Funding News Edition: July 18, 2018 See more articles in this edition
In our last issue, we told you that “NIAID Is Collecting Proposals on AMR Products, Novel Vaccines and Technologies Against Category A, B, and C Agents” through the 2018 NIAID Omnibus Broad Agency Announcement (BAA).
NIAID has amended the BAA to include a third research area: Collaborative Influenza Vaccine Innovation Centers (CIVICs).
The overarching goals of this added research area are to:
- Support improvements in the immunogenicity and durability of seasonal influenza vaccines
- Develop innovative influenza vaccine approaches that provide robust, durable, broadly protective mucosal and systemic anti-influenza immunity
- Conduct iterative vaccine design based on detailed immunologic assessment of influenza vaccine candidates through preclinical animal studies, early phase clinical trials, and healthy volunteer human challenge studies
- Advance the most promising vaccine candidates into Phase I and II clinical trials
CIVICs will include the following components:
- Component A: Vaccine Center—responsible for designing, developing, and evaluating preclinical/clinical immunology of influenza vaccine candidates.
- Component B: Vaccine Manufacturing and Toxicology Core—responsible for manufacturing and toxicity testing of selected vaccine candidates.
- Component C: Clinical Core—responsible for conducting Phase I and II clinical trials and maintaining of the CIVICs human sample repository.
Contractors awarded under CIVICs will:
- Employ an iterative process, based on principles of influenza immunity, to achieve the desired attributes of a universal influenza vaccine
- Work collaboratively across components to test novel combinations and conduct head-to-head comparisons of influenza vaccine approaches under development
NIAID encourages offerors to bring in expertise from outside the influenza field and employ state-of-the-art, cutting-edge techniques and strategies to design innovative influenza vaccine approaches.
NIAID’s expectations for a universal influenza vaccine are summarized below and available at A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases.
- Be at least 75 percent effective against symptomatic influenza virus infection
- Protect against group I and group II influenza A viruses (influenza B virus would be a secondary target)
- Provide durable protection that lasts at least one year and preferably through multiple influenza seasons
- Be suitable for all age groups, recognizing that different vaccines may be needed to provide optimal protection in certain populations
Find complete CIVICs technical details in HHS-NIH-NIAID-BAA2018 Amendment 1.
A peer review group will evaluate your proposal based on scientific and technical merit; scientific and technical personnel; project management; and organizational facilities, equipment, and other resources. See 6.3 Technical Evaluation Criteria within the BAA for detailed descriptions of each criterion.
Offerors must submit complete, separate proposals for each component they wish to propose:
- Component A: Vaccine Center
- Component B: Vaccine Manufacturing and Toxicology Core
- Component C: Clinical Core
Do not combine separate components into one proposal. Note that proposals are bound by page limits, which vary by component, as stated in the BAA.
NIAID anticipates issuing two or more Vaccine Center awards with a total first year base cost of roughly $13 million each; one Vaccine Manufacturing and Toxicology Core award with a total first year base cost of roughly $500,000; and one Clinical Core award with a total first year base cost of roughly $1 million.
Potential offerors interested in identifying partners who may wish to collaborate in order to address all required components of the solicitation are encouraged to contact Michael Finn by August 31, 2018. NIAID’s Office of Acquisitions will post a subsequent amendment to the 2018 NIAID Omnibus BAA at FedBizOpps listing all offerors and companies that have expressed such interest.
Actual funding will depend on the number of technically meritorious proposals, project scope, technical objectives, importance to agency programs, and availability of funds. We anticipate making awards in or around August 2019.
The total performance period you propose should not exceed seven years.
Proposals are due November 29, 2018, before 3 p.m. Eastern Time.
Contact Michael Finn, CIVIC’s contracting officer, if you have any questions.