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ID#: PA-12-038 (Reissue of PA-08-257 and companion FOA PA-12-037)      Posted: 11 Jan 2012
Research to Advance Vaccine Safety (R21) (NIH and CDC)
Deadline: 16 Jul 2012
Apply Here
Type of Grant: Research
Topics/Fields of Support: Adjuvants, Vaccine concepts and design
National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC)

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important medical discoveries that improve health and save lives.

Thanks in large part to NIH-funded medical research, Americans today are living longer and healthier. Life expectancy in the United States has jumped from 47 years in 1900 to 77 years today, and disability in people over age 65 has dropped dramatically in the past 3 decades. In recent years, nationwide rates of new diagnoses and deaths from all cancers combined have fallen significantly.

Scientific Leadership

NIH is the largest source of funding for medical research in the world, creating hundreds of thousands of high-quality jobs by funding thousands of scientists in universities and research institutions in every state across America and around the globe.

NIH is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems. NIH leadership plays an active role in shaping the agency's activities and outlook.

The Office of the Director is the central office at NIH, responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components. The NIH Director, with a unique and critical perspective on the entire agency, is responsible for providing leadership to the Institutes and for constantly identifying needs and opportunities, especially for efforts that involve multiple Institutes. The NIH Director is assisted by the NIH Deputy Directors including the Principal Deputy Director, who shares in the overall direction of the agency's activities.

More than 80% of the NIH's budget goes to more than 300,000 research personnel at over 3,000 universities and research institutions. In addition, about 6,000 scientists work in NIH’s own laboratories, most of which are on the NIH main campus in Bethesda, Maryland. The main campus is also home to the NIH Clinical Center, the largest hospital in the world totally dedicated to clinical research.

Successful biomedical research depends on the talent and dedication of the scientific workforce. NIH supports many innovative training programs and funding mechanisms  that foster scientific creativity and exploration. The goal is to strengthen our nation’s research capacity, broaden our research base, and inspire a passion for science in current and future generations of researchers.

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The purpose of this funding opportunity announcement (FOA) is to support research that will contribute to the overall understanding of vaccine safety. This research opportunity invites studies that address scientific areas potentially relevant to vaccine safety such as 1) physiological and immunological responses to vaccines and vaccine components, 2) how genetic variations affect immune/physiological responses that may impact vaccine safety, 3) identification of risk factors and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines, 4) creation/evaluation of statistical methodologies for analyzing data on vaccine safety, including data available from existing data sources such as passive reporting systems, or 5) the application of genomic/molecular technologies to improve knowledge of vaccine safety.

Examples of research topics include, but are not limited to:

  • Detailed evaluation of various host immune/physiological responses to currently licensed vaccine antigens and/or adjuvant combinations.
  • Evaluation of existing childhood immunization schedules to optimize safe and long-term protective immune memory.
  • Studies that define the capacity and quality of the immune response throughout infancy and childhood. Can vaccines be further optimized to minimize the need for secondary immunizations?
  • Identification of the molecular basis for differential immune/physiologic responses to vaccination at different stages of life or when underlying health problems exist.
  • Studies to determine if there are associations between genetic variations among individuals and susceptibility to serious adverse events in response to vaccination.
  • Identification of risk factors and biological markers that would allow for assessment of whether there is a relationship between certain diseases or disorders and licensed vaccines.
  • Creation/evaluation of statistical methodologies to provide rigorous analysis of vaccine safety data from existing sources including passive reporting systems (e.g., Vaccine Safety Datalink; Vaccine Adverse Events Reporting System) and to establish novel approaches to designing studies on vaccine safety. 
  • Comparison of the immunologic and physiologic effects of different combinations of vaccines and different schedules.

This Funding Opportunity Announcement aligns with the research goals and objectives outlined in the U.S. National Vaccine Plan (


Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)


  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession


  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. 

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   


We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts Customer Support (Questions regarding registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726 

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939

Scientific/Research Contact(s)

Barbara Mulach, Ph.D. 
Division of Microbiology and Infectious Diseases 
National Institute of Allergy and Infectious Diseases
Room 4103, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603 
Telephone: (301) 496-1884

Trudy Messmer, Ph.D.
Center for Disease Control and Prevention 
Director, Extramural Programs
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
CORP Bldg 12 Rm 3314  MS E60
Atlanta, GA  30329-1902
Telephone: 404.718.8845

Lyn Hardy, PhD
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd. Rm 710 MSC 4870
Bethesda, MD 20892-4870
Telephone: 301-594-5976

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Victoria P. Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC-7614
6700 B Rockledge Drive
Bethesda, MD 20892-7614
Express Delivery use 20817
Phone: (301) 402-5065
Fax: (301) 493-0597

Mr. Hector Buitrago
Lead Grants Management Specialist
OCOO/Procurement and Grants Office
Center for Disease Control and Prevention 
KOGR Bldg COLGA Rm 3635
Atlanta, GA  30341
Telephone: 770.488.2921 

Mr. Ron Wertz
Grants Management Specialist 
National Institute of Nursing Research
6701 Democracy Blvd, Rm 710 MSC 4870 
Bethesda MD 20892-4870
Telephone: 301-594-2807