TEN deaths have been linked to the nation’s flu immunisation program since the 2009 swine flu pandemic, including elderly patients and unborn babies.
The CSL flu vaccine, Panvax – which taxpayers spent $131 million stockpiling for the 2009 swine flu outbreak – triggered 1716 adverse-event reports, including seven deaths.
They included a stillbirth in October 2009 and another fetal death in April 2010, after “maternal exposure” to Panvax.
Doctors, drug companies and consumers then lodged 2136 reports of “adverse events” following injection with CSL’s Fluvax and Fluvax Junior, which replaced Panvax in 2010. Fluvax is used for about half the nation’s estimated 6 million flu vaccinations each year. But the number of reported side-effects for Fluvax is five times higher than the other three most popular brands of flu vaccines together.
The Therapeutic Goods Administration database of adverse events, made public this week, lists the death of a grandmother who caught the flu after vaccination last year.
Fifteen other patients were reported as “unresponsive to stimuli” after vaccination.
And 11 cases were reported of the rare Guillain-Barre syndrome, which the federal Health Department describes as a “one-in-a-million” occurrence.
The commonwealth has purchased 5.5 million doses of Fluvax under the free national immunisation program since 2010.
A TGA spokeswoman said yesterday many people receiving the flu vaccine were over 65 and had chronic underlying medical conditions that made them at risk of adverse events, whether they were vaccinated or not.
“In many cases the death happened some weeks or months after the immunisation, so determining whether there is a specific relationship with the vaccination itself is difficult,” she said.
The spokeswoman said the National Centre for Immunisation Research and Surveillance database had recorded two deaths linked to the flu vaccine in 2010. A two-year-old girl was found dead in her cot the morning after her Fluvax shot, but an autopsy “determined that a causal relationship between vaccination and death was not established”, the spokeswoman said.
An unborn baby died in the womb at 22 weeks, 16 days after her mother, 20, was vaccinated with Influvac, but the cause of death was most likely due to “intra-uterine infection”, she said.
The TGA database contains 10 reports of deaths, including one of the six cases of Guillain-Barre syndrome reported to the TGA after a Panvax jab.
Most of the reports were made in 2010, when Fluvax was withdrawn for children younger than five after triggering febrile fits at 10 times the expected rate.
But at least 57 under-5s were mistakenly given the banned vaccine this flu season, including a toddler admitted to intensive care after a seizure in April.
After a two-year probe, CSL stated in June its manufacturing methods might have failed to fully split the viruses used to make flu vaccines, over-stimulating children’s immune systems.
The TGA database reveals reports of possible side-effects from other brands of flu vaccine purchased for the national immunisation program.
Sanofi’s Vaxigrip was linked to 203 possible adverse reactions, including the death of an 81-year-old man from a nervous system disorder, and two reports of Guillain-Barre syndrome.
Abbott Australasia’s Influvac was linked to 177 possible side-effects, including the death of a 51-year-old man from a heart attack and the death of an unborn baby. Only 24 notifications were made for GlaxoSmithKline’s Fluarix brand.
The TGA spokeswoman said the reports did not mean the vaccines had definitely caused the side-effects. All deaths were probed, she said, but “even where the relationship is quite unlikely but still possible the event will remain in the database”.
A CSL spokeswoman said the company found that Fluvax and Panvax had not caused any of the deaths flagged in the TGA database. “Adverse events associated with CSL’s influenza vaccines remain consistent with the side-effects listed in the prescribing information and no deaths have been found to be caused by Fluvax or Panvax,” she said.