The FDA green lighted influenza vaccines from all 6 vaccine manufacturers licensed to produce and distribute in the U.S., making way for the 2012-2013 flu season.
The company attributed the problem to the levels of virus components in the end product and said the increased levels of fits must be related to characteristics of the virus unique to the 2010 strain.
In a warning letter two years ago, the FDA told Australian vaccine maker CSL that it should have thoroughly investigated whether its manufacturing processes had something to do with children having seizures after getting its Fluvax vaccine. The company on Thursday said a two-year study appears to confirm that suspicion.
A CSL executive said Thursday that the study found its manufacturing left excessive viral components in the drug, triggering convulsions in some children, Bloomberg reports.
Two companies which have fallen under the shadow of FDA inspectors in the last year initiated product recalls this week.
The company said construction will begin this year, and the facility is slated to be operational in 2018.
The common vaccine-making process of blending flu virus strains appears to have been a factor in the nearly 10% adverse reaction rate to CSL's Fluvax among children last year. Intermingling of the
Flu vaccine maker CSL has been cited by the FDA for GMP failures spanning a lack of follow-through on raw material test failures to half-hearted investigations into adverse reactions suffered by
Blood products group CSL cited foreign exchange losses, falling royalties from a drop in sales of its cervical cancer and swine-flu vaccines for a $117 million dive in first-half profit. The
Patient convenience is a key strategy for drugmakers looking to boost sales: Think Novartis' ($NVS) newly approved multiple sclerosis treatment Gilenya, for example; as a pill rather than an injected