Exclusive — FDA Commissioner Dr. Stephen Hahn: Coronavirus Antibodies Testing Ramping Up, Plasma-Based Treatments on the Way

Dr. Stephen M. Hahn, commissioner for food and drugs in the Food and Drug Administration t

Food and Drug Administration (FDA) administrator Dr. Stephen Hahn told Breitbart News exclusively on Wednesday that his agency is working with private industry leaders to bring more antibody testing and promising potential plasma-based treatments for the coronavirus to the American public.

First and foremost, Hahn told Breitbart News that mitigation—the wide-scale social distancing Americans nationwide are enduring as most states that have governor-issued stay-at-home orders in place—is working.

“First, big big issue I think that is important that you highlighted is that the most effective weapon we have against this virus right now, this horrible virus, is mitigation,” Hahn said. “Just a huge shoutout to the American people for their resiliency, and they’re getting the job done here.”

Hahn added that the scientific data coming in from hotspots across the country is suggesting that the United States may be at or near the peak—the top of the curve, so to speak—and that as long as Americans stick with the social distancing a little bit longer, they will make it through the end of this.

“I am optimistic. You can never predict the future. I’m a doctor and I realize that,” Hahn said. “But I’ll tell you I am completely confident we will win this battle. We have done a great job with the mitigation efforts. We will win the day and I am cautiously optimistic that we may be near our peak. But time will tell. But I am certainly confident that with the measures we have in place right now we will defeat the virus.”

Hahn is a member of Vice President Mike Pence’s White House Coronavirus Task Force and a top ally of Pence and President Donald Trump in battling the coronavirus plaguing the United States and the world right now. He is also an oncologist by profession, having practiced for many years nationwide at key institutions fighting cancer before President Trump appointed him to lead the FDA in late 2019–a position to which the U.S. Senate confirmed him on a bipartisan basis with a 72-18 vote.

The FDA, under Dr. Hahn’s leadership, is working to bring a number of new products to combat coronavirus to the market safely and with the proper scientific data to back up their release. These products include a variety of potentially promising therapeutics to treat those infected with coronavirus fromn potentially promising prophylactics to prevent infection, to testing for the disease, and perhaps most importantly for antibody testing to determine if someone’s immune system is already prepared to fight it.

In Hahn’s exclusive interview with Breitbart News on Wednesday afternoon, he explained a number of these that have received attention—beginning with hydroxychloroquine, the longtime anti-malarial drug that has received enormous amounts of attention since President Trump first cited it as a promising possibility in the White House briefings. While hydroxychloroquine has gotten perhaps the most attention in the media, as some opponents of Trump have attacked it as unproven—technically the FDA has not approved that drug, or any drug for that matter, to treat the novel coronavirus, since the virus is brand new to the world—there are many other potential antiviral therapeutics that the FDA commissioner said are in clinical trials now.

“With respect to treatments, we categorize this in a couple of different ways. The first is antivirals, meaning the drugs that could have a direct benefit against the virus. Hydroxychloroquine could be an example of that, but there’s a number of trials—a double-digit number of clinical trials out there for other agents as well including hydroxychloroquine. On hydroxychloroquine, there are preliminary data out there that suggests that it might be a benefit with or without the addition of another antibiotic called Azithromycin. There are number of clinical trials out there both for patients who are sick with COVID-19, but also what we call post-exposure prophylaxis. What that means is if you think you’ve been exposed–for example a healthcare worker taking the drug and seeing if it prevents you from getting the disease. There’s a number of clinical trials on that as well. So we’re looking at that and obviously those data will be very important for FDA’s determination about the safety and effectiveness of hydroxychloroqine. Now, that being said, this is a drug that is approved by FDA for treatment of other diseases like lupus, and what we need to make sure of is there’s adequate supply of that drug for lupus patients and patients that have approved indications by the FDA. We also want to make sure there’s enough of this drug available in the event that a particular doctor wants to write a prescription for a patient. Where this sits right now, and I think it’s a very appropriate place, is if a patient isn’t eligible for a clinical trial or doesn’t have one available, that really becomes an individual patient-doctor-family discussion. They have the information at hand, and FDA has some state-of-knowledge documents out regarding the risks and benefits. That information can guide physicians to make the best decisions for their patients.”

So while trials for hydroxychloroquine and other potentially promising therapeutic antiviral drugs are ongoing—they have been stood up quickly by industry leaders—doctors can, under the way the FDA has structured these matters, write a prescription for a patient with coronavirus for such drugs if the doctor decides they think it would be best for them, even though the FDA has not approved its usage for this purpose yet. The trials should come back soon, though, Dr. Hahn said, and there are many nationwide underway right now.

“We don’t run the trials. There are sponsors for the trials,” Dr. Hahn said. “We give them a letter to proceed. We review the trials and make sure there’s adequate protection of patients and that they’re looking at endpoints that will give us information to make a decision about its safety and effectiveness, and then those sponsors run those trials around the country. There’s a number you might have heard about in the press. There are some really great groups that are running trials right now. So that’s how that works from an FDA perspective.”

Perhaps the most interesting part of Dr. Hahn’s interview with Breitbart News was focused on potentially promising emerging convalescent plasma treatments whereby immunity developed in someone who has recovered from the coronavirus is transferred to someone who is sick. People who have recovered from coronavirus can donate plasma to the Red Cross or other blood banks—and they can donate more frequently than normal blood donations—and then scientists at drug companies take the plasma and transfer it and its immunity properties to a sick person. This kind of treatment, while not FDA-approved and still being studied, is available on a “compassionate use” standard as of now—and will eventually, when it gets up to scale, be available on an “expanded access” basis. The FDA, Dr. Hahn said, is working with the various elements of the supply chain for such treatment to help scale it up.

“This is really interesting, and there’s some preliminary data that suggests this is of some benefit to patients in particularly reversing some of the lung effects of the COVID-19 virus,” Dr. Hahn said when asked about convalescent plasma treatments in the works right now. “So, nothing proven yet, but some interesting and I think promising information. So what this is is if you’re a person who has recovered from COVID-19 after you had it—remember, the vast overwhelming majority of Americans who have had a COVID-19 illness will recover from it, and in fact there are probably people who have never had any symptoms who have recovered from it. Those folks, because they’ve recovered—the ones who have been exposed and have recovered, there’s a lot—what we would do, not us, but the blood collectors like Red Cross et cetera is take plasma, which is the protein part of the blood that has the antibodies in it. You take it from people who have had the disease and have recovered. Plasma can be donated several times a month, so it’s not like a regular blood donation where you can only do once every couple months. So what you do is you take that, you process it and you make sure it’s what we call pathogen-free—that there’s no virus in it—and then what we do is you take that unit and give it to someone who’s sick. About three weeks ago, FDA put out on our website that we were permitting this to be given to people on a compassionate use basis. So a number of hospitals around the country have done that—they’ve manufactured and done this. Last Friday, what we did was scale that program up to what we call Expanded Access. Through Red Cross and blood collectors, people who have recovered can donate plasma and then Red Cross will create that immuno-plasma and then a doctor at a hospital can order that for a patient. The major rate-limiting factor right now is donation. As we see more people recover, and they’re far enough out from the illness, we’ll be able to scale that up more.”

Even more interesting than the plasma treatments is what can be derived from them. Once the FDA and industry partners have convalescent plasma treatment up to scale so they deliver those treatments on an expanded access basis, they can then take the convalescent plasma and make a booster shot with a “concentrated form of the hyperimmune globulin.” This could transfer immunity to people more effectively than just a plasma transfusion, and could be used as a treatment or as a prophylaxis—to prevent infection—and could help front line healthcare workers exposed to the virus regularly develop short-term immunity to power through it.

“Think of it as a concentrated form of convalescent plasma,” Dr. Hahn said. “What you would do is instead of having to take a unit of plasma, what you would be able to do is give a shot—a concentrated form of the hyperimmune globulin. What will happen when the manufacturers starting ramping this up, and this is the next step after convalescent plasma, is it will be studied in another Expanded Access program, and we’ll study the safety and effectiveness of it. Basically it’s another way to transfer the immunity to people. One of the complications of this is it takes a lot of donors to actually create that, but this will be particularly for frontline healthcare workers and first responders who haven’t been exposed and don’t have antibodies against the virus. This is a bridge to a vaccine.”

Dr. Hahn brought some of this on convalescent plasma and potential hyperimmune globulin booster shots up with Fox News’s Maria Bartiromo in a recent interview, but did not mention this next thing at the time. He told Breitbart News that another thing in the works right now from various drug companies are potential treatments using what are called “monoclonal antibodies” as a potential treatment or prophylaxis as well. The beauty of the monoclonal antibodies route, unlike the hyperimmune globulin devised from convalescent plasma route, is that monoclonal antibodies doses can easily be made at a much greater scale to reach the general public again as a “bridge until a vaccine is ready.”

“One thing I didn’t mention in that previous interview was that there are all sorts of medically, manufactured by drug companies, antibodies that could help the immune system fight the virus—we call these monoclonal antibodies,” Dr. Hahn told Breitbart News. “We are working with a number of companies now to help them develop, scale up, and then helping them to the manufacturing of this—hoping that that could also act as a bridge until a vaccine is ready. The good thing about those monoclonal antibodies is they can also be used as a prophylaxis, but the scalability—the ability to generate more doses of this—is even greater than the hyperimmune globulin, but same concept.”

Testing for the actual virus is now very widely available across the country, but antibody testing is still ramping up. The difference between the two is diagnostic testing—to see if someone has coronavirus—can help doctors determine, or diagnose, someone with the disease. Antibody testing—or serological testing—can determine if someone has already had it and recovered. While coronavirus is potentially deadly for elderly and at-risk populations, for the vast majority of Americans they will have either no symptoms or very mild symptoms and may not even know they had it. What serological testing can do is help someone determine if they already had the disease and recovered from it, having built up antibodies against it along the way. Dr. Hahn said that while the FDA has approved one serological test, more are on the way—but he also warned Americans to beware of products including tests that are not approved by the FDA.

“We’ve been working for months with the test developers,” Dr. Hahn said. “One of the things that’s amazing about this is that all the pieces of testing—diagnostic, serology—often take months if not years to develop. The great American private sector machine has done this, in collaboration with the FDA and U.S. government, in record time. With regard to serology, that is the next step. We’ve been working over the last month to month-and-a-half with serology test developers—in fact I had a call with research and development and CEOs of many of these companies to talk about the pathway forward. FDA has authorized just one of these tests. There’s a lot out there on the market, but we’ve only authorized one of them. With the regulatory flexibility that we’ve done, folks can come to the market, but what I want to caution Americans and healthcare providers about is to pay very close attention to what FDA has authorized because we can put our stamp of approval behind those and we know those tests are valid. I know you’ve seen these reports about the diagnostic tests that come from other places that haven’t gone through this approval process, and inaccuracies associated with those. It’s really important and we post this on our website and have a daily update on authorizations, but a lot more is coming. And we’re working very closely with these companies to ramp that up and scale that up.”

The final phase of combatting the coronavirus is the development of a vaccine, which is something the FDA is also playing a critical role in fighting for. Dr. Hahn noted that candidates for a vaccine have moved into clinical trials at “record speed” because of the private sector working in collaboration with the federal government, including the FDA and National Institutes of Health (NIH) led by Dr. Anthony Fauci.

“On vaccine development, as you know it takes time for vaccines,” Dr. Hahn said. “In record time, a company in collaboration with the FDA and U.S. government—and N.I.H. was involved with this too—a company has gotten a vaccine into clinical trials. That’s a safety clinical trial, so the earliest—we’re working with a number of manufacturers, so PHARMA and vaccine manufacturers have stood up and really leaned in on this one. We are working with a number of manufacturers, and there are a number of promising candidates. We’re working hard to accelerate that timetable. Typically it takes years. Dr. Fauci has mentioned on TV that it may take 12 to 18 months. I think that is a typical and reasonable timeframe. But I don’t want the American people to think we’re resting on a standard timetable here. We’re really pushing hard to try to accelerate things here. There’s a number of things we can do from a regulatory point of view and with respect to manufacturing capacity to help the clinical trials get performed so they’re as efficient as possible—and also around sharing of data. This is where industry where again, normally as competitors, they have committed to sharing so we can have the absolute best products in the hands of the American people and that includes vaccines.”

Another thing he said is a “huge part of our job” is combatting misinformation from producers and marketers of products who claim to offer a cure or some kind of key part of fighting or testing for the virus. The FDA, he said, in an effort to protect American consumers and doctors and medical professionals, is fighting anyone falsely marketing something as a miracle cure but also anyone falsely claiming FDA authorization for something which has not received such approval.

“We are surveilling the landscape and receiving reports, looking online,” Hahn said. “We are having information forwarded to us on this. We are going after every false claim and making sure we use our enforcement powers to do so. Let me give you a couple examples. We have had some reports of people buying hydroxychloroquine online or going to the store and buying hydroxychloroquine that might have been marketed for fish tanks. That has devastating complications for people, including death. There is no over-the-counter hydroxychloroquine and there is no FDA-approved treatment for COVID-19. So, that, just to stress to your viewers and readers, this is a really complicated issue, but they can rely on FDA to say something is safe and effective. But rest assured we are going after false claims. That being said, with serology tests we’re seeing that as well, where people are claiming FDA authorization and there’s only been one that’s authorized, so providers and patients have to be careful of this. One last point: we have not authorized an at-home test for COVID-19. There are a lot of folks advertising or sending out emails and messaging about this, so my recommendation is no one should buy an at-home test for COVID-19 because I can’t assure as the FDA that they’re safe and effective.”

Dr. Hahn said, too, that from his position as the FDA administrator he is seeing what Trump and Pence call the “Whole of America” approach—partnership between the entire government at the federal, state, and local levels working with the private sector and key nonprofits and charities—to combat the coronavirus.

“It is a Whole of America approach, private sector with government—certainly with FDA—no question about that,” Dr. Hahn said. “I’m going to put on my previous cancer researcher and doctor hat for a moment. I was on the other side of the table facing FDA before I came to the agency so that’s where my experience in dealing with FDA was—always great professionals who really knew what they were doing and could help with development. But we’ve seen that accelerated. Our central objective has been to really remove unnecessary roadblocks to development. We totally understand that this is an urgent situation. We are working collaboratively with industry and–a little anecdote from a CEO who was talking about one of our center directors and said, ‘I really admire him, he works really collaboratively and tries to help us but he’s not a pushover. When it comes to using the science and data to make sure something is safe and effective, we all know we can rely upon him to do that.’ I think that story basically tells you what the agency has been doing—our usual kind of work, but on steroids. I’m incredibly proud of our 17,000 hardworking employees.”

He concluded the interview by noting that he is committed to ensuring that the FDA continues to uphold its high standards of scientific backing for various products including medicines, medical devices, treatments, and more—and the American people and medical community can depend on the FDA for sound advice.

“We have a solemn promise to the American people that we will use science and data to make our decisions and we will do that and be pragmatic,” Dr. Hahn said. “We want to practical and we want to be flexible, but we will keep our standards, because I think the American people—certainly as a doctor who when in practice we certainly depended upon FDA—and the American people can depend upon FDA.”


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