# 4941
Late last week Australia’s Therapeutic Goods Administration (TGA) issued an advisory on recent reports of a higher-than-expected number of pediatric febrile convulsions following administration of CSL’s monovalent Panvax (pandemic) H1N1 flu vaccine
CSL’s trivalent seasonal flu shot came under scrutiny last April with similar adverse reactions.
The total number of reports were small (several hundred) out of tens of thousands of shots given, but significantly higher than normal.
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).
This latest announcement regarding the Panvax vaccine suggests that the incidence of side effects for this monovalent shot - while higher than usual – was a fraction of that seen with CSL’s seasonal vaccine.
Thus far, we’ve not seen excessive reports like these from other countries or from other manufacturer’s vaccines.
Two reports.
First, excerpts from the TGA’s advisory, then a news report from The Sydney Morning Herald that suggests that these side effects may not prove as common as originally stated.
Suspected adverse reactions to Panvax® reported to the TGA 30 September 2009 to 17 September 2010
22 September 2010
The national immunisation program with Panvax® began on 30 September 2009. The TGA has been closely monitoring any side effects from the use of the vaccine.
As at 17 September 2010 a total of 1960 suspected side effects had been reported to the TGA following vaccination with Panvax® in Australia. The great majority of reported side effects have been mild and common problems such as headache, gastrointestinal upset, and soreness, swelling, or redness at the injection site. Most of the side effects that have been reported are well recognised and listed in the Panvax® Product Information. Of the suspected side effects reported, only 190 related to Panvax Junior®, and the majority of these reports were of fever (151) and/or vomiting (98).
The TGA's assessment remains that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza.
As at 17 September 2010 the TGA had received 48 reports of febrile convulsions in children following Panvax/Panvax Jr administration. Nine of these had occurred in children who had also been given other vaccines at the same time as they received Panvax.
Swine flu jab for children may not be so harmful
Mark Metherell
September 28, 2010
The Commonwealth chief medical officer, Jim Bishop, has sought to play down concerns following the revelation that a second influenza vaccine, Panvax, has been linked to febrile convulsions in infant recipients of the vaccine.
While often dramatic, febrile convulsions in young children are not uncommon with a fever, and only rarely prove serious.
