Trouble may be brewing for a vaccine supplier out of Australia according to new reports. The FDA has apparently written a warning letter to Australian vaccine maker, CSL Biotherapies, in regards to it’s influenza vaccine.The letter written June 15, 2011 accuses CSL of failing to adequately investigate why its Fluvax® influenza vaccine last year caused a sharply elevated rate of febrile convulsions in some children under the age of five. “There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 lots associated with Adverse Event reports compared to lots from previous seasons” the letter states.
“We are taking the warning letter very seriously,” said Jeff Davies, Executive Vice President of CSL Biotherapies, in a prepared statement. “Our technical team is in the process of preparing more substantive detail about our corrective actions to meet the FDA’s requirements.”
The FDA sent inspectors to CSL’s manufacturing plant in Melbourne, Australia in June following adverse reactions to the flu vaccine reported in 2010. After a second visit last March, the FDA issued its warning letter, which stated that CSL’s Quality Control Unit had failed to “fulfill its responsibility to assure the identity, strength, quality and purity of your monovalent influenza bulks and final drug products.”
A recent study by Paul Armstrong at the Department of Health in Western Australia and colleagues reported that the rate of febrile convulsions among young children was 3.3 per 1000 doses, 200 times that reported in a U.S. influenza vaccine safety study. The same study indicated that febrile convulsions were linked to CSL’s vaccine but not to equivalent vaccines such as Solvay’s Influvac® and Sanofi Pasteur’s Vaxigrip®.
According to the letter, apparently there were many concerns with the vaccine. Specifically, CSL’s manufacturing methods hindered the ability to root out the cause of the adverse reactions. CSL prepares the vaccine by killing flu virus and splitting it. The degree of splitting could influence how the vaccine triggers an immune response, said one influenza vaccine expert who asked for anonymity. But FDA says the degree of splitting was not determined in different batches. “You failed to determine optimal splitting conditions for new virus strains before the strains are used in production,” FDA said in its letter to CSL.
The concerns about Fluvax® are causing trouble in Australia’s biomedical research community. “I’ve never been convinced by the cost-benefit equations for vaccinating healthy people or children against influenza, but one of the things I didn’t think was that there was a problem with the manufacturing process,” says Peter Collignon, Director of Infectious Diseases at Australian National University Medical School in Canberra.
He also says that he’s troubled by the fact that FDA, not TGA (Therapeutic Goods Administration), first aired concerns about the vaccine. “This raises questions about the transparency of our own regulator,” he says.
On June 21, TGA revealed that it had sent letters since May 2010 to CSL after five audits flagged problems ranging from “inadequate investigations” to “poor management of corrective and preventative actions”, and “inadequate” cleaning and testing regimes. Davies of CSL told the media that TGA was “fully aware” of the issues, but didn’t feel it was appropriate to release correspondence with the regulatory agency.
FDA’s warning letter is obviously causing concern. It “means they’ll either get it right pretty quickly or they won’t be making these vaccines anymore,” says Collignon. “If you can’t market in the U.S. because it’s not safe enough, then it’s not going to be very satisfactory for Australia either.”
The letter gave CSL 15 days to respond to its concerns or risk losing its license to sell Fluvax® in the United States, where it is marketed under the name “Afluria“.
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