VACCINE

Biologicals • September 2014
Adventitious agents in viral vaccines:
Lessons learned from 4 case studies
Author Information
John Petricciania, Rebecca Sheetsb, Elwyn Griffiths, Ivana Knezevicd
IABS, POB 1925, Palm Springs, CA 92263, USA
Grimalkin Partners, 13401 Norden Drive, Silver Spring, MD 20906, USA
The Farthings, Kingston Upon Thames, Surrey KT2 7PT, UK
Group Lead, Norms and Standards for Biologicals
Department of Essential Medicines and Health Products (EMP)
Health Systems and Innovation (HIS) Cluster
WHO L276, Avenue Appia 20, 1211 Geneva 27, Switzerland
Abstract
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. We have therefore selected four instances
where an adventitious agent, or a signal suggesting the presence of an agent,
was found in a viral vaccine, and have developed a case study for each. The four
cases are: a) SV40 in polio vaccines; b) bacteriophage in measles and polio vaccines;
c) reverse transcriptase in measles and mumps vaccines; and d) porcine circovirus
and porcine circovirus DNA sequences in rotavirus vaccines. 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.
“We have therefore selected four
instances where an adventitious agent,
or a signal suggesting the presence of an
agent, was found in a viral vaccine, and have
developed a case study for each.
The four cases are: a) SV40 in polio vaccines;
b) bacteriophage in measles and polio vaccines;
c) reverse transcriptase in measles
and mumps vaccines; and d) porcine
circovirus and porcine circovirus DNA
sequences in rotavirus vaccines.”
http://www.sciencedirect.com/science/article/pii/S1045105614000748