Manufacturer
Moderna
Pfizer-BioNTech
Janssen
Type mRNA mRNA Adenovirus type 26 (Ad26)-vectored
Indicated Ages 18 years and older 12 years and older 18 years and older
Dose 0.5 mL 0.3 mL 0.5 mL
Schedule 2 doses; 1 month apart 2 doses; 3 weeks apart 1 dose
Route Intramuscular Intramuscular Intramuscular
Appearance White to off-white suspension may contain white or translucent product-related particulates White to off-white suspension and may contain white to off-white opaque amorphous particles. Colorless to slightly yellow, clear to very opalescent.
Concentration 100 mcg of nucleosidemodified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 5×1010 viral particles
Preservative None None None
Adjuvant None None None
Excipients
  • Lipids:
    • (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], 1.93 mg
    • Cholesterol
    • 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
  • Lipids:
    • (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
  • Ethanol
  • 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 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.05 mg Polysorbate 80
Media None None PER.C6® TetR Cell Line (no animal components)
Diluent None (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose None
Packaging Multiple-dose Vials are supplied as a carton of 10 multiple-dose vials Multipl-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 date 12/2020 5/2021 3/2021