Thimerosal in Vaccines 
By FDA U.S. Food and Drug Administration

Posted August 2, 2011 Disclaimer Info

All hepatitis B vaccines for the U.S., including for adults, are now available only as thimerosal-free or trace-thimerosal-containing formulations. In addition, all immune globulin preparations including hepatitis B immune globulin, and Rho(D) immune globulin preparations are manufactured without thimerosal.  CDC: New Vaccine information

Table 1. Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of Age and Younger

Vaccine Tradename
(Manufacturer)
Thimerosal Status Concentration**(Mercury) Approval Date for Thimerosal Free or Thimerosal / Preservative Free (Trace Thimerosal)*** Formulation
DTaP Infanrix
(GlaxoSmithKline Biologicals)
Free Never contained more than a trace of thimerosal, approval date for thimerosal-free formulation 9/29/2000
Daptacel
(Sanofi Pasteur, Ltd)
Free Never contained Thimerosal
Tripedia
(Sanofi Pasteur, Inc)
Trace(≤0.3 µg Hg/0.5mL dose) 03/07/01
DTaP-HepB-IPV Pediarix
(GlaxoSmithKline Biologicals)
Free Never contained more than a Trace of Thimerosal, approval date for thimerosal-free formulation 1/29/2007
DTaP-IPV/Hib Pentacel (sanofi pasteur Ltd.) Free Approved June 20, 2008, never contained thimerosal
DTaP-IPV KINRIX (Glaxo SmithKline Biologicals) Free Approved October 8, 2009, never contained thimerosal
Pneumococcal conjugate Prevnar
(Wyeth Pharmaceuticals Inc)
Free Never contained Thimerosal
Prevnar 13 (Wyeth Pharmaceuticals Inc.) Free Approved February 24, 2010, never contained thimerosal
Inactivated Poliovirus IPOL
(Sanofi Pasteur, SA)
Free Never contained Thimerosal
Varicella (chicken pox) Varivax
(Merck & Co, Inc)
Free Never contained Thimerosal
Mumps, measles, and rubella M-M-R-II
(Merck & Co, Inc)
Free Never contained Thimerosal
Mumps, measles, rubella and varicella ProQuad (Merck & Co., Inc.) Free Approved September 6, 2005, never contained thimerosal.
Heptatitis A Havrix (GlaxoSmithKline Biologicals) Free Never contained thimerosal
Vaqta (Merck & Co., Inc.) Free Never contained thimerosal
Hepatitis B Recombivax HB
(Merck & Co, Inc)
Free 08/27/99
Engerix B
(GlaxoSmithKline Biologicals)
Free 03/28/00, approval date for thimerosal-free formulation 1/30/2007
Haemophilus influenzae type b conjugate (Hib) ActHIB
(Sanofi Pasteur, SA)
OmniHIB
(GlaxoSmithKline)
Free Never contained Thimerosal
PedvaxHIB
(Merck & Co, Inc)
Free Approval date for thimerosal free formulation 08/99
HIBERIX (GlaxoSmithKline Biologicals) Free Approved August 19, 2009, never contained thimerosal
Hib/Hepatitis B combination Comvax
(Merck & Co, Inc)
Free Never contained Thimerosal

Seasonal Trivalent

Influenza

Fluzone (multi-dose presentation)
(Sanofi Pasteur, Inc)
0.01% (12.5 µg/0.25 mL dose, 25 µg/0.5 mL dose)2
Fluzone (single-dose presentation)
(Sanofi Pasteur, Inc)3
Free 12/23/2004
Fluvirin (multi-dose presentation)
(Novartis Vaccines and Diagnostics Ltd)
0.01% (25 µg/0.5 mL dose)
Fluvirin (single dose presentation)
(Novartis Vaccines and Diagnostics Ltd)
(Preservative Free)
Trace (<1ug Hg/0.5mL dose) 09/28/01
Fluarix (single-dose presentation) (GlaxoSmithKline Biologicals) Free Approved 10/19/09, never contained thimerosal

Afluria (multi-dose presentation)

(CSL Limited)

0.01% (24.5 µg/0.5 mL dose)
Afluria (single-dose presentation) (CSL Limited) Free Approved 11/10/09, never contained thimerosal
Seasonal Influenza, live FluMist
(MedImmune Vaccines, Inc)
Free Never contained Thimerosal
Rotavirus RotaTeq (Merck and Co., Inc.) Free Approved February 3, 2006, never contained thimerosal
Rotarix (GlaxoSmithKline Biologicals) Free Approved April 3, 2008, never contained thimerosal

** Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 mL dose or 25 µg of Hg per 0.5 mL dose.
*** The term "trace" has been taken in this context to mean 1 microgram of mercury per dose or less.
1 HibTiITER was also manufactured in thimerosal-preservative containing multidose vials but these were no longer available after 2002.
2 Children 6 months old to less than 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL; children 3 years of age and older receive 0.5 mL.
3 A trace thimerosal containing formulation of Fluzone was approved on 9/14/02 and has been replaced with the formulation without thimerosal.

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Table 2: Preservatives Used in U.S. Licensed Vaccines

Preservative Vaccine Examples (Tradename; Manufacturer)
Thimerosal TT (one)
Influenza multi-dose presentations (several)
Phenol Typhoid Vi Polysaccharide (Typhim Vi; Sanofi Pasteur, SA)
Pneumococcal Polysaccharide (Pneumovax 23; Merck & Co, Inc)
Benzethonium chloride (Phemerol) Anthrax (Biothrax; Emergent BioDefense Operations Lansing Inc.)
2-phenoxyethanol IPV (IPOL; Sanofi Pasteur, SA)

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Table 3: Thimerosal and Expanded List of Vaccines - (updated 3/14/2008)
Thimerosal Content in Currently Manufactured U.S. Licensed Vaccines

Vaccine Trade Name Manufacturer Thimerosal Concentration1 Mercury
Anthrax Anthrax vaccine Emergent BioDefense Operations Lansing Inc. 0 0
DTaP Tripedia2 Sanofi Pasteur, Inc ≤ 0.00012% ≤ 0.3 µg/0.5 mL dose
Infanrix GlaxoSmithKline Biologicals 0 0
Daptacel Sanofi Pasteur, Ltd 0 0
DTaP-HepB-IPV Pediarix GlaxoSmithKline Biologicals 0 0
DT No Trade Name Sanofi Pasteur, Inc < 0.00012% (single dose) < 0.3 µg/0.5mL dose
Sanofi Pasteur, Ltd3 0.01% 25 µg/0.5 mL dose
Td No Trade Name MassBiologics ≤ 0.00012% ≤ 0.3 µg mercury/0.5 ml dose
Decavac Sanofi Pasteur, Inc ≤ 0.00012% ≤ 0.3 µg mercury/0.5 ml dose
No Trade Name Sanofi Pasteur, Ltd 0 0
Tdap Adacel Sanofi Pasteur, Ltd 0 0
Boostrix GlaxoSmithKline Biologicals 0 0
TT No Trade Name Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Hib ActHIB/OmniHIB4 Sanofi Pasteur, SA 0 0
HibTITER Wyeth Pharmaceuticals, Inc. 0 0
PedvaxHIB liquid Merck & Co, Inc 0 0
Hib/HepB COMVAX5 Merck & Co, Inc 0 0
Hepatitis B

Engerix-B
Pediatric/adolescent

Adult

GlaxoSmithKline Biologicals

0

0

0

0

Recombivax HB

Pediatric/adolescent

Adult (adolescent)

Dialysis

Merck & Co, Inc

0

0

0

0

0

0

Hepatitis A Havrix GlaxoSmithKline Biologicals 0 0
Vaqta Merck & Co, Inc 0 0
HepA/HepB Twinrix GlaxoSmithKline Biologicals < 0.0002% < 1 µg/1mL dose
IPV IPOL Sanofi Pasteur, SA 0 0
Poliovax Sanofi Pasteur, Ltd 0 0
Influenza Afluria CSL Limited 0 (single dose)
0.01% (multidose)
0/0.5 mL (single dose)
24.5 µg/0.5 mL (multidose)
Fluzone6 Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Fluvirin Novartis Vaccines and Diagnostics Ltd 0.01% 25 µg/0.5 ml dose
Fluzone (no thimerosal) Sanofi Pasteur, Inc 0 0
Fluvirin (Preservative Free) Novartis Vaccines and Diagnostics Ltd < 0.0004% < 1 µg/0.5 mL dose
Fluarix GlaxoSmithKline Biologicals < 0.0004% < 1 µg/0.5 ml dose
FluLaval ID Biomedical Corporation of Quebec 0.01% 25 µg/0.5 ml dose
Influenza, live FluMist MedImmune Vaccines, Inc 0 0
Japanese Encephalitis7 JE-VAX Research Foundation for Microbial Diseases of Osaka University 0.007% 35 µg/1.0mL dose
17.5 µg/0.5 mL dose
MMR MMR-II Merck & Co, Inc 0 0
Meningococcal Menomune A, C, AC and A/C/Y/W-135 Sanofi Pasteur, Inc 0.01% (multidose)
0 (single dose)
25 µg/0.5 dose
0
Menactra A, C, Y and W-135 Sanofi Pasteur, Inc 0 0
Pneumococcal Prevnar (Pneumo Conjugate) Wyeth Pharmaceuticals Inc 0 0
Pneumovax 23 Merck & Co, Inc 0 0
Rabies IMOVAX Sanofi Pasteur, SA 0 0
Rabavert Novartis Vaccines and Diagnostics 0 0
Smallpox (Vaccinia), Live ACAM2000 Acambis, Inc. 0 0
Typhoid Fever Typhim Vi Sanofi Pasteur, SA 0 0
Vivotif Berna Biotech, Ltd 0 0
Varicella Varivax Merck & Co, Inc 0 0
Yellow Fever Y-F-Vax Sanofi Pasteur, Inc 0 0
Table Footnotes
  1. Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 ml dose or 25 µg of Hg per 0.5 ml dose.
  2. Sanofi Pasteur's Tripedia may be used to reconstitute ActHib to form TriHIBit. TriHIBit is indicated for use in children 15 to 18 months of age.
  3. This vaccine is not marketed in the US.
  4. OmniHIB is manufactured by Sanofi Pasteur but distributed by GlaxoSmithKline.
  5. COMVAX is not licensed for use under 6 weeks of age because of decreased response to the Hib component.
  6. Children under 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL (12.5 µg mercury/dose.)
  7. JE-VAX is distributed by Aventis Pasteur. Children 1 to 3 years of age receive a half-dose of vaccine, i.e., 0.5 mL (17.5 µg mercury/dose).

FDA information July 7, 2011:  FDA: common ingredients in vaccines