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Thimerosal in Vaccines
By FDA U.S. Food and Drug Administration
Posted August 2, 2011; Updated October 2021. 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.
Table of Contents
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) |
Table of Contents
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
- 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.
- 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.
- This vaccine is not marketed in the US.
- OmniHIB is manufactured by Sanofi Pasteur but
distributed by GlaxoSmithKline.
- COMVAX is not licensed for use under 6 weeks of age
because of decreased response to the Hib component.
- Children under 3 years of age receive a half-dose of
vaccine, i.e., 0.25 mL (12.5 µg mercury/dose.)
- 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).
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FDA information July 7, 2011: FDA: common ingredients in vaccines
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