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NIH Decision to Shelve Third-Generation Anthrax Vaccine Seen as Setback for "Bioshield"


NIH Decision to Shelve Third-Generation Anthrax Vaccine Seen as Setback for ‘BioShield’
By Matthew E. Berger, CQ Staff

The National Institutes of Health has scrapped plans to develop a third-generation vaccine against anthrax, CQ Homeland Security has learned.

The decision, made several months after multiple bids were received, further complicates efforts to stockpile a vaccine against the biological weapon. A contract for a second-generation drug was cancelled last year.

The National Institute of Allergy and Infectious Diseases acknowledged its “programmatic decision to cancel” a request for proposal titled “Development of Third Generation Anthrax Vaccines.” Officials at NIAID, a division of NIH, had no further comment. Companies that had bid on the contract last summer were told of the cancellation late last week, according to sources.

Analysts said the decision is puzzling because it leaves the nation dependent on an outdated vaccine, with nothing in the pipeline.

“If you don’t have a next-generation vaccine and you don’t have a third-generation vaccine, it’s going to be very hard to come up with any future vaccines because these things develop in building block form,” said Robert Housman, a Democratic biodefense consultant.

Currently, the government has 9 million doses of the only approved anthrax vaccine, known as anthrax vaccine absorbed, or AVA, which is produced by Emergent Biosolutions.

The company is expected to deliver an additional million doses this year and also supplies the Pentagon with the drug.

The Department of Health and Human Services cancelled an $877.5 million deal with VaxGen Inc. in December to produce 75 million doses of second-generation vaccine, after the Brisbane, Calif, company missed a deadline for clinical trials because of stability issues with the drug.

HHS had said at the time it would move “swiftly” to seek a new second- generation anthrax contract, but has yet to issue a request for proposal.

The third-generation contract was considered eight to 10 years away from production, but HHS officials had been touting it in the wake of the VaxGen cancellation.

The contract was for three years, scheduled to begin this June.A spokesman for HHS was unavailable for comment.

The reason for the latest contract termination is unknown, but analysts suggested the entire anthrax vaccine procurement process might be retooled.

“We don’t know what their strategic plan is for anthrax,” Housman said. “The department has said they have developed a strategic plan for how they are going to move forward with new anthrax countermeasures. We don’t really know from this how this fits into that plan.”

It is the latest setback for Project BioShield (PL 108-276), which was created in 2004 to provide $5.6 billion over 10 years to create countermeasures to biological weapons and epidemics.

The second-generation vaccine was to be a recombinant protective antigen (rPA) vaccine. The rPA vaccine would come from a more highly defined product and be more consistent between production lots than the current Emergent vaccine, according to government officials. It also potentially would have less adverse effects and provide immunity with fewer doses than AVA.

Only one company is believed to be equipped to produce a second- generation rPA vaccine similar to VaxGen’s — Avecia Biologicals Ltd., a British company. It has received NIH funding since 2002 for vaccine development. But sources said it may have run into similar stability issues in clinical trials as VaxGen. An Avecia spokesman was unavailable for comment.

The third-generation drug would have, theoretically, allowed for fewer doses and had a longer shelf life. The NIAID RFP did not say whether it was to be an AVA or rPA vaccine.

Both Emergent and Avecia bid on the third-generation contract, sources said. Emergent made several bids, both for an augmented version of their current vaccine and one using rPA technology.

Envelopes laced with anthrax were mailed in 2001, killing five people and sickening 17 others. It led to the temporary shutdown of Congress and several U.S. Postal facilities.

Housman, who formerly represented VaxGen, said the decision to scrap plans to develop a third-generation vaccine would send a “chilling effect” to other companies considering entering the vaccine business.“

At a time when [Bioshield] is now under review . . . after it’s been subject to a fairly significant amount of criticism, to turn off the pipeline for anthrax is going to make industry pretty wary,” he said.

HHS has repeatedly asked Emergent for more doses of its drug. But the drug has been criticized by some in the military who were forced to take it, and the Food and Drug Administration has found 21 people died after receiving it, and more than 4,000 reported health problems.

The Defense Department recently resumed mandatory vaccinations, after the drug received full FDA approval.

Sen. Joseph I. Lieberman, I-Conn., chairman of the Homeland Security & Governmental Affairs Committee, said he will try to find out whether the government will be able to protect people from an anthrax attack.

“It is not surprising that NIH is cancelling plans to develop a third generation anthrax vaccine given the failure of the second generation vaccine. but I am disappointed NIH would cancel early research and development of a vaccine that is safe, can be taken in 1 or 2 doses, and can be administered quickly to a large number of people,” he said in an e-mail. “At my request, GAO is investigating what went wrong with the second generation vaccine, which should help clarify whether HHS is on the road to developing a vaccine that will protect the American people in the event of an anthrax attack.”

Matthew E. Berger can be reached at mberger@cq.com.