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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.
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 b