FDA Insight: Episode 16 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us. I'm happy to welcome Dr. Peter Marks back to the show. He's director of FDA's Center for Biologics Evaluation and Research, or CBER, and as of this episode, he's our most frequent flier on the podcast. So, welcome back.
>> Peter Marks: Thank you. The vaccine conversation's only increased, so I'm glad to come back and provide an update.
>> Anand Shah: Well, Dr. Marks, let's jump right in. This week, FDA will be hosting an advisory committee meeting for COVID-19 vaccines. Can you tell us what advisory committees are in general and what function they serve at FDA?
>> Peter Marks: Sure. So, FDA's advisory committees are established to support the agency's mission of protecting and promoting the public health while meeting the requirements set forth in the Federal Advisory Committee Act. Committees are either mandated by statute, that's law, or established at the discretion of the Department of Health and Human Services. The committees may review scientific information on general matters, and they can provide the agency with their best scientific thinking, or alternatively provide recommendations on whether the quality, safety, or effectiveness of a specific product, such as a vaccine, can support approval.
>> Anand Shah: Dr. Marks, this specific FDA advisory committee on vaccines and related biological products meets regularly, independent of COVID-19. Can you tell us what kind of work this committee normally does?
>> Peter Marks: Yeah, this committee is standing committee that usually reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human disease, and, as required, they can look at other products for which we have regulatory responsibility. Sometimes, they also meet to discuss more general issues, and they also can meet to discuss FDA's research programs, which provide scientific support for the regulation of these products, and they'll make appropriate recommendations to us.
The committee consists of a corps of about 15 voting members, including the chair, and members and the chair are selected by the commissioner or a designee, such as someone from our center. And they must be among authorities knowledgeable in the fields of immunology, molecular biology, virology, bacteriology, epidemiology, or biostatistics. And one of the other things about these members is, they are vetted to make sure they don't have any conflicts of interest with any of the matters that are under discussion.
>> Anand Shah: As we all know, things are a bit different this year for COVID-19. Can you share with our listeners who will be on the advisory committee for COVID-19 vaccines and how the process will work?
>> Peter Marks: Yeah, the vaccine advisory committee has been augmented for COVID-19 with leading experts in the field. Those are people familiar with coronaviruses such as COVID-19, and all of those have been vetted for conflict of interest as I've mentioned to be independent of the companies that are involved in the development of these vaccines. The materials will be discussed in an open session of the advisory committee meeting for COVID-19 vaccines and will be posted on FDA's website and available to the public like they would be for any advisory committee meeting. And we'll intend to stream video of the meetings so that they can be viewed by members of the public who wish to do so. It's hope that this will increase public confidence in vaccines through transparency into the decision-making process that we use for the authorization or approval of a vaccine.
>> Anand Shah: What are some of the key things the panel of experts will be looking for in the data to evaluate whether the vaccine candidate is safe and effective?
>> Peter Marks: Well, I think the advisory committee will likely be looking into the same things regarding the vaccines that FDA does. And that is, they'll be looking to make sure it's made with quality. And that is, the manufacturing is a quality manufacturing process, that the vaccine is safe, and that it's effective. And they'll also be interested in the plans that the vaccine developers have regarding continued gathering of vaccine safety and effectiveness information after any potential authorization or licensure of a vaccine because that will be important to help us gain more information about these vaccines going forward.
>> Anand Shah: There's been a lot of talk about an emergency use authorization, or EUA, being brought to the advisory committee. What's an EUA, and how does it differ from approving a vaccine?
>> Peter Marks: That's a great question. And a lot of people are interested in knowing that because EUA was not a household term before, and now it's in the newspaper all the time. So, an emergency use authorization is explained as follows: Normally, manufacturers spend several months analyzing data they've obtained and submitting it to FDA as part of a biologics license application, also abbreviated BLA. And that's for a vaccine, in order to request approval to market it. And such an application can encompass tens of thousands of pages, and it usually takes the agency several months to review it.
However, because of the ongoing public health emergency, manufacturers may choose instead to submit a request for emergency use authorization, which we'll abbreviate as EUA, instead of the BLA. And this pathway was put in place after the terrorist attacks of 9/11 to ensure that potentially life-saving medical products could be available to people in medical need before they've fully been studied to the same level as approved products. That being said, the standard for an EUA is flexible, and for a product like a COVID-19 vaccine, we'll only be thinking about issuing this if it's demonstrated clear and compelling efficacy in a large, well-designed, phase-three clinical trial similar to that, which would be required to support an approval. And that's because it's potentially going to be administered to millions of individuals, including healthy people.
>> Anand Shah: Who will ultimately decide whether an emergency use authorization gets issued?
>> Peter Marks: Well, the career staff at FDA will ultimately decide whether an EUA is issued. The career staff consists of a group of physicians, scientists, and support staff at FDA who are devoted to the unbiased evaluation of information regarding the manufacturing and development of vaccines. It's their duty to uphold globally respected standards for product quality, safety, and efficacy, and they'll monitor the entire process of vaccine development from the beginning to the end. And then, they'll follow these products after they've been made available to the public.
>> Anand Shah: What measures will be put in place to ensure that a vaccine that receives an emergency use authorization is truly safe in the long term?
>> Peter Marks: Yeah, so, a law – this is one of those really important questions that people have, because it is true that, for these vaccines, we may have safety follow-up that is not quite as long with an emergency use authorization as it would be with a biologics license application. And although that will be the case, safety surveillance on millions of individuals receiving a vaccine will be conducted using large computer databases. And that's something we do for other newly approved vaccines, but by doing it here, it will allow us to identify any rare or late side effects that not – might not have been observed in the initial data collected. The important take-home here, though, is that even before the vaccine is placed into a situation such it's – as it's authorized under an EUA, we will make sure we feel very comfortable with the safety profile, and it will show clear and compelling efficacy.
>> Anand Shah: Dr. Marks, we're all looking forward to hearing more about the progress being made toward COVID-19 vaccines. So, thank you for coming on the podcast. Will we see or hear you again for another update?
>> Peter Marks: I'd be happy to come back and talk about where we are in the fight against COVID-19.
>> Anand Shah: Well, we'd be glad to have you. And I'd like to thank our audience for joining us again on FDA Insight. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts, Google Podcasts, and others. Thanks for listening.
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