23 December 2010
A yearly seasonal influenza (flu) vaccine is recommended for vulnerable population groups such as adults aged 65 years and older; adults or children aged 6 months and older with serious medical conditions such as asthma or heart disease; and pregnant women. If individuals in these groups catch flu, they are at an increased risk of developing severe symptoms or complications - which is why they are offered a vaccine against infection.
In Australia in April 2010, an excess risk of febrile convulsions (fever fits in children) was associated with flu vaccines manufactured by CSL. Because of this risk, the UK Department of Health advised doctors in the UK not to use flu vaccines manufactured by CSL in children aged less than 5 years, but to use alternative vaccine brands instead.
In addition, the MHRA monitored reports of febrile convulsions from the 2010 flu vaccination campaign, and analysed whether they were more frequent than would have occurred naturally in the population.
The analysis showed that the number of reports received was within the natural range, and that there is no indication of an excess risk of febrile convulsions in children following seasonal flu vaccination in the UK. This Public Assessment Report summarises the data obtained on this issue, and the conclusions drawn from the analysis.
Department of Health healthcare professional letter including a list of vaccines available in the UK
Follow-up letter sent to healthcare professionals (August 2010)
Article in January 2011 issue of Drug Safety Update (our monthly publication for health professionals on the safety of medicines and vaccines)
MHRA webpage on vaccine safety
This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).