NOT-AI-02-047: RFP ANNOUNCEMENT: DEVELOPMENT AND TESTING OF A MODIFIED VACCINIA ANKARA (MVA) VACCINE

Department of Health
and Human Services (HHS)
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RFP ANNOUNCEMENT: DEVELOPMENT AND TESTING OF A MODIFIED VACCINIA ANKARA (MVA) 
VACCINE - NIH-NIAID-DMID-03-44

Release Date:  August 14, 2002

NOTICE: NOT-AI-02-047

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

Receipt Date:  September 30, 2002

DESCRIPTION

The Division of Microbiology and Infectious Diseases, National Institute of 
Allergy and Infectious Diseases (NIAID), NIH, has a requirement for the 
development and testing of a Modified Vaccinia Ankara (MVA) Vaccine. The 
purpose of this RFP is to provide resources for the initial development of 
MVA vaccine candidates.  It is the intent of the Government to provide 
contract support for the development and stockpiling of MVA vaccines through 
the issuance of sequential RFPs.  This current RFP (NIH-NIAID-DMID-03-44) is 
intended to provide resources for the initial development of MVA vaccine 
candidates.

It is anticipated that one (1) or more cost reimbursement, completion type 
contracts will be awarded for a period of three (3) years, beginning 
approximately January 31, 2003.  This RFP also includes a Part B to the 
Statement of Work as an Option provision under FAR 17.2 for the conduct of 
expanded Phase II clinical studies in healthy populations (i.e., adult and 
children) and Phase I and II studies in "at risk" (i.e., immuno-compromised) 
populations.  RFP-NIH-NIAID-DMID-03-44 will be available electronically on or 
about August 15, 2002, and may be accessed through the NIAID Contract 
Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract, and 
will be posted on FedBizOpps at http://www.fedbizopps.gov/.  Any responsible 
Offeror may submit a proposal that will be considered by the Government.  
This advertisement does not commit the Government to award a contract.  No 
collect calls will be accepted.  No facsimile transmissions will be accepted.

In addition, the Government intends to issue a second RFP entitled 
"Production and Acquisition of MVA Vaccine" on or about June 2003.  The main 
objectives of the second RFP will be to:  a) execute a plan to manufacture, 
formulate, fill and finish, and test, assuming 30 X 106 doses of MVA in 
accordance with cGMP regulations, b) deliver to the Government up to 30 
million doses of vaccine to constitute a stockpile for emergency use under 
IND, and to maintain the stockpile as needed, and c) provide a licensure plan 
to include the conduct of expanded human safety studies required for 
licensure and the conduct of pivotal animal protection studies. Participation 
in RFP NIH-NIAID-DMID-03-44 will NOT be a pre-requisite for participation in 
the second RFP, "Production and Acquisition of MVA Vaccine", the second RFP 
will be a full and open, competitive procurement.

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:

Phil Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, E-
mail [email protected]
Jacqueline Holden, Senior Contracting Officer, Phone 301-496-7119, Fax 301-
402-0972, E-mail [email protected]
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