Components of COVID-19 Vaccines

Updated May 11, 2021

Components Page | Excipients Table | Allergens Table

TypemRNAmRNAAdenovirus type 26 (Ad26)-vectored
Indicated Ages18 years and older12 years and older18 years and older
Dose0.5 mL0.3 mL0.5 mL
Schedule2 doses; 1 month apart2 doses; 3 weeks apart1 dose
AppearanceWhite to off-white suspension may contain white or translucent product-related particulatesWhite to off-white suspension and may contain white to off-white opaque amorphous particles.Colorless to slightly yellow, clear to very opalescent.
Concentration100 mcg of nucleosidemodified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-25×1010 viral particles
-(SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], 1.93 mg
-1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC])
Tromethamine, 0.31 mg
Tromethamine hydrochloride, 1.18 mg
Acetic acid, 0.043 mg
Sodium acetate, 0.12 mg
Sucrose, 43.5 mg
-(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.43 mg
-2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.05 mg
-1,2-distearoyl-sn-glycero-3-phosphocholine, 0.09 mg
-Cholesterol, 0.2 mg
Potassium chloride, 0.01 mg
Phosphate Buffer:
-Dibasic sodium phosphate dihydrate, 0.07 mg
-Sodium chloride, 0.36 mg
-Monobasic potassium phosphate, 0.01 mg
Sucrose, 6 mg
Citric acid monohydrate
Trisodium citrate dihydrate
2-hydroxypropyl-β-cyclodextrin (HBCD)
Polysorbate 80
Sodium chloride
Sodium hydroxide
Hydrochloric acid
Amino Acids (from media)
Allergens(SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], 1.93 mg2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.05 mgPolysorbate 80
MediaNoneNonePER.C6® TetR Cell Line (no animal components)
DiluentNone(0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per doseNone
PackagingMultiple-dose Vials are supplied as a carton of 10 multiple-dose vialsMultipl-dose Vials (after dilution each vial contains 5 doses of 0.3 mL)Multiple-dose Vials containing 5 doses (5 mL each)
Storage• Stored frozen between -25°C to -15°C (-13°F to 5°F).
• Do not store on dry ice or below -40ºC (-40ºF).
• Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
• Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours.
• Do not refreeze once thawed.
• Prior to dilution, store at -80°C to -60°C (-112°F to -76°F).
• After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
• Discard after 6 hours.
• The vials should be protected from light.
• Unpunctured vials may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.
• After the first dose has been withdrawn, the vial should be held between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours.
• The vial should be discarded if the vaccine is not used within these times.
PI date12/20205/20213/2021