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HHS Amends Request for Proposal for Third Generation Smallpox Vaccine

By Michael Mair, July 28, 2006

On July 24, the U.S. Department of Health and Human Services (HHS) issued an amendment to its request for proposal (RFP) for the acquisition of third generation smallpox vaccine based on modified vaccinia Ankara (MVA) for the Strategic National Stockpile (SNS) [RFP-DHHS-ORDC-V&B-05-06].[1] MVA is a weakened (i.e., attenuated) strain of vaccinia virus that is expected to have a better safety profile than the smallpox vaccines currently stockpiled. The original RFP was for a minimum of 10 million and up to 20 million doses of usable MVA vaccine to be delivered to the SNS within 24 months of the contract award date. The amendment changes the timing of delivery of vaccine to the SNS from 24 months to 60 months.

Additional changes to the RFP include:

The primary use of the vaccine is changed from “pre-exposure prophylaxis of individuals considered to be at risk subsequent to a known or suspected smallpox virus release"[2] to “prophylaxis of individuals considered to be at risk for smallpox."[1]
The requirement to conduct supportive clinical trial(s) and animal studies to support an Emergency Use Authorization (EUA) “for pre-exposure prophylaxis of healthy individuals considered to be at risk subsequent to a known or suspected smallpox virus release"[2] is removed.
The requirement to “conduct supportive clinical trial(s) and animal studies to support an EUA…for pre-exposure prophylaxis of immunocompromised individuals considered to be at risk subsequent to a known or suspected smallpox virus release"[2] is changed to “[c]onduct supportive clinical trial(s) and animal studies to support an EUA…for prophylaxis of immunocompromised individuals considered to be at risk for smallpox."[1]
The requirement to “develop and submit non-clinical and clinical study plans for pre-exposure prophylaxis of (1) healthy individuals and (2) immunocompromised individuals considered to be at risk subsequent to a known or suspected smallpox virus release to support a CDC-held IND and/or EUA"[2] is changed to “develop and submit non-clinical and clinical study plans to support an EUA for prophylaxis of immunocompromised individuals considered to be at risk for smallpox."[1]
The requirement to “develop, submit, and execute non-clinical and clinical plans to demonstrate safety and efficacy under the Animal Efficacy Rule (21 CFR 601.91) and human safety and immunogenicity studies adequate for U.S. licensure, which “shall be designed in consultation with appropriate [U.S. government] agencies and should support the licensure of MVA for pre-exposure prophylaxis of (1) healthy individuals and (2) immunocompromised individuals considered to be at risk subsequent to a known or suspected smallpox virus release"[2] is changed to require that the “plans shall be designed in consultation with appropriate [U.S. government] agencies and should support the licensure of MVA for prophylaxis of healthy individuals considered to be at risk for smallpox."[1]

Acambis plc (Acambis) and Bavarian Nordic A/S are currently competing for contracts to deliver their MVA-based smallpox vaccines to the U.S. government under the RFP. On July 26, Acambis announced that the “revised testing requirement received from the FDA also impacts on Acambis' existing cost-plus MVA contractual activities, resulting in certain activities previously anticipated for 2006 continuing into 2007” and that “[w]ith this change in the timing of activities and, therefore, revenues, it is expected that “predictable" revenues overall will be marginally lower than the guidance for 2006 of £20-25m previously provided."[3]

According to Acambis, responses to the amendment to the MVA RFP “are to be provided to HHS by mid-August” and that “it is expected that Final Proposal Revisions will be requested prior to contract award(s) being made."[3]

References

Amendment #3; RFP-DHHS-ORDC-V&B-05-06; “Acquisition of Smallpox MVA Vaccine for the Strategic National Stockpile”. U.S. Department of Health and Human Services. July 24, 2006. Available at http://fs1.fbo.gov/EPSData/HHS/Synopses/37271/RFP-DHHS-ORDC-VB-05-06/MVARFPAmendment3.pdf. Accessed July 28, 2006.
Request for Proposal (RFP) Number DHHS-ORDC-V&B - 05-06; "Acquisition of Smallpox MVA Vaccine for the Strategic National Stockpile". U.S. Department of Health and Human Services. August 15, 2005. Available at http://fs1.fbo.gov/EPSData/HHS/Synopses/37271/RFP-DHHS-ORDC-VB-05-06/FinalMVARFP.pdf. Accessed July 28, 2006.
Update on U.S. Government MVA vaccine procurement process. Acambis plc. July 26, 2006. Available at http://www.acambis.com/default.asp?id=1542. Accessed July 28, 2006.

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