NOT-AI-02-018: RFP ANNOUNCEMENT: PRODUCTION AND ACQUISITION OF ANTHRAX VACCINE

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

RFP ANNOUNCEMENT: PRODUCTION AND ACQUISITION OF ANTHRAX VACCINE - NIH-NIAID-
DMID-03-29

Release Date: April 18, 2002

NOTICE: NOT-AI-02-018

National Institute of Allergy and Infectious Diseases (NIAID)
  (http://www.niaid.nih.gov)

Receipt Date: July 1, 2003

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 and will be 
posted on FedBizOpps at 
http://www.eps.gov/servlet/Documents/R/644095.

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.  

Contracting Office Address:

National Institutes of Health
National Institutes of Allergy and Infectious Diseases
Contract Management Branch 
6700-B Rockledge Drive
Room 2230, MSC 7612 
Bethesda, MD, 20892-7612

Point of Contact:
Phillip Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, 
E-Mail [email protected] 

This announcement does not commit the Government to award a contract. No 
collect calls will be accepted.
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