Seasonal flu vaccines
- Medicines and Healthcare products Regulatory Agency
- 12 January 2011
- Therapeutic area:
- Immunology and vaccination
No evidence of increased risk of febrile convulsions in children.
Article date: January 2011
To date, there is no indication of an excess risk of febrile convulsions in children associated with seasonal influenza vaccines.
From September 2010 to Dec 17, 2010, at least 46 000 children age 6 months to 5 years, have received a seasonal influenza vaccine in the UK. Up to Dec 17, 2010, there were tw0o reports of suspected febrile convulsions associated with seasonal influenza vaccines in children younger than 5 years (data are not available for specific brands). Both children recovered. Analysis of historical data 2000–10 shows that seven cases of febrile convulsions would statistically be expected among the number of children in this age-group who have received a seasonal influenza vaccine. Therefore the number of suspected reports received is within the normal expected range. This will remain under close review.
Further information is available in a report available on our website.
This analysis follows recent advice that the vaccines Enzira and CSL Biotherapies generic influenza vaccine are not indicated for use in children age less than 5 years this year because of an increased risk of febrile convulsions associated with a similar seasonal influenza vaccine, identified in Australia. Our analysis supports the evidence from Australia that this risk is most likely limited to CSL’s vaccine. Children age 6 months to less than 5 years in clinical risk-groups should still receive seasonal influenza vaccination, but health professionals are advised to use the alternative vaccines recommended by the Department of Health (see Drug Safety Update Oct 2010).
BNF section 14.4 Vaccines and antisera
Article citation: Drug Safety Update Jan 2011, vol 4 issue 6: S2.
Published: 12 January 2011
Therapeutic area: Immunology and vaccination