http://www.nytimes.com/2001/10/22/national/22VACC.html?ex=1004777648&ei=1&en=1b8cbeb625c7ea7d
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October 22, 2001 U.S. Begins Search for Medicine Used to Treat Adverse Reactions to
Smallpox Vaccine
By KEITH BRADSHER
Federal rules say the medicine, a colorless liquid known as vaccinia
immune globulin, must be on hand before smallpox vaccinations may be
administered. The medicine can be obtained only from people recently
inoculated against smallpox, and existing American reserves may have
deteriorated. Dr. Anthony S. Fauci, the director of the National Institute of Allergy
and Infectious Diseases, said in an interview today that the federal
government had a small quantity of the medicine in stockpiles and had begun
contacting medical companies to ask them to check their supplies. The American population appears to be more vulnerable to dangerous
smallpox vaccine reactions now than it was when civilians stopped being
vaccinated in 1972, Dr. Fauci and other experts said. Even when given to healthy people, smallpox vaccines infrequently produce
dangerous reactions because the vaccine uses a live vaccinia virus, which is
similar to smallpox. Vaccinia can cause large, oozing lesions spreading from
the site of the vaccine, especially in people with immune system problems or
severe skin problems. It can be life-threatening. A large but unknown number
of Americans now have immune systems that are either depressed because of
H.I.V., the virus that causes AIDS, or have been chemically suppressed during
treatments for cancer, organ transplants, severe burns, autoimmune diseases
like lupus, and other health problems. When Army doctors administered a routine smallpox vaccine in the mid-1980's
to a soldier in basic training who seemed healthy but was actually developing
AIDS, his body became covered with large sores and he nearly died. Saving him
required all of the vaccinia immune globulin in a large Army medical depot,
said Dr. D. Craig Wright, a former military doctor who treated the soldier. The Food and Drug Administration said two years ago that the nation's
small stockpile of vaccinia immune globulin had mysteriously turned pink, and
barred its use. An agency official said today that the agency had concluded
that the pink liquid could be used only as an "investigational new drug"
under close medical supervision. The agency is also trying to obtain fresh vaccinia immune globulin, an
official said. Vaccinia immune globulin can only be harvested from the blood of people
who have been inoculated against smallpox and have developed antibodies
against the disease, experts said. The United States stopped vaccinating
civilians against the disease in 1972, and stopped vaccinating soldiers in
the early 1990's. Only a small number of people, mainly lab workers, have
been inoculated since then. Dr. Fauci said federal authorities had asked companies to check supplies
of other globulin for whether it might be usable. Globulin from people
vaccinated in the military in the early 1990's might be effective, he said. Pharmaceutical companies will begin producing new batches of smallpox
vaccine within the next several months, and some of this vaccine will need to
be tested in people for safety and for whether it causes them to produce
antibodies. Participants in these clinical trials will be asked to donate
vaccinia immune globulin, Dr. Fauci said. Roughly 1 in 4,000 healthy recipients of the vaccine encounter serious
side effects that clearly require treatment with vaccinia immune globulin. Federal agencies have also begun contacting medical groups to estimate the
number of Americans with immune-system difficulties who will not be able to
receive smallpox vaccines, Dr. Fauci said; some doctors have guessed that
there are a million such Americans. If there is a smallpox outbreak and
vaccinations begin, these people will be urged to take extra care not only in
avoiding smallpox-infected people but also in avoiding any physical contact
with the sites of other people's vaccinations. |
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