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. The 45-minute presentation is followed by questions from the audience. #FDAGrandRounds.
Thursday, March 30, 2017
12:00 p.m. -1:00 p.m., Eastern Standard Time (EST)
Hana Golding, PhD
Chief, FDA Laboratory of Retrovirus Research
FDA Center for Biologics Evaluation and Research
Vaccine adjuvants: New ways to evaluate their safety and effectiveness
About the Presentation
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.
About the Presenter
Dr. Hana Golding is Chief of FDA’s Laboratory of Retrovirus in its Center for Biologics Evaluation and Research (CBER). She joined CBER’s Division of Viral Products in 1987 and became the Chief of the Laboratory of Retrovirus Research in 1993. Dr. Golding is also co-manager of FDA’s Influenza Research Program.
The Golding lab’s principal areas of research are:
- Vaccines against viral pathogens, including pandemic Influenza, RSV, Ebola, Zika, and HIV, and
- Vaccine Adjuvants: their mode of action, impact on immune responses, and new biomarkers predictive of their safety and efficacy in humans.
Dr. Golding received her PhD from Oregon Health Sciences University, Oregon and did postdoctoral training at the Experimental Immunology Branch of the National Cancer Institute, National Institutes of Health. She has authored more than 150 research papers and book chapters on immunology, virology, and infectious diseases topics.
- The Host Response to Whooping Cough Infection and Vaccination
- Antibiotic resistance surveillance in the age of genomics: New answers to old questions
- FDA Research into 3D Printing of its Regulated Products
- Rapid Screening of Dietary Supplements for Undeclared Ingredients
- Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies
Sign up for latest news on leading-edge scientific research, initiatives, and events at FDA