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Statement on adverse events following mumps vaccination

January 2004
The Global Advisory Committee on Vaccine Safety (GACVS) considered a proposal for an
international reference laboratory for mumps virus isolates and the development of a mumps vaccine
virus strain bank at its ninth meeting in Geneva, Switzerland on December 3-4, 2003. Parotitis and
aseptic meningitis have been described as complications of mumps vaccination with Urabe,
LeningradZagreb and Leningrad-3 strains of the vaccine but not with the JerylLynn strain 1. GACVS
noted that now that all mumps virus strains can be characterized by polymerase chain reaction and
nucleotide sequencing, it should be possible to address scientifically a number of unresolved questions
regarding vaccine safety. These include defining the molecular determinants of virus attenuation,
precise genetic determinants of virulence, safety of vaccines in relation to either pure or mixed virus
populations in the vaccine and their antigenicity, determining at what stage point mutations occur in
the virus (in passage, during replication in the body, or both), and the presence of sub-variant viruses
in different vaccines. The Committee recommended that a hypothesis that single point mutations at
certain positions of the haemagglutininneuraminidase protein gene region of the genome might be
associated with post-vaccination aseptic meningitis should be further investigated. Such knowledge
would improve current understanding of genetic and molecular characteristics of strains used for
production of mumps vaccines. Moreover, further investigation may help to define the safety and
immunogenicity profile of mumps vaccines. If molecular assays could distinguish wild-type from
vaccine strains of the mumps virus, it would improve the quality control of existing and future
vaccines. GACVS has recommended to WHO that an international reference laboratory for mumps
virus isolates from vaccinees should be established.
GACVS also took note of the updated review of the safety of mumps vaccine virus strains, which
showed that while existing data show different rates of parotitis associated with the different mumps
vaccine strains, the data are insufficient to be extrapolated to differential risks for aseptic meningitis.
The Committee had previously considered this review at its June 2003 meeting 1, and concluded that
risk estimates of vaccine-derived mumps meningitis vary between studies, reflecting differences in
study settings and circumstances, and degrees of surveillance. The Committee further concluded that
available data are insufficient to distinguish between the safety profile with respect to aseptic
meningitis for Urabe, Leningrad-Zagreb and Leningrad-3 strains. If Urabe, Leningrad-Zagreb and
Leningrad-3 strain vaccines are being used in mass vaccination campaigns, national immunization
programmes need to take into account the potential for clustering of aseptic meningitis following the
campaigns.
The GACVS is a scientific advisory body established by WHO to provide a reliable and independent
scientific assessment of vaccine safety issues in order to respond promptly, efficiently and with
scientific rigour to such issues. Membership includes experts from around the world in the fields of

epidemiology, paediatrics, internal medicine, pharmacology and toxicology, infectious diseases,

public health, immunology and autoimmunity, drug regulation, and safety.

WER No. 32, 2003, pp. 282284

Page last reviewed: 7 January 2009
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