States
Ration Low Supplies of 5 Vaccines for Children
By ROBERT
PEAR
 ASHINGTON,
Sept. 16 — States have begun rationing vaccines for children,
including those for measles, rubella and chickenpox, and have
reduced immunization requirements because of shortages, federal
investigators said today. They also warned of future shortages.
"Our vaccine supply will continue to be vulnerable," said Janet
Heinrich, director of public health issues at the General Accounting
Office, an investigative arm of Congress, which examined the problem
at the request of six senators and two representatives.
While several policy changes could ease the problem, Ms. Heinrich
said, none promise a quick solution.
In the last year, the accounting office said, children were
endangered by shortages of five vaccines that protect against eight
diseases: diphtheria, tetanus, whooping cough, measles, mumps,
rubella, chickenpox and pneumococcal disease, which can cause
meningitis and pneumonia.
The office said many factors contributed to the shortages. Some
manufacturers experienced production problems. Some had difficulty
complying with federal standards. One halted production of some
vaccines. Demand for a new vaccine exceeded expectations. Companies
had to reformulate some vaccines to remove a preservative that might
contain unsafe amounts of mercury.
The supply is easily disrupted, the office said, because "five of
the eight recommended childhood vaccines have only one manufacturer
each." Drug companies are not required to inform the government that
they intend to stop making a vaccine, though one company recently
promised to do so.
Manufacturers need a year or more to produce some vaccines, so
the industry cannot immediately increase output if the supply runs
short. Production requires the use of viruses and bacteria, which do
not always grow or respond on demand.
In addition, vaccine manufacturers said the threat of lawsuits
and huge liabilities had prompted some companies to consider
withdrawing from the market.
Senator Jack Reed, Democrat of Rhode Island, said, "It's clear
from this report that we have a system that cannot guarantee a
stable supply of vaccines and is inadequate to handle a potential
outbreak of any of a number of routine childhood diseases."
Mr. Reed is scheduled to preside over a hearing on the issue on
Tuesday by the Senate Committee on Health, Education, Labor and
Pensions.
The accounting office said the federal government had the
authority and the money to stockpile childhood vaccines, but had
reserves for only two of the eight standard vaccines. Federal health
officials do not have a strategy for creating such stockpiles and do
not know how much vaccine to set aside or where to store it, the
report said.
The Centers for Disease Control and Prevention said it could take
four or five years to build stockpiles of the recommended vaccines.
In 1986, Congress created a no-fault system to compensate people
injured by childhood vaccines. For more than a decade, that system,
under which the government reviews and pays claims for injuries,
helped ensure that vaccines would be available.
But Wayne F. Pisano, executive vice president of Aventis Pasteur
North America, one of four companies that produce almost all the
routine childhood vaccines for the United States market, said the
industry again faced "a surge in lawsuits with potentially
devastating financial exposure."
More than 100 lawsuits have been filed by parents who contend
that their children suffered nerve damage from thimerosal, Mr.
Pisano said. Thimerosal, which contains mercury, was used as a
preservative in some vaccines for more than 60 years.
Because of the shortages, the accounting office said, at least 30
states have adopted less stringent immunization requirements for
children entering school, and more than 40 states reported taking
steps to ration vaccines distributed to doctors and clinics. In
March, it said, Arkansas officials reported that they planned to cut
vaccine shipments to health care providers by 50 percent to 80
percent, and some states reported that they were "out of certain
vaccines for months at a time."
Deferring immunizations increases the risk of outbreaks of
disease and undermines years of effort to alert parents to the
importance of vaccinating children, the report said.
Dr. Timothy F. Doran, chairman of the department of pediatrics at
the Greater Baltimore Medical Center, said: "In my 22 years of
practicing pediatrics, I have never witnessed a vaccine shortage
such as we have seen over the last year. The system is a lot more
fragile than we had thought."
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