WASHINGTON (Reuters Health) Mar 06 - While the current US anthrax
vaccine appears safe and effective, government agencies and private companies
should speed efforts to develop easier-to-use vaccines, an expert panel
concluded in a report issued Wednesday.
The Institute of Medicine (IOM), a scientific group that advises the
federal government, concluded the vaccine appears effective in preventing
inhalation anthrax, the illness that killed five people last October after a
rash of anthrax-containing letters in the US. It also concluded that the
vaccine is likely to work even against anthrax spores that are "weaponized"
through genetic engineering to be more infective.
But the currently available vaccine requires six shots given over 18
months, a regimen that most experts consider impractical for public use. The
IOM panel recommended that government agencies step up efforts to develop a
vaccine in pill form or at least one that is effective with fewer shots. They
also recommend that long-term studies be conducted on vaccine safety.
"It is sufficiently safe to be useful. Still, its side effects, coupled
with the long series of doses required, are among the realities that
underscore the need for a new and improved alternative," said Dr. Brian L.
Strom, chair of the panel and director of the Center for Clinical Epidemiology
and Biostatistics at the University of Pennsylvania School of Medicine.
More than 2 million military personnel have received the anthrax vaccine
since 1998, when the Defense Department instituted a policy of universal
vaccination in the armed forces. Military planners became concerned during the
Gulf War in 1991 that US personnel could be at risk of anthrax attack during
combat.
The overall safety and effectiveness of the vaccine took on greater urgency
for the public last October when five people died and more than a dozen were
sickened after exposure to anthrax spores via the contaminated letters.
Nearly 200 civilians, mostly on Capitol Hill, received anthrax vaccinations
following the attacks as a supplement to antibiotic drugs designed to prevent
infection after exposure. US officials say that they have no plans to
vaccinate members of the public in anticipation of further attacks.
The usefulness of the vaccine for post-exposure prevention is clear,
according to Strom. "If that kind of event happened again and someone asked me
should I take the vaccine, my answer would be yes," he said.
Still, the safety of the anthrax vaccine has caused some worry in the
military. Some 400 armed forces personnel refused to comply with Pentagon
orders for mass vaccination because of fears that the vaccine contributed to
illnesses like those seen in Gulf War syndrome.
But studies of vaccinated servicemen and women found no unexpected risk of
serious illnesses after vaccination, according to the IOM committee. Skin
redness and soreness at the site of injection were common, occurring in one
third to one half of all recipients based on findings from one study. More
serious reactions, including fever and malaise, were far less common.
"There is no evidence that life-threatening or permanently disabling
immediate-onset adverse events occur at higher rates in individuals who have
received (anthrax vaccine) than in the general pollution," the report states.
Accurate studies of effectiveness are impossible to perform because they
would require vaccinated people to be deliberately exposed to anthrax.
Observational studies in the 1960s and 1970s suggest that a complete vaccine
course protected textile mill workers from becoming infected with inhalation
anthrax.
Today, concerns have also been raised about BioPort, the Michigan-based
company holding the military contract to make anthrax vaccine. The Pentagon's
vaccination program was slowed last year when BioPort was forced to refit its
factory in order to comply with Food and Drug Administration (FDA)
manufacturing guidelines.
FDA re-licensed the company at the end of January 2002, and concerns now
abound that vaccine produced before the refit could differ in safety and
effectiveness from vaccine produced afterward. Experts said that production at
BioPort's facility has been "fraught with difficulties."
Bioport officials said that they are working to develop more convenient
forms of anthrax vaccine, but that vaccine in pill form is unlikely to come
soon. "It is likely that these vaccines will still require injections," said
Robert Myers, BioPort's executive vice president.
The Centers for Disease Control is currently funding a study designed to
test the effectiveness of simpler vaccine dosing regimens.