SOLICITATION NOTICE
A -- Production and Acquisition of Anthrax Vaccine
- Notice Date
- 4/8/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700-B Rockledge Drive, MSC 7612 Room 2230, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DMID-03-29
- Response Due
- 7/1/2003
- Archive Date
- 7/16/2003
- Point of Contact
- Thomas Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, - Jacqueline Holden, Senior Contracting Officer, Phone 301-496-7119, Fax 301-402-0972,
- E-Mail Address
-
ph23k@nih.gov, jh55b@nih.gov
- Description
- The main objectives of this RFP are: (a) to develop a plan to manufacture, formulate, and fill as single doses up to 25 x 106 doses of rPA anthrax vaccine, and (b) to negotiate the sale of up to 25 million doses to constitute a stockpile for emergency use under IND and to maintain the stockpile. Recently, significant changes have occurred in both the nature and degree of the threat posed by the use of infectious agents as weapons of biological warfare. The risk of using such weapons once appeared to be restricted to international conflicts involving small numbers of industrialized nations and an increasing number of developing countries. However, with the recent deliberate exposure of postal workers, other government employees and the American public at large to anthrax spores, there is an urgent need to devise appropriate and effective measures to protect U.S. citizens from the harmful effects of Bacillus anthracis spores used as instruments of terror. Among the strategies that might be considered to protect the American public from deliberate environmental exposure to B. anthracis spores, two are based on elicitation of protective immunity with vaccines. The first involves prior immunization with minimal doses of a vaccine known to generate significant and long-term protective immunity against inhalation spore challenge (pre-exposure vaccination). The second involves immunization, soon after aerosol exposure to spores and initiation of antibiotic prophylaxis, with a vaccine known to generate protective immunity relatively quickly after only a few immunizing doses (post-exposure vaccination). The latter would enable one to immunize at the time antibiotic therapy is begun so that a significant degree of protective immunity is present when antibiotic therapy is either completed or discontinued. In view of the national tragedy of anthrax spread by mail in the Fall of 2001, there is sufficient justification to warrant the rapid development, testing and licensure of a vaccine for both situations, ideally a single vaccine. Although a licensed anthrax vaccine is required for both pre-exposure prophylaxis and post-exposure immunization, the primary purpose of this procurement is production and procurement of a stockpile of anthrax vaccine that would be available to protect the general US population against inhalation anthrax when administered in an immunization series of not more than three doses. Abundant preclinical evidence is available to indicate that immunization with native protective antigen (PA) and the recombinant protective antigen (rPA) of B. anthracis adsorbed to alum generates long-lasting protective immunity against inhalation spore challenge in animal models of the disease. This immunity is mediated by antibody directed at PA, and preclinical experience in animal models provides the basis for consideration of testing rPA in human clinical trials. The urgent nature of the current threat requires an accelerated pace of procurement of an emergency stockpile of vaccine, and several rPA anthrax vaccines are under development. This solicitation is a request for proposals to develop a plan to manufacture rPA vaccine under cGMP conditions and to deliver to the government up to 25 million doses of rPA vaccine to constitute a stockpile of vaccine for emergency use under IND. It is anticipated that one cost-reimbursement, completion type contract will be awarded with incremental funding over a period of eighteen (18) months RFP-NIH-NIAID-DMID-03-29 will be available electronically on or about April 22, 2002, and may be accessed through the Internet on the Contract Management Branch Homepage, located at http://www.niaid.nih.gov/contract/. Please note that the RFP for this acquisition has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, Offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due by 4:00 pm on Tuesday, July 1, 2003. Any responsible Offeror may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted.
- Record
- SN00054916-W 20020410/020408213138 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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