Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies

被引:8
作者
Hwang, Thomas J. [1 ]
Kesselheim, Aaron S. [2 ,3 ]
机构
[1] Bain Capital, Boston, MA USA
[2] Harvard Univ, Sch Med, Med, Boston, MA USA
[3] Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, 75 Francis St, Boston, MA 02115 USA
关键词
CONTROLLED FIELD TRIAL; HEAT-LABILE TOXIN; TRAVELERS DIARRHEA; ESCHERICHIA-COLI; DRUG DEVELOPMENT; DOUBLE-BLIND; CHALLENGES; INNOVATION; SAVINGS; SAFETY;
D O I
10.1377/hlthaff.2015.1073
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Many serious diseases lack safe and effective vaccines. Using a large commercial database, we examined trends in global vaccine research and development and found that the proportion of new vaccine candidates entering all stages of clinical development increased by 35 percentage points over the past two decades. Small and medium-size companies accounted for nearly twice as many new Phase I vaccine trials compared to large companies, but late-stage (Phase III) vaccine trials were dominated by large companies. There were no significant differences between vaccines and drugs in the probability of success in clinical trials or in profitability. Small and medium-size companies, including spin-outs from academic research centers, play an important role in innovative research and discovery. Our findings suggest that policy making targeted at smaller companies, such as prizes or opportunities for public-private partnerships, could support the development of new vaccines, particularly those targeting unmet medical needs and emerging public health threats.
引用
收藏
页码:219 / 226
页数:8
相关论文
共 32 条
[1]   Estimating the cost of new drug development: Is it really $802 million? [J].
Adams, CP ;
Brantner, VV .
HEALTH AFFAIRS, 2006, 25 (02) :420-428
[2]   Vaccination greatly reduces disease, disability, death and inequity worldwide [J].
Andre, F. E. ;
Booy, R. ;
Bock, H. L. ;
Clemens, J. ;
Datta, S. K. ;
John, T. J. ;
Lee, B. W. ;
Lolekha, S. ;
Peltola, H. ;
Ruff, T. A. ;
Santosham, M. ;
Schmitt, H. J. .
BULLETIN OF THE WORLD HEALTH ORGANIZATION, 2008, 86 (02) :140-146
[3]   The 21st Century Cures Act - Will It Take Us Back in Time? [J].
Avorn, Jerry ;
Kesselheim, Aaron S. .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (26) :2473-2475
[4]   The Challenges Of Developing New Tuberculosis Vaccines [J].
Barker, Lewellys F. ;
Leadman, Annmarie E. ;
Clagett, Bartholt .
HEALTH AFFAIRS, 2011, 30 (06) :1073-1079
[5]   Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala [J].
Behrens, Ronald H. ;
Cramer, Jakob P. ;
Jelinek, Tomas ;
Shaw, Hilary ;
von Sonnenburg, Frank ;
Wilbraham, Darren ;
Weinke, Thomas ;
Bell, David J. ;
Asturias, Edwin ;
Enkerlin Pauwells, Hermann L. ;
Maxwell, Roberto ;
Paredes-Paredes, Mercedes ;
Glenn, Gregory M. ;
Dewasthaly, Shailesh ;
Stablein, Donald M. ;
Jiang, Zhi-Dong ;
DuPont, Herbert L. .
LANCET INFECTIOUS DISEASES, 2014, 14 (03) :197-204
[6]   Factors affecting US manufacturers' decisions to produce vaccines [J].
Coleman, MS ;
Sangrujee, N ;
Zhou, FJ ;
Chu, S .
HEALTH AFFAIRS, 2005, 24 (03) :635-642
[7]   Improving Pharmaceutical Innovation By Building A More Comprehensive Database On Drug Development And Use [J].
Daniel, Gregory W. ;
Caze, Alexis ;
Romine, Morgan H. ;
Audibert, Celine ;
Leff, Jonathan S. ;
McClellan, Mark B. .
HEALTH AFFAIRS, 2015, 34 (02) :319-327
[8]  
Darrow JJ, 2015, FOOD DRUG LAW J, V70, P243
[9]   Failure-to-success ratios, transition probabilities and phase lengths for prophylactic vaccines versus other pharmaceuticals in the development pipeline [J].
Davis, Matthew M. ;
Butchart, Amy T. ;
Wheeler, John R. C. ;
Coleman, Margaret S. ;
Singer, Dianne C. ;
Freed, Gary L. .
VACCINE, 2011, 29 (51) :9414-9416
[10]   The expanding vaccine development pipeline, 1995-2008 [J].
Davis, Matthew M. ;
Butchart, Amy T. ;
Coleman, Margaret S. ;
Singer, Dianne C. ;
Wheeler, John R. C. ;
Pok, Angela ;
Freed, Gary L. .
VACCINE, 2010, 28 (05) :1353-1356