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COVID-19 CDC Update – Early January 2022

Former CDC Executive Secretariat of the Advisory Committee on Immunization Practices Amanda Cohn, MD, joins JAMA Associate Editor Preeti Malani, MD, for the latest on the need for vaccination and boosters, vaccine misinformation, and tackling the pandemic from a global perspective. Recorded January 6, 2022.

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Dr. Malani: Hello. I'm Dr. Preeti Malani, JAMA associate editor. I'm also the chief health officer at the University of Michigan and a professor of medicine in the Division of Infectious Diseases. I'm joined by Dr. Amanda Cohn from the CDC.

Dr. Cohn is the former executive of secretariat of the advisory committee on immunization practices, and she remains deeply involved with vaccine policy for the CDC. Clinically, she's trained as a pediatrician. Dr. Cohn, welcome. Thank you for joining me today.

Dr. Amanda Cohn: Thank you for having me.

Dr. Malani: Amanda, it's an understatement to say that this has been an exceptionally busy time at the CDC, so thank you.

You recently published a Viewpoint in JAMA titled, One year of COVID-19 Vaccines: A Shot of Hope, a Dose of Reality. This was coauthored by your colleagues, Dr. Barbara Mahon and of course, Dr. Rochelle Walensky, who's the CDC director.

It was published online on December 21st marking one year since the first authorized COVID-19 vaccine was administered in the US. I have to just say as a frontline infectious disease physician, I get a little emotional even talking about this.

In just over a year, worldwide nine billion doses. Nearly half the world fully vaccinated and closer to home, nearly 210 million in the US fully vaccinated. Having received their primary series. It's about 63% of the overall population and an estimated 35% are now boosted, but that means a lot of people are not vaccinated.

Some have had a single dose, some are not yet eligible, the under fives for example, and this leaves about 25% of the eligible population that has not received any COVID-19 vaccine, which gets back to my favorite statement in the Viewpoint, "Vaccines do not save lives. Vaccinations do." Can we dig into this a bit?

Dr. Amanda Cohn: Sure. Yeah. I think the title of the Viewpoint article is meant to describe exactly that dichotomy of this incredible feat, but also the huge problem of the unvaccinated and both those who choose not be vaccinated, but also we still need vaccines available for those who are less than five years of age.

That comment, "Vaccines don't save lives, vaccinations do," was made by one of my mentors, actually I think many mentors in the immunization world, but Dr. Larry Pickering many, many years ago to me. I think it just continues to remind us all that we can have these amazing scientific accomplishments that really have the capacity to save lives, to reduce the burden of disease, to get people back to normal, and we can do everything.

We have done everything over the past year to make these vaccines as accessible as possible. To educate the community, to educate providers, to really make this a very local activity to get people vaccinated. Yet we still have one in four people are choosing to not get vaccinated and we're still losing lives from COVID. Over a thousand a day. Almost all of those lives are lost in unvaccinated individuals. It remains sad.

I think we started writing the Viewpoint before we knew about Omicron and when we finished it, we did know that Omicron could be a problem. We didn't know what a huge problem it would be today, but I think it just is a stark reminder that vaccines are critical to saving lives. They may not prevent every infection.

We're having cases of breakthrough disease even in people who have gotten the booster shot, but these cases are much milder and we're not causing hospitalizations and ICU admissions in vaccinated persons. It doesn't help to have the technology. You got to get it in arms.

Dr. Malani: Yeah. As I reflect a year ago, there was this portion of people who immediately wanted to get vaccinated. In fact, they couldn't wait to get vaccinated. Then some needed a little time, a little bit of a nudge to feel comfortable, and others had issues with access.

I think back to online scheduling for especially older adults and transportation, and there were a lot of efforts to address those barriers through that social determinants of health, health equity lens, but today what is being done to turn vaccines into the vaccinations?

Dr. Amanda Cohn: Yeah. I mean, our options are getting more limited. We're still trying as hard as we can. I think, as you say, early in the program, there were clearly barriers to vaccination that frankly, I didn't anticipate. Many people didn't anticipate with regards to the digital technology that was needed to make appointments. The older individuals being able to get to appointments. People who were at most risk for severe COVID. People who are most vulnerable were having the hardest time accessing vaccines.

We were able to address those by getting community organizations to help support us. By getting health departments, and transportation companies, and people just literally jumped in and drove around and picked up people and took them to get vaccinated. Those are the types of things that were from my perspective so amazing to see.

Now, we're shifting to a demand problem. The people who are not vaccinated, there's probably still a small minority of people who may still really have trouble getting those vaccines. People who are either disenfranchised from either being very mobile or not having a home and things like that. Almost this entire group of people are individuals who don't believe they need to get vaccinated. Have concerns about vaccine safety and just don't trust vaccines. Don't trust the science and it's really hard to convince people with accurate information when they're getting so much disinformation and misinformation thrown at them through so many different avenues.

Sometimes that misinformation it's hard to disentangle. I do believe that there are people who haven't gotten vaccinated who have real concerns. It's not political. It's not just to be difficult or abstinent. They really do have concerns, but they're having a hard time accessing the right information. People may not trust CDC.

We really need healthcare providers. We need everybody who has a hand. When I say healthcare providers, I mean physicians, and pharmacists, and nurses, anybody who is in the healthcare space needs to talk to their family and friends and to their patients and to everyone who comes in and say, "These vaccines are safe. More people have received this vaccine and under the greatest amount of safety surveillance, and these vaccines will protect you from what can be a very serious disease and from potentially long term COVID and things that we still just don't understand."

Dr. Malani: Yeah. I guess lots of work to be done. Those first doses have been very flat and I think we did see some increase during that initial Delta surge. I love watching that CDC Dashboard and I'm kind of interested in seeing what happens right now with Omicron, but lots of work to do in January 2022.

I wanted to talk a little bit about the Janssen or J&J vaccine, which is in the US relatively small group of people compared to certainly the two mRNA vaccines. Again, around on the world, a larger population and there have been some well described safety concerns. They're very rare, but potentially devastating. Most notably this is the cerebral venous sinus thrombosis.

I know you were involved with this discussion last month when the CDC made a recommendation that people should not get J&J when either of the mRNA vaccines are available. Can you just talk about what is the status of people who've received it in the US and around the world, and are we using this vaccine at all?

Dr. Amanda Cohn: Yeah, I think in the United States, the use of the Janssen vaccine is limited. Very limited. I think there are still individuals who would still prefer to not get an mRNA vaccine and the J&J vaccine is available for those individuals. For those, people who have already gotten vaccinated, this very rare adverse event, which is very serious and has caused deaths in the United States, does occur the short period after vaccination.

We don't have concerns about the long term safety in individuals who have received the J&J vaccine already, but this rare side effect in the setting of COVID, when we didn't have widespread access to the mRNA vaccines, the risk benefit balance still favors the J&J vaccine. Getting vaccinated as opposed to getting nothing, but we're now in a setting where we have widespread availability of mRNA vaccines, which also demonstrate higher effectiveness with the two dose series and do not have this rare but serious adverse event.

The decision was made to prefer the mRNA vaccines from a vaccine policy perspective, while still ensuring that there's access to the J&J vaccine. Well, I still know it can be very hard to find, but there are doses out there and there are still individuals... For example, there are individuals who may be allergic to a component of the mRNA vaccine. There are some young adolescent boys who had myocarditis after their second dose of an mRNA vaccine, and they may choose to get a booster with the J&J vaccine.

Most of the cases of the thrombosis with thrombocytopenia were in women of childbearing age. We did see cases in older adults and in males, but for a young male who had myocarditis after an mRNA vaccine, the J&J vaccine may be a good choice for their next dose.

Dr. Malani: Yeah. Lots of nuance and that's helpful to think about that.

You are obviously at the CDC, but you're trained to as a pediatrician. A question that comes up all the time is what about the little ones, the under five? Can you talk about what's happening with COVID vaccines in the youngest kids, and when is it going to be their turn for vaccination?

Dr. Amanda Cohn: I know that our colleagues at the FDA and our colleagues in the pharmaceutical companies, at Pfizer and at Moderna, are doing everything they can to move as quickly as they can for vaccines to be available in the under fives.

They are testing a third dose in this age group. The results after the two doses of the Pfizer vaccine, did not meet the level of immunogenicity that they wanted to see in these kids. There's been a lot of discussions about whether or not these vaccines should be three dose series even in adults, but they're testing an additional dose. It is a lower dose. Just to remember that the five to 11 dose of the Pfizer vaccine is actually a third of the adult dose. Then the dose that they're testing in under fives is even smaller than that.

They're trying to find the most effective and safe dose and schedule. I do believe that we'll get there in the next couple of months. I'm hopeful that we will have vaccines available for that age group certainly before the summer, but I'm even hoping by late spring.

Dr. Malani: Yeah. That's helpful. I know lots of families are waiting for that announcement and they were certainly a little disappointed when the information came forth that it was not successful or immunogenic in the current studies.

I think that's interesting because the question is people send you they're like, "You know I have a four and a half year old, but the four and a half year old's like as big as a five year old." I just tell people like, "Listen, vaccination's not just about protecting the individual. It's about protecting everyone around you and just hang on." It's helpful to hear that from you.

[00:14:00] Dr. Amanda Cohn: We do need to tell those families to hang on. They're not available. They're not under this emergency use authorization. We really do need to stick with what FDA has authorized, but similar to what you say to families, make sure everyone around those young children are vaccinated and get their booster doses. That's the best way you can protect those young kids until we have vaccines available.

[00:14:27] Dr. Malani: Yep. I have to say many of them are very good at wearing masks and they've been wearing them for a good portion of their life. Hopefully they'll get to the point where they don't have to wear them, but in the meantime, that also works.

[00:14:39] You made a comment about the series, two doses versus three. I wanted to shift a little bit to boosters. Now I have to say this recommendation's evolved relatively quickly. Not that long ago, a few months ago the thought was, oh, maybe it's unlikely that we're going to need these because the vaccines are so great. Then they were doing boosters in Israel and then we were talking about third doses in immunocompromised individuals. Again, narrow list of people, pretty profoundly immunocompromised.

[00:15:09] Then it was nursing homes and healthcare workers. Then soon it was older adults and then all adults. Then just a few weeks ago, the CDC added 16 to 17 year olds. As of yesterday, and we're recording this on January 6th, the question of 12 to 15 year olds came up.

Is that definition of fully vaccinated shifting and alongside with that, what data have informed these incremental recommendations? I'd like to talk both about vaccine effectiveness as well as safety and you touched on this because this is a question I'm getting from parents sometimes who are concerned about that myocarditis risk because especially in younger kids, which of course is thankfully very rare, but so is severe COVID in this group.

Dr. Amanda Cohn: Right. The CDC director yesterday, last night, did approve the 12 to 15 year old booster dose recommendation. I think much of the rapidity of which these booster dose recommendations have been changed is in the setting of Omicron where we're really starting to see even though these cases are milder, there is such widespread disease right now. There is evidence that a third dose will protect. It may not prevent Omicron, but it will reduce some transmission and will likely be more effective.

I'm going to start with the fully vaccinated versus... The language that we're trying to shift to, which is really up to date on your immunizations. Fully vaccinated, that language was used initially to talk about the primary series, which was a two dose series for mRNA vaccines and a one dose vaccine for the J&J vaccine. Then as additional doses for immunocompromised persons and then booster doses came up, that language doesn't really mean makes sense for everyone.

Fully vaccinated is different given your individual circumstances. The CDC's trying to shift to language that says up to date on your vaccines. This is the type of language we use all the time in kids going to school. You have to be up to date on your immunizations.

For an immunocompromised person that might mean three doses, and then six months later, a booster dose. For somebody who's not immunocompromised, that would mean two doses of an mRNA vaccine and then a booster dose. These might change over time and it does depend on your age and all of that. For a five to 11 year old it is just two doses still.

The booster dose recommendations did evolve quickly, and it was the safety concern that... They evolved quickly, but they were iterative and incremental. Certainly in the beginning, the focus was on older adults and persons living in long term care facilities as the main focus. Those were clearly the individuals we were seeing with severe COVID and death in vaccinated persons that were occurring about six to eight months after vaccination.

As disease rates sort of started picking back up again and I think especially around concerns around people traveling and the holidays, it sort of kept pushing the desire to have booster doses more broadly available forward more quickly. At the same time, we were able to get additional data from Israel that demonstrated that the myocarditis risk after a booster dose is actually lower than the myocarditis risk after the second dose.

The concern was that we would be giving booster doses and the rate of myocarditis the risk would be higher. That risk benefit balance we would have to be careful about because the third dose, the booster dose, it's to give you a boost of protection. It's to sort of augment your protection. Two doses really does protect well in healthy individuals from hospitalization and severe COVID.

We don't want people to be hospitalized from myocarditis when they're unlikely to be hospitalized from COVID, but as data came out from Israel showing very clearly that the risk after a third dose, when you've had five months between the doses is between that first and second dose. The risk after a first dose for myocarditis is very low. It's really that second dose in adolescent, primarily boys, that that risk was higher.

Still rare, one in five to 10,000, and the cases were mild. As opposed to the J&J very rare, but very severe adverse event of thrombocytopenia with thrombosis. The risk benefit as we had more evidence to support the safety of that third dose, it started to shift more towards boosting. Especially as Omicron we started to recognize that it was going to take off very quickly.

Certainly as this was discussed quite a bit at the ACIP meeting yesterday, vaccine is not the only way that we can protect against Omicron. It is only one tool. We still have to mask. We still have to socially distance, but it will add an additional layer of protection for adolescents and adults to get that booster dose.

Dr. Malani: Yeah, it's really helpful. It just gets at how complicated this is and how difficult the communication has been around the pandemic really from day one.

Dr. Amanda Cohn: I know that we constantly get feedback that we're changing our recommendations too often and too quickly, but we have changing data coming in and changing information. It's that balance of do you make the right call based on the science in that moment, knowing it may shift or do you not? It's been incredibly challenging.

Dr. Malani: I often say as the pandemic changes, our recommendations have to change and it is frustrating, but we all have to remember we're still in the midst of this global pandemic. We're not done yet.

As you look ahead, do you expect fourth doses? Again, you mentioned Israel. There's some data now around people who are immunocompromised that maybe a fourth dose would be helpful. As we look at the general population too, the recommendation on additional boosters.

What data will the CDC be paying attention to, to really sort this out and to really determine timing if and when that even happens?

Dr. Amanda Cohn: Right. I think there's two questions. One is, will there be a need for fourth doses, for an additional booster dose? But then sort of the corollary question is do we need a new vaccine that targets some of these... As we have new strains for the flu vaccine every year, will we need to shift the strain of the vaccine as the virus evolves?

I think that question really remains to be seen. There was a lot of talk and I think the companies even started working on vaccines for Delta, but as soon as we got through Delta, Omicron happened. It's really hard to change the vaccine in a timely enough way to be impactful.

The wild type virus that's used in the current vaccine, we know that if you can boost the antibodies and you have high circulating antibodies, there will be some cross protection. It may not be as great as we're seeing with Omicron. We are seeing breakthrough cases, but it is preventing more serious disease.

There's a lot of discussion about what the overall goals of the vaccine program are. Is it to prevent severe disease, hospitalizations, and deaths or can the vaccination program help support reducing transmission and get people back to normal?

I think it's going to be too much to ask that these vaccines... These vaccines clearly will not eliminate transmission. They're not going to solve the pandemic. They could if we got vaccination coverage up really high, we could have much more endemic, minimal, less severe disease, and we could move on.

The thinking is that this is going to be an endemic virus, and we're going to have to continually work to keep rates low and to keep morbidity and mortality low. Hopefully there'll be some therapeutics that will help with that in the near future and I think that will be another really important tool to add to our toolbox, but vaccines are kind of the one tool that we have that you don't have to rely on people around you staying masked. It's sort of the one tool that could help us get more back to normal and get those masks off.

I still say, and everyone, I mean, this is the key point is we're not going to make progress until we get those 25% of unvaccinated individuals vaccinated. We can vaccinate the individuals who are vaccinated over and over again, but we're still going to see deaths and we're still going to have overburdened hospitals and an exhausted healthcare system because 25% is still millions and millions of people in this country.

I do think fourth doses and additional doses will likely need more doses, especially primarily in immunocompromised persons and potentially in older adults. We keep saying after this next phase maybe we'll get to a point where we have more limited transmission and we won't need an annual vaccine or a dose every six months against COVID.

Dr. Malani: Yeah, I guess it remains to be seen and I think we'll learn more in terms of reinfection. We're seeing that now with documented reinfections, mild infections, thankfully. I think that march towards endemicity is going to be different in different places since that 25% are not evenly distributed across the US certainly.

Dr. Amanda Cohn: Right. Yeah.

Dr. Malani: I want to circle back to misinformation and you addressed this in the Viewpoint. I want to read this you write, "Although spreading vaccine hesitancy at the population level is easy, counteracting disinformation is uniquely challenging in the context of widespread use of social media. It often requires time for one-on-one discussions, active listening, attention to personal concerns, and thoughtful answers to questions."

I have two related questions that come to mind. One is the issue of confidence and transparency, and the other is more specifically related to misinformation. You mentioned V-safe in the Viewpoint. Again, this was a really exceptional circumstance where hundreds of millions of doses of vaccine were given in a relatively short period of time. What has the CDC learned from V-safe?

Dr. Amanda Cohn: V-safe a has been really an amazing tool. We've had millions of people report into V-safe. It's really allowed us to see that the mild side effects, the reactogenicity that we saw in these clinical trials is very similar in the general population. We do have people reporting one or two days worth of fever, soreness, things like that after vaccination.

We're also seeing that the number of times that people are reporting that they had a medically attended or a more severe adverse event is really remarkably low. There are certainly things that we've followed up. Things like myocarditis have been identified. Partially through V-safe, but also from other types of studies that were being done in other countries.

It really allows us to quickly assess whether, for example, like right after booster dose implementation, we could see if there was a tick in medically attended adverse events really rapidly without relying on the need for reports to the vaccine adverse event surveillance system, which could take a little longer. It's really been a great signaling tool.

The other really unique thing about V-safe is that we've enrolled several thousand. Tens of thousands of pregnant women and so it's allowed us to follow pregnant women more carefully. We have a V-safe pregnancy registry where we are following up with moms, finding out about their deliveries, and after their deliveries to look at infant outcomes. I anticipate in the next month or two we'll have our first set of papers shows that we're not seeing birth defects or other adverse events in infants.

Dr. Malani: Yeah, no, I'm glad to hear that because pregnancy has been one of the risk factors that we see certainly for severe disease. I think that's been a difficult choice for pregnant people, and I guess, as more data are out physicians and others can also use that to really counsel people, which gets at sort of the harder question is getting at this misinformation.

You mentioned sort of leveraging that trusted clinician. I think about myself as an infectious disease doctor, but I really think about people in the primary care space who've known patients for years.

How do you even begin to counter that tsunami of information, especially on scale? What is your advice, just practical advice, for people to effectively counsel patients?

Dr. Amanda Cohn: Yeah, that's hard. My husband is a general internal medicine physician. I've watched him to try to counter this for the last year and it's exhausting. I think the first thing I will say is thank you to all of those providers who are trying their best.

Providers aren't given enough time in the office to have these discussions and they can be incredibly uncomfortable and hard conversations. I think that active listening, trying to get at what is this person really concerned about, and not being immediately closing that individual off. Trying to approach them from the perspective of they have valid concerns, and you want to hear what they are because even if they're not scientifically valid concerns from your perspective as a physician to that individual, they are likely valid concerns. That individual does believe this information that they're hearing.

Active listening and then really trying to talk about the risk of COVID. We know. We've given hundreds of millions of doses of these vaccines. They have an incredibly strong safety history at this point, but we also know that there are long term outcomes of COVID. There are severe outcomes. We don't know who's going to get very sick from COVID and COVID is still a risk to all of us.

I think of trying to balance that and bringing back that as a physician, I'm much more scared of a patient having COVID then in a patient having a vaccine adverse event is really an important thing to try to convey. It may take multiple times and I think the one other thing I'll say is that it's like the whole office has to be engaged in this. It has to be from the second the individual walks in the door. There has to be a positive, proactive recommendation to get vaccinated. I know that a lot of providers aren't offering the vaccine so it is just those conversations. It's likely that your nurses, and medical assistants, and the front office staff are just as trusted as you as their provider.

Dr. Malani: Yeah, no, absolutely. In fact, nurses are so trusted when you think about across the population. I think that nurses have been heroes from day one in this pandemic and even before the pandemic, for sure, but I've seen some really great outcomes with that. We just have to dig deeper, and empathetic listening, and just continue to do the hard work as you know it.

I'd like to shift to the last part of the Viewpoint, which titled, or the subhead anyway. I'd like to shift to the last part of the Viewpoint, A Global Pandemic Must Be Met With Global Solutions and you and your co-authors write, "The US and the global community must do all they can to ensure that populations have accurate informations about the benefit of vaccines, that doses are available, and that countries have of resources for administration."

Already the US has delivered nearly 300 million COVID vaccine doses to more than a hundred countries. Again, that number has increased since the time you wrote this not that long ago. This is kind of interesting, what are the major concerns in the global space?

I asked this because the many people assume that it's supply, it's infrastructure, it's systems, and vaccine hesitancy is an issue around the world. How do we better support vaccine equity around the world?

Dr. Amanda Cohn: Yeah, that's a great question. Vaccine hesitancy is one of the biggest challenges and one of the reasons why that's the first thing that we have to support from a global perspective. If we are concerned about misinformation being a problem in this country, it's more expansive in countries where social media may be their primary source of information.

Vaccine hesitancy and access go hand in hand, for sure. We have to make sure vaccines are highly accessible so that it's easy for individuals to make the choice to get vaccinated. This is especially true globally. If you think about all the other challenges. People having to get their water each day and just make sure they're fed, we need to make sure that they can get access to vaccines super, super easily. Kind of like with polio vaccines.

We went into people's homes and into those communities and villages across the world. It took incredibly extraordinary efforts to get that done, but at the same time one of the key ways to support increasing vaccine demand is to normalize it in communities. If we think that every community in this country is different, and unique, and has its own perspective and challenges, that's just times a million across the world.

We need to support local public health globally to go into these communities, to talk to those communities, and to have vaccine easily available to give them when they're ready for those vaccines. It is a huge effort that is kind of unquantifiable in terms of the just person time and the resources. This is in the context of many of these countries having huge COVID outbreaks at the same time and lots of other either political or other disease outbreaks and things like that. It's going to take time. We've got to work in that environment and just continue to push ahead and reach people where they're at. Kind of just like what we talked about with providers in the offices, with their patients, but at a local community level.

Dr. Malani: Yeah. There've been a lot of successes in from the HIV world and everything from treatment to testing. Probably lots to learn in that space.

Dr. Amanda Cohn: Yeah and in fact we're actually using a lot of our HIV partnerships to help support a lot of the work that we're doing both domestically and globally for that exact reason. They've been working for years on having local community efforts.

Dr. Malani: Yeah. It gets back to that ever important trust issue.

The last sentence in the editorial reads, "The dissonance between highly effective vaccines and a virus that continues to evolve is a reminder that while there have been some successes, it's essential to remain vigilant to what may come next." My last question for you is what may come next?

Dr. Amanda Cohn: Well, if you remember, we wrote this before Omicron took off. That's the current next. We don't know what will come next.

I feel confident that vaccine safety is something that we understand really well now. We understand the signals and that there will not be a big vaccine safety signal. I do think it'll be a potential change in a variant that even more greatly escapes protection from vaccines. That's the most likely scenario. Where we'll really have to either change the vaccine or have some other way to manage potentially cases that are not preventable by vaccines.

Hopefully with the onset of therapeutics and other ways to protect individuals, we can evade a next being too serious. Fortunately, we're not seeing increases in deaths. We're still seeing about a thousand deaths a day with Omicron, which is not low enough, but we're not seeing yet huge increases in deaths, but certainly a mutation that escapes the vaccine entirely will be really profoundly problematic if that happens, which hopefully it won't.

Dr. Malani: Yeah, it's a terrifying thought and a little bit depressing also. Very depressing actually. I hope that is certainly not the case and that in fact we can continue to march forward and get first doses in people and eventually in kids. As you mentioned, the therapeutics, which is a whole other success story.

We have learned a lot in two years. I hope some of what we learned though can also move beyond infectious disease and really support health more broadly.

Dr. Amanda Cohn: A hundred percent. I mean, the profound lessons we've learned in health disparities and really understanding social determinants of health is I hope will be... We're forever more changed the way we think about healthcare.

I do want to say on a positive note though, I do believe that if we do have that next, that we have incredible scientists and manufacturing processes in place to rapidly change the strain to address the next.

I don't want to leave everyone too depressed. I really do think that we could rapidly identify a vaccine strain that will protect. It will just be a whole nother process.

Dr. Malani: Thank you so much, Dr. Cohn for joining me today.

Dr. Amanda Cohn: Thank you for having me.

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