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Vaccine Excipient Summary Excipients Included in U.S. Vaccines, by Vaccine
In addition to weakened or killed disease antigens (viruses or bacteria), vaccines contain very small amounts of other ingredients – excipients.
Some excipients are added to a vaccine for a specific purpose. These include:
Preservatives, to prevent contamination. For example, thimerosal.
Adjuvants, to help stimulate a stronger immune response. For example, aluminum salts.
Stabilizers, to keep the vaccine potent during transportation and storage. For example, sugars or gelatin.
Others are residual trace amounts of materials that were used during the manufacturing process and removed. These can include:
Cell culture materials, used to grow the vaccine antigens. For example, egg protein, various culture media.
Inactivating ingredients, used to kill viruses or inactivate toxins. For example, formaldehyde.
Antibiotics, used to prevent contamination by bacteria. For example, neomycin.
The following table lists substances, other than active ingredients (i.e., antigens), shown in the manufacturers’ package insert (PI) as being contained in the final formulation of each vaccine. Note: Substances used in the manufacture of a vaccine but not listed as contained in the final product (e.g., culture media) can be found in each PI, but are not shown on this table. Each PI, which can be found on the FDA’s website (see below) contains a description of that vaccine’s manufacturing process, including the amount and purpose of each substance. In most PIs, this information is found in Section 11: “Description.”
All information was extracted from manufacturers’ package inserts.
The date shown in the Date column of the table is the edition date of the PI is use in February 2020.
If a date contains an asterisk (*), the PI was not dated and this is the date the PI was reviewed for this table.
If in doubt about whether a PI has been updated since this table was prepared, check the FDA’s website at:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm
All influenza vaccine in this table are 2019-20 northern hemisphere formulation.
Vaccine
Date
Contains
Adenovirus
10/2019
monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum albumin, potassium phosphate, plasdone C, anhydrous lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate, cellulose acetate phthalate, alcohol, acetone, castor oil, FD&C Yellow #6 aluminum lake dye
Anthrax (Biothrax)
11/2015
aluminum hydroxide, sodium chloride, benzethonium chloride, formaldehyde
BCG (Tice)
2/2009
glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron ammonium citrate, lactose
Cholera (Vaxchora)
6/2016
ascorbic acid, hydrolyzed casein, sodium chloride, sucrose, dried lactose, sodium bicarbonate, sodium carbonate
Dengue (Dengvaxia)
6/2019
sodium chloride, essential amino acids (including L-phenylalanine), non-essential amino acids, L-arginine hydrochloride, sucrose, D-trehalose dihydrate, D-sorbitol, trometamol, urea
DT (Sanofi)
6/2018
aluminum phosphate, isotonic sodium chloride, formaldehyde
DTaP (Daptacel)
12/2018
aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol
DTaP (Infanrix)
12/2018
formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80)
DTaP-IPV (Kinrix)
12/2018
Formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B
DTaP-IPV (Quadracel)
1/2019
formaldehyde, aluminum phosphate, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate, bovine serum albumin
DTaP-HepB-IPV (Pediarix)
2/2020*
formaldehyde, aluminum hydroxide, aluminum phosphate, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein
DTaP-IPV/Hib (Pentacel)
1/2019
aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate
DTaP-IPV-Hib-HepB (Vaxelis)
12/2018
polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, ammonium thiocyanate, yeast protein, aluminum
Ebola Zaire (ERVEBO)
2/2020*
Tromethamine rice-derived recombinant human serum albumin, host cell DNA benzonase, rice protein
Hib (ActHIB)
5/2019
sodium chloride, formaldehyde, sucrose
Hib (Hiberix)
4/2018
formaldehyde, sodium chloride, lactose
Vaccine
Date
Contains
Hib (PedvaxHIB)
10/2018
amorphous aluminum hydroxyphosphate sulfate, sodium chloride
Hep A (Havrix)
2/2020*
MRC-5 cellular proteins, formalin, aluminum hydroxide, amino acid supplement, phosphate-buffered saline solution, polysorbate 20, neomycin sulfate, aminoglycoside antibiotic
Hep A (Vaqta)
12/2018
amorphous aluminum hydroxyphosphate sulfate, non-viral protein, DNA, bovine albumin, formaldehyde, neomycin, sodium borate, sodium chloride, other process chemical residuals
Hep B (Engerix-B)
2/2020*
aluminum hydroxide, yeast protein, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate
Hep B (Recombivax)
12/2018
formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, yeast protein
Hep B (Heplisav-B)
2017
yeast protein, yeast DNA, deoxycholate, phosphorothioate linked oligodeoxynucleotide, sodium phosphate, dibasic dodecahydrate, sodium chloride, monobasic dehydrate, polysorbate 80
Hep A/Hep B (Twinrix)
2/2020*
MRC-5 cellular proteins, formalin, aluminum phosphate, aluminum hydroxide, amino acids, sodium chloride, phosphate buffer, polysorbate 20, neomycin sulfate, yeast protein, water
Human Papillomavirus (HPV) (Gardasil 9)
10/2018
amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, yeast protein
Influenza (Afluria) Quadrivalent
12/2019
sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, monobasic potassium phosphate, potassium chloride, calcium chloride, sodium taurodeoxycholate, ovalbumin, sucrose, neomycin sulfate, polymyxin B, beta-propiolactone, hydrocortisone thimerosal (multi-dose vials)
Influenza (Fluad)
4/2019
squalene, polysorbate 80, sorbitan trioleate, sodium citrate dehydrate, citric acid monohydrate, neomycin, kanamycin, barium, hydrocortisone, egg proteins, cetyltrimethylammonium bromide (CTAB), formaldehyde
Influenza (Fluarix) Quadrivalent
©2019
octoxynol-10 (TRITON X-100), α-tocopheryl hydrogen succinate, polysorbate 80 (Tween 80), hydrocortisone, gentamicin sulfate, ovalbumin, formaldehyde, sodium deoxycholate, sodium phosphate-buffered isotonic sodium chloride
Influenza (Flublok) Quadrivalent
4/2019
sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, polysorbate 20 (Tween 20), baculovirus and Spodoptera frugiperda cell proteins, baculovirus and cellular DNA, Triton X-100
Influenza (Flucelvax) Quadrivalent
8/2019
Madin Darby Canine Kidney (MDCK) cell protein, phosphate buffered saline, protein other than HA, MDCK cell DNA, polysorbate 80, cetyltrimethlyammonium bromide, and β-propiolactone, Thimerosal (multi-dose vials)
Influenza (Flulaval) Quadrivalent
2/2020*
ovalbumin, formaldehyde, sodium deoxycholate, α-tocopheryl hydrogen succinate, polysorbate 80, thimerosal (multi-dose vials), phosphate-buffered saline solution
Influenza (Fluzone) Quadrivalent
2019
formaldehyde, egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose vials)
Influenza (Fluzone) High Dose
1/2019
egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered isotonic sodium chloride solution, formaldehyde
Influenza (FluMist) Quadrivalent
8/2019
monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, ovalbumin, gentamicin sulfate, ethylenediaminetetraacetic acid (EDTA)
Japanese Encephalitis (Ixiaro)
9/2018
aluminum hydroxide, protamine sulfate, formaldehyde, bovine serum albumin, Vero cell DNA, sodium metabisulphite, Vero cell protein
Meningococcal (MenACWY-Menactra)
4/26/18
sodium phosphate-buffered isotonic sodium chloride solution, formaldehyde, diphtheria toxoid
Meningococcal (MenACWY-Menveo)
2/2020*
formaldehyde, CRM197 protein
Meningococcal (MenB – Bexsero)
2/2020*
aluminum hydroxide, sodium chloride, histidine, sucrose, kanamycin
Meningococcal (MenB – Trumenba)
2018
polysorbate 80, aluminum phosphate, histidine buffered saline
Vaccine
Date
Contains
MMR (MMR-II)
2/2020*
vitamins, amino acids, fetal bovine serum, sucrose, glutamate, recombinant human albumin, neomycin, sorbitol, hydrolyzed gelatin, sodium phosphate, sodium chloride, WI-38 human diploid lung fibroblasts
MMRV (ProQuad) (Frozen: Recombinant Albumin)
2/2020*
MRC-5 cells including DNA and protein, sucrose, hydrolyzed gelatin, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, recombinant human albumin, sodium bicarbonate, potassium phosphate monobasic, potassium chloride; potassium phosphate dibasic, neomycin, bovine calf serum
MMRV (ProQuad) (Frozen: Human Serum Albumin)
2/2020*
MRC-5 cells including DNA and protein, sucrose, hydrolyzed gelatin, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, human albumin, sodium bicarbonate, potassium phosphate monobasic, potassium chloride; potassium phosphate dibasic, neomycin, bovine calf serum
MMRV (ProQuad) (Refrigerator Stable)
10/2018
MRC-5 cells including DNA and protein, sucrose, hydrolyzed gelatin, urea, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate, recombinant human albumin, sodium bicarbonate, potassium phosphate, potassium chloride, neomycin, bovine serum albumin
Pneumococcal (PCV13 – Prevnar 13)
8/2017
CRM197 carrier protein, polysorbate 80, succinate buffer, aluminum phosphate
Pneumococcal (PPSV-23 – Pneumovax)
2/2020*
isotonic saline solution, phenol
Polio (IPV – Ipol)
2/2020*
calf bovine serum albumin, 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, polymyxin B, M-199 medium
Rabies (Imovax)
10/2019
human albumin, neomycin sulfate, phenol red, beta-propiolactone
Rabies (RabAvert)
©2018
chicken protein, polygeline (processed bovine gelatin), human serum albumin, potassium glutamate, sodium EDTA, ovalbumin, neomycin, chlortetracycline, amphotericin B
Rotavirus (RotaTeq)
2/2017
sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, fetal bovine serum [DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.]
Rotavirus (Rotarix)
2/2020*
dextran, Dulbecco’s Modified Eagle Medium (sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red), sorbitol, sucrose, calcium carbonate, sterile water, xanthan [Porcine circovirus type 1 (PCV-1) is present in Rotarix. PCV-1 is not known to cause disease in humans.]
Smallpox (Vaccinia) (ACAM2000)
3/2018
HEPES, 2% human serum albumin, 0.5 - 0.7% sodium chloride USP, 5% Mannitol USP, neomycin, polymyxin B, 50% Glycerin USP, 0.25% phenol USP
Td (Tenivac)
11/2019
aluminum phosphate, formaldehyde, sodium chloride, water
Td (TDVAX)
9/2018
aluminum phosphate, formaldehyde, thimerosal
Tdap (Adacel)
1/2019
aluminum phosphate, formaldehyde, 2-phenoxyethanol, glutaraldehyde, water
Tdap (Boostrix)
2/2020*
formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80
Typhoid (Typhim Vi)
3/2014
formaldehyde, phenol, polydimethylsiloxane, disodium phosphate, monosodium phosphate, sodium chloride, sterile water
Typhoid (Vivotif Ty21a)
9/2013
sucrose, ascorbic acid, amino acids, lactose, magnesium stearate. gelatin
Varicella (Varivax) Frozen
2/2020*
MRC-5 human diploid cells, including DNA & protein, sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, sodium phosphate monobasic, potassium phosphate monobasic, potassium chloride, EDTA, neomycin, fetal bovine serum
Varicella (Varivax) Refrigerator Stable
10/2018
MRC-5 human diploid cells, including DNA & protein, sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, urea, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, neomycin, bovine calf serum
Yellow Fever (YF-Vax)
2/2019
sorbitol, gelatin, sodium chloride
Zoster (Shingles) (Zostavax) Frozen
1/2019
MRC-5 human diploid cells, including DNA & protein, sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride; neomycin, bovine calf serum
Vaccine
Date
Contains
Zoster (Shingles) (Zostavax) Refrigerator Stable
8/2018
MRC-5 human diploid cells, including DNA & protein, sucrose, hydrolyzed porcine gelatin, urea, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, neomycin, bovine calf serum
Zoster (Shingles) (Shingrix)
2/2020*
sucrose, sodium chloride, dioleoyl phosphatidylcholine (DOPC), 3-O-desacl-4’monophosphoryl lipid A (MPL), QS-21 (a saponin purified from plant extract Quillaja saponaria Molina), potassium dihydrogen phosphate, cholesterol, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, dipotassium phosphate, polysorbate 80, host cell protein and DNA
A table listing vaccine excipients and media by excipient is published by the Institute for Vaccine Safety at Johns Hopkins University, and can be found at
http://www.vaccinesafety.edu/components-Excipients.htm.
February 2020
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