Safety warnings and messages for medicines
A yearly seasonal influenza (flu) vaccine is recommended for people in vulnerable groups, such as adults age 65 years and older, and any adults or children age six months and older with serious underlying medical conditions such as asthma or heart disease. Pregnant women are also included this year. These individuals are at increased risk of developing severe symptoms or complications with flu.
In Australia, an excess risk of febrile convulsions (fever fits in children) has been associated with one brand of flu vaccine (Fluvax, manufactured by CSL). A similar CSL vaccine is on the UK market this year branded as Enzira or CSL Biotherapies' generic influenza vaccine (marketed by Pfizer).
Therefore, as a safety measure in the UK, the Department of Health advised doctors not to use these CSL flu vaccines in children age less than five years, but to use alternative vaccine brands instead.
In addition, the MHRA monitored reports of febrile convulsions in this year's UK flu vaccination campaign, and analysed whether the reports were more frequent than would have occurred naturally.
The analysis found that reports of febrile convulsion received this year with other (non-CSL/Pfizer) vaccines* in the UK are within the natural range, and that there is no indication of an excess risk of febrile convulsions in children following seasonal flu vaccination.
The following Public Assessment Report (published December 2010) summarises the data obtained on this issue and the conclusions drawn from the analysis. It is important to remember that flu may lead to life-threatening complications in 'at-risk' groups such as children with serious medical conditions, which is why they are offered a vaccine against this disease.
MHRA Public Assessment Report on seasonal flu vaccines and febrile seizures
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* Department of Health healthcare professional letter including a list of vaccines available in the UK - (external link)
