You’re listening to a press conference from the Harvard T.H. Chan School of Public Health with Barry Bloom, the Joan L. and Julius H. Jacobson Research Professor of Public Health and former dean of the School. This call was recorded at 11:30 a.m. Eastern Time on Monday, September 14th.
MODERATOR: Dr. Bloom, do you have any opening remarks?
BARRY BLOOM: Only to say that the simplest thing about vaccines is the following kind of aphorism, that the most important ingredient in all vaccines is trust. And the last two to three weeks of having vaccines in every program and in every news broadcast and every press report makes that issue really complicated, because as my colleague Walter Orenstein at Emory said, vaccines don’t save lives, vaccination does. And if people don’t take them, this will be a futile effort. So, with that, I’m happy to answer questions.
MODERATOR: Thank you, Dr. Bloom. First question.
Q: Thank you. Can you hear me?
MODERATOR: Yes.
Q: This is sort of a behind the scenes question for Dr. Bloom. Can the NIH Data and Safety Monitoring Board stop a medical study in the middle of a trial with the vaccine. What’s involved in that? Particularly if you’re looking towards a vaccine by November, couldn’t they make a decision based on preliminary data and then continue to study. Explain a little bit how that works.
BARRY BLOOM: A really important question, and one of the more obscure but essential parts of all clinical trials are data safety and monitoring boards. They are, in principle, independent of everything. They are often set up by the companies, but they are the only ones who have access on an ongoing basis to the results generally in phase three trials of two things.
Often they work on vaccines on a weekly basis. So as you start to roll out thirty thousand people, the principle concern in any vaccine trial is safety. And they look for any reportable adverse effects. And particularly, what is a red flag is anybody who needs hospitalization. And that’s general for almost all trials. They are usually experts in vaccine, some are former pharmaceutical people, some academics, some former regulators, and they look at the data and you hear very little or anything from them unless one of two things actually happens.
One is there is an adverse effect. And they report that to the funders or sponsors, in this case the companies, with a recommendation. And in this case for AstraZeneca, there were two concerns about neurologic problems. And so they stopped the trial or put a pause is a more appropriate way to describe it.
And it’s my understanding that in large phase three, any kind of trial you’re talking about, thirty thousand people, somebody is going to get a heart attack. Somebody is going to get a stroke. Somebody is going to develop a rash. Somebody is going to develop fevers. And their job is to try to sort out, is it possible that that potential adverse effect is related or totally unrelated to the vaccine? And in the first case, for AstraZeneca, which is described not by the company, but by the newspapers as transverse myelitis, which is as a potentially serious condition, which was known to have been associated with other viral infections. There are three reported cases of COVID-19 infections, disease, that showed those symptoms. So they reacted appropriately. They made the recommendation to pause the trial and the company responded.
And rather than instilling doubt, my take on it is the system is working absolutely as it should, where any adverse effect is picked up, concerns or recommendation is made to try to look at all the data they can to see if there are any more cases that might look like this and make a decision whether it’s likely to be related or unrelated to the vaccine and then make a recommendation that it be contained. I think that’s a very good thing.
The second way that they can stop a trial is if the data are absolutely overwhelming. But the effect of the intervention, be it a drug or a vaccine, is so great and statistically likely to be so powerful that you are putting the placebo group at risk, whether it’s for cancer or cardiovascular disease or COVID disease, they have the ability to recommend that the Phase three trial stop because the data are good enough to draw the inference that the vaccine is safe and effective. It’s not a common event in vaccines, as far as I know. It is sometimes more common with drug treatments where a drug for a condition for which there are no drugs shows a spectacular result, there’s no reason to put the people in the control group at further risk. And then they would recommend that it stop. So thus far, despite all of the concerns about problems in any trial and there are problems, as I understand it, in almost every trial involving thirty thousand people, I think the system has worked as it should be thus far. Is that answer your question?
Q: Yeah. Thank you. Absolutely. Thank you so much. Let me ask a quick follow up question, if I could. Is it possible for the president or anyone else to reach into this data and say that we have strong preliminary data that this works; we’ll make something available in early November? So can he do that? Does he have the authority to do that?
BARRY BLOOM: Does he have the authority?
Q: Yeah. And would that data be transparent?
BARRY BLOOM: So the issue of transparency is is a very important one. Again, my understanding, and I’m not an expert on clinical trials of vaccines, is the work of the Data Safety and Monitoring Board, to start up there, as the only group that has ongoing access to trial data, is generally kept absolutely confidential from everyone, including the people in the companies. And the concern there, among other things, is if the results are either good or bad, the worry is people in the companies will have insider information and start to sell stocks or buy stocks. And that would be very unfair and it would be quite illegal in normal circumstances. So these are really confidential proceedings, as far as I know, in the middle of trials until they make a recommendation and then they don’t speak. Usually the companies or the sponsors speak.
So the question is, can the White House intervene to change those results? And this is going to be a little bit long-winded, but the process, as I understand it, is a lot more complicated than I think we generally appreciate. One level is the Data Safety and Monitoring Board that has all the data that you can get from the multiple centers that are putting in weekly data on how many people are vaccinated, what this short term fevers, sore arms, adverse effects might be, etc.. They make their decisions and whatever.
Let’s say the trial comes to the point where it looks like it’s 75 percent effective but the statistical power is not yet there to get a definitive number of endpoints. Which brings me to two questions. One is the transparency question that I will try to answer. But the other is to reiterate, we’ve talked before about trials are not based on a time frame. There is no target date for an outcome. In the planning of a trial, protocols are written in which the outcome is to learn a statistically significant result that would tell you that the vaccine works or doesn’t work greater than 90 or 95 percent chance, that it couldn’t be by chance alone. And we often take 90 percent as the cutoff point. And so you make a calculation of how many people you need in the trial. Don’t forget, you don’t know who has the vaccine and who is in the placebo. So you’ll have an elaborate statistical framework to say how many cases do we have to have where if we look at the results at that point, it is likely we will be having a degree of certainty of about 90 percent or 95 percent to know that it either works or doesn’t work.
That depends not on the design of the trial so much in terms of time, but how many people in the trial get sick because the outcome of the trial, the goal of the trial is, in this case, does the vaccine prevent disease or infection? And until you get the number of end points that gives you statistical power, you can’t make a decision as to whether to continue or not. And you can’t make the decision or recommendation that the vaccine is working or not working.
So that’s why the time is not inbuilt in the trial. The time is determined by the number of cases to get statistical power. Once that is achieved and they have already defined the number of cases, I don’t know precisely whether each trial has the same number, but it’s about 150 or 160 cases if you have thirty thousand people in 60 or 70 different centers, each with a different rate of infection and disease. So these are big guesses of how much it’s going to take to be able to make a rational decision. Let’s assume then all of that works. They have the data, it’s statistically sound, and that occurs actually before November 3rd. What happens with those data? And the data are then given by the Data Safety and Monitoring Board to the companies and the companies then can decide whether they want to wait for more patients, higher statistical probability. Maybe more patients means better effect. So there’s no obligation to request biological licensing, the approval from the FDA that allows a company to sells vaccine. That’s the goal of the company, is to get biological licensure to be able to sell the vaccine. In order to do that, they have to fill out an elaborate application with all the details, every single adverse effect seem trivial or otherwise, and all the data, including the statistical data to the FDA. The FDA then has an independent committee that looks at it, which consists of scientists that report to the FDA, and that’s an independent vaccine monitoring committee. And internally, the FDA has their elaborate statistical people who in principle should recalculate and check at least all of the data provided in the application to decide whether the data are solid enough, statistical enough, and the results are safe enough to be able to allow that vaccine to be distributed or drove on a wide basis. That process of the reanalysis of data is, my understanding, usually takes quite a while. If the results turn out at the FDA that are presented to them early and the data are overwhelmingly indicating that the drug or vaccine, vaccine in this case, is seventy five percent, let’s us say effective with virtually no or no adverse effects that are serious that can be related to the vaccine, the FDA has the prerogative to issue these emergency authority releases.
And that is not uncommon when the data are solid and in any case, drugs or vaccines, but there is a need for the FDA to review those data, taking lots of time to do the statistics, look at any of the adverse effects. And so the emergency use can be issued for a perfectly safe vaccine when the results are clear before the biological licensing authority is approved and the vaccines can be safe. That can be quite routine.
What isn’t routine is an emergency approval without the statistically valid proof that the vaccine or drug is safe or effective. And the problems that are being discussed now derive from, I believe, two quite serious failures of the FDA. One was hydroxychloroquine, where there was essentially no credible data that would say this drug was going to do anything useful. And with pressure that is clear from the White House, the FDA director, the administrator of the FDA has the power to make that recommendation. And they made a recommendation to give an emergency use authorization to hydroxychloroquine when I don’t know anybody in the medical community who thought there was any chance that was going to do anything. And that politicized a process that should never have been politicized, with press conferences and White House and all of that, advocating for a drug for which there was not a shred of scientific evidence about whether it did or did not work.
One would have hoped after the criticisms of that and then the later randomized control trial data, all of which indicates that it hasn’t been useful, you would have hoped that they would have been more cautious. And when it came now to the use of convalescent serum or plasma as the next possibility to prevent people from getting very sick, they’d have covered in our hospitalize. Again, there are no randomized controlled data that were available at the time they made their recommendation. The director of the NIH and Tony Fauci, director of the National Institute of Allergy and Infectious Diseases, opposed that decision. And the FDA director bowed to the wishes of the White House and gave that an emergency use authorization. And that’s problematic because with that, that’s been given to a hundred or more thousand patients, none of it in a randomized controlled fashion. So, whether it works or not, we can’t know because you give something to someone, they either live or die but you have no way to know whether that’s at all related, whether you gave them plasm or not. And what the scientists were begging for is wait till the data randomized controlled trials are in. Some of those data are now coming in. It’s my understanding there is no evidence that it is preventing progression to serious disease or death. There will be more data coming out in coming weeks but again, there was no scientific basis for the FDA to make that emergency use authorization.
We hope that in the case of vaccines, which has an enormous amount at stake. Millions of lives around the world are at stake on this one. And the credibility of the vaccine enterprise is at stake. If this vaccine doesn’t work or has terrible adverse effects and it’s been cleared without the data being used, I think there’ll be huge skepticism even beyond what currently exists for every childhood vaccine, and it would be catastrophic, it would seem to me, for the health of adults and children in the world. So the stake is far greater than whether these first two vaccines work or are perfect. It’s to go back to my comment. The critical ingredient in all vaccines is trust. If people don’t trust it to take and we’re never going to be able to get rid of this epidemic. And if kids don’t take the 14 childhood vaccines because they don’t trust the system, we’re going to have a lot more measles and many other completely vaccine-preventable infections. So a long-winded answer. There are multiple steps, each of which is carried out. While it is technically possible for an emergency use to be issued before November, it will not be possible for half all the analysis done that would be required for licensure and sale. That’s for sure.
Q: Thank you. Enormously helpful. Thank you so much.
MODERATOR: Next question.
Q: Very nice to get a chance to chat again. I wonder if we could explore this issue of trust a little further. I saw your New England Journal piece last week, and I was intrigued by the difference in the long view that that peace took on vaccines and trust vs. the really tight focus we seem to have right now on getting a workable vaccine. And I wonder if you could talk a little bit about the importance of trust and the difficulty of the lift of going from the 50 percent of Americans who say they will take a vaccine to the 60 to 70 percent required in order to get herd immunity for life to go back to normal.
BARRY BLOOM: There are two parts to that question, and I’ll save the life back to normal for another time or another question. Let me put the most positive spin on it that my colleagues, Glenn Novak and my former student in my life as a teacher in Albert Einstein Medical School in New York, Walter Orenstein, who helped them on that article. The issue is how do we foster that vital issue of trust. And the simplest answer is that people in the best case have to be informed. And the question is, what is the appropriate information? Does everybody in the world have to know what the dialog was in the Data Safety and Monitoring Board? Do they have to know what the deliberations were in the statistical division of the CDC? Is that useful and helpful information?
What do people need really to do to have a sense of trust? And that was part of what we were trying to deal with. What kind of information? Who’s got it? And how is it provided that people in a way that is credible? I don’t think I know of having had that question asked before. I may be wrong. There are antivaxers and skeptics from the original smallpox vaccinations. I think the first anti-vaccine groups were in the 1880s and huge protests before World War I on smallpox vaccine. But the issue there was not safety or effectiveness.
The issue of much of that is the libertarian view that the government shouldn’t be telling you what to do and making healthy people take anything that might put them at risk, even though that risk may be very much less than the risk of an infectious disease. So we don’t start with a tabula rasa. There are impressions and feelings already out there on vaccine. The priority, and one of the pieces I like in our article that has turned out to be of some interest unexpected, is that the National Academy of Sciences has a group that has been commissioned to make recommendations when vaccines first become available. Who gets them first? How do we set priorities? And from a public health perspective, there are two frameworks to think about the answers to that which we outlined. And one is people at greatest risk, people that have the greatest chance of dying or being seriously ill, and people that are essential for society to function. And that would be one set of priorities like the emergency health care workers, hospital workers, essential workers, and whatever. But the most vulnerable are people probably in nursing homes and prisons that would go along with that. And that is the recommendation of the Academy is to prevent disease and death.
The public health perception would be that the key to ending a pandemic or epidemic is interrupting transmission. Even if you protect everyone in nursing homes, they’re not major transmitters of infection. My guess is hospital workers in the data are more unlikely that a hospital worker will be infected by a household contact than they will in the conditions of PPE and careful preparation within hospitals. The Academy report is very clear, the object is to prevent death and disease to the best extent possible. That risks the long term possibility that if you don’t provide protection to those most likely to transmit, maybe not in the first phase, maybe not even in the second phase, but until those people that are likely to be transmitting are immune and infected or their contacts are no longer infected, you will have a continuation of the epidemic. And then you’re trading off short term gains for long term gains. And it’s a hard tradeoff.
And I think the Academy did an extremely thoughtful and ethical job. But I think we should be aware of that tradeoff. And that is part of why Operation Warp Speed has pressed so hard to get vaccines out quickly. Not for political reasons, but you won’t stop the epidemic until a huge number of people in this country and probably every other country are immunized to protect against the vaccine. In China, they have virtually no cases. They have to protect against the vaccine being re-entered through travelers, as it has in many other countries. So the long term goal is to have it in such a way that people actually want to take the vaccine to protect themselves. And that requires, in general, providing the basic information – it’s safe, this is what we found and this is how many people we tested and that it’s effective, this is what we found. And further, we have post-licensure surveillance. We will follow all the people in the trial for two years because there may be long term adverse effects that you don’t pick up in three months. So you can be assured, even if it looks great today, we will keep an eye on it for the next two years. And that’s absolutely essential. These have vowed to do that. But the details of that, protocols for that and reporting the adverse effects after the trials are approved or the vaccines are approved remains to be clarified. And that’s public information that I think would add to the perception of safety.
And then what makes this different, which I think is part of the point of your question, Al, is in the old days, the FDA would say it’s safe and effective. The physicians and the public health people would say, great, just get me as many vaccines as you can in the appropriate time and we will encourage our patients to take the vaccine. Because of the hydrocortisone and the plasma and the politicization at the present time, there is a real concern that this set of vaccines could be a powerful tool to save lives all over the world. But vaccines don’t save lives. Vaccination does. And we will require a very different kind of effort than just having the FDA approve it. In a world with social media, anti vaccines, disinformation, misinformation either from the public or foreign governments, this is a totally different circumstance than we’ve ever had before. And in that context, I have to say that my own view has been that the government has never been particularly effective at public information and messaging to motivate people to do anything. One has only to look at erectile dysfunction advertising on television and things for psoriasis that you’ve never heard coming out of the government to say if you want to persuade people to do something, you don’t go to learn how to do that from the government. That’s where the private sector is really enormously important.
And the one example where I think the United States has done a phenomenal job at getting vast numbers of people lined up and keen to take vaccines was in the 40s and March of Dimes in the early 50s, the March of Dimes, which was a foundation spun off from the foundation of the Infantile Paralysis Foundation. Circumstances were different. Kids were being paralyzed at a frightening rate. Adults were being paralyzed and dying. We had a president with polio who was an extraordinary proselytizer for the need and value of vaccines. And the Salk vaccine was completely paid for by the March of Dimes, not by the NIH. Sabin vaccine was largely contributed to by the NIH. And by the way, because so many kids in the US had the Salk vaccine, you couldn’t really test the Sabin vaccine effectively. And it was the Russians, who had vaccinated 10 million kids, that enabled us to know that the Sabin vaccine was safe and effective in one of the largest vaccine trials, probably the largest ever done. So I think we need something like the private sector to step up with all the skills and tools to provide accurate information in a way that people can trust.
Q: Just a short follow up. That was a very thorough answer. But do you see an organization on the horizon that might be able to step up and do this?
BARRY BLOOM: I do, but I don’t think it would be helpful to shame them by saying that they choose not to do it. There are lots that could do it. And as you know, there is something in the public good called the Ad Council, which does make very effective ads in public interest stuff, better than I think the government knows how to do. But I think there are many other players that know how to provide information to people in an appealing and motivating way.
And we’re dealing here with, you know, as my colleague, Mark Lipsitch, in one of these prior sessions and in the forums has indicated, this is a highly localized, hyper localized epidemic. Yes, you do it by country and you score it up by state. But if you just look at data now coming out of New York, there 20 percent differences across the boroughs of Manhattan – sorry, New York City – between Manhattan and Brooklyn and Queens of the number of people using the antibody tests that have already been infected with the coronavirus.
So that means you have to target your, we could call it advocacy, very specifically to groups in very different ways. The religious communities, the African-American and Latin X communities, will take messages in a very different way of trust than they might from hearing it from the local public health officials. So that’s what’s going to take to overcome. I think, many of the doubts one has about the process, which thus far I think has been working at the scientific level as it’s been designed to do.
Q: Thank you.
MODERATOR: Next question.
Q: Hi. Thanks for doing the call. You might’ve mentioned this earlier, I tuned in a little bit late. But I just had a general question about endemic. What are the prospects for a fall or winter resurgence of the virus? What might drive that spike? And do you think our elected leaders need to do a better job kind of steeling the public for that possibility? There’s been talk about turning the corner as cases go down. Just what are you looking at as the temperatures go down? Thanks.
BARRY BLOOM: Really important question, and it’s one of the questions that one has to simply say, we really don’t know. The expectation is perfectly reasonable. And I think at least our epidemiological people are anticipating that there will be a flare in cases in the fall as temperatures go down, as people can’t dine outside and as people spend more times in rooms indoors. And that will be contemporaneous with flu season. And if one looks at the flu, as it has occurred in the southern hemisphere, in Australia and New Zealand, with a little luck, this flu turned out not to be as bad as many past flus in terms of how virulent it was and how transmittable it was. So we will certainly have a flu season.
And then the question about the long-term expectation for COVID, in a world where everybody isn’t vaccinated is that it will continue to circulate. And that comes in two speeds. In the worst case, there will be flare-ups, as there is now, for example, in Israel, where they’re going to have to shut down and lock things down again, even in time for Jewish holidays, which I can imagine, is not going to be politically palatable. But the only way to deal with it when the numbers start to rise dramatically is to remember the increases are not what you see. What you see today is four weeks behind, the number of people who are going to be dead at one hundred-fold less than they will four weeks hence.
So having the public anticipate what exponential growth means from one hundred cases to sixty five thousand cases in six weeks. When the president said we only have five cases and we knew that was off by a hundred-fold, but those five cases when you played that out four weeks later was going to be a very large number. That’s not intuitive for anyone other than people who deal with public health and statistics. So getting an intuition of what’s going to happen without seeing dreadful things happen is what makes this epidemic so challenging. So in this case, the worst cases, we will have flare-ups. They’ll be dealt with. There’ll be lockdowns. They’ll flare up again and we’ll have to lockdown again. And the best case is that COVID will become endemic like influenza. They won’t change their antigens or be a different strain every year like flu, but they’ll be a low level of flu until there is herd immunity. And even there, in herd immunity, it only means there are enough people immune so that a person who isn’t vaccinated has a low probability of being infected. But people who are not vaccinated are not protected themselves. They’re protected only by the fact that their interactions and contacts are largely protected. So their ability to come in contact with the virus is lower. So until herd immunity arises, I think the absolute clear expectation of all the modelers is in what form and how bad? Unclear. Almost certainly, COVID will persist for at least all of 2021and they are models that play it out to 2024.
MODERATOR: Next question.
Q: Thank you. The U.S. has declined to join COVAX, the international effort to develop and manufacture and distribute a vaccine. Does that go it alone approach leaves us at risk of not getting a vaccine if one is created outside the US? Is it conceivable that could be developed somewhere else first and we don’t have access. Or is it just as likely that a U.S. company will plant something that we’ll have access to.
BARRY BLOOM: So that’s a vexed issue, certainly for me, who spent my entire career in global health and trying to bring the best in science we can to low and middle income countries and people who just don’t have the riches financially, institutionally, economically that we do.
So the anticipation that with now two hundred and eleven putative vaccines being developed, nine globally in phase three studies, there was a real, I think, two months or three months ago, march, there was a real anticipation that once these vaccines are found to be safe and effective, where are they being made? Well, they’re all being made in industrialized, wealthy countries.
And what kind of a world would we live in if only the rich got vaccines and everybody else had to suffer? The political, economic and moral challenges of that prompted a meeting hosted by President Macron in France, bringing country representatives from the European Union together with a number of vaccine producers. And they made an agreement to create a mechanism by which a fund would be created to enable purchase of vaccines for countries that don’t have the resources to make them able to buy vaccines for their people.
The fleshing out of that has been a proposal and plan developed and led by WHO and the Europeans called COVAX. In one of the mechanisms by which it works, that is what really is valuable for the vaccine companies, is why make 10 billion doses of vaccine if there’s no country that can afford to buy it? And if countries can’t afford to buy it, we’re going to be living with this epidemic in the real world, wreaking havoc. And so there is something called advance market commitments. They were proposed years and years ago by a Harvard professor. They have been picked up by the Gates Foundation for pneumococcal vaccines, and it’s a mechanism that seems to work. A fund has been developed such that they can guarantee so many purchases at a fixed price and provide that vaccine at a price that is reasonable for people in developing countries.
And that’s now generalized under COVAX to say that if we have a large enough fund, then it’s plenty billions of dollars, tens of billions of dollars, if you want to cover the whole world. But we don’t start necessarily where everybody in Burkina Faso gets the vaccine the same day as everybody in Washington, D.C. But we have a plan in which we are distributing vaccines, at least to the people of highest risk – health care workers, essential workers and elderly. And that plan is underway. The sad part is one, the United States did not attend the meeting of the Europeans, has no commitment to doing anything that I’m aware of in a multilateral way, joining all of the other vaccine producing companies. We’ve decided to do it in our own way. And then, as you know, US pulled out of WHO. WHO is leading the effort to coordinate the distribution of vaccines to one hundred ninety four, one hundred and seventy-some countries that will require it that can’t make them on their own. And we’re not part of that, and we’re not contributing to that effort. So I think to be honest, COVAX is a wonderful, humane and moral vision of how the world could save lives in every country of the world. Maybe not 100 percent equality. What’s sad is the United States is not part of that vision.
MODERATOR: Do you have a follow up?
Q: Thank you. That was such a good overview. So I guess this is a self-serving, selfish question. Does it put Americans at any particular risk if something were discovered, I don’t know, in the UK or somewhere and we won’t have access to it?
BARRY BLOOM: So vaccines are made by manufacturers, by vaccine companies. And there is no better market for a vaccine and the ability to charge higher prices in principle for any product in the United States. It is the world’s biggest, at least it’s one of the two biggest markets in the world. So, as you know, the Oxford vaccine was licensed to AstraZeneca. The U.S. has a tradition – I don’t believe it’s ensconced in law – that we don’t buy drugs or products that have not been shown to work in the United States, new products that have not been shown to work in the United States. So AstraZeneca pretty quickly decided they had to run clinical trials in the US to be sure that the FDA would see that it works in our population and that would also create demand. So we are paying for the development and testing of a British vaccine, if you will. We’re doing that now. If all of our nine vaccines fail and the Chinese or the Indians develop a vaccine that works better, I have no doubts they would be very pleased to sell their vaccines to the United States. And I would think if it is the best vaccine in the world, we would either argue that we have a better one even if it isn’t, or we would buy their vaccine. But that’s how the market works.
Q: Right. Thank you so much.
MODERATOR: Dr. Bloom, I have a quick question for you. So why is their policy, even though it may not be written down, but why is their policy to have drugs and products tested in the United States as opposed to accepting that testing from elsewhere?
BARRY BLOOM: My understanding is precisely because of the statistical analytical review the FDA does, that they often would not have access to the same degree of data if a trial is done and approved elsewhere. It’s another level of safety. It’s not distrusting that the products are not any good, but when the FDA allows licensing for sale, they want to make sure it’s safe and effective. And that means they want to look at all the data. Clearly, to be able to sell stuff in the U.S., you have to provide some data, but not to the degree in a new product that you would do unless you made all of the trial data available. And as you can already see, that’s not the easiest thing for companies to do in any case. So I think that’s why that’s been a tradition, shall we say.
MODERATOR: OK, great. Thank you. It looks like that may be it for questions for today. Dr. Bloom, do you have any final words you’d like to share with us before we go?
BARRY BLOOM: Thank you once again for really thoughtful questions. I hope they were not too long and helpful.
This concludes the September 14th press conference.