The Medicines Control Agency has ordered Idis Ltd, a pharmaceutical importer, to stop importing single antigen vaccines containing components of the measles, mumps and rubella (MMR) vaccine. The move comes among fear of a measles epidemic due to a fall in the number of children receiving the MMR vaccine.
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The MCA has acted to force use of the MMR triple vaccine |
In a statement issued on August 27, the MCA said that it was objecting to these imports because it believed that unlicensed medicines should not be imported when a safe, effective and licensed alternative was available, ie, the MMR triple vaccine.
The MCA quoted a study published recently in the British Medical Journal (1999:319:352-3) of an outbreak of mumps in a Swiss village following single-antigen inoculation. The study showed that vaccination with the Rubini strain offered no mumps protection.
The MCA said: "Parents whose children have been given this vaccine should be aware that their children may not be protected and should give careful consideration to agreeing to MMR vaccination, which can be given at any time to provide the missing immunity."
In addition, the MCA said that there was no evidence to show that the use of single antigen vaccines would prevent any of the suggested adverse outcomes from the MMR vaccine. Children were also put at risk because doses of the single component vaccines were given 12 months apart before protection was available.
A spokeswoman for Idis said that the company had been notified of the import ban on August 24. The company was still in discussions with the MCA.
The rate of immunisation with the MMR vaccine has fallen since a scare in 1998 linking it with autism and bowel diseases in children (PJ, March 7, 1998, p329). The Public Health Laboratory Service says that at present only 87 per cent of two-year-olds have received the MMR vaccine. The World Health Organisation recommends that the immunisation level in the population should reach 95 per cent to prevent an epidemic occurring. This has led to concern that an epidemic of measles could occur when these children start school.
Late news As The Journal went to press, Idis announced that the MCA had written to confirm that single dose measles vaccines and non-Rubini strain single dose mumps vaccines could be supplied by Idis in the following situations: where the medicine is part of a course of single vaccines that has already begun, and where the patient has a special need, such as an allergic reaction, that makes the licensed product unsuitable.