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Vaccine Oct 2016Significant progress has been made to increase access to vaccines in Africa since the 1974 launch of the Expanded Programme on Immunization (EPI). Successes include the... (Review)
Review
BACKGROUND
Significant progress has been made to increase access to vaccines in Africa since the 1974 launch of the Expanded Programme on Immunization (EPI). Successes include the introduction of several new vaccines across the continent and likely eradication of polio. We examined the contribution of polio eradication activities (PEI) on new vaccine introduction in the countries of the African Region.
METHODS
We reviewed country specific PEI reports to identify best practices relevant to new vaccine introduction (NVI), and analyzed trends in vaccine coverage during 2010-2015 from immunization estimates provided by WHO/UNICEF.
RESULTS
Of the 47 countries in African Region 35 (74%) have introduced PCV, 27 (57%) have introduced rotavirus, and 14 (30%) have introduced IPV. National introductions for HPV vaccine have been done in 5 countries, while 15 countries have held demonstration and pilot projects. In 2014, the regional coverage for the third dose of PCV (PCV3) and rotavirus vaccines was 50% and 30% respectively. By end of 2015, all countries within the meningitis belt will have introduced MenAfriVac™ vaccine.
CONCLUSIONS
PEI activities had a positive effect in strengthening the process of new vaccine introduction in the African Region. The major contribution was in availing immunization funding and providing trained and experienced technical staff to introduce vaccines. More investment is needed to advocate and sustain funding levels to maintain the momentum gained in introducing new vaccines in the region.
Topics: Africa; Disease Eradication; Global Health; Humans; Immunization Programs; Papillomavirus Vaccines; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Rotavirus Vaccines; United Nations; Vaccination Coverage; World Health Organization
PubMed: 27396517
DOI: 10.1016/j.vaccine.2016.05.063 -
Clinical Infectious Diseases : An... May 2017A Sabin strain-based inactivated poliomyelitis vaccine (Sabin-IPV) is the rational option for completely eradicating poliovirus transmission. The neutralizing capacity... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
A Sabin strain-based inactivated poliomyelitis vaccine (Sabin-IPV) is the rational option for completely eradicating poliovirus transmission. The neutralizing capacity of Sabin-IPV immune serum to different strains of poliovirus is a key indicator of the clinical protective efficacy of this vaccine.
METHODS
Sera collected from 500 infants enrolled in a randomized, blinded, positive control, phase 2 clinical trial were randomly divided into 5 groups: Groups A, B, and C received high, medium, and low doses, respectively, of Sabin-IPV, while groups D and E received trivalent oral polio vaccine and Salk strain-based IPV, respectively, all on the same schedule. Immune sera were collected after the third dose of primary immunization, and tested in cross-neutralization assays against 19 poliovirus strains of all 3 types.
RESULTS
All immune sera from all 5 groups interacted with the 19 poliovirus strains with various titers and in a dose-dependent manner. One type 2 immunodeficiency-associated vaccine-derived poliovirus strain was not recognized by these immune sera.
CONCLUSIONS
Sabin-IPV vaccine can induce protective antibodies against currently circulating and reference wild poliovirus strains and most vaccine-derived poliovirus strains, with rare exceptions.
CLINICAL TRIALS REGISTRATION
NCT01056705.
Topics: Antibodies, Neutralizing; Antibodies, Viral; Dose-Response Relationship, Immunologic; Humans; Immune Sera; Infant; Neutralization Tests; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Sequence Analysis, DNA; Vaccination
PubMed: 28419204
DOI: 10.1093/cid/cix110 -
Human Vaccines & Immunotherapeutics Aug 2021One dose of inactivated poliovirus vaccine (IPV) was introduced into the Chinese Expanded Program on Immunization (EPI) in 2016. IPV made from Sabin strains (sIPV) was...
Surveillance of adverse events following the introduction of inactivated poliovirus vaccine made from Sabin strains (sIPV) to the Chinese EPI and a comparison with adverse events following inactivated poliovirus vaccine made from wild strains (wIPV) in Jiangsu, China.
One dose of inactivated poliovirus vaccine (IPV) was introduced into the Chinese Expanded Program on Immunization (EPI) in 2016. IPV made from Sabin strains (sIPV) was newly licensed in China and its safety has been concerned. This study aimed to evaluate the safety of sIPV and provide a comparison with conventional IPV made from wild strains (wIPV). We collected all IPV-related AEFI reports in Jiangsu from the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) for 2016-2019. We obtained the administered doses of IPV from the Jiangsu provincial Electronic Immunization Registries System (JSEIRS). The AEFI reporting rates per 100,000 doses of vaccine administered were compared for sIPV and wIPV. A total of 699 sIPV and 908 wIPV AEFI cases were collected by CNAEFIS in Jiangsu during 2016-2019. The overall AEFI reporting rates were 53.02 per 100,000 doses and 41.25 per 100,000 doses for sIPV and wIPV, respectively ( < .001). For both sIPV and wIPV, the AEFIs were mainly classified as common adverse reactions. The reporting rate of common adverse reactions was higher for sIPV than for wIPV ( < .001). The most frequently reported symptoms/signs were fever, persistent crying, injection site erythema/swelling, rash, and injection site induration. Only 1.14% of sIPV-associated and 2.31% of wIPV-associated AEFI cases were diagnosed as serious. No difference in reporting rate was observed for serious AEFIs ( = .272). sIPV has a favorable safety profile, although it exhibits a slightly higher reporting rate of common adverse reactions than wIPV.
Topics: China; Humans; Immunization Programs; Immunization Schedule; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Vaccination
PubMed: 33780310
DOI: 10.1080/21645515.2021.1898306 -
Expert Review of Vaccines Nov 2022Multiple vaccine options are available for polio prevention and risk management. Integrated global risk, economic, and poliovirus transmission modeling provides a tool...
BACKGROUND
Multiple vaccine options are available for polio prevention and risk management. Integrated global risk, economic, and poliovirus transmission modeling provides a tool to explore the dynamics of ending all use of one or more poliovirus vaccines to simplify the polio eradication endgame.
RESEARCH DESIGN AND METHODS
With global reported cases of poliomyelitis trending higher since 2016, we apply an integrated global model to simulate prospective vaccine policies and strategies for OPV-using countries starting with initial conditions that correspond to the epidemiological poliovirus transmission situation at the beginning of 2022.
RESULTS
Abruptly ending all OPV use in 2023 and relying only on IPV to prevent paralysis with current routine immunization coverage would lead to expected reestablished endemic transmission of poliovirus types 1 and 2, and approximately 150,000 expected cases of poliomyelitis per year. Alternatively, if OPV-using countries restart trivalent OPV (tOPV) use for all immunization activities and end IPV use, the model shows the lowest anticipated annual polio cases and lowest costs.
CONCLUSIONS
Poor global risk management and coordination of OPV cessation remain a critical failure mode for the polio endgame, and national and global decision makers face difficult choices due to multiple available polio vaccine options and immunization strategies.
Topics: Humans; Poliovirus Vaccine, Oral; Poliovirus Vaccine, Inactivated; Disease Eradication; Global Health; Poliomyelitis; Poliovirus
PubMed: 36154436
DOI: 10.1080/14760584.2022.2128108 -
The Journal of Infectious Diseases Sep 2022Primary intestinal immunity through viral replication of live oral vaccine is key to interrupt poliovirus transmission. We assessed viral fecal shedding from infants...
Fecal Shedding of 2 Novel Live Attenuated Oral Poliovirus Type 2 Vaccine Candidates by Healthy Infants Administered Bivalent Oral Poliovirus Vaccine/Inactivated Poliovirus Vaccine: 2 Randomized Clinical Trials.
BACKGROUND
Primary intestinal immunity through viral replication of live oral vaccine is key to interrupt poliovirus transmission. We assessed viral fecal shedding from infants administered Sabin monovalent poliovirus type 2 vaccine (mOPV2) or low and high doses of 2 novel OPV2 (nOPV2) vaccine candidates.
METHODS
In 2 randomized clinical trials in Panama, a control mOPV2 study (October 2015 to April 2016) and nOPV2 study (September 2018 to October 2019), 18-week-old infants vaccinated with bivalent oral poliovirus vaccine/inactivated poliovirus vaccine received 1 or 2 study vaccinations 28 days apart. Stools were assessed for poliovirus RNA by polymerase chain reaction (PCR) and live virus by culture for 28 days postvaccination.
RESULTS
Shedding data were available from 621 initially reverse-transcription PCR-negative infants (91 mOPV2, 265 nOPV2-c1, 265 nOPV2-c2 recipients). Seven days after dose 1, 64.3% of mOPV2 recipients and 31.3%-48.5% of nOPV2 recipients across groups shed infectious type 2 virus. Respective rates 7 days after dose 2 decreased to 33.3% and 12.9%-22.7%, showing induction of intestinal immunity. Shedding of both nOPV2 candidates ceased at similar or faster rates than mOPV2.
CONCLUSIONS
Viral shedding of either nOPV candidate was similar or decreased relative to mOPV2, and all vaccines showed indications that the vaccine virus was replicating sufficiently to induce primary intestinal mucosal immunity.
Topics: Antibodies, Viral; Humans; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Randomized Controlled Trials as Topic; Vaccines, Attenuated
PubMed: 34610135
DOI: 10.1093/infdis/jiab507 -
Clinical Microbiology and Infection :... Dec 2016During 2013/14, Israel witnessed the silent reintroduction and sustained transmission of wild poliovirus type 1 (WPV1) detected through routine environmental... (Review)
Review
During 2013/14, Israel witnessed the silent reintroduction and sustained transmission of wild poliovirus type 1 (WPV1) detected through routine environmental surveillance performed on sewage samples. The public health response to silent poliovirus transmission in a population with high inactivated polio vaccine (IPV) coverage poses an emerging challenge towards the 'End Game' of global poliovirus eradication. This paper reviews the risk assessment, risk management and risk communication aspects of this poliovirus incident. Special emphasis is placed on the use of scientific data generated in the risk assessment phase to inform the public health response. Reintroducing a live vaccine in supplemental immunization activities in response to transmission of WPV or vaccine-derived poliovirus should be considered close to the 'End Game' of polio eradication, especially if targeting the population at risk is feasible. Such circumstances require a comprehensive contingency plan that will support the generation of important public health evidence at the risk assessment stage, thereby allowing to tailor the risk management approaches and underpin appropriate risk communication.
Topics: Communicable Disease Control; Humans; Israel; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Public Health Administration
PubMed: 28034372
DOI: 10.1016/j.cmi.2016.06.018 -
Plant Biotechnology Journal Nov 2016The WHO recommends complete withdrawal of oral polio vaccine (OPV) type 2 by April 2016 globally and replacing with at least one dose of inactivated poliovirus vaccine...
The WHO recommends complete withdrawal of oral polio vaccine (OPV) type 2 by April 2016 globally and replacing with at least one dose of inactivated poliovirus vaccine (IPV). However, high-cost, limited supply of IPV, persistent circulating vaccine-derived polioviruses transmission and need for subsequent boosters remain unresolved. To meet this critical need, a novel strategy of a low-cost cold chain-free plant-made viral protein 1 (VP1) subunit oral booster vaccine after single IPV dose is reported. Codon optimization of the VP1 gene enhanced expression by 50-fold in chloroplasts. Oral boosting of VP1 expressed in plant cells with plant-derived adjuvants after single priming with IPV significantly increased VP1-IgG1 and VP1-IgA titres when compared to lower IgG1 or negligible IgA titres with IPV injections. IgA plays a pivotal role in polio eradication because of its transmission through contaminated water or sewer systems. Neutralizing antibody titres (~3.17-10.17 log titre) and seropositivity (70-90%) against all three poliovirus Sabin serotypes were observed with two doses of IPV and plant-cell oral boosters but single dose of IPV resulted in poor neutralization. Lyophilized plant cells expressing VP1 stored at ambient temperature maintained efficacy and preserved antigen folding/assembly indefinitely, thereby eliminating cold chain currently required for all vaccines. Replacement of OPV with this booster vaccine and the next steps in clinical translation of FDA-approved antigens and adjuvants are discussed.
Topics: Chloroplasts; Communicable Diseases; Humans; Molecular Farming; Poliovirus Vaccine, Oral; Vaccination
PubMed: 27155248
DOI: 10.1111/pbi.12575 -
MMWR. Morbidity and Mortality Weekly... Sep 2016Since the 1988 World Health Assembly resolution to eradicate poliomyelitis, transmission of the three types of wild poliovirus (WPV) has been sharply reduced (1). WPV...
Since the 1988 World Health Assembly resolution to eradicate poliomyelitis, transmission of the three types of wild poliovirus (WPV) has been sharply reduced (1). WPV type 2 (WPV2) has not been detected since 1999 and was declared eradicated in September 2015. Because WPV type 3 has not been detected since November 2012, WPV type 1 (WPV1) is likely the only WPV that remains in circulation (1). This marked progress has been achieved through widespread use of oral poliovirus vaccines (OPVs), most commonly trivalent OPV (tOPV), which contains types 1, 2, and 3 live, attenuated polioviruses and has been a mainstay of efforts to prevent polio since the early 1960s. However, attenuated polioviruses in OPV can undergo genetic changes during replication, and in communities with low vaccination coverage, can result in vaccine-derived polioviruses (VDPVs) that can cause paralytic polio indistinguishable from the disease caused by WPVs (2). Among the 721 polio cases caused by circulating VDPVs (cVDPVs*) detected during January 2006-May 2016, type 2 cVDPVs (cVDPV2s) accounted for >94% (2). Eliminating the risk for polio caused by VDPVs will require stopping all OPV use. The first stage of OPV withdrawal involved a global, synchronized replacement of tOPV with bivalent OPV (bOPV) containing only types 1 and 3 attenuated polioviruses, planned for April 18-May 1, 2016, thereby withdrawing OPV type 2 from all immunization activities (3). Complementing the switch from tOPV to bOPV, introduction of at least 1 dose of injectable, trivalent inactivated poliovirus vaccine (IPV) into childhood immunization schedules reduces risks from and facilitates responses to cVDPV2 outbreaks. All 155 countries and territories that were still using OPV in immunization schedules in 2015 have reported that they had ceased use of tOPV by mid-May 2016.(†) As of August 31, 2016, 173 (89%) of 194 World Health Organization (WHO) countries included IPV in their immunization schedules.(§) The cessation of tOPV use is a major milestone toward the global goal of eradicating polio; however, careful surveillance for polioviruses and prompt, aggressive responses to polio outbreaks are still needed to realize a polio-free world.
Topics: Disease Outbreaks; Drug Substitution; Global Health; Humans; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 27606675
DOI: 10.15585/mmwr.mm6535a3 -
Bulletin de L'Academie Nationale de... Oct 2015
Topics: Diphtheria-Tetanus Vaccine; France; Humans; Mandatory Programs; Mass Vaccination; Poliovirus Vaccines; Public Health Administration; Tetanus Toxoid
PubMed: 29879341
DOI: No ID Found -
Vaccine Mar 2018Widespread administration of oral poliovirus vaccine (OPV) has decreased global incidence of poliomyelitis by ≈99.9%. However, the emergence of vaccine-derived... (Meta-Analysis)
Meta-Analysis Review
Widespread administration of oral poliovirus vaccine (OPV) has decreased global incidence of poliomyelitis by ≈99.9%. However, the emergence of vaccine-derived polioviruses (VDPVs) is threatening polio-eradication program. Primary immunodeficiency (PID) patients are at higher risks of vaccine-associated paralytic poliomyelitis (VAPP) and prolonged excretion of immunodeficiency-associated VDPV (iVDPV). We searched Embase, Medline, Science direct, Scopus, Web of Science, and CDC and WHO databases by 30 September 2016, for all reports of iVDPV cases. Patient-level data were extracted form eligible studies. Data on immunization coverage and income-level of countries were extracted from WHO/UNICEF and the WORLD BANK databases, respectively. We assessed bivariate associations between immunological, clinical, and virological parameters, and exploited multivariable modeling to identify independent determinants of poliovirus evolution and patients' outcomes. Study protocol was registered with PROSPERO (CRD42016052931). 4329 duplicate-removed titles were screened. A total of 107 iVDPV cases were identified from 68 eligible articles. The majority of cases were from higher income countries with high polio-immunization coverage. 74 (69.81%) patients developed VAPP. Combined immunodeficiency patients showed lower rates of VAPP (p < .001) and infection clearance (p = .02), compared to humoral immunodeficiency patients. The rate of poliovirus genomic evolution was higher at early stages of replication, decreasing over time until reaching a steady state. Independent of replication duration, higher extent (p = .04) and rates (p = .03) of genome divergence contributed to a less likelihood of virus clearance. PID type (p < .001), VAPP occurrence (p = .008), and income-level of country (p = .04) independently influenced patients' survival. With the use of OPV, new iVDPVs will emerge independent of the rate of immunization coverage. Inherent features of PIDs contribute to the clinical course of iVDPV infection and virus evolution. This finding could shed further light on poliomyelitis pathogenesis and iVDPV evolution pattern. It also has implications for public health, the polio eradication effort and the development of effective antiviral interventions.
Topics: Animals; Child, Preschool; Female; History, 20th Century; History, 21st Century; Humans; Immunocompromised Host; Immunologic Deficiency Syndromes; Infant; Male; Odds Ratio; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Proportional Hazards Models; Serogroup; Vaccination
PubMed: 29478755
DOI: 10.1016/j.vaccine.2018.02.059