Doubts fail to halt U.S. anthrax plan
By Thomas Maier
Newsday
The nation is spending more than $1 billion for vaccines some officials say aren't effective. America's homeland-defense program is spending more than $1 billion on anthrax vaccines earmarked for wide civilian use despite uncertainty about their effectiveness and an ongoing debate about potential health problems, Newsday has found.
The vaccine stockpiling is a key element of the federal Project BioShield program, awarded $5.6 billion in funding in 2004 to develop drugs and vaccines to protect Americans against biological and chemical attacks. It constitutes the largest federal effort to protect civilians from an anthrax attack.
In May, BioPort Corp., the only manufacturer licensed in the United States to produce an anthrax vaccine, won a $123 million contract to make 5 million new doses for the public. Earlier this month, federal officials doubled their request.
In November 2004, another company, California-based VaxGen, received an $877 million contract, plus up to $69 million in other potential fees, to manufacture 75 million doses of an updated vaccine.
The product, which still lacks approval by the U.S. Food and Drug Administration, will not be available until 2007, company officials say.
Federal officials say an airborne anthrax attack could kill thousands of people in an urban setting and tout the vaccines as key parts of the civilian-defense program.
Though a body of scientific research shows that the current vaccine is effective if administered before skin exposure to anthrax -- and the rate of serious side effects is comparable to other common vaccines -- several public-health experts have raised questions about the vaccine's safety and whether it would work after an airborne attack.
Professor: Antibiotics best
David Ozonoff, a professor at Boston University's School of Public Health, said there was "scant" evidence the vaccine will work to treat people who inhale the airborne spores.
He said studies show antibiotics as the most effective treatment, and that the vaccine could cause potentially serious health problems among civilians.
Hillel W. Cohen, an epidemiologist at the Albert Einstein College of Medicine in the Bronx, agreed.
"The only possible benefit of a vaccine is if there's a danger of exposure, and that danger is small because of the technological hurdles of weaponizing anthrax," Cohen said. ". . . It's not something you can do in your basement."
If an anthrax attack were to occur today, the nation would rely on stocks of the BioPort vaccine, which, like the VaxGen product, would be provided in combination with antibiotics.
The only major study of the use of the BioPort vaccine after inhalation exposure found it ineffective on laboratory animals unless used in conjunction with antibiotics.
Animal trials under way
VaxGen also is conducting animal studies of its vaccine, but company officials say they are not certain it will work safely and effectively on humans exposed to airborne anthrax attacks.
"We'd hopefully achieve a high level of protection, and the alternative is severe disease," said Harry Keyserling, a pediatrics professor at Emory University School of Medicine in Atlanta and a key researcher in early VaxGen trials.
The issue of whether the vaccines themselves may cause health problems, and even death, also remains in dispute.
In documents of the FDA, Newsday found reports of more deaths and serious health problems among anthrax-vaccine takers than previously reported.
Until late last year, the FDA had listed reports of six deaths and 1,850 "adverse" reactions since 1990, ranging from minor redness at the inoculation site to severe cardiovascular and respiratory-system problems, that "possibly" were caused by the BioPort vaccine.
However, in a little-noticed report issued in December, the FDA said 16 deaths were possibly linked to the BioPort vaccine.
After Newsday asked about other fatalities cited in FDA filings, the agency upped the total number of fatalities possibly linked to the vaccine to 21.
The same report tallied more than 4,100 illnesses, including 347 it characterized as "serious," as possibly associated with the vaccine.
