The U.S. Food and Drug Administration has announced that it is investigating the fluzone vaccine after data from the Vaccine Adverse Events Reporting System (VAERS) showed that a higher number of children up to the age of two have suffered febrile seizures after the shot.
This comes after Australia suspended the child flu vaccine program after a record number of children were taken to the ER suffering fits and one child, 2-year-old Ashlee Epapara, died the morning after her shot, despite being previously healthy. Her twin sister also suffered fever and vomiting after the shot.
Ashlee’s father said “We don't know much about what happened at this stage, but it seems too much of a coincidence for a healthy girl, after having this vaccine, to just pass away. It is shocking."
Although the vaccine is recommended for all U.S. people aged 6 months and up, the fluzone vaccine is different from previous years. It contains H1N1 flu, a strain not added until 2009-2010. This particular strain has not been tested on children. The safety information that manufacturers and the government have relates to the 2003-2004 version of the vaccine, which did not contain H1N1. Even the testing of the regular fluzone flu vaccine only involved 31 children, a number too small to determine safety.
The most recent product information sheet, dated July 2010, says:
"The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults. No reported local or systemic reaction required a therapeutic intervention other than analgesics."
In addition to this, the vaccine has been recommended for pregnant women, yet it hasn’t been tested on pregnant women and hasn’t even been tested on animals. The data sheet goes on to say:
"Animal reproduction studies have not been conducted with Fluzone vaccine.