Aventis Pasteur, B-291584, January 23, 2003

B-291584 Jan 23, 2003 Jump To VIEW DECISION RELATED PAGES GAO CONTACTS Highlights DIGEST Protest is denied where it is clear from the record that the protester was not misled during discussions concerning the criticality of an offeror's proposed approach to satisfy the solicitation's milestone requirements. Explained that there was an urgent need to devise appropriate and effective measures to protect the general population from the harmful effects of anthrax spores used as instruments of terror. There was sufficient justification to warrant the rapid development. The RFP provided that the milestones were considered contract deliverables. The RFP provided that the technical evaluation factors were significantly more important than cost. The evaluators determined that there were a number of technical weaknesses and disadvantages in the Aventis proposal. View Decision Aventis Pasteur, B-291584, January 23, 2003 * REDACTED DECISION DIGEST Attorneys DECISION Aventis Pasteur protests the rejection of its proposal under request for proposals (RFP) No. NIH-NIAID-DMID-02-26, issued by the Department of Health and Human Services for the development and testing of anthrax vaccines. Aventis challenges the agency's conduct of discussions with the firm. We deny the protest. The RFP, issued on April 22, 2002, explained that there was an urgent need to devise appropriate and effective measures to protect the general population from the harmful effects of anthrax spores used as instruments of terror. The RFP provided that in view of the events since September 11, 2001, there was sufficient justification to warrant the rapid development, testing, and licensure of a vaccine to cover pre-exposure and post-exposure to anthrax, preferably in a single dose. Accordingly, the RFP stated that this procurement to develop, manufacture, characterize, and evaluate a pilot lot of B. anthracis recombinant protective antigen (rPA) vaccine would be "milestone-driven." RFP Statement of Work. The acquisition of an anthrax vaccine would be conducted in three phases, with the first two phases covered by this RFP. Under the first phase, the agency anticipated making (in September 2002) multiple cost-plus-fixed-fee, completion-type contract awards, under which the contractors would be required to develop an anthrax vaccine in accordance with the following milestones, as described in the RFP: (1) within 3 months of award, produce a pilot lot of rPA vaccine suitable for phase 1 and optional phase 2 clinical trials; /1/ (2) within 6 months of award, provide 2,000 doses of the vaccine previously developed as a pilot lot so that the agency could seek approval from the Food and Drug Administration to conduct its own clinical trials; (3) furnish protocols for phase 1 and optional phase 2 clinical trials; (4) conduct phase 1 clinical trials; and (5) within 12 months of award, provide a plan for emergency production of 25 million doses of the vaccine previously developed as a pilot lot. The RFP provided that the milestones were considered contract deliverables. Under the second phase, an option under this RFP, the agency would select one of the multiple awardees from the first phase to conduct phase 2 clinical trials. /2/ The RFP provided that the awards would be made to the offerors whose proposals represented the best overall values to the government, considering technical evaluation factors and cost. The technical evaluation factors included technical approach (70 points), personnel (15 points), and facilities (15 points). Under technical approach, the following areas would be evaluated: (1) technical adequacy and feasibility of proposed plan to develop candidate vaccine with attributes included in the statement of work (30 points); (2) technical adequacy and feasibility of proposed process development plan leading to the manufacture of required amounts of vaccine approved for emergency use within the specified time mentioned in the statement of work (30 points); and (3) technical adequacy and feasibility of clinical development plan, including proposed protocols for phase 1 and phase 2 clinical trials as described in the statement of work (10 points). The RFP provided that the technical evaluation factors were significantly more important than cost. Four firms, including Aventis, Avecia, Ltd., and VaxGen, Inc., submitted initial proposals by the closing time on June 6. As relevant here, Aventis proposed an rPA vaccine produced by [deleted] to support the phase 1 clinical trials. Aventis described items (e.g., yield, expression level, and production process) that would be "optimized and scaled-up in order to meet future demand," and it also stated that ten extraneous amino acid residues would be removed from the [deleted] vaccine. Aventis Initial Proposal, at 1-24. The agency's technical evaluation panel assigned the Aventis initial proposal a score of 89 out of a possible 100 points, the highest technical score received.