John Innes
A SINGLE mumps vaccine should not be imported or
used because of concerns about its safety and quality, scientific advisers
to the government said yesterday.
The committee on the safety of medicines (CSM) said use of the unlicensed vaccine Pavivac should be suspended while the Medicines Control Agency (MCA) carries out further studies.
Between April and September this year, UK clinics applied to bring 5,720 doses of Pavivac into the country. However, it is not known if all were successfully imported nor is it clear how many of the vaccines were given to people.
The government provides combined MMR jabs to protect children against mumps, measles and rubella and so single vaccines for these diseases are not licensed in the UK. But after fears were raised about the MMR jab, some clinics began offering single vaccines which they import into the UK for specific patients having notified the MCA.
Earlier this week , the CSM met to discuss Pavivac after concerns were raised about its manufacture, testing and storage.
The committee looked at the most up-to-date data available on Pavivac and said it had insufficient information to be able to offer any assurances on its safety, quality or efficacy.
It has asked the MCA to seek further information from Pavivac’s Czech manufacturer, Sevapharma, and the Czech Regulatory Authority.
In the meantime, the MCA will also contact clinics that have imported the vaccine and will instruct them that any remaining stocks should not be used.
Professor Alasdair Breckenridge, the CSM’s chairman, said: "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.
"Because of this lack of information, we are advising that its importation and use should be halted as a precautionary measure."
The committee on the safety of medicines (CSM) said use of the unlicensed vaccine Pavivac should be suspended while the Medicines Control Agency (MCA) carries out further studies.
Between April and September this year, UK clinics applied to bring 5,720 doses of Pavivac into the country. However, it is not known if all were successfully imported nor is it clear how many of the vaccines were given to people.
The government provides combined MMR jabs to protect children against mumps, measles and rubella and so single vaccines for these diseases are not licensed in the UK. But after fears were raised about the MMR jab, some clinics began offering single vaccines which they import into the UK for specific patients having notified the MCA.
Earlier this week , the CSM met to discuss Pavivac after concerns were raised about its manufacture, testing and storage.
The committee looked at the most up-to-date data available on Pavivac and said it had insufficient information to be able to offer any assurances on its safety, quality or efficacy.
It has asked the MCA to seek further information from Pavivac’s Czech manufacturer, Sevapharma, and the Czech Regulatory Authority.
In the meantime, the MCA will also contact clinics that have imported the vaccine and will instruct them that any remaining stocks should not be used.
Professor Alasdair Breckenridge, the CSM’s chairman, said: "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.
"Because of this lack of information, we are advising that its importation and use should be halted as a precautionary measure."
