Tuesday, March 18, 2008

The Expanding Development Pipeline for Vaccines in the Private Sector

Matthew M. Davis1, Angela Pok1, Margaret S. Coleman2, Acham Gebremariam1, Jack RC Wheeler3, Dianne C. Singer4, and Gary L. Freed4. (1) Division of General Pediatrics, University of Michigan, 300 North Ingalls, Room 6E06, Campus Box 0456, Ann Arbor, MI, USA, (2) NIP/HSREB, CDC, 1600 Clifton Road, NE, MS-E52, Atlanta, GA, USA, (3) Health Management and Policy, School of Public Health, University of Michigan, Observatory Dr, Ann Arbor, MI, USA, (4) Child Health Evaluation and Research (CHEAR) Unit, University of Michigan, 300 North Ingalls, Room 6E06, Campus Box 0456, Ann Arbor, MI, USA

Learning Objectives for this Presentation:
By the end of the presentation participants will be able to describe recent trends in research and development (R&D) of vaccines in the private sector.

R&D by private biotech firms and pharmaceutical manufacturers has facilitated the recommendation of an unprecedented number of new vaccines for children and adolescents over the past 10 years. However, the dominant role of government purchase of vaccines in the US has raised questions about whether vaccine prices may be too low to encourage ongoing private R&D in vaccines.

To assess private-sector activity in vaccine R&D for the period 1997-2006.

The investigators queried a proprietary database (Pharmaprojects) to identify prophylactic vaccines in any stage of development from 1997-2006. Development stages of principal interest were: preclinical, Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, and fully launched (licensed and distributed). Vaccines were counted in each year, so that year-to-year changes in distribution of vaccines across different developmental stages could be characterized.

The number of distinct prophylactic vaccines in development or fully launched by private industry globally climbed steadily from 1997 through 2006. Overall, the total number of vaccine entities almost doubled, from 245 (1997) to 441 (2006). Much of this growth occurred in the preclinical stage (102 to 182), Phase I clinical trials (25 to 54), and Phase II clinical trials (19 to 44), as well as in fully launched vaccines. The number of vaccines in Phase III clinical trials remained comparatively flat over this time period (minimum 12, maximum 20 in a given year).

Trends over the past 10 years indicate substantial expansion of vaccine R&D activity in the private sector. Whether this will sustain the recent pace of new vaccine recommendations may depend largely on the comparatively static “bottleneck” of development, in Phase III clinical trials.