Benefits and Challenges of Introducing a Dengue Vaccine in Saudi Arabia - Case Study Example

Individual Report Introduction Dengue fever is a communicable tropical disease that is caused by the dengue virus. The symptoms of this disease are characterized by severe headaches, fever, skin rashes and muscle and joint pains. In some cases, this disease can be life-threatening and contribute low blood pressure and the leakage of blood plasma. Currently, there are no specific treatment approaches thus much effort is often directed towards the prevention and management of the disease. The prevention of the dengue fever often entails limiting the exposure of an individual to mosquito bites. This approach has proved to be ineffective when it comes to preventing and minimising the a risk of transmission. Hence, it has become evident that there is need for a vaccine to help mitigate the outbreak and transmission of the dengue fever (White 2003). Currently, the development of the dengue vaccine has reached a significant milestone. With time, the vaccine is set to be introduced to the national immunization program of various countries (Guy et al, 2011). The key aim of this report is to examine the key factors involved in introducing the new vaccine in Saudi Arabia. Foremost, this report will examine some of the key factors that will impact of the introduction of the vaccine in Saudi Arabia. Among the factors that will be examined in this case include; the disease burden and disease surveillance of the dengue fever and the vaccine efficacy and safety. Subsequently, this report will discuss the benefits and challenges of introducing a dengue vaccine in Saudi Arabia. Disease Burden The disease burden is one of the essential policy issues in the introduction of a vaccine into the national health system of Saudi Arabia. According to the WHO, the disease burden provides an evidentiary basis for setting national health priorities (WHO 2005). The higher the disease burden as expressed in incidence and prevalence rates, hospitalization cases, long term disability and mortality rates due to it, the more important it is compared to other health conditions and the greater the priority it should be assigned in national health policy (WHO 2005). Dengue fever is an endemic disease in Saudi Arabia’s western and southern regions (Ahmed, 2010; El-Gilany et al, 2010). The spread of cases of Dengue fever in Jeddah and Mecca (Makkah) is mostly associated with the annual influx of pilgrims attending the Hajj (Fakeeh and Zaki, 2003). Jeddah receives millions of pilgrims annually travelling to the holy city of Islam which provides opportunities for introduction and exchange of dengue viruses among the pilgrims. Saudi Arabia is therefore regularly placed on dengue fever alert during the Hajj season (Ahmed 2010). Saudi Arabia first experienced a major epidemic of Dengue Fever in 1994 with approximately 500 infections and two reported deaths. Another epidemic occurred in 2006 with slightly more than 1300 cases of infection of the various dengue fever viral strains reported and six deaths. The most recent epidemic occurred in 2008 with approximately 790 cases of dengue and four deaths (Shahin et al, 2009). Therefore, while dengue fever infection is an emergent and life threatening disease, it is endemic in Saudi Arabia and has lower incidence, prevalence and mortality rates outside of western and southern regions of Saudi Arabia. As earlier noted, the main risk associated with dengue fever is the Hajj season which has the potential to increase incidence, prevalence and mortality rates in Jeddah and Mecca (Makkah). This has confined burden of disease studies on dengue fever in Saudi Arabia mainly to Jeddah and Mecca (Makkah) and there is a lack of verified national statistics on incidence, mortality or morbidity rates which can be used as an evidence base to inform national health policy on introduction of dengue fever vaccine. There is also little research on the spillover effect or spread of dengue fever to other parts of Saudi Arabia as a result of movement in and out of Jeddah by residents who may have come into contact with the different viral strains introduced by immigrant pilgrims. However, Shahin et al (2009) conclude that as compared to other parts of Asia and other health conditions such as HIV/AIDS and tuberculosis, dengue fever has lower morbidity and mortality rates and does not effectively constitute a major health problem in Saudi Arabia. Disease Surveillance Disease surveillance constitutes the most important part of national burden of disease studies as it is surveillance which provides the data on incidence, prevalence, hospitalizations, mortality and disability due to a disease. Surveillance is an important input both prior to the introduction of a vaccine and in assessment of its impact as it not only provides the evidence for policy decision making but also enables effective assessment of the impact of a specific vaccine after it is introduced (WHO, 2005). In Saudi Arabia, as in most countries, surveillance data for dengue fever is incomplete as data collection is largely confined to cities such as Jeddah and Mecca (Makkah) which does not provide sufficient data for decision making on the introduction of the dengue fever vaccine on a national scale (Shahin et al, 2009). Therefore, there is a need to invest in public health surveillance of dengue fever in hospitals and other health centres outside of Jeddah and Meccah to increase the amount and an accuracy of information available to decision makers before the vaccine can be introduced. Vaccine Efficacy and Safety Another policy issue that informs the introduction of a vaccine into a country’s national health system is vaccine efficacy. A vaccine’s efficacy refers to its intended impact on measurable end points such as biological markers and clinical disease stages observed during clinical trials. A vaccine may have different impacts on different people who have been vaccinated (Simmons et al, 2012). It may slow down or reduce the probability of disease progression, reduce susceptibility of infection, modify the infectivity to others by persons who have been vaccinated or indirectly immunize non-infected persons by shedding (WHO, 2005). The efficacy of a vaccine is an important consideration in the introduction of a vaccine into a country’s health system since national health policies such as Saudi Arabia’s often establish certain thresholds or standards for vaccine efficacy and safety before any vaccine can be licensed or introduced into the health system. Any vaccine candidate needs comprehensive data on its efficacy in preventing the disease before it can be licensed. The vaccine candidate needs to complete a full set of treatment, prevention, early detection, diagnostic and supportive care trials which may take up to 10-12 years, involve a large number of animal and human subjects and cost millions of dollars (Simmons et al , 2012). Currently, the Sanofi Pasteur CYD tetravalent dengue vaccine candidate is undergoing the third phase of clinical trials to establish its safety and efficacy. While the first two phases have reported no major safety risks and have shown significant immunogenicity, the efficacy and safety of the dengue vaccine is yet to undergo large scale efficacy testing since the results have been reported based on testing for cohorts of children in Latin America and Asia (Guy et al, 2010; Simmons et al, 2012). Guy et al (2011) note that one of the challenges to the introduction of the Sanofi Pasteur CYD tetravalent dengue vaccine in countries such as Saudi Arabia is establishing its safety and immunogenicity to satisfy the stringent demands of Saudi health policy on introduction of new vaccines. Production needs to be scaled up to generate data on efficacy and further testing must be conducted on Saudi Arabia or areas with similar climatic conditions to satisfy the demanding requirements of Saudi health policy on licensing vaccine candidates. Benefits and Challenges of introducing a Dengue Vaccine in Saudi Arabia The Mecca is one of the potential risk areas in Saudi Arabia that is prone to the Dengue fever. Given that the fever spreads easily, it has potential to spread rapidly during the annual Hajj taking place at the Mecca. It is estimated that over 1.5 million tourists visit the Mecca each year for the pilgrimage. As a result, this area is often overcrowded and can be a potential spot for the spread of infectious diseases such as the Dengue fever. Hence, the introduction of the Dengue vaccine would help to contain the spread of the fever during the Hajj. The introduction of the Dengue vaccine would help to avert the transmission of the fever to other regions within and without the Mecca region. This will in turn help to prevent Dengue from becoming a major disease burden in Saudi Arabia especially during the Hajj season. Moreover, the introduction of the Dengue vaccine in Saudi Arabia will help to enhance the immunogenicity of populations in the country. This will in turn help to minimize the risk of transmission and the re-occurrence or further outbreaks of the fever in future especially in high risk areas (Ahmed et al, 2006; White, 2003). One of the key challenge facing the introduction and implementation of dengue vaccination programs in Saudi Arabia revolves around vaccine policies in Saudi. Saudi Arabia has strict policies relating to the introduction and use of vaccines in the country. For example, in order for any vaccine to be licensed in Saudi Arabia, the safety, efficacy and quality of the vaccine needs to be proved beyond reasonable doubt. Currently, vaccine trials to determine the safety, efficacy and quality of the dengue vaccination have not been concluded. The vaccine trials are still in phase three thus there are no definite evidence regarding the safety, efficacy and quality of the vaccine. This could be a major hindrance for the introduction of the vaccine in Saudi Arabia due to its existing vaccine policies (WHO, 2005; Ahmed et al, 2006; El-Gilany et al, 2010). Another challenge that would impact on the introduction of the Dengue vaccine in Saudi Arabia is the burden of the disease in the country. Currently, reports show that the burden of the Dengue fever in Saudi Arabia as compared to other diseases is insignificant. Mortality rates related to the disease are very low as compared to other diseases. This implies that Dengue fever is not a major national health risk in Saudi Arabia. In most cases, the occurrence of this fever is only experience in a few regions in the Saudi Kingdom. The current estimates of the disease incidence in Saudi Arabia are mainly based on reported cases which are relatively few. As a result, the magnitude and disease burden of the Dengue fever is not significant. Thus it will be difficult to justify the costs of implementing a national wide vaccine program (WHO, 2005; Fakeeh & Zaki, 2003). In addition to this, the lack of sufficient funding to support the implementation of the Dengue vaccination program is another challenge that may be encountered. As compared to other diseases, such as Malaria, Hepatitis, Arterial diseases and Sickle Cell, the health risk of Dengue is very insignificant. Thus it may be difficult for the Saudi government to priorities its funding towards the implementation of the vaccine program. It is plausible to conclude that the Saudi government will give priority to high risk diseases such as Malaria, Hepatitis, Arterial diseases and Sickle Cell when it comes to funding rather than the Dengue fever which is not a major national health risk in Saudi Arabia. Conclusion This report has examined the key factors involved in introducing the new vaccine in Saudi Arabia. It has also examined the benefits and challenges of introducing a dengue vaccine in Saudi Arabia. Based on the findings of this report, it is evident that the burden of the Dengue fever in Saudi Arabia as compared to other diseases is less significant. As a result, the introduction of a dengue vaccine in Saudi Arabia may be faced with challenges revolving around, efficacy and safety, the feasibility of the program, vaccine policies and funding. Nevertheless, the introduction of the dengue vaccine would help to enhance the immunogenicity of populations in the country and avert the transmission of the fever to other regions (Ahmed et al, 2006; White, 2003). References Ahmed, A., Arabi, M. & Memish, A. (2006). ‘Health risks at the Hajj’. Lancet 367; 1008–1015. Ahmed, M. (2010). ‘Clinical profile of dengue fever infection in King Abdul Aziz University Hospital Saudi Arabia’. Journal of Infection in Developing Countries 4(8): 503-510. El-Gilany, A., Eldeib, A. & Hammad, S. (2010). ‘Clinico-epidemiological features of dengue fever in Saudi Arabia’. Asian Pacific Journal of Tropical Medicine, 220-223. Fakeeh, M. & Zaki, M. (2003). Dengue in Jeddah, Saudi Arabia, 1994-2002. Dengue Bulletin, 27:13-18. Guy , B. , Barrere, B. , Malinowski, C. , Saville, M., Teyssou, R. & Lang, J. (2011). From research to phase III: Preclinical, industrial and clinical development of the Sanofi Pasteur tetravalent dengue vaccine. Vaccine.29:7229-7241. Simmons, M., Teneza-Mora, N. & Putnak, R. (2012). Advances in the development of vaccines for dengue fever. Vaccine: Development and Therapy 2: 1–14. Shahina, W., Nassara, C., Kalkattawia, M. & Bokhari, H. (2009).Dengue fever in a tertiary hospital in Makkah, Saudi Arabia. Dengue Bulletin 33: 34-44. White, K. (2003). Dengue Fever. New York: Rosen Publishing Group. World Health Organization (2005). Vaccine Introduction Guidelines. Adding a vaccine to a national immunization programme: decision and implementation. Department of Immunization, Vaccines and Biologicals, Geneva, Switzerland. Read More