Today, the FDA approved a newly
formulated version of Tripedia, a diphtheria and tetanus toxoids
and acellular pertussis (DtaP) vaccine without preservatives
and with only a trace amount of thimerosal.
"This approval is significant
because now all routinely recommended pediatric vaccines will
be available as either completely thimerosal free or without
any significant amounts of thimerosal, a preservative that
contains mercury," said Dr. Bernard Schwetz, Acting Principal
Deputy Commissioner. "Although thimerosal is a very effective
preservative, the Public Health Service recommended that thimerosal
should be reduced or eliminated from vaccines as soon as possible
to minimize the exposure of infants and young children to
mercury."
Tripedia now contains less than
0.5 micrograms of mercury per dose, a greater than 95% reduction
in the amount of thimerosal per dose compared to the original
version of Tripedia.
The pediatric vaccines that
are recommended for routine use are: DTaP, hepatitis B, Haemophilus
conjugate (Hib), pneumococcal conjugate, inactivated poliovirus,
varicella, measles, mumps and rubella. Since 1999, pediatric
formulations of hepatitis B vaccines that either contain no
thimerosal (Recombivax HB) or trace amounts (EngerixB) have
been approved.
In recent years, various federal
agencies have been addressing the health risks of mercury,
which is found in the environment, in food and in household
products. Although no harmful effects have been reported
from thimerosal at doses that were used in vaccines, the PHS
agencies, the American Academy of Pediatrics, and vaccine
manufacturers agreed that thimerosal should be reduced or
eliminated in vaccines to make already safe vaccines even
safer.
Further information about thimerosal
is available at
http://www.cdc.gov/nip.vacsafe/concerns/thimerosal/thimerosal.htm.