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Vaccine Excipient Summary 

Excipients Included in U.S. Vaccines, by Vaccine 

In addition to weakened or killed disease antigens (such as weakened, killed, or parts of 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: 

y	Preservatives, to prevent contamination. For example, thimerosal. 

y	Adjuvants, to help stimulate a stronger immune response. For example, aluminum salts. 

y	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: 

y	Cell culture materials, used to grow the vaccine antigens. For example, egg protein, various culture media. 

y	Inactivating ingredients, used to kill viruses or inactivate toxins. For example, formaldehyde. 

y	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. 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.” Please refer to the PI for a complete 

list of ingredients or excipients. 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. 

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Appendix B-8 

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Vaccine Excipient Table 

Vaccine (Trade Name) Package 

Insert Date Contains(a) 

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) 02/2009 glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron 

ammonium citrate, lactose 

Cholera (Vaxchora) 06/2016 ascorbic acid, hydrolyzed casein, sodium chloride, sucrose, dried lactose, sodium 

bicarbonate, sodium carbonate 

Dengue (Dengvaxia) 06/2019 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) 06/2018 aluminum phosphate, isotonic sodium chloride, formaldehyde 

DTaP (Daptacel) 01/2021(b) aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol 

DTaP (Infanrix) 01/2021(b) formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80) 

DTaP-IPV (Kinrix) 01/2021(b) formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 

80), neomycin sulfate, polymyxin B 

DTaP-IPV (Quadracel) 02/2021 formaldehyde, aluminum phosphate, 2-phenoxyethanol, polysorbate 80, 

glutaraldehyde, neomycin, polymyxin B sulfate, bovine serum albumin 

DTaP-HepB-IPV (Pediarix) 01/2021(b) formaldehyde, aluminum hydroxide, aluminum phosphate, sodium chloride, 

polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein 

DTaP-IPV/Hib (Pentacel) 12/2019 aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, 

bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate 

DTaP-IPV-Hib-HepB (Vaxelis) 10/2020 polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, 

neomycin, streptomycin sulfate, polymyxin B sulfate, ammonium thiocyanate, 

yeast protein, aluminum 

Ebola Zaire (ERVEBO) 01/2021(b) Tromethamine, rice-derived recombinant human serum albumin, host cell DNA, 

benzonase, rice protein 

Hib (ActHIB) 05/2019 sodium chloride, formaldehyde, sucrose 

Hib (Hiberix) 04/2018 formaldehyde, sodium chloride, lactose 

Hib (PedvaxHIB) 01/2021(b) amorphous aluminum hydroxyphosphate sulfate, sodium chloride 

Hep A (Havrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum hydroxide, amino acid supplement, 

phosphate-buffered saline solution, polysorbate 20, neomycin sulfate, 

aminoglycoside antibiotic 

Hep A (Vaqta) 01/2021(b) amorphous aluminum hydroxyphosphate sulfate, non-viral protein, DNA, bovine 

albumin, formaldehyde, neomycin, sodium borate, sodium chloride, other 

process chemical residuals 

Hep B (Engerix-B) 01/2021(b) 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) 05/2020 yeast protein, yeast DNA, deoxycholate, phosphorothioate linked 

oligodeoxynucleotide, sodium phosphate, dibasic dodecahydrate, sodium 

chloride, monobasic dehydrate, polysorbate 80 

Hep A/Hep B (Twinrix) 01/2021(b) MRC-5 cellular proteins, formalin, aluminum phosphate, aluminum hydroxide, 

amino acids, sodium chloride, phosphate buffer, polysorbate 20, neomycin 

sulfate, yeast protein

 HPV (Gardasil 9) 08/2020 amorphous aluminum hydroxyphosphate sulfate, sodium chloride, 

L-histidine, polysorbate 80, sodium borate, yeast protein 

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Vaccine (Trade Name) Package 

Insert Date Contains(a) 

Influenza (Afluria) 

Quadrivalent(c) 

03/2021 sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, 

monobasic potassium phosphate, potassium chloride, calcium chloride, sodium 

taurodeoxycholate, ovalbumin, sucrose, neomycin sulfate, polymyxin B, betapropiolactone, hydrocortisone, thimerosal (multi-dose vials) 

Influenza (Fluad) 

Quadrivalent(c) 

03/2021 squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid 

monohydrate, neomycin, kanamycin, hydrocortisone, egg protein, formaldehyde 

Influenza (Fluarix) 

Quadrivalent(c) 

2021 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(c) 

03/2021 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(c) 

10/2021(b) 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(c) 

2021 ovalbumin, formaldehyde, sodium deoxycholate, α-tocopheryl hydrogen 

succinate, polysorbate 80, phosphate-buffered saline solution 

Influenza (Fluzone) 

Quadrivalent(c) 

2021 formaldehyde, egg protein, octylphenol ethoxylate (Triton X-100), sodium 

phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose 

vials) 

Influenza (Fluzone) 

High Dose(c) 

07/2021 egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered 

isotonic sodium chloride solution, formaldehyde 

Influenza (FluMist) 

Quadrivalent(c) 

08/2021 monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic 

potassium phosphate, monobasic potassium phosphate, ovalbumin, gentamicin 

sulfate, ethylenediaminetetraacetic acid (EDTA) 

IPV (Ipol) 01/2021(b) calf bovine serum albumin, 2-phenoxyethanol, formaldehyde, neomycin, 

streptomycin, polymyxin B, M-199 medium 

Japanese Encephalitis (Ixiaro) 09/2018 aluminum hydroxide, protamine sulfate, formaldehyde, bovine serum albumin, 

host cell DNA, sodium metabisulphite, host cell protein 

MenACWY (Menactra) 04/2018 sodium phosphate buffered isotonic sodium chloride solution, formaldehyde, 

diphtheria toxoid protein carrier 

MenACWY (MenQuadfi) 01/2021(b) sodium chloride, sodium acetate, formaldehyde 

MenACWY (Menveo) 07/2020 formaldehyde, CRM protein 197

MenB (Bexsero) 01/2021(b) aluminum hydroxide, sodium chloride, histidine, sucrose, kanamycin 

MenB (Trumenba) 2018 polysorbate 80, aluminum phosphate, histidine buffered saline 

MMR (MMR-II) 12/2020 sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, neomycin, 

fetal bovine serum, WI-38 human diploid lung fibroblasts 

MMRV (ProQuad) 

(Frozen: Recombinant 

Albumin) 

01/2021(b) 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, other buffer and media ingredients 

PCV13 (Prevnar 13) 08/2017 CRM carrier protein, polysorbate 80, succinate buffer, aluminum phosphate 197

PPSV-23 (Pneumovax) 09/2020 isotonic saline solution, phenol 

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) 01/2021(b) sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium 

hydroxide, polysorbate 80, cell culture media, fetal bovine serum 

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Vaccine (Trade Name) Package 

Insert Date Contains(a) 

Rotavirus (Rotarix) 01/2021(b) 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 (PCV1) is present in Rotarix. PCV-1 is not known to 

cause disease in humans.] 

Smallpox 

(Vaccinia) (ACAM2000) 

03/2018 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 

Td (TDVAX) 09/2018 aluminum phosphate, formaldehyde, thimerosal 

Tdap (Adacel) 12/2020 aluminum phosphate, formaldehyde, 2-phenoxyethanol, glutaraldehyde 

Tdap (Boostrix) 09/2020 formaldehyde, aluminum hydroxide, sodium chloride, polysorbate 80 

Typhoid (Typhim Vi) 03/2020 formaldehyde, phenol, polydimethylsiloxane, disodium phosphate, monosodium 

phosphate, sodium chloride 

Typhoid (Vivotif Ty21a) 9/2013 sucrose, ascorbic acid, amino acids, lactose, magnesium stearate, gelatin 

Varicella (Varivax) Frozen 01/2021(b) sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium 

phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 

human diploid cells including DNA & protein, sodium phosphate monobasic, 

EDTA, neomycin, fetal bovine serum 

Yellow Fever (YF-Vax) 2/2019 sorbitol, gelatin, sodium chloride 

Zoster (Shingles) (Shingrix) 01/2021(b) sucrose, sodium chloride, dioleoyl phosphatidylcholine (DOPC), 3-O-desacl4’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 

Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; Hep A = Hepatitis A; Hep B = Hepatitis B; Hib = 

Haemophilus infuenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated infuenza vaccine; MenACWY = quadrivalent 

meningococcal conjugate vaccine; MenB = serogroup B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, varicella; PCV13 

= pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria 

toxoid, and acellular pertussis.

 (a)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 in use in January 2021 by 

month and year. In some cases, only a year was printed on the PI. 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 

(b)The PI was not dated and this is the date the PI was reviewed for this table. 

(c)All infuenza vaccine in this table are 2021-22 northern hemisphere formulation. November 2021 

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