Vaccination News Home Page

http://reuters.com/newsArticle.jhtml;jsessionid=VGKGB2D34CNCWCRBAEZSFFA?type=healthNews&storyID=1740374

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.

Vaccination News Home Page

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.