Influenza virus vaccine, inactivated; Begrivac
Status: marketed in Germany and U.K.
Organizations involved:
Chiron Corp. – R&D; Tech.; Former
Novartis AG – Manuf.; R&D; Tech.; World mark.; Parent
Behringwerke AG – Former
Cross ref.: See the Influenza Virus Vaccines entry, and the entries for other influenza vaccines.
Description: Influenza vaccine from Chiron Corp./Novartis facilities in Marburg, Germany, is a conventional trivalent split-virion vaccine. This is one of multiple influenza vaccines manufactured by Chiron/Novartis.
Nomenclature: Influenza vaccine/Novartis Germany [BIO]; Begrivac [TR]; Influenza Virus Vaccine [FDA, if it were approved in the U.S.]
Companies.: The vaccine was originally developed and manufactured by Behringwerke AG, which was acquired by Chiron Corp., which merged into Novartis AG in spring 2006. The vaccine is manufactured at facilities in Marburg, Germany, and is marketed by Novartis, primarily in Germany and U.K. Both thimerosal (preservative)-free prefilled syringes and thimerosal-preserved multi-dose vials are planned to be marketed in the U.S.
Status: Begrivac was the first preservative-free influenza vaccine.
In July 2005, Chiron announced a halt in the manufacture of Begrivac for the 2005/6 flu season due to contamination problems, with this following its problems manufacturing Fluvirin at its U.K. facilities affecting the 2004-2005 flu season (see Fluvirin entry above). Chiron originally reduced its expected output of Begrivac for the upcoming 2005-2006 flu season to 4 million doses from 12 million, and later in July this announced a complete halt to manufacture and that Begrivac would not be available for the 2005-06 flu season. Begrivac manufacture resumed for the 2006/7.
Market: Chiron reported no sales of Begrivac in 2005, compared to $53 million sales in 2004. Novartis does not report sales of specific influenza vaccines.
Index Terms:
Companies involvement:
Full monograph
473 Influenza Vaccine/Novartis Germany
Nomenclature:
Influenza vaccine/Novartis Germany [BIO]
Begrivac [TR]
Influenza Virus Vaccine [FDA]
FDA Class: Biologic BLA
biopharmaceutical products
chicken source materials
vaccines, inactivated
vaccines, subunit
vaccines, viral
chicken embryo (egg) culture
influenza virus
virus culture
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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