Biodefense Showdown

Two anthrax vaccine makers vie for contract.

Four and a half years after the anthrax attacks that killed five people in several states, the federal program to stockpile countermeasures against the deadly pathogen has become highly politicized, observers agree. The $877.5 million contract that vaccine manufacturer VaxGen Inc. won from the Health and Human Services Department in November 2004 has been followed by critical letters, oversight hearings and accusations between competing firms.

The latest is a call from Rep. Mike Rogers, R-Mich., for an investigation into that contract and into alleged discrepancies in an HHS deal with BioPort Corp., a VaxGen rival located in Rogers' district.

It all began with the VaxGen award. The first high-profile procurement under Project BioShield, a federal program created in 2004 to lure pharmaceutical companies to the traditionally less lucrative biodefense market, called for 75 million doses of anthrax vaccine. That would represent about 90 percent of the Centers for Disease Control and Prevention's Strategic National Stockpile.

BioPort and its supporters on Capitol Hill criticized the deal, arguing HHS was "putting all of its eggs in one basket." That is, if VaxGen fails to deliver its vaccine, which is still under development and yet to be licensed by the Food and Drug Administration, the government will not be able to quickly replace those doses. They point to an example in 2004 when Chiron Corp.'s license was suspended unexpectedly, leading to shortages of flu vaccine in the United States. Instead, they say, the department should minimize risk by procuring vaccines from several manufacturers-for example, BioPort.

VaxGen and its supporters say this analogy is flawed because VaxGen's product would represent a next-generation formula with improvements over the current BioPort drug, the only licensed vaccine. BioPort also has been the source of controversy, with some members of the military suing to stop the Defense Department's mandatory anthrax vaccination program following questions about the vaccine's safety and the firm's financial practices.

But the argument that HHS should get vaccine from multiple sources resonated with some federal lawmakers, generating letters and pointed questions for agency leaders during congressional hearings. Last spring, the department awarded BioPort a $122.7 million contract for 5 million doses of anthrax vaccine, and department officials indicated that they might buy 5 million more. But those doses had yet to be added to the contract as of press time.

Rogers wants to know why not. Spokeswoman Sylvia Warner said the congressman has contacted HHS six times on this issue and is frustrated that he can't get a straight answer. "Over the last year, the congressman has had numerous contacts [with HHS], in which he was assured the [BioPort] anthrax vaccine contract was being taken care of," she says. "He is not telling HHS that they need to buy from his constituents. What he is saying is that he does not believe there ought to be a single source for any of these vaccines."

Recent events with VaxGen have added fuel to the fire of those arguing for multiple vaccine sources. Last fall, the company announced it would have to redo its Phase 2 trial that tested the drug's safety and efficacy and push back its delivery to the end of 2006. And last month, FDA sent the company a letter warning that promotional materials VaxGen officials distributed at a conference in Washington last fall contained false and misleading statements.

VaxGen spokesman Paul Laland could not comment on the letter except to say the firm is responding to it. But he did say the delayed delivery announced last fall is not uncommon in the drug development industry, and that VaxGen has fixed the problems with the vaccine and will perform a new Phase 2 trial later this year.

"Drug development is a very vigorous process, and it does take time to develop a new vaccine," Laland says. "And developing a new vaccine is not without risk, as it is with any drug development."

According to figures from HHS' Office of Public Health Emergency Preparedness, drugs that have completed only preclinical Phase 1 trials have an 8 percent chance of reaching market. Countermeasures that have completed Phase 3 safety and efficacy trials have a 50 percent chance.

BioPort officials say they have delivered 5 million vaccine doses to the Strategic National Stockpile, which would be enough of the three-dose therapy to treat about 1.7 million people. Michael Greenberger, director of the University of Maryland Center for Health and Homeland Security, believes that VaxGen ultimately will deliver and that HHS made the right move in awarding the contract.

"I agree that it has become politically charged, and I attribute it to the fact that some intelligent judgment, based on risk, was made to gamble on a second manufacturer who would develop an approved vaccine. And there are some hurdles that have cropped up that were unanticipated," he says. "And this creates an opening for those who favor BioPort and the continuation of BioPort's vaccine to complain and say the system isn't working."

Top officials at the Brisbane, Calif.-based VaxGen have been spending much of their time on Capitol Hill. "On average, we're probably in Washington every other week," Laland says. He understands the need to update legislators, given the size of the contract, and says company officials welcome the opportunity to educate policy-makers about the program. But he also admitted that the firm has spent more money on resources in Washington than originally expected.

"We just want to do our job, which is [to] make a vaccine that goes in the national stockpile," Laland says. "That's the fundamental goal of the company."