TY - JOUR
T1 - Rotavirus vaccines
T2 - Targeting the developing world
AU - Glass, Roger I.
AU - Bresee, Joseph S.
AU - Turcios, Reina
AU - Fischer, Thea K.
AU - Parashar, Umesh D.
AU - Steele, A. Duncan
N1 - Funding Information:
Rotavirus vaccines have been granted a high priority on the global agenda for the development and introduction of a new vaccine. GAVI has identified the development and introduction of rotavirus vaccines as 1 of 3 key priorities requiring increased attention. This priority will be promoted by the Rotavirus Vaccine Program, a $30-million-dollar effort funded for 3 years to achieve these goals. This program will accelerate the introduction of vaccines nearing licensure, with the specific goal of assessing whether these vaccines are safe and efficacious for children in the poorest countries, where support for the purchase of vaccine might be facilitated through the Vaccine Fund. Additional efforts will be needed to encourage work on vaccines in earlier stages of development, including those being prepared by emerging manufacturers in the developing world—in particular, in India, China, and Indonesia. A consortium of 4 organizations funded by the Bill and Melinda Gates Foundation and supported through the Program for Appropriate Technology in Health is working with an Indian manufacturer to develop the Indian neonatal vaccine as a first vaccine for India [41]. The goal of these efforts will ultimately be to demonstrate that the next generation of rotavirus vaccines can be safe, ef- fective, affordable, and available in a supply adequate to immunize up to 60% of the world’s children within a decade. This will require a massive effort, but quick, early, and visible reductions in the number of hospitalizations should help to accelerate rapid introduction of vaccine and encourage greater investment, increased supply, and lower cost. The challenge is considerable, and the effect should be measurable quickly, within 2–3 years.
PY - 2005/9/1
Y1 - 2005/9/1
N2 - For the past 2 decades, rotavirus infection, the most common cause of severe diarrhea in children, has been a priority target for vaccine development. This decision to develop rotavirus vaccines is predicated on the great burden associated with fatal rotavirus disease (i.e., 440,000 deaths/year), the firm scientific basis for developing live oral vaccines, the belief that increased investment in development at this time could speed the introduction of vaccines in developing countries, and the appreciation that implementation of a vaccine program should result in a measurable decrease in the number of hospitalizations and deaths associated with rotavirus disease within 2-3 years. RotaShield (Wyeth-Ayerst), the first rotavirus vaccine licensed in the United States, was withdrawn after 9 months because of a rare association of the vaccine with the development of intussusception. In the developing world, this vaccine could still have had a measurable effect, because the benefits of preventing deaths due to rotavirus disease would have been substantially greater than the rare risk of intussusception. Two live oral vaccines being prepared by GlaxoSmithKline and Merck have completed large-scale clinical trials. The GlaxoSmithKline vaccine has been licensed in Mexico and the Dominican Republic, and the Merck vaccine could be licensed in the United States within 1 year; several other candidate vaccines are in earlier stages of testing. However, many challenges remain before any of these vaccines can be incorporated into childhood immunization programs in the developing world. First, vaccine efficacy, which has already been demonstrated in children in industrialized and middle-income countries, needs to be proven in poor developing countries in Africa and Asia. The safety of vaccines with regard to the associated risk of intussusception must be demonstrated as well. Novel financing strategies will be needed to ensure that new vaccines are affordable and available in the developing world. Decision makers and parents in developing countries need to know about this disease that has little name recognition and is rarely diagnosed. Finally, for the global effort toward the prevention of rotavirus disease to be successful, special efforts will be required in India, China, and Indonesia, because one-third of all deaths due to rotavirus disease occur in these countries, and because these countries depend almost entirely on vaccines manufactured domestically.
AB - For the past 2 decades, rotavirus infection, the most common cause of severe diarrhea in children, has been a priority target for vaccine development. This decision to develop rotavirus vaccines is predicated on the great burden associated with fatal rotavirus disease (i.e., 440,000 deaths/year), the firm scientific basis for developing live oral vaccines, the belief that increased investment in development at this time could speed the introduction of vaccines in developing countries, and the appreciation that implementation of a vaccine program should result in a measurable decrease in the number of hospitalizations and deaths associated with rotavirus disease within 2-3 years. RotaShield (Wyeth-Ayerst), the first rotavirus vaccine licensed in the United States, was withdrawn after 9 months because of a rare association of the vaccine with the development of intussusception. In the developing world, this vaccine could still have had a measurable effect, because the benefits of preventing deaths due to rotavirus disease would have been substantially greater than the rare risk of intussusception. Two live oral vaccines being prepared by GlaxoSmithKline and Merck have completed large-scale clinical trials. The GlaxoSmithKline vaccine has been licensed in Mexico and the Dominican Republic, and the Merck vaccine could be licensed in the United States within 1 year; several other candidate vaccines are in earlier stages of testing. However, many challenges remain before any of these vaccines can be incorporated into childhood immunization programs in the developing world. First, vaccine efficacy, which has already been demonstrated in children in industrialized and middle-income countries, needs to be proven in poor developing countries in Africa and Asia. The safety of vaccines with regard to the associated risk of intussusception must be demonstrated as well. Novel financing strategies will be needed to ensure that new vaccines are affordable and available in the developing world. Decision makers and parents in developing countries need to know about this disease that has little name recognition and is rarely diagnosed. Finally, for the global effort toward the prevention of rotavirus disease to be successful, special efforts will be required in India, China, and Indonesia, because one-third of all deaths due to rotavirus disease occur in these countries, and because these countries depend almost entirely on vaccines manufactured domestically.
UR - http://www.scopus.com/inward/record.url?scp=23944440959&partnerID=8YFLogxK
U2 - 10.1086/431504
DO - 10.1086/431504
M3 - Article
C2 - 16088799
AN - SCOPUS:23944440959
SN - 0022-1899
VL - 192
SP - S160-S166
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - SUPPL. 1
ER -
