Review of effectiveness of vaccine potency control testing published.

2003 SEP 3 - (NewsRx.com & NewsRx.net) -- A review of the effectiveness of vaccine potency control testing has been published in a recent issue of the International Journal for Parasitology.

"The use of potency control testing is a valuable tool for testing the actual relative strength of manufactured assembly lots of vaccine. Biological-based manufacturing methods are inherently variable and potency testing is a tool to ensure lot-to-lot consistency of commercial vaccines. A strong historical link to clinical efficacy has been established where correlation to efficacy and adequate test validation have been achieved," scientists in the United States report.

"The link to immunogenicity and efficacy has traditionally been strongest with attenuated vaccines and toxoids," stated David Scott McVey and collaborators at Pfizer, Inc. and the United States Department of Agriculture. "Control potency test failure does predict that a serial or batch of vaccine would most likely provide insufficient immunogenicity in typical field applications. Because of the complexity of pathogenic processes and associated immune responses, potency tests may not always directly predict the effectiveness of a vaccine. Thus, vaccines that pass control potency testing may not always provide adequate efficacy. This is particularly true of adjuvanted, inactivated vaccines."

"In the development of vaccine formulations and control tests for ...