1001 - Vaccines 101: How FDA Regulates Vaccines
Public Health On Call
The Johns Hopkins Bloomberg School of Public Health
4.6 • 644 Ratings
🗓️ 26 January 2026
⏱️ 21 minutes
🔗️ Recording | iTunes | RSS
🧾️ Download transcript
Summary
About this episode:
The U.S. Food and Drug Administration is responsible for reviewing the safety and effectiveness of vaccines—a job that requires deep scientific understanding as well as thoughtful regulatory judgment. In this episode: Dr. Jesse Goodman, a former top vaccine regulator and chief scientist at the FDA, explains how the agency came to lead the world in vaccine oversight—and shares his concerns for the future.
Guests:
Dr. Jesse Goodman, MPH, is a professor and the director of Georgetown University's Center on Medical Product Access, Safety and Stewardship. He worked at the FDA from 1998 until 2014, including as chief scientist.
Host:
Dr. Josh Sharfstein is distinguished professor of the practice in Health Policy and Management, a pediatrician, and former secretary of Maryland's Health Department.
Show links and related content:
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How HHS, FDA, and CDC Can Influence U.S. Vaccine Policy—KFF
-
Vaccines 101—Johns Hopkins Bloomberg School of Public Health
-
Recent "Expert Panels" Could Undermine the FDA's Credibility—Public Health On Call (September 2025)
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Transcript
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| 0:00.0 | Welcome to Public Health On Call, a podcast from the Johns Hopkins Bloomberg School of Public Health, |
| 0:05.9 | where we bring evidence, experience, and perspective to make sense of today's leading health challenges. |
| 0:16.2 | If you have questions or ideas for us, please send an email to public health question at jhhhu.edu. |
| 0:23.8 | That's public health question at jhhu.edu for future podcast episodes. |
| 0:31.1 | Hi listeners, it's Lindsay Smith-Rogers. |
| 0:33.4 | Today, the role of the Food and Drug Administration in Vaccine Regulation. |
| 0:38.0 | The Centers for Disease Control and Prevention capture a lot of vaccine headlines, but it's the |
| 0:42.8 | FDA that decides when a vaccine is safe and effective for use. Who usually makes those decisions |
| 0:48.2 | and what's changing now? Dr. Jesse Goodman is a professor at Georgetown University and a former |
| 0:53.6 | senior official at the FDA. He speaks to Dr. Josh Sharf is a professor at Georgetown University and a former senior official at the FDA. |
| 0:55.5 | He speaks to Dr. Josh Sharfstein about how the FDA views vaccines as medical products |
| 1:00.1 | and his concern that the FDA status as the global gold standard in vaccine regulation is at risk. |
| 1:06.6 | Let's listen. Dr. Jesse Goodman, thank you so much for joining me today in public health on call. |
| 1:11.6 | How are you doing? Yeah, I'm doing well, Josh. It's a pleasure to join you. |
| 1:15.6 | Now, you are many things. You're a professor at Georgetown. For many years, you worked at the U.S. Food and Drug Administration. Remind me the various roles you had there. |
| 1:24.9 | Well, when I first came, I was a senior advisor to the commissioner and was |
| 1:29.1 | putting together the United States Antimicrobial Resistance Plan. And then I became deputy director |
| 1:35.5 | and then director of the Center for Biologics, which regulates vaccines, among other things, |
| 1:41.3 | and other biologics like blood and gene therapies and cell therapies. |
| 1:46.2 | And then later you were two scientists. Right. And then in 2009, I became chief scientist of the FDA |
| 1:52.6 | and for a time, a deputy commissioner. And in that capacity, oversaw all the agency scientific |
| 1:58.7 | activities and also all of our pandemic preparedness. |
... |
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