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Biosecurity News in Brief
VaxGen Responds to Concerns About its Anthrax VaccineBy Michael Mair, March 24, 2006 On March 17, VaxGen, Inc.'s (VaxGen) CEO and President, Lance K. Gordon, Ph.D., responded[1] to a recent Washington Post report[2] that VaxGen has encountered problems with its anthrax vaccine, rPA102, that may delay its delivery to the federal government for storage in the Strategic National Stockpile (SNS). Dr. Gordon stated that The Washington Post article presented "no new material information about VaxGen's anthrax vaccine . . . or our plans to deliver 75 million doses to the U.S. government," and that it "mischaracterized the results of our first Phase II trial."[1] The Washington Post article characterized VaxGen's anthrax vaccine as having "flunked" a human clinical trial, which revealed that the vaccine was unstable and lost its potency within months of production.[2] According to Dr. Gordon, although all of the objectives of the trial were not met, it "did confirm the strong safety and immunogenicity of the vaccine" which had been seen in previous trials.[1] Dr. Gordon acknowledged that the trial revealed "an unexpected interaction between the vaccine's protein, rPA, and a standard FDA-approved adjuvant, aluminum hydroxide," which prompted VaxGen to introduce "small but important changes to its formulation process."[1] Dr. Gordon announced that "the improved vaccine formulation at lab scale has remained stable for more than eight months when refrigerated according to standard storage protocols" and the "changes to the adjuvant have already been successfully incorporated into large-scale production of vaccine lots."[1] With regard to its federal contract to deliver rPA102 to the SNS, Dr. Gordon stated that VaxGen "continue[s] to estimate that [it] will have an anthrax vaccine available for delivery to the Department of Health and Human Services in the fourth quarter of 2006."[1] However, Dr. Gordon noted that VaxGen is in "discussions leading to an update to [its] contract" which "will be announced when an amendment has been finalized," and that if additional data on the vaccine is required "beyond that which is required by our existing contract, prior to accepting deliveries of the vaccine, which could delay delivery," VaxGen "would seek appropriate financial compensation."[1] References
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