-
Risk Analysis : An Official Publication... Feb 2024Due to the very low, but nonzero, paralysis risks associated with the use of oral poliovirus vaccine (OPV), eradicating poliomyelitis requires ending all OPV use... (Review)
Review
Due to the very low, but nonzero, paralysis risks associated with the use of oral poliovirus vaccine (OPV), eradicating poliomyelitis requires ending all OPV use globally. The Global Polio Eradication Initiative (GPEI) coordinated cessation of Sabin type 2 OPV (OPV2 cessation) in 2016, except for emergency outbreak response. However, as of early 2023, plans for cessation of bivalent OPV (bOPV, containing types 1 and 3 OPV) remain undefined, and OPV2 use for outbreak response continues due to ongoing transmission of type 2 polioviruses and reported type 2 cases. Recent development and use of a genetically stabilized novel type 2 OPV (nOPV2) leads to additional potential vaccine options and increasing complexity in strategies for the polio endgame. Prior applications of integrated global risk, economic, and poliovirus transmission modeling consistent with GPEI strategic plans that preceded OPV2 cessation explored OPV cessation dynamics and the evaluation of options to support globally coordinated risk management efforts. The 2022-2026 GPEI strategic plan highlighted the need for early bOPV cessation planning. We review the published modeling and explore bOPV cessation immunization options as of 2022, assuming that the GPEI partners will not support restart of the use of any OPV type in routine immunization after a globally coordinated cessation of such use. We model the potential consequences of globally coordinating bOPV cessation in 2027, as anticipated in the 2022-2026 GPEI strategic plan. We do not find any options for bOPV cessation likely to succeed without a strategy of bOPV intensification to increase population immunity prior to cessation.
Topics: Humans; Poliovirus Vaccine, Oral; Serogroup; Poliovirus; Poliomyelitis; Poliovirus Vaccine, Inactivated; Global Health; Disease Eradication
PubMed: 37344934
DOI: 10.1111/risa.14158 -
Chinese Medical Sciences Journal =... Dec 2023The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the...
The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.
Topics: Child; Humans; Poliovirus Vaccine, Inactivated; Poliomyelitis; Disease Outbreaks; China
PubMed: 38073062
DOI: 10.24920/004284 -
Cadernos de Saude Publica 2020This article's objective is to review the "state of the art" in the progress, obstacles, and strategies for achieving global polio eradication. Poliomyelitis control...
This article's objective is to review the "state of the art" in the progress, obstacles, and strategies for achieving global polio eradication. Poliomyelitis control measures began in the 1960s with the advent of two vaccines, the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV). From 1985 to 2020, strategies were implemented to reach the goal of eradication of wild poliovirus (WPV). Following the success with the interruption of indigenous WPV transmission in the Americas, the goal of global eradication was launched. We describe the process of eradication in four historical stages: (1) The advent of the inactivated and oral polio vaccines launched the age of poliomyelitis control; (2) The massive and simultaneous use of OPV had a significant impact on WPV transmission in the late 1970s in Brazil; (3) Domestic and international public policies set the goal of eradication of indigenous WPV transmission in the Americas and defined the epidemiological strategies to interrupt transmission; and (4) The implementation of eradication strategies interrupted indigenous WPV transmission in nearly all regions of the world except Pakistan and Afghanistan, where in 2020 the WPV1 transmission chains have challenged the strategies for containment of the virus. Meanwhile, the persistence and dissemination of circulation of OPV-derived poliovirus in countries with low vaccination coverage, plus the difficulties in replacing OPV with IPV, are currently the obstacles to eradication in the short term. Finally, we discuss the strategies for overcoming the obstacles and challenges in the post-eradication era.
Topics: Afghanistan; Brazil; Disease Eradication; Humans; Immunization Programs; Poliomyelitis; Poliovirus Vaccine, Oral
PubMed: 33146314
DOI: 10.1590/0102-311X00145720 -
Viruses Jul 2021The oral poliovirus vaccine (OPV), which prevents person-to-person transmission of poliovirus by inducing robust intestinal immunity, has been a crucial tool for global... (Review)
Review
The oral poliovirus vaccine (OPV), which prevents person-to-person transmission of poliovirus by inducing robust intestinal immunity, has been a crucial tool for global polio eradication. However, polio outbreaks, mainly caused by type 2 circulating vaccine-derived poliovirus (cVDPV2), are increasing worldwide. Meanwhile, immunodeficiency-associated vaccine-derived poliovirus (iVDPV) is considered another risk factor during the final stage of global polio eradication. Patients with primary immunodeficiency diseases are associated with higher risks for long-term iVDPV infections. Although a limited number of chronic iVDPV excretors were reported, the recent identification of a chronic type 2 iVDPV (iVDPV2) excretor in the Philippines highlights the potential risk of inapparent iVDPV infection for expanding cVDPV outbreaks. Further research on the genetic characterizations and molecular evolution of iVDPV2, based on comprehensive iVDPV surveillance, will be critical for elucidating the remaining risk of iVDPV2 during the post-OPV era.
Topics: Disease Eradication; Disease Outbreaks; Evolution, Molecular; Global Health; Humans; Immunocompromised Host; Poliovirus; Poliovirus Vaccine, Oral; Primary Immunodeficiency Diseases; Vaccination
PubMed: 34372613
DOI: 10.3390/v13071407 -
Vaccine Apr 2022Several vaccine events causing public concern have occurred in China that were investigated and responded to by the central government. We describe causes, influences,...
INTRODUCTION
Several vaccine events causing public concern have occurred in China that were investigated and responded to by the central government. We describe causes, influences, and policy or practice changes associated with vaccine events that occurred between 2005 and 2021. We make recommendations to foster resilience in China's Expanded Program of Immunization (EPI) system and vaccination enterprises and to sustain vaccine and program confidence.
METHODS
Our study included all vaccine events since 2005 that were investigated and responded to by the central government of China. We verified mainstream and social media visibility of the events through Internet search. We extracted event times, causes, investigation processes, results, actions, and policy or practice regulation changes from official reports of government meetings and from official websites with media briefings.
RESULTS
Seven vaccine events were identified, each of which caused more than 100,000 mainstream or social media reports nationally or nationally and internationally. The events ranged in magnitude from 145 children receiving out-of-date oral poliovirus vaccine to a measles supplementary immunization activity involving 103 million children. Few, if any, children were directly harmed by vaccines in the events. Government responded to each event with program or policy changes, and in one case, with legislation. Responses affected the conduct of campaigns and supplementary immunization activities, use of schools as vaccination venues, financial incentives for vaccinating with non-program vaccines, vaccine procurement and distribution, and program policy making. The most fundamental response was enacting the country's first vaccine law, the 2019 Vaccine Administration Law, which guides virtually all aspects of vaccination work, from vaccine development through regulation, program implementation, and safety and impact monitoring.
CONCLUSIONS
All seven events generated substantial national and international mainstream and social media criticism and discussion, most commonly expressed through concerns of vaccine safety or vaccine effectiveness. Most had temporally associated temporary declines in vaccine confidence and coverage, jeopardizing decades of vaccination effort. The central government responded to each event by attempting to address root causes. Faithful implementation of the Vaccine Administration Law is fundamental to program strengthening and sustaining confidence of families, stakeholders, and government in vaccines and immunization in China.
Topics: Child; China; Health Policy; Humans; Immunization; Immunization Programs; Poliovirus Vaccine, Oral; Vaccination
PubMed: 35339307
DOI: 10.1016/j.vaccine.2022.03.035 -
Medecine Tropicale Et Sante... Jun 2021In 2019, the Central African Republic identified foci of circulating vaccine-derived poliovirus 2 (PVDV2c). The objective of this work is to describe the vaccination...
OBJECTIVE
In 2019, the Central African Republic identified foci of circulating vaccine-derived poliovirus 2 (PVDV2c). The objective of this work is to describe the vaccination status of children paralyzed by PVDV2c and their contacts and to assess the circulation of this strain in these contacts.
PATIENTS AND METHOD
The study population of this retrospective survey consists of children with acute flaccid paralysis (AFP) and their contacts. We included paralyzed children whose sequencing results showed the presence of PVDV2c.
RESULTS
A total of 21 children paralyzed by PVDVc and 64 contacts were enrolled in the survey. Fourteen out of 21 children who are paralyzed (66%) received at least one dose of bivalent oral polio vaccine (OPV) compared to 36 out of 64 contacts (57%, non-significant difference). Of the vaccinated patients, 7 had received less than three doses. For the injectable polio vaccine (IPV), vaccination coverage for both patients and contacts was 33%.The proportion of children who received both doses of OPV and IPV was 33% among patients and 25% in contacts. Contacts with VDPV2 were vaccinated with OPV and IPV, respectively 55 and 27%. VDPV2 and Sabin 2 were also found in contact stools, 34% and 9% respectively.
CONCLUSION
The absence or inadequacy of IPV vaccination has a serious impact on children by the occurrence of virus derived from the vaccine responsible for life-old paralysis. Protecting children from poliomyelitis requires a combination of a good cold chain, multiple doses and adherence to the vaccine schedule.
Topics: Central African Republic; Child; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Retrospective Studies
PubMed: 35586583
DOI: 10.48327/mtsibulletin.2021.114 -
Vaccine Mar 2023Inactivated trivalent poliovirus vaccine (IPV) induces humoral immunity, which protects against paralytic poliomyelitis but does not induce sufficient mucosal immunity... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety, tolerability, and immunogenicity of inactivated poliovirus vaccine with or without E.coli double mutant heat-labile toxin (dmLT) adjuvant in healthy adults; a phase 1 randomized study.
BACKGROUND
Inactivated trivalent poliovirus vaccine (IPV) induces humoral immunity, which protects against paralytic poliomyelitis but does not induce sufficient mucosal immunity to block intestinal infection. We assessed the intestinal immunity in healthy adults in Belgium conferred by a co-formulation of IPV with the mucosal adjuvant double mutant Labile Toxin (dmLT) derived from Escherichia coli.
METHODS
Healthy fully IPV-vaccinated 18-45-year-olds were randomly allocated to three groups: on Day 1 two groups received one full dose of IPV (n = 30) or IPV + dmLT (n = 30) in a blinded manner, and the third received an open-label dose of bivalent live oral polio vaccine (bOPV types 1 and 3, n = 20). All groups received a challenge dose of bOPV on Day 29. Participants reported solicited and unsolicited adverse events (AE) using study diaries. Mucosal immune responses were measured by fecal neutralization and IgA on Days 29 and 43, with fecal shedding of challenge viruses measured for 28 days. Humoral responses were measured by serum neutralizing antibody (NAb).
RESULTS
Solicited and unsolicited AEs were mainly mild-to-moderate and transient in all groups, with no meaningful differences in rates between groups. Fecal shedding of challenge viruses in both IPV groups exceeded that of the bOPV group but was not different between IPV and IPV + dmLT groups. High serum NAb responses were observed in both IPV groups, alongside modest levels of fecal neutralization and IgA.
CONCLUSIONS
Addition of dmLT to IPV administered intramuscularly neither affected humoral nor intestinal immunity nor decreased fecal virus shedding following bOPV challenge. The tolerability of the dose of dmLT used in this study may allow higher doses to be investigated for impact on mucosal immunity. Registered on ClinicalTrials.gov - NCT04232943.
Topics: Humans; Adult; Poliovirus Vaccine, Inactivated; Poliomyelitis; Hot Temperature; Poliovirus Vaccine, Oral; Adjuvants, Immunologic; Antibodies, Neutralizing; Immunoglobulin A
PubMed: 36746739
DOI: 10.1016/j.vaccine.2023.01.048 -
The Journal of Infectious Diseases Sep 2021Both inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) have contributed to the rapid disappearance of paralytic poliomyelitis from developed...
Both inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) have contributed to the rapid disappearance of paralytic poliomyelitis from developed countries despite possessing different vaccine properties. Due to cost, ease of use, and other properties, the Expanded Programme on Immunization added OPV to the routine infant immunization schedule for low-income countries in 1974, but variable vaccine uptake and impaired immune responses due to poor sanitation limited the impact. Following launch of the Global Polio Eradication Initiative in 1988, poliomyelitis incidence has been reduced by >99% and types 2 and 3 wild polioviruses are now eradicated, but progress against type 1 polioviruses which are now confined to Afghanistan and Pakistan has slowed due to insecurity, poor access, and other problems. A strategic, globally coordinated replacement of trivalent OPV with bivalent 1, 3 OPV in 2016 reduced the incidence of vaccine-associated paralytic poliomyelitis (VAPP) but allowed the escape of type 2 vaccine-derived polioviruses (VDPV2) in areas with low immunization rates and use of monovalent OPV2 in response seeded new VDPV2 outbreaks and reestablishment of type 2 endemicity. A novel, more genetically stable type 2 OPV vaccine is undergoing clinical evaluation and may soon be deployed prevent or reduce VDPV2 emergences.
Topics: Disease Eradication; Global Health; Humans; Immunization Programs; Immunization Schedule; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Vaccination
PubMed: 34590135
DOI: 10.1093/infdis/jiaa622 -
Journal of the Pediatric Infectious... Feb 2022Following the withdrawal of Sabin type 2 from trivalent oral poliovirus vaccine (tOPV) in 2016, the introduction of ≥1 dose of inactivated poliovirus vaccine (IPV) in... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Following the withdrawal of Sabin type 2 from trivalent oral poliovirus vaccine (tOPV) in 2016, the introduction of ≥1 dose of inactivated poliovirus vaccine (IPV) in routine immunization was recommended, either as 1 full dose (0.5mL, intramuscular) or 2 fractional doses of IPV (fIPV-0.1mL, intradermal). India opted for fIPV. We conducted a comparative assessment of IPV and fIPV.
METHODS
This was a 4-arm, open-label, multicenter, randomized controlled trial. Infants were enrolled and vaccines administered according to the study design, and the blood was drawn at age 6, 14, and 18 weeks for neutralization testing against all 3 poliovirus types.
RESULTS
Study enrolled 799 infants. The seroconversion against type 2 poliovirus with 2 fIPV doses was 85.8% (95% confidence interval [CI]: 80.1%-90.0%) when administered at age 6 and 14 weeks, 77.0% (95% CI: 70.5-82.5) when given at age 10 and 14 weeks, compared to 67.9% (95% CI: 60.4-74.6) following 1 full-dose IPV at age 14 weeks.
CONCLUSION
The study demonstrated the superiority of 2 fIPV doses over 1 full-dose IPV in India. Doses of fIPV given at 6 and 14 weeks were more immunogenic than those given at 10 and 14 weeks. Clinical Trial Registry of India (CTRI). Clinical trial registration number was CTRI/2017/02/007793.
Topics: Antibodies, Viral; Humans; Immunization Schedule; Immunogenicity, Vaccine; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 34791350
DOI: 10.1093/jpids/piab091 -
Lancet (London, England) Jan 2021
Topics: Child; Diabetes Mellitus, Type 2; Humans; Infant; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 33308426
DOI: 10.1016/S0140-6736(20)32629-5