Vaccine Factory Rapped for Hygiene Breaches
A factory run by the drug company Medeva, linked to
the controversial polio
vaccine distributed to Irish children and adults in
1998, has a history of
contamination and blunders and was censured by the
US Food and Drug
Administration (FDA), following an inspection which
found unsanitary
conditions and poor hygiene.
During the summer of 1999 a team of FDA
investigators carried out a
week-long inspection of the Medeva plant on
Merseyside. They found that
Medeva had failed to clean, maintain and sanitize
equipment at appropriate
intervals to prevent malfunction or contamination.
The inspection concluded
that Medeva had failed to prove that vaccines
dispatched to doctors were free
from bacteria and fungi.
About two months ago the Irish Medicines Board
withdrew the Medeva polio
vaccine because it contained trace elements sourced
from UK cattle. This was
a completely separate issue from last week's news
that a donor whose
plasma contributed to making the vaccine was
diagnosed as having CJD, the
human form of mad cow disease.
