Men C vaccine is safe for infants

October 21, 2001

A Men C vaccine, introduced into the UK immunisation schedule two years ago is safe, with minimal side effects, reports a study in the Archives of Disease in Childhood.

Concerns were raised about possible adverse side effects when these vaccines were first introduced because only one large scale safety study had been reported.

The researchers monitored adverse events after Men C vaccination in almost 3000 infants between the ages of 2 and 5 months. The children were recruited by general practitioners in the North Trent Region and Scotland.

They received all the routine vaccines at 2, 3, and 4 months, as well as Men C. All adverse events requiring medical attention and occurring within a month of each injection were recorded, including common childhood illnesses and injuries.

Adverse events were reported for almost two thirds of the children, but most were mild and thought to be unrelated to the vaccine. No serious adverse events were thought to be possibly or definitely associated with the vaccine.

Four serious events occurred, including brief loss of muscle tone (hypotonia), inconsolable screaming for a few hours, rash, and agitation. All these are know to occur occasionally after the other vaccines the children received. In all cases, the children made a full recovery.

The only adverse events thought to be definitely related to Men C vaccine were injection site reactions of swelling and redness, which five infants had.

Large scale effectiveness and safety studies are the norm before the introduction of a new vaccine, but the sheer logistics, timing, and cost made this difficult in the case of Men C. Similar dilemmas about how best to establish safety are likely to arise again as more childhood vaccines against rare but serious diseases are developed, they conclude.
[Safety of a new conjugate meningococcal C vaccine in infants 2001; 85:391-7]

BMJ Specialty Journals

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