In this issue:   

 

 

Vol. 11, May 2009

 

 

Greetings partners,

 

Welcome to the latest highlights regarding partners’ efforts to control JE in communities at highest risk. Critical activities continue in several countries, including the development of plans in Bangladesh and Vietnam to expand surveillance, and the progression of mass vaccination campaigns in India to introduction in routine JE immunization. Lessons learned from each country’s experience will make valuable contributions to future efforts throughout the regions affected by JE, and we look forward to hearing more about the accomplishments and challenges as partners convene at the fourth Biregional Meeting on JE in Bangkok next month.

 

Momentum to expand JE immunization continues to grow, and it is critical that technical assistance and partnership remain available to all countries that seek to loosen the grip of JE on their populations. To answer this need, a new coalition for JE control continues to set its agenda and develop strategies beyond the life of the PATH JE project. It is heartening to see this important work move forward, as such collaboration is a testament to the broad commitment to seek an end to suffering caused by this neglected and terrible disease.

 

 

Sincerely,

Dr. John R. Wecker
Director, PATH’s JE Project
jeproject@path.org

 

Coalition of partners to maintain momentum of JE control

 

With PATH’s JE project entering its last few months of activity, a new and exciting partnership has emerged to sustain the momentum of JE control. A coalition for JE control has arisen from the combined efforts and commitments of the World Health Organization (WHO), the US Centers for Disease Control and Prevention, the United Nations Children’s Fund (UNICEF), PATH, and others to continue the advocacy, immunization, and surveillance activities needed to protect Asia’s children against death and disability from JE.

 

PATH’s JE project, funded by the Bill & Melinda Gates Foundation, has led crucial work in JE-endemic countries since its inception in 2003, including raising awareness of the disease and its effects; helping countries bring safe, affordable, lifesaving vaccines to at-risk children; and increasing the quality and availability of surveillance data.

 

These key activities will be continued by the coalition with the close of the PATH JE project in October 2009. All coalition partners are committed to sustaining the substantial progress of JE-endemic countries in enhancing their children’s quality of life through effective JE control and prevention.

 

On February 17, 2009, a sub-group of the future members of the coalition gathered in New York City at the WHO/UNICEF Global Immunization Meeting. The eventual location, staffing, funding, and terms of reference for a coalition secretariat were discussed. A leadership transition plan is in development to ensure the momentum of JE control is maintained as the new WHO-led coalition secretariat begins its vital work.

 

The coalition for JE control will meet next on June 10, 2009, with the goal of finalizing the coalition’s terms of reference, and the location and staffing of the coalition secretariat.

 

India prepares to combat JE in 2009 with campaigns and routine immunization

 

In partnership with the Government of India, PATH recently hosted JE vaccination planning workshops in Lucknow and Chennai to prepare for campaigns throughout the country, targeted to reach almost 26 million children this year.

 

Routine immunization was also a major topic for discussion. Districts participating in the successful immunization of nearly 44.2 million children in vaccination campaigns from 2006 to 2008 will transition to routine immunization of 1- to 2-year-old children beginning in 2009. This is a significant milestone for India and program officers addressed a number of logistical issues, including vaccine supply management, calculation of target population, and cold chain management. Discussion of preparations for the 2009 campaigns mirrored these considerations and also addressed the reporting and management of adverse events following immunization, vaccine vial monitor use and interpretation, and timing and resources needed for successful implementation.

 

The JE project salutes PATH’s India team for assisting the states and districts as they gained experience through several years of large-scale vaccination campaigns. The team’s hard work, coupled with the Government of India’s commitment to protecting its children from JE, set the stage for this important transition in immunization delivery.

 

CDIBP proceeds with commissioning of new JE vaccine production facility

 

The commissioning of the new JE vaccine production facility is progressing at the Chengdu Institute of Biological Products (CDIBP), with no critical issues emerging to date. Austar, a pharmaceutical and life sciences company based in China, is writing the commissioning protocols, performing the tests, and will write the final commissioning reports.

 

After Austar completes the commissioning process, French engineering firm Technip will conduct the Installation Qualification/Operational Qualification (IQ/OQ) in accordance with WHO requirements. The completion of IQ/OQ is expected by September 2009. CDIBP, Austar, and Technip are working hand-in-hand to ensure the success of this major step toward WHO prequalification of the SA 14-14-2 JE vaccine.

 

The next phase of the process is the Performance Qualification/Process Validation, which prepares a series of vaccine lots to demonstrate consistency in production—an exciting step closer to the submission of the vaccine’s prequalification file on schedule in September 2010.

 

2009 Biregional Meeting on JE announced for June 8–9 in Bangkok

 

The WHO Southeast Asia Regional Office has announced the fourth Biregional Meeting on Control of Japanese Encephalitis, slated for June 8–9, 2009, in Bangkok, Thailand. The Biregional Meeting is held every other year to bring together participants from partner organizations, WHO offices, and JE-endemic countries in the WHO’s Southeast Asia and Western Pacific regions to discuss progress and planning toward JE control and prevention.

 

Over 80 participants will attend sessions on disease burden, diagnostics, and vaccines, exchanging experiences with country-specific disease surveillance and vaccine introduction activities. Countries will have the opportunity to work on their priorities and planning for the next two years.

 

This gathering takes on special significance this year as PATH’s JE project reaches completion in October. PATH’s JE project is pleased to add its effort to those of WHO and the committed scientists and policymakers in JE-endemic countries to make the 2009 Biregional Meeting a successful recognition not only of the striking progress already made to understand and prevent JE, but also the promising future of JE control.

 

Bangladesh meeting explores JE prevention and control

 

The Consultative Meeting on JE Prevention and Control was convened by the Institute of Epidemiology, Disease Control and Research (IEDCR) in Dhaka, Bangladesh, on February 12. Participants included a broad array of Bangladesh government officials from the Directorate General of Health Services, Expanded Program on Immunization IEDCR, the Institute of Public Health, and the National Drug Administration, as well as representatives from international organizations like the International Center for Diarrheal Diseases Research–Bangladesh, PATH, UNICEF, and WHO.

 

The meeting featured an overview of the national and regional situation of JE, as well as information on the safety and efficacy of currently available vaccines. Discussions resulted in a number of specific recommendations in support of future decision-making about JE vaccine introduction in Bangladesh, including convening policymakers to discuss JE control measures, expanding knowledge of JE disease burden and epidemiology, articulation of vaccine regulatory and financial mechanisms, and coordinating with neighboring countries. Participants also recommended the development of a strategic plan for JE control in Bangladesh that called on the combined efforts of all partners to identify and close existing gaps. 

 

Vietnam considers expansion of JE surveillance

 

The Government of Vietnam has committed to maintaining the current sentinel surveillance sites set up in collaboration with PATH, and is considering phased extension of JE surveillance. In 2008, the central province of Quang Ngai joined the original provinces of the JE surveillance system—Thai Binh in the north and Binh Duong in the south. This trio of sites recorded 30 JE-positive cases between 2006 and 2008, allowing for a better understanding of the disease burden of the country.

 

Vietnam’s JE surveillance plan will be finalized with the input of national and regional EPI technical experts, and PATH is prepared to provide necessary technical support for the Government of Vietnam if the surveillance system is expanded.

 

Intercell’s IC51 JE vaccine for travelers gains regulatory approvals

 

In early April 2009, the European Commission approved IC51, Intercell’s purified, inactivated vaccine against JE virus, successfully completing the series of three simultaneous regulatory filings for the vaccine in Australia, the United States, and the European Union (EU). IXIARO is the first JE vaccine ever approved in the EU, and the ruling authorizes the formal marketing of the vaccine in all EU member states, as well as Norway and Iceland.

 

Intercell had only recently gained product approvals from both the Australian Therapeutic Goods Administration and the United States Food and Drug Administration (FDA).

The Australian approval in January 2009—the vaccine’s first—cleared the way for immunization of Australian military personnel and travelers to JE-endemic areas. Distributed and marketed by CSL Biotherapies Pty Ltd. as JESPECT, it is the only registered JE vaccine currently available in the Australian market.

 

The US FDA announced approval of IC51 in March 2009 as IXIARO, which will be promoted and distributed by Novartis Vaccines and Diagnostics to the US civilian market, while Intercell will market and distribute directly to the US military. Commercial launch of IXIARO in the US is slated for the second quarter of 2009, and pediatric trials are ongoing.

 

The IC51 vaccine was developed by Intercell over 10 years under a collaborative agreement with the Walter Reed Army Institute of Research, and will provide protection against JE to Australian, US, and European travelers to JE-endemic areas of Asia.

 

Recent publications consider surveillance, disability, and partnerships

 

Recent articles present a wide range of topics from country research on JE in Cambodia and Indonesia to a new JE vaccine and how partnerships can address global immunization needs. For nonsubscribers in developing countries, the articles may be freely accessible through the WHO’s Health InterNetwork Access to Research Initiative (HINARI).

 

A strategic plan for Japanese encephalitis control by 2015.

Elias C, Okwo-Bele JM, Fischer M. Lancet Infectious Diseases. 2009 Jan;9(1):7.

This letter of response to a Newsdesk feature provides a brief preview of the effort among international partners to develop a plan to control JE by 2015. Authors stress the need to work within country priorities while addressing key strategic activities.

 

Investing in vaccines for developing countries: how public-private partnerships can confront neglected diseases. (Abstract)

Yach M. Human Vaccines. 2009; 5(7):1–2.

Vaccine price remains a barrier to sustainable immunization programs in developing countries, and the author discusses new mechanisms to overcome these issues through public–private partnerships. The partnership between PATH and the Chengdu Institute of Biological Products is discussed as an example.

 

The rationale for integrated childhood meningoencephalitis surveillance: a case study from Cambodia.

Touch S, Grundy J. Hills S, et. al. Bulletin of the World Health Organization. 2009;87:320–324.

The authors demonstrate how linking sentinel JE surveillance to syndromic reporting systems can provide an accurate and credible disease burden estimate.

 

IC51: a new investigational Japanese encephalitis vaccine. Dr. Christoph Klade speaks to Duc Le, editor.

Klade CS. Expert Review of Vaccines. 2008;7(8):1139–1140.

Intercell’s Vice President for Technology Development and Clinical Immunology discusses the company’s new JE vaccine, including the vaccine’s (then) pending licensures, immunogenicity, and marketing and distribution.

 

Outcome and extent of disability following Japanese encephalitis in Indonesian children. (Abstract)

Maha MS, Moniaga VA, Hills SL, et al. International Journal of Infectious Diseases. 2009. [ePub ahead of print.]

Indonesian children diagnosed with lab-confirmed JE were evaluated using the Liverpool Outcome Score at a minimum of four months after their discharge from the hospital. One quarter of the children died, while another quarter experienced severe disability that would prevent them from living independently. The authors stress the need for prevention of the economic and social burdens of JE through immunization.

 

Partner profile: Cambodia Ministry of Health

 

The Ministry of Health (MOH), Royal Government of Cambodia, institutionalized in 1997, is solely responsible for all aspects of Cambodia’s health, including administering and managing health services. It is committed to ensuring sector-wide, equitable, quality health care for all the people of Cambodia through targeting resources, especially to the poor and to areas in greatest need. Under the Rectangular Strategy of the Royal Government of Cambodia, maternal and child health is a top priority.

 

PATH has been privileged to collaborate with the various arms of the MOH instrumental in Cambodia’s steady progress toward JE control. Under the leadership of Prof. Eng Huot, Secretary of State for Health, Prof. Sann Chan Soeung, National Immunization Program Manager, Dr. Sok Touch, Director of the Communicable Disease Control Department, and Dr. Ung Sam An, Director of the National Institute of Public Health, the MOH has established a surveillance system, estimated JE disease burden, and generated cost-effectiveness evidence that demonstrates JE is endemic in Cambodia, and which has informed Cambodia’s national decision-making to control Japanese encephalitis through immunization.

 

As the country continues to plan for JE immunization of all children at risk, the ministry can celebrate their many contributions to the future health of Cambodia’s children. 

 

Who’s who at PATH’S JE project: Pritu Dhalaria

 

Ask Dr. Pritu Dhalaria about his most memorable experiences with PATH’s JE project and he will demonstrate not only that he remembers every detail, but also that he has been a vital link in the exciting and complex JE project work in India.

 

From his early days as a surveillance officer with India’s National Polio Surveillance Project, through his move to PATH after widespread JE outbreaks in 2005, Dr. Dhalaria has developed exceptional skills in microplanning that have allowed him to assist state and district immunization program managers. His skills have been tested in a series of ambitious vaccination campaigns in India since 2006, which, although “very challenging,” have allowed the successful immunization of nearly 45 million children.

 

As PATH’s Associate Director of Immunization for India, Dr. Dhalaria led a team to help the Government of India navigate the complexities of vaccine studies, campaign planning and implementation, and vaccine procurement that led to the recent decision to begin routine immunization against JE in 2009. Even in the midst of so many vivid memories, Pritu’s satisfaction at that achievement is easy to hear.

 

JE resources


JE project web page   
www.path.org/je

 

JE on PATH’s Vaccine Resource Library
www.path.org/vaccineresources/japanese-encephalitis.php   

Japanese encephalitis online training module (AIM series)
http://aim.path.org/en/vaccines/je/index.html

 
WHO position paper on JE

www.path.org/vaccineresources/files/WHO_JE_position_paper_2006.pdf

 

Masthead photo: Richard Lord