How Harmful Are Additives and Preservatives in Childhood Vaccines? Review of Scientific Data May Allay Parental Concerns on Vaccine Safety, Says Expert

PHILADELPHIA -- After reviewing dozens of scientific studies, a leading vaccine expert concludes that preservatives, additives and other substances contained in vaccines pose very little risk to children receiving those vaccines.

In addition to the primary ingredient that stimulates a protective immune response, various vaccines may contain small amounts of metals, proteins, and other chemicals, some of which are residual by-products of normal vaccine manufacturing. "Parents can be reassured that the trace quantities of mercury, aluminum and formaldehyde contained in vaccines will not harm their children," says the study's lead author, Paul A. Offit, M.D., chief of infectious diseases and director of the Vaccine Education Center at The Children's Hospital of Philadelphia.

The article, which summarizes studies of human and animal exposures, appears in the December 2003 issue of Pediatrics. Offit's co-author is pharmacist Rita K. Jew, Pharm.D., also of The Children's Hospital of Philadelphia.

Of the substances studied, say the authors, only gelatin proteins and egg proteins are known to have harmful effects while in vaccines, but such effects are very rare. Those proteins may cause severe hypersensitivity reactions in children with allergies to gelatin or eggs. Offit adds that physicians should take appropriate safeguards for children known to have those allergies. For instance, children with allergies to the egg protein found in influenza vaccine can be desensitized to the vaccine.

One controversial vaccine-related substance is thimerosal, a compound of mercury used as a preservative to prevent contamination by bacteria or fungi. It has received considerable scrutiny by Congress and the news media since its removal from most U.S. childhood vaccines in 2001. Thimerosal was removed from vaccines as a precaution, even though there has never been scientific evidence of a link between thimerosal and adverse effects.

One confusing element, say the authors, is an incorrect assumption that ethylmercury, contained in thimerosal, has the same effects as methylmercury, a more toxic mercury compound found in the environment, but not in vaccines. "An important difference is that the body eliminates ethylmercury far more quickly than it eliminates methylmercury," adds Offit.

Other substances found in vaccines, in addition to the active agent designed to stimulate a protective response, are additives, adjuvants and manufacturing residuals.

Additives, which include various sugars, amino acids and proteins, are used to stabilize vaccines during processing and storage. Except for very rare hypersensitivity reactions to gelatin proteins, vaccine additives have not been associated with disease.

Adjuvants, such as aluminum compounds, enhance the desired immune response the vaccine is designed to produce. "The safety of aluminum has been established by experience over the past 70 years with hundreds of millions of people inoculated with aluminum-containing vaccines," say the authors, who add that the small quantities of aluminum in vaccines have not been shown to be harmful in animal studies.

Substances remaining in vaccines as residuals of the manufacturing process may include antibiotics, formaldehyde, and egg and yeast proteins. With the exception of the very rare reactions caused by egg proteins, the quantities of other residual substances are too small to demonstrate any documented reactions in those receiving the vaccines.

"Based on the best available scientific evidence," concludes Offit, "parents can be confident that vaccines are overwhelmingly safe, as well as effective in preventing infectious diseases."

Under the direction of Offit, The Children's Hospital of Philadelphia established The Vaccine Education Center in October 2000 to respond to the rapidly growing need for accurate, up-to-date, science-based information about vaccines and the diseases they prevent. The Center is a nationally recognized educational resource for healthcare professionals and parents, providing information on the full spectrum of vaccine-related topics.

Source: The Children's Hospital of Philadelphia