Just 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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Career opportunities

The International Alliance for Biological Standardization (IABS), located in Geneva, Switzerland, is a non-profit association recognized as an NGO by WHO. The mission of IABS is to contribute to the scientific and medical advancement of biologicals by facilitating the communication among those who develop, produce and regulate biological products for human and animal health.

IABS launches its European affiliate: IABS-EU

This is a landmark event in the history of IABS and will open the way for greater participation with EU partners in scientific activities. The objective of the Association IABS-EU is to support the mission and projects of the International Alliance for Biological Standardization and to enhance its image and develop its outreach within the European Union. The Association will contribute to scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health. More specifically, it will focus on issues concerning the regulation and standardization of biological products that are intended for market use.

A unique feature of IABS is that it acts as a neutral meeting point for the major stakeholders - regulators, academia, and industry- to consider the impact of regulatory requirements on innovation, with the objective of identifying sections that may require modification.

IABS-EU is officially recognized by French authorities as a nonprofit organization.

You will be hearing more about IABS-EU in the months ahead.

Founding Members :

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Latest News



Human Challenge Trials in Vaccine Development: Scientific and Regulatory Issues



September 29 – October 1, 2014


European Directorate for the Quality of Medicines & Healthcare (EDQM)

Strasbourg, France



Human challenge trials can help overcome some of the hurdles inherent in vaccine development as the results obtained in these studies have more relevance than those obtained in animal models. Nevertheless, human challenge studies also face a series of scientific, ethical and regulatory issues related to the design, the execution and the use of these studies. The volunteers, healthy adults, may not represent the final target population of the vaccine, in terms of age, status of immunity and environment. The microbial strains used for challenge may behave differently from the wild pathogens. Experiments that induce infections in healthy volunteers give rise to significant ethical and regulatory issues.

This IABS workshop will bring together representatives from academia, industry, regulatory and public health agencies to discuss the scientific, ethical and regulatory framework required for safe and ethical conduct of challenge trials. In addition, the workshop is expected to provide guidance on the best use of challenge trials for the definition of potential correlates of protection and for preliminary efficacy evaluation of investigational vaccines.


View the Agenda





WHO Request for Comments


Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site

for public comments:



BS 2232 - Regulatory Risk Evaluation on Finding an Adventitious Agent in a Marketed Vaccine


Comment form

Comments should be sent to the Responsible Officer:  Dr Hye-Na Kang at email:

DEADLINE: 22 September 2014



BS 2233 – Recommendation to Assure the Quality, Safety and Efficacy of Poliomyelitis Vaccine (inactivated)


Comment form

Comments should be sent to the Responsible Officer: Dr TieQun Zhou at email:

DEADLINE: 22 September 2014



BS 2238 – Guidelines for procedures and data requirements for changes to approved vaccines


Comment form

Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email:

DEADLINE: 30 September 2014


All comments received by published deadlines will be considered in the preparation of the discussion at the ECBS meeting on 13-17 October 2014.


WHO - ECBS documents posted on WHO biologicals web site


The following documents, adopted by the WHO ECBS in October 2013, were posted on WHO biologicals web site ( (on the right hand side, under New Publications), last week:


1. Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines

2. Guidelines on the quality, safety and efficacy of typhoid conjugate vaccines

3. Guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Replacement of Annex 3 of WHO Technical Report Series, No. 814.


A few words from the President


We are now half-way through 2014, and much has happened during these first 6 months.

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Veterinary Scientific Committee

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

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Now available !

Vaccines and Diagnostics for Transboundary Animal Diseases

International Symposium, Ames, Iowa, September 2012: Proceedings

Editor(s): Roth J.A. (Ames, Iowa) ; Richt J.A. (Manhattan, Kansas); Morozov I.A. (Manhattan, Kansas)

Please use this link to order the book:

IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration


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