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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:1696.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved a new, preservative-free formulation for a diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine (Tripedia, Aventis Pasteur, Swiftwater, Pa). The reformulated product contains less than 0.3 µg mercury per dose (as thimerosal), which is less than 5% of the amount of thimerosal in the original version that the FDA approved in 1992.

Although no harmful effects have been reported from thimerosal in vaccines when used at the recommended dosages, federal public health agencies, the American Academy of Pediatrics, and vaccine manufacturers have agreed to reduce or eliminate its use in vaccines to protect children against the potential cumulative health risks of mercury.

Since 1999, the FDA has approved pediatric formulations of hepatitis B vaccines that contain no thimerosal (Recombivax HB, Merck, West Point, Pa) or only trace amounts of the ingredient (Engerix B, Glaxo SmithKline, Rixensart, Belgium). Thimerosal-containing Haemophilus influenzae type . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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