Components of

Varicella and Zoster Vaccines

Components Page
Excipients Table
Allergens Table
       
  Varicella Vaccine Herpes Zoster (Shingles) Vaccine
Name Varivax Shingrix Zostavax
Manufacturer Merck GlaxoSmithKline Merck
Viability Live, attenuated Recombinant Live, attenuated
Indicated Ages 12 mos and older 50 yrs and older 50 yrs and older
Dose 0.5 mL 0.5 mL 0.5 mL
Schedule 1 dose booster 2 doses 1 dose
Route Subcutaneous Intramuscular Subcutaneous
Appearance Clear, colorless to pale yellow liquid Opalescent, colorless to pale brownish liquid Lyophilized preparation
Concentration Oka/Merck varicella virus, ≥1350 PFU Varicella Zoster virus gE Oka/Merck varicella virus, 19,400 PFU
Preservative None None None
Adjuvant None AS01B None
Excipients • Sucrose, 25 mg
• Hydrolyzed gelatin, 12.5 mg
• Sodium chloride, 3.2 mg
• Monosodium L-glutamate, 0.5 mg
• Sodium phosphate dibasic, 0.45 mg
• Potassium phosphate monobasic, 0.08 mg
• Potassium chloride, 0.08 mg

Residual quantities of:
• MRC-5 cells including DNA and proteins
Sodium phosphate monobasic
• Ethylenediaminetetraacetic acid (EDTA)
• Neomycin
• Fetal bovine serum
• Sucrose, 20 mg
• Sodium chloride, 4.385 mg
• DOPC, 1 mg
• Potassium dihydrogen phosphate, 0.54 mg
• Cholesterol, 0.25 mg
• Sodium dihydrogen phosphate dihydrate, 0.160 mg
• Disodium phosphate anhydrous, 0.15 mg
• Dipotassium phosphate, 0.116 mg
• Polysorbate 80, 0.08 mg

Residual quantities of:
• Host cell proteins, ≤3.0%
• DNA, ≤2.1 pg
• Sucrose, 31.16 mg
• Hydrolyzed porcine gelatin, 15.58 mg
• Sodium chloride, 3.99 mg
• Monosodium L-glutamate, 0.62 mg
• Sodium phosphate dibasic, 0.57 mg
• Potassium phosphate monobasic, 0.10 mg
• Potassium chloride, 0.10 mg

Residual quantities of:
• MRC-5 cells including DNA and proteins
Neomycin
• Fetal bovine serum
Allergens • Hydrolyzed gelatin, 12.5 mg
• Neomycin, trace amounts
None • Tip caps of the prefilled syringes contain natural rubber latex
Media MRC-5 human diploid-cell culture  
Packaging • Single-dose vial and box of 10 vials diluent
• 10-pack single-dose vials and box of 10 vials of diluent
• 1 dose package of single-dose vial of antigen and single-dose vial of adjuvant without syringes or needles
• 10 dose package of 10 single-dose vials of antigen and 10 single dose vials of adjuvant
• Single and 10-pack single-dose prefilled syringes without needles
• 10-packs single-dose vials
Storage • During shipment, maintain temperature between −58 and +5F (−50 and −15C).
• Before reconstitution, store at temperature between −58 and +5F (−50 and −15C). VARIVAX may be stored at refrigerator temperature 36-46F (2-8C) for up to 72 hours prior to reconstitution. Vaccine not used within 72 hours of removal from +5F (−15C) storage should be discarded.
Adjuvant suspension component vials
• Store refrigerated 2-8C (36-46F)
• Protect vials from light
• Do not freeze
• Discard if the adjuvant suspension has been frozen

Lyophilized gE antigen component vials
• Store refrigerated 2-8C (36-46F)
• Protect vials from light
• Do not freeze
• Discard if the adjuvant suspension has been frozen
• Store and transport 36-46F (2-8C) for ≤72 hours before reconstitution. If not used withitn 72 hours of removal from +5F (−15C) storage should be discarded.
• Store diluent separately at room temperature 68-77F (20-25C) or refrigerated at 36-46F (2-8C).
• Do not freeze reconstituted vaccine.
PI date February 2017 October 2017 September 2017
      Table last updated 3/8/18