NEW YORK — America's domestic defense program is spending at least $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, which was 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-ever 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 doses for the public. And this month, federal officials doubled their request, saying they wanted to buy another 5 million for about the same price.
Last November, another firm, California-based VaxGen, received an $877-million contract, plus as much as $69 million in potential fees, to manufacture 75 million doses of an updated vaccine.
The product, which does not have 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 such as New York, and they describe the vaccines as key parts of the civilian defense program.
But although 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 following an airborne attack.
David Ozonoff, a professor at Boston University's School of Public Health, said there was "scant" evidence the vaccine would work to treat people who inhaled airborne spores.
He said studies show antibiotics to be the most effective treatment, and that the vaccine could cause potentially serious health problems among civilians.
"The number of doses they are amassing is wildly out of proportion to any possible threat from anthrax," Ozonoff said. "What the benefits are is very unclear, and there are always risks when you vaccinate a whole lot of people."
Hillel W. Cohen, an epidemiologist at the Albert Einstein College of Medicine in the Bronx, N.Y., 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 following inhalation exposure found it ineffective on laboratory animals unless used in conjunction with antibiotics.
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.
"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.
Still, several prominent members of Congress are skeptical of the amount of federal money going to VaxGen.
"I do question the BioShield acquisition strategy being pursued that bets $800 million on an untested vaccine," said Rep. Christopher Shays (R-Conn.), chairman of the House Subcommittee on National Security, Emerging Threats and International Relations.
"In the event of an attack, we need to know the vaccines and medicines in the national stockpile are the best modern science can produce."
The issue of whether the vaccines themselves may cause health problems, perhaps even death, also remains in dispute.
In FDA documents, 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, which "possibly" were caused by the BioPort vaccine.
The government's monitoring system collects voluntary reports of illness but does not determine exact causes.
But in a little-noticed report issued in December, the FDA said 16 deaths may be linked to the BioPort vaccine.
After Newsday asked about other fatalities cited in FDA filings, the agency raised the number possibly linked to the vaccine to 21, including one the agency said had been "incorrectly coded" in its database.
The same report tallied more than 4,100 illnesses, including 347 it characterized as "serious," as possibly associated with the vaccine.
Government officials say the rate of serious illness associated with anthrax injections is lower than that for other common vaccines such as influenza, smallpox, tetanus, diphtheria and hepatitis.