Introduction of new vaccines: decision-making process in Bangladesh.

The understanding of the decision-making process in the introduction of new vaccines helps establish why vaccines are adopted or not. It also contributes to building a sustainable demand for vaccines in a country. The purpose of the study was to map and analyze the formal decision-making process in relation to the introduction of new vaccines within the context of health policy and health systems and identify the ways of making decisions to introduce new vaccines in Bangladesh. During February-April 2011, a qualitative assessment was made at the national level to evaluate the decision-making process around the adoption of new vaccines in Bangladesh. The study population included: policy-level people, programme heads or associates, and key decision-makers of the Government, private sector, non-governmental organizations, and international agencies at the national level. In total, 13 key informants were purposively selected. Data were collected by interviewing key informants and reviewing documents. Data were analyzed thematically. The findings revealed that the actors from different sectors at the policy level were involved in the decision-making process in the introduction of new vaccines. They included policy-makers from the ministries of health and family welfare, finance, and local government and rural development; academicians; researchers; representatives from professional associations; development partners; and members of different committees on EPI. They contributed to the introduction of new vaccines in their own capacity. The burden of disease, research findings on vaccine-preventable diseases, political issues relating to outbreaks of certain diseases, initiatives of international and local stakeholders, pressure of development partners, the Global Alliance for Vaccines and Immunization (GAVI) support, and financial matters were the key factors in the introduction of new vaccines in Bangladesh. The slow introduction and uptake of new vaccines is a concern in the country. Rapid action on the application of GAVI support and less time taken by the Government in processing the implementation and administrative work may expedite the introduction of new vaccines in future in this country.


INTRODUCTION
Immunization, a proven tool for controlling and eliminating life-threatening infectious diseases, can avert 2-3 million deaths each year globally. It is one of the most cost-effective health investments (1). Universal immunization of children against six vaccine-preventable diseases, such as tuberculosis, diphtheria, whooping cough (pertussis), tetanus, polio, and measles, is crucial to reducing infant and child mortality (2)(3)(4)(5)(6)(7). Consequently, childhood immunization remains a key channel for the attainment of the Millennium Development Goal 4 (MDG 4) of reducing child mortality by two-thirds within 2015.
In recent years, vaccines have been available against other diseases that are also important in terms of public-health perspectives. However, most developing countries did not have the means of accessing, evaluating, and implementing these newly-developed vaccines (8). This situation led to a divergence in global vaccine-use, and many children who were in most need were deprived of access to the new vaccine options

Introduction of New Vaccines: Decision-making
Process in Bangladesh (9). Of these new vaccines, Haemophilus influenzae type b (Hib), hepatitis B (Hep-B), pneumococcal conjugate vaccine (PCV), and rotavirus vaccines are particularly geared toward children of developing countries where the burden of disease is high (10)(11)(12).
These new vaccines differ from those originally included in the Expanded Programme on Immunization (EPI). New vaccines tend to be considerably more expensive than existing vaccines, and some targeted diseases are relatively 'hidden' and, therefore, may lack demand from public and political perspectives (13). The slow introduction and uptake of new vaccines reinforces the importance of information for making decisions (12). After the new vaccines are licensed, policy-makers require information on the burden of disease, costs of vaccines, and cold-chain facilities to make decision to introduce new vaccines (14)(15)(16). The decisionmaking process is complex, notably because it is driven by many different factors and involves multiple actors. Increasing the understanding of the decision-making process in the introduction of new vaccines helps establish why vaccines are adopted or not and contributes to building a sustainable demand for vaccines in a country (17).
To control the vaccine-preventable diseases, the Government of Bangladesh has been working to expand the EPI by introducing new vaccines. Bangladesh introduced the pentavalent Hib vaccine in January 2009 to prevent severe child pneumonia and meningitis. However, the formal decisionmaking process in relation to the adoption of vaccines was never studied in Bangladesh. The purpose of the present study was, therefore, to map and analyze the formal decision-making process in the introduction of new vaccines within the context of health policy and health systems and identify the ways of making decisions to uptake new vaccines in the country.

MATERIALS AND METHODS
During February-April 2011, a qualitative assessment was made at the national level to assess the decision-making process in relation to the adoption of new vaccines in Bangladesh.
For policy analysis of the decision-making process in the adoption of vaccines, the study included: policylevel people, programme heads or associates, and key decision-makers of the Government, private sector, non-governmental organizations (NGOs), and international agencies at the national level.
In total, 13 key informants were purposively selected from relevant government, non-government and international agencies, and most informants were the members of any or more committees on EPI.

Analysis of data
Secondary data: Evidence from the review of policy documents provided general information necessary to describe the general context and introduction of new vaccines.
Analysis of qualitative data: Analysis of qualitative data began following the initial data collection from the field and led to refinements as the study progressed. The interviewers prepared transcripts after the completion of each interview. At first, the transcripts were carefully read, the main findings were listed, and then the coding of main findings was carried out. After reading, re-reading, and coding the texts, the main themes were begun to formalize. Each theme was then examined separately and fully within the available data.

Ethical considerations
The respondents were interviewed after obtaining their informed consents. Efforts were made to ensure that all respondents were properly informed about the study and they thoroughly understood their involvement. Participation was voluntary.
The participants were ensured that refusal would have no adverse consequences for them. They were also assured that the information provided by them would be used for research purposes only and would not be shared anywhere by their names. Interviews were conducted according to the convenience of the respondents.
The Research Review Committee and Ethical Review Committee of icddr,b approved the study before its implementation.

Government
The

Academicians
According to the key informants, the academicians also play important roles in introducing new vac-cines. The academicians included professors of paediatrics, immunology, virology, and liver transplantation. Most respondents reported that high value is given to the opinions of the academicians in relation to the introduction of new vaccines. They stated that, if the specialists and academicians do not agree with the introduction of any vaccine, the concerned authority would not approve its introduction.

Researchers
All the informants reported that the introduction of new vaccines is determined based on scientific evidence. They stated that researchers and scientists are very important in providing scientific information on the need for the introduction of new vaccines. Most respondents mentioned the contribution of researchers in the introduction of the Hib vaccine. They said that, before the introduction of the Hib vaccine, good data were available to understand the burden of disease. According to them, a survey was conducted by the international research institutions and medical colleges. Findings of studies provided information on the burden of diseases and the need for the introduction of Hib vaccine. They shared the findings with the policy level, which influenced the introduction of the vaccine in the country. The respondents informed that the researchers conduct studies and make recommendations to determine which vaccine should be introduced on a priority basis.

Representatives from professional associations
Representatives from different professional associations play an important role in the introduction of new vaccines. The associations included: Bangladesh Paediatric Association, Bangladesh Medical Association (BMA), and Bangladesh Hepatological Society (BHS). Some of them are members of different committees on EPI, and they influence in introducing a new vaccine. One respondent said: You know.…BHS has been pressurizing the Government to introduce Hep-B birth dose. At a certain point, our Hon'ble Health Minister became convinced about it, and he is in favour of introducing it at least at the facility level before its introduction at the outreach centres.

Media
The informants stated that the media generally do not have a major role in the introduction of new vaccines. The media play roles in the implementation of a new vaccine but their role in decision-making is minor. Normally, the vaccines are introduced in phases. The respondents mentioned that the reason for the lower level of influence of the media is that, if the media are involved in decisionmaking, they may publicize about the vaccine all over the country, which may create confusion among the people.

Development partners
All key informants reported that the development partners, especially WHO, UNICEF, and GAVI, play important roles in introducing a new vaccine in Bangladesh. The other development partners, such as World Bank, USAID, and UK-AID, are also the key actors in this regard. WHO and UNICEF provide technical support to Director, PHC and Programme Manager, EPI, about initiation and preparation of GAVI application, capacity assessment of cold-chains, and implementation of a new vaccine.
Some key informants stated that the role of WHO and UNICEF is more important than the Government in terms of the introduction of new vaccines. They said that no matter whether the Government is interested or not but if WHO desires, they can introduce a vaccine in Bangladesh In response to a question about the role of GAVI, the respondents mentioned that the GAVI mainly provides financial support for the introduction of new vaccines. They also added that the GAVI has some priority vaccines to introduce. If their requirements are fulfilled, they support us and provide vaccines.

ICC, NCIP, and Technical Sub-committees
The

Decision-making process
Information on the burden of disease from research organizations leads to initiation of the process of introducing a new vaccine. Whenever information on the burden of disease comes from researchers and the Government and other technical personnel become convinced, the Government starts the process of introducing a new vaccine. The first step in the process of introducing a new vaccine is to discuss it in the STSC. The STSC also discusses about the possible funding sources, GAVI support, cold-chain capacity, and sources of other support in introducing the vaccine. If the STSC is satisfied and approves, a proposal is sent to the NCIP for its approval. Whenever the approval is provided from the NCIP, steps are taken to apply for GAVI support for the introduction of the vaccine. Before submitting the GAVI application, the ICC must endorse the proposal (Figure).
The respondents informed that whenever the NCIP and ICC approve the introduction of a new vaccine, the EPI headquarter starts the preparation of GAVI application for support. After receiving the com-plete application, the GAVI reviews it and sends it back with their comments and queries for clarification. After having satisfactory responses to their comments, the GAVI approves the application for the introduction of a new vaccine (Figure).
The respondents actively involved in the preparation and submission of the GAVI application informed that almost two years are normally required to start the implementation of a vaccine after the submission of an application to the GAVI. The GAVI generally sends their comments six months after receipt of an application. It also takes some time to address the comments provided by the GAVI and resend the application to them. After resubmission of the application, it requires again around six months for the GAVI to take a decision and inform of their approval. According to the respondents, almost another one year is required to complete all the formalities and administrative work to start the

Influencing factors in the introduction of new vaccines
The prevalence and burden of disease, findings of research on vaccine-preventable diseases, active participation of all key stakeholders, political issues relating to outbreaks of certain diseases, initiatives from international and local stakeholders, pressure from development partners, financial matters, and the GAVI support are the key factors that influence the introduction of new vaccines in Bangladesh. All the key informants stated that the GAVI, WHO, UNICEF, and other development partners have influenced the introduction of new vaccines. These international stakeholders not only influence by financing the introduction of new vaccines, they also provide technical support to the Government for the introduction.
The political issues relating to the outbreaks of certain diseases also influence decision-making.
Some key informants stated that, in 2009, the newly-formed political government felt certain pressure of the Haemagglutinin type 1 and Neuraminidase type 1 (H1N1) pandemic in Bangladesh. At that time, the H1N1 pandemic became a political issue through the media coverage. Without any analysis of mortality and morbidity due to H1N1, the Government had to take decision to bring the H1N1 vaccine in the country to reduce the public panic prevalent at that time.
Most respondents stated that the financial factor is important for introducing new vaccines because new vaccines are usually more costly than the traditional vaccines. For introducing any new vaccine, the Government needs support from the development partners, particularly from the GAVI. The respondents also acknowledged the GAVI's contribution to two vaccines previously introduced, such as Hep-B and Hib. They stated that the Government can co-finance in introducing the new vaccines. The process of introducing a new vaccine contributed to establishing a formal procedure in Bangladesh. Whenever information on the burden of disease becomes available from researchers and the Government and other technical personnel are convinced, the Government starts the process of introducing a new vaccine. The first step in the process is to discuss it in the STSC. The STSC also discusses about the possible funding sources, GAVI support, cold-chain capacity, and support from other sources in introducing the vaccine. If the Sub-committee is satisfied and approves, a proposal is sent to the NCIP for its approval. When the approval of the NCIP is accorded, steps are taken to apply for GAVI support for the introduction of the vaccine. Before submitting the GAVI application, the proposal has to be endorsed by the ICC. This formal procedure became structured and functional while introducing the Hib vaccine in Bangladesh in 2009.

DISCUSSION
The findings of the present study have shown that about two years are generally required to introduce a new vaccine after the submission of an application to the GAVI. The GAVI generally takes six months to send their comments to the Government. A considerable time is also needed in the resubmission of the application and making a decision by the GAVI. The findings of the study revealed that, after according approval by the GAVI, one year was required to complete all formalities and administrative work to start the implementation of the Hib vaccine. The slow process in the introduction and uptake of new vaccines is, thus, a concern in Bangladesh.
The prevalence and burden of a disease, research findings on vaccine-preventable diseases, political issues relating to outbreaks of certain diseases, initiatives from international and local stakeholders, pressure from the development partners, and financial matters are the key factors in the introduction of new vaccines in Bangladesh. The GAVI, WHO, UNICEF, and other development partners influence the decision in the introduction of a new vaccine. Political issues relating to the outbreaks of vaccinepreventable diseases also influence in making decisions. The Government needs financial support from the development partners, particularly from the GAVI, for introducing a new vaccine,. The issue of co-financing helped the Government take over the vaccine cost gradually. Therefore, the system of co-financing may be considered while introducing new vaccines in the country.
The GAVI Alliance's initiative to introduce new vaccines in Bangladesh is of utmost importance for children of the country. The role of Alliance in providing financial and technical resources for this purpose is crucial, especially given the high costs of such vaccines (17).
The findings of the study indicate that slashing the funding gaps for immunization and achieving financial sustainability will require several important actions in Bangladesh. For instance, a larger public-sector budget resulting from economic growth, greater government commitments to immunization within health budgets, greater multi-year commitments from donors, reduction in vaccine prices, and a major sustained effort by the GAVI Alliance to support Bangladesh to introduce new vaccines and to permit sufficient time and planning for a transition away from GAVI support may enable Bangladesh to become financially self-sustainable. Findings of others suggest similar actions for poor countries (17,18).

Conclusions
The burden of disease, findings of research on vaccine-preventable diseases, political issues relating to outbreaks of certain diseases, initiatives of international and local stakeholders, pressure from the development partners, GAVI's support, and financial matters are the key factors in the introduction of new vaccines in Bangladesh. To expedite the introduction and uptake of new vaccines, it is important that the GAVI takes rapid action on the application for its support and the Government takes less time to complete the administrative work.