The Director of Immunization, Department of Health, UK has written a letter to UK doctors warning about the risk of febrile convulsions in children aged under five years and seasonal influenza vaccines marketed by Pfizer Vaccines (Enzira® and CSL Biotherapies generic influenza vaccine).
Professor D M Salisbury CB wrote that epidemiological data from Australia revealed a higher-than-expected increase in febrile convulsions in children related to the use of Fluvax (manufactured by CSL Biotherapies).
This is the same vaccine that will be marketed in the UK by Pfizer as Enzira® and generic influenza vaccine for the 2010/11 influenza vaccination season.
According to Australian evidence, there is a 1% risk of febrile convulsions for children under 5 years who were vaccinated with Fluvax.
Salisbury added that the increased risk appears to be a “a product specific reaction and evidence from Australia of vaccination with other products has so far not indicated a similar level of risk.”
The alert letter also stated that it does not apply to the generic influenza vaccine marketed by Sanofi Pasteur MSD, Inactivated Influenza Vaccine (Split Virion) BP.
Doctors are told to avoid offering Enzira® or CSL Biotherapies generic influenza vaccine marketed by Pfizer to children aged under five years. Children who are over six months of age and also in clinical risk groups should receive influenza vaccination, the letter stresses. Doctors are told to use other influenza vaccine products.
UK doctors have been asked to check which manufacturer’s products they have ordered (including the possibility that you have ordered CSL Biotherapies generic influenza vaccine) and to make sure that they have stocks of alternative influenza vaccines to give to such children in the 2010/11 influenza vaccination program.
There is no current evidence linking other flu vaccines with this level of risk in young children, Salisbury added. “Nonetheless, the Medicines and Healthcare products Regulatory Agency (MHRA) intends to closely monitor this and will issue further information in advance of this year’s immunization program,” Salisbury wrote.
Source: Dept. of Health, UK.
Written by Christian Nordqvist
Medical News Today