Greetings partners and colleagues, As 2008 winds down, momentum to bring vaccines to the developing world is speeding up. We have seen the achievement of unprecedented milestones in the past couple of months, including the first announcement of country-level rotavirus vaccine introduction support from the GAVI Alliance. In addition, new global surveillance data illuminate the worldwide burden of rotavirus. These data and increasing detection rates of rotavirus underscore the need for vaccination in order to protect children from this resilient killer. The evidence base on rotavirus vaccines also continues to grow, and it will be boosted in early 2009 with the results of ongoing clinical trials in Africa and Asia. According to the World Health Organization (WHO), positive results could lead to a global recommendation on their use. A WHO global recommendation, along with two rotavirus vaccines approved for procurement by UNICEF and GAVI, and future rotavirus vaccine candidates heading into clinical trials, can help put global rotavirus control soon within our reach. The end of 2008 brings the end of regular activities for the PATH Rotavirus Vaccine Program (RVP). We are planning a commemorative issue of Rotavirus Update in the weeks to come, highlighting the partnerships that have made all achievements possible. Sincerely, John R. Wecker Director, PATH Rotavirus Vaccine Program	December 2008 In this Issue GAVI rotavirus vaccine introduction support expands to Nicaragua Expert group reviews data on rotavirus vaccine safety and efficacy in Africa Successful trial results could lead to global recommendation on use of rotavirus vaccines Enrollment underway for rotavirus vaccine effectiveness study in Bangladesh Study reveals RotarixTM is well tolerated among HIV-positive infants in South Africa Vietnam launches plans for renewed commitment to diarrheal disease control Rotavirus resources
GAVI rotavirus vaccine introduction support expands to Nicaragua The GAVI Alliance announced provision of support for rotavirus vaccine introduction to Nicaragua, which will allow the public sector to administer rotavirus vaccine to approximately 334,600 children. GAVI also announced support for pneumococcal vaccine introduction in Cameroon, Congo, and Yemen, while Armenia, Bhutan, Cambodia, Laos, and Sao Tome will receive support for introduction of a vaccine against Haemophilus influenzae type b (Hib). The decision follows an October board meeting at which GAVI committed to seek the US$3 billion necessary to continue existing programs and expand its portfolio of new vaccine support through 2015. Expert group reviews data on rotavirus vaccine safety and efficacy in Africa A recent meeting of the WHO’s Strategic Advisory Group of Experts (SAGE) featured an update on rotavirus disease and vaccines, including preliminary results of vaccine safety and efficacy trials in Africa. The trials, which PATH is sponsoring in collaboration with manufacturers GlaxoSmithKline (GSK) and Merck, will provide important data that speak to a previous SAGE recommendation that studies be conducted in these regions to inform a review of available data toward a global recommendation on the use of rotavirus vaccines. SAGE will review complete results in April 2009. A full report of the November 2008 meeting will soon be available on the SAGE website. Successful trial results could lead to global recommendation on use of rotavirus vaccines A recent summary of global rotavirus surveillance in the WHO’s Weekly Epidemiological Record emphasized the importance of data on epidemiology and burden of rotavirus disease for decision-makers considering vaccine introduction. Also essential for building an evidence base for review by country- and global-level officials are forthcoming data from clinical trials in Africa and Asia, which PATH is supporting in collaboration with the vaccine manufacturers. “If they demonstrate that the vaccine is efficacious,” states the article, “rotavirus vaccines might soon be recommended for global use by WHO.” Data generated through surveillance networks in all regions of the world not only provide information on existing disease burden, but they also provide a baseline for evaluating the future impact of routine rotavirus vaccination. Click here to read the full article. Enrollment underway for rotavirus vaccine effectiveness study in Bangladesh In late September, investigators at the International Centre for Diarrheal Disease Research, Bangladesh, in partnership with RVP, GSK, the Government of Bangladesh, and UNICEF, initiated a phase IV cluster-randomized effectiveness study of Rotarix^TM. The study will evaluate the population effectiveness of Rotarix^TM and its impact on reducing rates of hospitalization for acute diarrhea due to rotavirus. Study reveals RotarixTM is well tolerated among HIV-positive infants in South Africa Results from a phase II study of the safety and immunogenicity of Rotarix™ among HIV-infected infants in South Africa demonstrated that the vaccine was well tolerated and immunogenic when co-administered with routine childhood vaccines. Additionally, the rotavirus vaccine did not impact the clinical status of the HIV-positive infants. Presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, in October, the data add to a growing evidence base on rotavirus vaccines’ performance in Africa. Vietnam launches plans for renewed commitment to diarrheal disease control PATH and the Vietnam Ministry of Health (MOH) formally initiated an effort to strategize for diarrheal disease control. A day-long workshop brought together officials from a range of MOH divisions, pediatricians from national and provincial hospitals, and representatives from PATH, UNICEF, and the Pasteur Institute. Presentations provided an overview of the diarrheal disease burden in Vietnam and information about interventions for diarrheal disease control, as well as a summary of an Enhanced Diarrheal Disease Control Initiative (EDD) project in Kenya. Led by the Vice Minister of Health, the MOH and PATH will establish a technical working group to develop new national guidelines for diarrheal disease control, including the use of zinc treatment, low-osmolarity ORS, enteric vaccines, and the appropriate use of antibiotics. Development of the national strategy will be informed in part by an EDD demonstration project in the central province of Binh Dinh, where a community-based program will build awareness of interventions and train health care workers on proper management of diarrheal disease. Rotavirus resources PATH Vaccine Resource Library Rotavirus Vaccine Program website Enhanced Diarrheal Disease Control Resource Center PATH: Controlling diarrheal disease CDC rotavirus page WHO rotavirus page
The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.

Masthead photo by Richard Lord.

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