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The Advisory Committee on Immunization
Practices (ACIP) of the Centers for Disease Control (CDC)
held its meeting in Atlanta October 16 and 17th. At the end
of the session, Marie McCormick of the Institute of Medicine
(IOM) gave a presentation to the Committee on the IOM report
on thimerosal in vaccines and neurodevelopmental disorders.
Of special note, in light of ACIP's refusal
since 1999 to give preference to thimerosal-free vaccines,
was the IOM's unequivocal recommendation for
(a) the exclusive use of thimerosal-free
DTaP, Hib, and Hep B vaccines for infants and children,
even if thimerosal-containing versions are still on the
shelves
(b) for
professional societies and government agencies to ensure
the removal of thimerosal-containing vaccines.
A study by the CDC was conducted during
the week of September 10-17, 2001 among a sample of healthcare
providers covering 225 sites in 16 states. The survey asked
providers to physically check their inventory of DTaP, Hib,
and Hepatitis B vaccines and to record the number of doses
in the refrigerators, the brand, and the lot numbers.
With the assistance of the vaccine manufacturers,
the lot numbers were matched to production records to determine
whether the vaccine contained thimerosal or not. Nearly 66,000
doses were evaluated.
Among
these doses, 5.5% contained thimerosal.
Welcome news was given by the representative
from GlaxoSmithKline, who announced a voluntary exchange program
for thimerosal-containing vaccines.
Any
US healthcare provider may exchange, for free, their thimerosal
vaccine stocks with thimerosal-free versions upon request.
This program covers the GSK Engerix Hepatitis
B vaccine, in both pediatric and adult versions. Safe Minds
urges pediatricians and family physicians to take advantage
of this program. Parents should ask their doctors to find
out about this program and make this exchange without delay.
The GSK DTaP vaccine, Infanrix, has never
contained thimerosal. Additionally, to preserve high public
confidence in immunization programs, a GSK spokesman has said
that GSK will roll out thimerosal-free vaccines throughout
the world, as reformulations pass through the regulatory process
in each country.
The Merck representative at the ACIP
meeting said that a similar exchange program was under consideration
but no decision had been reached. Merck's Recombivax Hepatitis
B used to contain thimerosal but since last year has been
made preservative-free in single dose vials.
Representatives from Wyeth Lederle and
Aventis said their products no longer contain thimerosal.
Exchange programs for remaining thimerosal stocks are not
under consideration but have not been ruled out.
Roger Bernier of the NIP/CDC announced
that a Working Group on Thimerosal had been formed to determine
the official response to the IOM thimerosal recommendations.
Six options were under consideration:
1. A recommendation for the immediate
cessation of use of thimerosal vaccines for infant
DTaP, Hib, and Hep B.
2. A recommendation to state an immediate
preference for thimerosal-free infant DTaP, Hib, and Hep
B vaccines.
3. Establishing a date in the future
by which only thimerosal vaccines will be given.
4. A recommendation for the primary
immunizations (given at 6 months of age or younger) to be
thimerosal free with no preference given for boosters given
to older children until thimerosal stocks are used up.
5. Stating a preference for the Hib
and Hep B vaccines to be only thimerosal-free, while waiting
for the DTaP shortage to resolve before stating a preference
for mercury-free DTaPs.
6. Making no change to ACIP policy,
which was set in 1999 and says that thimerosal should be
removed from vaccines as soon as feasibly possible but no
preference would be given to thimerosal-free formulations.
The recommendation of the Working Group
is to state a preference for thimerosal-free DTaP, Hib, and
Hep B vaccines as of March 31, 2002, which is when the 2002
Routine Infant Immunization Schedule is scheduled to be announced.
FEAT
Daily Newsletter October
18, 2001
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