Greetings partners and colleagues,

While the previous issue of Rotavirus Update brought you news on global commitments to fight rotavirus from key partners including the GAVI Alliance, this edition highlights recent events that are spurring regional momentum. As one of the regions GAVI tapped as eligible for support in 2008, Eastern Europe is at the forefront of considering the impact immunization can have on rotavirus morbidity. At a workshop hosted by the Republic of Georgia’s Ministry of Labor, Health, and Social Affairs last month, we saw enthusiasm grow for use of rotavirus vaccines, along with a renewed commitment to addressing diarrheal disease control through an integrated approach at both regional and national levels.

Likewise, partnerships are critical elements of success in Latin America. Rotavirus vaccine programs in some countries are now more than a year old, and we are beginning to see the impact of these achievements, including recent global recognition of an innovative demonstration project in Nicaragua.

We are energized by the dedication of our partners in Eastern Europe and Latin America and look forward to continuing our work together to reduce rotavirus and diarrheal disease burden. Lessons learned from such collaborations will be crucial as we look ahead toward accelerating access to rotavirus vaccines on a global scale.

Sincerely,

John R. Wecker, PhD

Director, PATH Rotavirus Vaccine Program

February 2008

In this Issue

Workshop informs diarrheal disease control planning in Eastern Europe

Advisory panel recommends Rotarix® licensure in US

US government acknowledges Merck contributions to public health in Nicaragua

Announcing the 8th International Rotavirus Symposium; Call for abstracts

Moldova joins European Rotavirus Surveillance Network

New staff join PATH to advance control of diarrheal disease and cervical cancer

PATH resources summarize diarrheal disease control interventions

Partner Profile: Noguchi Memorial Institute for Medical Research, Ghana

New resource to assist countries applying for GAVI support of rotavirus vaccines

Rotavirus resources

 

Workshop informs diarrheal disease control planning in Eastern Europe

Child health experts and immunization program managers from Eastern Europe and Central Asia discussed new opportunities for controlling diarrheal disease at a two-day workshop in Tbilisi, Georgia, sponsored by PATH in partnership with the Republic of Georgia’s Ministry of Labor, Health, and Social Affairs and the Curatio International Foundation. Health officials from Kyrgyzstan, Ukraine, Uzbekistan, Armenia, Azerbaijan, Moldova, Tajikistan, and Georgia discussed the burden of diarrheal disease in their own countries and summarized existing control strategies. Representatives from UNICEF, the World Health Organization (WHO), the GAVI Alliance, and PATH presented regional morbidity and mortality data, along with evidence on zinc treatment, low-osmolarity oral rehydration solution, and rotavirus vaccines as critical tools for an integrated approach to enhance diarrheal disease control.

PATH is now working with the Georgian MOH to develop a national diarrheal disease control plan, and the workshop opened the door to future collaborations with other countries interested in developing or updating control plans, introducing rotavirus vaccines, or accelerating uptake of other interventions.

Advisory panel recommends Rotarix® licensure in US

The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation this week that the US Food and Drug Administration (FDA) approve GlaxoSmithKline’s application for licensure of Rotarix® for use in the US.

The panel’s recommendation followed a review of data from clinical trials on the safety and efficacy of Rotarix®. The FDA should make its ultimate decision on Rotarix® licensure in the US within the coming weeks. The other currently available rotavirus vaccine, RotaTeq® manufactured by Merck & Co., Inc., received FDA approval in 2006.

US government acknowledges Merck contributions to public health in Nicaragua

In recognition of an innovative partnership with the Nicaraguan MOH to introduce RotaTeq®, the US State Department selected Merck & Co., Inc., as a finalist for its 2007 Award for Corporate Excellence (ACE). Representatives from project partners including the Pan American Health Organization, NicaSalud, UNICEF, the Nicaraguan Pediatric Society, and PATH attended a ceremony to acknowledge the nomination, held at the US embassy in Managua on February 8, 2008.

The vaccine’s launch on October 27, 2006, made Nicaragua the first GAVI-eligible country to introduce rotavirus vaccine and marked the first time a vaccine was introduced in the public sector of a developing country during the same year it was introduced in the industrialized world. Historically, it has taken up to 15 years for new vaccines to reach the world’s poorest countries.

Announcing the 8th International Rotavirus Symposium; Call for abstracts

The 8th International Rotavirus Symposium will bring together public health professionals, ministry officials, and representatives from industry and the donor community to provide updates on clinical trials of new rotavirus vaccines, early post-marketing data on vaccine impact and safety, issues in vaccine policy and introduction, and other relevant topics. The symposium will be held June 3 to 4, 2008, at the Sheraton Istanbul Maslak Hotel in Istanbul, Turkey. Registration details and other relevant information, including a working agenda and session abstracts, will soon be posted at http://www.rotavirus2008.com (under construction).

The Scientific Organizing Committee is now accepting abstracts for posters relevant to rotavirus, rotavirus vaccines, and rotavirus vaccine introduction. Click here for guidelines. Submissions should be sent to mailto:rvpinfo@path.org.

Moldova joins European Rotavirus Surveillance Network

Representatives from PATH and the WHO Europe regional office recently visited Moldova to establish rotavirus surveillance and generate data for officials to consider regarding a potential application to GAVI for vaccine introduction support. The Children’s Infectious Disease Hospital in Chisinau will establish sentinel surveillance, with diagnostic support from the national polio laboratory. With the initiation of these activities, Moldova became the seventh country in the European Rotavirus Surveillance Network, with activities supported by the US Centers for Disease Control and funding provided by the PATH Rotavirus Vaccine Program. Click here to read more about the European Rotavirus Surveillance Network.

New staff join PATH to advance control of diarrheal disease and cervical cancer

Two key staff members recently joined PATH to bring their experience to new initiatives. Dr. Duncan Steele joined PATH as a technical advisor on projects to develop vaccines against enteric diseases and rotavirus. Most recently a scientist with the WHO Department of Immunization, Vaccines, and Biologicals, where he served as primary liaison and advisor for PATH’s Rotavirus Vaccine Program, Dr. Steele has worked in various fields of diarrheal disease control since the early 1980s.

Dr. Juan José Amador joined PATH’s Nicaragua office as Director of Technology and Health Systems for the START-UP project, aimed at creating sustainable cervical cancer treatment programs in low-resource countries. Prior to joining PATH, Dr. Amador worked for the Nicaraguan MOH as National Director of Epidemiology. His leadership was instrumental in reinvigorating diarrheal disease control strategies, including the successful introduction of RotaTeq® in Nicaragua in October 2006.

PATH resources summarize diarrheal disease control interventions

A new set of fact sheets from PATH aims to raise awareness about new and established tools to fight rotavirus and other causes of diarrheal disease in the world's poorest countries. Click the title below to access a fact sheet on each intervention:

Rotavirus Vaccines

Oral Rehydration Therapy/Oral Rehydration Solution

Zinc Treatment for Diarrhea

Breastfeeding and Diarrhea

Partner Profile: Noguchi Memorial Institute for Medical Research, Ghana

An avid investigator of rotavirus for more than 25 years, Dr. George Armah hopes that his own drive is reflected in the momentum of future policy decisions on rotavirus vaccines in Africa. Such policies will be boosted by data from critical studies including the one he directs on behalf of PATH and Merck to evaluate RotaTeq® in Ghana. Above all, he would like to see his team’s work ease the burden of parents traveling miles on bicycle or by foot to seek treatment for their ailing children. Prevention with rotavirus vaccines as could be an important solution.

Dr. Armah’s initial work with rotaviruses focused on strain identification and epidemiology, eventually leading to his post as co-investigator and researcher on immunogenicity studies of rotavirus vaccines manufactured by Wyeth and GSK. In mid-2006, PATH partnered with the Noguchi Memorial Institute for Medical Research, University of Ghana, where Dr. Armah leads a team of researchers at the Navrongo Health Research Centre to evaluate the safety and efficacy of RotaTeq® among infants. The partnership allows the site to build capacity in human resources and research skills, and in turn the investigators are contributing crucial data to not only inform the use of rotavirus vaccines in Ghana but also to benefit the global public health community. The trial’s enrollment is now complete, and the site is actively participating in subject follow-up visits. Dr. Armah expects study results by the end of 2009.

New resource to assist countries applying for GAVI support of rotavirus vaccines

Developed by PATH in partnership with GAVI and WHO, Introduction of rotavirus vaccine with support from the GAVI Alliance: Information to assist the national decision-making and application process summarizes scientific evidence and operational guidelines for introducing rotavirus vaccines. As a supplement to GAVI’s detailed guidelines, the document aims to support decision-making by GAVI-eligible countries in the WHO European region and provides information on the burden of rotavirus disease; efficacy, safety, and cost-effectiveness of available rotavirus vaccines; eligibility criteria; application procedures; co-financing requirements; and health system considerations.

The information pack is also available in Russian, and updates will be posted on GAVI’s website in accordance with new information and GAVI decisions on eligibility in other WHO regions.

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.

Questions or comments about the PATH Rotavirus Vaccine Program? Contact us at rvpinfo@path.org.

Masthead photo by Richard Lord.

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