The past few weeks have been remarkable in terms of advancing the agenda to make rotavirus vaccines available to children in developing countries who will benefit from their lifesaving potential. The bold decision by the GAVI Alliance Board to approve investment cases for rotavirus and pneumococcal vaccines last month set the standard for access to new vaccines and changed the global immunization landscape forever.

It has been a pleasure and a privilege for me to work with our partners at the WHO and the CDC in developing the investment case for rotavirus vaccines, as well as to collaborate with the GAVI Working Group, the Independent Review Committee, and the ADIP Management Committee. These discussions provided invaluable insights that will help the Rotavirus Vaccine Program to further hone our vision while keeping close tabs on the activities that will support accelerated and streamlined introduction of rotavirus vaccines for the children who need them most. The experience and expertise of our collaborators will continue to inform our strategy and objectives as we move ahead, including a focus on establishing the systems and policies necessary to appropriately conduct post-marketing surveillance and to evaluate the impact of introduction.

I would like to personally acknowledge the collaborative efforts of the RVP team and, as well, to thank the members of the GAVI Secretariat and the GAVI Board for their tremendous contributions and dedication to this most worthy cause.

Sincerely,

John R. Wecker, PhD

Director, PATH Rotavirus Vaccine Program

December 2006

In this Issue

Developing country officials weigh in on GAVI support for rotavirus vaccines

New support from GAVI enables RVP to gather critical evidence in Africa and Asia

Spotlight on reference centers to support global rotavirus surveillance

Enrollment begins in trial to determine Rotarix® efficacy and safety in Africa

RVP to present updates at 2007 Vaccines for Enteric Diseases conference

Bond sales to accelerate support for new vaccines and system strengthening

Review of surveillance data in US confirms safety profile of Merck's rotavirus vaccine

Rotavirus resources

Developing country officials weigh in on GAVI support for rotavirus vaccines

The GAVI Alliance Board's unanimous decision last month to subsidize funding for rotavirus and pneumococcal vaccines will have a significant impact on the health of children in developing countries, beginning as soon as 2008. Officials in these countries shared their reactions to this landmark advancement:

"The Health Ministry of Uzbekistan applauds GAVI's funding for the vaccines against rotavirus and pneumococcal diseases. These much needed vaccines will protect our children and allow us to reduce [our country's] mortality rate." - Mr. B.I. Niyazmatov, Deputy Minister of Health, Republic of Uzbekistan

"Guyana is determined to introduce these new vaccines into our routine program, and we are grateful that GAVI has included the two vaccines for funding. With GAVI's continued support, further inroads in infant morbidity and mortality can be achieved. Guyana looks forwards to being a pioneer country in this respect." - Dr. Leslie Ramsammy, Minister of Health, Guyana

"The decision of GAVI to fund rotavirus and pneumococcal vaccines for our country will help to protect Ukrainian children and give them new life." - Dr. Lyudmila Mukharskaya, Deputy Chief Sanitary Doctor, Ukraine

Click here to learn more about this landmark decision.

New support from GAVI enables RVP to gather critical evidence in Africa and Asia

Earlier this year, the GAVI Alliance awarded $15 million to the Rotavirus Vaccine Program (RVP) to advance the clinical trials agenda for rotavirus vaccines produced by GlaxoSmithKline (GSK) and Merck & Co, Inc. Ongoing trials and upcoming studies, conducted in collaboration with GSK and Merck, will evaluate the vaccines' efficacy and safety among pediatric populations in Africa and Asia and will provide fundamental information regarding the value of rotavirus vaccines in these settings.

Spotlight on reference centers to support global rotavirus surveillance

The latest issue of Rotavirus Surveillance News, published by the US CDC, provides an overview of the Rotavirus Collaborating Centers and Reference Centers supported by RVP. These essential resources provide consultation and training on strain characterization, laboratory diagnostics, and other standard procedures for scientists conducting active rotavirus surveillance around the world. To date, laboratory personnel from more than 35 countries have received training and other support from the five centers. Center directors are also finalizing a unified laboratory manual for use in the field. To learn more, read the latest issue online.

Enrollment begins in trial to determine Rotarix® efficacy and safety in Africa

On October 17, 2006, investigators in Malawi initiated enrollment for a clinical trial supported by RVP and GSK to determine the safety and efficacy of Rotarix®. As part of the same clinical trial, enrollment in South Africa was reinitiated in November 2006, where more than 1,800 infants have been enrolled to date.

Rotarix® is orally administered and, historically, these types of vaccines have performed differently in different regions of the world. Large-scale trials of Rotarix® in North and South America affirmed their safety and efficacy among these populations. However, the WHO's Strategic Advisory Group of Experts recommended that new rotavirus vaccines should also be studied among infants in Asia and Africa, where the burden of rotavirus disease is very high.

RVP to present updates at 2007 Vaccines for Enteric Diseases conference

Next year's Vaccines for Enteric Diseases conference will feature presentations by RVP staff and partners on the growing evidence of the value of rotavirus vaccines in developing countries.

·    "Achievements and challenges in accelerating rotavirus vaccine use in developing countries" Dr. John Wecker, PATH

·    "Rotavirus vaccine presentation and packaging-operational implications for developing countries" Dr. Robin Biellik, PATH

·    "The experience of the RotaADIP in mobilizing demand and resources for vaccines" Dr. Deborah Atherly, PATH

·    "Vaccine research and development for diarrhoeal diseases: WHO's perspective" Dr. Duncan Steele, WHO

·    "New WHO estimates of global mortality from rotavirus disease" Dr. Umesh Parashar, CDC

·    "Networks for global surveillance of rotavirus disease" Dr. Mark-Alain Widdowson, CDC

·    "Rotavirus vaccines: Present status and future challenges" Dr. Roger Glass, National Institutes of Health

Click here for registration information and to view a complete meeting agenda.

Bond sales to accelerate support for new vaccines and system strengthening

The International Finance Facility for Immunisation (IFFIm) issued its inaugural bonds last month, kicking off an innovative scheme to accelerate funding for vaccination programs in the world's poorest countries. IFFIm is the latest in groundbreaking strategies spearheaded by the GAVI Alliance to accelerate delivery of lifesaving interventions to benefit the world's children. Through this new initiative, immediate financing for national immunization programs in developing countries will be raised by selling bonds in the international capital markets, based on legally-binding long term commitments from donors-including the governments of Britain, France, Italy, Norway, Spain, and Sweden. Click here to learn more.

Review of surveillance data in US confirms safety profile of Merck's rotavirus vaccine

During their meeting on October 25 and 26, 2006, the US Advisory Committee on Immunization Practices reviewed early surveillance data on the safety of RotaTeq®. As of September 30, 2006, nearly 1.8 million doses of the vaccine had been distributed, and the estimated incidence of intussusception (six reported cases total) was lower than the expected background rate, even after accounting for underreporting. CDC will continue to collect data on intussusception and other adverse events through its Vaccine Safety Datalink and Vaccine Adverse Event Reporting System. Click here to view a presentation of surveillance data provided by Penina Haber, epidemiologist of the CDC's Immunization Safety Office.

Rotavirus resources

Rotavirus Surveillance News, November 2006

"New Hope for Defeating Rotavirus," Scientific American

PATH rotavirus resource library

Rotavirus Vaccine Program website

CDC rotavirus page

WHO rotavirus page

PATH/UNICEF Enhanced Diarrheal Disease Control Resource Center

 The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.