Transcript: Trump Holds Coronavirus Meeting with Pharmaceutical Executives

Donald Trump: (00:00)
Discuss how the federal government can accelerate the development of vaccines and therapeutic treatments for the coronavirus. We want to welcome Dr. Deborah Birx. And Dr. Birx has been to the White House a lot over her career, and she’s now going to be here working with Mike Pence and everybody full-time. And we appreciate it. We appreciate it very much, Dr. Birx, and a real expert in her field. And if you’d like, you can ask her a couple of questions when we’re finished.

We’re working very hard to expedite the longer process of developing a vaccine. We’re also moving with maximum speed to develop therapies so that we can help people recover as quickly as possible. We have a lot of recovery going on. We want to see if we can advance that. It’s likely that therapies will be available before a vaccine is actually ready and we’ll seek to bring all effective treatments to market as soon as possible. Some very good work has been done on the vaccine. However, they have some good progress and you’ll be able to ask a couple of questions of the folks here. We’re also working with Congress to ensure that America has what it needs to respond to this challenge, this great challenge, but everybody’s responding very well. Since the start of the outbreak, my administration has taken the most aggressive action in history to protect our citizens, including closing our borders very early, a lot earlier than people wanted us to do and that turned out to be a good decision.

I ordered sweeping travel restrictions, increased travel advisory levels, established screening measures and opposed historic quarantines. We have quarantines all over the country. A lot of the Coronavirus shows the importance of bringing manufacturing back to America so that we are producing at home, the medicines and equipment and everything else that we need to protect the public’s health. And I’ve been talking about this for a long time.

That process has already started. It started long before we ever knew about this. We want to make certain things at home. We want to be doing our manufacturing at home. It’s not only done in China, it’s done in many other places, including Ireland and a lot of places make our different drugs and things that we need so badly. And it’s not good to be dealing with one or two or three countries and we do very little at home and we’re going to start doing it at home.

And we’ve been talking about that for long time. And a lot of the drug companies, because of what we’ve done in terms of incentives and taxes, they’re heading back here anyway. The Coronavirus shows the importance of bringing all of that manufacturing back to America, and we will have that started. It’s already started, frankly. It started about a year ago.

The White House Coronavirus Task Force led by Vice President Mike Pence has been meeting daily and coordinating closely with the state and local governments. Mike had a call today with 53 governors and I heard it was a very good call and everybody’s very well coordinated and the Governors and the States, all of them, I can’t think of an exception, they’ve been really working closely with us. It’s been a very good relationship.

We will confront this challenge together and we will continue to do exactly what we’re doing and we’re going to be very successful. A lot of things are happening, a lot of very exciting things are happening and they’re happening very rapidly. So with that, I’d like to introduce Mike and you can say a little bit as to your calls and some of the things that are happening today.

Mike Pence: (03:40)
Well, thank you Mr. President and the White House Corona Task Force, we’ll be meeting again this afternoon. But as you mentioned earlier today, at your direction, we hosted a video and telephone conference call with 53 governors. As the President said many times, we’re all in this together. And today’s meeting is a reflection of the fact that this President understands that industry is a part of the one team in America that’s going to address the coronavirus in this country.

Mike Pence: (04:10)
And I’m grateful for these leaders of the nation’s top pharmaceutical companies to come in to speak to us about the development of vaccines, but also the development of therapeutic medications that can be available in the short term, and we’re grateful for your participation. The President will also be traveling tomorrow to the National Institute of Health, CDC, before the week is out and we will be meeting with leaders of the airline industry.

Mike Pence: (04:39)
We’ll be meeting with leaders of the cruise line industry. And we welcome the partnership with industry in this country as we work out the President’s top priority, which is the health and safety and wellbeing of the American people. And let me also, Mr. President, extend my welcome to Dr. Deborah Birx, one of the leading experts in infectious diseases in the world. She has served in uniform in the United States. She has served in multiple administrations and she’s going to be our right arm here as we implement your vision for putting the health and safety and wellbeing of the American people first. So with that, Mr. President, I know Secretary Azar has a few thoughts and look forward to the meeting.

And Alex maybe you can give a little update and then we’ll go around the room and people can introduce themselves, if that’s okay? Go ahead, please.

Alex Azar: (05:36)
Absolutely. Thank you, Mr. President, Mr. Vice President. We continue to see cases here in the United States. As you know, we tragically have experienced several more deaths reported today and our condolences go out to their families of course. That’s why the President’s leading this whole government response at the direction of the Vice President.

Alex Azar: (05:56)
We’re here working with the pharmaceutical company leaders on three key issues: how do we speed vaccines, how do we speed therapeutics and what are the supply chain challenges that we may be facing for pharmaceutical products here in the United States? With regard to therapeutics and vaccines, we want to know how we can not get in the way but rather speed that development process along.

Alex Azar: (06:20)
And I want to make sure that they all know that we’ve got Commissioner Hahn here from the FDA and this is all in the context of emergency powers, emergency use authorizations and the President will be asking you, how can we make it faster? How can we make anything faster? How can we challenge some of those normal pharma timelines? That can be a little slow and bureaucratic. What can we do to speed that along given the nature of this emergency and be a good partner with you in making that happen, especially once we get the emergency supplemental passed by Congress in the next week or so. So with that said, Mr. President, thank you very much.

Supplemental is moving along very rapidly. Everyone wants to get that done. Moving along quickly, Emma, please.

Emma Walmsley: (07:05)
Emma Walmsley from GlaxoSmithKline. First of all, I’d like to really say how much we welcome the leadership, Mr. President, of this task force, the NIH and BARDA, and recognize the very substantial efforts that have already been made by the administration to protect people here in the US. As a science led company with a very large, including manufacturing, presence here, we know we have a responsibility and a vital role to play.

And our priority is to make sure we make available, as part of this one team, our pandemic adjuvant technology available to any company with a highly promising vaccine because this new technology could make these other vaccines either bring more efficacy or indeed allow them to be antigen sparing, which means we could protect more people. Which is obviously incredibly important as we’re trying to work at pace and at scale.

We’ve already announced two collaborations and hope to announce more and we’re also ready to produce, should the US Government require it, a stockpile of this adjuvant. We know fighting COVID-19 requires a global effort and the US is the vital leader in this and we’re absolutely committed to play our part in the task force.

Thank you, Emma. Beautiful. Thank you very much. Please, Anthony, go ahead. I’d like you to say something anyway, I think [inaudible 00:08:31].

Anthony Fauci: (08:30)
I’m Tony Fauci, the Director of the National Institute of Allergy and Infectious Diseases. Very pleased to be on this task force, which I think you’re going to see is working extraordinarily smoothly under the leadership of the Vice President and Secretary Azar. And as you know, we’re involved and that’s the reason why I am pleased to be in this room with you all because we are involved in the fundamental basic and clinical research to develop countermeasures in the form of therapeutics and vaccines and I’m sure I’ll be working with many of you around the room and I look forward to it. Thank you, Mr. Presidnet.

Thank you, Tony, very much. Bob?

Bob Redfield: (09:03)
Thank you, Mr. Presidnet. Bob Redfield, the Director of CDC. I also want to thank you all for being here. I want to extend that if there’s anything CDC can also do as you begin to try to evaluate some of your fruits of your labor, we’re here to make that what we have available to help. We’re all counting on the new countermeasures to be in the arena pretty quickly.

Thank you, Bob. Please.

Daniel Menichella: (09:32)
Thank you, Mr. President, Mr. Vice President. Thanks for having me here. Good afternoon, I’m Dan Menichella, CEO of CureVac. We are a clinical stage biotech company. We use messenger RNA technology, optimized messenger RNA molecules once injected into the body they instruct the cells on how to make proteins. For instance, we can use the MRNA technology to trigger an immune response against viruses or we can get the body to increase its production of T-cells for cancer vaccines.

In this way CureVac can make potent prophylactic vaccines and cancer treatments. The technology also works well to replace missing proteins so we can also work in a rare disease case. One strength of our technology is that we can produce prophylactic vaccines using a very low dose. For instance, the phase one rabies trial that we just completed was done at a one microgram dose. In other words, millionth of a gram dose, a very, very tiny dose.

And so more broadly, our company focuses … This year we have four programs in phase one clinical trials and the coronavirus program will be the fifth program in phase one. We expect that the phase one program for coronavirus will start beginning of June. Our technology platform is fast and it’s agile. We were the first messenger RNA company to have GMP manufacturing. We started in 2006. Currently we have three large scale GMP facilities and we are up and running up now.

Today we have a fourth facility built and we’re looking for additional capex to put the machinery in there. Once we have that machinery in the fourth building, we can make hundreds of millions of doses of the coronavirus vaccine. We’re very excited about that and we want to help there.

Additionally, we have developed a fully automated production machine. This automated machine is part of the collaboration with CEPI and additionally with CEPI we are working on the coronavirus. They have funded our efforts to get the program and the vaccine through phase one by June. The key point here being that we believe we can develop the vaccine for COVID-19 very, very quickly and we have the where with all to manufacturer it, although we would like some additional help on our largest GMP four facility. Again, we appreciate the opportunity to be here today and thank you very much.

Thank you very much. Appreciate it. John, go ahead, please.

John Shiver: (11:42)
Sure. I’m John Shiver, Head of Vaccine Research Fraud and Development for Sanofi Vaccine. Sanofi has been making vaccines for over 100 years. And for this project we’re working with proprietary, recombinant, protein technology that makes the first flu vaccine, that’s not an X. That’s based on this technology.

It has the potential to be applied very readily to coronavirus. Some early work done with SARS, the related virus, was very promising. We intend to leverage that work so that we can get to the clinic as soon as possible because we are a major flu vaccine producer, with this technology, we have the ability to produce large amounts of vaccine. We predict, depending upon the final formulation, 100 to 600 million doses per year made in New York and Pennsylvania, which is where we make about 90% of our flu product.

And we can do this without jeopardizing our flu vaccine production. Importantly, because we know that’s very important to maintain that. Mr. President, we’re willing to do whatever it takes to work with you and this administration, the collaboration we’ve had with NIH and with BARDA, who’s co-sponsoring our research to make sure that we do what we can to help with this problem.

When do you think you could have the vaccine? When do you think you’d be able to have it, start producing it?

We’re producing it now. The experimental lot, proteins take somewhat longer than some of the other technologies, more exploratory, but it’s approached, it’s a technology that works. We think we can be ready for the clinic in a year. And depending upon the nature of how the epidemic goes or doesn’t go, and with the help of the agencies of this country, perhaps as few as several years. Difficult to predict, Mr. President, knowing that a vaccine has to be both safe and efficacious because it’s given to healthy people.

All right. Okay. Thank you very much. Lenny?

Lenny Schleifer: (13:35)
Thanks, Mr. President for having us. I’m Lenny Schleifer the founder and CEO of Regeneron, a company that I built with the George Yancopoulos over the last 30 years. And we are a monoclonal antibody primarily centered company. We are no strangers to collaborating with the administration. We work with Secretary Azar’s group, BARDA, and we came up with a cure for Ebola. And we’re very proud of that.

Dr. Fauci’s group was really instrumental in testing that under unbelievable conditions in the Congo. And it didn’t create quite as much excitement because thank goodness it didn’t hit our shores, but we can use the exact same technology and we already have, we have 1000 antibodies that are already sitting in dishes. We’re screening them, we’re selecting them. We anticipate if all goes well, 200,000 doses per month can come out of our factory in New York starting in August. The unique thing about our technology-

That means you’d be able to use a vaccine that early?

Depends on what we see, how we work closely with the FDA, which we will do. The FDA has already reached out to us, but we’ve got to work closely-

That process would be faster than John’s?

It would be.

Can you explain why that would be?

Well, so we make passive vaccine and therapeutic. Our drug will be able to protect you, whether or not you’re infected, it’ll protect you from getting infected or if you are infected, it would treat you. And we have just taken processes that normally take years, literally years, and we put them end to end and now do them in weeks to months that nobody else in the industry can do. So we’re very excited to collaborate once again.

So this would be a combination of a vaccine and also it will put it in a different way, make you better quicker.

Yeah. Well think of it this way. If you get immunized with one of these vaccines, you’re going to make some antibodies to protect you. We’re going to already make those antibodies and give them to you so you don’t have to go through that whole process, so it will protect you. And as we showed with Ebola, you give enough of them, it was lifesaving, truly lifesaving.

That’s true.

It beat out anti virals, it really was the way to go. It’s very predictable. I just want to say I hope everybody succeeds here. This is bringing everybody together here is really critical and there’s going to be success. This industry is really talented as an industry. Sometimes we run astray, but we’re going to get this done.

Thank you very much. Thanks, Lenny. Appreciate it. Please.

Stephane Bancel: (16:12)
Thank you, Mr. President, for the invitation. Stephane Bancel the CEO of Moderna. So, Moderna team [inaudible 00:16:18] very proud to be a working with US Government, and to have already sent in only 42 days from the sequence of a virus, our vaccine to a Dr. Fauci’s Team at the NIH. And we’re now waiting for the vaccine to be green light from the FDA so that the team can start dosing as soon as possible. What is very interesting about our technology is that we use messenger RNA.

So basically it’s an information molecule that allows us to move very quickly from vagility to formation of a virus, to having a vaccine. So we have already have nine vaccine in the clinic, in the US, in Germany, and in Australia. We have five of those for respiratory diseases. We work with the partnered with data from Department Of Defense, with BARDA [inaudible 00:17:02] we’re having ongoing discussions. We were able to go so fast because we are working for many years with the NIH and we had worked with Dr. Fauci’s team on the MERs vaccine for the Middle East Respiratory Syndrome, which is coronavirus.

And so we’re able to move very, very fast from a few phone calls to getting a vaccine made ready for the clinic. We’re now working on the phase two material. So that as soon as we get the phase one dose out of the NIH, we’ll be able to start the phase two right away.

And what is your timing then? What would you say?

So we’re hoping to get the phase one start very soon now, we’re just waiting for a green light. The product is at the NIH and then it’ll be a few months to get the human data that will allow us to pick a therapeutic dose to start the [inaudible 00:17:50] right away.

So you’re talking over the next few months you think you can have a vaccine?

Correct. For phase two.

Yeah.

You won’t have a vaccine. You’ll have a vaccine to go and get tested.

For phase tow, yes.

And how long would that take?

The phase two would take a few months before we can go into phase three.

So you’re talking within a-

A year. Like I’ve been telling you, Mr. President.

[crosstalk 00:18:09] So 18 months.

A year to a year an a half.

Lenny’s talking about two months.

And we would be there in June. We will be there in June, in phase [crosstalk 00:18:18]-

In a couple of months.

Yes.

I mean, I like the sound of a couple of months better. Let’s be honest.

Alex Azar: (18:23)
But when you say June phase one initiation then right? In June? Not a completed vaccine is what I mean.

Yeah, well it would be a vaccine that would be ready for testing in phase one [crosstalk 00:00:18:31]-

Ready to use [crosstalk 00:18:33]-

Got it completed.

Ready to use when? Would you say. Ready to use?

On the public?

I think-

For next season.

So assuming that the vaccine is well tolerated and safe and efficacious, as John said then I think the question is how do we work with the FDA to expedite that as fast as possible to some sort of fast track program to get it through phase two and three testing to get to [crosstalk 00:18:54]-

Go quickly.

So, as quickly as possible.

What do you say to that, Lenny?

Look, I sense a cautiousness of Dr. Fauci, and he’s right to be cautious.

Speaker 1: (19:03)
It’s the cautiousness of Dr. Fouchey, and he’s right to be cautious because vaccines have to be tested because there is precedent for vaccines to actually make diseases worse. And you really don’t want to make it… You don’t want to rush and treat a million people and find out you’re making 900,000 of them worse.

President Trump: (19:17)
That’s a good idea.

Speaker 1: (19:17)
So yeah. So that’s, I think, why Dr. Fouchey is being a little bit cautious. I don’t want to speak for him. We need to prove that. I think that with our technology, by knowing that we have neutralizing antibodies that we give, we know that this approach worked for Ebola. We know that it worked for MERS in animals. We’d have a greater degree of confidence that this would work sooner, I think.

Okay.

Speaker 1: (19:42)
But that’s just the way it is.

Thank you very much. Daniel.

Daniel: (19:46)
Yeah, Mr. President, Mr. Vice President, thank you for having us here. I’m going to switch it up a little bit. We’re not a vaccine company. We’re a therapeutic company focused on antivirals.

Good. Let’s talk about that.

Daniel: (19:55)
Gilead Sciences, I know has worked with a lot of people around the table here. Let me first take the opportunity to thank you for the efforts of the administration, the Secretary on the HIV Elimination Program, which we’re closely connected with.

Right. Incredible what they done with HIV, incredible.

Daniel: (20:08)
To be able to prevent and treat this disease is just extraordinary.

So we’re saying 10 years, but now we’re into 9 years because it could have been started earlier and somebody else didn’t start it earlier. But we started it right away. And I’m now saying, I started off saying 10 years, now I’m down to nine years. Do you think by the end of nine years, HIV is where?

Daniel: (20:28)
I hope we can eliminate it in the developed world.

Can you imagine? We’ll be eliminated in this country.

Daniel: (20:32)
Because we have the ability to prevent it now.

That’s such a great thing.

Daniel: (20:35)
And if you can get to the people to really prevent it and then treat everybody. I think it’s certainly something we’re fully committed to.

If you remember back 10 years ago, horrible that was and a little beyond the 10 years and now, to think about what’s happened. So Daniel, let’s talk about this-

Daniel: (20:50)
We’re using that same anti-viral experience that Gilead has had decades too now to apply it to coronavirus. So we have a medicine called Remdesivir, which is like a decade-long development that’s an antiviral used to treat coronaviruses, the same viruses, the same family of SARS and MERS. And we’re hoping it has an effect now against the Covid-19. So we know in-vitro that it has very high effect.

So you have a medicine that’s already involved with the coronaviruses and now you have to see if it’s specifically for this. When?

Daniel: (21:25)
Correct.

You can know that tomorrow, can’t you?

Daniel: (21:27)
So now the critical thing is to do clinical trials, and we’re in the process. We have two clinical trials going on in China that were started several weeks ago. They’re 400 patient trials each. They’re getting close to halfway enrolled or-

Any response yet?

Daniel: (21:42)
Well, we don’t know because they’re double-blind randomized trials, so we have to wait until the conclusion of the trial. We expect to get that information in April. Then we’ve been working with Tony and the group at NIH to have another protocol, an NAAID that will also be a protocol that we’ll use in China, outside of China, here in the United States to test for the virus. And we have two other clinical trials that we’re going to initiate next week.

Anything here? Anything?

Daniel: (22:07)
Yes, yes. Well, the NAAID trial already had its first patients in Nebraska. And I think Tony, we’re working on getting-

Tony: (22:14)
In Washington also.

Daniel: (22:15)
In Washington state now.

Would you go to Washington state where it seems to have the problem?

Daniel: (22:19)
Absolutely. So the intention is to begin-

I think it’s a great idea.

Daniel: (22:22)
… with patients here in the coming days.

Yeah.

Daniel: (22:24)
Because the trial is really ready to go. So we’re fully-

You can go to specifically the nursing home where that outbreak?

Daniel: (22:30)
Yes, and the community, of course, that that touches because all the healthcare workers and that, the family members that have-

When will that take place?

Daniel: (22:38)
Literally, I think, Tony, go ahead. I think it’s the next couple of days.

Tony: (22:41)
Probably a couple of days, yeah.

If Tony is involved, it’ll be tomorrow morning.

Daniel: (22:45)
But this is a collaboration. We worked on the protocol together. Obviously, we’re providing the investigational medicine. We’re working hand in glove with many people around the table to make sure that whether it’s FDA, or CDC, or NIH.

So when will you know of it works? I mean you already have this medicine. When will you know?

Daniel: (23:02)
Well, I think we’ll know in the April timeframe.

That’s good.

Daniel: (23:05)
Yeah.

Speaker 2: (23:06)
Do you all, if you’re able to say, do you have any negative kick outs like futility analyses or DSNB reviews that will occur that-

Daniel: (23:13)
There is DSNB review in and the trial in China. They would probably take a look at some of that data in March. So far there’s that would be only stopped though for safety reasons.

Speaker 2: (23:22)
Okay.

Daniel: (23:23)
You really have to wait until the end of the trial to see efficacy. So we’re moving as fast as we can. I think everybody around the table is moving as fast as we can. And on top of that, of course, we have to anticipate success that we’re significantly investing in the manufacturing facility and capacity. We’ve been working closely with the administration to make sure we keep that supply chain.

And you’ve already built the facility to manufacture?

Daniel: (23:42)
We have facilities that we’re repurposing for the coronavirus.

This would be tremendous news if that works because you’re there. I mean you’re there. You have the plant. Do you have everything ready?

Daniel: (23:51)
We have a trial in severe patients and in more moderate patients, and we’re trying to understand as we all are with the epidemiology of this disease, where and when is the best place to treat.

That’s very exciting. Get it done, Daniel.

Daniel: (24:02)
We’re on it.

Don’t disappoint us, Daniel. Do you understand that? Great company, really great company. Thank you. Doctor, perhaps you’d like to say a few words, please.

Doctor: (24:12)
Thank you, Mr. President, Mr. Vice President. It’s really an honor to be here with you. I’m really interested in hearing on the efforts that are ongoing. You know that we’re working with you very closely now, with many of you, and it’s been a great relationship. We’re very interested. This is the message I want to send, we’re very interested in facilitating the development of therapeutics, diagnostics, vaccines for the benefit of the American people. And we, of course, want them to be safe and efficacious, but really look forward to working with you on this. Thank you.

Thank you. Thank you. You do a fantastic job.

Doctor: (24:42)
Thank you, Doug.

Please.

Pfizer: (24:45)
Mr. President, Mr. Vice President, I’m chief scientist for Pfizer. We are very pleased to be here. And for us, it’s been always important when major public health threats to come together across the industry with biotechs and federal agencies. So we were highly appreciative of the initiative that you’ve taken in this powerful way to have all of us around this table.

Pfizer: (25:11)
Pfizer, as you know, is a proud American company. We have 170 years of experience, originally founded in Brooklyn and headquartered in New York, and we have brought many vaccines, therapeutics of the small or large types for patients suffering from many different diseases including infectious diseases. Now, specifically for the Covid-19, the coronavirus, we have identified compounds, medicines that we have that we think, due to their activity against very related viruses, have good high probability to be active against Covid-19.

Pfizer: (25:51)
And in March, we are confirming that assumption with laboratories that have access to do this hazardous work of using the live virus to confirm activity. That would allow us to work closely with Dr. Horn here at the FDA and identify the fastest path to bring it to patients. That should happen if things go well this year. And as soon as possible I can hear your encouragement to all of us.

Pfizer: (26:24)
I wanted also to say that Pfizer has a 30 R&D and manufacturing sites in the US, more than 30,000 Americans involved in making or discovery medicines, and we’re willing to share our experience, our capabilities as a team here to make sure that the public in America gets the best solutions.

Do you expect to be dealing with each other a little bit? You’re competitors, but in this case it’s different. This is something we want to get done very quickly. Do you expect to be sharing your own capabilities with Pfizer and everybody else?

Tony: (26:58)
Absolutely.

Good.

Pfizer: (27:00)
I think the call to action that has come from you makes all of us feel that we should be one team here.

I agree. We would appreciate that.

Pfizer: (27:07)
As a closing remark, we’ve had a tremendous partnership with NIH and NIAID in many areas pioneering to bring medicine or advances forward with CDC dialogues and with FDA here. So for us, we look forward to extend this relationship to make sure that Americans can, as fast as possible given your encouragement to us, and with having different options to protect them, protection is by vaccines to deal with those that are exposed. We need treatments and those that are ill will need treatment. So it’s not just one solution. I think from this team we should offer multiple approaches, therapeutic and vaccines for patients.

Do you see that happening because I noticed you have a few different variants of what we’re talking about? Do you see that happening where maybe there are different either therapeutics, or vaccines, or both where you use combinations of each in different areas?

Pfizer: (28:08)
You are right on the frontier of science. It is about combination. And even looking at our colleagues here at Gilead, we have learned that if you have two different mechanisms and put them together as treatment, the likelihood of curing or very long lasting responses is higher. And we actually work on complimentary mechanisms.

I think that’s fantastic.

Daniel: (28:28)
It’s been the story of HIV.

I love it. Yeah. I love the complimentary. If you can do that, I love the complementary.

Pfizer: (28:34)
You can count on [inaudible 00:28:35].

Yeah, that’s fantastic. Thank you very much. That’s really very exciting. Please.

Joseph Kim: (28:40)
Mr. President, Mr. Vice president. My name is Joseph Kim. I run a company called Inovio Pharmaceuticals out of Pennsylvania. We’re a proud American biotech company with R&D and manufacturing in California as well. Inovio is the leader in coronavirus vaccine development in the world. We have a phase two product for a related MERS coronavirus vaccine in phase two stage. When the new outbreak occurred, we applied our very innovative 21st-century platform called DNA Medicines Platform to Covid-19.

Joseph Kim: (29:24)
By getting just the DNA sequence of the virus, we were able to fully construct our vaccine within three hours. And we’ve been working on preclinical and preparation work with the help of the FDA, and acceleration, and really working very well together. Our plan is to start the US-based clinical trials for Covid-19 vaccine in April of this year followed by shortly thereafter a trial in China and South Korea. There are a lot more infections in those areas.

We can give you an area too where we. Now we can. I mean, you take a look at Seattle again, we can give you an area.

Joseph Kim: (30:08)
Absolutely.

If you don’t mind, yeah.

Joseph Kim: (30:11)
We’ve been collaborating with US agencies like DARPA, NIH. We collaborated with Dr. Bergstein HIV vaccines many, many years ago. With existing resources and capacity, by end of this year, Inovio could deliver about one million doses, but to scale by end of this year. But to scale beyond that, we need your help, Mr. President. We need to work with you and your agencies, Barta and others to help us scale our vaccine to manufacture in America, to protect American public, also to lead the world in vaccine development from America. Thank you very much.

All right, thank you very much. You’ll have our help. Thank you. Please.

Paul Stoffels: (31:04)
Mr. President, Mr. Vice president, I’m Paul Stoffels. I’m Vice chairman and Chief Scientific Office for Johnson & Johnson and in direct vaccine research since 30 years. I did several drugs for HIV. At the moment, working within the vaccine platform, which has been deployed or is being deployed in HIV. We did in the times of Zika as well as now in Ebola. We are working with Tony on a phase two and phase three study with the HIV, with the same platform. With Barta, We have extensively collaborated on an Ebola vaccine.

At the moment, we are vaccinating a thousand people a day in Rwanda and in DRC showing the safety of the … and the same vaccine platform we are now deploying for corona. And since the availability of the information on the virus mid January, we have been working day and night on getting to a vaccine. The first versions of that are being tested in animals at the moment with positive results. And in parallel, the company has decided to start upscaling now. Time to resolve will depend to on GMP manufacturing, safety, preclinical safety. You have to work closely together with the FDA that.

Before the year and hopefully in November, we have the first clinical data starting. And early next year, the results of that. And at the same time, you’re looking for significant quantity of vaccines being already produced in that timeframe. But you can’t do anything else then. At the moment, starting parallel, the biological clinical work and parallel doing the upscaling. And let’s see where we end as fast as possible.

Did you have different concepts and methods than, you know, Pfizer and Johnson & Johnson? All great companies. Are you having different? Some seem to be faster than others, and others, they do seem to be different concepts.

The difference in the concept is that we are using a cold virus, an Athena vector, which there is a place where you can place a piece of corona, Ebola, or HIV. So we treat the body with another virus and generate the antibodies like that.

And that’s different from the others?

That’s different from the others. The difference is also it’s been used for many years now. It has been proven for many years that you can do it like that. And we also have a validated upscaling platform which can produce millions of doses in a very short timeframe. And that’s a parallel process where we developed a cell line, which, if we follow what we could do with Ebola, we could produce up to hundreds of millions of vaccines in a small, let’s say reasonably small, facility for manufacturing.

So can you have it ready for next season, any of you? I mean would you say for next season?

The next season should be-

That would be your goal.

Yeah. But like many people said-

It seems to be very seasonal, right?

We have to be very careful here if you vaccinate several hundred million.

You’ve got to make sure it works.

Works and it’s safe.

And doesn’t hurt. Right. I agree. I agree. Thank you very much. Thank you. Great company. Thank you.

Speaker 1: (34:08)
Dr. [inaudible 00:34:09].

Would you like to say something?

Anne Schuchat: (34:13)
Anne Schuchat from the CDC, and we really appreciate the chance to hear everyone.

Thank you.

Speaker 11 Louis?: (34:19)
Mr. President, Mr. Vice President, thank you for saving the most exciting company for the last. So we’re Novavax. We’re down the street in Maryland. We’re a vaccine company. We make recombinant nanoparticles. We make respiratory vaccines. We have two in phase three trials. We have an RSV vaccine where we vaccinated 4,600 pregnant women to protect infants from RSV disease and the youngest kids. We have a flu vaccine. We all know we need a better flu vaccine, and we have one in phase three trials we’re going to unblind in four weeks, exciting time for the company.

But we actually are a company that is focused on emerging infectious diseases. We’ve made two coronavirus vaccines. We’ve made one for SARS. We made one for MERS. We tested MERS all the way through animal challenge trials and showed 100% infection protection.

We have an Ebola vaccine that with the NIH showed in four different nonhuman primate studies that we had 100% protection at extremely low doses. And we’ve made a pandemic flu vaccine for H7N9 and others. And we’ve twice now taken from the gene sequence to the first in human studies done in 90 days and published it in the New England Journal. And we’re once again doing the same thing since the gene sequence was identified, I think it published on January 10th. We’ve taken our same recombinant nanoparticle platform and have been in animal studies for a couple of weeks. We expect data this week from one of them.

Speaker 1: (35:52)
And on this is on corona?

I’m sorry, on corona, yes. And we’re going into nonhuman primates this week with a coronavirus vaccine candidate.

So what do you think in terms of timing? What do you think?

Timing is what you hear around the table with this. We can get into humans in the May-June timetable, and in a phase one study also, but we’ll have primate data.

So those are unheard of speeds, I think, right? Pretty much. Well make it very easy for you, and we have to be very safe, but those are unheard of speeds. Go ahead, Louis.

No, and we’re trying to identify scale so that we can get to the billion unit scale, both where we have a vaccine antigen and we also have an adjuvant. And we put those together and you get the most promising result we think. And so we desperately need and have good relationships with the FDA and to work with the FDA to see where, instead of waiting 30 days to get to an IND, you get it in 10 days or 20, whatever the number is.

But there are a lot of things that we could do with the FDA. And frankly, we need money. We’re a biotech company. I am not one of the larger pharma companies, and so we need money to get scaled.

You work with the other companies also?

We have worked with the other companies. In this particular instance, we have not yet, but can.

Dr. Stephen Hahn, by the way, is the new head of the FDA for those of you that don’t know. And he’s one of the most respected people in the country, and this is the man we wanted, and this is the man we got. You didn’t know you were going to be hit with this your first month. You’ve been here for a couple of months and this was a pretty big. Debra, would you like to say something?

Debra: (37:37)
Well, thank you. It’s a privilege to be here. Thank you, Mr. President, Mr. Vice President. I think what was exciting to hear around the table is you have a potential for a bridge, a bridge between the therapeutics and monoclonals while we work on the vaccines. And I think that’s the most promising piece for the American people to know that there’s technology that can be used as an immediate bridge, and then as we work on the vaccines. I think making sure that we’ve tested all of the antivirals that you have in your …

Ambassador Birx : (38:03)
Making sure that we’ve tested all of the antivirals that you have in your collection against this particular virus. Do IC50s across the board. Many of you have antiviral medication, and I think just to assure the American people that we have tried using our innovators to actually screen all the current drugs for potential activity against this virus would be key. But I think this is very promising with this linkage that you put together in this room between monoclonal antibodies, therapeutics, and vaccines. It’s very encouraging.

It is, very exciting, and the speed is very exciting, too. Anybody else have anything to say? Anybody at all?

Speaker 3: (38:39)
I’ve got something on the screening. So, we set up already an industry construction where everyone is now able to submit, biotech or pharmaceuticals, to submit to a screening, which is set up for everybody supported by Barda and supported by Europe.

Yeah. That’s fantastic. You’ll move rapidly. Media, would you like to ask any questions of any of the geniuses around the table?

Speaker 4: (39:00)
Mr. President, what economic stimulus measures are you considering to boost the economy as a result of the virus?

Well, I guess the market’s up today. Our country is very strong economically, as you know. This was something that came out of China that was a big surprise to the world. It happened just a few weeks ago. I’m sure the Fed is looking at it. I hope the Fed is looking at it. They should be, but a lot of these central banks are looking at it for stimulus.

One thing I want to add, we keep talking about for America, but really we’re looking at for a cure for the whole world because this is a world cure, not just the United States. We want to take care of the United States, but whatever we do is going to inure it to the benefit of the world, so we want to do that. Fortunately, some of your companies are so large, you can handle that. But you work together, thereby making it even better, so we appreciate that. We would love to have you work together on this. Get it done and get it done safely and quickly.

But I think, we’re in very strong shape, very strong shape financially. I have to tell you. I came into the room not expecting to hear quite what I’ve heard, but a lot of work has already been done. We’ve been encouraging them for the last few weeks. I mean literally from the first day, when we shut down the border, so to speak, we shut it down to China, something we didn’t like to do, but we made a good decision. But we also called some of the companies around the table, said, “Get going. Just in case, get going.” We’re very proud of the work that some of them have done. Some are very advanced already on this particular coronavirus, so we appreciate it. That’s tremendous news, and I think the speed is a lot greater than a lot of people would have thought.

Speaker 4: (40:40)
Do you see a need for federal dollars to go to some of these drug companies? I think two of the CEOs around the table-

I don’t know. I think you’re so rich. I know the companies very well. Some of them are so rich, I think they can actually loan money to the federal government. They don’t need money. They need time. I think what they need more than anything else, Dan, you might tell me, but I think what you need is FDA and Tony have to help you get through the process as quickly as possible, the bureaucratic stuff and we don’t have bureaucrats here. We have people that really know how to get it done between Tony, and Bob, and Steven, they’ll get you folks through very, very quickly. [crosstalk 00:03:17].

Speaker 4: (41:20)
Do you think that they should have called an emergency meeting before the meeting in a couple of weeks that cooperates, is your administration-

Well, I think they should have had a meeting already, so I think they should have, and the central banks are going to be talking about various things tomorrow, but we’ll see what happens. But I think they should have had a meeting already. I don’t know what takes them so long. [crosstalk 00:03:40]. I’ll see what happens. Let’s see what happens tomorrow.

Speaker 5: (41:48)
What would you say to Americans who are buying out all the hand sanitizers at CVS?

Buying what?

Speaker 5: (41:48)
Buying out all the hand sanitizers at CVS, or stockpiling groceries and face masks. We’re concerned about a long term situation.

Speaker 6: (41:57)
Listen, as the President has said and we’ve said from the outset, we’re going to see more cases here in the United States, and we need to be prepared. We prepare for the worst case. We hope for the best case. Part of preparing is normal preparedness activities by individuals. Go to cdc.gov to get information about just sound preparedness at home like you would have for a hurricane or for the flu season. That’s the same type of activity now, so having some food, having some hand sanitizer, but frankly soap and water are good, a good soap and water hand washing for an appropriate amount of time. If you look@cdc.gov for guidance, is as effective as that kind of sanitizer, but people should not be panicked. They shouldn’t be. I know they may feel that. They may feel a sense of unease. They feel the uncertainty. We’re trying to reveal all information we have, but there are steps people could take like that, just good everyday prepared us. Nothing different today than I would have advised six months ago to people.

Speaker 7: (43:01)
Mr. President, are you considering tightening any of the travel regulations that you said-

Yes, we are to certain countries where they have more of a breakout. We are. You know what those countries are. I don’t have to say, but we are doing that, and we’ve already done it, as you know, with three countries in addition to China. So, we will be doing it. Yes.

Speaker 8: (43:20)
Mr. President, you said supplementals here. What’s the [inaudible 00:05:24], and are you also considering a national emergency declaration that would allow states and local governments [inaudible 00:43:32]?

I don’t think you’ll need that because I really think we’re in extremely good shape. We’re prepared for anything and we could always do that at a later date if we need it. But I don’t think we need that at this stage. Interestingly, we were discussing it. A question I get asked a lot by people is on average you lose from 26,000 to 70,000 or so and even some cases more from the flu. We have deaths of that per year, worldwide it’s hundreds of thousands of deaths from the common flu. They ask what’s the difference and how does this differ?

I guess there are things that are similar and things that are different. Every one of them is different. It might not be a bad question to ask because I get that all the time. So far we have six here. You have in other countries, I mean China obviously got hit the hardest. I noticed that South Korea is hit very hard. Italy is being hit very hard. But I would like to maybe now, because I am often times asked. We average, I suspect, Tony, I think you said from around 26, 27,000 up to 60 or 70,000 deaths per year. That’s a lot of deaths. Here we’re talking about a much smaller range. Now, hopefully it stays at a much smaller range. Again, we’re prepared for anything. Could I ask you, or any of you, if you’d like to answer that question? What would the public think when you have so many? That’s taken routinely, and I was shocked to hear this. Three, four weeks ago I said, “Well, how many people die a year from the flu?” Of this country, I think last year was 36 or 37,000 people. I’m saying, “Wow, nobody knew that information worldwide.” You just multiply it out times the world, right? So, what is the difference then?

Speaker 9: (45:17)
Well, I think there are people around the table that probably are more medically qualified, but I mean, clearly when we’re bringing up represented around the table is the ability to prevent an endemic of sorts and the ability to treat. Those two things going together, I think, are really, really important as the best [inaudible 00:45:37] presented.

We may have to up our research on the flu.

Speaker 9: (45:40)
Well, yeah, right.

The common flu.

Speaker 9: (45:44)
We have treatments for the flu, and we have vaccinations for the flu, and we need to continue to improve upon.

Doctor.

Speaker 9: (45:48)
We’ve actually taken on the challenge that you just mentioned. So, we are investing in what could be new technology to completely [inaudible 00:45:56] out from a flu, and you need to think about how you can move fast from the first cases to have the right type of vaccine, and how you can be able to manufacture it very fast, because I think you are right on to point that the numbers in flu are so large and we haven’t come to that level yet. But I think it’s also the fear that there is no experience yet with these survivors, and we don’t have the feeling of going to CVS and get the flu vaccine, or use some of the drugs. But I think you’ve summarized it very well. These are challenges we should take on year by year that [inaudible 00:46:34] and protect lives. [crosstalk 00:00:46:37].

Including, Tony, that maybe we have to step up our work on the flu because when you lose that many people, that’s something.

Dr. Tony Fauci: (46:45)
Mr. President, What we’re doing is that we have a major effort to develop what we call the universal flu vaccine, namely a vaccine that you can give that would cover all the different strains so you don’t have to keep worrying about it mutating from year to year. So, that’s a major effort that we have.

Because I notice every year they say a different vaccine, they have a little different, a little, and then you know, I hear numbers that are not great, 60%, 70% coverage success, and yet I hear numbers that are better than that with respect to corona. You think you can really knock it out and that’s because you know specifically what it is, I suspect, so that’s impressive. What do you think Lenny?

Speaker 10: (47:28)
I think one thing we can be sure and we’re going to be surprised about what happens over the next couple of months, and we’ve got to be prepared as you’re trying to do for every surprise that’ll come at us, because remember, maybe 100 million people, I was just checking, get vaccinated for the flu, even if there’s 60% protection. We have nobody in this country vaccinated for coronavirus right now, so that if it goes through the-

But the same vaccine could not work. You take a solid flu vaccine, you don’t think that would have an impact or much of an impact on corona?

Speaker 10: (47:58)
No, probably none. So, that’s why you have a difference when you have a population that is totally naked to this virus. That’s why a vaccine approach getting out as quick as we can of course is paramount. The other thing is we have a group of people around this table, myself included, who are in an industry where optimism is an essential part of the toolkit, but realism is that 95% of what we all work on doesn’t go too far.

Speaker 10: (48:30)
So, that’s why it’s so important to have so many different approaches. We can’t-

It seems to me just based on what you said and also what the other folks said from great companies, companies I know very well from just seeing what they do, and I find it very interesting. I have for a long time. It would seem to me that you already know pretty much where you’re going, and where you’re headed, and what the answer’s going to be. It would seem that, Steve. Doesn’t it seem? You seem to know what the answer is to this. You have to get it done, or is that too optimistic a statement?

Speaker 9: (49:02)
I think some of the new technologies that have come, that we heard today about [inaudible 00:49:08] MR 99, where you use completely new tools and technologies. They give us an opportunity to move fast, and that’s why some of the companies that have been working under the CDC can quickly change priorities and need huge public health threat.

Speaker 9: (49:24)
But, I think we should take on as a team to do something with seasonal flu, and actually I think, Robert Redfield, that has been one of your key priorities, and we have certainly picked up on that.

By the way, it’d be a great thing if you could do that. Just aside from this meeting, if you could do that, that would be a great thing. Does anybody else have anything to say, please? Well, I want to just thank you all very much for being here and it’s a very optimistic meeting. I didn’t realize you were that far advanced and you’ll get together if you have to. You’ll deal with Tony and Bob, and you’ll deal with Steven and get it done. We need it. We want it fast. Okay? [crosstalk 00:12:02].

Speaker 11: (50:01)
Mr. President, do you expect that this will take longer, probably than you would like?

I don’t know what the time will be. I don’t think they know what the time would be. I’ve heard very quick numbers, a matter of months, and I’ve heard pretty much a year would be an outside number. So, I think that’s not a bad range. But if you’re talking about three to four months in a couple of cases, and a year in other cases. Wouldn’t you say, doctor, would that be about right?

Speaker 11: (50:28)
Is it realistic to think, really, that a vaccine could be ready-

Well, you have the greatest companies in the world sitting around the table. I mean, Johnson and Johnson, and Pfizer, and all of the companies, Gilead, you have all of these great companies and that’s what they’re saying. So, I think that-

Would you make sure you get the President the information that a vaccine that you make and start testing in a year is not a vaccine that’s deployable. So, he’s asking the question, when is it going to be deployable? That is going to be, at the earliest, a year to a year and a half, no matter how fast you go. Do you think that’s right? [Crosstalk 00:51:02].

Well, I think treatment, in many ways, it might be more exciting.

Speaker 12: (51:10)
Yeah. That’s what I think. Ambassador Birx, I think, laid out a really nice framework as we think about managing expectations, which is be thinking antiviral therapeutics, transitioning to monoclonal antibodies, and eventually to vaccines, as we think about the continuum of research and development here. Is that fair for [inaudible 00:51:32]?

Well, I think, Tony, I think that’s interesting because the concept of treatment in a certain way, especially when you have people that are looking for treatment, they’re beyond the vaccine stage. That would be very exciting.

It always goes faster than vaccine because you’re dealing with someone who’s already sick. The safety issues are going to be much, much different, and you will know your result almost immediately, whereas with vaccines it takes-

So, then what would be your timing for treatment therapeutics, commonly known as, I call it, what would be your number?

Speaker 13: (52:08)
For us, we can think about producing 20,000 doses by the end of the summer of a course of treatment, and as Doctor Fauci said, you’re going to find out very quickly. It’s not going to be a mystery whether these things work or not. We’re pretty confident that ours is the monoclonal antibody approach. We think that that approach has a very high probability in the near term of delivering.

So, treatment, I mean just for the media, so the treatment element of it goes faster than the vaccine element of it, which in my opinion in this case would be better. Go ahead, please sir.

Speaker 14: (52:44)
Mr. President, I mean, [inaudible 00:52:46] our medicine is in phase three trials right now and these trials are conducted very fast. I mean, we’re talking about 30 day endpoints, so you recruit them, you know in 30 days, once you recruit, whether it works or not. Thankfully, so far the drug seems to be very safe, but we have to determine is its level of efficacy, it’s clinical effectiveness, and that as I said, we’ll know potentially as early as April.

So, it could be used as a treatment. Somebody is sick, they have the problem, Tony, when do you think it could be used?

Is well, if the trial that Daniel was talking about proves efficacy, which you likely might know in a few months whether it’s effective or not, if you know by June that it’s effective, then you just scale up and manufacture it and you’re good to go.

How good is that? You hear that, Jeff? That’s good even by your standpoint, Jeff.

Speaker 6: (53:35)
Well, let me give you an example, for instance, with the Regeneron product with Ebola. So, Tony Fauci and his team, and the World Health Organization ran a historic forearm clinical trial in the war zone in eastern Congo, and two of the products, one of them developed by NIAID, and the other [crosstalk 00:53:55] one developed by Regeneron proved so effective that the ethical board said stop on the other two. I’m sorry, yeah. [crosstalk 00:54:03] They said, and start treating, and when I went to the Congo, I got to see people that even before FDA approval are being treated still in the extension of this clinical trial, and being cured of Ebola now, walking out where they would have had a death sentence before. That’s what we would try to do.

Speaker 15: (54:22)
So, for us, that’s an end of the summer type of an event.

Speaker 6: (54:23)
That’s what we would try to do.

He just got back from the Congo and that’s dedication. That was not an easy trip, wasn’t it?

Speaker 15: (54:33)
I mean, it wasn’t easy to do that trail there, but kudos to Tony.

I want to thank everybody in this room. Mike, go ahead.

Vice President Pence: (54:41)
I was about to do the same as the President, just pledge that our whole task force, this whole team, HHS, I know CDC, President and I will be at NIH tomorrow, look forward to working with all of you, and I want to commend each and every one of you for responding to the President’s call for action. This is all hands on deck and the news out of this meeting that you’ve already formed a consortium. We know we have the greatest pharmaceutical industry in the world, in the United States, Mr. President, now we know they will be working together to create therapeutics and ultimately a new vaccine to deal with the coronavirus.

That’s fantastic.

Vice President Pence: (55:15)
I want to thank you all.

Anybody delays you, please call me. They don’t just call Tony and Bob.

Speaker 16: (55:21)
The DOW jumped 1300 points today.

1300?

Speaker 16: (55:26)
Yeah, 1293, 5%.

They must have heard about this meeting. Who’s talking outside? This is very optimistic. I know optimism, and not optimism, and the worst pessimism, and I will tell you, the whole thing with therapeutics to me is very exciting, and obviously vaccine, but therapeutics is very exciting, especially when you’re so far advanced. That’s great. That’s really great. Thank you. Thank you very much. Say hello to everybody. [crosstalk 00:55:54] [inaudible 00:56:00]

Transcript: Trump Holds Coronavirus Meeting with Pharmaceutical Executives

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