Yellow Card Scheme update: seasonal flu vaccines in children
- Medicines and Healthcare products Regulatory Agency
- 11 October 2010
- Therapeutic area:
- Immunology and vaccination
Report of febrile promptly.
Article date: October 2010
We are requesting your particular help with the monitoring of all seasonal flu vaccines in children for the approaching flu season.
As a reminder, the Department of Health has advised against the use of two particular brands of seasonal influenza vaccine in children younger than age 5 years: Enzira and CSL Biotherapies generic influenza vaccine (both manufactured by CSL and marketed by Pfizer; for further information see the immunisation section of the Department of Health’s website).
Recent use of these vaccines in Australia was associated with an increased risk of febrile convulsions within 72 hours of vaccination (see the Australian Therapeutic Goods Administration website). Approximately 9 cases per 1000 doses were reported to the Therapeutic Goods Administration in Australia, and this risk appears to be product-specific to CSL’s influenza vaccines.
Children older than age 6 months and younger than 5 years who are in clinical risk-groups should still receive flu vaccination, but should use the alternative vaccines as recommended by the Department of Health (see letter from the Chief Medical Officer).
Although there is no evidence that other seasonal flu vaccines carry this risk, it is important that we continue to closely monitor the safety of all flu vaccines. Please help us monitor the safety of flu vaccines by promptly reporting every case of febrile convulsion occurring within 72 hours of receiving the vaccine. It is vital that the brand name of the vaccine given, and batch number if available, are reported to us.
However, if you do not have this information at hand, please still report to us and we will contact you for further information. Report online at www.yellowcard.gov.uk. Alternatively, you can report by post (paper Yellow Cards are available at the back of the British National Formulary, or call 0800 731 6789).
See also our hot topic this month for a summary of the safety profile of pandemic antivirals and vaccines.
Article citation: Drug Safety Update Oct 2010, vol 4 issue 3, Y1.
Published: 11 October 2010
Therapeutic area: Immunology and vaccination