Thimerosal and Safety
Thimerosal Is a Preservative
Thimerosal is a very effective preservative that has been used since the 1930s to prevent contamination in some multi-dose vials of vaccines (preservatives are not required for vaccines in single-dose vials).
Thimerosal contains approximately 49% ethyl mercury. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.
However, in July 1999, the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.
Today, with the exception of some flu vaccines, none of the vaccines used in the U.S. to protect preschool children against 12 infectious diseases contain thimerosal as a preservative.
Thimerosal in the Flu Vaccine
The removal of thimerosal as a preservative from influenza vaccine is a complicated process. The total amount of flu vaccine without thimerosal as a preservative will be increased as vaccine manufacturing capabilities are expanded.
The benefits of influenza vaccination outweigh the theoretical risk, if any, for exposure to thimerosal. Each year, an average of about 36,000 people in the United States die from influenza, and 114,000 are admitted to the hospital as a result of influenza. People age 65 years and older, people of any age with chronic medical conditions, and very young children are more likely to have complications from influenza than from thimerosal in the vaccine.
With the newly formulated childhood vaccines, the maximum total exposure to mercury during the first six months of life is now less than three micrograms of mercury. Based on guidelines established by the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Agency for Toxic Substances and Disease Registry (ATSDR), no child will receive excessive mercury from childhood vaccines regardless of whether or not their flu shot contains thimerosal as a preservative.
The risks of severe illness from influenza infection are elevated among young children. In 2003, 12 Colorado children died from influenza. The benefits of influenza vaccination outweigh the theoretical risk, if any, of thimerosal exposure through vaccination.
Women’s Reproductive Safety
A study of influenza vaccination examining over 2,000 pregnant women demonstrated no adverse fetal effects associated with influenza vaccine. Case reports and limited studies indicate that pregnancy can increase the risk for serious medical complications of influenza. One study found that out of every 10,000 women in their third trimester of pregnancy during an average flu season, 25 will be hospitalized for flu-related complications.
Additionally, influenza-associated excess deaths among pregnant women have been documented during influenza pandemics. Because pregnant women are at increased risk for influenza-related complications and because a substantial safety margin has been incorporated into the health guidance values for organic mercury exposure, the benefits of influenza vaccine with reduced or standard thimerosal content outweighs the theoretical risk, if any, of thimerosal.