healthcare in Low-resource Settings ◽

10.4081/hls.2014.1978 ◽

2014 ◽

Vol 2 (2) ◽

Author(s):

Jayakrishnan Thayyil ◽

Thejus Jayakrishnan

Keyword(s):

International Health ◽

Main Tool ◽

Oral Polio Vaccine ◽

Polio Eradication ◽

World Health ◽

Wild Poliovirus ◽

Polio Vaccine ◽

Vaccination Strategies ◽

Health Agencies ◽

Health Organization

In 1988, the World Health Organization (WHO) resolved to eradicate poliomyelitis globally. Since then, the initiative has reported dramatic progress in decreasing the incidence of poliomyelitis and limiting the geographical extent of transmission. 2013 is recorded as the second consecutive year not reporting wild poliovirus (WPV) from India. If the country can retain this position for one more year India will be declared as polio eradicated. What should be the future vaccination strategies? We searched and reviewed the full text of the available published literature on polio eradication via PubMed and examined Internet sources and websites of major international health agencies. The oral polio vaccine (OPV) has been the main tool in the polio eradication program. Once WPV transmission is interrupted, the poliomyelitis will be caused only by OPV. India could expect 1 vaccine-associated paralytic polio per 4.2-4.6 million doses of OPV. Considering the threat of vaccine-derived viruses to polio eradication, WHO urged to develop a strategy to safely discontinue OPV after certification. The ultimate aim is to stop OPV safely and effectively, and eventually substitute with inactivated polio vaccine (IPV). The argument against the use of IPV is its cost. From India, field based data were available on the efficacy of IPV, which was better than OPV. IPV given intradermally resulted in seroconversion rates similar to full-dose intramuscular vaccine. The incremental cost of adopting IPV to replace OPV is relatively low, about US $1 per child per year, and most countries should be able to afford this additional cost.

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Epidemic poliomyelitis, post-poliomyelitis sequelae and the eradication program

Microbiology Australia ◽

10.1071/ma20053 ◽

2020 ◽

Vol 41 (4) ◽

pp. 196

Author(s):

Margaret M Peel

Keyword(s):

Late Onset ◽

Oral Polio Vaccine ◽

The United States ◽

Polio Eradication ◽

Oral Route ◽

World Health ◽

Paralytic Poliomyelitis ◽

Polio Vaccine ◽

The Central Nervous System ◽

Health Organization

Epidemics of paralytic poliomyelitis (polio) first emerged in the late 19th and early 20th centuries in the United States and the Scandinavian countries. They continued through the first half of the 20th century becoming global. A major epidemic occurred in Australia in 1951 but significant outbreaks were reported from the late 1930s to 1954. The poliovirus is an enterovirus that is usually transmitted by the faecal–oral route but only one in about 150 infections results in paralysis when the central nervous system is invaded. The Salk inactivated polio vaccine (IPV) became available in Australia in 1956 and the Sabin live attenuated oral polio vaccine (OPV) was introduced in 1966. After decades of stability, many survivors of the earlier epidemics experience late-onset sequelae including post-polio syndrome. The World Health Organization launched the global polio eradication initiative (GPEI) in 1988 based on the easily administered OPV. The GPEI has resulted in a dramatic decrease in cases of wild polio so that only Pakistan and Afghanistan report such cases in 2020. However, a major challenge to eradication is the reversion of OPV to neurovirulent mutants resulting in circulating vaccine-derived poliovirus (cVDPV). A novel, genetically stabilised OPV has been developed recently to stop the emergence and spread of cVDPV and OPV is being replaced by IPV in immunisation programs worldwide. Eradication of poliomyelitis is near to achievement and the expectation is that poliomyelitis will join smallpox as dreaded epidemic diseases of the past that will be consigned to history.

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Corrigendum to: Epidemic poliomyelitis, post-poliomyelitis sequelae and the eradication program

Microbiology Australia ◽

10.1071/ma20053_co ◽

2020 ◽

Vol 41 (4) ◽

pp. 223

Author(s):

Margaret M Peel

Keyword(s):

Late Onset ◽

Oral Polio Vaccine ◽

The United States ◽

Polio Eradication ◽

Oral Route ◽

World Health ◽

Paralytic Poliomyelitis ◽

Polio Vaccine ◽

The Central Nervous System ◽

Health Organization

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Efforts Towards Polio Eradication in Madagascar: 1997 to 2017

Journal of Immunological Sciences ◽

10.29245/2578-3009/2021/s2.1102 ◽

2021 ◽

Vol Special Issue (2) ◽

pp. 102-111

Author(s):

Marcellin Mengouo Nimpa ◽

Noëline Ravelomanana Razafiarivao ◽

Annick Robinson ◽

Mamy Randriatsarafara Fidiniaina ◽

Richter Razafindratsimandresy ◽

...

Keyword(s):

Health System ◽

Oral Polio Vaccine ◽

Polio Eradication ◽

Routine Immunization ◽

World Health ◽

Political Commitment ◽

African Region ◽

Wild Poliovirus ◽

Polio Vaccine ◽

Free Status

Background: In 1988, the World Health Assembly launched the Global Polio Eradication Initiative. WHO AFRO is close to achieve this goal with the last wild poliovirus detected in 2014 in Borno States in Nigeria. The certification of the WHO African Region requires that all the 47 member states meet the critical indicators for a polio free status. Madagascar started implementing polio eradication activities in 1996 and was declared polio free in June 2018 in Abuja. This study describes the progress achieved towards polio eradication activities in Madagascar from 1977- 2017 and highlights the remaining challenges to be addressed. Methods: Data were collected from the national routine immunization services, Country Acute Flaccid surveillance databases and national reports of SIAS and Mop Up campaign. Country complete polio and immunization related documentation provided detailed historical information’s. Results: From 1997 to 2017, Madagascar reported one wild poliovirus (WPV) outbreak and four circulating Vaccine Derived Polio Virus (cVDPV) oubreaks with a total of 21 polioviruses (1 WPV and 21 cVDPV). The last WPV and cVDPV were notified in 1997 in Antananarivo and 2015 in Sakaraha health districts respectively. Madagascar met the main polio surveillance indicators over the last ten years and made significant progress following the last cVDPV2 outbreak in 2014 -2015. In addition, the country successfully implemented the switch from trivalent Oral Polio Vaccine (tOPV) to bivalent Oral Polio vaccine (bOPV) and containment activities. Environmental Surveillance established since 2015 did not reveal any poliovirus. The administrative coverage of the 3rd dose of oral polio vaccine (OPV3) varied across the years from 55% in 1991 to a maximum of 95% in 2007 before a progressive decrease to 86% in 2017. The percentage of AFP cases with more than 3 doses of oral polio vaccines increased from 56% in 2014 to 88% in 2017. A total of 19 supplementary immunization activities (SIA) were conducted in Madagascar from 1997 to 2017, among which 3 were subnational immunization days (sNID) and 16 were national immunization days (NIDs). Poor routine coverage contributed to the occurrence of cVDPC outbreaks in the country; addressing this should remain a key priority for the country to maintain the polio free status. From 2015 to June 2017, Madagascar achieved the required criteria leading to the acceptance of the country’s polio-free documentation in June 2018 by ARCC. However, continuous efforts will be needed to maintain a highly sensitive polio surveillance system with emphasis on security compromised areas. Finally strengthening the health system and governance at all levels will be necessary if these achievements are to be sustained. Conclusions: High national political commitment and support of the Global Polio Eradication Partnership were critical for Madagascar to achieve polio free status. Socio-political instability, weakness of the health system, sub-optimal routine immunization performance, insufficient SIA quality and existing security compromised areas remain critical program challenges to address in order to maintaining the polio free status. Continuous high-level advocacy should be kept in order to ensure that new government authorities maintain polio eradication among the top priorities of the country.

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