than 2 million deaths and 5 million cases of disability still occur annually as a result of diseases (such as measles and Haemophilus influenzae) that are preventable by vaccination. In addition, a number of childhood diseases for which effective vaccines are not yet available, including malaria and acute diarrheal and respiratory infections, claim millions of lives annually.
The situation in the United States is also discouraging. Although almost all school-age children are well immunized, only about half of U.S. children under the age of 2 years have received the complete set of recommended immunizations, and the problem is particularly severe in inner-city areas and among indigent populations. The resurgence of measles in 1989 and 1990 was largely due to the failure of immunization programs to reach these groups. Most developed and many developing countries have achieved higher rates of immunization among their preschoolers than has the United States.
Vaccine delivery systems and schedules in the United States and the developing world are based on and restricted by existing vaccine-related technologies. Vaccines should be given early in life, when a child is most vulnerable to vaccine-preventable diseases. Most vaccines, however, require multiple administrations and, hence, multiple and costly contacts with the health-care system. And many vaccines require constant refrigeration. The complexity of vaccination schedules in the United States and much of the developing world exacerbates two categories of problems common to many immunization programs: high dropout rates and missed opportunities for vaccination.
The last decade has brought significant advances in the science of vaccinology. Genetic engineering and other new vaccine technologies offer the promise of revolutionizing the ways that vaccines are made and simplifying the ways in which they are administered to children. It was the recognition of the role that science might play in developing new vaccines and improving currently available vaccines, and a perception that the translation of scientific advances into new vaccines needed by developing countries was lagging, that led to the Children's Vaccine Initiative. (CVI).
The CVI is both a concept and an organization. The concept of the CVI was launched at the World Summit for Children in New York City in September 1990. The purpose of the CVI is to harness new technologies to advance the immunization of children. At the summit, it was proposed that the ideal CVI vaccine should be given as a single dose (preferably orally), effective when administered near birth, heat stable, contain multiple