Expanding access to non-traditional vaccines: a perspective from Indonesia

Abstract

In addition to the use of traditional vaccines in the National Immunization Program, the introduction: of additional vaccines in Indonesia appears to be important to further reduce rates of childhood mortality. However, it typically takes at least two decades for additional vaccines to be introduced into the National Immunization Program since decisions to introduce additional vaccines must be supported with clear strategies to guarantee the supply of affordable vaccines, financial sustainability and long-term commitments.

Keywords::

• budget
• immunization
• Indonesia
• non-traditional
• vaccination

Vaccinations against vaccine-preventable diseases have been one of the most important contributors to reducing childhood mortality and increasing life expectancy in Indonesia. Recently, the Indonesian government has launched the pentavalent vaccine (diphtheria-tetanus-pertussis [DTP], Haemophilus influenzae type b and hepatitis B) in the form of a single shot for newborn infants to reduce the mortality rate of children under 5 and increase the coverage of the National Immunization Program (NIP), which was only 81% as reported in 2012 [1,2]. A 25% reduction in the mortality rate of children under 5 years of age was linked to the high vaccination coverage of 90% for both traditional and non-traditional vaccinations by the WHO [3]. A traditional vaccine is identical with a vaccine that has been included into the NIP in a country, such as DTP, polio, measles, hepatitis B and TB vaccines in Indonesia. In addition to the use of traditional vaccines in the NIP, the Indonesian government has been developing and introducing additional vaccines to further reduce the rates of childhood mortality. However, it typically takes at least two decades for additional vaccines to be introduced into the NIP. Several critical factors are responsible for this long delay, such as insufficient political commitment, cost of new vaccines and insufficient vaccine supply [4]. Accelerating access to non-traditional vaccines in Indonesia appears to be crucial since it will not only save the lives of children but also reduce the tremendous economic and health burdens caused by vaccine-preventable diseases. The key to expedite the process of introduction of new vaccines is through engaging the national decision makers on issues of primary healthcare services and convincing them with evidence on the burden of diseases for society and the potential impacts of new vaccine introductions [4].

With an annual birth cohort of approximately 4.7 million [5], Indonesia is the third biggest market in Asia, after China and India, for infant vaccine manufacturers. From a business perspective, the market entry hurdles for the vaccine business in Indonesia differ significantly from other pharmaceutical industries in the high-capital investments needed to build vaccine manufacturing plants combined with reticence among vaccine buyers to commit to long-term agreements [6]. Nevertheless, both hurdles become surmountable when the government commits to long-term strategic investments in vaccines. Unlike the majority of countries in the South-East Asia Region, Indonesia produces traditional vaccines domestically through Biofarma. It was the first vaccine manufacturer in the South-East Asia Region to achieve WHO prequalification status, which enabled participation in the United Nations Children’s Fund vaccine tenders (e.g., DTP, hepatitis B, DTP–hepatitis B, measles and oral polio vaccines) [6]. With respect to non-traditional vaccines, Biofarma has been a driving force in the further development of these vaccines. For instance, in collaboration with the Murdoch Children Research Institute, Biofarma has been working on the development of RV3: a new rotavirus vaccine, which is being designed to be given orally to babies at birth to provide the earliest possible protection [7]. Despite the fact that mass production of non-traditional vaccines has the potential for application at a global scale because of more affordable costs and higher assurance of quality, there are still two major challenges that must be overcome in Indonesia: the lack of interest, incentive and support from the government for research and development and the lack of coordination and cooperation among stakeholders, universities, research institutes, manufacturers, national regulatory authorities and the NIP [3].

Once a vaccine is developed, extra challenges exist regarding the potentially high budget needed for self-sustaining storage and delivery systems for the vaccine in Indonesia because it is an archipelago country. In some cases, the introduction of non-traditional vaccines will require additional budgeting for cold chain and logistic systems. Specifically, the introduction of rotavirus vaccines may require additional costs to expand cold chain capacity because the present packing volume of rotavirus vaccines is approximately 7–18 times greater than the packing volume of traditional vaccines (e.g., DTP vaccines) [8]. To address this, Biofarma should consider their rotavirus vaccines’ packaging and have initiatives to minimize the packing volume. With respect to the Indonesian government, they may consider to prepare additional infrastructures and more effective vaccine management policies before they introduce a new vaccine as required by the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunization). In particular, the WHO and the United Nations Children’s Fund have also developed new communication framework for introductions of new vaccines, which would be included in pre-introduction phase assessments, focusing on new delivery technologies, readiness of cold chain storage, improvement of adapted vaccines and training of health care workers. These requirements were primarily designed to assure a country’s systematic readiness when introducing new interventions and, more specifically, to minimize failure due to economic factors.

During the period from 2006 to 2011, Indonesia’s gross domestic product per capita grew from US$1601 to US$3472 [9], allowing Indonesia to grow from the level of lower-income country to middle-income country. Even though its gross domestic product per capita had increased significantly, the Indonesian government expenditure on the NIP fluctuated over this period. In 2011, the Indonesian government spent US$ 68 million on the NIP (US$ 14 per infant) for seven traditional immunizations [10]. In addition to supporting the NIP, the Indonesian government also spent US$61 million on vaccines during the same period [10]. Given these limited budgets, the implementation of non-traditional vaccines in Indonesia appears to be dependent on potential financing arrangements surrounding the immunization programs, including international support. However, decisions related to these financing matters are usually complicated, even in a high-income country [11]. The selection among financing options should be made after estimating the number of required resources to achieve the NIP’s goals, such as access, utilization, quality, safety and equity [11]. The financing arrangements also should be chosen with an understanding of the specific characteristics of each of the options considered.

In order to enhance the market for vaccines in real practice and the introduction of non-traditional vaccines, future approaches should address several priorities: greater access and equity with respect to the coverage of the NIP, well-implemented, accelerated disease control and prevention strategies and development of a public-health infrastructure [12]. It should be noted that introduction of new interventions against infectious diseases, including the use of new vaccines, is often strongly associated with less frequent use of hospital services and lower hospital costs. Therefore, accelerating the introduction of non-traditional vaccines appears to be in line with the policy of several preventive efforts, such as lowering antibiotic use, reducing antimicrobial resistance and extending herd immunity and protection effects. Also, another important benefit to the health system facilitated by new vaccine introduction is the increase in awareness of improving disease surveillance.

In conclusion, since access to endemic and non-traditional vaccines is still needed in Indonesia, further economic evaluation studies of adding non-traditional vaccines to the routine immunization schedules are required. In the case of rotavirus vaccine, up to now, two studies have confirmed that the implementation of rotavirus vaccination would be a cost–effective intervention in Indonesia [13,14]. However, decisions to introduce additional vaccines must be supported with clear strategies to guarantee the supply of affordable vaccines, financial sustainability and long-term commitments.

Financial & competing interests disclosure

MJ Postma has received grants, honoraria and travel stipends from various pharmaceutical companies, including those interested in the subject matter of this paper. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.