If it were not so serious, the FDA could be telling Australian vaccinemaker CSL "I told you so," after a two-year study apparently confirmed what the agency suggested in a warning letter in 2011: CSL's manufacturing process had something to do with the adverse reactions to its Fluvax in young children.
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. CSL has been unable to get Fluvax licensed for children under age 5, since health authorities in Australia suspended its use in response to reports of hospitalizations. Doctors reported at the time there were two or three children hospitalized from reactions to Fluvax for every flu-related admission avoided, Bloomberg says.
While the vaccines must contain virus components, "it appears that components of the inactivated virus retained in Fluvax in 2010 overstimulated the developing immune systems of some young children compared to previous seasons," Darryl Maher, vice president of medical and research at CSL's biotherapies division, said in a statement.
The FDA in 2010 summoned CSL executives after inspectors found problems at the manufacturing plant. It then sent a warning letter chastising the company, for, among other things, having no documentation that it had investigated possible ties between manufacturing and the adverse reactions.
Maher said CSL is now investigating how to adjust its manufacturing so it doesn't happen again. Until "CSL and the regulators are fully confident that our manufacturing process can consistently produce a safe and effective influenza vaccine for children," CSL will support age restrictions in all markets, he said.
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