WHO-R&D Preparedness for epidemics
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WHO Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations

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Published in the September 2014 issue of Biologicals

Adventitious agents in viral vaccines: Lessons learned from 4 case studies

Since the earliest days of biological product manufacture, there have been a number of instances where
laboratory studies provided evidence for the presence of adventitious agents in a marketed product.
Lessons learned from such events can be used to strengthen regulatory preparedness for the future.

Four case studies where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, are presented in this paper. The lessons learned from each event are discussed.

Based in part on those experiences,certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future.



Invitation to Join Brighton Collaboration


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A few words from the President


As we start the new year, I’d like to review our 2014 accomplishments and hi-lite what we have planned for 2015.

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Veterinary Scientific Committee

Read more about Alternatives to Antibiotics, Challenges and Solutions in Animal Production

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IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration

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World Organization for Animal Health


International Alliance for Biological Standardization, Coordinated by Dodet Bioscience