Controversy Surrounds Anthrax Vaccine
Manufacturing Woes continued...
No one is quite sure how much anthrax vaccine is available or
will be available in the near future. That is because the FDA forced the sole
U.S. manufacturer of anthrax vaccine to stop distribution two years ago after
an inspection found 30 violations at the manufacturing plant. Those violations
included vaccine safety and sterility problems.
BioPort Corp. of Lansing, Mich., has actually been making and
stockpiling the vaccine again for over a year, but the reserves can not be used
or distributed until it passes another FDA inspection. That could be as early
as Thanksgiving, but there are no guarantees, officials say.
If BioPort does pass inspection, some 5.4 million doses of
anthrax vaccine will be available for immediate distribution, Health and Human
Services secretary Tommy G. Thompson said late last week. But Rep. Christopher
Shays, R-Conn., who has held hearings on the anthrax vaccine, says it is
unclear if the stockpiled doses are safe.
The anthrax vaccine used in the United States was developed
during the 1950s and '60s and was licensed by the FDA in 1970. It is given as a
series of six injections over 18 months and poses no risk of developing the
disease because it is a killed vaccine.
Critics say there is no guarantee that the vaccine is effective
against all strains of anthrax and that terrorists could conceivably
manufacture vaccine-resistant strains to use as weapons. The only human study
ever done in the U.S. evaluated the vaccine during an outbreak of anthrax among
New Hampshire mill workers 40 years ago. It was found to be 93% effective in
workers who got the vaccine, and studies in monkeys have shown similar rates of
The main controversy surrounding the vaccine involves its
safety, not effectiveness. Hundreds of military personnel have faced
disciplinary actions since 1998 for refusing to take it, and about 50 have been
court-martialed. The Government Accounting Office recently reported that a
significant number of reserve and National Guard pilots have left the military
rather than take the anthrax shots.
Nass says she has been contacted by many people in the military
who blame the vaccine for chronic health problems. Most have been women, and
most complaints have been symptoms such as chronic fatigue and pain, which are
the same symptoms of several chronic diseases common in women such as
fibromyalgia and lupus. There is no direct evidence that these symptoms are
linked to the vaccine, however.
"The best information we have suggests that this vaccine is
safe," Modlin says. "But a vaccine is only one means of protecting
one's self from disease, and in this case there are other equally or more
important things we can do. A vaccine is never going to be the answer to the
problem. It is only one measure we can take to address it."