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Introduction : Across Europe, immunization programs have brought immense benefits to the prevention of infectious diseases. The vaccines used are procured through a variety of models such as tenders and Pricing & Reimbursement. However, to date, the impact of the procurement method on the performance and sustainability of vaccination programs and on public health has received little attention. Areas covered : Drawing on a review of the academic and policy literature, complemented by an interview program with stakeholders involved in the procurement of vaccines, the authors have documented the relationship between procurement method dynamics and the level of protection against vaccine-preventable diseases in Germany, Italy, Spain and Romania for, measles-containing vaccines, hexavalent and influenza vaccines. Expert opinion : Price-based tenders can contribute to vaccine supply issues, discourage the provision of value-added services supporting vaccination coverage and disincentives future R&D. Although it is observed that price-based tenders can intensify competition in the short term, there can be unintended consequences such as damage to long-term competition. As European countries are committed to strengthen their immunization programs, they should consider the implications of current vaccine procurement models on the vaccine ecosystem and on public health.

In 2016, the World Health Organization (WHO) announced a global shortage of inactivated poliovirus vaccine that was expected to last until 2020 at least. In response, WHO's Strategic Advisory Group of Experts on Immunization recommended that countries consider a strategic shift to fractional-dose inactivated poliovirus vaccine, which involves a new dosing schedule (i.e. administered at 6 and 14 weeks of age) and has a different mode of delivery than full-dose inactivated poliovirus vaccine (i.e. intradermal rather than intramuscular). Introduction of fractional-dosing requires careful planning and management to ensure adequate vaccine supplies, to prevent wastage, to provide training for health workers, and to ensure accurate record-keeping. In early 2016, given the global vaccine shortage and a limited supply from domestic manufacturers, India's Expert Advisory Group on polio recommended the staggered introduction of fractional-dosing. India was the first country to introduce fractional-dose inactivated poliovirus vaccine into routine immunization, initially in eight states in 2016. Following a rapid assessment of its initial implementation, fractional-dosing was extended and, by June 2017, all Indian states were covered. Here we summarize India's experience with the introduction, discuss the challenges faced and the strategies used to address them, and report on the outcomes achieved. We also describe the lessons learnt, especially managing vaccine supplies and wastage, monitoring and supervision, and training needs. As the use of fractional-dose inactivated poliovirus vaccine is dose-sparing and reduces the cost of the immunization programme, it will remain an important part of India's long-term strategy for polio vaccination.

As part of the Polio eradication and endgame strategic plan 2013-2018 to achieve and sustain a polio-free world, the use of oral polio vaccine (OPV) must eventually be stopped. This process started in April 2016, with the worldwide, planned synchronized "switch", whereby use of OPV containing poliovirus type 2 ceased. Prior to the switch, in line with international guidance on risk mitigation, Sri Lanka had introduced a single full dose (0.5 mL intramuscularly) of inactivated polio vaccine (IPV) into routine immunization. However, the two global suppliers of World Health Organization (WHO)-prequalified IPV had significant challenges in scaling up production to meet the new demand, resulting in a global shortage in April 2016. The WHO Strategic Advisory Group of Experts on Immunization recommended that countries should consider a two-dose schedule of intradermal fractional IPV (fIPV). After rapid consideration of the programmatic cost and logistic implications, Sri Lanka was the first country to roll out this dose-sparing schedule nationwide. The country ensured smooth implementation of fIPV use, reaching out to all eligible infants, maintaining equity and sustaining the IPV vaccination. With expedited refresher training in intradermal vaccination, confident, well-trained and dedicated health-care staff, from the field up to provincial levels, worked together as a dedicated team. Health authorities at all levels reported that public acceptance of the additional injections of the new schedule was high. A post-introduction evaluation and an assessment of population-level immunity are under way., Competing Interests: None declared

Combination vaccines represent a valuable technological innovation in the field of infectious disease prevention and public health, because of their great health and economic value from the individual, societal, and healthcare system perspectives. In order to increase parents' and healthcare professionals' confidence in the vaccination programs and maintain their benefits to society, more information about the benefits of innovative vaccination tools such as combination vaccines is needed. Purpose of this work is an examination of available hexavalent vaccines, that protect against Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B and Haemophilus influenzae type b infections. From the epidemiological updates of vaccine preventable diseases to the vaccine development cycle, from the immunogenicity of antigenic components to the safety and co-administration with other vaccines, several aspects of available hexavalent vaccines are discussed and deepened. Also a number of practical considerations on schedules, age of employment, strategies for vaccination recovery, vaccination in at-risk births are issued, based on the recommendations of Italian Ministry of Health, Italian Society of Pharmacology (SIF), Italian Society for Pediatrics (SIP), Italian Federation of Family Paediatricians (FIMP) and Italian Society of Hygiene, Preventive Medicine and Public Health (SItI).

Background: Introduction of inactivated polio vaccine creates challenges in maintaining the cold chain for vaccine storage and distribution., Methods: We evaluated the cold chain in 23 health facilities and 36 outreach vaccination sessions in 8 districts and cities of Bangladesh, using purposive sampling during August-October 2015. We interviewed immunization and cold-chain staff, assessed equipment, and recorded temperatures during vaccine storage and transportation., Results: All health facilities had functioning refrigerators, and 96% had freezers. Temperature monitors were observed in all refrigerators and freezers but in only 14 of 66 vaccine transporters (21%). Recorders detected temperatures >8°C for >60 minutes in 5 of 23 refrigerators (22%), 3 of 6 cold boxes (50%) transporting vaccines from national to subnational depots, and 8 of 48 vaccine carriers (17%) used in outreach vaccination sites. Temperatures <2°C were detected in 4 of 19 cold boxes (21%) transporting vaccine from subnational depots to health facilities and 14 of 48 vaccine carriers (29%)., Conclusions: Bangladesh has substantial cold-chain storage and transportation capacity after inactivated polio vaccine introduction, but temperature fluctuations during vaccine transport could cause vaccine potency loss that could go undetected. Bangladesh and other countries should strive to ensure consistent and sufficient cold-chain storage and monitor the cold chain during vaccine transportation at all levels., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

The requirements under objective 2 of the Polio Eradication and Endgame Strategic Plan 2013-2018-to introduce at least 1 dose of inactivated poliomyelitis vaccine (IPV); withdraw oral poliomyelitis vaccine (OPV), starting with the type 2 component; and strengthen routine immunization programs-set an ambitious series of targets for countries. Effective implementation of IPV introduction and the switch from trivalent OPV (containing types 1, 2, and 3 poliovirus) to bivalent OPV (containing types 1 and 3 poliovirus) called for intense global communications and coordination on an unprecedented scale from 2014 to 2016, involving global public health technical agencies and donors, vaccine manufacturers, World Health Organization and United Nations Children's Fund regional offices, and national governments. At the outset, the new program requirements were perceived as challenging to communicate, difficult to understand, unrealistic in terms of timelines, and potentially infeasible for logistical implementation. In this context, a number of core areas of work for communications were established: (1) generating awareness and political commitment via global communications and advocacy; (2) informing national decision-making, planning, and implementation; and (3) in-country program communications and capacity building, to ensure acceptance of IPV and continued uptake of OPV. Central to the communications function in driving progress for objective 2 was its ability to generate a meaningful policy dialogue about polio vaccines and routine immunization at multiple levels. This included efforts to facilitate stakeholder engagement and ownership, strengthen coordination at all levels, and ensure an iterative process of feedback and learning. This article provides an overview of the global efforts and challenges in successfully implementing the communications activities to support objective 2. Lessons from the achievements by countries and partners will likely be drawn upon when all OPVs are completely withdrawn after polio eradication, but also may offer a useful model for other global health initiatives., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: Kano State, Nigeria, introduced inactivated polio vaccine (IPV) into its routine immunization (RI) schedule in March 2015 and was the pilot site for an RI data module for the National Health Management Information System (NHMIS). We determined factors impacting IPV introduction and the value of the RI module on monitoring new vaccine introduction., Methods: Two assessment approaches were used: (1) analysis of IPV vaccinations reported in NHMIS, and (2) survey of 20 local government areas (LGAs) and 60 associated health facilities (HF)., Results: By April 2015, 66% of LGAs had at least 20% of HFs administering IPV, by June all LGAs had HFs administering IPV and by July, 91% of the HFs in Kano reported administering IPV. Among surveyed staff, most rated training and implementation as successful. Among HFs, 97% had updated RI reporting tools, although only 50% had updated microplans. Challenges among HFs included: IPV shortages (20%), hesitancy to administer 2 injectable vaccines (28%), lack of knowledge on multi-dose vial policy (30%) and age of IPV administration (8%)., Conclusion: The introduction of IPV was largely successful in Kano and the RI module was effective in monitoring progress, although certain gaps were noted, which should be used to inform plans for future vaccine introductions., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

A fractional dose of inactivated poliovirus vaccine (fIPV) administered by the intradermal route delivers one fifth of the full vaccine dose administered by the intramuscular route and offers a potential dose-sparing strategy to stretch the limited global IPV supply while further improving population immunity. Multiple studies have assessed immunogenicity of intradermal fIPV compared with the full intramuscular dose and demonstrated encouraging results. Novel intradermal devices, including intradermal adapters and disposable-syringe jet injectors, have also been developed and evaluated as alternatives to traditional Bacillus Calmette-Guérin needles and syringes for the administration of fIPV. Initial experience in India, Pakistan, and Sri Lanka suggests that it is operationally feasible to implement fIPV vaccination on a large scale. Given the available scientific data and operational feasibility shown in early-adopter countries, countries are encouraged to consider introducing a fIPV strategy into their routine immunization and supplementary immunization activities., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

Introducing a new vaccine is a large-scale endeavor that can face many challenges, resulting in introduction delays and inefficiencies. The development of national task teams and tools, such as prelaunch trackers, for the introduction of new vaccines (hereafter, "new vaccine introductions" [NVIs]) can help countries implement robust project management systems, front-load critical preparatory activities, and ensure continuous communication around vaccine supply and financing. In addition, implementing postlaunch assessments to take rapid corrective action accelerates the uptake of the new vaccines. NVIs can provide an opportunity to strengthen routine immunization, through strengthening program management systems or by reinforcing local immunization managers' abilities, among others. This article highlights key lessons learned during the introduction of inactivated poliovirus vaccine in 3 countries that would make future NVIs more successful. The article concludes by considering how the Immunization Systems Management Group of the Global Polio Eradication Initiative has been useful to the NVI process and how such global structures could be further enhanced., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

A total of 105 countries have introduced IPV as of September 2016 of which 85 have procured the vaccine through UNICEF. The Global Eradication and Endgame Strategic Plan 2013-2018 called for the rapid introduction of at least one dose of IPV into routine immunization schedules in 126 all OPV-using countries by the end of 2015. At the time of initiating the procurement process, demand was estimated based on global modeling rather than individual country indications. In its capacity as procurement agency for the Global Polio Eradication Initiative and Gavi, the Vaccine Alliance, UNICEF set out to secure access to IPV supply for around 100 countries. Based on offers received, sufficient supply was awarded to two manufacturers to meet projected routine requirements. However, due to technical issues scaling up vaccine production and an unforecasted demand for IPV use in campaigns to interrupt wild polio virus and to control type 2 vaccine derived polio virus outbreaks, IPV supplies are severely constrained. Activities to stretch supplies and to suppress demand have been ongoing since 2014, including delaying IPV introduction in countries where risks of type 2 reintroduction are lower, implementing the multi-dose vial policy, and encouraging the use of fractional dose delivered intradermally. Despite these efforts, there is still insufficient IPV supply to meet demand. The impact of the supply situation on IPV introduction timelines in countries are the focus of this article, and based on lessons learned with the IPV introductions, it is recommended for future health programs with accelerated scale up of programs, to take a cautious approach on supply commitments, putting in place clear allocation criteria in case of shortages or delays and establishing a communication strategy vis a vis beneficiaries., (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: Antigens contained in vaccines are inherently unstable biologically; such a characteristic is conferred by their three-dimensional structure. Preserving the ability of the vaccines to protect against disease is necessary to ensure the supervision and monitoring of all steps of the cold chain. DTPa-HBV-IPV/Hib vaccine (Infanrix hexaTM, GSK Vaccines, Belgium) is designed to prevent disease due to diphtheria, tetanus, pertussis (DTP), hepatitis B virus (HBV), poliomyelitis and Haemophilus influenzae type b (Hib); it was first licensed for use in Europe in 2000 and is currently licensed in at least 95 countries. Since October 2013, more than 102 million doses of GSK's DTPa-HBV-IPV/Hib vaccine have been distributed globally, with nearly 15 million doses distributed in Italy. DTPa-HBV-IPV/Hib components are stable up to a temperature of 25°C for 72 hours. Lacking of officially approved stability data may generate some concern in case of cold chain accidents., Methods: An analysis based on collected data was carried out to estimate potential costs attributable to events of "out-of-temperature" in the stockpiling of hexavalent vaccines occurring in Italy in 2014., Results: The analysis, based on real data, documented that the loss for the National Health Service (NHS) was in the range of 100,000 - 400,000 euros in one year. However, the amount of money that in principle could have been lost would have ranged between nearly half and one million euros/year., Conclusions: A substantial loss of money was avoided thanks to the availability of officially approved stability data for GSK's DTPa-HBV-IPV/Hib vaccine.

OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil. METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated polio vaccine, compared with the oral polio vaccine-only regimen. The costs of the vaccines were estimated for routine use and for the "National Immunization Days", during when the oral polio vaccine is administered to children aged less than five years, independent of their vaccine status, and the strategic stock of inactivated polio vaccine. The presented estimated costs are of 2011. RESULTS The annual costs of the oral vaccine-only program (routine and two National Immunization Days) were estimated at US$19,873,170. The incremental costs of inclusion of the inactivated vaccine depended on the number of vaccine doses, presentation of the vaccine (bottles with single dose or ten doses), and number of "National Immunization Days" carried out. The cost of the regimen adopted with two doses of inactivated vaccine followed by three doses of oral vaccine and one "National Immunization Day" was estimated at US$29,653,539. The concomitant replacement of the DTPw/Hib and HepB vaccines with the pentavalent vaccine enabled the introduction of the inactivated polio without increasing the number of injections or number of visits needed to complete the vaccination. CONCLUSIONS The introduction of the inactivated vaccine increased the annual costs of the polio vaccines by 49.2% compared with the oral vaccine-only regimen. This increase represented 1.13% of the expenditure of the National Immunization Program on the purchase of vaccines in 2011.

Outreach immunization services, in which health workers immunize children in their own communities, are indispensable to improve vaccine coverage in rural areas of developing countries. One of the challenges faced by these services is how to reduce high levels of vaccine wastage. In particular, the open vial wastage (OVW) that result from the vaccine doses remaining in a vial after a time for safe use -since opening the vial- has elapsed. This wastage is highly dependent on the choice of vial size and the expected number of participants for which the outreach session is planned (i.e., session size). The use single-dose vials results in zero OVW, but it increases the vaccine purchase, transportation, and holding costs per dose as compared to those resulting from using larger vial sizes. The OVW also decreases when more people are immunized in a session. However, controlling the actual number of people that show to an outreach session in rural areas of developing countries highly depends on factors that are out of control of the immunization planners. This paper integrates a binary integer-programming model to a Monte Carlo simulation method to determine the choice of vial size and the optimal reordering point level to implement an (nQ, r, T) lot-sizing policy that provides the best tradeoff between procurement costs and wastage.

During the United States polio immunisation campaign in 1955 a number of children immunised with Cutter Laboratories vaccine were stricken with the disease, halting the programme. This event, the Cutter Incident, had major repercussions in the United States but also in many other countries such as New Zealand, Britain, and Australia. In New Zealand scarcity of vaccine left children exposed to the 1955-6 epidemic and the Department of Health's planned immunisation campaign at the mercy of erratic supply. This paper examines how the consequences of the Cutter Incident shaped the New Zealand polio immunisation programme. The New Zealand experiences with the polio vaccine are set in an international context in order to give an appreciable understanding of the events that occurred.

Objective: Global eradication of poliomyelitis may soon be achieved, but circulating polioviruses could reemerge years after eradication by reversion of live attenuated oral vaccine virus to a virulent form, laboratory stock mishandling, or bioterrorism. If a poliomyelitis outbreak occurs in the United States, access to a vaccine stockpile to interrupt viral spread will be necessary. Options for the stockpile include the inactivated polio vaccine and the live-attenuated trivalent and monovalent oral poliovirus vaccines. With differences in immunogenicity, adverse effects, availability, and other issues, the optimal vaccine choice for the stockpile is not clear. We sought to compare vaccine interventions for poliomyelitis outbreak control., Design: We applied decision analysis to 8 strategies for outbreak control: no intervention, 1 or 2 inactivated polio vaccine doses, 1 or 2 trivalent oral poliovirus vaccine doses, 1 or 2 monovalent oral poliovirus vaccine doses, and sequential inactivated polio vaccine-monovalent oral poliovirus vaccine. Historical data from outbreaks in developed countries were used to estimate the risk of paralytic disease after a hypothetical reintroduction of circulating polioviruses. The outcome measure was cases of paralytic poliomyelitis., Results: Monovalent oral poliovirus vaccine provided optimal outbreak control in most scenarios because of high seroconversion rates with 1 dose. Control provided by trivalent oral poliovirus vaccine and inactivated polio vaccine was equivalent at high vaccine coverage rates. At low intervention rates, trivalent oral poliovirus vaccine produced fewer paralytic cases than inactivated polio vaccine in highly immune populations but more cases than inactivated polio vaccine in poorly immunized groups because of secondary transmission of oral poliovirus vaccine virus and vaccine-derived viruses., Conclusions: This model suggests that monovalent oral poliovirus vaccine would be the most advantageous vaccine for outbreak control. If a monovalent oral poliovirus vaccine stockpile is impractical, the optimal vaccine choice depends on the previous immunity and the anticipated intervention rates.

Objectives: We determined the effect of national vaccine shortages on coverage with 4 doses of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine for American Indian/Alaska Native (AIAN) children., Methods: Data on DTaP coverage for children aged 19 to 27 months were abstracted from Indian Health Service (IHS) immunization reports. Coverage with the fourth DTaP dose (DTaP4) was compared for different periods to determine coverage levels before, during, and after the shortage. Data were stratified geographically to determine regional variation., Results: AIAN children experienced a significant decline (14.8%) in DTaP4 coverage during the shortage. Considerable variation was seen among IHS regions (declines ranged from 4.5% to 26.5%)., Conclusions: AIAN children included in IHS immunization reports experienced a greater decline in DTaP4 coverage during the shortage than the decline reported nationally for children receiving vaccine at public clinics (14.8% vs 6%). Variations in the decline in coverage highlight possible inequities in vaccine supply and distribution and in implementation of vaccine shortage recommendations. We must identify ways to ensure more equitable vaccine distribution and consistent implementation of vaccine recommendations to protect all children from vaccine-preventable diseases.

I have been a strong advocate, for many years, for the merits of IPV for the control of poliomyelitis, and the ultimate eradication of the disease and of poliovirus from the environment (Beale AJ. Poliovaccines: time for a change in immunization policy? Lancet 1990; 335:839-842). I have also recognized how fortunate we are in the Public Health field to have such an excellent vaccine as Sabin's OPV. Dr. Foege has argued aloquently and cogently for an approach that uses both vaccines: OPV and IPV. The EPI programme has used 3 or 4 doses of OPV, but in a number of developing countries this has proved inadequate to provide satisfactory control. In South America the use of 10 or more doses has been required to bring the disease under control. A combined approach of using killed poliovaccine combined in DTP and three doses of OPV seems to be the preferred consensus solution. It would cause the minimum and, hopefully, no disruption of the existing programmes of the EPI. It would almost certainly bring forward the day when poliomyelitis will be controlled and the disease at least will be eradicated. It is clear that the sooner this is done the better. It is cheaper to do it now, although it requires more funds in the short term; and it is better for the children of the world--present and future. The extra cost of putting IPV into DTP is probably about one US$ per course, which is probably no more expensive than giving six more doses of OPV, when the total costs of administration are considered.(ABSTRACT TRUNCATED AT 250 WORDS)

There are serious obstacles, particularly on the African Continent, to the application of the official strategy for eradication of poliomyelitis. Outbreaks in countries where a potent OPV was used keep raising the question of its efficacy in routine programs. Based on the South American strategy, 200 million doses of OPV are needed for the 11 million children born each year. Such quantities of vaccine can hardly be procured for the rest of the world. Organization of vaccination campaigns will be competing with other public health programs. Studies in Africa and in the Middle East have shown the good performance of one or two doses of eIPV combined with DTP. At the current price of the quadruple vaccine DTP-eIPV, its cost effectiveness not only in money, but in practical terms, especially for the inventory, the cold chain, and the delivery, would be extremely attractive.

Successful poliomyelitis prevention depends upon the epidemiological characteristics of the infection and the immune status of the population in the area. Presently available polio vaccines may prove very useful for progress with polio control, provided the prevention programme has been adequately chosen and the limitations of the vaccine used have been taken into consideration. In the present and near future, polio prevention should aim at the containment and local elimination of the paralytic disease, which can be obtained with either OPV or E-IPV. The vaccine-associated disease remains an unsolved issue in an OPV programme. The association of OPV and E-IPV offers a clear advantage over the immunization with a single vaccine, particularly with OPV alone. Global eradication of polio, possible in principle, will be difficult to achieve by the year 2000, because of the present global dimensions of polio infection and the unequal environmental development of the world.

In the span of 5 years since the eradication initiative was launched and only 3 years since external funds were made available, PAHO has been able to develop and implement a comprehensive program strategy for polio eradication that includes the following components: achievement and maintenance of high immunization levels (which include the supplemental strategies of national immunization days and mop-up operations); effective surveillance to detect all new cases; and a rapid response to the occurrence of new cases. Despite yearly increases in the number of cases of acute flaccid paralysis reported to the surveillance system, a decline in reported confirmed cases of polio has occurred since 1986 to record low levels in 1989. Cases in 1989 were reported from only 0.7% of the counties in the Americas. The occurrence of 24 wild-type virus isolates in 1989 were limited to only three geographic areas: northwestern Mexico; the northern Andean Region; and northeastern Brazil. At this writing the clock is ticking with only 3 months left to achieve the goal of interrupting transmission by the end of 1990. If the current level of effort is sustained and special efforts are directed at the remaining foci of infection, the eradication of the transmission of wild-type poliovirus from the Americas can be achieved. Continued external financial support will be critical if the effort is to succeed. The prospect of poliomyelitis eradication in the Americas led the 41st World Health Assembly of WHO to adopt a resolution in May, 1988, to eradicate the indigenous transmission of wild-type poliovirus from the world by the year 2000.(ABSTRACT TRUNCATED AT 250 WORDS)

Declining numbers of adequately vaccinated persons, new data about the comparative safety and effectiveness of live, attenuated and killed poliomyelitis-virus vaccines, increased consumer awareness of adverse reactions and pressure from manufacturers seeking protection from liability were factors leading the Institute of Medicine to re-examine poliomyelitis vaccination programs. The relative merits of live and killed virus vaccines as immunizing agents were reviewed within the context of the 60 to 70 per cent level of poliomyelitis vaccination now reached in the United States. Until about 90 per cent of persons are adequately immunized, the continued use of live-virus vaccines for infants is recommended, with provision that certain categories of persons receive killed-virus vaccine. Vaccination with attenuated live virus of children 11 to 12 years old is suggested to reduce vaccine-associated disease when they become parents of vaccinated infants. Recommendations are made on education, research, liability and informed consent as they pertain to prevention of polyomyelitis.