Britain Suspends Mumps Vaccine from Czech Republic
Thu November 14, 2002 12:55 PM ET
By Richard Woodman
LONDON (Reuters Health) - Britain's Committee on Safety of
Medicines (CSM) on Thursday advised that use of a mumps vaccine
imported from the Czech Republic be suspended as a precautionary
measure.
Pavivac is a single mumps vaccine manufactured by Sevapharma. It
is licensed by the Czech Regulatory Authority but not by Britain's
Medicines Control Agency.
British doctors have been prescribing it because some patients
are concerned about the safety of combination measles-mumps-rubella
(MMR) vaccines following hotly disputed reports that these may
increase the risk of autism.
The CSM said in a statement that it had insufficient information
to be able to offer any assurances on the safety, quality or
efficacy of Pavivac.
"There are a number of major questions about the manufacture,
testing and storage of the unlicensed vaccine Pavivac which are not
answered by the information currently available," said CSM chairman
Professor Alasdair Breckenridge.
"Because of this lack of information, we are advising that its
importation and use should be halted as a precautionary measure.
Further information and clarification has been urgently requested,"
Breckenridge added.
A Department of Health spokesman said 5,720 doses of Pavivac were
imported into Britain between April and September.
The CSM said it would review the issue again on December 11.
Unlicensed medicines may only be imported into the UK to meet the
special needs of individual patients, which an equivalent licensed
product cannot meet. |