Use of Single Compnent Vaccines

Notice type: Warning

Date: 14/11/2002


Product name or type:

Problem Or Issue:
The Irish Medicines Board (IMB), the competent authority for the licensing of medical products in Ireland would like to advise parents and doctors against the use of unlicensed single component measles, mumps and rubella vaccines. 

Specifically, the IMB has concerns in relation to the manufacture, testing and storage of the single component vaccines, Pavivac (single Mumps vaccine) and Movivac (single Measles vaccine). There is insufficient information about these two vaccines to be able to offer any assurances about the safety, quality or efficacy of these products, which are manufactured by Sevapharma in the Czech Republic. 

Following preliminary investigations undertaken, the IMB understands that Movivac has been imported for use into Ireland and believes that Pavivac may also be available here. Neither Pavivac or Movivac are licensed for use in Ireland. However, in accordance with the Medicinal Products (Licensing and Sale) Regulations the importation or sale of unlicensed medicines is permitted by registered doctors or dentists for patients under their care. 

The IMB is aware that their counterparts in the UK, the Medicines Control Agency (MCA) has issued similar recommendations pending further investigation. The two combined MMR vaccines (M-M-R II and Priorix) currently used in the Primary Immunisation Programme in Ireland have undergone rigorous assessment and have been licensed by the IMB. In line with the National Immunisation Guidelines, the IMB advocates that parents presenting their children for immunisation against measles mumps and rubella should use these products.

Background Information Or Related Documents:
Use of Single Compnent Vaccines Document

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