Novartis Flu Vaccine Nightmare Ends; Worries Over Pharmacovigilance Overreaction Remain
This article was originally published in The Pink Sheet Daily
As Italy, France, Switzerland and Austria lift bans on two Novartis flu vaccines, Germany’s more sober approach to specific batch suspensions proves more palatable for manufacturers.
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CSL’s (formerly Novartis’) flu vaccine was shown to be non-inferior, but not superior, on immunogenicity endpoints compared to an unadjuvanted vaccine in individuals ages 65 years and older.
GSK believes detrimental government policies such as reference pricing and tendering in the vaccines sector are threatening this part of the pharmaceutical industry, and patient health.
Quality issues that have seen two Novartis influenza vaccines suspended in a number of European countries have highlighted the shortfalls of a co-ordinated European approach to such problems.