miércoles, 5 de diciembre de 2012

Lot Release (Biologics) > Influenza Virus Vaccine for the 2012-2013 Season

Lot Release (Biologics) > Influenza Virus Vaccine for the 2012-2013 Season

Influenza Virus Vaccine for the 2012-2013 Season

Cumulative 2012/2013 Season Lot Release Status (Updated 12/5/2012)
Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. For information on flu vaccine distribution schedules, please contact the manufacturers directly.
ManufacturerTotal Number of Lots Released by FDA
AFLURIA
CSL Limited
37
Fluarix
GlaxoSmithKline Biologicals
23
FluLaval
ID Biomedical Corp. of Quebec
16
FluMist
MedImmune, LLC
27
Agriflu
Novartis Vaccines and Diagnostics Incorporated
3
Fluvirin
Novartis Vaccines and Diagnostics Limited
48
Fluzone
Sanofi Pasteur, Inc.
77

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on February 28, 2012, to select the influenza viruses for the composition of the influenza vaccine for the 2012-2013 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2011-2012 vaccines, and the availability of candidate strains and reagents.
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2012-2013 influenza season contain the following:
  • an A/California/7/2009 (H1N1)-like virus;
  • an A/Victoria /361/2011 (H3N2)-like virus;
  • a B/Wisconsin /1/2010-like virus.


The committee also recommended the following additional B strain for inclusion with the three strains included in the trivalent formulation for quadrivalent formulation influenza vaccines:
  • a B/Brisbane/60/2008-like virus
A quadrivalent influenza vaccine will not be available for the 2012-2013 influenza season.

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