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Fulltext Unique product quality considerations in vaccine development, registration and new program implementation in Malaysia

Khoo YSK, Ghani AA, Navamukundan AA, Jahis R, Gamil A

Hum Vaccin Immunother, 2020 03 03;16(3):530-538.
PMID: 31652090 DOI: 10.1080/21645515.2019.1667206

This review aims to present the unique considerations for manufacturing and the regulation of new vaccines in Muslim-populated countries such as Malaysia. Our specific objectives are to highlight vaccine production and the ingredients of concern, summarize the current mechanism for ruling and recommendations on new vaccines, outline the different steps in decision-making on incorporating a new vaccine into the National Immunization Program, describe its issues and challenges, and explore the commercial viability and challenges of producing local permissible (halal) vaccines. Through this review, we hope readers understand that alternatives are present to replace ingredients of concern in vaccines. Halal certification and introduction of a new vaccine into a program are strictly conducted and health-care providers must be prepared to educate the public on this. At the same time, it is hoped that the production of halal vaccine in Malaysia will promote self-reliance in Muslim-populated countries.
Fulltext Viral Aetiology of Acute Flaccid Paralysis Surveillance Cases, before and after Vaccine Policy Change from Oral Polio Vaccine to Inactivated Polio Vaccine

Saraswathy Subramaniam TS, Apandi MA, Jahis R, Samsudin MS, Saat Z

J Trop Med, 2014;2014:814908.
PMID: 24772175 DOI: 10.1155/2014/814908

Since 1992, surveillance for acute flaccid paralysis (AFP) cases was introduced in Malaysia along with the establishment of the National Poliovirus Laboratory at the Institute for Medical Research. In 2008, the Ministry of Health, Malaysia, approved a vaccine policy change from oral polio vaccine to inactivated polio vaccine (IPV). Eight states started using IPV in the Expanded Immunization Programme, followed by the remaining states in January 2010. The objective of this study was to determine the viral aetiology of AFP cases below 15 years of age, before and after vaccine policy change from oral polio vaccine to inactivated polio vaccine. One hundred and seventy-nine enteroviruses were isolated from the 3394 stool specimens investigated between 1992 and December 2012. Fifty-six out of 107 virus isolates were polioviruses and the remaining were non-polio enteroviruses. Since 2009 after the sequential introduction of IPV in the childhood immunization programme, no Sabin polioviruses were isolated from AFP cases. In 2012, the laboratory AFP surveillance was supplemented with environmental surveillance with sewage sampling. Thirteen Sabin polioviruses were also isolated from sewage in the same year, but no vaccine-derived poliovirus was detected during this period.
Potential Health And Economic Impact Of Introducing A Dengue Vaccine In Malaysia: Assessment Using Dynamic Transmission Modelling

Yeo HY, Shafie AA, Coudeville L, Steinberg LD, Gill BS, Jahis R

Value Health, 2015 Nov;18(7):A582.
PMID: 26533272 DOI: 10.1016/j.jval.2015.09.1949
The Potential Cost Effectiveness of Different Dengue Vaccination Programmes in Malaysia: A Value-Based Pricing Assessment Using Dynamic Transmission Mathematical Modelling

Shafie AA, Yeo HY, Coudeville L, Steinberg L, Gill BS, Jahis R, et al.

Pharmacoeconomics, 2017 May;35(5):575-589.
PMID: 28205150 DOI: 10.1007/s40273-017-0487-3

BACKGROUND: Dengue disease poses a great economic burden in Malaysia.
METHODS: This study evaluated the cost effectiveness and impact of dengue vaccination in Malaysia from both provider and societal perspectives using a dynamic transmission mathematical model. The model incorporated sensitivity analyses, Malaysia-specific data, evidence from recent phase III studies and pooled efficacy and long-term safety data to refine the estimates from previous published studies. Unit costs were valued in $US, year 2013 values.
RESULTS: Six vaccination programmes employing a three-dose schedule were identified as the most likely programmes to be implemented. In all programmes, vaccination produced positive benefits expressed as reductions in dengue cases, dengue-related deaths, life-years lost, disability-adjusted life-years and dengue treatment costs. Instead of incremental cost-effectiveness ratios (ICERs), we evaluated the cost effectiveness of the programmes by calculating the threshold prices for a highly cost-effective strategy [ICER <1 × gross domestic product (GDP) per capita] and a cost-effective strategy (ICER between 1 and 3 × GDP per capita). We found that vaccination may be cost effective up to a price of $US32.39 for programme 6 (highly cost effective up to $US14.15) and up to a price of $US100.59 for programme 1 (highly cost effective up to $US47.96) from the provider perspective. The cost-effectiveness analysis is sensitive to under-reporting, vaccine protection duration and model time horizon.
CONCLUSION: Routine vaccination for a population aged 13 years with a catch-up cohort aged 14-30 years in targeted hotspot areas appears to be the best-value strategy among those investigated. Dengue vaccination is a potentially good investment if the purchaser can negotiate a price at or below the cost-effective threshold price.
Applying a Constrained Optimization Portfolio Model to Aid Prioritization of Public Health Interventions in Malaysia

Varghese L, Ezat Wan Puteh S, Schecroun N, Jahis R, Van Vlaenderen I, Standaert BA

Value Health Reg Issues, 2020 May;21:172-180.
PMID: 32044690 DOI: 10.1016/j.vhri.2019.11.001

OBJECTIVES: Countries have constrained healthcare budgets and must prioritize new interventions depending on health goals and time frame. This situation is relevant in the sphere of national immunization programs, for which many different vaccines are proposed, budgets are limited, and efficient choices must be made in the order of vaccine introduction.
METHODS: A constrained optimization (CO) model for infectious diseases was developed in which different intervention types (prophylaxis and treatment) were combined for consideration in Malaysia. Local experts defined their priority public health issues: pneumococcal disease, dengue, hepatitis B and C, rotavirus, neonatal pertussis, and cholera. Epidemiological, cost, and effectiveness data were informed from local or regionally published literature. The model aimed to maximize quality-adjusted life-year (QALY) gain through the reduction of events in each of the different diseases, under budget and intervention coverage constraints. The QALY impact of the interventions was assessed over 2 periods: lifetime and 20 years. The period of investment was limited to 15 years.
RESULTS: The assessment time horizon influenced the prioritization of interventions maximizing QALY gain. The incremental health gains compared with a uninformed prioritization were large for the first 8 years and declined thereafter. Rotaviral and pneumococcal vaccines were identified as key priorities irrespective of time horizon, hepatitis B immune prophylaxis and hepatitis C treatment were priorities with the lifetime horizon, and dengue vaccination replaced these with the 20-year horizon.
CONCLUSIONS: CO modeling is a useful tool for making economically efficient decisions within public health programs for the control of infectious diseases by helping prioritize the selection of interventions to maximize health gain under annual budget constraints.
Fulltext Development and validation of a cognitive, affective and behaviour questionnaire on pet-associated zoonotic diseases (CAB-ZDQ)

Yong TSM, Panting AJ, Juatan N, Perialathan K, Ahmad M, Ahmad Sanusi NH, et al.

Vet Med Sci, 2021 Sep;7(5):1558-1563.
PMID: 34137200 DOI: 10.1002/vms3.547

BACKGROUND: Zoonoses among household pets are recognized as disease and infections transmitted between animals and humans. World Health Organization-estimated zoonotic diseases have contributed about one billion cases of illness and millions of mortalities every year. Despite the emerging and re-emerging zoonotic disease, most pet owners are unaware of the risks posed by their pets. As there are a lack of studies assessing infections at home, this study aimed to develop and validate a cognitive, affective and behaviour questionnaire (CAB-ZDQ) to assess household pets' zoonotic diseases.
METHODS: This paper covers detailed explanation on the various developmental and validation process stages of the CAB zoonotic disease questionnaire development. The development phase comprised thorough literature search, focus group discussion, expert panel assessment and review. The validation process included pre-test and pilot testing, data analysis of results, analysis of internal consistency and the development of the final version of the questionnaire. Participants selected represented main ethnicities, gender, levels of education and population type (urban/rural) in the Klang Valley area.
RESULTS: The items in the questionnaire has undergone various changes in structurally and linguistically. The final refined CAB questionnaire consists of 14 items cognitive (no items removed at pilot phase), nine items affective (one item removed at pilot phase) and five items behaviour (no items removed from pre-test phase), respectively. Reliability analysis revealed Cronbach's alpha values were 0.700 (cognitive) and 0.606 (affective) which indicated good internal consistency after item reduction.
CONCLUSIONS: The developed questionnaire has proved its feasibility in assessing the Malaysian general population cognitive, affective and behavior regarding the household pets' zoonotic diseases.
Historical epidemiology of hepatitis C virus in select countries-volume 4

Maaroufi A, Vince A, Himatt SM, Mohamed R, Fung J, Opare-Sem O, et al.

J Viral Hepat, 2017 10;24 Suppl 2:8-24.
PMID: 29105285 DOI: 10.1111/jvh.12762

Due to the introduction of newer, more efficacious treatment options, there is a pressing need for policy makers and public health officials to develop or adapt national hepatitis C virus (HCV) control strategies to the changing epidemiological landscape. To do so, detailed, country-specific data are needed to characterize the burden of chronic HCV infection. In this study of 17 countries, a literature review of published and unpublished data on HCV prevalence, viraemia, genotype, age and gender distribution, liver transplants and diagnosis and treatment rates was conducted, and inputs were validated by expert consensus in each country. Viraemic prevalence in this study ranged from 0.2% in Hong Kong to 2.4% in Taiwan, while the largest viraemic populations were in Nigeria (2 597 000 cases) and Taiwan (569 000 cases). Diagnosis, treatment and liver transplant rates varied widely across the countries included in this analysis, as did the availability of reliable data. Addressing data gaps will be critical for the development of future strategies to manage and minimize the disease burden of hepatitis C.
The present and future disease burden of hepatitis C virus infections with today's treatment paradigm: Volume 4

Chan HLY, Chen CJ, Omede O, Al Qamish J, Al Naamani K, Bane A, et al.

J Viral Hepat, 2017 10;24 Suppl 2:25-43.
PMID: 29105283 DOI: 10.1111/jvh.12760

Factors influencing the morbidity and mortality associated with viremic hepatitis C virus (HCV) infection change over time and place, making it difficult to compare reported estimates. Models were developed for 17 countries (Bahrain, Bulgaria, Cameroon, Colombia, Croatia, Dominican Republic, Ethiopia, Ghana, Hong Kong, Jordan, Kazakhstan, Malaysia, Morocco, Nigeria, Qatar and Taiwan) to quantify and characterize the viremic population as well as forecast the changes in the infected population and the corresponding disease burden from 2015 to 2030. Model inputs were agreed upon through expert consensus, and a standardized methodology was followed to allow for comparison across countries. The viremic prevalence is expected to remain constant or decline in all but four countries (Ethiopia, Ghana, Jordan and Oman); however, HCV-related morbidity and mortality will increase in all countries except Qatar and Taiwan. In Qatar, the high-treatment rate will contribute to a reduction in total cases and HCV-related morbidity by 2030. In the remaining countries, however, the current treatment paradigm will be insufficient to achieve large reductions in HCV-related morbidity and mortality.
Strategies to manage hepatitis C virus infection disease burden-Volume 4

Chen DS, Hamoudi W, Mustapha B, Layden J, Nersesov A, Reic T, et al.

J Viral Hepat, 2017 10;24 Suppl 2:44-63.
PMID: 29105286 DOI: 10.1111/jvh.12759

The hepatitis C virus (HCV) epidemic was forecasted through 2030 for 17 countries in Africa, Asia, Europe, Latin America and the Middle East, and interventions for achieving the Global Health Sector Strategy on viral hepatitis targets-"WHO Targets" (65% reduction in HCV-related deaths, 90% reduction in new infections and 90% of infections diagnosed by 2030) were considered. Scaling up treatment and diagnosis rates over time would be required to achieve these targets in all but one country, even with the introduction of high SVR therapies. The scenarios developed to achieve the WHO Targets in all countries studied assumed the implementation of national policies to prevent new infections and to diagnose current infections through screening.