The Food and Drug Administration in the US has released details of its concerns about CSL’s influenza vaccine manufacturing processes. It says, however, that it is not aware of any findings that endanger patients.
The concerns relate to an inspection of CSL Biotherapies in Victoria during April 2010, when FDA investigators observed “deviations from current good manufacturing practice requirements in the manufacture of licensed influenza vaccines”.
The FDA says there is no direct connection between the adverse reactions of fever and febrile seizures reported in young children and the deviations noted during the inspections. The majority of the manufacturing concerns are related to the multi-dose vials that contain thimerosal. The adverse reactions that have been reported in Australia are associated with single dose syringes, which do not contain thimerosal, it says.
The FDA also says it is collaborating with TGA, other international regulatory counterparts, and CSL to assess the implications of the adverse reactions associated with CSL’s 2010 seasonal trivalent influenza vaccine, which contains the 2009 H1N1 and two other influenza virus strains, and has not yet been approved by FDA for the upcoming 2010-2011 influenza season. (For a previous Croakey report on these issues, see here).
The FDA also released its letter to CSL’s CEO, Brian McNamee, which says: “We would like to meet with you and other senior management at CSL Biotherapies to further discuss the issues cited in this letter and how you will address them going forward. Given the potential contributions of safe, pure, and potent vaccines to the public health, we encourage frequent interactions between your technical staff and FDA in an effort to help CSL Biotherapies move forward with corrective actions as rapidly as possible.”
According to the FDA: The observed deviations involved failure by the company to: 1) thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet specifications; 2) assure that drug product containers or closures do not react with substances contained in the product and do not leach into the product; 3) assure that reserve samples from representative sample lots or batches are examined at least once a year for evidence of deterioration; and 4) establish testing procedures designed to assure components conform to appropriate standards of identity strength, quality, and purity.
What strikes me as particularly interesting about this development is the way the FDA has publicly released the information. It’s a far cry from how the TGA and health authorities in Australia tend to handle these matters.
I couldn’t find anything on these issues from searching the TGA site just now, but perhaps I just don’t know where to look…
Update, July 2. Meanwhile, this report says the US is about to incinerate 40 million unused doses of swine flu vaccine. Up in smoke…