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  1. About Science & Research at FDA


Event Title
Activity Outline

FDA Grand Rounds:
Vaccine adjuvants: New ways to evaluate their safety and effectiveness

March 30, 2017
12:00 PM-1:00 PM

Series Description
The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Remote Access Instructions:
To register for the webcast, please click this link and follow the instructions.  After you register you will receive a link to access the live webinar by logging in with your username and password which you create when you register. 

For technical assistance:
please contact Jeffery Rexrode at Jeffery.Rexrode@fda.hhs.gov.

Session Description
Effective vaccines should generate specific and strong immune responses against disease-causing microorganisms.  In the past, live weakened or killed whole organisms were often used for vaccination. Many provided long-lived protective immunity, but a few were associated with reactogenicity, that is, adverse reactions like fever, in a low percentage of vaccinated individuals.

New vaccines against emerging and re-emerging diseases often contain well-defined proteins designed to elicit more targeted immune responses against microorganisms, while also being safer.  However, such vaccines are often weakly immunogenic (they produce a short and mild immune response).

Adjuvants are compounds designed to improve the immunogenicity of vaccines by triggering early innate responses--that is, immediate, generic responses in cells such as monocytes and dendritic cells.  These cells transfer vaccine components to lymph nodes, where they activate specific B cell and T cell populations that target the microorganism.  However, in some cases, excessive activation of the innate response leads to local and systemic toxicities, including fever.

Hana Golding’s laboratory has developed new cellular assays to evaluate the safety of new adjuvants using human cells.  Additionally, the lab developed new molecular tools to analyze the antibody responses elicited by adjuvanted vaccines and compare them with responses of unadjuvanted vaccine recipients, as well as with patients who have recovered from the infection.  The insights gained from her group research could improve the evaluation of future adjuvanted vaccines against diverse disease-causing microorganisms and identify biomarkers of safety and efficacy.

Series Objectives:
1. Discuss the research conducted at the FDA
2. Explain how FDA science impacts public health

Session Learning Objectives

After completion of this activity, the participant will be able to:
1. Explain adjuvants and how they work
2. Describe how adjuvants improve the quality of immune responses
3. Discuss whether adjuvanted vaccines elicit broader (cross-reactive) immunity against pandemic influenza
4. Examine safety concerns related to adjuvants
5. Discuss whether in vitro assays complement pre-clinical studies in animals 

Target Audience:
This activity is intended for physicians, pharmacists, nurses and other scientists within the agency and external community.



 Lecture Title

Thurs., March 30, 2017
12:00 PM-1:00 PM

FDA Grand Rounds:
Vaccine adjuvants: New ways to evaluate their safety and effectiveness

 Hana Golding, PhD

Reasonable Accommodations
FDA provides reasonable accommodations for all individuals with disabilities who apply for training or developmental opportunities. If you need a reasonable accommodation for any part of the training application process please notify the training contact for this particular event. Reasonable accommodation requests are granted on a case-by case basis. Should you need sign language interpretation to attend this event, please send the request to Interpreting.Services@oc.fda.gov.

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