Coronavirus (COVID-19): Press Conference with Rachael Piltch-Loeb, 09/23/21


You’re listening to a press conference from the Harvard School of Public Health with Rachael Piltch-Loeb, preparedness fellow in the Division of Policy Translation and Leadership Development and a research associate in the Department of Biostatistics. This call was recorded at 11:30 a.m. Eastern Time on Thursday, September 23rd.

Transcript

RACHAEL PILTCH-LOEB: Hi everyone, thanks so much for joining today. As we all are probably aware, we’re right in the midst of the FDA review of boosters. And with the EUA yesterday for boosters for those over 65, as well as 18- to 64-year-olds who are high risk and those who are in high risk occupations, we kind of are right in the thick of it. We know today that there’s going to be ongoing meetings as to who qualifies as high risk for a booster, as well as kind of the professional groups that are likely to be included. And the reality is we are in a little bit of a special time. We’ve had uncertainties and unknowns throughout the phase of the pandemic. But we’re really in a phase where we have a lot more questions than answers about what the next phase of the vaccine availability and uptake is going to be in the United States.

The way I’ve been thinking about this is that while it’s fantastic that boosters will be available for those who the data supports need it most, we’re going to be entering in, or already have, kind of an interesting time where we almost have a super vaccine, kind of some portion of our population, those who where we know that there are individuals who have gone and sought boosters even before they were recommended. And we have a other portion of our population that is still hesitant and choosing to be unvaccinated. So we’ve got a real discrepancy here in the United States. And even with these third doses becoming available, it’s really critical to remember that the bump immunity that’s going to be associated with a third dose for those who take it is is not going to necessarily be enough to reduce community transmission, especially in areas where we have high portions of the unvaccinated. So the effort still, despite the availability of boosters, are going to need to be on getting folks to take kind of the initial set of doses of the vaccine and similar that we we should be thinking about what’s to come with vaccines for five to 11 adolescents. And we should logically expect that there may be lower uptake of vaccines for this population, kind of given that COVID-19 has had less of a severe impact in terms of hospitalizations and deaths on these younger groups. And to the best of what I can gather, there’s currently very limited discussion of mandated vaccination in the under 12 group, given kind of ongoing uncertainty around the data and around large-scale trials and whether that would be necessary.

So as I kind of lead with a lot of a lot up in the air at the moment as to what’s to come in terms of recommendations, and I think that makes for an incredibly challenging set of kind of communication efforts for individuals and this really challenging space where people have kind of started to take matters into their own hands and make decisions for what they think is best for them, despite what FDA or CDC or ACIP recommends. So, happy to take questions and do my best to answer anything related to kind of these the vaccine decisions, the rollouts, what we may expect, and and can also try and answer your questions a little bit more broadly. And we’ll let you know if it’s outside the scope of my expertize. Thank you.

MODERATOR: Thank you, Dr. Piltch-Loeb. All right, first question.

Q: Doctor, thank you for doing this. Appreciate it.

RACHAEL PILTCH-LOEB: No problem.

Q: I want to ask first from a standpoint of, we’ve got the boosters approved for the groups that you’ve already talked about. But I’m trying to figure out, does this mean if I had a J&J shot, I can get the Pfizer booster or a Moderna? Can I get the Pfizer booster? And we’ve seen in Europe that they’re saying that in the U.K., at any rate, that they think getting a booster of a Pfizer shot, if you’ve had Moderna, is actually proving to be even more effective.

RACHAEL PILTCH-LOEB: Yep, it’s a great question. As of yesterday, and the data that was released, my understanding is this only applies to individuals who have received the Pfizer vaccine and who can get a Pfizer booster. So it does not apply yet to those who have received other vaccines. I think that both J&J and Moderna have not yet submitted their data for review as to whether what a third dose kind of looks like. And there is not yet been insufficient data reviewed to support mixing and matching in the US. I recognize that in the UK and in other places they have done this already with success and there is outside evidence to kind of support the use of it, or certainly to suggest that it doesn’t appear to be harmful. But I think now, CDC is not moving forward with that recommendation, citing lack of evidence to do so. I would imagine that from a practical perspective, in some settings, some long-term care facilities, nursing homes, et cetera, where folks received either Pfizer or Moderna and they will be making a booster available to their entire population, we may be hit with a reality where some folks who received other vaccines initially do end up getting a Pfizer booster. But that is hypothetical and not supported by anything besides a likely reality of what happens when entities attempt to actually deliver the booster to these populations.

Q: At this point, are we going to be talking mass vaccination sites, do you think? Are we going to be talking go to your doctor’s office, go to your CVS? How is this going to happen?

RACHAEL PILTCH-LOEB: Realistically where I think we are not going to see mass vaccination sites again; we are going to see a reliance on existing providers and existing facilities. So for the over sixty five or those who are in long term care facilities, we will likely see providers they already work with delivering these shots. We may see another partnership between pharmacies and some of the nursing homes, our long-term care facilities, like we saw in early phase of the rollout, especially in the in the Massachusetts area, all states did it a little bit differently. But given the supply of vaccines has made its way to our local pharmacies in addition to doctors’ offices, and that doctors now with full approval, especially with the Pfizer vaccine, have kind of vaccine supply available at their disposal, especially now to give, given the approval, the third dose, we will likely just rely on the existing established supply chain to deliver these doses.

Q: There continues to be, finally, this debate over whether this is actually the right course or whether we should be focusing on those unvaccinated people that you mentioned, countries that are underserved at this point and haven’t got enough vaccine. What do you think? That debate is still going on, isn’t it?

RACHAEL PILTCH-LOEB: Yes, I think that debate is going to be ongoing for a very long time. I think if there’s anything we’ve learned over the last 18, 20, it’s hard to even count the months at this point. We’re going to start saying two years soon. It’s that this is a global problem. We know that there are nations that have fewer than 5, 10 percent of their population vaccinated. Yesterday, Biden committed that by fall 2022, we would push to have 70 percent of the world vaccinated against the virus that many have cited, that that’s too slow and still associated with some vaccine hoarding by the US, given that on a global level, the supply chain should support the availability of enough vaccine to have that done by the spring. So this is absolutely still a global problem. We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants, they can come from all different places. And we don’t know when there’s going to be a variant that can change our estimates of what the pandemic is going to look like in the United States and globally. So I think that that debate will continue to rage. I think we absolutely should be doing more to get vaccine to other countries. And the reality is that we should be focusing on getting an initial dose and initial set of doses to more people. That being said, I think that it is unlikely to change the course of action in the US comparing kind of the global need with the domestic policy priorities of the administration. I think it’s unlikely to sway the decision making around booster’s, meaning I think it’s unlikely that the global need is going to sway the decision around boosters. We’ve already seen that. That doesn’t appear to be the case. However. The US certainly has enough supplies that they could be sharing more, and we don’t want our vaccines to be going to waste, so we need to be thinking about how do we expand the reach of the supplies we already have.

Q: Thank you, doctor, appreciate it.

RACHAEL PILTCH-LOEB: Thank you.

MODERATOR: Next question.

Q: Hey, thank you both for doing this. Sort of a bio stats question is the ACIP seemed really interested in the differences that we’re seeing between the Israeli data on Booster’s and US data on Booster’s that shows immunity is pretty durable. So just thinking about the differences between how immunity was studied there and here, are there. How are you thinking about the differences that we’re seeing there?

RACHAEL PILTCH-LOEB: It’s a good question and I think it continues to be kind of a logical question. Right. Why did we see such different results, perhaps from Israel as we did in the more recent studies of health care workers in the US? I think first, it’s important to point out that one of the things that really struck me during the meeting yesterday was that the Israeli definition of a severe infection, where they’re taking a look at whether or not the vaccines continue to provide immunity is different than us, different definition of severe infection. So in the US, we have looked at hospitalizations and deaths. From what I heard yesterday and saw the Israeli definition is what we would probably call a moderate infection here, meaning they had two or more symptoms and they visited a health care provider. And so I think that when we’re looking at numbers of what severe infection looks like between the US and Israeli data, we’re not comparing like to like I think that that’s the bigger message that I take away from looking at the US study to the Israeli study and to any studies that we have to look at in many of these different papers that come out is are we comparing apples to apples or not? And I think that the biggest takeaway is that we’re not comparing apples to apples in the US data and the Israeli data. That could expand to kind of the inclusion criteria of who is in the study, the sample selection of the reality is that Israel got the back, for example, that Israel got the vaccine to a far greater portion of their population initially earlier on. And the reality is eventually, if more of the population is vaccinated, from a percentage basis we’re going to see more infections and some symptoms coming up just from a likelihood perspective in the vaccinated versus the unvaccinated.

So, again, our samples end up being a little bit different. Our definitions of a case end up being a little bit different. And so I think that then when we compare just a percentage, we’re left with a kind of confusing statistic. And so I think that the best that we can do is and of course, we don’t want to wait, we make decisions based on the best evidence of the time. But I think that the reality is the reason that the Israeli data is not necessarily compelling the FDA or more is because the way in which they have looked at the data and define things a bit differently than how we have done it here when we are making decisions about whether or not the vaccines are effective at preventing hospitalization and death.

Q: Thank you. And my second question is, Pfizer submitted data based on a median of six months and Biden announced a vaccination campaign of eight months after your primary series. Do you think from a logistical communications standpoint that that is challenging?

RACHAEL PILTCH-LOEB: To be honest with you, I think that there’s a lot of challenges, but I’m not sure that that six month versus eight months is particularly the one that I would harp on. I think that the time frame of six versus eight months, I don’t want to say is arbitrary, but Pfizer opted to look at that as kind of the follow up period of time while the eight months. It’s still unclear why that is particularly meaningful, I think, folks, the reality is that once boosters start, folks will proceed to attempt to get them, even whether it was six months, seven months, eight months, I think, from their initial approval period. So I think that the recommended time frame is big. But I think that the administration moving forward, announcing that they were going to make boosters available prior to FDA, CDC, ACIP recommendations was kind of a more challenging communications issue than the exact months they picked. So I think that overall, the critique of the release of the recommendation or the suggestion that boosters would be available had a lot of communications challenges wrapped up into it that are not necessarily about the months, if that’s a fair response to your question.

Q: Yeah, definitely. Could you just elaborate what you think the main communication challenges coming out of sort of premature?

RACHAEL PILTCH-LOEB: I think that the reality is that a policy was announced that boosters were going to be available. You could pick any policy announcement, but it has nothing to do with COVID, universal pre-K is going to be available. And then people say, OK, what and when and for whom and how and are we talking about? Tomorrow, are we talking about in two months, the first policy was announced without supporting evidence to suggest why? So you had a scientific community that was a little bit confused. Second, there was no so one challenge is lack of supporting evidence. Two is lack of detail to follow it up. And we’re talking about when the administration initially announced this policy. Right. What’s the process going to be? Who is it going to be for going back to the question that was just asked before by Brian, how is it going to be rolled out? So there was no supporting details, lack of evidence, lack of supporting details and lack of, I would say, one of the kind of critical aspects of this communication is, is to make it a two way street. Right. To be available to take questions and understand kind of what the challenges were. And it seemed like there were more questions and answers that arose from the strategy. I think we are starting to get some of those details, but it’s still up to the administration to decide whether they’re going to follow the recommendations that have been put forth in terms of who gets it, how and when.

Q: Yeah, as I recall, there was no press call or anything after.

RACHAEL PILTCH-LOEB:  Exactly. So I think that, you know, the reality is that I’m sure everything we’re all everyone’s making the best decisions they can with the evidence they have at the time. But I think the reality is for such a large policy recommendation or change to be announced without that supporting detail, I think leads to more questions than answers and likely also drove some people to just say, OK, I’m going to go get a booster, which perhaps may not have done them harm. But it also, I think, contributes to this. Everyone is their own doctor or scientist now type of environment that we’re in.

Q: That’s it for me. Thank you.

RACHAEL PILTCH-LOEB: Thank you.

MODERATOR: Next question.

Q: Hey, thanks so much for taking my question. How concerned should people be who are six months out from finishing their first round of vaccination of any of the vaccines that you were just talking about? Well, there might be this rush to the clinic moment, but immunologically is there a reason to give it more time to let your B and T cells mature?

RACHAEL PILTCH-LOEB: So it’s a great question. Well, I’m not an immunologist I can speak to my best understanding of the data is that there is no magic cutoff whereby we see that today things look one way and tomorrow they look some more different for those who have kind of reviewed a variety of scientific studies, oftentimes we bucket people or time frames into groups. And that’s how we kind of come up with some of these cutoffs as to what is considered either high risk or where there’s going to be a different recommendation. It’s kind of like how women over thirty-five are treated as a high risk pregnancy. But at thirty-four, and three hundred and sixty four days, they’re not right. There is there tends to at times be what I would call a little bit of an arbitrary distinction around time or age or characterizing someone as overweight or obese, BMI, for example. So I think that the six month time frame from an immunological perspective has come as a result of that’s what the follow on periods were for monitoring. And that’s when some of the studies were conducted and took a look at the time frame for when immunity may start waning. I think that the reality is also when we think about kind of studies that have pointed to immunity waning, they also coincided and looked at the six-month time frame. They also coincided with the rise of the Delta variant, which we also knew was more transmissible for folks who were both vaccinated and unvaccinated.

So from an immunologic perspective, this six month date as a drop dead date, I think is slightly arbitrary to studies that kind of looked six months out from second dose when folks had it were also kind of being conducted at the time when Delta was on the rise. So tying the study result to say that it’s the vaccine effectiveness waning, especially if we were looking at effectiveness in preventing infection, which was, of course, not one of the initial intentions of the vaccine, but was something that was initially kind of hoped for. It’s really hard to disentangle that from the vaccine needing to protect individuals from the transmission or infection of a more transmissible variant Delta. And so I think that for individuals who are saying, OK, I’m six months past my shot, am I now less protected? If I was in that conversation, my initial reaction would be no meaning, whether it’s six months, seven months, eight months, you at the individual level, may still have excellent protection, especially against severe infection death. We’ve seen that the vaccines, the two dose vaccines are still incredibly effective at preventing that severe infection and death. More than six months passed for many individuals, and it’s for older individuals, those who are more immunocompromised, where perhaps we are seeing that a reduction in vaccine effectiveness as time continues to go on. To answer your second question as to whether it would be more difficult to make more sense to let kind of our innate immune system, our B cells and our T cells kind of mature more, it’s a little bit beyond my scope. So I don’t want to misstate anything about our specific immune response or the underlying immune response. But I hopefully was able to answer some of your question.

Q: Thanks so much.

MODERATOR: Next question.

Q: Yes, hi, thank you, I join this call a little late, so I apologize if this ground has already been covered, but I was wondering from the 5- to 11-year-olds, it looks like most likely being eligible for the shots sometime by Halloween roughly. What does that mean for the overall pandemic? Is that enough more people getting vaccinated? It will really help with to bring numbers down? Or how do you see that in the wider picture of the pandemic?

RACHAEL PILTCH-LOEB: Yeah, so I think that I certainly don’t have enough hubris to try and predict too much about the future of the pandemic. But I think that a variety of modelers have suggested more recently that we are likely to see decline in cases, I think, through March 2022 to kind of what the extent of where their models are going, projecting out around six months at this point in time with the assumption that there will be increasing vaccine uptake in the under 12 group, as well as kind of a waiting from the peaks of Delta. And this can vary certainly state to state. So we definitely think it will help in terms of a reduction in transmission. But it is important to remember that we still have a large portion of our adult population that is unvaccinated and what would be an even more substantial help or actions and a greater help. But what would be a significant help was if adults also who are unvaccinated or remain unvaccinated were to get the shot. I think it’s also really critically that we don’t necessarily rely on the under 12 group to kind of get vaccinated, reduce kind of those levels of infection and to kind of bring us out of the pandemic. It’s important to remember that throughout the pandemic so far, the youngest age group seems to be sort of less hospitable hosts, they seem, though, they certainly can transmit it, they seem less able to do so and so relying or thinking that this group is going to necessarily turn the tide, meaning that their vaccination status would shift things dramatically one way or another, I think would be insufficient in and of itself.

Q: OK, and then I guess kind of piggybacking on what you were saying about the adult population, as you know, like there’s by region, there’s quite a big discrepancy in the percentage of adults who are vaccinated in Maine and New England, pretty high levels. And then in other parts of the country, notably the south, some parts of the west, pretty low levels of adult vaccination. So do you think that these models that were that we’re talking about, that we could still see like some pretty big regional differences and what the pandemic looks like a few months from now.

RACHAEL PILTCH-LOEB: Yeah, I think that they’re absolutely hypothesizing that the pandemic is going to look different in different states. I think that there’s also weather-related factors that can come up. But the pandemic has also waxed and waned a little bit on a two-month cyclicality for reasons that we don’t fully understand in terms of kind of what happens with viral transmission and flow. So we do expect that there’s going to be significant differences regionally. There have been significant differences regionally throughout the pandemic that’s absolutely related to vaccination status. We know that there are parts of the country where crisis standards of care need to be enacted, where health care facilities are overwhelmed, people are being rerouted to hospitals hundreds of miles away. And those are overwhelmingly in states where the vaccination rate is below average. But I think that is incredibly unlikely that if we have low vaccine uptake in an adult population, we will have high vaccine uptake in a minor population. Parents are less likely in general; some studies have suggested that parents in general are less likely to be vaccinated than non-parents or adults without minor children in the home. And if they are more hesitant for themselves, they’re more hesitant for their children, especially given that the evidence we have about the effects of COVID-19 on the adult population in comparison to what’s gone on with younger adult populations.

Q: If I could squeeze one more question in, do you think there is a seasonality to the virus, considering that the North is going to be coming upon our indoor season?

RACHAEL PILTCH-LOEB: So I hesitate to call it a seasonality, there does seem to be some level of cyclicality in the ups and downs of the case rates, but they are it’s not necessarily tied so far, at least to a given season. I think what we are going to see, though, is the northeast or north heads into the winter months is an increase in respiratory infections overall, especially now that mask wearing is less required. I know some states have it more than others in indoor spaces. And so I think that we are likely to see an increase in the burden of respiratory infections on the health care system, whether that be RSV, flu, COVID-19, or kind of pick a respiratory infection, poison, and that kind of combined effect on the health care system and just on how people feel on and potentially in kind of the severity of their infections is likely to be a burden this winter.

Q: Thank you.

RACHAEL PILTCH-LOEB: Thank you.

MODERATOR: Next question.

Q: Great, thank you so much and my apologies, I also find it a little late. So if you’ve already touched on this, I apologize for asking repeat yourself, but I was just expecting this announcement from the CDC advisory committee today on who gets the booster. And I just wanted to ask, I guess, number one, what you expect to see in that and also what you’d like to see.

RACHAEL PILTCH-LOEB: Sure. So I think I would be surprised if CDC doesn’t follow kind of what came out of the FDA and the EUA yesterday, meaning that we expect boosters to move forward for the 65 and older population, for those who are high risk between 18 and 60 for and for those who work in high risk occupations. I hope to see some specificity around what we mean by high-risk occupations and higher risk kind of immunocompromised groups. Meaning and I think especially on the workforce front, there’s been talk that, of course, about health care workers or those who are more likely to be exposed as part of their profession with the notion that kind of a booster is likely to reduce kind of the severity of infection, should they be infected so that they can get back to work more quickly, that they kind of experience less burnout. But it’s a question if that’s going to apply more broadly to grocery store workers, other front line essential workers, transit workers, for example, to K through 12 teachers or preschool teachers or kind of that broad bucket. The question is, it’s going to apply to that broad bucket that was in kind of the groups one, A, B and C when the vaccines were first rolled out. Is it going to be more limited? Because it does apply that broad bucket, we’re talking about an incredibly large portion of the domestic workforce here. And that’s different from making it kind of recommended for those who different meaning just in terms of sheer population, then those who are just, say, only health care or emergency service workers. So I think I’m hoping that there will be some clarity and guidance around those two issues in particular.

Q: And should it apply to those workers, to the people working in grocery stores and the nurses and the teachers? Would you like to see that it extended to them?

RACHAEL PILTCH-LOEB: I mean, I think it goes to a question of why is it being recommended for the for those workforce groups if it’s to thus far there really haven’t been studies to the to the best of my knowledge, if anyone on this call knows, I would love to see it, but to demonstrate that folks in any of those what have been deemed essential workers, grocery store workers, transit workers, et cetera, had higher rates of infection, hospitalization, death than those who are in other professions. That being said, you know, which I think would be the logic for giving the booster to those groups and health care workers. That being said, if folks who are working in those professions perceive that the booster is going to help protect them so that they can continue to go to work, and it will add to that level of kind of comfort and security and continuing to go to work where they have to interact with folks who may not be vaccinated, who don’t want to wear masks, et cetera, then they should be able to get a booster if you’re asking me, does the data support them being included, I’m not sure what data supports it at this time. I don’t think we’ve had significant population level studies of these groups. There have been kind of smaller studies, but I think that those are two different questions, meaning do we have the data to support them being included versus should they be able to get one for their kind of comfort and security as they pursue their professional obligations?

Q: Thank you very much.

RACHAEL PILTCH-LOEB: Thank you.

MODERATOR: Next question.

Q: My question is, now that the FDA has approved a vaccine for certain groups, does that place a burden on doctors, pharmacists, anyone who’s giving the shot to prove that someone’s over 65 or that they have some sort of high risk element that makes them eligible? I mean, it’s sort of seems like it’s not approved for everyone. So how do the doctors sort of navigate that, whether someone really is eligible or not?

RACHAEL PILTCH-LOEB: Yeah, so it’s a good question and I think that it’s a little bit of an honor system. So if we go back to how the vaccine was being rolled out initially and there were certain priority groups that were supposed to get it first, depending on where you were located, you needed to certify that you fit and you didn’t really need to prove anything otherwise. And so I think that it is likely to be kind of a similar system now. Pharmacists, doctors, et cetera, will ask, do you work in a high exposure profession or are you high risk because of X, Y and Z underlying condition? Over 65, probably the easiest to prove by just showing a form of I.D., but in some locations, you’re not even asked to show ID because of immigration status or various other reasons that folks weren’t asked. And so I think it is likely to be an honor system. And I think that it is very unlikely that there will be punishments, ramifications in terms of licensure or something else if doses are administered beyond kind of the approved usage.

Q: Great. Thank you.

RACHAEL PILTCH-LOEB: Thanks.

MODERATOR: While waiting for anybody else to raise your hand, I have a question in Greece. She said the Greek schools was open recently and already one out of four COVID-19 patients are children. Many scientists predict a new pandemic wave as winter is approaching. And the US, you have already felt the impact. How can a new wave be prevented?

RACHAEL PILTCH-LOEB: Yes, I mean, so I haven’t looked at the Greek data, but from what I understand about the question, one in four patients that are hospitalized have been children. And I think that that’s certainly scary and something we want to keep in mind. But I guess the question, it becomes a broader picture question, meaning when we say one in four of those who are hospitalized have our overall hospitalization numbers gone down. And now the groups that are left who are kind of dealing with the experience are sort of a smaller, rarer number of people who have been infected. So I think the question is, you know, there are various it’s a pretty broad question, but there are various strategies that are being tried in various parts of the US around what to do around kids. The notion that if there’s been exposure in schools, there’s kind of the concept of tests to stay, meaning, you know, individuals who may have been exposed as long as they continue to test negative for a seven-day period, they can continue to participate in school. So one concept is relying a lot on rapid antigen testing, should it be available kind of in the area where folks kind of can kind of provide proof of a negative test to continue to participate in school and other aspects of society? Again, unsure about the vaccination rates in Greece. And I apologize for just being less familiar but, of course, you know, continuing to make vaccination be the norm so people have to opt out to be vaccinated. It’s similar to Italy’s kind of green pass. You either need to show proof of vaccination or proof of a negative test within the last 48 hours in order to participate in indoor activities or for various other kind of aspects of daily life. So relying on kind of a multi prong strategy that includes rapid antigen testing, of course, vaccination mask wearing, et cetera, would be kind of the general the general recommendation. I think if we’ve seen anything over the course of dealing with the Delta variant, it’s that relying on just one thing alone, such as vaccination, for example, is not enough, especially given, at least in parts of this country, the rates of vaccination. Relying on vaccination is not enough to prevent another wave of the pandemic.

MODERATOR: Thank you. She had another question. Do you worry about new, more dangerous mutations of the virus?

RACHAEL PILTCH-LOEB: I think we should absolutely, absolutely be monitoring this additional virus variants. I think that we are there’s efforts to do that globally, but there it’s still relatively limited. And I think that what we want to do is get as many people vaccinated as quickly as possible to limit the opportunity for variance and additional mutations of the virus kind of going on checked in unvaccinated populations. So I think it is always kind of a lingering concern. But so far at least, we have not encountered a variant that the vaccines do not work against.

MODERATOR: And her last question is, how can we persuade people to get vaccinated?

RACHAEL PILTCH-LOEB: Oh, that is a wonderful question, and I’m sure we would all love to answer that. And I think that my answer is it depends like any good researcher would say. But what it depends on is kind of what are their underlying concerns or reasons for not getting vaccinated. So they think step one is understand what the issues are, understand the reasons that people are hesitant, I think, depending on what those responses are, proceed with a targeted kind of communication strategy and be prepared to have individual at times really lengthy conversations about the reasons for vaccination, I think include comments, the strategy that makes people aware that there’s a lot of misinformation out there about vaccines and individuals are going to go and pursue their own online searches. They’re going to talk to their family, their friends, their whomever. But I think one of the things we often just don’t say or talk about is that, you know, be aware that there’s misinformation. I can’t tell you what all of it’s going to be, but just be cognizant of that. And if you have questions, try and find some trust messengers. And maybe that’s your position and maybe that’s a risk communicator at the government level. It’s going to vary a lot. But be aware of misinformation, be willing to have kind of hard conversations. And then, of course, there’s the carrot and the stick approach, meaning, you know, incentivize people to be vaccinated, be willing to have those conversations. And at various points, you require vaccination for various activities where it’s too risky to not have to have that unvaccinated groups together. And in the US, there has been various vaccine requirements for entry into given activities, and it varies by locality. But it has been and certainly employers have started to require it. And there has been a shift, at least in some portions of the population, because getting vaccinated has become the path of least resistance. So to summarize, understand the issues, be willing to kind of have a detailed communication strategy that recognizes misinformation and is prepared to have ongoing conversations with populations or population groups that are hesitant and think about how to incorporate vaccine requirements but don’t rely on them alone.

MODERATOR: Thank you. Next question.

Q: Thank you for another shot it I, I just wanted to ask a little bit about the ethical balance with regards to booster’s when there’s a lot of concern about global vaccination rates being as low as they are and that you should perhaps not be giving a third shot when so much of the world has not yet had a first as the CDC is making its recommendation today. Can you just sort of weigh in about that challenge?

RACHAEL PILTCH-LOEB Besides just say it’s definitely a challenge? No, I completely agree with you that we and the US had originally committed it in pretty vague terms that they would kind of support. And they have continued to acknowledge that they will support kind of the donations of millions, hundreds of millions of doses of the vaccine, the Pfizer vaccine. That being said, there has been a lot of criticism, critique, whatever, from the global community that the US in particular is not doing enough to actually get that vaccine out. And I think that that’s an echo, that sentiment that the US could certainly be doing more to bring the vaccine to more people. What giving vaccine is, is a pretty vague statement. You know, there needs to be support for kind of health systems strengthening in health systems delivery and rollout to actually bring the vaccine to two individuals, oftentimes, who are in not only urban but incredibly rural communities. And so, yes, the US has an obligation. No, they are not doing enough. Does that change what the CDC is likely to recommend in terms of booster shots? No, meaning, I think that the US will continue to look internally at the data, what the needs of the United States population are, and make a recommendation related to booster’s despite the need to support things more globally. So I think it’s definitely a ethical challenge as the US, as a citizen of the world. But I do not think yet that that challenge has risen to the level that it is shifting domestic policy related to boosters. I think that the conversations are largely uncoupled for better or worse.

Q: And if I could just follow up quickly to your point. We’re talking about Pfizer here, and as a Massachusetts based journalist, very interested in Moderna, local company here. And any thoughts about the future? It sounds like we should be hearing about the Moderna booster sometime in the near future.

RACHAEL PILTCH-LOEB: I think that Moderna is likely to submit a package very similar to Pfizer looking for approval for a booster for their vaccine. I think that, as someone else asked earlier in the call, I think that the open question is going to be whether or not CDC and FDA approved or really the CDC recommends that vaccines can be mix and match, as other countries have done, which would frankly make the delivery of boosters just more practical.

Q: Thank you.

MODERATOR: Next question.

Q: Hi, thanks for letting me double dip. I just wanted to ask how you’re thinking about whether boosters should be a tool for reducing transmission. And you mentioned that you watched the meeting yesterday and there was some evidence around nursing homes and boosters not reducing transmission as much as reducing it in the community and making sure staff was vaccinated. So I think Peter Marks said before the overpack, like consider this evidence as it could help transmission and curb this pandemic. But should we be thinking about booster’s that way? I hope that makes sense.

RACHAEL PILTCH-LOEB: Yeah, I think it’s a good question and it just reflects the complicated environment of what we’re talking about. Right. We have do affect transmission really to translate that, it’s also basically do they prevent infection. Right? The evidence of transmission is whether or not somebody else gets infected by the virus versus do booster’s kind of reduce the likelihood of a severe infection or symptomatology? We don’t know. Obviously, sometimes we don’t know unless we’re doing kind of an ongoing kind of surveillance program whether or not somebody had been infected in the first place until they show symptoms. And I think that from what we’ve seen with the nursing home data, for example, is that the biggest threat to presenting with disease is unvaccinated staff continuing to come in to nursing home settings and transmit the virus to patients there. And I think that the way we should be thinking about vaccines in general, including the boosters, is that these are a tool to prevent severe disease or prevent disease and then hospitalization and death. I think that in general, to ask any vaccine to prevent the ability to be infected excuse me, is unrealistic and oftentimes really difficult to figure out if we’ve been successful at that. Meaning, what are we actually measuring to determine that somebody was never infected? And it’s hard to figure out that counterfactual. So I think that we should we think that we know that it’s less likely that somebody who’s vaccinated is infected. If we look at the rates of transmission. But if you continue to circulate or have unvaccinated folks, unvaccinated, vaccinated folks in a population vaccinated, folks are more likely to pass it on. They shed virus for longer. They have higher viral loads for more prolonged periods of time. There is data to suggest this. So the biggest threat to even super-vaxed or people who have gotten the third shot and have gotten that booster in a nursing home are the unvaccinated. So I guess to summarize or hopefully answer your question, the way I’m thinking about the boosters is really to prevent kind of any symptomatology in those who are at high risk for kind of really adverse effects should they become infected with the virus. And we can actually measure that because we can see kind of how the disease presents in the event that somebody even test positive for the virus. We also can simply just see whether or not there’s a reduction in the number of people who are hospitalized coming from nursing homes, if we’re not going to be have to have ongoing surveillance of these populations. So the way I’m thinking about boosters is as a tool to prevent even the most limited infections rather than as a tool to prevent limited infections being symptomatic rather than as a tool to basically say that the virus will no longer exist in these populations.

Q: Thank you.

MODERATOR: All right, it looks like that is our last question real quickly, anybody else have anything? OK, Dr. Piltch-Loeb, do you have any final thoughts to share with us before we go?

RACHAEL PILTCH-LOEB: I don’t. Thank you all so much for your time today. And please let me know if anything comes up after this.

This concludes the September 23rd press conference.