By Nick Evans, Perth Now
US REGULATORS have hammered Australian vaccine maker CSL over its “inadequate” investigation of manufacturing problems that may have led to severe reactions in children given the flu vaccine last year.
In April last year Australian health authorities withdrew CSL’s season flu vaccine from use in children under five after 23 children from Western Australia were admitted to hospital with convulsions and high fevers following their injections.
CSL stopped distributing the Fluvax vaccine and later voluntarily recalled the product, with subsequent investigations saying the reactions were confined to a single batch of the vaccine.
The investigations said reactions to that batch ran at around 1 in 100 children, around 10 times the expected rate. More than 410 adverse reactions in children under five were reported to health authorities before Fluvax was withdrawn, including 67 cases of convulsions, high fever and vomiting.Investigations by State and Federal health authorities could not point to a cause of the problem, and CSL has previously denied they were linked to manufacturing issues at its Melbourne facilities.
But the powerful US Food and Drug Administration has criticised CSL’s internal investigation as “inadequate”, in a letter to the Australian biotech company released to the public this week.