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Eyckman 38, West Java, Bandung Indonesia. In this study, we analyzed the process that led to the decision to introduce pentavalent vaccine in Indonesia. Using process tracing and case comparison, we used qualitative data gathered through interviews with key informants and data extracted from written sources to identify jadal distinct but interrelated processes that were involved in the decision making: We hypothesized that each process is associated with four necessary conditions that are jointly sufficient for the successful introduction of pentavalent vaccine in Indonesia, namely a an evidence-based vaccine use recommendation, b sufficient domestic financing capacity, c sufficient domestic vaccine manufacturing capacity and d political support for introduction.

This analysis of four processes that led to the decision to introduce a new vaccine in Jsdwal may help policy makers and other stakeholders understand and manage activities that can accelerate vaccine introduction in the future. The introduction of new vaccines in lower income countries usually lags behind that in higher income countries. Previous studies have demonstrated factors that are associated with a higher probability of accelerated introduction.

For example, higher probability of introduction correlates with country per-capita gross domestic product, vaccine cost, immunization program strength, disease burden, disease treatment cost, access to external funding and the political and institutional capacity to decide and implement the introduction Gauri and KhalegianMiller and Flanders Accelerated introduction of Haemophilus influenzae type b Hib vaccine was correlated with democratic institutions, introduction by neighboring countries and eligibility for funding from Gavi, the Vaccine Alliance Gavi formerly the Global Alliance for Vaccines and Immunization, whereas an increase in vaccine price, financing uncertainty, and being situated in East Asia, Pacific, Europe and Central Asia contributed to delayed introduction Shearer et al.

Although frameworks to assist decision makers for introducing new vaccines are available Burchett et al. Imunisas more thorough within country assessment can highlight the complex and diverse process of new vaccine introduction across countries.

For example, domestic vaccine production was an important driver for the introduction of hepatitis B vaccine in Taiwan but not in Thailand, whereas vaccine price was important in Thailand but not in Taiwan Munira and Fritzen Understanding the processes and drivers of the introduction of new vaccines within countries is important for accelerating future introductions Gauri and Khalegian ; Munira and Fritzen Indonesia introduced Hib-containing pentavalent vaccine in its National Immunization Program NIP in16 years after introducing hepatitis B vaccine in Yulitasari As described elsewhere Mahoney ; Muraskinthe introduction of hepatitis B vaccine was highly influenced by the involvement of the International Task Force on Hepatitis B Immunization.

The model was successfully replicated in several other countries and led to the integration of Hepatitis B vaccine in the Expanded Program for Immunization and a push to establish a global fund for its financing. In the intervening period between the two vaccine introductions, major political reforms occurred in Indonesia following the economic crisis—including the transition from an authoritarian regime to a democratic state, an increase in local government autonomy, and a move to decentralize the health system.

Hence, the introduction of the pentavalent vaccine in offers an opportunity to examine the current process of vaccine introduction in Indonesia in this new political context. This study explores the process through which the decision to introduce the pentavalent vaccine in Indonesia was made. We supplemented the pentavalent vaccine introduction case with other cases where new vaccines were proposed to be introduced to postulate hypotheses of necessary and sufficient conditions for successful vaccine introduction.

Findings from this study may help policy makers focus on those factors that may accelerate future vaccine introduction in Indonesia. We used process tracing to explore the processes and conditions leading to successful vaccine introduction in the cases of pentavalent and other vaccines in Indonesia.

We sought to identify whether the presence of certain conditions was necessary and sufficient for a successful introduction. Following WHO, we defined new vaccine introduction as the addition of a new vaccine or vaccine formulation into the national immunization program World Health Organization b. As such, the pentavalent introduction was identified as the only successful case in Indonesia in recent years.

Additionally, we identified plans and processes to introduce Japanese encephalitis B JEthe pandemic H1N1 flu, rotavirus and inactivated poliovirus IPV vaccines that did not or had not yet resulted in successful introduction. We conducted in-depth interviews between June and October of with 13 individuals knowledgeable about the process of pentavalent vaccine introduction in Indonesia, selected based on their relevant positions in organizations known to have influenced the process Richards An interview guide was used and included questions exploring the process of vaccine introduction, actors and organizations that were involved in the process, and contexts considered to be important or influential throughout the process.

Introduction of pentavalent vaccine in Indonesia: a policy analysis

All interviews were conducted by first author. Written documentation, such as regulations, presentations made by relevant officials, newspaper articles and peer-reviewed papers were also obtained to corroborate and complement claims made during the interviews. Interview transcripts were used as our main data source to identify the intervening processes that resulted in the introduction of the pentavalent vaccine Tansey We systematically identified factors that potentially determined the outcome of pentavalent and other vaccine introduction in Indonesia by following a policy analysis framework Buse et al.

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Specifically, we used this policy analysis framework in a thematic analysis to predefined categories Table 1 into which specific codes emerged from the interview transcripts and written sources would be assigned Gale et al.

We subsequently identified and organized sufficiently distinct information within each category as subcategories Buse et al. imunisxsi

Idsi, we constructed hypotheses of necessary conditions using available information from other vaccine introduction plans Goertz and Levy Coding of the interview transcripts and written documentations were done in OpenCode 4. Required ethical approvals were obtained from Harvard T. An invitation imunissai sent to a private vaccine manufacturer representative office in Jakarta, but no response was received. We identified four separate but interdependent processes occurring between and that affected the decision to introduction the vaccine.

The first process involved an official government recommendation to use the new vaccine. This took place one year after WHO revised its recommendation to introduce Imuniassi vaccine globally regardless of demonstrated disease burden World Health Organization Idi to this revision, WHO recommended the introduction of Hib vaccines for the prevention of pneumonia and meningitis among children under-5 years of age World Health Organizationfocusing on countries with demonstrated disease burden.

However, local evidence of Hib disease burden was not demonstrated until a vaccine-probe randomized control trial in Lombok, Indonesia, was concluded in Gessner et al.

The WHO recommendation was followed by the Indonesian Pediatric Society that included Hib vaccine in their immunization schedule Indonesian Pediatric Society Task Force on Immunizationbut the government did not yet issue any specific consideration about its use in the NIP.

The Ministry of Health passed a ministerial decree in June to introduce the pentavalent vaccine. The second process involved assured financing for the new vaccine. Pentavalent vaccine introduction in Indonesia was supported by Gavi. The proposed pentavalent introduction financing had to be approved within the Ministry of Health, and then by the National Development Planning Bureau and be subjected to negotiation with the Ministry of Finance before finally being discussed with the parliament and passed as a bill Ministry of Finance of the Republic of Indonesia Additionally, provincial and district level governments had to contribute to finance the operational cost of the immunization program Health Minister of Republic of Indonesia Decree a.

However, because the pentavalent vaccine only added an antigen to the tetravalent vaccine already included in the NIP, it did ajdwal impose additional operational costs to local governments. In addition to the availability of funding for introducing a new vaccine, the Ministry of Health considered sustainability of funding to be an important consideration prior to making a decision to introduce a new vaccine I Even though the Ministry of Health had allocated immunization program financing within a routine expenditure category, which in theory would guarantee funding availability, the program had experienced funding cuts.

Sustainability of the immunization program was considered important to maintain public trust and hence the continued successful delivery of immunization services. The third process addressed the existence of a domestic producer for the new vaccine.

PT Bio Farma is a government-owned company and is the only local vaccine manufacturer in Indonesia.

Jadwal Imunisasi Bayi Hingga Anak Remaja Usia 18 Tahun – Versi US CDC

One interviewee considered the lengthy process for acquiring the capability to produce the vaccine as one of the key rate limiting factors for introducing the pentavalent vaccine I-6 ; but once PT Bio Farma was able to produce the vaccine there was a need to purchase and use the product I The fourth process involved political 22012 and actions within government bodies. The political process of pentavalent vaccine introduction was embedded within the existing technical and bureaucratic processes inside the Ministry of Health and between the Ministry of Health and other stakeholders.

Within the Ministry of Health, the immunization program had to compete with other priorities and eventually would need to gain support from the Health Minister I The rejection of JE vaccine use, described later in this article, also occurred imunisadi the same Ministry of Health leadership for allegedly similar anti-foreign sentiment I-2, I By contrast, her successor, a Harvard graduate and accomplished researcher at the Ministry of Health, was described as more open to global collaboration Sciortino Advocacy was considered important to secure political support from the jaxwal through regular consultation meetings between the Ministry of Health and the parliament I In addition to the Ministry of Health, 20122 also played a role in advocating pentavalent vaccine introduction.

This had a positive impact on generating political support for pentavalent introduction in Indonesia Berita Satu Online Of note, the issue of pentavalent vaccine introduction seemed to have circulated within a closed network of policy makers, unlike the ongoing immunisasi program that could produce a wide public discussion and to some extent rejection, especially with regard to possible use of certain porcine elements that would make the vaccine impermissible by Islamic law.

The view that a domestically manufactured vaccine was necessary for the introduction was expressed strongly by two of the interviewees I-3, I Procuring vaccines from PT Bio Farma provided economic advantages compared udai importing vaccines Isuch that purchasing vaccines from PT Bio Farma was considered as a good investment and jadwzl prevent national reserves from going abroad I-8, I We briefly looked at four cases of unsuccessful vaccine introduction ijunisasi Indonesia, to see the role idi the four processes described above.


Although Japanese encephalitis infections have been identified in Indonesia sinceevidence supporting a new vaccination policy was not available until results of a 2-year hospital-based surveillance in Bali were published in April of Kari et al. Presentation of the evidence in a meeting organized by the International Vaccine Institute in September resulted in jzdwal strong support by the Ministry of Health to introduce JE vaccine in Bali as soon as possible.

Subsequently, an action plan for routine and catch-up vaccination of Balinese imynisasi using live attenuated vaccine from China was developed in February International Vaccine Institute However, the introduction plan was reportedly rejected by the Health Minister, because the minister did not want to use an imported vaccine in the NIP I The case demonstrated the failure to introduce a new vaccine due to the absence of several necessary conditions, mainly political support.

In the presence of evidence supporting the use of JE vaccine, we argue that this lack of support stemmed from the lack of domestic production capacity.

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Financing process, on the other hand, was not initiated or was terminated very early as a result of the political decision not to introduce the vaccine. WHO declared H1N1 influenza a pandemic in June and called for the full use of global influenza vaccine jadwall capacity to produce the pandemic vaccine Chan Shortly thereafter WHO called for assistance for least-developed countries to cope with the pandemic, resulting in a total of Local news media reported that the parliament urged the Ministry of Health to refuse the donation because of the possibility of virus strain mismatch Republika Online Similar to JE introduction, this case demonstrates the necessity of having political support to introduce a new vaccine and underlines the involvement of the parliament in the process.

Further, as the vaccines were donated, a large part of funding for the program should have jaddal addressed. Physicians from Gadjah Mada University in Indonesia had been studying rotavirus infection in children since late s and were actively engaged to accelerate the introduction of rotavirus vaccine in Indonesia.

Domestically produced vaccine was considered necessary to reduce costs and therefore increase the possibility of introduction I In this case, the introduction of rotavirus vaccine was still very early in its process. Although very limited information was available regarding the process, the presence of avid advocates who were keeping the process moving was readily observable.

It could be argued that the process thus far—from research to technology transfer—was taken based on insights that having PT Bio Farma produce the vaccine would increase the likelihood of getting other processes, politics and financing, moving toward supporting rotavirus vaccine introduction.

Switching to IPV was suggested as part of the global polio eradication strategy by WHO to maintain a high level of population immunity against polio in light of possible circulating vaccine derived polio viruses from the oral form. Following a recommendation from the Indonesian acute flaccid paralysis expert group, a pilot study was conducted in the city of Yogyakarta starting from year and was planned to be finished in using an imported vaccine. Because of favorable results from the switch, the Ministry of Health decided to continue the use of IPV in Yogyakarta beyond the pilot study using the imported vaccine, financed from the central and local government budget Health Minister of Republic of Indonesia Decree b.

Unlike the other cases above, the polio IPV immunization program was using imported vaccine financed by the government. However, this case is different from the other cases, in that the IPV immunization program was a pilot conducted in one province.

This case shows that the government could agree on introducing an imported vaccine in a certain program. We hypothesize that the processes described above are associated with certain conditions that are necessary for new vaccine introduction in Indonesia. The Ministry of Health included in its — Comprehensive Multi-Year Plan the plan to introduce or to prepare for the introduction of JE, pneumococcal and typhoid vaccines and to have ITAGI actively review evidence to introduce rotavirus and influenza vaccines Directorate General for Disease Control and Environmental Health However, even though WHO recommendations have been the starting point of new vaccine introduction in Indonesia, availability of some supporting evidence of local disease burden and vaccine cost-effectiveness are necessary prior to introduction.

This can be demonstrated by the Lombok study prior to Hib vaccine introduction, and studies being done in preparation for the introduction of other vaccines such as JE surveillance study in Bali, and studies for supporting the use of rotavirus and IPV vaccines.

Local evidence is necessary for policy makers to design appropriate vaccination scheduling and targeting and more importantly to justify new vaccine introduction amidst competing priorities.

Evidence from neighboring countries or from countries with similar characteristics to Indonesia does not suffice to justify new vaccine introduction, as demonstrated by the case of pandemic flu vaccine introduction. In this case, even though it was evident that the novel H1N1 flu virus was circulating worldwide, the vaccine was rejected because of the absence of local evidence supporting its use.

In addition, this recommendation includes other considerations such as cold chain capacity, preferred vaccine presentation, and vaccination schedule.

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