Lot Release (Biologics) > Influenza Virus Vaccine for the 2013-2014 Season

Lot Release (Biologics) > Influenza Virus Vaccine for the 2013-2014 Season

Influenza Virus Vaccine for the 2013-2014 Season

Cumulative 2013/2014 Season Lot Release Status (Updated 8/8/2013)
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.

Manufacturer	Total Number of Lots Released by FDA
AFLURIA CSL Limited	15
Fluarix GlaxoSmithKline Biologicals	0
Fluarix - Quadravalent GlaxoSmithKline Biologicals	6
Flublok Protein Sciences Corporation	0
Flucelvax, Novartis Vaccines and Diagnostics, Inc.	0
FluLaval ID Biomedical Corp. of Quebec	10
FluMist Quadrivalent MedImmune, LLC	9
Fluvirin Novartis Vaccines and Diagnostics Limited	0
Fluzone Sanofi Pasteur, Inc.	34
Fluzone - Quadravalent Sanofi Pasteur, Inc.	0

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Rockville, Maryland, on February 27, 2013, to select the influenza viruses for the composition of the influenza vaccine for the 2013-2014 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 2012-2013 vaccines, and the availability of candidate strains and reagents.|
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2013-2014 influenza season contain the following:

• an A/California/7/2009 (H1N1)-like virus;
• an (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011;
• a B/Massachusetts/2/2012-like virus.

The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:

• a B/Brisbane/60/2008-like virus

Influenza Virus Vaccine for the 2013-2014 Season

Cumulative 2013/2014 Season Lot Release Status (Updated 8/8/2013)
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.

Manufacturer	Total Number of Lots Released by FDA
AFLURIA CSL Limited	15
Fluarix GlaxoSmithKline Biologicals	0
Fluarix - Quadravalent GlaxoSmithKline Biologicals	6
Flublok Protein Sciences Corporation	0
Flucelvax, Novartis Vaccines and Diagnostics, Inc.	0
FluLaval ID Biomedical Corp. of Quebec	10
FluMist Quadrivalent MedImmune, LLC	9
Fluvirin Novartis Vaccines and Diagnostics Limited	0
Fluzone Sanofi Pasteur, Inc.	34
Fluzone - Quadravalent Sanofi Pasteur, Inc.	0

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Rockville, Maryland, on February 27, 2013, to select the influenza viruses for the composition of the influenza vaccine for the 2013-2014 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 2012-2013 vaccines, and the availability of candidate strains and reagents.|
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2013-2014 influenza season contain the following:

• an A/California/7/2009 (H1N1)-like virus;
• an (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011;
• a B/Massachusetts/2/2012-like virus.

The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:

• a B/Brisbane/60/2008-like virus