PreFluCel influenza vaccine regulatory update

EMA's CHMP recommended updating the marketing approval for Baxter's PerFluCel influenza vaccine to include changes to the manufacturing process after Baxter voluntarily recalled batches of the product in October due to reports of serious adverse events, including cases of anaphylactic reactions, influenza-like symptoms and eye reactions. CHMP said the company "appropriately investigated" the causes of the problems and identified corrective measures as well as additional manufacturing steps to address the issue. CHMP recommended Baxter submit an application for approval of the changes and conduct a study to show the vaccine produced under the new process is as effective at stimulating the production of antibodies against influenza as was seen at the time of initial authorization and has at least as good a safety profile as other authorized influenza vaccines. ...