Scientific Publications by FDA Staff
Expert Opin Drug Metab Toxicol 2011 Sep;7(9):1117-27
Animal models to assess the toxicity, immunogenicity and effectiveness of candidate influenza vaccines.
Eichelberger MC, Green MD
Introduction: Every year, > 100 million doses of licensed influenza vaccine are administered worldwide, with relatively few serious adverse events reported. Initiatives to manufacture influenza vaccines on different platforms have come about to ensure timely production of strain-specific as well as universal vaccines. To prevent adverse events that may be associated with these new vaccines, it is important to evaluate the toxicity of new formulations in animal models. Areas covered: This review outlines preclinical studies that evaluate safety, immunogenicity and effectiveness of novel products to support further development and clinical trials. This has been done through a review of the latest literature describing vaccines under development. Expert opinion: The objective of preclinical safety tests is to demonstrate the absence of toxic contaminants and adventitious agents. Additional tests that characterize vaccine content more completely, or demonstrate the absence of exacerbated disease following virus challenge in vaccinated animals, may provide additional data to ensure the safety of new vaccine strategies.
|Category: Journal Article, Review|
|PubMed ID: #21749266||DOI: 10.1517/17425255.2011.602065|
|Includes FDA Authors from Scientific Area(s): Biologics|
|Entry Created: 2011-10-03||Entry Last Modified: 2012-08-29|