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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on product submitted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FD7220
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:41:21 -04'00'
For Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on
product submitted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FE3592
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:40:29 -04'00'
For Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on product submitted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FF2587
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:39:41 -04'00'
For Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on product submitted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FF2588
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:38:42 -04'00'
Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on product submitted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FF2590
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:37:00 -04'00'
For Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage RoadKalamazoo, Michigan 49001
Report on action taken on product subm
itted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FF2593
Sincerely,
John A. Eltermann -
SDigitally signed by John A. Eltermann -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:36:07 -04'00'
For Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
August 23, 2021
Christopher Nagra
BioNTech Manufacturing GmbH
7000 Portage Road
Kalamazoo, Michigan 49001
Report on action taken on product subm itted:
Released
COVID-19 Vaccine, mRNA
Lot No(s).:
FF8841
Sincerely,
John A. Eltermann -SDigitally signed by John A. Eltermann -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23 09:35:05 -04'00'
Peter Marks, MD, PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
125742-0 /2229 /FC
DEPARTMENTOFHEALTH&HUMANSERVICES
FoodandDrugAdministration
SilverSpring MD20993
October4,2021
ChristopherNagra
BioNTechManufacturingGmbH
7000
PortageRoad
Kalamazoo,Michigan49001
Reportonactiontakenonproductsubmitted:
Released
COVID-19Vaccine,mRNA
LotNo(s).:
FH8027
Sincerely,
Joseph A. Quander -SDigitally signed by Joseph A. Quander -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300068705, cn=Joseph A. Quander -S Date: 2021.10.04 11:35:03 -04'00'
For PeterMarks,MD,PhD
Director
CenterforBiologicsEvaluationandResearch
U.S.FoodandDrugAdministration
125742-0/2229/FC
DEPARTMENTOFHEALTH&HUMANSERVICES
FoodandDrugAdministration
SilverSpring MD20993
October4,2021
ChristopherNagra
BioNTechManufacturingGmbH
7000PortageRoadKalamazoo,Michigan49001
Reportonaction
takenonproductsubmitted:
Released
COVID-19Vaccine,mRNA
LotNo(s).:
FH8028
Sincerely,
Joseph A. Quander -SDigitally signed by Joseph A. Quander -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300068705, cn=Joseph A. Quander -S Date: 2021.10.04 11:33:35 -04'00'
For PeterMarks,MD,PhD
Director
CenterforBiologicsEvaluationandResearch
U.S.FoodandDrugAdministration
125742-0/2229/FC