U.S., Canada Partner to Obtain Licensed Stockpile of Smallpox Vaccine
By Gerry J. Gilmore
American Forces Press Service
WASHINGTON, April 30, 2002 -- DoD scientists and
contractors are working to obtain U.S. Food and Drug
Administration approval for a smallpox vaccine developed by
the military a decade ago, according to an Army medical
researcher at Fort Detrick, Md.
However, it will likely take a few years of testing until
the FDA approves the vaccine for licensure and renewed
production, said Army Col. David L. Danley, project manager
for the Joint Vaccine Acquisition Program. He noted that an
agreement signed March 27 by DoD and Canada's Department of
National Defence will facilitate that goal.
Danley, a research scientist, holds a doctorate in
biological sciences, immunity and infectious diseases. He
said his organization is responsible for advance
development, FDA licensure, and management of biological
defense vaccines for the DoD.
The U.S.-Canada agreement, he explained, "ensures that we
will produce a vaccine that is licensed in both the United
States and Canada" that can be shared between the two
countries and used by our armed forces.
"This is both a DoD and a national concern. There are no
potential bioterror weapons that are as communicable or
infectious as smallpox," he said.
He said the DoD smallpox vaccine under development was
created at the U.S. Army Medical Research Institute of
Infectious Diseases at Detrick in the early 1990s. "But
there was no requirement at that time to make a licensed
smallpox vaccine," he noted.
While authorities seek FDA approval, Canadian defense
officials will work to have the vaccine licensed by their
counterpart government agency, Health Canada, DoD officials
have said.
The U.S.-Canada agreement uses a structured process to
obtain licensure and to set up production of approved
vaccine, Danley said. He added that the contractor uses
"acquisition processes you'd use to build a tank" in
looking for manufacturers to make and test the vaccine.
The unit cost of the vaccine probably won't be influenced
by the agreement, but its availability will be improved, he
said. Canada and the United States will be able to share
military smallpox vaccine stockpiles, he said, as
production of the new, approved vaccine picks up.
However, he said, the U.S.-Canada agreement should reduce
the cost of developing the vaccine. The U.S. military,
Danley noted, is working with Dynport Vaccine Co., a prime
contractor in Frederick, Md., that is developing new DoD
biodefense vaccines, except the currently licensed anthrax
vaccine.
He said DoD is working with the Department of Health and
Human Services to ensure availability of current smallpox
vaccine and antiserum stockpiles for military use. HHS has
a contractor that's also making a new vaccine to support
the civilian population.
Smallpox vaccine uses live vaccinia virus, which is not
smallpox, but a related virus, Danley said. Healthy vaccine
recipients might feel short-term side effects, he noted,
but there is little chance they'd become seriously ill from
vaccinia.
The vaccine can be dangerous -- possibly fatal -- to
patients with impaired immunity systems, he remarked. He
noted, however, that the antiserum VIG, short for Vaccinia
Immune Globulin, can be used to treat some adverse events
associated with smallpox vaccination.
Danley noted people haven't died from smallpox in a long
time. World health officials declared naturally occurring
smallpox wiped out in the 1980s. The last laboratory-
acquired human smallpox infection occurred in 1978 in Great
Britain, he said, and the last field case of smallpox was
discovered in Somalia in 1977. DoD stopped routine smallpox
vaccinations in 1989-1990 at the end of the Cold War.
U.S. military concern about the disease was rekindled by
the discovery that the former Soviet Union weaponized
smallpox during the Cold War, he said.
The world's only smallpox virus samples were believed
contained in two depositories, one in the old Soviet Union,
and the other at the Centers for Disease Control in
Atlanta. "There is suggestion that unfriendly Third World
countries may hold smallpox samples," Danley said.
Third, he noted, the genetic code of smallpox is known.
Related viruses could be genetically engineered into
smallpox, he said, pointing to recent news reports about
the close relationship between so-called camel pox and
smallpox.
Military and other federal, local and state authorities are
concerned about smallpox as a bioweapon, Danley said,
noting qualities that make it dangerous to human
populations: Smallpox is highly infectious and easily
transmitted in the air and by contact. Symptoms can take up
to two weeks to show, so the disease conceivably can spread
before anyone realizes there's been an attack.
Smallpox is a debilitative disease and is fatal in about 30
percent of infections. Victims become badly and permanently
scarred over their faces and bodies by pox, which are skin
eruptions. Danley said the very young and very old seem the
most susceptible, perhaps due to immature or weakened
immune systems.
Smallpox victims generally experience "first a fever, then
tiredness, until a rash appears that becomes skin
eruptions," he said.
New vaccine work began during the 1980s, he added, but
advanced development started in 1998. But the new smallpox
vaccines "have not undergone the extensive clinical trials
required to demonstrate product safety and effectiveness
for FDA licensure," Danley said. Even if vaccine trials
that start this summer go well, it will be 2004 or 2005
before FDA licensure could be expected, he noted.
"However, existing smallpox vaccines may be used as
investigational new drugs, and can be administered to
troops with informed consent," he noted. "We would have to
screen recipients very carefully to ensure that we don't
administer the smallpox vaccine to somebody who might
become critically ill."
|