Rotavirus Update

Brazil to make rotavirus vaccine available in public sector
Breaking new ground in efforts to combat rotavirus, it was recently announced that Brazil will likely be the first country to introduce a rotavirus vaccine into the public sector, according to a report in Brazilian news publication O Estado de São Paulo. Beginning this December, the country will begin providing Rotarix®, the rotavirus vaccine manufactured by GlaxoSmithKline (GSK). This is a significant and exciting development, as the experiences of early-adopting countries will provide valuable lessons.

The Brazilian Ministry of Health purchased eight million doses from GSK, at a cost of US$7 per dose, to vaccinate the 3.3 million children born in Brazil annually. The vaccine will be given in two doses, with the first dose administered at two months of age and the second given at four months. The Ministry plans to ultimately produce the vaccine in Brazil, and the Butantan Institute, a state biomedical research center in São Paulo, signed a technology transfer agreement with the US National Institutes of Health for future production of the vaccine.

Special Supplement to Journal of Infectious Diseases highlights rotavirus in Asia
Advances in rotavirus vaccine development and surveillance were highlighted in a special supplement to the Journal of Infectious Diseases, "Rotavirus in Asia," published September 1, 2005. Studies reported upon the efforts of the Asian Rotavirus Surveillance Network, along with data addressing disease trends and the effect of rotavirus on the economies of Asian countries. Highlights of the data presented in the supplement include the following:

• According to new surveillance, rates of incidence in Asian children are higher than previously estimated. A study found that on average rotavirus causes 45 percent of hospitalizations for gastroenteritis among this population, an incidence that is twice as high as recorded in earlier studies.
  
  
• New estimates show that a universal Asian rotavirus immunization program could save US$118 million in the region's health care costs annually, averting 93,000 deaths and more than one million hospitalizations.
  
  
• Studies of rotavirus strains found a larger genetic diversity than previously believed. Future studies in this arena may help inform vaccine development and the evaluation of a vaccine's impact.
  
  
• For the first time, a current vaccine candidate was clinically tested in Asia. GSK's Rotarix® vaccine was studied in Singapore, and results showed it was highly effective and well tolerated. A clinical trial evaluating the immunogenicity and safety of Rotarix® in Bangladesh is underway in collaboration with PATH's Rotavirus Vaccine Program.

RVP clinical trial to test vaccine in Malawi
Beginning next year, RVP will evaluate the efficacy of a rotavirus vaccine in Malawi through clinical trials of the Rotarix® vaccine developed by GSK. RVP also supports ongoing disease burden and surveillance studies in Malawi, initiated in March 2005. The Rotarix® trial will be conducted in South Africa as well, with activities scheduled to be underway by the end of the year.

Dr. Kathy Neuzil, PATH's senior clinical advisor for vaccines, recently returned from Malawi, where investigators and partners are eager to move toward clinical trials. Dr. Neuzil joined PATH in August from the University of Washington Division of Allergy and Infectious Diseases, where she conducted burden of illness studies and clinical trials, focusing on vaccine-preventable diseases. While in Malawi, Dr. Neuzil and GSK representatives joined delegates from the University of Liverpool and the University of Malawi College of Medicine, PATH's partners in the clinical trial, to visit study sites and review infrastructure needs to be addressed prior to the study's initiation in February 2006.

Reference and training laboratory to support rotavirus surveillance in North Africa and Middle East
A new RVP-supported project will establish an interim regional reference and training laboratory for Northern Africa and the Middle East. The Naval Medical Research Unit-3 (NAMRU-3) in Cairo, Egypt, will coordinate the laboratory and provide quality control and quality assurance services in collaboration with the World Health Organization's Eastern Mediterranean Regional Office in Cairo. The laboratory's activities, including training on rotavirus detection and strain typing for scientists, will provide important resources for member countries initiating rotavirus surveillance for the regional network. Laboratory scientists from the Egyptian Ministry of Health (MOH) are scheduled for training during the next year, and the Egyptian MOH will assume responsibilities for coordinating the reference laboratory once this training is completed.

Collaboration among partners develops key positioning statement
The New Vaccines Meeting, held June 23 in Baltimore, brought together a variety of organizations leading efforts toward the development of vaccines for the developing world. PATH served as cosponsor for this event, which aimed to develop strong and consistent messages in making the case for new vaccines, and was attended by representatives from GAVI/Vaccine Fund, PneumoADIP, PAHO, WHO, USAID, and UNICEF. Participants developed a common positioning statement, "Healthier people with less infectious disease through vaccination," and created supporting messages aimed at target audiences such as investors, manufacturers, researchers, and advocacy groups.

© 2004-2005, Rotavirus Vaccine Program.