UK Safety Committee Advises Suspension of Mumps Vaccine

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http://www.medscape.com/viewarticle/444616?mpid=6225

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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