Coronavirus (COVID-19): Press Conference with Barry Bloom, 11/16/20


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 a.m. Eastern Time on Monday, November 16th.

Transcript

MODERATOR: Dr. Bloom, do you have any opening remarks for us?

BARRY BLOOM: Thanks very much, Nicole. It’s a very exciting time to be talking about vaccines for COVID. In the last little over a week, we’ve had preliminary results of two major randomized double blind controlled trials of two different structured messenger RNA vaccines made by two different companies being tested total in about 60 thousand people and results for protection against disease at the level of 90 percent or better, which is, I think, probably better than almost any expert’s expectation. And I think the importance, among many other things, obviously, having the potential for a vaccine sooner rather than later is the ultimate importance, but the fact is this is a new concept. Messenger RNA vaccines never used before and verified in a Phase three trial. And to have both of them, which may compete in the commercial world but in the scientific world, validate each other, is a tremendous advance, both for a first set of vaccines against COVID, but a new platform that can be used for other infectious threats. So in that sense, I think it’s a momentous occasion and just the beginning of lots of good things coming in the way of vaccines. So with that optimistic note, I am open for questions.

MODERATOR: Thank you, Dr. Bloom. First question.

Q: Hi, thanks so much for doing this. So given what we’ve seen so far when it comes to testing and PPE and all of that, if the vaccines are authorized, one or both, do you feel right now that the states are in position to manage effective distribution? Do they have the supplies they need, the logistics, the data use agreements, et cetera? Can we get the vaccines from the states into people’s arms effectively?

BARRY BLOOM: It’s a crucial question and the answer is things are in process, but if those vaccines were available today, I am not confident we could get even the first batch of either of them organized to get out today. The question is, how is that going to get done? And as you know, that’s the providence of the Advisory Committee for Immunization Practices at CDC. I am quite confident they’re working morning, noon and night to work the distribution chains that we have had for many years and that have been able to vaccinate over 90 percent of our kids in a reproducible way over time. But this is a quite different vaccine in that sense this is not a child vaccine. In fact, there are virtually, with the exception of a small number in the trial, there are no children at all in these trials because children are not the most susceptible to severe disease and death, which is what these vaccines are designed to deal with. So there’s a different kind of targeted recipient, and this will require a very much more complex supply chain, massive speed difference between this and regular orders on an ongoing basis of childhood vaccines. Lots of this has to be essentially invented on the spot. We need to register everyone who gets their vaccines to be able to follow them for two years for adverse effects to follow them in the long term, in the real world for how really effective the vaccines are. That requires a really complex registry system, whether the CDC current system is expandable to take care of the tens of millions of doses that will have to come out and probably hundreds of millions by the end of twenty-one. These are enormous challenges. All I can say is I know from the Commonwealth of Massachusetts and I have heard from the CDC, people are working flat out to be able to work on the cold chain, the supply chain, the registration and the information on adverse effects to be able to make this work pretty much starting in the first quarter of the new year.

Q: So if I may just follow up really quick, you said you’re not confident today, what would it take for you to be confident, I guess the vaccines are expected in December, maybe January, but I think I heard December. What would you need to see to feel that we’re ready to hit the ground running?

BARRY BLOOM: I would really need to see every single immunization district in the country being able to type in somewhere that we are ready to receive X number of doses of vaccines and we can keep track of the people who will receive them to monitor the effectiveness and the safety over the next two years. And that’s a huge undertaking. And as you know, health care in the US is crazy. It’s a state function rather than primarily a national function. So getting 50 states to organize each of their own priorities, get the information to a central source, hopefully CDC, but there may be other data sources that will be engaged is a huge undertaking, but absolutely essential if we’re to assure the equitable, fair and safe distribution of the vaccines and then accountability for effectiveness and adverse effects so that people can have confidence in it. This is a big deal.

Q: Thank you.

MODERATOR: Next question.

Q: Yes, hi, thanks for taking our questions. I was wondering if you could kind of compare and contrast the Moderna vaccine with the Pfizer vaccine in terms of the requirements for cold storage and whether Moderna doesn’t have to be kept as cold, whether that is helpful in terms of vaccine distribution. And considering that Pfizer looks to be ahead of Moderna by a week or two, is that going to matter in terms of how these vaccines are distributed? Thanks.

BARRY BLOOM: I think it’s an excellent question. There is clearly an upgrading of the formulation of the Moderna vaccine that no longer requires ultra-cold temperatures to maintain stability, which is the characteristic of the Pfizer vaccine. It will clearly be something that every physician’s office, every clinic will have a refrigerator that can keep the vaccine cold for various periods of time and can keep it for six months in the freezer compartment of ordinary refrigerators, as opposed to ultra-cold freezers, which are not going to be available in very large parts, particularly in rural places in the United States, and certainly much more restricted for global distribution in low- and middle-income countries. So there’s a practical advantage at the moment for the distribution of the Moderna vaccine because of its formulation and apparent stability.

MODERATOR: Do you have a follow up?

Q: I guess my only follow up is, in terms of how the approval process is going Moderna versus Pfizer, that Moderna will be just a week or two behind and that will continue? Or do you think that they’re farther behind?

BARRY BLOOM: I think that they’re pretty much together in time. From their perspective, the next question is, can they ramp up the production to 50 million doses a month for 2021? And for Moderna, this is a new exercise with contract manufacturing organization, which we don’t have a lot of prior experience of with either of these technologies. So in any vaccine, any process of production can have a glitch. But assuming the best that one hopes for, there should be enough vaccine to get at least the top phases recommended for immunization in the United States by the end of spring and hopefully enough for everybody by the end of the year, if these vaccines can be made at the level they’re being promised to be produced and there will be new vaccines, different concepts that will add to the kitty. So I think we have to be very optimistic that we will need more vaccines even for the US than any one company can make. And for the world, we will need lots of different production capacities to be able to contribute to global elimination or at least reduction of the current epidemic.

Q: Thank you.

MODERATOR: Next question.

Q: Dr. Bloom, thank you for joining us today and doing this. One thing I want to ask is, now that we have both these early results from Pfizer and Moderna and these sort of spectacularly high numbers of over 90 percent effectiveness rate. Do you expect that number to kind of fall or fluctuate a bit as we get more data? Since this is still just a pretty small slice of the data, we expect to come from these very large tens of thousands of people trials.

BARRY BLOOM: There are a couple of answers to this. Every graduate student in immunology knows that after the booster shot within one to three weeks, you get the highest titers of antibody in a rabbit. People are not rabbits, but these data are very shortly starting to be collected after the second shot. So we are approaching the time that one would expect the way these vaccines are administered, we would be getting the peak response. In the phase two studies, both of these vaccines did as well as convalescent serum, so in essence, inducing the immune system to make a response, the people who got over COVID found to be sufficient to recover and stay healthy. The higher the amount of antibodies that you make at the beginning, because the half-life of, let’s say, IGG antibodies is about twenty-one days, you’re losing half of the antibodies every twenty-one days. The more you start with, the longer they last. And the questions that are not able to be answered here for either of these vaccines or in essence for any of the vaccines that will go into phase three trials is because of the speed of getting the interim data and the speed of getting the vaccines out. We won’t have really good data until the post licensure surveillance to say how long the antibody responses lasts that correlate with protection. So there’s a lot of science still to be done on these populations, for example.

Do we know why the vaccines are working? We know that they’re producing an immune response against the spike protein. But do we know that the key response is neutralizing antibodies or the case, can we measure for every new vaccine levels of neutralizing antibodies and have a pretty good guess that they too, will be 90 or 95 percent protective? That’s going to require an analysis here. In the case of the Moderna vaccine, there were ninety-five recipients of the placebo who got COVID disease. But there were five in the vaccine group. We’d love to know, did those five fail to make neutralizing antibodies or did they make neutralizing antibodies, but not efficiently enough to be able to tell? So what I’m suggesting is this is a terrific first start and we’re just going to have to follow along to see how long the immune responses that appear to be protective will endure within the vast majority of the population. And I would point out, at least to my knowledge and experience, there is no vaccine that we know of that is one hundred percent protective in everybody. And so I think we have to be very grateful that we have two vaccines off the bat that at least short term are looking to be relatively safe, except for some minor short term inconveniences, fevers, muscle pain, et cetera, that you get from almost every vaccine and a very much higher degree of protection than I think most experts would have predicted.

MODERATOR: Are you all set?

Q: I do have a quick follow up.

MODERATOR: Sure.

Q: One thing is, why do you think these vaccines sort of beat all expectations, do you think that says something about the mRNA platform that we’re testing for the first time here? Or does it have something to do with sort of the design of this particular vaccine and the spike protein on the coronavirus?

BARRY BLOOM: No, I think this is an incredible scientific advance. All the way through this process of after SARS 1 in 2003, after H1N1 in 2009, the efforts, particularly in the NIH, US government, BARDA, DARPA in the US and CEPI in Europe, and probably parallel work in China and Russia. To switch from one off vaccines, each one starting from scratch to creating these new platforms of which this is the newest never really tested before in a phase three trial. But this didn’t come as a great surprise that it should have had efficacy in that between Pfizer and BioNTech and Moderna, they have made constructs for two different strains of influenza for MERS, for probably Ebola, where they had laboratory data to indicate that these vaccines could produce antibodies to the introduced viral proteins into the RNA. And so when the US government decided to put 10 billion dollars into new platforms for which we had no prior phase three data, I think what they were saying is they had enough confidence in the scientific work that had been done in the previous four or five years to believe there was a very good chance that these vaccines would be pretty protective. 90 percent is at the higher end of the expectation table, by all means. But this was the result of a lot of investments, both scientific, over quite a short period of time, five to ten years, if you will, and a lot of financial investments that are now beginning to pay off. And I think it’s a great day for science, to be honest.

Q: Thank you.

MODERATOR: Next question.

Q: Thanks so much for doing this. Following up on that a little bit, you alluded in your intro to the platform that these mRNA vaccines create. What do you see in the future for these mRNA vaccines, what is this telling you?

BARRY BLOOM: So I think the potential is why this was a favored platform. And I think in an earlier conference, I once mentioned that for a couple of years I had been involved at the Kennedy School and a program on biosecurity, which I had wished they had maintained, but it ended before COVID and we had the head of BARDA present to us a couple of years ago. And BARDA had set as a goal to have a vaccine from the time the DNA of a new pathogen was identified to a vaccine injected into people in a phase one study within 60 days, which two or three years ago seemed mind bogglingly implausible and has been shown to be realizable. The Moderna vaccine, when they claim in sixty-three days my count is sixty five days, we could split the difference. This becomes then a platform for any new, particularly viral pathogen. As soon as the DNA sequence is done, if it has homologies to other viruses of the same category, it should be possible to guess which is the major surface antigen that might result in neutralization. The glycoprotein, for example, in Ebola, the spike proteins in coronaviruses. And with that guess, start to make RNA constructs that can be tested within a month within laboratory animals to test the concept. So this is a platform that I have great confidence, has the ability to be moved as quickly as humanly possible, maybe other delivery systems and platforms like adenoviruses that can also be moved quickly. But this is the quickest and simplest to get moving and has the fewest moving parts, if you will, that can go wrong technically. So its virtue is more than just its application to COVID, and I think that was why the support from the NIH and from CEPI switched from individual vaccines to platforms that might have more general use.

Q: Thank you.

MODERATOR: Next question.

Q: Hi, Doctor, how are you? Thank you for taking time to speak with us. Quick question regarding more practical, I know that you’re a member of the Governance Advisory Committee here in the state. Curious to know when the problems are worked out and the distribution begins, what will it look like from a practical matter for folks who want to get vaccinated? And secondarily, of course, you know, the population will be vaccinated based on vulnerability. And I wonder if you could talk a little bit about that. Who will be the most vulnerable? Who are the people who will receive the vaccine first and sort of how it will fall out?

BARRY BLOOM: So, as you know, that’s a very important question, and I think every state is struggling with that, as is the advisory committee for Immunization Practices. So I just put it in the context, if you take a first year course in immunology of infectious diseases, what you learn is the key to stopping an epidemic is interrupting transmission. And that has not been the priority that was initiated by the National Academy of Science Engineering and Medicine. Because of the high death rate in elderly people and people with comorbidities and because of the high risk of people actually working in hospitals with patients with COVID-19, the priority that is recommended is to protect the most vulnerable from serious disease and death, which in its own way protects the hospitals for people with other conditions, but at this point are not able to get into hospitals. We could talk about the excess death problem. Translating that into who are at the greatest risk. It is clear that the people working in hospitals that are currently being overrun are exhausted. They’re working under enormous pressure. And if we don’t protect the health care workers at every level, not just the people who run the respiratory clinics, but the nurses, the nurse’s aides and the people who work in the hospitals, in the service functions, preparing the food and the bed linens and all of that, we’re not going to have a health care system. So it is obvious why they are critically involved and they’re there to protect everybody else. Second, we know that the vast majority of deaths are people over 65 years of age and a very high death rate, over 80 percent in people in nursing homes and assisted living conditions. So they are to be given in the recommendations so far, high priority, as are people who are essential service workers, who everything from transport workers to food stores and everything we need to keep society going, who travel from one part of each city to another are at risk every day for contracting this, they become other essential workers.

To my knowledge, no one has actually defined what is an essential health care worker and who is not. When vaccines are really in short supply, we’re talking about 20 million doses to start with for the whole country for one of these vaccines. Divide that by 50 states and figure out how many emergency health care workers you have. It won’t even stretch just for the first category of essential health workers. So there are hard decisions to be made at the beginning of who will get them first. clearly with the Pfizer vaccine, another consideration has to be facilities that have the capacity to store the vaccine at minus 80 degrees centigrade, and that will not be your local pediatrician or internists office. So there will be special arrangements being made, certainly in the major cities. It’s going to be tougher in more rural areas. And I think in that sense, it is a great relief that the Moderna vaccine has temperature capacities that are less stringent and make it easier to get more points for distribution. I am hopeful that the ACIP will make final recommendations. They have asked all 50 states to send in what they see as their priorities, and I am hopeful that they will give states some flexibility among the top two or three phases that are recommended to meet their own initial needs, because this epidemic varies in different parts of the country. I mean, even within New York City, in the five boroughs of New York City, it’s a 15 percent difference in infection rates, as measured by serosurveillance. So getting the right vaccine to the right place is dealing with the most vulnerable people, it’s something that is really best done at the local and community level. So if we have that flexibility, I know the states are working hard to define their own priorities within the general framework recommended by the academy. And I presume similarly they will come from the ACIP. I don’t know if that answers your question.

Q: You certainly hit a number of topics. I mean, the only thing would follow up with, just sort of listening to you talk about distribution and your look at the vaccine, I wonder, from a layman’s point of view, it almost seems like coming up with a vaccine at 90 percent effectiveness was easy. The distribution of it is going to be the hard part. I don’t know if that’s simplifying it too much, but it certainly it seems that the distribution will be a lot more difficult to manage because obviously dealing with millions and millions of people across the country.

BARRY BLOOM: Yeah, I think in the beginning it’s going to be very, very challenging. I think that bringing in the body to be able to use the cold chain and provide supplies of the minus 80 to those places that are able to use it is terrific, using a well understood consulting company that is good at logistics, adding to what CDC knows how to do for childhood in the small number of adult vaccines that we provide, gives me rather great confidence that it’s going to be tough at the beginning, but by the end of the spring, if not well before then, in the end of the first quarter, this should be running smoothly unless there are any technical glitches. So I think it may not be as formidable over time as you’re concerned about. The other concern, of course, is the issue of vaccine hesitancy and the politicization of masks and vaccines, which is not going to help in getting the kind of coverage we need to develop a level of immunity to bend the curve and ultimately stem this epidemic. So I have a lot more confidence that we know how to fix a logistical supply chain problem than we do to change people’s attitudes for the safety and efficacy of vaccines and a highly politicized circumstance. That’s going to be a real challenge.

Q: Thank you.

MODERATOR: Hi Dr. Bloom, this is Nicole really quick, we have quite a few more questions to go, so if we can make the comments a little shorter that would be great, maybe we can get everybody in. To kind of continue on the conversation of vaccine distribution, which vaccine will patients be getting? Will it be like the flu vaccine or physician signed contracts with middlemen? Or can people shop around for Moderna versus Pfizer vs. any others?

BARRY BLOOM: It’s a complicated answer in the sense that Pfizer has taken no money from the federal government at this point but has accepted an advance purchase agreement with the United States government, who has offered at a fixed price to buy one hundred million doses with options for more. Those vaccines will be distributed by the federal government and will, as I understand it, be free for those who are in the phase is to receive it. The Moderna vaccine was from the beginning invested in by funds from the United States government and has also an advance purchase agreement so that initial hundred million doses up to a billion doses perhaps will be contracted for and distributed. Some percentage of that free of charge to those within the phases given early priority to vaccines. The question of what happens to those not receiving in those groups, how much, if any, will be available on private markets, how your local physician can arrange through the states and the CDC to have distribution? At this point, I have absolutely no idea. And that’s part of the logistics that has to be worked out.

MODERATOR: Great, thank you, Dr. Bloom. Another quick question, somebody is wondering if you have any disclosures regarding Pfizer or Moderna that we should be aware of?

BARRY BLOOM: No, no, I have no relationships, take no money advice, no companies. That’s why I can be on this phone call.

MODERATOR: Right, thank you. Next question.

Q: Hi, sorry. Can you hear me now?

BARRY BLOOM: Yes.

Q: Two quick questions. One is, if somebody has already gotten the coronavirus, would they also be taking a vaccine or would they go to the end of the line perhaps? And the second question is, these are both mRNA vaccines. Do we know why there’s such a difference in terms of the cold chain between the two of them?

BARRY BLOOM: Yeah, the second I can answer, if you just put RNA in by itself, every cell in the body has something called ribonuclease that chews it up. And the way they’ve protected against that is to substitute non-natural nucleosides that don’t appear in nature. And that makes it difficult for the enzyme to chew it up. So both of these vaccines have very cleverly genetically engineered stability into the messenger RNA. However, the reason why they actually are able to be so effective is they are packaged in liquid droplets that target them and protect them from being degraded until they get into cells where the RNA can then be released and work to start to produce the spike protein. And each of those lipid droplets is made differently by the two companies and the formulations are different. And one of them, as we now know, has been designed to have a greater temperature stability than the ones initially made by Pfizer. So the stability is more a property of the delivery system than it is for the RNA itself. If that answers your question.

Q: Yes, it does. And then in terms of the of the person who’s had COVID already, would they be getting the vaccine?

BARRY BLOOM: You know, one of the wonderful things about taking media calls is you get questions like this one that I never heard or thought of before. So thank you. If there is an answer to the question, it would be we don’t know how long the duration of protection is either from recovery from COVID itself, let alone the duration of protection from these vaccines. There is reason to believe these recombinant lipid adjuvanted vaccines may work a lot better than recovery from natural infection. That is certainly the hope in many other infectious diseases like tuberculosis. So we may have to do better than the natural infection. But the answer to your question is, if people recovering from COVID retain their immunity, there would be no need for a second shot. But as in the case of many things, even including probably our best vaccine, measles, it can be ninety four percent protective in kids, but it wears off in adolescence. So booster shots are necessary and strikes me as not unlikely that we will learn what the duration of protection is and people will need, whether naturally infected or vaccinated, to have booster shots over some period of time, once a year, once every two years, once every five years. That would be my guess.

Q: OK, but there’s no danger if you had COVID and maybe even didn’t know it, to get the vaccine is not going to be harmful, right?

BARRY BLOOM: We have no data on that. There’s no reason to assume it is, but no one in these trials, I believe, was tested to see if they had had COVID before.

Q: OK.

MODERATOR: Next question.

Q: Thanks very much, Dr. Bloom, I appreciate it. Two quick questions and then a follow up, if that’s all right. You’ve touched on this, but with both Pfizer and Moderna moving along here, I’m wondering just how successful a combination of two or even more vaccines might be in fighting the virus. Is that in any way better or worse than just having one? Or should we really be focusing on one vaccine? I think distribution and production of the vaccine is probably a challenge. And along those lines also, you know, Moderna is a Massachusetts based company. I’m just wondering actually if any of the production of the vaccine might also be happening here in the state?

BARRY BLOOM: Yeah. My understanding is that Moderna has engaged a Swiss contract manufacturing organization that is apparently high quality and high level but is organizing itself to be able to produce vaccines in the United States as well. I think Pfizer is the same, and as far as the distribution goes, it probably doesn’t make a great deal of difference where it’s made if it’s being purchased by the government and distributed under the guidelines the ACIP will arrange with the states. The other part of the question, if you can repeat it.

Q: Just about the effectiveness of having different vaccines, if that is going to be as successful as focusing on just one?

BARRY BLOOM: You know, when you’re at the level of 90 percent, if it could stay that way, it becomes a benchmark for every other vaccine. And if other vaccines can achieve this level of protection, let’s assume that the subunit vaccines and the recombinant adenoviruses vaccines all get to this level of 90 percent. That’s all terrific because no one company has the capacity to produce seven hundred million doses that we would require to get everybody to shots in the in the States. If new vaccines in the pathway are single shot vaccines, that would simplify the use, cut the cost, make it easier for people not to have to be found twenty-one or twenty-eight days later and brought back for a second shot. So there are improvements that I’m expecting in other candidates down the line that may not be any more effective, but may be easier and simpler to use. And all of them will have something useful to contribute, assuming they’re safe and reasonably highly effective.

Q: OK, great. Thank you. If I could just ask a real quick follow up, a slightly different topic, and I apologize for that. But since you’re advising governor in that panel, looking at this new metric that the state is using for determining what cities and towns are in the high-risk red zone, which is taking the population size and positivity rate and tests into account. That’s really cut the number of cities and towns that are considered high risk as the cases are spiking. And I was just wondering if you could quickly just give me your assessment of that new metric. Is it accurate and do you have any concerns about how the state’s determining what cities and towns are considered high risk right now?

BARRY BLOOM: As I said, what’s remarkable about this pandemic is we read national figures and we have state figures, but really the epidemic is remarkably local. And I think that the effort to identify those hotspots as the areas of highest priority is really valuable and to identify populations who are often underserved but at higher risk here because of their employment, their inability to stay home, their inability to protect themselves from exposure to crowded environments, as in transport and stores. I think those efforts to provide the vaccines in the earliest possible times to those places that are at the greatest risk for severe disease and death, it’s hard to do. It can’t be perfect, but that’s better than just allowing everybody who has the most money to buy us out of vaccines and everybody else can’t do it. So it’s an effort to both stem the hot spots in the epidemic and to provide some degree of fairness and equity for those people who have the greatest vulnerability. Is that reasonable?

Q: Yes, I guess I was sort of more about how the cities and towns are considered to be in the high-risk red zone and the map has been cut drastically by the new metric, and if you had any thoughts on that part of it?

BARRY BLOOM: I would just leave that to the testing people who were collecting the numbers.

Q: OK, thank you.

MODERATOR: Next question.

Q: Hi there, thank you, Dr. Bloom, I appreciate your taking our questions. Quick question on these two vaccines, is there anything either in the clinical trials that have led up to this point or in the vaccine, the nature of the vaccines themselves that lend themselves to particular benefits for any special populations? In other words, are they particularly effective for any special populations that are among the first?

BARRY BLOOM: So that’s a really important and wonderful question. So in the initial design of the phase three trials, and earlier trials, in general one starts with a healthy population because the principal mandate in any kind of medical intervention is to do no harm. So the trial started here with age 18 to 55, which is not the highest risk groups for severe disease and death, which is, you know, older people and people with preconditions. And one of the striking things about both of these trials, but in the most recent trial, providing numbers for that is they have included groups of people over the age of 55. They have quite a large number of those, 7000. They’ve included people known to have comorbidities, heart disease, presumably diabetes, and they have included a significant number of African Americans and Latin X recipients trying to collect data on the broadest groups that are at high risk. And I give them credit for having stretched from the original designs and phase two to be able to get some data in these phase three studies on exactly the groups that would be most vulnerable. And as you know, for many people, people over the age of 60 do not respond well in general, as well in general as young people to vaccines, and for example, in the case of shingles vaccine, the initial shingles vaccine was 50 percent effective. But with an angiogram and the newer version, it’s in the 90 percent effectiveness, even in people who are over 60. So targeting vaccines to, in this case, the most vulnerable, which would be people in the older age groups, is a challenge for any vaccine. And these trials have broken out how many of those were in the vaccine group and how many in the placebo group? But in the Moderna, there were only five people that got a disease at all. And we don’t know at this point from the press release anything about their age, preconditions and ethnicity.

Q: So while there is some reason to hope that eventually they will begin to identify populations?

BARRY BLOOM: We have been collecting data on that and in the registration that CDC and the ACIP will be requesting, they will not only be requesting the names of who got the vaccine and whether they got their booster shots, asked something about where they are in terms of geographic location and preconditions and ethnicity. So we are hopeful over a period post licensure, we will be able to collect two years’ worth of data to know a lot more about how effective the vaccine is in the current vulnerable populations.

Q: One other quick question, and that is that, if indeed these prove to be over 90 percent effective, does that adjust downward the proportion of the larger population that needs to be immunized for, you know, some level of herd immunity to be attained? I mean, the relative effectiveness of these vaccines is a factor, I think, in devising the herd immunity.

BARRY BLOOM: There’s no question the higher the effectiveness of the vaccine, the smaller number of people that have to receive the vaccine to get to the level of protection of, let us say, 60 to 70 percent of the population. If the vaccine is only 75 percent protective, it means twenty five percent of the people who got the vaccine are not protected and they don’t contribute to herd immunity. So this is very good news for speeding up the time, hopefully, if people would take the vaccine to get to a level where you really can protect communities against this epidemic.

Q: Thank you.

MODERATOR: Next question.

Q: Hi, thanks very much. I have two questions. The first is, this not related vaccines, but how important is it for colleges to test all their students before sending them home for Thanksgiving? And then my second question is, when would you expect college students, staff and faculty to sort of be on the list to get a vaccine? I assume that students might take a long time since they’re sort of younger. Thanks very much.

BARRY BLOOM: So on the first question, obviously, I’m a big fan of rapid testing and frequent testing, I would like to see every college student tested two or three times a week. I would like to see them tested before they go home so they don’t transmit infections to their family members. I’d like to see them tested when they come back and get a quick result to be sure that they don’t transmit to their dorm mates. And as you know, we are not tooled up to do rapid testing in every place. It’s expensive. Not every school, university and college have the capacity to do that. And I wish they did. And that’s the best that I can tell you. Sorry, what was the second part of the question?

Q: Yeah, I was wondering when college students, staff and faculty, with vaccines…

BARRY BLOOM: They do not appear in any of the highest priority categories. And as young people, which isn’t to say young people don’t die and young people don’t get sick, but somewhere close to over 80 percent are in people over 65 and closer to 90 percent of people in nursing homes are the ones who die. Young people unlikely to be a high priority group until the highest risk groups are already vaccinated. And I think most people would find that a reasonably fair circumstance. There may be predisposing conditions where they would fit, even at a younger age, into those with comorbidities, which is in the second phase. But what you haven’t, and no one has yet asked but is a real problem that I think every state is worrying about is how do we keep schools open and where should school teachers, for example, a high percentage of which are over 55, for example, in the United States, and many are over 65, how do we balance their need as essential to society to keep schools open? And that’s a struggle that hasn’t been resolved, to my knowledge, anywhere. And that’s something that we in Massachusetts and I think every other state is trying to wrestle with.

Q: Is there a guest, like for what month or season a vaccine would be available to a typical college student?

BARRY BLOOM: The person, Dr. Slaoui, whom I don’t know, who has been recruited from GlaxoSmithKline, who oversaw production of many, many vaccines and is the scientific guide for this operation warp speed operation, if he is right and these plus new vaccines get introduced into the approval ratings by spring, we will have most people who are willing or keen to take a vaccine, we will have vaccines for them. He hopes by the end of spring before summer. That would be wonderful. And clearly, students would be part of phase four when everybody has access to vaccines. I think it’s on time, assuming everything goes perfectly got it.

Q: Thanks very much.

MODERATOR: Next question.

Q: Dr. Bloom, thanks so much for taking our calls today and our questions and for just being so thorough in explaining everything to us. Something that you touched on and kind of glossed over, but you were mentioning the difficulty, you were saying you had more confidence in them and all the states figuring out the distribution and being ready for the vaccine that you do over the politicizing of masks and that type of thing. Given that we are not expected to have widespread distribution of the vaccine until this spring, possibly April or even later in terms of everyone being able to get it, can you talk about the importance of just people continuing their precautions for coronavirus and not getting it specifically? We’ve seen, especially in the Midwest, we’re seeing such an explosion of cases right now, exactly what you referenced and we’re seeing that political pushback. Our state’s epidemiologist leading our pandemic told me last week that masks are a political issue. That was from our state’s epidemiologists. And our health commissioner told me that they don’t work because people will be defiant and do exactly the opposite. So exactly what you were saying. I mean, we continue to see such pushback and such, you know, just really not wanting to do everything possible. What everybody says is possible to help reduce the cases in states that are having explosions. We have no ICU beds in Tulsa or Oklahoma City right now.

BARRY BLOOM: So it’s a very important question. And obviously it’s a kind of political question that I have absolutely zero expertise in. But I would point out that the strongest supporters of moving these funds into developing vaccines rapidly are in the current Trump administration. And I would hope that the supporters of this administration and the next administration in the current version may have some of their followers concerned about mandates, about masking. No one is going to be forced to take this vaccine initially, as far as I’m aware, without the pressure of a government mandate telling people what to do and vaccines that are shown to be safe and effective and vaccines that are being taken by the health care personnel who can vouch for their safety and efficacy. I am hopeful that there will not be the politicization of the vaccine that we’ve seen with masking and personal isolation and the closing of certain congregational settings. That’s a fond hope and I hope that that’s true.

In the second part of your question is they will still be lots of people that are not vaccinated in the first six months or year, and they have the capacity to transmit infection. And I would point out vaccines are wonderful, but they’re not perfect. You can overcome the power of an immune response by simply overwhelming the immune response with a high level of virus or bacteria so that we work within a biological framework such that we will need to wear masks. We will need to be protective even if we’ve had vaccines. And the two worries that the public health community has is now that some of them are effective, will people take them? And the other one reciprocal question is, if they take them, will they take risky behavior and not wear masks and feel they can congregate in bars all night and run around where even with the vaccine, they may not be protected and be at some risk? Those are challenges for communications, for education and for political advocacy, best done at the community level to persuade people to protect themselves and everyone else, with or without vaccine until everybody is protected, carrying out the simplest of public health measures.

MODERATOR: Did you have a follow up?

Q: Yes, just something quickly. In bigger cities, we have seen that, but in suburbs and, you know, being from Kansas, Midwest suburbs that just run one town into the other, Overland Park from Kansas City, here we have a suburb called Broken Arrow. You know, you drive from one part of Tulsa to the next and you don’t know that you’ve crossed into a suburb, but continued reluctance to do that. All the while, every CEO of every hospital here has begged for all of the suburbs to do, you know, mask mandates. Today, we saw one of the counselors for that suburb posting something from the federal US that she’s federalized, that she’s going to present tomorrow night, the 12 graphics of why masks don’t work. So what do you make of this? I mean, aside from just the science and the data and rejecting that, it just seems also, is it puzzling to you or have you been surprised by just the lack of wanting to help out our health care workers who are in such a crisis right now and so, so exhausted?

BARRY BLOOM: I’m disappointed whether it’s surprised the American people have a tradition of not liking government mandates. That’s why we have health care in 50 different states doing different things. It doesn’t make a lot of sense to me, but that’s the tradition here. And we’ve had backsliders since the first anti vaccine league in the States, I think was nineteen hundred and eight. So this is not a new phenomenon. It’s a little more aggressive and politicized, if you will, on masks. I am concerned about the anti-vaccine movement with respect to vaccines and not just the United States. The anti-vaccine movements are strong and in South Africa they were strong enough in India to block the introduction for many years of the human papilloma virus and by stopping that millions of young women are going to be destined to get cervical cancer. So it’s a powerful movement. And the tools that we have to deal with misinformation and disinformation are a lot more limited than the tools we know how to do to make a vaccine and get an adjuvant to work.

MODERATOR: Are you all set?

Q: I am all set. Dr. Bloom, thank you so much. Much appreciated.

MODERATOR: Dr. Bloom, it’s twelve thirty-seven and we have two more questions. Do you have time for those, or do you need to go to another call?

BARRY BLOOM: No, it’s fine. I’m free.

Q: Thank you so much. Thank you, Dr. Bloom, for your generous time. I have hopefully two quick questions. One is and forgive me if you cannot answer it, but I’ll try anyway. A lot of folks in searching for answers online will look at and see that they’re trying to figure out if you can get COVID more than once. Can you weigh in on that and tell us, based on the currently available scientific data, can you get COVID more than once?

BARRY BLOOM: It’s a fair question, and the answer is this not a lot of clear-cut data and the actually only way to know that at the simplest level is to have the DNA or CDNA sequence of this RNA virus. So we have a fingerprint from the virus that you got the first time to be sure that if you seem to get sick the second time that we know you got infected with a different virus rather than having the first virus just hang around. So the number of documented cases of which I’m aware and they haven’t really been confirmed but have done that have been less than twenty five in the literature that I’m aware of. And as I was discussing this with one of my epidemiological colleagues who’s very smart and I asked about people getting reinfected and his guess was the chances were higher that there was a mislabeling of the nasal swab tubes for the PCR test, where they were thought to be given the infection a second time. It was more likely to be mislabeling of the tubes than they actually got infected. So all I’m suggesting is it is possible that people get infected. There are clearly five people in this group from the Moderna who got sick. They didn’t get seriously ill. None of them were seriously ill, but they all got the vaccine. So it is possible that you can have the vaccine and still get some degree of clinical symptoms. It’s not impossible, but the data are not good. And the good news is it doesn’t appear to be of the hundreds of thousands of people who have been tested, not an awful lot of them appear to have had a second infection, doesn’t see a big public health problem.

Q: Thank you, sir. I report for the entire state of Texas, and my next and last question is, is there anything that Texans should be doing right now to get ready for the vaccine availability? Like are there any actionable steps that you could recommend people take?

BARRY BLOOM: Yeah, I think the same as every other state. They have been asked to put together a set of plans for a distribution of each of these vaccines and those future ones to come. They’ve been asked to set up a registry system so that everybody who gets a vaccine and that we know who they are, Texas knows who they are, gets a reminder out to get their second dose, 21 days for Pfizer, 28 days for Moderna. Any adverse effects that they see are to be reported. And whether they get sick over the next two years is to be reported to the CDC. That’s a lot for every state to do. Texas is being asked to do that. In addition, they’re being asked to set their priorities of who gets the limited amount of vaccine that they will get first and the needs of Texas for the requirements of Texas. The numbers are bigger than in many other places, but the needs and the requirements will be the same.

Q: OK, thank you, Dr. Bloom.

MODERATOR: I think our final question.

Q: So, Dr. Bloom, I have two questions, what would you tell people what we know right now about how safe these vaccines are? And the second question is, what do you think that these two mRNA vaccines working seemingly so well, says about other vaccines. They were more tried and true platforms, is there any reason to think they would be any less effective than these experimental ones demonstrating this kind of effectiveness? Thank you.

BARRY BLOOM: So on the safety question, the reason these are interim data and the companies are not in a position to request that they be approved for general distribution is first, there is a real requirement to be certain about their effectiveness that they get to the target population. For Pfizer, 161 cases distributed in the vaccinated or placebo population. And in the Moderna,151, I think. So they have to continue the study to get very good data on the first cut on how effective they are. And if they’re 90 percent now, it would not surprise me, as they get more and more people, it gets a little lower. But these are going to be very effective in the short term. The second is for safety. You really want to follow them for two years? We don’t have the luxury of doing that. We’re in the middle of a pandemic that’s killing people and hospitalizing people. So it was agreed upon by everybody, including the companies, that most serious adverse effects that we know that come from vaccines occur within two months after the last shot. And so the safety period that FDA will be looking at, which the companies have agreed to, is are there any serious adverse effects that are picked up in these 15 thousand people who are being vaccinated and followed over two months after their last shot? And the hope is there will not be and if that’s the case, I think we can be pretty confident they’re safe. You’re dealing with a circumstance then where in these two studies, sixty thousand or seventy thousand people are in the studies. Some people are going to get heart attacks. Some people are going to get strokes. Some people are going to get run over by cars. The challenge is how do you know whether any of those untoward events and sixty thousand people have anything to do with the vaccine? That’s a challenge. But if you’re likely to see things related to the vaccine, they should be picked up mostly after two months after the last shot. That’s the best I think we can do.

Q: The other question I had was like, is there any reason to think that the other more tried and true vaccine platforms would do worse than these? And your answer also made me wonder, should we say anything about Moderna reporting severe cases only among its placebo? That seems encouraging. Is that worth noting to people?

BARRY BLOOM: Yeah, I think that to my great pleasure that while I’m not a big fan, as I mentioned, of promulgating science by press releases, I believe they’ve been pretty honest with what they have provided. There may be things that they haven’t perfected that we don’t know about, but what they have provided, I think has been, as far as I can tell, truthful and straightforward and very helpful to try to understand it, an interim time where things stand. The second part of your question is the other vaccines I have to say 90 percent or better is a pretty high bar. And whether the other tried and true vaccines with protein antigens and adjuvants or recombinant adenoviruses will produce as high an immune response as enduring an immune response, as safe and immunization, we really won’t know until the phase three studies are done. There is every reason to believe they will be good, or the companies wouldn’t have invested the amount of time and effort and the government wouldn’t have issued advance purchase agreements which provide that. We will buy them if they’re shown to be safe and effective. Whether they will be at the 90 percent level we have, we simply can’t say at this point.

Q: Would a one-shot vaccine with 75 percent effective be still worth putting out there?

BARRY BLOOM: In some parts of the Third World where you’re going to have real trouble finding people for a second shot? Absolutely, yes. That would be a decision that different governments, different countries, different communities should have the option of making. And that’s part of the advantage of having multiple vaccine.

Q: Thank you very much.

This concludes the November 16th press conference.