A shot in the dark?

U.S. presses ahead with $1B plan to fight anthrax despite concerns about the drugs' cost and safety

BY THOMAS MAIER | STAFF WRITER

November 20, 2005

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, 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 federal effort ever to protect civilians from an anthrax attack.

In May, BioPort Corp., the only manufacturer currently licensed in the United States to produce an anthrax vaccine, won a $123-million contract to make 5 million new doses for the public. And earlier this month, federal officials doubled their request, saying they wanted to buy another 5 million doses for approximately the same amount.

Last November, another firm, 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 like New York and tout the vaccines as key parts of the civilian defense program.

But while 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 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.

"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 [health] risks ... when you vaccinate a whole lot of people."

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 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 yet 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.

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 dollars 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," Shays said.

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. The government's monitoring system collects voluntary reports of illness, but does not determine exact causes.