Luciana Borio, MD, Previews the 2021 Pandemic Response

[MUSIC PLAYING] Welcome, everyone. I'm Dr. John Whyte, Chief Medical Officer at WebMD, and welcome to Coronavirus in Context. We're hearing a lot of information about the vaccine as well as how things might change next year with the new administration. So I've asked my good friend, the former acting Chief Scientist of the US Food and Drug Administration and a member of the President-Elect's COVID Advisory Board. Please welcome Dr. Luciana Borio.

How are you, John? It's a pleasure to be here with you today. It's great to see you again.

It's great to see you again. I want to start off with you and I both worked at the FDA, and some people are saying if there's such good data about safety and efficacy for these mRNA vaccines, why go through an EUA and not a full approval? What's the difference that people should know, and does it really matter?

Yeah. That's a great question. You know, first of all, I have to say that I am so incredibly proud of the work that the Office of Vaccines and the staff in the Office of Vaccines have done in the last several months. They really set the standard for how a regulatory agency ought to support a development in a way that expedites availability, but also is very responsible to the public health.

And you may recall that from the earlier days, they communicated to industry very clearly about expectations for what the trials should look like, that it would be important to have really hard clinical trial data from the gold standard double-blind, placebo-controlled trials. They had to be adequately sized to be able to really detect meaningful differences between the placebo arm and the vaccine arm. So and that has been really crucial, this development path that we are seeing today that give us such confidence in the vaccines that we have. Really wouldn't have been possible without their leadership and guidance.

And Pfizer did announce that they're going to request a full approval of BLA in April, but were you surprised that they weren't given a full approval early on? Is it mostly because this is still a new technology? What are your thoughts on that?

You know, that's a very important question, the difference between an EUA and a licensed product. And of course there are differences. In this case, the EUA, what we know for the EUA, we have that these vaccines are highly effective in the randomized controlled trials, and we have a very good idea of their adverse event profile.

What we don't know yet is, what is the frequency of potentially rare adverse events? So when you study a vaccine in 30,000 people or 40,000 people in a clinical trial, you may not be able to detect the rare adverse events. And I think it's very important for us to be able to have a grasp on that before a vaccine is licensed.

The other thing that sometimes precludes the licensure of a vaccine like this is that we want to make sure that the manufacturing is scaled up and consistent, and the vaccine that is used in the future, licensed vaccine, is going to be the same vaccine that we are actually rolling out today. That is a crucial component of a licensed vaccine is this confidence in the manufacturing systems. These vaccines, the FDA has very good confidence in those that have been released, but some of the manufacturing systems are still being optimized. Some vaccines are being made in different plants. Again, I have full confidence in the vaccines that have been released, but there is a little bit of a different bar for licensed vaccine.

If you were offered it today, would you take it today?

Absolutely. As a matter of fact, I'm a health care provider. I still practice at Johns Hopkins. And last week, I received an email with an option to already stand in line, if you will. And I do not-- I'm not, like, in the highest priority tier because I do not work in wards where we are treating COVID patients, but I have a lot of outpatient encounters. And my name is on the list, and I'm anxiously awaiting for my turn to get this vaccine.

Now technically, by law, under an EUA, a vaccine or a drug is still considered investigational. What's your feelings on whether there'll be a push early next year for mandatory immunization? Do you think that's on the radar, or are we going to use the power of persuasion?

Well, and I'm speaking for myself here, right? So the statute, the EUA statute that governs the way FDA reviews and issues that EUA make it very clear that patients, recipients should have the ability to opt in or out of the EUA product. It is an approved product.

And also, I think that the vaccines are-- there's been such care in the development of these products and such transparency around it that I think we ought to-- this information is available to people to make their own decisions. And I personally believe that people should have the autonomy to make decisions for themselves. To me, it's a no-brainer. Everybody really who is at risk for COVID should opt in.

And you know, it's very understandable to have some anxiety around a new technology, a new product. And there's still much that we're going to learn about this product. But it does make perfect sense, given what we're seeing with COVID, the way this disease really devastates people's health for the long term sometimes in families, communities, the economic impact it has had on our country. You know, even with these theoretical unknowns about the vaccine, it seems that the benefits greatly outweigh the known risks of getting COVID.

So how do we inspire confidence? I think sometimes when we use terms like mRNA, which people don't necessarily understand what that is, we talk about as we just were about EUA, no one knows that unless they know FDA parlance. You know, we're talking about adverse events, all these terms that people aren't familiar with. What are some of the best strategies, as you just talked about, that we can help people evaluate that benefits versus risk and understand why they, too, can have a lot of confidence in this vaccination program?

Yeah. I think-- so communication is going to be clear and honest, transparent communications to explain to people in plain language what is known, what are the unknowns. I think that we need to look for trusted sources of information. And sadly, we're in an environment where there is a tremendous amount of misinformation being shared on social media. It makes it even harder to be able to put forth the credible sources of trusted information that patients really need to have to make these decisions for themselves. These are not easy decisions, and they should really speak to people that they trust, but also people that are trusted and know what they're talking about in this instance.

Everyone who has a blog isn't an expert on vaccine development. You've had a global perspective throughout your career, and I wanted to ask you about a report today that talks about, low-income countries may not see a vaccination program till 2022. So recognizing the global economy as well as global travel, doesn't that work against the idea of figuring out how we crush this pandemic if some areas of the world aren't going to be able to participate in a vaccination program for more than another year?

That's right. So this is something that really weighs heavily on, I think, everybody involved who understands how pandemics work and the global nature of them and how we really-- you know, you can't be protected until everybody is protected. And this is something that the Biden-Harris administration is taking very seriously and examining different options to be able to engage in the global community to be able to have a global effort to combat the pandemic, not just, you know, a domestic effort.

Do you think we'll have to wait that long, or do you think we'll figure out strategies to get it to them sooner, both logistically as well as being able to immunize a large percentage of the world's population?

Yeah. It will take a while because the global manufacturing capacity for vaccines is finite. And there are some candidates, for example, that can be more easily manufactured, that very, very large quantities can be manufactured. And if those candidates really shown to be safe and effective, then will lead to what the Moderna and the Pfizer vaccine have demonstrated. I think that will get us much closer to the goal of having that protected Earth, you know, and not just specific countries.

But that's something that we're going to have to work. And there is-- the good news, I think, is that there is a strong interest and intent by the new administration, once they are in place, which this only happens after January 20, as you know, to engage globally to tackle this pandemic.

You're a member of that transition team as well. What do you think are some of the biggest changes that we'll see next year? As you and I have talked about before, there really has been an attack on science. And what I've seen is that, in the past, people would say, I don't understand science. Now sometimes they say, I don't believe in science. So what are the changes that perhaps we can expect to see next year in terms of how we communicate about the pandemic as well as how we all have to participate in these public health strategies to really eliminate the virus?

Yeah. So I think the biggest change will be really to focus on a response that is science-based and fact-based. And the President-Elect has made it very clear that the scientists and the physicians and the public health professionals are going to be developing the plans, and he's going to be listening to them. So that's going to be the major, major difference.

And I expect agencies that are science-based like the FDA and the CDC to regain the autonomy to be able to develop and recommend what really ought to be done because they know best. They are experienced. They have thousands of professionals, as you know, working, and who's been preparing their whole life to tackle pandemics. And I'm looking forward to hearing their voice again.

Will there be more of a global perspective in terms of how we address health issues in general?

Well, absolutely. You know, the President-Elect has made no secret that he really thinks it's going to be critical for the US to reengage in the global community, that he intends to rejoin the WHO, the World Health Organization, after he's president. So there will be, I think-- I expect to see a very different process for how the US is going to be engaging in global health security, global biodefense preparedness, global health. There will be a significant change from what we've seen in the last 4 years.

Will we see a more centralized process, even in terms of how we think about testing? So it's great we have a vaccination program, but it's also about therapeutics, it's also about testing as well, more testing, more convenient testing. Will we expect to see changes in terms of a testing strategy?

Yeah. I do expect that for areas where a more central coordination is essential that we will see leadership, you know, willingness to take ownership to do so. So for example, you mentioned the national testing strategy. And there are so many diagnostic tests out there. There are so many different algorithms that can be used for-- that can effectively be used to deploy effective testing strategies, depending on what people are trying to do, diagnose a sick patient or reopen a school or do surveillance in a workplace. And the idea that we need a national strategy to be able to inform all levels of government and public health to how to best deploy these important assets that we have, it doesn't work so well when each locality is left to make its own decisions and develop its own testing strategy.

So again, I think that for areas where this kind of central coordination really does help, we will see leadership, willingness to own the problem and to work with state and local officials to be able to support them and to guide them, instead of lea-- in contrast of just leaving things to different localities, which really doesn't help anybody. We hear loud and clear, also from the device manufacturers, the diagnostic test manufacturers that it's very difficult for them to respond in the most robust, effective, efficient way when there is this federated system across our big country.

You've dealt with emerging threats much of your career. So what are the lessons that we've learned? I mean, you've dealt with addressing Ebola, SARS, other viruses. What can we take from our experience in addressing COVID-19 to prevent a future pandemic?

Yeah. So I think that it's important to lead with science. It's important to lead with integrity. And we have to deal with the facts as they exist, not the way we wish they would be. So the pandemic is very real. The pandemic is killing so many around the world.

But sadly, in America, in our country, it's really causing a tremendous amount of pain and hurt, both in terms of health and economic stress for so many of our families. And it is really critical that we tackle it with our best tools. Every pandemic is going to be different. Every one of these emergencies will require a different, slightly different approach, but the fundamentals don't change. It's science, transparent, honesty, courage, responsibility. And that's what I have for you today.

Well, thank you. And finally, I'm going to-- before I let you go, I'm going to ask you for a prediction. How do you think things will look six months from now?

The future is bright. And it look much better than it is, than this dark winter we have today. I'm looking forward to the spring and the summer. Not only are we going to have the government that is going to tackle this in a most serious way, but I'm looking forward to more vaccines becoming available, and I just can't wait to be able to go outdoors again and see the American people smiling and happy that this is almost behind us.

Well, Dr. Borio, I want to thank you for taking time today to provide your insights. I know you have a lot on your plate, addressing the pandemic. And I hope we can talk to you again in the near future.

It's such a pleasure to be here. Thank you for having me.

And if you have questions about COVID-19, send them our way. You can send them to [email protected] as well as on our social, Instagram, Pinterest, Facebook, and Twitter. Thanks for watching.