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Vaccine Ex~lpient & Media Summary

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This section begins with a summary of the excipients included in licensed vaccines in the United States, as of the revision date at the bottom ofthe page.

Excipients are inactive ingredients of a drug product necessary for production of a finished pharmaceutical formulation.

After the list of excipients is a list of culture media used in the manufacturing process of vaccines licensed in the United States.

Growth media are culture materials used to produce mass quantities of a microorganism antibody, or other immunologic agent, suitable for further processing into a finished pharmaceutical product.

All reasonable efforts have been made to ensure the accuracy of this information, but manufacturers may change product contents before that information is reflected here.

Excipients Included in US Licensed Vaccines"
Excipient Use Vaccine
Albumin, egg (Ovalbumin) Growth medium Influenza (Fluarix, Flul.avaly; Rabies
(RabAvert)
Albumin, human serum Component of growth Measles (Atlenuvax), MMR (MMR-If),
medium, protein stabilizer MMRV (ProQuad), Mumps
(Mumpsvax), Rabies (ItnlJvax), Rubella
(Mentvax If)
Albumin or serum, bovine Component of growth Hepatitis A (Havrix, Vaqta), Measles
medium, protein stabilizer (Attenuvax), MMR (MMR-Il), MMRV
(ProQuad), Mumps (Mumpsvax), Rabies
(lmovax, RabAvert), Rotavirus
(RotaTeq), Rubella (Meruvax Il), Vac-
cinia (Dry\IOX), Varicella (Varivax)
Aluminum hydroxide Adjuvant Anthrax (BioThrax), DTaP (lnfanrix),
bTaP-Hep B-IPV (Pediarix), Td (Massa-
chusetts), Hepatitis A (Havrix), Hepatitis
A-Hepatitis B (Twinrix), Hepatitis B
(EI!gerix-B), Tdap tBoostrixy
Aluminum hydrox.ypbosphate Adjuvant Hlb (PedvaxHlB, Rib-Hepatitis B (Com-
sulfate vax), Hepatitis A (Vaqta), Hepatitis B
tRecombivax lIB), Human papillomavi-
rus (Gardasil)
Aluminum phosphate Adjuvant DTaP tDaptaceh, Hepatitis A-Hepatitis
B (1II'inrix), Pneumococcal (Prevnary,
Rabies (BioRab), Td (Decavac), Td(Mas-
sachusetts), Tdap (AdaceI)
, Aluminum potassium sulfate Adjuvant DTaP iDaptacel, Tripediai, DTaP-Rib
(TriHlBlr), DT (Sanofi Pasteur)
'Amino acids Component of growth Anthrax (BioThrax), Hepatitis A
medium (Havrix), Hepatitis A-Hepatitis B
(Twintix), Rotavirus (Rotarix), Td
(Aventis Pasteur), Typhoid oral (Vivotif)
Ammonium sulfate Protein fractionation DTaP-Hib (TriHlBit), Rib (Act-HIB)
Amphotericin B Antibacterial Rabies (RabAvert)
,
Ascorbic acid Antioxidant Typhoid oral (Vivotif) E-1

Vaccine Excipient. & Media Summary,

Excipient

Vaccine

Bactopeptone

Use

Exdplents Included In US Licensed. Vaccines"

Influenza (varies seasonally)

Viral inacti valor

Preservative

Dye

Antacid

Mediu_m nutrient

Antibacterial

Medium nutrient

Medium nutrient

Manufacturing residue

Growth medium

Preservative

Manufacturing residue

Medium nutrient

Antimicrobial, toxin inactivator, stabilizier

Stabilizer in freeze-drying, solvent

Antibacterial

. Medium nutrient

Medium nutrient

TOxl n detoxitl.er

Solvent

Protei n stabilizer

Stabilizer

Adjust pH

Component of growth medium

Influenza (FI.uvirin), Rabies (lmovax, . RaMwtrl)

Bet.a-propiola.ctone

Vaccinia (Dryvax-historfc)

Benuthonium chloride

Anthrax (BioThrax)

Rotavirus (Roram)

Brilliant green

Calcium carbonate

Rabies (RabAverl), Vaccinia (Dryvax)

Calcium chloride

Rotavirus (Rotarix)

Roravirus (Rotarix)

Chlortetrac ycline

Dextran

Rctavirus (Rotam)

Cystine

DNA

Dulb0cco's Modified Eagle Medium (DM£M)

Hepatitis A (VaqIO)

Rotavirus (Rorum)

Rabies (RabAverl), Varicella (Varivax)

Ethylenediam_ine-tetraacetic acid sedium (EnTA)

Eggprorein

Influenza (all brands), Yellow fever .(YF-~)

Ferric (III) ni trate

Rotavirus (Rota ,ix)

Formaldehyde, formalin

Anthrax (BioThrax), DTaP (all brands), DTaP-Hep B-IPV (Pediarix), DTaP-Hib

.. (TriHIBit), DT (all brands), Td (aU brands), Hepatitis A (Havrix, Vaqta), Hepatitis A-Hepatitis B (1Willrix), Rib (ActH1B), Hib-Hepatltis B (Com vax) , Influenza (F/ul()lIe, Fluarix, FluLa~af), Japanese encephalitis (IE- \.b.r), PI)Liovirus inactivated (lpor), Tdap (Adncel, Bo()s/rix)

Gelatin

DTaP (Tripedill), DTaP-Hib (TriHlBit), Hepatitis B (Rec()mbivax-HB). Human papillomavirus (Gardasif), Influenza (Fluume), Japanese encephalitis

(lE- Vax), Measles (Altenu~ax), Mumps (Mumpsvax), Rubella (Mer.uvax JI), MMR (MMR-Il), M:MRV (ProQI/adJ, Rabies (RabAvert), Typhoid oral (Vivorif), Varicella (Varivax), Yellow fever (YF-Vax), Zoster (Zoslavax)

Gentamicin

Rota.virus (Rotarix)

Influenza tFluari», FluMist)

Glucose

Glutamine

Rotavirus (R()tarix)

DTaP (lnfanm), DTaP-Hep B·IPV (Pediarix), Tdap (B()os/rix)

Glutaraldehyde

DT (moot brands), Td (most brands)

Glycerin

Vaccinia (D.ryVax)

Human papillomavirus (Gardasi{)

Glycine

Histidine

Hydrochloric acid

DTaP (most brands), DT (most brands)

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Vaccine excipient & Media Summary

Excipient

Vaccine

Exdpiellfs In!!l'oded 10 US Licensed VacciIJes"

Hydrocortisone

Use

eomponentofgrQ~ medium

Influenz.a (Fluarix)

BeG (Ike),. Rib (some packages), Meningococcal (Memmlllne), Typlloid oral (Vivofif)

Lactose

Stabili:z.erio free.ze-dry1og, .. fiUiIlg

Rotavirus (Rofarix)

Magnesium stearate

Lubricant for capsule filling

Typhoid oral (Vivot;'j')

Magnesium sulfate

Medium nutrient

Monosodium. glutamate

Stabm:z.er

Infl.ueoza (FfuMi5t), MMRV (ProQllati), VariceUa (VariVCU),Zoster (Z,stavax)

MRCS cellular protein

Japanese encephalids (IE- Vax)

Mouse serum protein

Manufacturing residae

Manufacturing resldue

Neomycin

Anti bacterial

DTaP-Hep B-lPV (Ped/arix), Hepatitis A-Hepatitis B (1Winrix), Influenza (F/U\iirin), Measles (Attenuvax). Mumps (Uumpsvax), RubeUa (Meruvax If),

, MMR (MMR-I.f), MMRV (ProQuad), Poliovirus inactivared apall, Rabies (fmovax, RabAven), Vaccinia (DryVox), VaricelJa (Var/vax), Zoster (Zostavax)

Phen.o.1

Preservative, antibacterial

Pneumococcal (Pl1ellmovax-23), Typhoid inactivated (Typhim Vi), Vaccinia (Dryvax)

Phenol red (phenolsulfonphthalein)

pH indicator, dye

Rabies (fmovax), Rotavirus (Rotarix)

Z-Phenoxyethanol

Phosphate buffers (eg, disodium, monosodium, potassium, sodium diIlydro-genphosphate)

Preservative, stabilizer

Adjust pH

DTaP(lnfanrix, Daptaceh, DTaP-Heb B-IPV (Pediarix), Hepatitis A (Hallrix). Hepatitis A-Hepatitis B (Tlvinrix). Poliovirus inactivated (fpo!), Td (Saoofi Pas-

, leur)

DTaP (most brands), DT (most brands), Rib (Acl-Hib), Hepatitis A (J{a~rix), Hepatitis A-Hepatitis B (nvinrix), Hepatitis B (Engerix-B), lo.fluenza (Flua.rix, FluMis/, F/uLclYa!), Measles (AI/enuvax). Meningococca1 (Menoe/ra), Mumps (MumpJ'\lax),. Poliovirus inactivated (fpo!), Rabies (BioRab), RubelJa (Menrvax If), MMR (MMR-ff), MMRV (ProQuad), Rotavirus (RolaTeq), Typhoid inactivated (1YpMm Vi), Varicella (Varivax), Zoster (Zost(lVax)

PolydimethylsiIowne

Typhoid inactivated (Typhim Vi)

Polyl!Jyx.inB

Aatifoaming agent

Antibacterial

DTaP-Heb B-IPV (Pediarix). Influenza (FIJtvirin), Poliovirus inactivated (fpo!), Vaccinia (Dl)'l'ax)

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Vaccine Excipient & Media Summary

Excipients Included in US Licensed Vaecine.o;B
Excipient Use Vaccine
Polyoxyethylene9-10 nonyl Nonionic surfactant (viral Influenza (Fluviri/l)
phenol (Triton N-I 0 I , inactivation)
ocloxynol9)
.Polyoxyethylated octyl phe- Nonionic surfactant (viral Infiuenza (Fluarix, Fluzcne)
nol (also called ethylene inactl v arion)
glycol octyl phenyl ether,
oetoxynol-10, octyl-
phenoxypolyethoxyetha-
nol, p-isooctyphenyl ether,
Triton X-lOO)
Polysorbate 20 Surfactant Hepatitis A (Havrix). Hepatitis A-
Hepatitis B (TlYillrix)
Polysorbate 80 Surfactant DTaF (Ill/anrix. Tripedia), DTaP-Heb
B-IPV (Pediarix). DTaP-Hib (TriHlBit),
Human papiUomavirus (Gardasil). lotio-
enza (Fluarix), Rotavirus (/?OlaTeq).
Tdap (Adacel, Boostrix)
Potassium chloride Adjust pH, tonicity, medium MMRV (ProQuadJ, Rotavirns (Row/ix),
nutrient z.oster (ZoSIOVax)
Potassium glutamate Stabilizer Rabies (RobA\ler/)
Serum, bovine calf Component of growth z.oster (Zostavax)
medium
Sodium acetate Adjust pH DT (some brands), Td (some brands)
Sodium bicarbonate Adjust pH MMRV (ProQuadJ
Sodium borate Adjust pH Hepatitis A (Vaqta). Rib-Hepatitis B
(Comvax), Human papillomavirus
(Gardasil)
Sodium chloride Ad just tonicity Most vaccines, including Anthrax, BOO,
Human papillomavlrus (Ga.rdasif), Influ-
enza (Fluarix), Measles, Meningococcal
(Me:nactra), Mumps, MMR, MMRV,
Pneumococcal, Polio inactivated,
Rabies, Rotavirus (ROIarix), Rubella,
Typhoid inactivated, Varicella, Yellow
fever, Tdap (Boostrix), Zoster (Zostavax)
Sodium citrate Adjust pH Roravirus (RotaTe:q)
Sodium deoxycholate Anionic surfactant Influenza (Fluarix, FluLaval)
(viral inactivation)
Sodium hydrogenocarbonate Medium nutrient Rotavirus (Rotarix)
Sodium hydroxide Adjust pH DT (most brands), Rotavirus (RolaTeq),
Td (most brands)
Sodium phosphate Medium nutrient Rotavirus (Rotarlx)
Sodium pyruvate Medium nutrient Rotaviru s (Rolarix)
Sorbitol Stabi lizer, solvent ' Measles (Atte:nuvax), Mumps
(Mumpsvax), Rotavirus (Rotarix),
Rubella (Meruvax Il), MMR{MMR-Jl),
MMRV (ProQuad), Yellow fever
(YF-Vax)
Streptomycin Antibacterial Poliovirus inactivated (lpo/), Vaccinia
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Vaccine ExcipJent I Media Summary

Excipients Included in US Licensed Vaccines"
Excipient Use Vaccine
Sucrose Stabilizer DTaP-Hib (TriHIBit), Rib (Act-HIB),
Influenza (FluMist), Measles (Attenu-
vax), Mumps (Mumpsvax), MMR (MMR-
ll), MMRV (ProQuad), Rotavirus
(RotaTeq), Typhoid oral (Vivotif), Vari-
cella (Varivax), Zoster (Zostavax)
Sucrose Medium nutrient Rota vires (Rotarix)
Thimerosal Preservative in some multi- DTaP (some multidose containers),
dose containers (see package DTaP-Hib (TriHIBit), DT (some mal-
labeling for precise content) tidose containers), Td (some multidose
containers), Hib (some multidose con-
tainers), Influenza (some multidose con-
tainers), Japanese encephalitis (JE- Vax),
Meningococcal (Menomune), Rabies
(BioRab). Some single-dose containers
contain trace amounts of thimerosal from
the production process, but substantially
lower concentrations than if used as a pre-
servative, Consult product monographs
and labeling for details.
Tocopherrl hydrogen succi- Component of growth Influenza (Fluarix)
nate medium
Tyrosine Medium nutrient Rotavirus (Rotarix)
Urea Stabilizer Varicella vaccine (Varivax, refrigerator
stable)
Vitamins unspecified Component of growth Anthrax (BioThrax), Rabies (Imovax),
medium Rotavirus (Rotarix), Td (Sanofi Pasteur)
Xanthan Thickening agent Rotavirus (Rotarix)
Yeast protein Component of growth DTaP-Heb B-IPV (Pediarix), Hepatitis
medium A-Hepatitis B (Twinrix), Hepatitis B
(Engerix"B, Recombivax-Hlh, Rib
(Hib1iter). lib-Hepatitis B (Comvax) " Propnet.ary names appear In italICS.

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Vaccine excipient & Media Summary

Vaccme-ProducdoD Media-
Vaccine Culture Media Vaccine(s)
Bovine protein DTaP-Hep B-IPV (poliovirus component, Pedi-
arix), Pneumococcal (Plleumovax-23). Typboid
oral (Vivotif)
Calfskin Vaccinia (Dryvax)
Chick embryo fibroblast tissue culture Measles (ALIenI/vax), Mumps (Mumpsvax), combi-
nation vaccines containing them, MMRV (Pro-
Quad), Rabies (RabAvertj
Chick kidney cells In1Iuenza (master viruses for FluMisl)
Chicken embryo (fertilized egg) Influenza (all brands), Yellow fever (YF-Vax)
Cohen-Wheeler, modified (pertussis components) DTaP (alternate is Stainer-Scholte media)
Fenton media containing bovine casein Tdap (Boosrrix)
Human djploid tissue culture, MRC-5 Hepatitis A (Havrix, Vaqta), Hepatitis A-Hepatitis B
(n .. inrix), MMRV (ProQuad). Poliovirus inacti-
vated (PQliovax.), Rabies (/movax), Varicella
(Varivax), Zoster (Zosravax)
Human diploid tissue culture, WI-38 Rubella (Meruvax 11), combination vaccines con-
taining it, MMRV (ProQuad), Varicella (Varivax),
Zoster (Zostuvax)
Lathan medium derived from bovine casein DTaP (ltifanrix, tetanus component), DTaP-Hep B,-
IPV (pedi.arix), Tdap (Boosrrix)
Linggoud-Fenron medium containing bovine DraP (lnjanrix diphtheria component). DraP-Hep B-
extract IPV (Pediarix), Tdap (BooslTa)
Medium 199 (including amino acids, vitamins, Measles (Attemtvax). Mumps (MlllllfJsvax), combi-
SUC£Qse., phosphate, glutamate, human albumin, nation vaccines containing them
fetal bovine serum)
Minimum essential medium (including atbino acids, Rubella (Meruvax 11), combination vaccines con-
vitamins, fetal bovine serum, human albumin) taini~it
Monkey kidney tissue culture, Vero (Vervet or DTaP-Hep B-IPV (poliovirus component, Pedi-
African green monkeys) arix), Poliovirus inactivated (lpol). Rotavirus
(RolaTeq)
Mouse brain culture Japanese encephalitis (lE- Vax)
Mueller-Hinton agar medium Meningococc411 conjugate {MenDc/ra)
Mueller-Miller medium Diphtheria and tetanus vaccines (most brands),
meningococcal conjugate (Menaclra)
Puziss-Wngb] medium 1095 Anthrax (BioTllrax)
Rhesus fetal lung tissue culture Rabies (BioRab)
Stainer-Seholte medium DTaP (Daptacel, lrifanrix, pertussis component),
DTaP-Hep B-IPV (Pediarix), Tdap (Boostrix)
Soy peptone broth Pneumococcal (PrevnDr)
Synthetic/semi-synthetic Anthrax (BioThrax), BCG (nce), DT (all brands).
Td (all brands), Rib (all brands), Meningococcal
(Melwmune), Pneumococcal (Pneumova:c-23),
Typhoid inactivated (7'jphim Vi)
Watson-Scberp medium Mening.ococcal conjugate (MenDClra)
Yeast or yeast extract (typically Saccharomyces Hepatitis A-Hepatitis B (nvinrlx), Hepatitis B
cerevisiae) (Engerix-B, Recombivax-HB), Hib (HibTiter, Ped-
vaxHlB), Rib-Hepatitis B (Comvax), Human papil-
lomavirus (Gardasil), Medium for growing
Corynebacterium diphtheriae strain C7 (bI97) to
obtain CRM'97 protein for conjugation [0 polysae-
charides (Hib1iler, Prevnar). a Propnclary names appear in ilaJjcs.

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Vaccine Excipient & Media Summary

References: Canadian National Advisory Committee on Immunization. Statement 00 thimerosal. Can Comm Dis Rep. 2003;29(ACS-1): 1-10.

CDC. Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. MMWR. 1999;48:563·565.

Fletcher MA, Hessel L. PlotkiD SA. Human diploid cell strains (HOeS) viral vaccines. Dell Bioi Starrd. 1998;93:97-107.

Grabenstei.n ID.lmmullologic necessities: Diluents, adjuvants, and excipients, Hasp Pharm. 1996;31: 1387-92, 1397-1401.

Grabenstein JD. Clinical management of hypersensitivities to vaccine components. Hasp Pharm. 1997;32:77-84,87.

Hayftick L. The limited in vilIo lifetime of human diploid cell strains. up Cell Res. 1965;37:614-6.36. Jacobs JP, Jones CM, Bame JP. Characteristics of a human diploid cell designated MRC-5. Nature. 1970;227(5254): 168-170.

Jacobs IP. The status of human diploid cell strain MRC-S as an approved substrate for the production of viral vaccines. J Bioi Stand. 1976;4(2):97-99.

Offil PA, Jew RK. Addressing parents's concerns: Do vaccines contain barmful preservatives, adjuvants, additives, or res.iduals. Pediatrics. 2003; 112: 1394- J 40 I.

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