Licensure of vaccines using the animal rule

Current Opinion in Virology

Volumn 2, Issue 3, 2012, Pages 353-356

  Burns, Drusilla L ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VACCINE;

ANTIBODY RESPONSE; ANTIBODY TITER; DISEASE COURSE; DRUG EFFICACY; ENDEMIC DISEASE; FOOD AND DRUG ADMINISTRATION; HOST SUSCEPTIBILITY; IMMUNE RESPONSE; IMMUNOGENICITY; LICENSING; NONHUMAN; PATHOPHYSIOLOGY; PRIORITY JOURNAL; REVIEW; VACCINATION;

ANIMALS; DISEASE MODELS, ANIMAL; DRUG APPROVAL; HUMANS; UNITED STATES; VACCINES;

EID: 84862881941     PISSN: 18796257     EISSN: 18796265     Source Type: Journal    
DOI: 10.1016/j.coviro.2012.01.004     Document Type: Review

References (12)

1. FDA: New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Federal Register 2002, 67:37988-37998.
2. FDA: Draft Guidance. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule. 2009 http://www.fda.gov/ downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ucm078923.pdf.
3. FDA: Public Meeting on the Draft Guidance for Industry. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule. 2010 http://www.fda.gov/downloads/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/UCM245299.pdf. This public meeting was held to discuss the FDA Draft Guidance on animal models used to support efficacy of new drugs and biologics.
4. Bergman KL: The animal rule and emerging infections: the role of clinical pharmacology in determining an effective dose. Clin Pharmacol Ther 2009, 86:328-331.
5. Roberts R, McCune SK: Animal studies in the development of medical countermeasures. Clin Pharmacol Ther 2008, 83:918-920. (Pubitemid 351704922)
6. Snoy PJ: Establishing efficacy of human products using animals: the US Food and Drug Administration's "Animal Rule". Vet Pathol 2010, 47:774-778.
7. FDA: Transcripts of Workshop. Anthrax Vaccines: Efficacy Testing and Surrogate Markers of Immunity. 2002 http://www.fda.gov/ cber/minutes/workshop- min.htm.
8. FDA: Transcripts of Workshop. Animal Models and Correlates of Protection for Plague Vaccines. 2004 http://www.fda.gov/cber/ minutes/workshop-min.htm.
9. FDA: Transcripts of Workshop. Anthrax: Bridging Correlates of Protection in Animals to Immunogenicity in Humans. 2007 http:// www.fda.gov/cber/minutes/ workshop-min.htm.
10. NIH: Transcripts of Workshop. Filovirus Animal Model Workshop. 2007 http://www.niaid.nih.gov/news/events/meetings/filo/ Documents/filotrans-091107. pdf.
11. FDA: Transcript of FDA Advisory Committee Meeting. Vaccines and Related Biological Products Advisory Committee Meeting; November 16, 2010: 2010 http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/ VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ ucm237045.htm. The discussions at this FDA Advisory Committee Meeting outlined a scientific strategy for bridging animal protection data to humans via an immune marker for anthrax vaccines for a post-exposure indication. The strategy outlined might serve as a model for other vaccines.
12. FDA: Transcripts of Workshop. The Development and Evaluation of Next-Generation Smallpox Vaccines. 2011 http://www.fda.gov/ downloads/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/UCM277095.pdf.