The Need for and Design of Combination Vaccines
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THE NEED FOR AND DESIGN OF COMBINATION VACCINES WILLIAMP. HAUSDORFF, PHD Associate Director. Scientific Affairs and Research Strategy, Wyeth-Lederle Vaccines and Pediatrics, West Henrietta, New York
Combination vaccines, by increasing the number of antigens that can be delivered at a single visit, will dramatically extend the range of diseases preventable by childhood immunization. As the antigenic possibilities and researchers ’ technical capabilities increase, the rational design and development of combination vaccines become especially complex. A variety of epidemiological, medical, physicochemical, and commercial considerations are taken into account by manufacturers in determining which set(s) of antigens make “sense” as combinations. A key challenge will be to predict a d o r influence which antigens will be recommended for inclusion in the infant schedules in key markets in the coming years. Resource constraints dictate that companies must minimize the numbers of combinations to be developed, while at the same time offer combinations appropriate to diyerent markets around the globe. Key Words: Combination vaccines; Pediatric immunization; Vaccine strategy
INTRODUCTION
including cancer, autoimmune diseases, and allergies. Historically, most immunization programs have centered around immunization in early childhood, and the majority of vaccine development efforts remain targeted at vaccines to be delivered in that age group. How to deliver the plethora of new potential vaccine antigens to young infants, however, poses a challenge. There is substantial reluctance among parents and health care providers to administration of multiple injections to young infants at a single visit. Indeed, this reluctance may be reflected in the fact that, until very recently, no more than two injections have been offered at a single visit in the first five months of life in any childhood immunization program in North America and Europe, even among countries which routinely utilize injectable instead of oral polio vaccine (2). While the tolerance for multiple injections may increase in the short term with the introduction of high priority vaccines (such as the combination of acellular pertus-
RESEARCHERS ARE ON THE BRINK of an explosion of new vaccine possibilities. The last 15 years have seen great strides in understanding of the immunological mechanisms that protect people from pathogens, and in researchers’ abilities to manipulate molecular components of microorganisms. These scientific advances have fueled tremendous commercial and academic activity in the development of new vaccines. (See, for example, the invaluable Appendices of The Jordan Report [l].) While still mainly aimed at preventing and in some cases treating infectious diseases, a significant portion of this activity is focused on new targets,
Presented in part at the DIA 33rd Annual Meeting “Op timizing Pharmaceutical Development: The Global Experience,”
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