Dr. Jerome Kim

Guy Kawasaki:
I'm Guy Kawasaki, and this is Remarkable People.
This episode's guest is Dr. Jerome Kim. He's the Director General of the International Vaccine Institute.
The International Vaccine Institute was established in 1997 as an initiative of the United Nations Development Program. Its mission is to discover, develop, and deliver safe, effective, and affordable vaccines for global public health.
Dr. Kim has a BA from the University of Hawaii and an MD from the Yale University School of Medicine. He completed his training in Internal Medicine and a Fellowship in Infectious Diseases at the Duke University Medical Center.
He was the principal deputy and chief at the Laboratory of Molecular Virology and Pathogenesis at the Military HIV Research Program. He also served as the project manager for the HIV Vaccines and Advanced Concepts Evaluation Project Management Offices. He led the army's phase three HIV vaccine trial, RV 144, the first demonstration that an HIV vaccine could protect against the infection.
He has authored over 200 publications. He was named one of the fifty most influential people in vaccines in 2004 by the Vaccine Industry Organization, Vaccine Nation.
Another of his claim to fame is that we went to the same high school in Hawaii, Iolani. We even had many of the same teachers, which we will discuss in this episode.
I'm Guy Kawasaki, and this is Remarkable People.
Now, bringing you the straight scoop on vaccines, here is Dr. Jerome Kim.
How did you go from Iolani to Seoul, Korea running an institution like this? That's quite the transition.
Dr. Jerome Kim:
Yeah. It's funny because my senior year in high school, my dad lost his job so I didn't go out. I didn't go to the mainland for college.
I stayed at the UH, worked in his restaurant in Fort Street Mall, and worked on the weekends as a work clerk at Straub.
That was my introduction to medicine. I already had known ... I knew that I wanted to go to medical school. As soon as I could, three years, I graduated and left and went about as far away as you can get to Connecticut for medical school.
In those days, remember, right, you didn't go on interview trips to the mainland. You look at a catalog and say oh yeah this looks like a great place. This is where I want to go.
For medical school then, two of my Iolani classmates worked at Yale, Michael Ho and Allan Tanaka, and it was great to actually start medical school but have friends that you knew from high school there.
In order to pay for it, I joined the Air Force. The Air Force has this program where if you're in medical school, they pay for four years. It was a great program. Then they said okay you can go and do your residency fellowship at Duke, so I did.
I got a grant and got an extension, so I was in the Air Force, and I got another grant and I wrote to them again and said “Can I get another five year extension because I'm doing research and it's really great.” The first Gulf War had started so 1990.
I wrote to them and said, “Can I have another five years”, and I got this email back “Who are you and why don't I know about you?” They brought me on to active duty. They didn't send me to the Gulf, but they sent me to San Antonio to be an infectious disease doctor, which is what I was trained at, and the guy said, “Neal Boswell”, he said “we've got this program with the army, and they do HIV vaccine research. I mean, you're qualified. You should go there.”
I did and I went to work for Robert Redfield who is now the Director of CDC. His deputy was Debbie Birx who is now serving as the White House Coronavirus Response Coordinator.
We did HIV vaccine research in the military because, at that time, there wasn't a lot of work being done on HIV vaccines. That's how I learned about vaccines.
Spent twenty years in the army, did a brief interlude at the University of Maryland working for Bob Redfield and Bob Gallo, and then I went back to work under Debbie Birx.
The Army sent me to Thailand to do a phase three trial for the HIV vaccine, which is still the only one to have shown protection against HIV infection.
In 2015, I was up at twenty years. I got a call from somebody who said this International Vaccine Institute is in Seoul. They work on vaccine development for diseases in developing countries. Would you like to interview. I thought about it and my wife said absolutely.
I interviewed and they offered me a job, so for the last five years, I've been here.
We work on everything really but HIV. All those diseases that you can get if you travel somewhere that really aren't found in the United States. I mean, IVI is very small.
We're not that well known, but we are an international organization, so we have all flags of our signatory IVI and some of the countries fund us like WHO, World Health Organization, some countries fund IVI.
Then we get money from the Gates Foundation, the Wellcome Trust, and others to work on different kinds of vaccines, and so it's essentially like a little biotech company.
We have a lab. We generate our own vaccine. Sometimes we help other people with their vaccines. Right now, if you hear about a cholera outbreak, cholera is a very severe form of diarrhea, that's our vaccine.
It started at IVI. We transferred the ability to make it to some companies, one in Korea, one in India.
Whenever there is an outbreak, our vaccine made by these two companies is being used to help control the outbreak. We are a bit, I mean, really like a little company, but we're also a research institute where we do research in the lab, we do clinical research to evaluate vaccines, and then we actually take vaccines and vaccinate large populations to make sure that the vaccines are working the way we advertise.
Guy Kawasaki:
Wow.
What's your current activity vis-a-vis coronavirus?
Dr. Jerome Kim:
With coronavirus, actually we made it a really ... I think probably the right decision. We decided to help other groups to develop vaccines rather than to develop one of our own.
In that way then, we can facilitate multiple efforts. There are over 150, I think over 170 now, different efforts to develop coronavirus vaccines and we can help any of them without showing favoritism.
What we do is we help the companies to evaluate the defensive responses, so when you get a vaccine, your body makes a defensive response against the virus or the bacterium. Our group, our laboratory helps the companies evaluate these responses, and that's really important, so the USFDA or the Ministry of Food and Drug Safety in Korea will look at these, and that will be a part of the package that goes into them for approval.
IVI is helping multiple companies with that, and then also yesterday we were approved to go forward with the vaccine trial in Korea. Hopefully, it will be the first COVID-19 vaccine trial actually performed in Korea although we're still waiting. It has to actually formally start.
Guy Kawasaki:
Why do these companies, many of whom have more money than God, why do they need you to help with this process?
Dr. Jerome Kim:
Actually, we work with smaller companies. In Korea, there are four groups now that are working with us, and we can do something very simple like take their vaccine, inject it into an animal, and check to see if the animal, if infection is prevented in that animal model, or we can just measure the defensive or immune responses that are made to the vaccine.
We are trying to facilitate efforts by smaller companies in groups, many of which have a real development efforts and activity and have funding to do it on their own through venture capital or investors.
We thought it would be important to try and move these products along as well because we don't really know what's going to work in the end, and so with the bigger company, we can actually offer to help them. If they'd like to test the vaccine in Africa or South America or South Asia because in the end this is a global vaccine.
The other thing is if you thought you were going to be able to test the vaccine in Italy or in England, in the UK, with the rates of infection going down, you can't actually test the vaccine there or it would be more difficult. You have to enroll tens of thousands of people. Or if you're a Chinese company and you thought well, we'll develop a vaccine and test it in China.
You can't actually test the vaccine in China now because there aren't enough infections. In order to test the vaccine, you have to compare the vaccine to an inactive substance and see if the vaccine prevents infection.
If you're not having any infections, you can't do the clinical trials, so you have to find parts of the world where you can do that, and IVI can help in parts of the world that companies, big companies usually don't work.
Guy Kawasaki:
Do you pick the companies you wanted to work for? Are you buying or selling your services?
Dr. Jerome Kim:
We go to some companies where we already have a relationship.
Sometimes companies will approach us, but typically we go out to different companies and say “We're the International Vaccine Institute. This is what we do and how we believe we can help you.” Sometimes that kind of approach works pretty well.
I think particularly for, say, a company in Korea, where you can't test a vaccine in Korea either because there aren't enough infections, so a big Korean company that's developing a vaccine may request assistance from IVI to help develop the vaccine outside of Korea.
We offer services to a lot of people. It is a bit of selling ourself. Organization that can help you do the animal studies, can help you with the essays, can help you do a clinical trial, and if you need help, as we do for the smaller companies.
A Korean company that makes cholera vaccine, this was their first vaccine, we help them with Gates Foundation funding through the whole process of testing and evaluation by the Ministry of Food and Drug Safety, approval by the World Health Organization, so we can help along the entire spectrum of getting a vaccine over the finish line, over the goal line.
Guy Kawasaki:
As a lay person, how do I interpret this that there are 170 efforts going on? Is that the more the merrier? Is it just a random luck? Am I supposed to be happy that there are so many trial test possible drugs going on?
How do I interpret that?
Dr. Jerome Kim:
Normally, it would be invisible. There were a lot of groups that in the thirty-year history of HIV that have started work on an HIV vaccine only to fall away because the vaccines never showed enough generation of protective responses in animals or didn't do well in human studies, early human studies.
With COVID-19, because of the publicity and the intense spotlight that's been put on trying to develop a vaccine, a lot of groups are saying “We can do this, we can grow up the virus and kill it or take a bit of the virus, put it into something like an adenovirus and then grow it up ... oh, yeah it makes a great immune response.”
The thing is that most of those won't make it, so when you look at vaccine development in general, 93 percent of the products that start out of the lab don't make it to the end. If you had 176 and not all of them are really serious efforts, there's a good chance that a large number of them aren't going to make it into humans, so what we call the first valley of death, you know in tech?
The valley of death where you have a great idea, but it just doesn't get any traction. It happen to the vaccines. The last thing that you want is a vaccine that protects mice against COVID.
You really have to test it in humans, in phase one, which is for safety, phase two, which really looks at the protective response, and then phase three which looks at protection against infection and disease.
Then if it works, the company decides okay we'll take it forward to the FDA, and FDA says okay go ahead, you can market it. Dropout rate is 93 percent.
Guy Kawasaki:
I'm surprised it's that good, I mean, that 7 percent make it because it seems to me that this is a very difficult process.
Speaking of difficulty, you've talked about cholera, and there's typhoid and strep vaccines and stuff, and it seems to me those took so long to come to fruition.
Why do we have people saying well by January, we might have a coronavirus?
Dr. Jerome Kim:
That's an interesting thing. The spotlight and the number of deaths is really important.
I mean, this is a disease that is not a disease that's only Bangladesh or in Yemen or in Haiti. This is a disease on our doorstep. It's killing Americans, and Brits, and people in the European Union, as well as people in China and Korea, I mean, over 200 countries around the world, so the visibility of it and the intense spotlight. I mean, this is the biggest pandemic outbreak of the last 100 years.
There's so much intense scrutiny on it that we're saying okay we have to develop a vaccine because in the US , people are on lockdown. You couldn't leave, you couldn't conduct your business, the economy took a huge hit, and I guess why it was 22 percent unemployed. That's incredible.
The best way to get back to normality, back to the way it was would be for us to have an effective vaccine, for us to vaccinate enough people so that we have protective immunity in the community. That will allow us to get on with our business, go back outside, go to the theater, have friends over for graduation parties. Those are the kinds of things that are needed.
What normally would take five to ten years is now been telescoped. Where we would normally do this first phase for safety, and then wait, and look at the data and decide if we have to fix anything, and they go to phase two, right now we're telescoping them.
We start phase one. Before phase one is done, we start phase two because we've looked at the protective responses, they looked good. People haven't had any side effects that we can see, and so we move on to phase two. We will look at phase two, and after we analyze the protective responses in phase two, we can start phase three.
We go from fifty people to several hundred people, to thousands of people, and we go from is it safe to the very end is it safe and does it actually protect against the disease. We can do that fast, hopefully, and so by the end of the year maybe, beginning of next year, we'll know if the vaccine works, but proving it work is only the first step.
Guy Kawasaki:
What's the next step?
Dr. Jerome Kim:
Sorry. Then next step would be making it. I mean, making billions of doses. There are actually more than seven billion people in the world, everybody needs at least one shot, one dose.
Sometimes depending on the vaccine, you need two or three, so that's fourteen or twenty-one billion doses. We usually don't make that much, and we don't need it as quickly. Usually you can roll out vaccination to different populations at different times.
Now, everyone's going to want that vaccine. How are you going to make that much so quickly and distribute it around the world fairly? That's going to be a big issue coming up.
Guy Kawasaki:
What is the most promising new vaccine technology that you are aware of?
Dr. Jerome Kim:
For COVID or in general?
Guy Kawasaki:
Well both actually, so if you can answer that both ways.
Dr. Jerome Kim:
The most promising, I think that the mRNA vaccines, which is what the USNIH is pursuing with Moderna, and what the German company called CureVac has gotten, and I think now one of the other big companies that purchased one have a lot of really amazing potential because you can make them fast, theoretically you can make a lot of it in a very small space.
I don't know if you've ever been to a vaccine manufacturing plant, but it's like the old Dole Pineapple cannery. I mean, these giant 2,000 liters stainless steel fermenters with pipes that go everywhere and a series of rooms and clean rooms, you could make fifteen million doses of mRNA vaccine theoretically in the classroom.
Guy Kawasaki:
Really?
Dr. Jerome Kim:
Theoretically.
Guy Kawasaki:
Wow.
Dr. Jerome Kim:
I say theoretically because no one's ever have to do it because there's no licensed vaccine yet.
Guy Kawasaki:
Oh.
Dr. Jerome Kim:
That's technology. Say this COVID vaccine, the Moderna vaccine works, which we don't know that it will, it becomes a platform. The next time we have pandemic influenza or COVID-23, we can very rapidly make the mRNA, which is already a platform for COVID-19, and begin testing it very quickly.
Moderna was the first out of the box. They got their first trial started in mid-March, I think March seventeenth.
We'd known about the virus, really known the sequence since the first or second week in January, two months later, we're doing our first test in human. That would be incredible. I mean, that's the speed that you can move when you have an mRNA vaccine.
The problem is we don't have a licensed vaccine yet. We know it generates the right immune responses. We know, we think, but we don't know that those responses protect.
It could be useful for cancer or it could be ... You could actually personalize a cancer vaccine very quickly. You know exactly what you want to make in a particular person with cancer, and you create a RNA for their own vaccine in a matter of weeks, and you would start their injection.
It has a lot of potential because it's fast and scalable in theory. We don't have an actual example.
Guy Kawasaki:
Pardon my ignorance. What does licensed vaccine mean?
Dr. Jerome Kim:
Ah, okay.
Vaccines are highly regulated, in our case the Food and Drug Administration, in Korea by the Ministry of Food and Drug Safety, but every country almost has a regulatory agency that allows vaccines to be used in a country.
Medicines as well, so the FDA regulates medicines. The Europeans have their own organization that covers most of their European Union, the Brits now have their own, used to and once again. Usually, they're charged.
For instance, USFDA's charged with safe and effective medicines. Not everyone has that same requirement. Sometimes it's mainly safe, not necessarily effective.
In the US, it's safe and effective. For vaccines, safe and effective is very important because as opposed to a medicine, if a person is sick and you're giving them medicine, it's one thing, but when a person is well or your child is well, and you're giving them a vaccine, you want to make sure that pain that you inflict on them or any potential safety issues are for a very well-defined and significant benefit.
The government looks at all the data from phase one ... actually, they look initially at the animal data, then at the phase one, the safety data, then the larger test phase two of whether the vaccine's generating the right protective responses and then the phase three efficacy data. These trials generate 100,000 pieces of paper in the old days.
Now, it's a computer disk or a series of high-density transfers to the Food and Drug Administration on electronic format, but it's still hundreds of thousands of document-equivalent pages. The Food and Drug Administration goes through everyone. They'll ask questions. If you have lost too many patients in follow up, or if they notice that you weren't following the protocol, which happens, or that you didn't get consent forms from people. They'll note these things and they come back to you as a series of questions, and you have to answer them.
The worst thing is when statistician goes through your data and they say, “We disagree with your conclusion.” You used a very funny definition here, and that funny definition allowed you to show an effect, which we don't think is an effect.
That is not what you want to hear from the FDA because you just invested 500 million, one billion dollars in a vaccine, you're sitting in this meeting, and people are asking you questions and disagreeing with whether or not the vaccine should be licensed or approved by the FDA. What the FDA approval does is it allows you to market the vaccine. For a company, that's the bottom line.
You don't make money until you actually can market it. In the US and actually most countries there's another step.
Just because you have a vaccine doesn't mean that doctors will use it. Usually the doctors wait until there's a recommendation from the Advisory Committee on Immunization Practices, ACIP, which is a US organization that says ... it's ran by CDC.
They say this vaccine looks good. It has cost benefit analysis that is favorable. It will protect children against ... I don't know if your children were vaccinated against Meningitis E, my children were. You should recommend vaccination.
Then pediatricians around the country say we just got a recommendation to use this. Your child is in the right age range. Your child should get vaccinated.
It's the approval to begin to sell a vaccine. For the company, that's the key.
Guy Kawasaki:
With the CDC and the FDA involved, are we in danger of those kinds of rigorous science and testing being politicized?
Dr. Jerome Kim:
The FDA is supposed to be independent.
Guy Kawasaki:
So is the Supreme Court.
Dr. Jerome Kim:
I mean, yeah. FDA, the drug companies call it The Agency. They talk about, they say “The Agency is really tough on this.”
Right now, the FDA is saying “In order for us to approve this vaccine, we're going to need to see”, and it's a statistical thing, when you do a clinical trial, you get an upper and lower bound of confidence of the confidence interval.
In the case of a really effective vaccine, they want that confidence interval to be above 30% protection. If it's below 30 percent, then the FDA is usually okay I think you probably need to redo this or we're not going to approve it above zero, but less than thirty.
I mean, that's highly suggestive but it's not enough. The question is, and right now they're saying that. For COVID vaccine, that's the requirement, whether they'll come under political pressure or whether they'll grant emergency use is really not known.
In fact, there's I guess some speculation in one of the editorials that that maybe a surprise, a political surprise in October. The FDA though they take their jobs pretty seriously.
It took a lot even, I mean, a lot of lobbying to even get them to allow AIDS drugs to be used before they were licensed. Because essentially AIDS was back in the early nineties, it's a disease that you've gotten and died of, they allowed an accelerated pathway, but the same thing applies.
You have to keep records. I mean, it's really, we call it compassionate use of a medicine. It's important for cancer drugs and some of it back then, the AIDS drugs that were coming out that had these amazing effects.
It was good that the FDA did that, but they were very uncomfortable because their job, the thing that they're cast with doing is to ensure that the vaccines are safe and effective, and they take it very seriously.
Hopefully, they won't fall to political influence, and I think you pointed out that we've been surprised.
Guy Kawasaki:
What do you think of human challenge studies? Which just to be sure that I understand what a human challenge study is, that you give people a vaccine or placebo and you purposely infect them and see if it prevents it.
What do you think of that?
Dr. Jerome Kim:
I think they have a real use. I retired from the US Army in the vaccine development area, and the Army really has pioneered some of these, human challenge phase.
I mean, it's not well known but the current licensed, I guess approved, malaria vaccine actually came originally out of the Army. It's transferred to GSK, which is a huge company.
The initial set of experiments on that vaccine were done with volunteers. I mean, the proof that the vaccine was protective, so you would give the Army, sorry, they're often civilian, but in those days probably some active duty who volunteered.
You gave them the vaccine and then you gave them malaria. A malaria that you could cure with a drug. Once they developed fever and you could see the malaria parasites in their blood, you treated them. Under those circumstances, it's quite safe.
The Army's done challenges with things like dengue fever, which actually is occasionally in Hawaii and there have been challenge studies with cholera, which is a very severe diarrheal disease. We know that people lost twenty-three liters worth of fluid from their bodies, but again you can replace fluid and you treat them, so it's done under a very controlled experimental circumstance.
There's recently been a vaccine for typhoid that's been tested that way. We did a study. We showed that it made the correct protective responses. That was sufficient getting the approval, but people really wanted to know if the vaccine worked, and so some doctors at Oxford did a challenge study, and it protected. I mean, it really protected well, and now two years later, a formal study was done in Nepal, and it actually does what we predicted, so great. It has a capability to accelerate vaccine development.
The problems here are, for COVID in particular, you'd actually have to first determine how much virus to it. You'd have to take probably a COVID, a person who had been infected with COVID who had protective antibody and give them a dose and see that they didn't get reinfected.
Now we think they won't because remember, theoretically, infection protects you. Then you'd have to lower it or raise it to the point where you're comfortable with that dose, and then we have to go “all right, now we're going to test it in people who are naïve, people who've never had COVID.”
To do that, you probably have to lower the dose significantly, challenge them, if they don't get infected, begin to raise it. Step by step until you reach a dose that causes infection in enough people, but not so much that it's an overwhelming challenge because one of the things we fear is that it's the size of the challenge that may contribute to severity of disease, so we want to start low and work our way up.
You can imagine that takes time. In the US, that challenge stuff is also regarded as a medicine, so it has to go through the same levels of quality control that any medicine has to go through.
Of course, the FDA is watching and telling you that it's okay to go ahead with the challenge. In other countries, for instance in England, it's not considered a medicine. Actually, challenge studies are easier to do there than in the United States.
In some countries in the world like in Korea, it's not considered ethical to do that. Again, different countries have different approaches to this issue. Once you determine the right dose, then you start testing your vaccines.
You give a person a vaccine, then you have to wait usually a month or so after the final dose of the vaccine, and then you challenge. The question is you could get some very useful information, but right now we're anticipating having a vaccine maybe by the end of the year or knowing a vaccine works by the end of the year and/or early next year.
How much time would you save with a challenge model? I think that's one question. If the first set of vaccines fails, then yes definitely challenge model, you might want to have it, and why? What else does the challenge model tell you?
Well, it tells you if a vaccine works or not, but also because we have them under very very strict conditions. We can actually draw a fair amount of blood from the volunteers and find something we call the biomarker.
What's a biomarker? You give a person the vaccine, and then you measure the protective responses. You might measure the level of antibody that binds to and neutralizes virus, or you might measure the killer cells that are in the blood. Then when you look in the end and some people are protected and some people aren't, you can find this biomarker, say it's a level of antibody, a one to ten dilution or one to fifty dilution of antibody. Here's to protect people against infection.
That becomes something you can use instead of doing a trial in 30,000 people, now you can do a simple trial in several hundred people and look for just the biomarker because the biomarker is the marker that shows that a vaccine is protective, and so it shortcuts the system, allows you to more rapidly develop a vaccine, and then the first vaccine we rushed to get it.
You might want to optimize it. But if you have the biomarker, you don't have to do big, huge 10,000-person trial. Do a small quick trial, adjust the dose or the interval between doses, and the biomarker we call it the Correlate, a Correlate of Protection is the thing that we are looking for. The challenge studies really help you to define those biomarkers.
Guy Kawasaki:
In the examples you cited though, there was an important caveat in the cholera you put fluid back, malaria a mild form. If you purposely infect someone and the vaccine doesn't work, what do you do with coronavirus?
Dr. Jerome Kim:
Right. A great question.
Typically, you want to have backups. In the case of coronavirus, you take people who are young, so I would guess under thirty. They wouldn't have any risk factors, so no obesity, no underlying heart disease or other things.
We know that Remedesivir, this is a drug made by Gilead, decreases the duration of illness, so you'd have Remdesivir there as a backup.
There are some thought that these antibodies are collecting blood from people who had COVID infection, purifying out the protective proteins and potentially using that as a treatment. You'd have all these things that would be available.
The important thing is when you're doing a challenge study, I mean, the ethics and the science have to be really, really carefully done. The ethics means that when you are getting a volunteer, you have to tell them okay we are giving you an infection. You're very young, it should be fine. We don't think it will be ... You could get very sick though. You could need to be on a ventilator or be in a hospital.
We have a medicine called Remdesivir that at least in one trial seems to show an effect, and so you have to really carefully document all the things that you told people that you're going to do.
It's easier for disease that has a fatality rate for young people under 1 percent or actually in the case of COVID-19, initially when we're just still learning about it, there were almost no deaths in people under thirty, and even now, unless you develop a severe, one of the rare complications, you're, in general, going to be well, but you have to be very careful and you have to really carefully explain because people have to understand what they're getting into.
That's the ethical side. On the scientific side and medical side, you have to be absolutely sure that you could diagnose infection early and that you provide some sort of symptomatic relief and treatment, and it can't cause the volunteer any harm.
There are people, I mean, there are people who will volunteer for this.
Guy Kawasaki:
What's their motivation?
Dr. Jerome Kim:
It's usually altruistic.
They feel like “I'm sitting down at home watching Netflix all day. I want to do something that will potentially benefit all of mankind.” It's really an interesting set of things that motivate. Or they know someone who died, and they say “Well I've seen someone die. I really think this is something I should do.” It's complex.
There are actually people, I don't know if they're on the internet, but talked to newspapers and said “Yeah, if there were challenge study and this could advance vaccine development more quickly, I would do it.”
The question is, at least for now, it looks like the first set of vaccines we should get a readout of safety and efficacy by the end of the year. It'll take that long to get the challenge models up and running.
Guy Kawasaki:
Now I understand a challenge test.
How do you test a regular vaccine? You just give it to thousands of people and see if they get it, but they may have never been exposed?
Dr. Jerome Kim:
Yes. You definitely have to pick people who haven't been exposed.
I can give you an example. In the phase three of the HIV vaccine trial that the Army conducted in Thailand with the Prime Ministry of Public Health, 8,200 people got vaccine. 8,200 people got placebo. It was 16,402 people without HIV. You watch them over time. In the traditional trial, typically you watch them for months to years.
In our case, it was three and a half years of follow up, and we tally the number of infections in the vaccine group and in the placebo group, and in our case, there was 30 percent reduction in the number of infections in the vaccine group compared to the placebo group. That was a little disappointing.
At month twelve, we saw 60 percent and that amount, that protection, decreased over time so we thought ah maybe we need a booster.
You learn something during these tests that they're huge. This trial cost 100 million dollars. The COVID vaccine trials, they're thinking ... The number that people are throwing around now is 30,000 people per trial. We did 16,000 and it cost 100 million in Thailand. If you're doing a 30,000-person trial in the United States, you can just imagine how much that's going to cost.
If you're a drug company or a vaccine company, and you had to pay for this yourself, you're like okay I really want to make sure that what I take into phase three has a pretty high likelihood of success because I'm about to plunk down several hundred million dollars to prove it.
Sometimes we actually have to have a second phase three trial. That's a lot of money and the companies are going well let's go back and optimize this more.
Let's think about it. Let's make it better. Let's fiddle with it so that when we're going to phase three and we spend all that money, we're going to be guaranteed a success.
Right now because of the pressure, we're assuming success, right? Several people have said we can have 100 million doses of vaccine available in January.
To do that, they're going to have to start manufacturing before we know it works. There are a lot of things that we're doing now that we wouldn't normally do.
Why are companies willing to take the risk? Because somebody else is paying for it. Operation Warp Speed is giving companies a significant amount of funding in order to accelerate development and de-risk it for them.
I think at least one company has decided to go do it on its own with its own money, but many companies have accepted the several hundreds of millions of dollars from US government for commitments of millions and millions of dollars from CEPI, Coalition for Epidemic Preparedness Innovations, in order to make sure that they can accelerate the timelines and to ensure that they're not going to lose money on this.
Guy Kawasaki:
Does the United States have the capacity to make the vaccine without dependency on China and India?
Dr. Jerome Kim:
Yes. The US has actually invested in a lot of different kinds of the bio preparedness starting after nine-eleven. The ability of the US to handle a big flu epidemic, for instance, is probably second to none anywhere in the world, so the government has these mechanisms to put into place large scale manufacturing.
The companies also have a substantial capability to manufacture vaccines. You actually have vaccine manufacturing in the United States.
If unfortunately you are like Germany, most of the vaccine manufacturing company has left Germany for other parts of Europe, so how does the German government do it? Well, they participate in a global effort called CEPI. CEPI has contracts with a lot of different manufacturers and they'll depend on companies to fulfill obligations using different means, but for the US, you have this organization called BARDA, which is meant to help prepare the US for pandemic typically flu because that's the usual one, but in this case, COVID.
Guy Kawasaki:
What if the vaccine is created or discovered by a country or company that doesn't want to share the intellectual property?
What if China develops a vaccine and says, “We're taking care of China first?”
Dr. Jerome Kim:
I think everyone's concerned about that. I mean, everyone is. One of the things is that this organization of now thirteen or fourteen countries, the Gates Foundation and the Wellcome Trust, it's called CEPI, Coalition for Epidemic Preparedness Innovations, US is not a part of it.
CEPI was actually the first funder of a lot of these companies. Moderna, which is an mRNA company, Inovio, all of them were funded by CEPI. Even this vaccine made by Oxford University got initial funding from CEPI.
In the CEPI contract, it says that as a result of this, you commit to making the vaccines accessible and affordable. At least for the non-Chinese vaccines, because China's also not a part of this, there are commitments to CEPI for access.
If China had a vaccine, they could, in fact, hold it back. I think that the president of China, Xi Jinping, actually made a statement in the World Health Assembly that China considers a vaccine for COVID-19 to be a global good and would be willing to share the vaccine and make it available around the world.
Now, it's easy to say it on one hand. On the other hand, China doesn't have much disease right now.
Guy Kawasaki:
They won't have a market?
Dr. Jerome Kim:
For instance, for Chinese company now, say, there are several Chinese companies now in the second stage of testing. Some of them are huge.
One of the companies manufactures 70 percent of the vaccines used in China, a large number of vaccines. They're in phase two.
Can they test the vaccine in China? No. They'll have to form international collaborations in order to test the vaccine.
Again, just the nature of the epidemic will compel certain groups to work with others, which is important. I mean, this is a global pandemic. The solution is a global solution.
It's like this is a fire, and like all these seven-alarm fires, there are seven engines pumping, you really don't want one of them to leave. You really need cooperation, collaboration.
Like these big companies are talking around the world and talking to other manufacturers about potentially transferring technology to other manufacturers. I mean, some of these big companies and maybe I haven't been around long enough but ... are talking about no-profit vaccines.
Again, I think, now it'll be important to see what happens when the vaccine is actually there. On the other hand, I think right now, even in the biggest companies, there's really a commitment to this global health good.
Guy Kawasaki:
You have to say that the US has done a pathetic job, right?
Of the 220 countries in the world, we're number thirteen or something. I looked at the statistics and normalize for population, the US has about thirty times the infection rate that South Korea has.
Now, why is that?
Dr. Jerome Kim:
That is an appropriate question, and you know it's really hard to watch what's happening in the US from Korea.
Actually, I had the opportunity here, someone from Australia talked about what they did, and actually the Korean experience and the Australian experience are not that different because they're both been successful at controlling the outbreak initially.
The first is that there is top-down commanding control. Now, as a former military personnel, commanding control is very important, and the pandemic is like a war.
To have a single unified chain of command, Korea did that, so once you reach a certain pandemic level, the person in charge of the outbreak, of the response, the government response, becomes the Prime Minister, and that means that everything flows down from there. His deputy, his technical ... actually the person really running the campaign is the Director of the Korea CDC, Centers for Disease Control.
An expert really embedded in the structure that is designed to make sure that decisions are made with data. They're made on the basis of science and not emotion.
I mean, the things that were put into place, the changes that were made tweaked the process and make it better are all things that are decided and implemented through the country.
The US doesn't have that. The US has a state system.
Now, they could pull things together but that would require special legislation, special effort, special coordination, and it's been difficult because we don't have the structure.
Korea set this up because of previous experiences, so they have the Infectious Diseases Prevention and Control Act that puts all of these into place, and it's a lot. It was passed not during an epidemic but when we could reflect calmly on what the best practices are.
Australia did the same thing. They have a similar thing. They were able to pull ... Australia is federal. It's like the United States. Each of the states is separate. The heads of all those states join the cabinet, the national cabinet in order to create unity of governance, so that means messages are consistent, governance is consistent, the information that's flowing down is clear and unequivocal, and both countries practiced, so they did tabletop exercises like war games for pandemics. Korea had one right in December.
Two people went on a tourist, Korean tourist, went to China came back with pneumonia, unknown cause. They ran a tabletop exercise in December. What happens in January? Operate. Pneumonia from people who visited China. They'd already practiced the scenario.
The Australians had done exactly the same thing. Korea had the test kits available. Australia, when they found out about the outbreak, they looked at their stockpile and said “We have twenty million masks, we think ... Let's see, the estimate is a billion, how are we going to get a billion masks?” They found a single mask manufacturer in Australia.
The Army and the Ministry of Industry built it up so it could make enough masks for Australia. I mean, control with this.
Guy Kawasaki:
We do have a Commander in Chief, are you saying the US' problem is a systemic problem or a leadership problem?
Dr. Jerome Kim:
Again, you have a federal government with responsibility and you have state governments. Right now, there isn't an ability for the federal government. The US can nationalize the national card, can federalize the national card. There is no ability to pull all this state Departments of Health into one group that thinks and … the data that is reported to US Center for Disease Control differs from state to state.
The CDC compiles data, but the data may not be the same. You get apples from California and oranges from Georgia. It's difficult. Data is important.
Then there is the question of leadership. You're seeing leadership at the state level, and the federal government has taken its role in a particular way. It has more authority. It could exercise authority, and you've seen it.
Operation Warp Speed. They pulled all these federal agencies together, put a pharmaceutical executive and an Army general together and said you need to get these vaccines. Now they've picked five companies. They've given them two-point-two billion dollars.
I mean, the federal government has tremendous capacity to organize, and the thing is that they need to take control. With the abilities that they have, now they don't have the authority that the Korean government has during a pandemic, during actually any natural disaster.
These response things are set in place. There is an equivalent law in the United States that allows them to do that.
Guy Kawasaki:
Then maybe you can explain this mystery to me.
My impression of Singapore is that it is as organized and yet they are very high on the list of normalized infection rates.
How come somebody, Lee Kuan Yew's great grandson, didn't say this is the way? What happened in Singapore?
Dr. Jerome Kim:
This is the problem with special populations.
Singapore has a large number of migrant workers. This population is not like the regular Singaporean population.
The ability of the government to track and control it is less than is the case outside of the tenements where these migrants live. They're critical to the economy, yet they're a weak spot.
As you would expect, as has happened in multiple countries, the COVID-19 virus has targeted the weak or found a weak spot and exploited it.
In Korea, the outbreaks were in churches. Actually they continue now to be in churches. It's a very religious society, and people get together.
It's difficult to control social separation. A month ago, churches really weren't gathering. I mean, our church is still online, but other churches are gathering, and as you would expect, there's been transmission.
You open up the bars and tell people okay it's fine, and all of a sudden you've got hundreds of twenty to thirty year olds milling around in a club. You'll have transmission, one case to 300 cases.
Guy Kawasaki:
I can probably guess your answer to this, but the US is now getting about 20,000 new cases per day and a thousand deaths per day. If you look at those statistics, would you say now is the time to open up again?
Dr. Jerome Kim:
I think the important thing to think about is Korea never had to close. It was never a lockdown.
We could go to the supermarket. Actually, we never ran out of toilet paper.
It's amazing. I mean, through all this time, we wore masks, the supermarket were less crowded, the restaurants were less crowded because most people did take out and ate at home.
A shutdown like the one in California or most of the US has devastating consequences. The purpose of the shutdown, the flattening of the curve was really temporizing.
It was only to gain you enough time to put into place the kinds of things you needed. The testing, the tracing, the strengthening the hospital system, getting more protective equipment, masks and gloves and face shields for people. It was only meant to be a temporary measure.
At some point, no country can exist on lockdown, so you had to let it go.
Ideally, you would've put into place all those things that would allow you to control the infection at a lower level, and to some extent, some states have been successful at it.
I think everyone's concern two weeks from the Labor Day weekend that we're going to start seeing the numbers trend upwards again.
20,000 infections means there's still a lot of infection out there. I don't think the case fatality rate, the mortality rate is above ten. I think it's probably closer to 2 to 3 percent, which means that in the United States, there are millions of people who've been infected, and they have no idea who they are, and they're spreading infection.
Guy Kawasaki:
It doesn't sound like you think we should be opening up yet.
Dr. Jerome Kim:
Again, you have to understand the outbreak.
You need to be ready to pounce on major outbreaks, so you have to protect the people in nursing homes, you should protect healthcare providers, and keep the messaging around, masks, distancing have to continue. When you open up the schools, it's going to entail particular risk. You have to anticipate them, and you have to put into place a system that will make sure that if we start to see things, we'll be able to act really quickly.
People need to be reminded because in Korea, they'd forgotten. It was difficult. I mean, there were days when we went to a mall beginning of April, a really big mall. It was the first time we could find parking in the first level parking.
I mean, that's the extent to which people were really following. You only went shopping for things that you absolutely that you needed, and only when you needed it ... People weren't going to coffee shops.
Basically in Korea, there's two or three coffee shops per block. It was really you got your coffee and you took it outside and you finished it somewhere else. Now, you see people in restaurants and in shopping malls.
Guy Kawasaki:
Would you catch a commercial flight in America today?
Dr. Jerome Kim:
Would I? If I had to, if it was essential.
How is my daughter going to get to college? I don't know. We haven't come to that decision yet, but if I had to, I would.
It's actually difficult for us, for instance. I mean, we work in a lot of countries in Africa and now in South America and South Asia, some things we can do by video conferencing.
Some things like if you're setting up a new site to do a COVID vaccine trial, I mean, you want to actually see what's there, what people can do, and where they are. There are a lot of things that have to be done in person, so we're thinking about how we're going to protect the staff from IVI who have to travel to these sites, how we're going to get them in and around quarantines because we can't send a person, they're quarantined for two weeks before they get there, then they come back to Korea and they're quarantined for two weeks.
How do we do that? I mean, I would travel if I have to, but for a vacation? No.
Guy Kawasaki:
Let's pretend that Donald Trump calls you up and says “We need help. I'm going to make you the Coronavirus Czar of the United States. You're in charge.” You're the commanding control. You're at the top of the thing.
What would you do?
Dr. Jerome Kim:
Interesting question. Again, just thinking I would divide the country into regions and appoint regional committees of states because it's not only a New York problem, it's a New York, Connecticut, New Jersey problem including Pennsylvania.
We would come up with a set of rules that were based on best practices. Actually, the CDC did come up with some recommendations that were subsequently modified, so I don't think I've seen the original recommendations.
I would put into place a much more effective tracing. I would strongly encourage the use of these handshake-tracking apps, which aren't exactly what the Korean government has done.
I think I would push Congress a bit to challenge them on the question of privacy versus the ability to know where the infection is.
I mean, I understand the need for privacy, and I, on the other hand, understand that we have to control this pandemic and we have to prevent our grandparents and elderly neighbors from contracting an infection that has a 50 percent mortality.
I understand the impact on privacy, and I think that we, as a nation, are going to have a recent discussion on what these pandemics do, and what the government can and should be able to do in the context of a pandemic.
For instance, you all have been on lockdown, which I think is a real restriction on your freedoms. I mean, you can't go out of the house.
I mean, in Italy where my wife is from, the police will stop you and ask for your papers, your permission to be outside. That's a real restriction on your freedoms.
In exchange for that, in Korea there was no lockdown, the Korean government, which again maybe one of the extremes in a democracy, has the ability during this kind of pandemic to track your GPS signal for your cellphone. When they found that single case in Itaewon, they immediately knew who had activated their cellphone between midnight and 3am in the morning on the following dates.
They used that cellphone information to send texts to people to say you could've been exposed, why don't you come in and be tested? When only 2,500 people responded, they said fine, we'll make it anonymous. Just send us your number, come in and get your test, and we'll send you your test result, but if you're positive, you need to be under quarantine.
We'll put you under observation actually in a government hospital. If you're exposed, then you should self-quarantine.
They use this information, now anonymous testing, to really try to contact all of the original 10,000 and then later a much larger population of people who were exposed. That's a discussion that Congress has to have and that the states have to have.
It's really tough to do it in an outbreak, but I think that's something that we need to start thinking about. More practically, these tracking teams have to be trained.
We have significant unemployment. Let's start utilizing people, training them to do the kinds of things that are necessary in order to try to really contribute. And you can use these tracing teams for other things.
They can educate. They can provide some relief. Do we need teams of people who understand how to control infection, who can go and visit the houses of people who are elderly and really help them get the things that they need?
I mean, there are lots of things that you can do that will keep people busy, that will engage everyone in the fight.
Again, one of the things that Korea did and in Australia, I mean everyone was a part of this, so your contribution was important to help control this and defeat it.
I don't get that feeling. It's difficult because I'm watching the US from far. This was an opportunity to unite us in something, unite us against a common threat.
You saw George W. Bush do it after 9-11. It was reasoned, it was careful, we're going to get out of this, but it also heightened, made very clear what the threat was, so again, I think that coronavirus task force, the daily briefings stopped.
I mean, people really respect Tony Fauci and Debbie Birx, and they got a lot of useful information from them. It informed the way people were thinking, and that's important.
We went back and forth on ... “So if we had a vaccine, would Americans use it”, and there's one study that said only 50 percent would and another said that 70 percent would.
There has to be really much more consistent messaging around this is the threat. “This is how we are going to get around the threat, these are the things that we're looking at, drugs, vaccines.”
If you look at the countries that did well, somebody pointed out that a lot of them have female leaders. Korea doesn't. What they did was the people in charge stepped back and let the public health folks do what they do best.
The same way in a war. The president doesn't direct a war. I mean, he's the Commander in Chief, but the generals do the planning and the execution and the training and the logistics. That's what they know how to do.
Again, I would try to, if you're going to make me king of COVID for a day, I would try to put into place things that respecting the fact that the United States have fifty states, and that we don't have a system for making them all work together.
At least, make them consistent. Make sure that the reporting is consistent. Make sure that states all equally recognize the necessity to understand how big the pandemic is.
Guy Kawasaki:
What happens if only 50 percent of the people take the vaccine or seventy? What are the ramifications of something like that?
Dr. Jerome Kim:
I mean, we talked a lot about social distancing, right, those stay two meters apart. What a vaccine does is it creates immunological distance.
Once you get to around between 60 and 70 percent of the people being vaccinated, you have herd protection, herd immunity, which is like what you see if 60 to 70 percent of people of the United States were to come down with COVID at one point, enough people would be protected so that the individual cases would no longer propagate.
An individual person could be infected, but they wouldn't spread it to others efficiently. A vaccine does that. It creates, by having 70 percent of people vaccinated, individual cases which will continue to occur, won't spread, and I think that's ideal.
Guy Kawasaki:
But trying to achieve herd immunity without a vaccine, isn't that like saying oh well, 30 percent of you are going to get it and 2 percent of those people are going to die, but that's the breaks because we want herd immunity? Essentially, is that what you're saying?
Dr. Jerome Kim:
Right. Herd immunity, basically now I think people call it the Swedish experiment. It's just social distancing without any lockdown, without actually no ... I think the person in charge said “Yeah, it's not going to success. We were unable to protect the elderly.” They conducted that. They took that path and their mortality, again, adjusted for the size of the population, is much higher than even the United States.
Guy Kawasaki:
I've taken up a lot of your time.
I have two more questions for you, okay? Question number one is who was your favorite Iolani teacher?
Dr. Jerome Kim:
That's a hard one.
Guy Kawasaki:
We had the same teachers.
Dr. Jerome Kim:
We probably did. I had some teachers that I took multiple classes from. Captain Slate, Mr. Keables. I took three classes from Mr. Keables actually. Although I only had him for one year, Mr. Braden, Math teacher.
A lot of them influenced me. I majored in Biology and History. Maybe see Mr. K and Captain Slate there. A lot of what I do is writing. I mean, you can't be assigned just to not write. For that, Mr. Keables.
Guy Kawasaki:
Harold Keables. As I look back of the arc on the arc of my life, Harold Keables was the singlest biggest influence I think that.
Well, I mean Steve Jobs influenced me too, but Harold Keables taught me how to write essentially and taught me how to think, and I hate it. That class was so hard.
Dr. Jerome Kim:
Mr. Keables was quite a remarkable teacher.
I did Creative Writing, Advanced Creative Writing, and AP English with him. I learned a lot, and it was tough.
I can still correct people's grammar.
Guy Kawasaki:
Between two independent clauses, a comma, and all that. No passive voice.
Okay. My very last question is we all heard the recommendations that just in case, you talked about everybody can do something, so what should everybody do?
I mean, we're not all scientists or doctors, but just the random person listening to this. Okay, this is my contribution. What would that contribution be?
Dr. Jerome Kim:
The most important thing is not only to protect yourself but to protect others.
I think sometimes we forget. We think that the masks are protecting us against infection. Actually, the masks are protecting other people.
The US government in recommending that everyone wears masks is actually saying we can't tell who's infected. You may be infected and not know it, and rather than let your grandma or grandpa, or your elderly friends, or your neighbors get infected, in protecting yourself with this mask, you're also, very importantly, protecting others.
All the other things during the loosening of restrictions still apply. If you have to be in a close setting indoors, wear a mask. Wash your hands frequently. If you're coughing or have a fever, get checked. Stay home.
You have to remember that this is not over especially in the United States.
There are 20,000 infections as you said a day. It could be your neighbor, it could be the person passing you on the street, the person standing in line with you. So social distancing and use of the masks and hand washing is going to be important.
We really need to remember that. I mean, this is our part. I, as an infectious disease doctor, masks have a particular purpose, and so I'm wearing a mask now outside.
Part of it is I think people in Korea feel uncomfortable when you're not wearing a mask, and they'll tell you. They'll point to you and point to their mask. Actually, someone gave me a mask once and I didn't say no I don't believe it works, but it does in fact there is data that would suggest that if you have infection, that it does prevent transmission.
There's less data that would support in the general population that the mask actually protects you against infection, but there are some data that say it does. Again, the masks reminds us that we're still in it, that it's still around, and that we still we all have to participate in helping to control it so we can carry on at least with a bit of what we used to do before.
Guy Kawasaki:
Well, I hope we can get to a place in America where, as you say, if you're not wearing a mask, it's socially unacceptable because we are not there at all yet, not even close.
I'm in Santa Cruz right now, and if you were to walk down at the beachfront, I'd say 5 percent of the people have a mask.
Dr. Jerome Kim:
Yeah. I mean, when I go running in the morning, I can't run with a mask on.
I'd say about 20 percent of the people who are walking, so I'm running on a path, are wearing masks, but when you start to look, for instance, in the subway here, everyone has a mask on.
In the closed setting, people wear masks. Depending on the workplace, we went to Seoul National University Hospital where we agreed to start the trial of the vaccine against COVID, we wore masks during the meeting, and actually the picture of us we're all wearing masks because standing with a sign in the background.
I mean, they take it seriously here, but it reminds you. It's a constant reminder that it's not over.
Guy Kawasaki:
Meanwhile, our vice president goes to the Mayo Clinic and doesn't wear a mask. I mean, I don't get that at all.
Dr. Jerome Kim:
Yeah. There's a bit of leadership by example. I understand if a politician's at the podium. They make a sign.
They take off the mask and speak because it does, it's difficult to understand people sometimes when they're talking behind the mask on the one hand. On the other hand, when they're out interacting with people, masks are important, and it's an important thing.
Again, this consistent messaging is very important. If the government is saying that you need to do something, this is a thing by inclusion and by example, not by exception.
Guy Kawasaki:
Well, thank you very much. I will sleep better tonight knowing that you and IVI are working on this, and I now know more about vaccines than I ever thought I would.
I hope to meet you face-to-face someday when it's safe in Korea or Hawaii or California.
Dr. Jerome Kim:
Thank you, Guy. It was great to talk to you and reminisce.
Guy Kawasaki:
Thank you. All right. Iolani No Ka 'Oi.
Dr. Jerome Kim:
Iolani No Ka 'Oi.
Guy Kawasaki:
Review time.
“Social influencers get a lot of attention nowadays. Their job is just that, to get attention, not necessarily make a mark on the universe by doing something. Hey, it's a living for them, I guess. Good for them. Guy connects me in these conversations with people who are truly remarkable. These people have made a mark. They have taken action, done some good, made stuff, and/or changed minds. These are exemplars I want to be more familiar with. I'm grateful Guy is having these conversations and bringing attention to the real social influencers.”
Thank you, Chad. That made my day.
I feel better with people like Dr. Kim being involved in the development of a coronavirus vaccine. As you heard, the creation of a vaccine is a complex and difficult process, and the medical industry is doing things very differently this time around.
Let's hope that Dr. Kim and his colleagues around the world are successful in the near future. I, for one, would probably not fly commercially until there is a vaccine.
By the way, at the very end of the podcast, you heard both of us say Iolani No Ka 'Oi. That's Hawaiian for Iolani is the best.
I'm Guy Kawasaki, and this is Remarkable People.
My thanks to Jeff Sieh and Peg Fitzpatrick for their remarkable work to make this podcast as good as it is.
Until next time, wash your hands, maintain a social distance of two meters or six feet. If someone coughs or sneezes near you, hold your breath and get away.
Take care and Mahalo.
This is Remarkable People.