VaxGen, Brisbane, CA, March 24 (CBER).FDA's Center for Biologics reviewed a Question and Answer (Q&A) document distributed by the firm's sales representatives at a promotional booth in connection with the 4'h Annual Federal Biodefense Research FY 2006 meeting, Oct. 17-19, 2005, in Washington, regarding VaxGen's investigational product--Bacillus anthracis Recombinant recombinant /re·com·bi·nant/ (re-kom´bi-nant)
1. the new entity (e.g., gene, protein, cell, individual) that results from genetic recombination.
2. pertaining or relating to such an entity. See also under DNA. Protective Antigen antigen: see immunity.
Foreign substance in the body that induces an immune response. The antigen stimulates lymphocytes to produce antibodies or to attack the antigen directly (see antibody;immunity). 102 (rPA102) (anthrax vaccine An´thrax vac´cine
1. (Veter.) A fluid vaccine obtained by growing a bacterium (Bacillus anthracis, formerly Bacterium anthracis) in beef broth. It is used to immunize animals, esp. cattle. ) with Alum.
According to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. the warning letter, the Q&A document contained false and misleading statements that represented the product as already being safe and effective for the purposes for which it is still being investigated.
Misleading statements in the Q&A document to which the agency objected included such claims as "Modem recombinant technology has allowed VaxGen to consistently produce the vaccine at nearly 100 percent purity--significantly higher than what can be obtained using older technologies ..."; and, "BioPort's product is less consistent and has greater impurities than VaxGen's rPA102."
"It is false or misleading for you to make any claims about the consistency of your vaccine production at this early stage of product development," the agency emphasized.
The agency further objected because VaxGen claimed it could consistently produce its product "at nearly 100% purity"; and that VaxGen's vaccine "requires significantly fewer doses for protection, and people receiving it will achieve the immune response immune response
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. in a far less time than they would with BioPort's vaccine." F-B F-B Forward - Backward (radar image analysis) , Lab; Doc. 13758W