UK Safety Committee Advises Suspension of Mumps Vaccine
LONDON (Reuters Health) Nov 14 - Britain's Committee on Safety of Medicines (CSM)
on Thursday advised that use of a mumps vaccine imported from the Czech Republic
should 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 MMR vaccines following hotly disputed reports
that they 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."
A Department of Health spokesman said 5720 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 that an equivalent licensed product cannot meet.
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