Certificate of Analysis

   

Batch Number: Date Generated: 19-Jan-2022

Product Name: COMIRNATY"® Tris/Sucrose, 30 mcg/0.3 mL Dispersion for Injection (COMIRNATY
O.img/mi 10x2.25ml GVL EU)

Material Number

Date of Manufacture: 03,12.2021
Expiration Date: 31.05.2022

Importing Country:-All countries that accepted Marketing -Authorisation Application

 

    
  

COMPOSITION AND STRENGTH
Appearance (Visual) |
Appearance White to off-white suspension | Meets test

Appearance (Particles)
| Visible Particulates
i

 
 
     
   
 
 

   

May contain white to off-white opaque, | Meets test
amorphous particles |

Subvisible Particulate Matter
Subvisible particles

Potentiometry
| pH
Osmometry
Osmbolality

Dynamic Light Scattering (DLS)

LNP Size

LNP Polydispersity

Fluorescence assay

RNA Encapsulation

RNA Content
HPLC-CAD

ALC-0315 Content

ALC-0159 Content

DSPC content
Cholesterol content

Container content
Vial content (volume)

IDENTITY

HPLC-CAD
Lipid identities

 
 
   
 
  
 
   

   

  
 
 
 
 
 
 
 
   
 
    

 

 

   
 
   
       
  
 
 

 
  

 
    

 
  

Retention times consistent with Meets test
references {ALC-0315, ALC-0159,

Cholesterol, DSPC)

   

  
 

RT-PCrRO
Identity of encoded RNA sequence

  
 
     

  

Identity confirmed Identity confirmed

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an nern een An sen aememannn msn

‚REGISTERED: ‚TESTS.;

POTENCY

Cell-based Flow Cytometry
In Vitro Expression.

| Capillary Gel Electrophoresis
| RNA Integrity

ADVENTITIOUS AGENTS
Endotoxin (LAL)
Baäcterial endotoxin

   

\ ————
; Sterility |

| Sterility No.growth detected No growth detected

IHEREBY CERTIFY THAT THE ABOVE INFORMATION IS AUTHENTIC AND ACCURATE.

 

 

 

QUALITY ASSURANCE REVIEW: THE BATCH DOCUMENTATION FOR THE ABOVE LISTED LOT OF
PRODUCT HAS BEEN REVIEWED AND ALL ASPECTS WERE FOUND ACCEPTABLE. ALL
DEVIATIONS HAVE BEEN THOROUGHLY REVIEWED AND APPROVED. THE RESULTS OF ALL IN-
PROCESS TESTING MEET THE REQUIREMENTS. THE BATCH HAS ALSO BEEN TESTED AND
CONFORMS TO ALL MAA SPECIFIGATIONS AND INTERNAL CONTROL TARGETS. ALL BATCH
DOCUMENTATION IS RETAINED AT PFIZER MANUFACTURING BELGIUM NV AND AVAILABLE
FOR REVIEW.

MANUFACTURING/PACKAGING REVIEW: THE BATCH DOCUMENTATION FOR THE ABOVE LISTED
LOT OF PRODUCT HAS BEEN REVIEWED AND ALL ASPECTS OF THE MANUFACTURING AND
PACKAGING WERE JUDGED ACCEPTABLE AND CONSISTENT WITH THE REQUIREMENTS
OUTLINED IN THE MAA AND MASTER MANUFACTURING DOCUMENTS. ALL MANUFACTURING
DEVIATIONS HAVE BEEN THOROUGHLY REVIEWED AND APPROVED.

run

ALL ACTIVITIES ARE PERFORMED BY QUALIFIED PEOPLE, UNDER THE SUPERVISION OF THE
QUALIFIED PERSON.

Prepared by:

    
  

Name:

Signatu Date: AdJ/eAl2o8

Approved by:

Name:

Title: ® @ ea che

Signatu Date: ASfer fLos 22.

Documentation is considered PROPRIETARY and is made available for business operations and review

———by-employees-and regulatoryagencies: Distribution to third ‘parties without prior permission is prohibited”

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