Development pathway for biodefense vaccines

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

At the present time it is estimated that the process of development of a vaccine from discovery to licensure takes approximately 18-20 years and costs in excess of US$ 500 million. For "routine" vaccines, the case for developing a vaccine is straightforward in terms of economics and large scale public health utilization each year. For vaccines used for biodefense and emerging diseases, the considerations are somewhat different as the vaccine may not be needed every year to control outbreaks and may be stockpiled only as a countermeasure that hopefully may never be needed. Furthermore, efficacy trials are often difficult as the natural disease may be rare or not present. Consequently, animal models will play a critical role in demonstrating efficacy. Nonetheless, the vaccine pathway still requires the same fundamental components of basic science/discovery, preclinical development, clinical trials, registration/licensure, and a plan for implementation.

Original languageEnglish (US)
JournalVaccine
Volume27
Issue numberSUPPL. 4
DOIs
StatePublished - Nov 5 2009

Fingerprint

Vaccines
vaccines
Licensure
emerging diseases
vaccine development
clinical trials
public health
animal models
Disease Outbreaks
Animal Models
Public Health
economics
Economics
Clinical Trials
Costs and Cost Analysis

Keywords

  • Biodefense
  • Vaccine development

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Development pathway for biodefense vaccines. / Barrett, Alan; Beasley, David.

In: Vaccine, Vol. 27, No. SUPPL. 4, 05.11.2009.

Research output: Contribution to journalArticle

@article{5ecc68ac65dd4128a50dbb832781ffd9,
title = "Development pathway for biodefense vaccines",
abstract = "At the present time it is estimated that the process of development of a vaccine from discovery to licensure takes approximately 18-20 years and costs in excess of US$ 500 million. For {"}routine{"} vaccines, the case for developing a vaccine is straightforward in terms of economics and large scale public health utilization each year. For vaccines used for biodefense and emerging diseases, the considerations are somewhat different as the vaccine may not be needed every year to control outbreaks and may be stockpiled only as a countermeasure that hopefully may never be needed. Furthermore, efficacy trials are often difficult as the natural disease may be rare or not present. Consequently, animal models will play a critical role in demonstrating efficacy. Nonetheless, the vaccine pathway still requires the same fundamental components of basic science/discovery, preclinical development, clinical trials, registration/licensure, and a plan for implementation.",
keywords = "Biodefense, Vaccine development",
author = "Alan Barrett and David Beasley",
year = "2009",
month = "11",
day = "5",
doi = "10.1016/j.vaccine.2009.07.094",
language = "English (US)",
volume = "27",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "SUPPL. 4",

}

TY - JOUR

T1 - Development pathway for biodefense vaccines

AU - Barrett, Alan

AU - Beasley, David

PY - 2009/11/5

Y1 - 2009/11/5

N2 - At the present time it is estimated that the process of development of a vaccine from discovery to licensure takes approximately 18-20 years and costs in excess of US$ 500 million. For "routine" vaccines, the case for developing a vaccine is straightforward in terms of economics and large scale public health utilization each year. For vaccines used for biodefense and emerging diseases, the considerations are somewhat different as the vaccine may not be needed every year to control outbreaks and may be stockpiled only as a countermeasure that hopefully may never be needed. Furthermore, efficacy trials are often difficult as the natural disease may be rare or not present. Consequently, animal models will play a critical role in demonstrating efficacy. Nonetheless, the vaccine pathway still requires the same fundamental components of basic science/discovery, preclinical development, clinical trials, registration/licensure, and a plan for implementation.

AB - At the present time it is estimated that the process of development of a vaccine from discovery to licensure takes approximately 18-20 years and costs in excess of US$ 500 million. For "routine" vaccines, the case for developing a vaccine is straightforward in terms of economics and large scale public health utilization each year. For vaccines used for biodefense and emerging diseases, the considerations are somewhat different as the vaccine may not be needed every year to control outbreaks and may be stockpiled only as a countermeasure that hopefully may never be needed. Furthermore, efficacy trials are often difficult as the natural disease may be rare or not present. Consequently, animal models will play a critical role in demonstrating efficacy. Nonetheless, the vaccine pathway still requires the same fundamental components of basic science/discovery, preclinical development, clinical trials, registration/licensure, and a plan for implementation.

KW - Biodefense

KW - Vaccine development

UR - http://www.scopus.com/inward/record.url?scp=79952223316&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952223316&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2009.07.094

DO - 10.1016/j.vaccine.2009.07.094

M3 - Article

C2 - 19837280

AN - SCOPUS:79952223316

VL - 27

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - SUPPL. 4

ER -