Opportunity Information: Apply for EP IDS 10 003
Apply for EP IDS 10 003
- The Assistant Secretary for Preparedness and Response in the other (see text field entitled explanation of other category of funding activity for clarification) science and technology and other research and development sector is offering a public funding opportunity titled "Development and Sustainable Manufacturing of Adjuvanted Pandemic Influenza Vaccines in Developing Countries" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.360 Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development.
- This funding opportunity was created on Jul 22, 2010 and posted on Jun 18, 2010.
- Applicants must submit their applications by Aug 6, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Domestic or foreign public or private non profit entities including state and local governments, Indian tribal governments and organizations (American Indian/Alaskan Native/Native American), faith based organizations, community based organizations, hospitals, and institutions of higher education.. The Department of Health and Human Services does not prohibit awards to for profit institutions. However, for profit awardees may not profit on federal cooperative agreement funds.
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Opportunity Summary:
The Development and Sustainable Manufacturing of Adjuvanted Pandemic Influenza Vaccines in Developing Countries opportunity is a BARDA cooperative agreement aimed at strengthening real-world pandemic influenza preparedness by expanding vaccine capacity in developing countries and, in particular, enabling the use of adjuvant-based "antigen-sparing" approaches. BARDA, housed within ASPR at HHS, funds and coordinates the advanced development and procurement of medical countermeasures for public health emergencies, and this announcement fits that mission by trying to reduce the global gap between vaccine need and vaccine supply during a severe influenza pandemic.
The public health problem motivating the award is straightforward: strains such as H5N1 (avian influenza) and the more recent H1N1 (swine influenza) highlighted the ongoing risk of a fast-moving, high-impact influenza pandemic, yet global influenza vaccine manufacturing capacity is not sufficient to meet expected demand. Developing countries are especially vulnerable because they often rely on multinational manufacturers in wealthier countries for supply, meaning access can be delayed or limited precisely when every country is trying to secure doses at the same time. The grant frames increased manufacturing capacity in developing countries as a practical solution, both for local protection and for potential regional supply that could help neighboring countries without domestic production.
A key technical theme of the opportunity is antigen sparing, which is essentially getting more usable doses out of the same amount of vaccine antigen. The announcement emphasizes that one way to do this is by increasing immunogenicity so that each dose requires less antigen, and another is improving responses enough that protective immunity can be achieved with a single dose rather than a two-dose regimen. The program points to adjuvants and related immune-enhancing components as promising antigen-sparing tools, including adjuvants, immunostimulants, immune cytokines, or other biologicals that can be formulated with influenza antigens or co-administered alongside them. If successful, these approaches can multiply available supply several-fold, speed population coverage during an emergency, and improve the feasibility of mass vaccination campaigns.
The opportunity also makes a strong point about practicality and accessibility for developing-country manufacturers. It highlights that the most advantageous approaches are those that can be implemented broadly without being blocked by intellectual property restrictions and that are not tied to a single manufacturer or proprietary platform. In other words, BARDA is not only interested in a scientifically effective adjuvant strategy, but one that can realistically be adopted by multiple manufacturers in resource-variable settings. For any antigen-sparing technology to matter in a pandemic, the announcement lays out three essential conditions: it must demonstrably reduce antigen needed to achieve protection, it must be licensed and available when the pandemic hits (not perpetually in development), and it must be feasible at mass-vaccination scale.
This announcement builds on earlier BARDA investments made through a cooperative agreement with the World Health Organization. Between FY 2006 and 2008, BARDA provided a total of $24.4 million to support accelerated development and production of H5N1 influenza vaccines across multiple countries, including Vietnam, Thailand, Indonesia, India, Mexico, Brazil, Egypt, Romania, and Serbia. The description lists the kinds of capacity-building activities that funding supported, which helps clarify what BARDA considers in-scope: workforce training; laboratory equipment; manufacturing process development; development and validation of product release assays; clinical sample analysis; production of pilot lots; scale-up work toward larger manufacturing runs; acquisition of vaccine production equipment; and steps toward eventual commercial-scale production suitable for clinical trials and pandemic use. The new opportunity extends that general capacity-building logic into the specific area of adjuvanted pandemic influenza vaccines, addressing the stated problem that developing countries generally do not have access to appropriate adjuvant technologies for development and manufacturing.
From an administrative standpoint, the opportunity was issued as a discretionary cooperative agreement under CFDA 93.360 (BARDA Biodefense Medical Countermeasure Development). The funding opportunity number is EP-IDS-10-003, with a posted date of June 18, 2010 and a final closing date of August 6, 2010 (originally July 23, 2010). Awards were expected to range from $650,000 to $2,000,000, with no cost-sharing or matching requirement noted.
Eligibility was broad and included domestic or foreign public or private nonprofit entities, including state and local governments, tribal governments and organizations, faith-based and community-based organizations, hospitals, and institutions of higher education. The notice also states that HHS does not prohibit awards to for-profit entities, but for-profit recipients may not earn profit from federal cooperative agreement funds. A named contact for the announcement was Chuong Huynh (Project Officer), reachable by phone at 202-205-4520 or by email at Chuong.Huynh@hhs.gov.
Frequently Asked Questions (FAQs)
What is the "Development and Sustainable Manufacturing of Adjuvanted Pandemic Influenza Vaccines in Developing Countries" opportunity?
This is a BARDA cooperative agreement focused on strengthening real-world pandemic influenza preparedness by expanding influenza vaccine capacity in developing countries, with a particular emphasis on adjuvant-based, "antigen-sparing" vaccine approaches.
Which agency is sponsoring this opportunity?
The sponsor is BARDA (Biomedical Advanced Research and Development Authority), which is housed within ASPR (Assistant Secretary for Preparedness and Response) at HHS (U.S. Department of Health and Human Services).
What is the main public health problem this award is trying to address?
The opportunity is motivated by the risk of a fast-moving, high-impact influenza pandemic (highlighted by strains such as H5N1 and H1N1) and the fact that global influenza vaccine manufacturing capacity is not sufficient to meet expected demand during a severe pandemic.
Why does the opportunity emphasize developing countries?
Developing countries are described as especially vulnerable because they often depend on multinational manufacturers in wealthier countries for vaccine supply. During a pandemic, that reliance can lead to delayed or limited access when every country is trying to secure doses at the same time.
What does BARDA mean by "pandemic influenza preparedness" in this announcement?
In this announcement, preparedness is closely tied to practical manufacturing capacity and the ability to rapidly produce and deploy enough pandemic influenza vaccine doses to reduce the gap between vaccine need and vaccine supply during an emergency.
What is an "antigen-sparing" approach?
Antigen sparing refers to strategies that allow more vaccine doses to be produced from the same amount of influenza vaccine antigen. The announcement links antigen sparing to improving immunogenicity so that each dose needs less antigen and/or enabling protective immunity with a single dose rather than a two-dose regimen.
How do adjuvants relate to antigen sparing in this program?
The opportunity highlights adjuvants and related immune-enhancing components as promising tools to increase immunogenicity and reduce the amount of antigen required per dose, potentially multiplying available supply several-fold and speeding population coverage during an emergency.
What kinds of immune-enhancing components are mentioned besides adjuvants?
The announcement references adjuvants, immunostimulants, immune cytokines, and other biologicals that can be formulated with influenza antigens or co-administered alongside them.
Why is single-dose protection mentioned as a program goal?
If protective immunity can be achieved with a single dose (instead of two doses), the same manufacturing output can cover more people more quickly, which can improve the feasibility of mass vaccination campaigns during a pandemic.
What does the opportunity say about intellectual property (IP) and practicality?
It emphasizes that the most advantageous approaches are those that can be implemented broadly without being blocked by intellectual property restrictions and that are not tied to a single manufacturer or proprietary platform.
What makes an antigen-sparing technology "matter" in a pandemic, according to the announcement?
The opportunity lays out three essential conditions: (1) it must demonstrably reduce the antigen needed to achieve protection, (2) it must be licensed and available when the pandemic hits (not perpetually in development), and (3) it must be feasible at mass-vaccination scale.
Does this opportunity focus only on scientific development, or also on manufacturing capacity?
It is aimed at strengthening preparedness by expanding vaccine capacity in developing countries, and it frames increased local manufacturing capacity as a practical solution for local protection and potential regional supply.
How does this announcement relate to earlier BARDA work?
It builds on earlier BARDA investments made through a cooperative agreement with the World Health Organization. Between FY 2006 and 2008, BARDA provided a total of $24.4 million to support accelerated development and production of H5N1 influenza vaccines across multiple countries.
Which countries were listed as part of the earlier BARDA-supported work?
The description lists Vietnam, Thailand, Indonesia, India, Mexico, Brazil, Egypt, Romania, and Serbia.
What kinds of activities were supported under the earlier capacity-building efforts (and help indicate what is in scope)?
The announcement lists examples of supported activities such as workforce training; laboratory equipment; manufacturing process development; development and validation of product release assays; clinical sample analysis; production of pilot lots; scale-up work toward larger manufacturing runs; acquisition of vaccine production equipment; and steps toward eventual commercial-scale production suitable for clinical trials and pandemic use.
What is new or distinct about this opportunity compared to earlier work?
The opportunity extends prior capacity-building logic into the specific area of adjuvanted pandemic influenza vaccines and addresses the stated problem that developing countries generally do not have access to appropriate adjuvant technologies for development and manufacturing.
What type of award is this?
It was issued as a discretionary cooperative agreement.
What is the CFDA number for this program?
The CFDA number listed is 93.360 (BARDA Biodefense Medical Countermeasure Development).
What is the funding opportunity number?
The funding opportunity number is EP-IDS-10-003.
When was the opportunity posted and when did it close?
The posted date was June 18, 2010. The final closing date was August 6, 2010 (originally July 23, 2010).
What funding amount range was expected for awards?
Awards were expected to range from $650,000 to $2,000,000.
Is cost sharing or a match required?
No cost-sharing or matching requirement is noted in the provided description.
Who is eligible to apply?
Eligibility was broad and included domestic or foreign public or private nonprofit entities, including state and local governments, tribal governments and organizations, faith-based and community-based organizations, hospitals, and institutions of higher education.
Are for-profit entities allowed to receive an award?
The notice states that HHS does not prohibit awards to for-profit entities; however, for-profit recipients may not earn profit from federal cooperative agreement funds.
Who was the point of contact for the announcement?
The named contact was Chuong Huynh (Project Officer).
How can the point of contact be reached?
Phone: 202-205-4520. Email: Chuong.Huynh@hhs.gov.
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