CSL vaccine probe likely to rule out manufacturing errors
pharmafile | September 6, 2011 | News story | Manufacturing and Production |Â Â CSL Biotherapies, flu, pharma manufacturing news, vaccinesÂ
CSL Biotherapies has said that manufacturing errors were likely not to blame for febrile seizures in children who received its banned flu vaccine Fluvax, but that the combination of flu virus strains contained within it were a contributing factor.
The company recalled the vaccine last year after 1 out of every 100 children who received it suffered fits. It was the first vaccine to combine the recommended seasonal vaccine strains with the H1N1 swine flu strain.
Earlier, it had been speculated that some breakdown in manufacturing process had contributed to the adverse reactions, but now CSL says that preliminary indications from its 18-month investigation point to interactions between the three strains.
“Comprehensive investigations into our manufacturing operations have not identified any change or deviation in our standard registered manufacturing process that could have contributed to the increased reactions,” a spokesperson for the company told The Australian newspaper.
The company probe, for which the US Centers for Disease Control and Prevention (CDC) performed sample analysis, has not however been able to establish the mechanism behind the adverse reactions.
In June 2010, the FDA sent CSL a letter citing a number of quality deficiencies in the Parkville manufacturing facility in Victoria, Australia, where the Fluvax vaccine is produced. The letter focused however on observations made in the manufacture of a seasonal flu vaccine called Afluria and an H1N1 monovalent product, rather than Fluvax.
The agency followed that up in June 2011 with a warning that it could block imports of products made at the plant into the USA, because the deficiencies in good manufacturing practice had not been completely addressed and also because CSL had not carried out a sufficiently thorough investigation into the Fluvax-related febrile fits.
Phil Taylor
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