Fluvax investigation
June 11, 2014
BIOCSL has changed its
manufacturing process for Fluvax
and initiated a clinical development
program, following an investigation
into adverse events.
Fluvax was associated with a
“significant” increase in reports of
fever-related convulsions in young
children in the 2010 influenza
season, compared with previous
seasons, bioCSL said.
Findings published today in
two papers in Vaccine came from
what bioCSL called an “extensive
and highly complex investigation”
involving clinical data analyses,
manufacturing reviews and
scientific studies.
“The investigation found that
as a result of bioCSL’s standard
method of manufacture, virus
components contained in the 2010
formulation of Fluvax combined to
overstimulate the immune system
of some young children, triggering
increased fever and fever-related
convulsions.
“Following consultation with
regulators, bioCSL has now
implemented increased levels
of virus splitting agent into its
standard method of manufacturing
for Fluvax.”
It should not be used in children
under five, bioCSL said - CLICK HERE
and HERE for the papers.
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