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Expert Review of Vaccines 2023Achieving polio eradication requires ensuring the delivery of sufficient supplies of the right vaccines to the right places at the right times. Despite large global... (Review)
Review
BACKGROUND
Achieving polio eradication requires ensuring the delivery of sufficient supplies of the right vaccines to the right places at the right times. Despite large global markets, decades of use, and large quantity purchases of polio vaccines by national immunization programs and the Global Polio Eradication Initiative (GPEI), forecasting demand for the oral poliovirus vaccine (OPV) stockpile remains challenging.
RESEARCH DESIGN AND METHODS
We review OPV stockpile experience compared to pre-2016 expectations, actual demand, and changes in GPEI policies related to the procurement and use of type 2 OPV vaccines. We use available population and immunization schedule data to explore polio vaccine market segmentation, and its role in polio vaccine demand forecasting.
RESULTS
We find that substantial challenges remain in forecasting polio vaccine needs, mainly due to (1) deviations in implementation of plans that formed the basis for earlier forecasts, (2) lack of alignment of tactics/objectives among GPEI partners and other key stakeholders, (3) financing, and (4) uncertainty about development and licensure timelines for new polio vaccines and their field performance characteristics.
CONCLUSIONS
Mismatches between supply and demand over time have led to negative consequences associated with both oversupply and undersupply, as well as excess costs and potentially preventable cases.
Topics: Humans; Poliovirus Vaccine, Oral; Disease Eradication; Poliovirus Vaccines; Poliomyelitis; Vaccination; Immunization Programs; Poliovirus Vaccine, Inactivated; Global Health
PubMed: 37747090
DOI: 10.1080/14760584.2023.2263096 -
Biologicals : Journal of the... Sep 2014Instability of vaccines often emerges as a key challenge during clinical development (lab to clinic) as well as commercial distribution (factory to patient). To yield... (Review)
Review
Instability of vaccines often emerges as a key challenge during clinical development (lab to clinic) as well as commercial distribution (factory to patient). To yield stable, efficacious vaccine dosage forms for human use, successful formulation strategies must address a combination of interrelated topics including stabilization of antigens, selection of appropriate adjuvants, and development of stability-indicating analytical methods. This review covers key concepts in understanding the causes and mechanisms of vaccine instability including (1) the complex and delicate nature of antigen structures (e.g., viruses, proteins, carbohydrates, protein-carbohydrate conjugates, etc.), (2) use of adjuvants to further enhance immune responses, (3) development of physicochemical and biological assays to assess vaccine integrity and potency, and (4) stabilization strategies to protect vaccine antigens and adjuvants (and their interactions) during storage. Despite these challenges, vaccines can usually be sufficiently stabilized for use as medicines through a combination of formulation approaches combined with maintenance of an efficient cold chain (manufacturing, distribution, storage and administration). Several illustrative case studies are described regarding mechanisms of vaccine instability along with formulation approaches for stabilization within the vaccine cold chain. These include live, attenuated (measles, polio) and inactivated (influenza, polio) viral vaccines as well as recombinant protein (hepatitis B) vaccines.
Topics: Adjuvants, Immunologic; Animals; Antigens; Chemistry, Pharmaceutical; Cold Temperature; Drug Stability; Drug Storage; Hepatitis B Vaccines; Humans; Influenza Vaccines; Measles Vaccine; Poliovirus Vaccines; Vaccines
PubMed: 24996452
DOI: 10.1016/j.biologicals.2014.05.007 -
Revista Chilena de Infectologia :... Dec 2020Oral poliovirus vaccine (OPV) has been instrumental in controlling the polio epidemic, and stands out for its safety, efficacy, ease of oral administration, and low... (Review)
Review
Oral poliovirus vaccine (OPV) has been instrumental in controlling the polio epidemic, and stands out for its safety, efficacy, ease of oral administration, and low cost. However, despite these advantages, as it is a live attenuated virus vaccine, there is the possibility of mutations that confer neurovirulence. Therefore, surveillance for acute flaccid paralysis (AFP) is important, whether associated with live vaccines (VAPP) or vaccine-derived viruses (VDPV). In this review we present important data from Latin America in recent years, where data on VDPV of community transmission, of ambiguous origin and associated with immunodeficiencies are reviewed. Due to the presence of VDPV, it is important to strengthen the epidemiological surveillance system for AFP, with data much lower than those recommended in recent years in the Americas. Additionally, it is essential to improve vaccination coverage to reduce the number of infants at risk of acquiring poliomyelitis. Consequently, we present the vaccination coverage rates with the inactivated vaccine against poliovirus (IPV) in the region and analyze the vaccination programs against poliomyelitis in accordance with the recommendations of the Latin American Society of Pediatric Infectious Diseases (SLIPE; minimum 3 doses of IPV) and the WHO Strategic Advisory Expert Group (SAGE) on Immunization (minimum 2 doses of IPV). The study concludes with recommendations from the authors for the change from OPV to exclusive use of IPV, to increase vaccination coverage and to strengthen surveillance for AFP in the region.
Topics: Child; Humans; Immunization Schedule; Infant; Latin America; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Vaccination
PubMed: 33844811
DOI: 10.4067/S0716-10182020000600701 -
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 -
Emerging Infectious Diseases Nov 2018Pakistan began using inactivated poliovirus vaccine alongside oral vaccine in mass campaigns to accelerate eradication of wild-type poliovirus in 2014. Using case-based...
Pakistan began using inactivated poliovirus vaccine alongside oral vaccine in mass campaigns to accelerate eradication of wild-type poliovirus in 2014. Using case-based and environmental surveillance data for January 2014-October 2017, we found that these campaigns reduced wild-type poliovirus detection more than campaigns that used only oral vaccine.
Topics: Disease Eradication; Environmental Monitoring; Geography; Humans; Mass Vaccination; Pakistan; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Public Health
PubMed: 30252646
DOI: 10.3201/eid2411.180050 -
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 -
The Journal of Infectious Diseases Nov 2014Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event associated with oral poliovirus vaccine (OPV). This review summarizes the epidemiology and... (Review)
Review
BACKGROUND
Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event associated with oral poliovirus vaccine (OPV). This review summarizes the epidemiology and provides a global burden estimate.
METHODS
A literature review was conducted to abstract the epidemiology and calculate the risk of VAPP. A bootstrap method was applied to calculate global VAPP burden estimates.
RESULTS
Trends in VAPP epidemiology varied by country income level. In the low-income country, the majority of cases occurred in individuals who had received >3 doses of OPV (63%), whereas in middle and high-income countries, most cases occurred in recipients after their first OPV dose or unvaccinated contacts (81%). Using all risk estimates, VAPP risk was 4.7 cases per million births (range, 2.4-9.7), leading to a global annual burden estimate of 498 cases (range, 255-1018). If the analysis is limited to estimates from countries that currently use OPV, the VAPP risk is 3.8 cases per million births (range, 2.9-4.7) and a burden of 399 cases (range, 306-490).
CONCLUSIONS
Because many high-income countries have replaced OPV with inactivated poliovirus vaccine, the VAPP burden is concentrated in lower-income countries. The planned universal introduction of inactivated poliovirus vaccine is likely to substantially decrease the global VAPP burden by 80%-90%.
Topics: Adolescent; Adult; Child; Child, Preschool; Developed Countries; Developing Countries; Female; Global Health; Humans; Infant; Infant, Newborn; Male; Poliomyelitis; Poliovirus Vaccines; Prevalence; Risk Assessment; Young Adult
PubMed: 25316859
DOI: 10.1093/infdis/jiu184 -
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 -
Clinical Microbiology and Infection :... Jan 2018
Topics: Child, Preschool; Disease Eradication; Humans; Immunization Programs; Pakistan; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Vaccination
PubMed: 28962994
DOI: 10.1016/j.cmi.2017.09.008 -
Risk Analysis : An Official Publication... Feb 2021Countries face different poliovirus risks, which imply different benefits associated with continued and future use of oral poliovirus vaccine (OPV) and/or inactivated...
Countries face different poliovirus risks, which imply different benefits associated with continued and future use of oral poliovirus vaccine (OPV) and/or inactivated poliovirus vaccine (IPV). With the Global Polio Eradication Initiative (GPEI) continuing to extend its timeline for ending the transmission of all wild polioviruses and to introduce new poliovirus vaccines, the polio vaccine supply chain continues to expand in complexity. The increased complexity leads to significant uncertainty about supply and costs. Notably, the strategy of phased OPV cessation of all three serotypes to stop all future incidence of poliomyelitis depends on successfully stopping the transmission of all wild polioviruses. Countries also face challenges associated with responding to any outbreaks that occur after OPV cessation, because stopping transmission of such outbreaks requires reintroducing the use of the stopped OPV in most countries. National immunization program leaders will likely consider differences in their risks and willingness-to-pay for risk reduction as they evaluate their investments in current and future polio vaccination. Information about the costs and benefits of future poliovirus vaccines, and discussion of the complex situation that currently exists, should prove useful to national, regional, and global decisionmakers and support health economic modeling. Delays in achieving polio eradication combined with increasing costs of poliovirus vaccines continue to increase financial risks for the GPEI.
Topics: Costs and Cost Analysis; Disease Eradication; Disease Outbreaks; Global Health; Health Care Costs; Humans; Immunization Programs; Models, Economic; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Risk; Risk Management; Serogroup; Vaccination
PubMed: 32645244
DOI: 10.1111/risa.13557