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Articles:
DTP-Vaccine Shortage
May Delay Immunization of Millions of Infants
by
GARDINER HARRIS
Staff Reporter of THE WALL STREET JOURNAL
ATLANTAA serious shortage of the combined DTP vaccine, for diphtheria, tetanus and
pertussis, may soon lead pediatricians to delay the scheduled vaccinations of millions of
American infants, the Centers for Disease Control and Prevention said.
Spot shortages of the combined vaccine, also known as DTaP, have already occurred in some
areas. The shortages result from efforts by manufacturers to remove mercury,
which was used as a preservative,
from vaccines. Aventis SA is having trouble ramping up production of its mercury-free DTP
vaccine, and GlaxoSmithKline PLC hasn't been able to make up the difference, so supplies
are running Short. American Home Products Corp., which stopped production
last year of its mercury-containing DTP vaccine, said that the cessation had nothing to do
with mercury.
Officials from the CDC estimate that nearly 1.4 million vials of the vaccine have been
back-ordered. That is about a month's supply of the CDC's public vaccine program, which
provides vaccinations to roughly 60% of U.S. children. "It could be touch and go for the
next several months," said Walter Orenstein, director of the National Immunization Program.
Critics want all mercury-containing vaccines withdrawn. "Our organization is asking,
and this will be the third time, that the [Food and Drug Administration] recalls them all,"
said Lyn Redwood, president of Safe Minds, a group of parents of children with mental
problems they believe were caused by vaccinations. But more than 9% of DTP vaccines
on doctors' shelves have mercury in them. Recalling them would worsen an already
serious shortage, officials say.
In an announcement reflecting the concern about mercury, GlaxoSmithKline said Wednesday
that it would exchange any vaccines containing mercury that still sit on doctors' shelves for
mercury-flee vaccines. While GlaxoSmithKline's DTP vaccine never contained mercury, its
childhood vaccine against
hepatitis B, called Engerix-B, contained mercury until March 2000. "This is not a recall,
it's a voluntary exchange program," said Carmel Hogan, a GlaxoSmitixKline spokeswoman.
Concerns over the use of mercury in vaccines began in June 1999, when the FDA issued
a report showing that children receiving the entire recommended schedule of vaccinations
might ingest more mercury during a six-month period than is considered safe by the U.S.
Environmental Protection Agency. The CDC's Advisory Committee on Immunization
Practices responded by urging manufacturers to remove mercury from their
vaccines "as rapidly as possible."
But some parents of children who developed mysterious aliments soon after being
immunizedincluding autism and other neurological disordersprotested that no child
should be vaccinated with potentially dangerous medicines. When ingested in large
quantities, mercury causes a variety of problems including neurological deficits.
Experts at the CDC, however, noted that there was no proof that mercury in vaccines
had harmed anyone, while the evidence is overwhelming that vaccinations save lives.
The CDC asked the nonpartisan Institute of Medicine to analyze the relevant
science. The institute released a report on Oct. 1 that, while acknowledging that
there is no evidence that mercury-containing vaccines caused harm, recommended that
such vaccines be removed. A week later, a group of lawyers sued Vaccine manufacturers,
claiming mercury in their products had injured children. As a result, the CDC vaccines
committee recommended yesterday that mercury-containing vaccines no longer be used in
children after March 31, 2002.
Six mercury-containing vaccines are still being used by physicians but mostly to treat
adults. One is RecombivaxHB and is made by Merck & Co. to fight hepatitis B. Tom Vernon, a
Merck vice-president, said the Whitehouse Station, N.J., concern stopped distributing
RecombivaxHB last month.
He said the company is "having serious conversations" about whether to withdraw
supplies of the vaccine still in doctors' offices and warehouses.
Aventis officials said they hoped to ramp up production of its mercury-free
DTP vaccine in the next several months. The Franco-German company has all but stopped
selling vaccines to the CDC, which buys the drugs cheaply and in bulk, in favor of
supplying private doctors, who generally pay more.
Philip Hosbach, an Aventis spokesman, said the pharmaceutical firm wasn't
making enough of the vaccine to supply the CDC.
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