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BNT162b2
3.2.P.1 Description and Composition of the Drug Product
PFIZER CONFIDENTIAL
Page 13.2.P.1. DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT
The BNT162b 2 drug product issupplied as a preservative -free, multi- dose concentrate to be
diluted for intramuscular injection , containing 6 doses. The drug product is a sterile
dispersion of RNA -containing lipid nanoparticles (LNPs ) in aqueous cry oprotectant buffer .
Each vial, containing 0.45 mL of the drug product at pH 7.4 is designed to contain a total of
6doses after dilutio n by addition of 1.8 mL of sterile 0.9% sodium chloride solution, with
each dose containing 30 µg of RNA in 0.3 mL . There is no manufacturing overage.
The drug product is supplied in a 2 mL glass vial sealed with a bromobut yl rubber stopper
and an aluminum seal with flip -off plastic cap.
The composition of the drug product, including amounts per vial and function and quality
standar d applicable to each component, are given in Table 3.2. P.1-1.
090177e19703931d\Approved\Approved On: 12-May-2021 09:11 (GMT)
FDA-CBER-2021-5683-1150803
BNT162b2
3.2.P.1 Description and Composition of the Drug Product
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.1-1. Composition of BNT162b 2 Drug Product, multi- dose vial
(225 µ g/vial )
Nam e of Ingredients Reference to
StandardFunction Concentration
(mg/mL)Amount
per vialAmount per
dose
BNT162b 2drug
substanceIn-house
specificationActive ingredient 0.5 225µg 30µg
ALC -0315 In-house
specificationFunctional lipid 7.17 3.23 mg 0.43 mg
ALC -0159 In-house
specificationFunctional lipid 0.89 0.4mg 0.05mg
DSPC In-house
specificationStructural lipid 1.56 0.7mg 0.09mg
Cholesterol Ph. Eur. and/or
USP-NFStructural lipid 3.1b1.4mg 0.2 mg
Sucrose USP-NFandPh.
Eur.Cryoprotectant 103b46mg 6mg
Sodium chloride USP-NFandPh.
Eur.Buffer component 6 2.7 mg 0.36 mge
Potassium chloride USP-NFand/or Ph.
Eur.aBuffer component 0.15 0.07 mg 0.01 mg
Dibasic sodium
phosphate, dihydratecUSP-NF andPh.
Eur.Buffer component 1.08 0.49 mg 0.07 mg
Monobasic potassium
phosphatedUSP-NF and/or Ph.
Eur.aBuffer component 0.15 0.07 mg 0.01 mg
Water for Injection USP-NF andPh.
Eur.Solvent/vehicle q.s. q.s. q.s.
a.Supplier Certificate of Analysis confirms compliance to both USP -NF and Ph. Eur., however incoming
testing may be performed only in accordance w ith a site’s local compendia.
c.Dibasic s odium phosphate, dihydrate is named as disodium phosphate dihydrate in the Ph. Eur.
d.Monobasic potassium phosphate is named as potassium dihydrogen phosphate in the Ph. Eur.
e.The diluent (0.9% sodium chloride Injection) contributes an additional 2.16 mg per dose .
Abbreviations:
ALC -0315 = ((4 -hydroxybutyl)azanediyl)bis(hexane -6,1-diyl)bis(2 -hexyldecanoate)
ALC -0159 = 2 -[(polyethylene glycol) -2000] -N,N-ditetradecylacetamide
DSPC = 1,2 -distearoyl -sn-glycero -3-phosphocholine
q.s. = quantum satis (as much as may suffice)
HEPES = 4 -(2-hydroxyethyl) -1-piperazineethanesulfonic acid
EDTA = edetate disodium dihydrate
090177e19703931d\Approved\Approved On: 12-May-2021 09:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1150804