Views of EPI managers and WHO regional officers on the impact of new vaccine introductions on immunization and health systems

Transcription

1 Views of EPI managers and WHO regional officers on the impact of new vaccine introductions on immunization and health systems Report of interviews held during the 2011 meeting of the New and Under-utilized Vaccine Initiative (NUVI) Prepared by: Denise DeRoeck Independent consultant February 4, 2012

2 1. Executive Summary Interviews with nine national immunization and health officials and seven WHO regional office staff were conducted during the annual meeting of the New and Under-Utilized Vaccine Initiative (NUVI) in June 2011 to gain their perspectives on the impact on introducing a new vaccine on immunization and health systems. Informants were also asked during the interviews and at a side meeting their views about possible tools to guide countries in considering the impact of introducing a new vaccine in order to minimize potential negative effects and maximize positive effects. Many of the country experiences discussed concerned the introduction of Hib vaccine mainly the pentavalent DPT-hepatitis B-Haemophulis influenza type b (hib), which replaced DPT or DPT-hepB. A number of countries had, however, introduced more recently available vaccines, such as HPV, H1NI influenza vaccine, pneumococcal conjugate vaccine or others (e.g., yellow fever, Japanese encephalitis). Overall, interviewees believed that introducing new vaccines has had a positive impact on the immunization program as a whole and on health systems. However, negative effects on certain aspects were also reported by most informants. The impact on service delivery was most frequently cited and was largely positive. According to informants, the introduction of the new vaccine led to an increase in coverage of all childhood vaccines in a number of countries, due to the greater awareness of immunization in the community as a result of social mobilization campaigns for the new vaccine, and to the demand generated by new vaccines against frightening, highly-visible diseases such as meningitis and pneumonia (prevented by Hib and pneumococcal vaccines), which brought in new, previously unimmunized children to health facilities. Safety concerns about the new vaccine fueled by anti-vaccine lobbies did result in short-term declines in coverage of other vaccines in several countries (e.g., Latin America with H1N1 introduction). Injection safety was reportedly improved in several countries, due to the introduction of auto-disabled syringes that accompanied GAVI-supported vaccine introductions and to refresher training of health workers and in one country this led to a switch to AD syringes for all medical injections. The second most-frequently cited health system component impacted by new vaccine introductions and one of the biggest challenges was the area of vaccine logistics and management. The majority of countries discussed had insufficient cold storage capacity to adequately handle the new vaccine, which mainly came in one or two-dose vials. This resulted in more frequent vaccine deliveries to the districts and even inadequate cold storage of other vaccines (due to overcrowded cold rooms). These problems led, however, to the expansion of national cold chain systems, in some cases taking into consideration the introduction of other new vaccines well into the future. New vaccine introductions also exposed weaknesses in vaccine forecasting and stock management, which resulted in stock-outs of the new vaccine in several instances. Introducing a new vaccine had both positive and negative effects on the health workforce. Many countries provided refresher training on various aspects of immunization during trainings for the new vaccine, which reportedly improved their skills and motivation level. Having a new vaccine to offer patients also was motivating to health workers in some countries, though the extra workload as more and more vaccines are introduced without an increase in the work force, has reduced their motivation in other countries. Constraints on human resources were cited as the immunization program s biggest limitation in one Latin American country. The introduction of new vaccines with GAVI support has increased the financial commitment for immunization of some governments that were largely or entirely dependent on 1

3 donor support for their immunization program. However, government financing for new vaccines including co-financing for GAVI-supported vaccines has been a significant challenge in a number of countries, reportedly leading to shortages of other vaccines in one country and to less funding for other health programs in others. Donor dependency has actually increased in some countries that have reduced the government budget for the immunization program as a result of increased donor support, and will likely increase in the future as even self-financing countries consider requesting donor support for new, more expensive vaccines, such as pneumococcal conjugate vaccine. Another largely positive effect of new vaccine introductions in several countries has been improvements in the decision-making process, including the creation or strengthening of national immunization technical advisory groups (NITAGs) and the introduction of an evidencebased approach to decision-making. In some countries, the NITAG model led to the establishment of similar advisory committees for other health programs. However, the political attractiveness of some new vaccines (e.g., HPV, pneumococcal conjugate) can have the opposite effect, leading political leaders in some countries to bypass the formal decision-making process and even the EPI in making the decision on its own. A new vaccine introduction created the opportunity to greatly improve a country s capacity to conduct disease surveillance, especially post-conflict countries with little or no functional laboratories or surveillance systems. These improvements due to donor support for laboratory equipment, construction of laboratories, and training of lab and health workers led not only to surveillance for diseases targeted by new vaccines (e.g., rotavirus, bacterial pneumonia and meningitis), but also in some countries to surveillance of other critical infectious diseases, such as TB, malaria and hospital-acquired infections. Safety concerns about the new vaccines also led to strengthening of AEFI surveillance systems in several countries. People who were interviewed and participants of the side meeting generally felt that guidelines to assist countries in thinking through the potential impact of introducing a new vaccine on the broader immunization program and health systems would be useful. They could especially be used in a situation analysis to determine the health systems readiness to handle a new vaccine, to determine what systems and areas can be strengthened with the vaccine introduction, and to monitor the impact of the introduction. Instead of creating a new, separate tool, it was strongly suggested that checklists and other guidance on this topic be incorporated into a new version of the WHO Vaccine Introduction Guidelines. Among the limitations of this brief survey was the fact that most persons interviewed were involved in implementing or supporting vaccine introductions. This may have biased their views towards the positive aspects of introducing a new vaccine and to focus on the impact on immunization systems, instead of examining the broader issue of the impact on health systems. In addition, the main vaccine introduction in many of the countries discussed concerned the replacement of DPT or DPT-hepatitis B with the pentavalent vaccine, which limited the impact compared to vaccines requiring additional vaccinations, a change in the immunization schedule, or a different target age group or population. However, experiences with the introduction of several newer vaccines that many countries will be introducing in the coming years, including pneumococcal conjugate and HPV vaccines, were also examined. 2. Introduction This report is based on interviews with nine national EPI managers and other public health officials, as well seven immunization focal points from WHO regional offices, conducted 2

4 during the annual NUVI meeting in June A list of those interviewed can be found in Appendix 1. Most of the interviews took place individually, while some were conducted in pairs, and lasted around 45 to 90 minutes. A table given during the interviews showing the WHO building blocks of a health system and specific areas within each one proved to be a useful tool in guiding the interviews (Appendix 2). A luncheon meeting to discuss whether tools should be developed to assist countries in addressing issues surrounding the impact of new vaccine introductions on immunization programs and on health systems and the possible form and uses of these tools also took place. The meeting was attended by 33 country and regional participants (i.e., WHO regional office EPI experts), as well as by members of the ad hoc Working Group studying this issue (see Appendix 3 for a list of the meeting participants). While the information gleaned from the interviews hopefully add to our knowledge about the impact of new vaccine introductions, several limitations should be noted. First, many of the countries discussed during the interviews had introduced mainly pentavalent vaccine replacing DPT only or DPT and hepatitis B 1, especially low-income countries in AFRO and SEARO. Thus, the impact of this vaccine is likely less than for other new vaccines that require additional vaccinations (e.g., pneumococcal conjugate vaccine (PCV) and rotavirus) and/or a change in target ages and immunization schedule (e.g., Japanese encephalitis (JE), HPV). The consultant who conducted the interviews did, however, meet with informants from countries or regions that had introduced or planned to introduce other new vaccines, including HPV in EURO and Argentina; pneumococcal conjugate vaccine in Kenya and South Africa; H1N1 flu vaccine in Jordan, Argentina, and other PAHO countries; JE in Nepal; and yellow fever in Kenya. Many countries, especially those receiving GAVI support, will be introducing pneumococcal, rotavirus and other vaccines in the next few years, which will provide a lot more information on the impact of these new, more expensive vaccines on health systems and immunization programs. It should also be noted that most persons interviewed were involved in supporting (in the case of WHO regional staff) or implementing (in the case of EPI managers and other country participants) the introduction of new vaccines. There was likely therefore, a natural tendency for them to focus on the effects of new vaccine introduction on immunization programs rather than on health systems, and to emphasize the positive aspects of new vaccine introduction and deemphasize any negative effects. A number did discuss negative effects and lessons learned, when probed, however. Future studies should include interviews with persons outside of the EPI who have a broader perspective of health systems and who are not as wedded to the EPI, such as officials responsible for primary health care and health services in general. Interviews were also limited in time and thus longer, more in-depth interviews would provide more detailed information. 3. Ranking of the impact of new vaccine introduction by component of the health system Informants were asked to rank the components of health systems (using the six WHO building blocks) that new vaccine introduction has had the greatest impact on either negative or positive. The impact of introducing a new vaccine on services delivery, especially the positive effects on increasing community acceptance and demand for vaccines, as well as the perceived resulting increase in coverage, was ranked #1 by the most number of informants (see Table 1). 1 Provided either in a quadravalent formulation or separately. 3

5 The second highest area ranked was medical products (logistics, cold chain, waste management), which vaccine introduction has presented significant challenges to, especially in the short-term before countries have adequately responded to the increased needs in this area. The impact on the health workforce especially the positive impact of refresher training that accompanies a new vaccine introduction and on motivation, but also the increased workload placed on health workers ranked third, followed by the area of financing and sustainability, which has been both positively and negatively affected. Some informants also felt that the introduction of new vaccines has had an important positive impact on decision-making and planning, as well as on improving and expanding disease surveillance in the context of gathering data for decision-making. The greatest challenges mentioned were: 1) stock and cold chain management; 2) the strain of new vaccines and vaccine introduction costs on health budgets and the sustainability of the EPI once GAVI support ends; and 3) the lack of sufficient human resources as the burden on health workers increases with each new vaccine. A summary of responses by the six building blocks, starting with those that have had the greatest impact as a result of new vaccine introduction, follows. 4. Service delivery Community acceptance, demand, immunization coverage and social mobilization Many informants claimed that introducing a new vaccine mainly Hib and PCV increased coverage of all childhood vaccines. In Ghana, after pentavalent vaccine was introduced in 2002, measles coverage increased from 68% to 75%. And according to EMRO EPI officials, there was a 10% or so increase in DPT3 coverage in Afghanistan and Sudan with the introduction of pentavalent vaccine. Increased coverage of other vaccines was less the case in countries, such as EURO countries and Nepal, where coverage was already quite high. It should be noted that these were largely respondents perceptions or impressions and that other factors may have contributed to or largely accounted for increased in coverage. The main reasons informants attribute to the increase in overall vaccination coverage in several countries are: 1) Countries used the opportunity of a new vaccine launch and accompanying social mobilization campaigns to promote all vaccines and immunization in general. This was mentioned by most informants. Kenya conducted a study of communications about immunization, which informed its communications strategy for the introduction of PCV. There was an increase in coverage of other EPI vaccines, which the EPI manager attributes in part to a successful communications strategy. In several countries, the EPI engaged political leaders, opinion leaders and other prominent persons to take part in the social mobilization campaigns around the new vaccine. 4

6 Table 1. Top rankings by informants of areas that have been most affected by the introduction of new vaccines Health system building block Frequency of ranking by informants Main effects (positive and negative) #1 #2 #3 1 Service delivery 6 (5 positive, 1 negative) 0 0 Five responses: positive impact on improving advocacy of vaccination (process impact), which in turn increased community acceptance of and demand for vaccines and improved coverage. One response: negative impact on vaccine acceptance due to safety 2 Logistics, cold chain, vaccine and waste management 3 Health workforce 3 (2 positive, 1 negative) 4 Financing and sustainability 5 Decision-making and planning 6 Disease surveillance and AEFI concerns about new vaccine Largely negative, short-term impact. Needs of new vaccines exceeded cold chain storage capacity and increased waste disposal needs (and consequently costs). 2 (both positive) 0 Four responses about positive impact of refresher training on health workforce, and impact of new vaccine introduction on improving motivation of health workers and in increasing supervision in the short-term (1 response). One response: negative impact on health workers work load Both positive impacts (has increased government commitment to financing immunization) and negative impacts (co-financing and other costs associated with new vaccine introduction are taking funds away from other vaccines or health programs, plus new vaccines create long-term sustainability problem) Positive impacts of new vaccine introduction: increase in evidencebased decision-making and impetus for creation of NITAGs Positive impact on increasing disease surveillance capabilities and on improving AEFI surveillance Note: The sum of #1 responses is greater than the number of persons interviewed, as some interviewees ranked two areas as #1 (i.e., giving equal weight to both). The total number of responses for #2 and especially for #3 rankings is low, since many interviewees mentioned only their top one or two areas most impacted by new vaccine introductions. 5

7 2) Social mobilization for the new vaccines has brought in children who were unvaccinated or those behind in their immunizations. This allowed them to get caught up on all vaccinations. Vaccines against diseases that are well-known to and that frighten the community, such as meningitis and pneumonia, may be especially effective in bringing in unimmunized children. The high visibility of these diseases created a demand for Hib and PCV. According to the EPI manager in Kenya, PCV introduction provides a great opportunity to increase the demand for immunization in general. Kenya exploited this opportunity by promoting and providing PCV along with other EPI vaccines at Child Health Weeks. Children who hadn t been immunized showed up to get PCV at the campaigns and were caught up on other vaccinations. The EPI manager in Sudan used the opportunity of the pentavalent vaccine introduction to develop a defaulter tracking system for both pentavalent and measles vaccination. Measles coverage increased from 80% to 86% over a 3-4 year period. 3) In Latin American countries, the introduction of a new vaccine involves intensive onemonth campaigns to provide the vaccine through a variety of strategies, including doorto-door visits. Other EPI vaccines, such as measles, are administered at the same time, as needed, and thus the mass campaigns for the new vaccines provide the opportunity to increase coverage of all childhood vaccinations. 4) According to informants from WPRO, Jordan and Sudan, a reduction in the number of injections per visit increased mothers acceptance of quadrivalent and pentavalent vaccines, over separate DPT and hepatitis B injections that had been provided previously. As a result, in Jordan, coverage of both DPT and hepatitis B vaccines increased following the introduction of pentavalent vaccine, according to the Director- General of primary health care. Informants reported that combination vaccines are attractive to health workers as well as to mothers. Greater acceptance of these vaccines should also lead to increased coverage of other vaccines administered during the same visits or that children are behind on, especially oral vaccines, such as OPV, that do not require an additional injection. While the effects of a new vaccine introduction on immunization coverage appeared to be positive in many countries discussed, safety concerns about new vaccines, fueled by growing anti-vaccine lobbies, resulted in not only low coverage for the new vaccine in some countries, but also in a reduction in coverage of other EPI vaccines. According to a PAHO informant, safety concerns about the new H1N1 flu vaccine introduced in several Latin American countries led to a 5% reduction in coverage of other vaccines (e.g., measles, OPV) in Bolivia and Peru in In Bosnia, shortly after Hib vaccine was introduced with GAVI support and co-administered with DPT, a death following immunization with the two vaccines resulted in plummeting coverage of both DPT and Hib vaccines. Community fears about the safety of new vaccines and their potential impact on acceptance and coverage of immunization in general are, in fact, the greatest concern that the informant from EURO has about new vaccine introductions. She stressed the importance of countries having plans in place to counter such reports of adverse events and recommended that WHO prepare crisis communications guidelines. And in India, one informant believes that community concerns about the safety of new vaccines and the anti-vaccine lobby there have contributed to delays in the introduction of pentavalent vaccine, along with service delivery and decision-making issues. Countries have developed different strategies to counter possible or real negative effects of safety concerns and anti-vaccine campaigns on the acceptance of new vaccines and on immunization coverage in general. Due to fears that the introduction of H1N1 flu vaccine in 6

8 Jordan (for all persons one year and older) would result in a decline in coverage of other childhood immunizations, the Government developed a separate delivery system for the flu vaccine using hospitals and did not allow EPI workers to administer the vaccine. A well-regarded EPI can also minimize the impact of safety concerns on the utilization of public immunization services. After the pentavalent vaccine was suspended in Sri Lanka, following a number of suspicious deaths following immunization, mothers turned to the private sector to have their children vaccinated. However, when the vaccine was reintroduced in 2010 with a lot of social mobilization, children went back to the public sector for their immunizations. Immunization schedules and strategies The switch to pentavalent vaccine resulted in a number of countries moving up their immunization schedule from 2,3, and 4 months to 6, 10 and 14 weeks, since Hib vaccine can be given at six weeks of age and countries want to provide it as early as possible in infancy. This change was reportedly well accepted by health workers in Armenia, as it provided the opportunity to vaccinate infants earlier (e.g., before teething when children easily become irritable). In many other countries, the introduction of pentavalent or pneumococcal conjugate vaccine did not require any schedule changes and thus the transition was smooth in terms of service delivery. Most vaccine introductions also did not result in changes in delivery strategies, frequency of immunization sessions, or vaccination venues. An exception is the campaigns that launch new vaccines in many Latin American countries, which can include door-to-door delivery of the new and other EPI vaccines. Even with HPV introduction in countries in the European region, countries that provided the vaccine through schools already had a system of schoolbased vaccination for adolescents in place (e.g., for DT boosters, catch-up doses for measles, hepatitis B and rubella). However, some countries, such as Belgium, developed an alternative system of delivering HPV through doctors offices instead of through schools. These countries tended to achieve lower HPV coverage than those that added the vaccine to their existing school-based immunization program. Integration of immunization with other health interventions In most countries that were discussed during the interviews, introducing a new vaccine did not lead to greater integration of immunizations with other health interventions or services; many countries were already conducting Child Health Weeks during which immunization and other child health interventions are provided. One exception was in Kenya, where the EPI used the introduction of PCV and the demand created for this vaccine to beef up its provision of EPI vaccinations during Child Health Weeks. This reportedly resulted in increased coverage of measles and other vaccines. One argument that was apparently powerful in convincing governments in EURO countries to invest in rotavirus and pneumococcal vaccine introduction, however, was that these vaccines are an important part of an integrated approach towards the control of childhood pneumonia and diarrhea. Reaching MDG #4 to reduce child mortality has been a powerful incentive for countries to control these diseases and thus to consider introducing these vaccines, as mentioned by three informants. Safety and quality of injections Informants generally felt that the introduction of new vaccines has led to improved injection safety, as a result of both the switch to auto-disable (AD) syringes that were bundled 7

9 with the new vaccines provided by GAVI, and refresher training in safe injection included in the training for the new vaccine. With the introduction of AD syringes in GAVI-eligible countries, many switched to these syringes for all of their EPI vaccines with GAVI support, making, in the case of Nepal, abscesses following vaccination disappear. The introduction of AD syringes prompted by new vaccine introductions has had a positive impact beyond the immunization program in Tanzania. Once they were introduced for the EPI, health workers wanted to use them for injectable drugs as well and now other health programs and interventions using medical injections have switched to AD syringes. 5. Vaccine management, cold chain and waste disposal Cold chain systems Cold storage systems were inadequate to handle the new vaccines especially the pentavalent vaccine in one-dose vials in a number of countries, even those that had conducted cold chain assessments prior to vaccine introduction. Several countries had insufficient capacity in their central cold rooms, but adequate capacity at the local level with the purchase of additional refrigerators, while other countries had the opposite problem. As a result, the EPI programs in Ethiopia and Tanzania had to deliver pentavalent vaccine monthly to the regions or districts, compared to quarterly for other vaccines. Vaccine storage fees at the airport also increased in Ethiopia, due to a lack of space in the central cold rooms. Vaccine shipments to the local level also had to increase in Kenya when pneumococcal conjugate vaccine was introduced. Even in a relatively wealthy country like Argentina, a six-month supply of flu vaccine required frequent, even weekly, shipments to local areas. On the other hand, Ghana had sufficient central storage and procured enough new equipment at the local level to accommodate pentavalent vaccine introduction, with no increase in the frequency of vaccine deliveries required. Most informants did not report any negative impact of this problem on other vaccines or medical products, although the increased cost of transport and personnel incurred by the more frequent deliveries of the new vaccine must have had an impact on other parts of the immunization or health budget. However, in Ethiopia, overcrowding in the central cold rooms that occurred when pentavalent vaccine was added, reportedly led to the VVMs of measles and other vaccines going to Stage 2 while still in the central cold rooms 2. Most of the countries discussed during the interviews have expanded their cold chain systems to remedy the situation caused by the new vaccines, and are now increasing capacity further in anticipation of other new vaccine introductions, with external funding. New cold rooms in Ethiopia and Tanzania allowed them to go back to quarterly deliveries of all vaccines to the regions or districts, including the pentavalent vaccine. 3 In Tanzania, the cold chain limitations exposed by the pentavalent vaccine opened up their minds and led to a situation analysis that was very forward-thinking, as it examined possible future cold storage needs for PCV, HPV, rotavirus and H1N1 vaccines, instead of taking an incremental approach. The extra strain that pentavalent vaccine introduction placed on cold chain equipment in Ethiopia worsened their problem with maintenance of cold chain equipment and a lack of spare parts. This led, however, to national and local level training of cold chain technicians. Similarly, Ghana is currently building cold rooms in all of the country s ten regions, with donor support, to prevent cold 2 The 2 nd of four stages, with Stage 3 or 4 requiring that the vaccine be discarded. 3 Tanzania now uses pentavalent vaccine produced in India in 10-dose vials, reducing its cold storage needs considerably. 8

10 storage problems at the regional level when PCV and rotavirus vaccines are added to their program. Thus, the negative impact of new vaccines in further stressing logistics and cold chain systems was largely short-term in the countries discussed, and led in several countries to the long-term expansion of these systems to accommodate future vaccine introductions. Some countries had found innovative ways to finance the additional costs of transport and storage caused by the new vaccines, sparing the EPI budget. In South Africa, no new funds for cold chain expansion was added to the budget when three new vaccines were being introduced in 2008 and 2009 (the pentavalent DPaT-Hib-IPV, rotavirus and PCV). Consequently, vaccine producers agreed to cover the costs for BIOVAC the public-private partnership responsible for vaccine procurement, storage and distribution to move to a new space with much expanded cold storage capacity. A few informants mentioned that the expansion of cold chain systems may have had a positive impact on the storage of other medical products and thus on other health interventions. The cold chain assessment that took place in Tanzania following pentavalent vaccine introduction looked at other medical products requiring a cold chain and the current expansion takes these into account. In Ghana, they are now considering using the EPI cold chain system to store a drug given during childbirth. Vaccine forecasting and stock management The introduction of new vaccines exposed weaknesses in current forecasting and stock management practices in several countries, especially at the local level, and these weaknesses have not yet been adequately addressed with the introduction of new vaccines. Poor forecasting by health facilities and provinces in South Africa has led to both overstocks and stock-outs, especially of the new rotavirus and pneumococcal conjugate vaccines. In part due to stock-outs at the local level, coverage for the complete series in 2010 was only 64-66% for PCV and rotavirus, while it was higher for the DPaT-Hib-IPV vaccine co-administered with the new vaccines. The EPI manager in Nepal reported that EPI sessions can run out of vaccine, due to poor forecasting at the local level. Kenya actually ran out of PCV because the demand was greater than anticipated, but other vaccines had a sufficient buffer stock to prevent stock-outs when the demand for PCV resulted in increased coverage of other EPI vaccines (see above under Service Delivery). Waste management According to several informants, the introduction of new vaccines and AD syringes has created huge waste disposal problems and has increased the costs of waste management. This has been an issue in Kenya, where the addition of pneumococcal vaccination given during the same visits as the pentavalent vaccine has created a challenge in disposing the AD syringes. 6. Health workforce Staffing and training None of the countries that were discussed increased its staff at any level, including the national EPI program office, as a result of the introduction of a new vaccine. In South Africa, for instance, government posts were frozen, so three staff in the national EPI had to conduct all of the planning and organizing for the nearly-simultaneous introduction of three vaccines (DPaT- 9

11 Hib-IPV, rotavirus and pneumococcal conjugate vaccines), with technical and financial support from vaccine producers. However, Ethiopia benefited from the expansion of its health extension worker workforce that was occurring at the same time as pentavalent vaccine was introduced, though the expansion was unrelated to the new vaccine introduction. Views of the effect of new vaccine introductions on the workload and motivation of health workers were mixed, and likely depended on the number of new vaccines that have been introduced and the effort required to deliver them. Some interviewees felt that the workload for most frontline health workers did not increase significantly with the addition of a new vaccine to the EPI or at least it did not affect the rest of the immunization program, while they recognized the extra workload on the national EPI staff. Instead, they stressed the fact that having a new vaccine to offer patients increased the motivation and interest of frontline workers. According to one WPRO official, health workers were proud to have been involved in the introduction of hepatitis B vaccine, since it was the first vaccine added to the EPI in many countries in more than 20 years. In South Africa, no one complained about the extra workload and health workers realized that the new vaccines could have an impact on health, increasing their motivation. However, according to several informants, the introduction of new vaccines has increased the burden on health workers, negatively affecting their motivation in some cases. In Argentina, which introduced pentavalent vaccine in 2009 and influenza vaccine, HPV vaccine and PCV all in 2011, the lack of an increase in human resources at the same time that there s been a large expansion in EPI services has been the program s biggest limitation and has contributed to burn-out of health workers, according to the country s EPI manager. As in several other PAHO countries, new vaccines are introduced in Argentina through intensive month-long campaigns that even involve house-to-house visits in some areas, thus significantly increasing the workload of the existing nurses and vaccinators. The EPI must also compete with other priority programs for the same frontline workers time and attention. In one African country, health workers receive incentives for HIV and TB programs, but no additional funds to conduct social mobilization for the new vaccine. Consequently, many did not show up in the field for the planned social mobilization activities that hey had received training for. Some, especially wealthier countries, such as South Africa and Argentina, have tried to address the problem of extra workload and reduced motivation with salary incentives and overtime pay. In most countries discussed during the interviews, EPI programs used the opportunity of introducing a new vaccine to provide refresher training to all health workers involved in immunization in a range of areas, as well as specific training for the new vaccine. The refresher training typically two days at the higher (e.g., provincial) level and one day at lower (e.g., district or sub-district) levels covered such areas as AFP and measles surveillance, cold chain and stock management, injection safety, monitoring and supervision. In countries with high turnover of frontline health workers, the combined new vaccine/refresher training constituted the first formal training in immunization for many new workers. According to nearly all those interviewed, one of the most important and positive effects of new vaccine introductions has been the refresher training and presumably the resulting improvement in health workers immunization skills. Several informants believed that injection safety and waste disposal had improved as a result of the training conducted in conjunction with the new vaccine introduction. However, one-day training of frontline workers was viewed by some as too short. 10

12 Supervision A few country EPI managers mentioned that supervision was strengthened with the introduction of pentavalent vaccine. In Ghana, there were considerably more supervisory visits, including to EPI sessions. However, once the vaccine became routine and enthusiasm waned, supervision declined as well, and thus the positive impact on supervision was short-lived. In other countries, such as Nepal, the introduction of a new vaccine had no impact on the quality or frequency of supervision. 7. Financing and sustainability Financing of new vaccines The introduction of new vaccines has had largely positive or largely negative effects on the financing and sustainability of immunization and health programs, depending on the informant and country discussed. On the one hand, GAVI support for new vaccine introduction has led some countries to use their own funds for immunization for the first time to pay for cofinancing of new vaccines, AD syringes and safety boxes and has provided other countries with a means of increasing their financial commitment to immunization. In Sudan, all vaccines were provided free by UNICEF and there was not even a government budget for EPI prior to GAVI support. Now the Government is paying for safe injection supplies and is co-financing pentavalent and soon rotavirus vaccine. The introduction of new vaccines in Sudan has increased the attention and priority of the EPI within the Government. A number of informants claimed that GAVI co-financing has not taken funds away from other vaccines or other health programs (e.g., in Kenya, Tanzania and SEARO countries). In Jordan, which pays for 100% of its immunization program, financing for new vaccines has not affected the rest of the MOH budget, as they have been reportedly financed with new funding. On the other hand, some regional and country-based informants reported that cofinancing of GAVI-supported vaccines (e.g., in Sudan, Ethiopia) has been a challenge. The most dramatic case mentioned was in Kyrgyzstan, which met its commitment to co-finance Hib vaccine, but had no funds remaining to procure OPV. OPV coverage declined and put children at risk during a polio outbreak in neighboring Tajikistan. According to two WHO regional officials, funding for new vaccines is taking money away from other health programs, such as TB, malaria and dengue control programs, and expenditures such as new or improved infrastructure. They also mentioned that GAVI support has actually led some countries (e.g., in the Western Pacific region) to shift funds away from the EPI to other programs, thus reducing governments financial commitment to immunization. Their rationale was that donors would cover the EPI costs in any event. Sustainability of new vaccines and the EPI Nearly all persons interviewed believed that it will be a significant challenge to sustain the financing for new vaccines in the future, as current GAVI support ends in 2015, as GAVIeligible countries graduate, and as non-gavi countries try to finance more expensive new vaccines, such as pneumococcal conjugate and rotavirus vaccines, on their own. According to one country-level informant, I don t want to think about what will happen after People are hoping that either GAVI will continue to support new vaccines after 2015, or that vaccine prices will fall low enough for countries to afford to pay for them themselves. 11

13 As a result of the high prices of new vaccines, some countries that are financially selfreliant for vaccines are now thinking about asking donors for support. Jordan would like to introduce PCV, but the cost of the vaccine will double the country s vaccine budget, making it difficult to convince the government to approve its introduction. The Jordanian informant contrasted that with the relatively low prices of hepatitis B and pentavalent vaccines, which were approved quite easily. The MOH would therefore like donor support to introduce PCV. Nepal, which pays for all vaccines except the GAVI-supported pentavalent vaccine, assumes that it will continue to require donor funding for the vaccine after Introducing the newer, more expensive vaccines such as PCV, rotavirus and HPV, may therefore increase donor dependency for financing immunization in countries that have been financing all or most of their vaccines themselves. Countries are finding a variety of ways to improve the financial sustainability of their immunization programs as new vaccines are added. Some examples: To make the transition from GAVI support to self-financing easier, Sri Lanka pays higher co-financing levels to GAVI than required, while Ghana started co-financing before it was required. Uzbekistan did not have enough funds for vaccine procurement, so it switched to procuring all vaccines through UNICEF, whose prices are considerably lower than most countries can obtain on their own. Argentina plans to have flu vaccine produced locally and eventually other vaccines as well, as a result of technology transfer from Novartis to a local producer. South Africa was able to introduce three vaccines over a two-year period with no provision in the budget for the costs of introduction by having vaccine producers make huge financial contributions to cover the added costs of social mobilization, expansion of cold chain capacity, and training of health workers on the new vaccines. 8. Decision-making, planning and regulation ( leadership and governance ) Decision-making process The introduction of new vaccines has provided the opportunity to improve decisionmaking for the introduction of new vaccines and other changes to the immunization program. The need to make decisions about new vaccines was the impetus for establishing national immunization technical advisory groups (NITAGs) in both GAVI-eligible countries (e.g., Armenia, Kyrgyzstan, Nepal) and non-gavi countries (e.g., Belarus). It has also led in some countries, such as Egypt, Syria, Jordan and Morocco, to the strengthening of vaccine committees that were controlled by the Health Ministry and had been one-man shows, often with assistance from WHO regional offices. Committees were strengthened by adding experts in a number of specialty areas, including health economics, and by including people outside of the Health Ministry, such as academicians. The creation or strengthening of NITAGs plus the high cost of new vaccines has resulted in many countries using a more systematic approach to analyzing disease burden and other evidence, and in considering new types of data for the first time. The need for disease surveillance data which started in many countries with hepatitis B led countries to strengthen or even establish laboratory-confirmed surveillance capacities and to conduct surveillance 12

14 studies for the first time (see the next section on disease surveillance). Countries are also learning to estimate disease burden from available data, including regional data. Others, especially those that do not receive GAVI support, such as Jordan and the Philippines, are requiring robust, local morbidity and mortality data before investing in new, more expensive vaccines, such as rotavirus and PCV. Besides evidence of disease burden, data that policymakers and NITAGs are now requesting include estimates of cost-effectiveness and cost savings (including productivity gains from caregivers not having to miss work), programmatic feasibility and system capacity, and affordability. In some countries, such as Lebanon, the NITAG makes a decision based only on the scientific evidence, while a separate technical committee in the MOH examines programmatic issues. The latter may result in a decision to delay the introduction of a vaccine recommended by the NITAG. Interviewees also mentioned that having a NITAG has greatly increased the speed of decision-making about new vaccine introductions. The recent strengthening of the national immunization advisory committee in Jordan had an impact well beyond the decision-making process for new vaccines. There was a movement in some circles within the government to drastically cut the EPI budget and to start charging people for immunizations. The Chair of the committee, who organized meetings with the government, was instrumental in stopping this movement and in protecting the EPI going forward. Some informants mentioned that the decision-making process for introducing new vaccines even countries presumably without NITAGs results in closer relationships between EPI managers and top government decision-makers. This leads to increased knowledge and appreciation of immunization on the part of the policymakers and puts the EPI program in a stronger position to request funding for other EPI-related activities. The impact of new vaccine introductions on the decision-making process has gone beyond immunization programs in some countries. A new committee for the control of nonvaccine preventable infectious diseases (e.g., TB, STDs) is being established with EMRO assistance in Tunisia, modeled on the country s NITAG, while the NITAG in Jordan has been a model for a new pandemic flu committee. Not all countries have changed their decision-making process with the advent of new vaccines, and others have sometimes bypassed the process in place. Decisions to introduce PCV in Kenya and HPV in Mongolia were made by political leaders and not by the EPI. The First Lady in Mongolia decided to accept a donation from Merck for HPV vaccine without consulting the EPI, and thus no data were considered. Therefore, there is still much room for improvements in the decision-making process for immunization programs in many countries. Planning and budgeting According to some interviewees, programmatic and financial planning has improved with the introduction of new vaccines, especially in GAVI-supported countries, as a result of their need to complete comprehensive multi-year plans (cmyps). The cmyps have provided a model that forces countries to make detailed plans for the next five years which was new to many countries. As a result, according to one WHO regional official, planning for the introduction of new vaccines is much better in countries receiving GAVI support than in those that are not. To this official, the lesson learned is that countries need to be exposed to a strong planning and 13

15 budgeting model. In the one country where this was discussed, the budget plans for new vaccines were included in the SWAP. In Sudan, the improved planning process is benefiting other health programs besides immunization. Because the cmyp process is considered the best in the Ministry of Health, the Ministry s Planning Department is using it as a model to train people from other departments in planning. The cmyp process may also be benefiting several non-gavi eligible countries, as EMRO cmyp trainings have included participants from non-gavi-eligible as well as GAVIeligible countries. However, some WHO regional officials felt that many countries do not have a sense of ownership of the cmyps, which are often prepared by external consultants. Consequently, the cmyps are viewed in some countries as merely a document requirement for GAVI funding, they are not used or updated beyond the GAVI process, and have not improved the planning for other vaccines or health interventions. It appears, therefore, that the planning process for new vaccine introductions has been applied differently in different countries, resulting in a large variation in the extent to which it has been institutionalized within the immunization program or used for other health programs. Vaccine regulation The introduction of new vaccines, such as Hib, has been a catalyst in some countries, such as Lebanon and Yemen, to develop functional national regulatory authorities (NRAs), starting with vaccine regulation, with assistance from WHO. Other countries are also considering improving their NRA in the area of vaccine regulation, due to the new and upcoming vaccines on the market. In other countries that procure all of their vaccines through UNICEF, there has been little improvement in their capacity to regulate vaccines, since all UNICEFprocured vaccine are pre-qualified by WHO. 9. Information systems Discussions mostly centered around disease surveillance and AEFI surveillance and reporting and not on routine EPI reporting. The EPI manager from Nepal, however, reported that data collection and verification of routine EPI data have improved due to training for the introduction of Hib and JE vaccines. Disease surveillance The need to make decisions about the introduction of new vaccines, along with more rigorous evidence-based decision-making that is now occurring in many countries has resulted in improvements and expansion of laboratory-supported disease surveillance in many countries, often with support from WHO, vaccine producers and other donors. In the post-conflict countries of Afghanistan and Sudan, disease surveillance was limited or non-existent until surveillance laboratories and other surveillance capacity was built with EMRO support around invasive bacterial diseases (meningitis, pneumonia) and rotavirus (in the case of Afghanistan). Many other countries are now conducting sentinel site surveillance for pneumonia, meningitis and diarrhea in order to make decisions about introducing PCV and rotavirus vaccines 4. 4 And Hib vaccine in the Philippines. 14

16 The surveillance that has been established or expanded not only builds capacity and skills in laboratory testing and in epidemiology, but also provides data in non-vaccine preventable causes of these syndromes (e.g., diarrhea). Another broader impact of improved disease surveillance for vaccine-preventable diseases is that the increased skills, laboratory capacity and new equipment are now being used for the control of other diseases. In Afghanistan, the surveillance capacity built with EMRO support has allowed the country to expand to TB and malaria surveillance, while in Yemen, the establishment of a laboratory in a local pediatrics hospital for pneumonia surveillance has led to the establishment of infectious disease control surveillance in the hospital. AEFI surveillance Several interviewees reported that surveillance and reporting of adverse events following immunization have improved with the introduction of new vaccines. AEFI surveillance systems were strengthened in several PAHO countries when they introduced H1N1, due to fears of adverse events, such as Guillame-Barre syndrome. With the introduction of JE and pentavalent vaccines in Nepal, AEFI surveillance and reporting was reactivated and, following four deaths after vaccination with pentavalent vaccine, an AEFI committee was established. The introduction of pentavalent vaccine in Ghana also provided the opportunity to train health workers in AEFI reporting and to improve reporting forms; however, the system still needs considerable strengthening. 10. Summary of views on the overall impact of new vaccine introductions on immunization programs and health systems Positive impacts Overall, interviewees felt that the introduction of new vaccines has been positive on immunization programs and health systems. New vaccine introductions have in many cases led to improved planning, decision-making, cold chain systems, and disease surveillance sometimes affecting other non-vaccine preventable disease control programs and health interventions. Of great importance, they have provided the opportunity to increase the public s awareness and the visibility of immunization through accompanying social mobilization campaigns that promote all childhood immunizations as well as the new vaccine. According to several informants, the increased awareness, coupled with the demand created by several of the new vaccines that target highly visible, frightening diseases such as meningitis and pneumonia, has resulted in many instances in increased coverage of all vaccines offered by national immunization programs, including measles. Even in countries that experienced an initial decline in coverage due to safety concerns about a new vaccine (e.g., H1N1, Hib), coverage rebounded after a period of time. Nearly all informants stressed the benefits that new vaccine introductions had on providing new or refresher training in a range of areas of immunization, presumably improving their safe injection practices and other skills. One WHO regional official contrasted the introduction of a new vaccine into the routine EPI schedule with the impact that SIAs (special vaccination campaigns) can have on the routine program. While SIAs can be disruptive, since health workers are out conducting the campaigns instead of providing routine immunization services, many of the new vaccines are introduced into the routine program, 15