Vaccine Shortage May Delay Immunization of Millions of Infants

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DTP-Vaccine Shortage May Delay Immunization of Millions of Infants

By Gardiner

Staff Reporter of The Wall Street Journal

10/19/2001

The Wall Street Journal

B8 (Copyright © 2001, Dow & Company, Inc.)

ATLANTA -- A 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 GlaxoKline 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Critics want all mercury-containing vaccines withdrawn.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,

GlaxoKline said Wednesday that it would exchange any vaccines

containing mercury that still sit on doctors' shelves for mercury-

free vaccines. While GlaxoKline'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 GlaxoKline

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 ailments soon

after being immunized -- including autism and other neurological

disorders -- protested 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.

Copyright © 2000 Dow & Company, Inc. .