ASHINGTON,
March 6 The anthrax vaccine is safe and effective, and is likely to work
even against strains of the bacteria that have been engineered as weapons,
according to a new study that could clear the way for the Pentagon to resume
its program of vaccinating all soldiers.
The study, financed by the Pentagon and made public today by the
Institute
of Medicine, an independent
research institution that advises the federal government, is the most
comprehensive study ever conducted of the vaccine's safety and effectiveness.
It found no evidence to support claims of soldiers who said they had been
injured by their inoculations. But the study did say that the current
vaccine, which is administered in six doses over 18 months, is "far from
optimal," and urged the Defense Department to accelerate its research to
find a new one.
Even so, Pentagon officials said they were delighted by the outcome.
"This is good news for service members," Lt. Col. John Grabenstein, who runs the military's immunization
program, said after the study was released. "The bad guys have the
anthrax weapon and the vaccine that we are using works."
The anthrax vaccine, which was most recently in the news when it was
offered to postal workers and Congressional employees who were exposed to
anthrax in the bioterrorist attacks, has been mired
in controversy since the Pentagon's mass vaccination program began in 1998.
More than 400 soldiers have been disciplined for refusing to take the
vaccine, and the program was all but suspended when the sole manufacturer, BioPort of Lansing, Mich., failed Food and Drug
Administration inspections.
The manufacturing deficiencies have been corrected. A scientist close to BioPort said today that Pentagon officials had informed
the company that "the Pentagon was waiting only for this report to sign
off on a resumption of mass vaccination."
But Dr. William Winkenwerder, the assistant
secretary for health affairs, said a decision on whether, or how, to resume
the program would be announced within "a couple of weeks at the
outside."
While the vaccine can cause malaise and muscle pain that may be
temporarily disabling, the most common side effects are redness and swelling
at the injection site, said the panel of experts who conducted the Institute
of Medicine study. The panel said the reactions were no more serious than for
other vaccines given to adults, such as tetanus shots.
"Our committee concluded that it is sufficiently safe to be
useful," Dr. Brian L. Strom, a University
of Pennsylvania epidemiologist
who was the chairman of the panel, said at a news conference.
The BioPort vaccine, first approved by the
F.D.A. in 1970, relies on technology that dates from the 1950's. The Defense
Department is working on an alternative, and clinical trials may begin as
early as this year, Colonel Grabenstein said. But
it could be five years before a new vaccine is approved for use.
Meanwhile, BioPort, the government's only
supplier, has produced about 500,000 doses of the vaccine under an unusual
arrangement in which the Defense Department pays the salaries of the
company's employees. Dr. Winkenwerder said today
that the government needed to give the company financial help to keep it
viable while its plant was essentially shut down by the F.D.A.
After the report was released, the company's president, Robert G. Kramer
Sr., said, "This is a great day for BioPort."
The vaccine's critics said today that the study was flawed because
soldiers were typically reluctant to complain about adverse reactions, and so
the medical literature did not reflect the true extent of the vaccine's
problems.