United Kingdom - In November 1999, a mass national immunization campaign to vaccinate all children under 18 years of age with the new meningococcal group C conjugate vaccine commenced. Two vaccines were used (Meningotec® and Menjugate®). Before licensing, the vaccines were tested in approximately 8000 children and adolescents in the United Kingdom and over 20 000 children and adults in other countries. To date over 15 million doses have been distributed in the United Kingdom.

Recent press reports of death following Meningitis C vaccination are based on misinterpretation of data which have not been linked to fatal outcomes. By 1 June 2000 the Committee on Safety of Medicine had received 4764 reports of patients experiencing adverse reactions to the vaccine. This corresponds to a reporting rate of 1 per 2875 doses distributed. The adverse reactions reported most frequently include dizziness, pyrexia, headache, nausea, vomiting and fainting. Patients normally recover rapidly.

After reviewing the data, the Committee on Safety of Medicines has recommended that the following adverse reactions should be added to the product information: nausea, vomiting, rash, malaise, lymphadenopathy, headache, myalgia and allergic reactions, including anaphylactic reactions which were reported once in 500 000 doses distributed. The Committee considers that the risk/benefit ratio is overwhelmingly favourable and there is no suggestion that the vaccine has led to any deaths.

References

1. The Pharmaceutical Journal, 265: 353 (2000).

2. Message from the Chairman of the Committee on Safety of Medicines, 30 August 2000.