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MJA: Safety Of Flu Shot In Young Children

 

 


# 5612

 


Last year a significant number of young Australian children receiving a specific brand of flu shot - FluVax or FluVax Junior (CSL) - developed adverse reactions. Most of the side effects were related to fever, with some children experiencing febrile convulsions.

 

Others experienced nausea and vomiting, or injection site inflammation (see Australia Investigating Adverse Vaccine Reactions).

 

For a while, Australia placed a moratorium on dispensing flu shots to children under the age of 5, but that was lifted after investigations found the problem was only linked to one manufacturer (see Australia Lifts Ban On Flu Vax For Under Five’s).

 

Since then, Australia, the United States, and Great Britain have recommended that CSL’s vaccine not be used in children under the age of 5 (see FDA Approves 2010-2011 Flu Vaccines), and investigations into the cause of these adverse reactions have continued.

 

On Monday, the Medical Journal of Australia (MJA) published a letter that looked at early flu-season testing of several non-CSL TIVs (Trivalent Influenza Vaccines) given to thousands of children under the age of 5. 

 

Ensuring safety of the 2011 trivalent influenza vaccine in young children

Christopher C Blyth, Tracy Y Markus, Paul V Effler and Peter C Richmond

 

Briefly, during a six week period (March 15th-April 30th) 2227 doses of TIV were administered to children under 5, out of which adverse events in four children were reported to WAVSS (Western Australian Vaccine Safety Surveillance).

 

Two reported mild fevers (38°C yet < 39.5°C), one nausea, vomiting & diarrhea, and one with fever and convulsions 4 days post vaccination (this child also had a respiratory infection at the time of vaccination).

 

All four children received other vaccines at the same time as the TIV.

 

Additionally, 144 children were enrolled in a safety study during the same time period. Adverse reactions  were reported in 10 children (7%), 2 of whom received other vaccines in addition to TIV.

 

All 10 children reported fever, and one child’s fever exceeded > 39.5°C although no convulsions were reported. Two children developed vomiting.

 

None of these children required professional medical attention.

 

The reassuring bottom line is that the pediatric flu shots manufactured by both Sanofi Pasteur and Solvay proved to be very safe when administered to young children, with no repeat of the significant number of adverse reactions reported last year.

 

The authors conclude by writing:

 

These data demonstrate that the significant adverse events that occurred after administration of TIV in 2010 have not been observed in WA during early 2011. Ongoing surveillance is underway and will continue.

 

Poor uptake of influenza vaccination in Australian children is likely to result in increased influenza-related hospitalisation, morbidity and mortality. Data such as those reported here are required to reassure the community of the safety of this vaccination program before the expected start of the 2011 influenza season.

Related Post:

Pediatric
Influenza
Australia

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