Biden Adviser Dr Luciana Borio Previews the 2021 Pandemic Response

John Whyte, MD, MPH; Luciana Borio, MD

Disclosures

December 23, 2020

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  • After showing high efficacy in randomized controlled trials, two COVID-19 vaccines received FDA emergency use authorization.

  • Before the vaccines are fully licensed, we need to learn the frequency of potentially rare adverse events. The manufacturing systems also need to be optimized.

  • Emergency use authorization considers vaccines "investigational" and offers people the ability to opt in or out of vaccination. This might factor into whether vaccination will be required.

  • To encourage people to get vaccinated, clinicians need to be transparent and communicate with patients in plain language.

  • The Biden administration will place greater emphasis on central coordination of a national pandemic response strategy. It will also reengage and focus on global health security and biodefense preparedness.

This transcript has been edited for clarity.

John Whyte, MD, MPH: Welcome, everyone. I'm Dr John White, chief medical officer at WebMD. 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 presidential administration.

So, I've asked my good friend, the former acting chief scientist of the US Food and Drug Administration (FDA) and a member of the president-elect's COVID Advisory Board, to join us. Please welcome Dr Luciana Borio.

Luciana Borio, MD: John, it's a pleasure to be here with you today. It's great to see you again.

Whyte: And it's great to see you again. You and I both worked at the FDA. Some people are saying, "If there's such good data about safety and efficacy for these mRNA vaccines, why go through an emergency use authorization (EUA) and not a full approval?" What's the difference that people should know, and does it really matter?

Borio: That's a great question. First of all, I have to say that I am so incredibly proud of the work that the staff at the FDA Office of Vaccines Research and Review have done in the past several months. They really set the standard for how a regulatory agency ought to support the development in a way that expedites availability but also is very responsible to the public health.

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. That has been really crucial. This development path that we are seeing today, that gives us such confidence in the vaccines, really wouldn't have been possible without the leadership and guidance.

Whyte: Pfizer did announce that they're going to request a full approval, a BLA (biologics license application), 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?

Borio: That's a very important question — the difference between an EUA and a licensed product. And of course there are differences. In this case, what we know for the EUA we have is 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 the frequency of potentially rare adverse events. When you study a vaccine in 30,000 or 40,000 people in a clinical trial, you may not be able to detect the rare adverse events. 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 that the vaccine that is used in the future — the licensed vaccine — is going to be the same vaccine that we actually rolled out today. A crucial component of a licensed vaccine is this confidence in the manufacturing systems. With these vaccines that we have, the FDA has very good confidence in those that are being 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 a licensed vaccine.

Whyte: If you are offered it today, would you take it today?

Borio: Absolutely. As a matter of fact, I'm a healthcare provider and still practice at Johns Hopkins Hospital. Last week, I received an email with an option to already stand in line, if you will. I'm not 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 my turn to get this vaccine.

Whyte: Now, technically, by law, under an EUA, a vaccine or a drug is still considered investigational. What are 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?

Borio: I'm speaking for myself here: The EUA statute that governs the way FDA reviews and issues the EUA makes very clear that patients, recipients, should have the ability to opt in or out of the EUA product. It is an approved product. Also, there has been such care in the development of these products and such transparency around it; this information is available for 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 who is at risk for COVID should opt in. It's very understandable to have some anxiety around a new technology and a new product. There's so much that we're going to learn about this product. But it does make perfect sense, given what we're seeing with COVID in the way this disease really devastates people's health for the long term, sometimes in families, communities, and the economic impact that it has had on our country. Even with these theoretical unknowns about the vaccine, it seems that the benefits greatly outweigh the known risks of getting COVID.

Whyte: How do we inspire confidence? I think sometimes when we use terms like mRNA and EUA, no one knows that unless they know FDA parlance. We're talking about adverse events — all of these terms that people aren't familiar with. What are some of the best strategies, as you just talked about, that we can use to help people evaluate benefits vs risk, and understand why they, too, can have a lot of confidence in this vaccination program?

Borio: I think communication has to be clear and honest — transparent — to explain to people in plain language what is known. What are the unknowns? I think 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 to people who know what they're talking about in this instance.

Whyte: Not everyone who has a blog is an expert on vaccine development. You've had a global perspective throughout your career. I wanted to ask you about a report today that talks about how low-income countries may not see a vaccination program until 2022. 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?

Borio: That's right. This is something that really weighs heavily on everybody involved who understands how pandemics work and the global nature of them, and how we really can't be protected until everybody is protected. This is something that the Biden-Harris administration has taken very seriously in 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 a domestic effort.

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

Borio: It will take a while because the global manufacturing capacity for vaccines is finite. There are some candidates, for example, that can be more easily manufactured in very, very large quantities. If those candidates are shown to be safe and effective, similarly to what the Moderna and Pfizer vaccines have demonstrated, I think that will get us much closer to the goal of having that protected earth and not just specific countries. But that's something that we're going to have to work on. The good news, I think, is that there is a strong interest and intent by the new administration once they are in place — which only happens after January 20, as you know — to engage globally to tackle this pandemic.

Whyte: 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. 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 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?

Borio: I think the biggest change would be to focus on a response that is science-based and fact-based. The president-elect has made it very clear that the scientists, 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 difference. I expect agencies that are science-based, like the FDA and the Centers for Disease Control and Prevention, to regain their 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 working professionals who've been preparing their whole life to tackle pandemics. I'm looking forward to hearing their voices again.

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

Borio: Absolutely. 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 World Health Organization after he's president. I expect to see a very different process for how the US is going to be engaging in global health security and global biodefense preparedness. In global health, there will be a significant change from what we've seen in the past 4 years.

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

Borio: I do expect that for areas where a more central coordination is essential, we will see leadership, willingness to take ownership to do so. For example, you mentioned the national testing strategy. There are so many diagnostic tests out there; there are so many different algorithms that can be used to deploy effective testing strategies, depending on what people are trying to do: diagnose a sick patient, reopen a school, or do surveillance in a workplace. The idea is that we need a national strategy to be able to inform all levels of government and public health how best to 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's 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 just leaving things to different localities, which really doesn't help anybody. We hear loud and clear also from the device and 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.

Whyte: You've dealt with emerging threats much of your career. 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?

Borio: I think that it's important to lead with science. It's important to lead with integrity. We have to deal with the facts as they exist and not the way we wish they would be. The pandemic is very real and is killing so many around the world; but sadly, in our country, it's really causing a tremendous amount of pain and hurt, in terms of health and economic stress for so many of our families. 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 slightly different approach, but the fundamentals don't change. It's science, transparency, honesty, courage, responsibility. That's what I have for you today.

Whyte: Well, thank you. And finally, before I let you go, I'm going to ask you for a prediction: How do you think things will look 6 months from now?

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

Whyte: 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.

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

Whyte: If you have questions about COVID-19, send them our way. You can send them to drjohn@webmd.net, as well as on our social: Instagram, Pinterest, Facebook, and Twitter. Thanks for watching.

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