TWiV 780 COVID-19 Clinical Update #71

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 17 July 2021

pdf of this transcript available (link)

Vincent Racaniello: This Week in Virology, the podcast about viruses, the kind that make you sick.

[music]

From MicrobeTV, this is TWiV, This Week in Virology, Episode 780, recorded on July 15th, 2021. I’m Vincent Racaniello and you’re listening to the podcast all about viruses. Joining me today from New York, Daniel Griffin.

Daniel Griffin: Hello, everyone.

VR: Daniel, this is update number 71. What’s going on here in New York City?

DG: There’s a lot of stuff going on and not great stuff going on, so I’m going to jump right in with my quotation, and then I’m going to give the update because things are headed in the wrong direction, maybe we’ll talk a little bit about why. “In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual.” And that’s Galileo 1632. He was Italian. Wasn’t he Italian, Vincent?

VR: He was.

DG: [laughs] Okay, and I think revered in his time, right?

VR: Well, by some, not by everyone. A lot of people thought he was heretical to propose that the Earth was round and all of that stuff.

DG: Yes, and the whole thing’s not revolving around the Earth to move away from an Earth-centric world of view.

VR: Yes, he got death threats for sure.

DG: Yes, so maybe some of our colleagues are having [laughs] similar treatment today and I think we were all locked in our towers, so a lot of parallels here. The reason I bring that up is, I know Vincent you really are a leader in this, but I try to do this as well. I want to share what the science says and not just echo what so many people are saying. If you say it 10 times, it does not make it any more true. What is going on? We are seeing an uptick, and you can read the same article with just a different title. What is this being driven by? It’s being driven by the virus, it’s being driven by behavior, but we’re also seeing some other new developments.

I just want to give people a sense of the amount of COVID we’re seeing across the country is increasing. My buddy, Po, out at the Everett Clinic in Washington, went for quite a while not seeing much and we talked on Monday. He was now seeing 30, 40 a day. I was on the phone earlier today with a friend of mine, Adam Fiterstein, who runs our urgent care centers in the New York area. Bonnie Simmons is his boss and he was saying he went many days without seeing COVID, now he’s seeing 10 or 12 a day.

There’s a little bit of a twist on this. I’m seeing some interesting situations and I’m just going to share a couple of stories. The first one was a colleague of mine, a physician fully-vaccinated, maybe enjoying himself a little bit more than I do, maybe not taking any precautions, ended up starting to feel not well, tested positive for COVID, so had a mild outpatient experience with COVID but then actually brought it home to his spouse and so then his spouse had COVID. Also, his spouse was vaccinated, so it was another mild case. One vaccinated person getting infected, spreading it to another vaccinated person, in this case, both were mild.

Another story was a dad and this is, actually, a friend of mine, not a clinician. He does something else for a living. He started to feel crummy right about July 4th, July 4th is a target date here, went and got tested, he was fully-vaccinated and to his surprise, he tested positive for COVID. Then his son, who’s below the age of 12, started to feel not great and also tested positive for COVID.

It’s interesting, we have a lot of ideas about early on after vaccination, having really high antibody levels, maybe keeping people from getting infected, keeping people from transmitting, but now we’re starting to get six months out from those early vaccinations. Are we starting to see this because of waning antibody levels or we’re starting to see this because of changes in behavior? I just want to share those stories just in case people have a question, “If you’re vaccinated, can you get COVID?” Yes. “If you’re vaccinated, can you get COVID and spread it to other people?” Well, there’s just two real-life examples in addition to the science I’ve shared in the past.

VR: The majority of infections are presumably in unvaccinated people, right?

DG: It is completely true and not only are the infections predominantly in unvaccinated individuals, but looking around 99% of the admissions are in unvaccinated individuals. Just to repeat that; vaccinations are huge at protecting you from serious disease and hospitalization. 99% of the people that end up in the hospital, that are dying from COVID, over 99% are unvaccinated. Get vaccinated, if I haven’t mentioned that before, I feel like I may have.

Now, there’s a lot of pressure, I know, to keep up each week in terms of what’s happening with COVID. I had a nightmare the other night. I was being asked a question and something new had come out in the last hour and I did not know about it, so I woke up in a cold sweat. Yes, it was not COVID. I don’t know what it is. My hope with these weekly clinical updates is to take some of the pressure off our busy clinicians and listeners, and my commitment continues to be, if there’s something really critical that you need to know, I’m going to make sure that I bring it up in my clinical update.

For a deeper dive, I want people to keep listening to Vincent and the crew on the other TWiV episodes. It really is important, and I think we went into this, “Why do I need to know so much about viruses? I think that most people have realized that you need to know a lot about viruses and the more we know, hopefully, the longer period of time before we have something like this and hopefully, we’ll do better the next time.

All right. I will try to keep this at my 30 minutes, but this was an exciting last week. We got updated school and child care guidance from the CDC. This is the much-awaited K-12 school guidance and I’m going to go through that part of this in some detail. Don’t worry, as I go through this, I’m also going to return to the hot button issues because I have realized as I’ve discussed this, there are some.

Number one, the CDC has come out, students benefit from in-person learning and safely returning to in-person instruction in the fall 2021 is a priority. I’ve been saying this for a long time. A lot of us have been saying this. The CDC is really stepping up and saying, “School is a priority.” Number two, right here at the top of the list, vaccination is currently the leading public health prevention strategy to end the COVID-19 pandemic. Remember, we’re ending the pandemic. We have realized we will never get rid of COVID-19. This is going to be part of our life, but in the same comment, promoting vaccination can help schools safely return to in-person learning as well as extracurricular activities and sports.

Now, I know it’s a little bit of a hot button issue, people have said the schools need to open. It’s number one priority, there should be no qualifications, there should be no rules, just make it happen. We’ll get into this a little bit more. There are ways to do this safely and I’m going to go through the science behind these recommendations. Next, and this is the hot button issue, masks should be worn indoors by all individuals aged two and older who are not fully-vaccinated. Consistent and correct mask use by persons who are not fully-vaccinated, people who are not fully-vaccinated is especially important indoors and in crowded settings when physical distancing cannot be maintained.

I’m going to get back to that because not everyone is happy about masks, I don’t know if people have noticed. The CDC recommends schools maintain at least three feet of physical distance between students within classrooms combined with indoor mask-wearing by people who are not fully-vaccinated to reduce transmission risk. This is when it gets a little touchy for some people. When it is not possible to maintain a physical distance of at least three feet such as when schools cannot fully reopen while maintaining these distances, it is especially important to layer multiple other prevention strategies such as mentioned indoor masking.

What they’re saying here is if you can’t get that three feet, if that’s going to prevent you from opening, do not prevent it from opening. You’ve got to open. We’re going to use a multi-layered strategy. Got to get those schools open, is the push from the CDC. Screening, testing, don’t forget testing. Screening, testing, ventilation, hand washing, and respiratory etiquette, staying home when sick and getting tested, contact tracing in combination with quarantine and isolation, and cleaning, and disinfection are also important layers of prevention to keep schools safe. Remember, these are layers. These are lots of things adding up to achieve that safe environment.

Students, teachers, and staff should stay home when they have signs of any infectious illness and be referred to their healthcare provider for testing and care. This should have seemed to me like an obvious thing for many years, COVID is bringing this out. You send sick people to a school, what do we think is going to happen? Now, many schools serve children under the age of 12, who are not eligible for vaccination at this time. Therefore, this guidance emphasizes the implemented layered prevention strategies.

COVID-19 prevention strategy should remain critical to protect people including students, teachers, staff who are not fully-vaccinated, especially in areas of moderate to high community transmission levels. Finally, locality should monitor community transmission, vaccination coverage, screening-testing, and occurrence of outbreaks to guide decisions on the level of the layered prevention strategies. This is all available to go through, even in more detail, at the CDC site.

As I mentioned going through this, there are a couple hot-button issues. Let me talk a little bit about the science behind this multilayered approach that includes masks, improved ventilation, testing, and vaccination in children. The CDC, in addition to this guidance, they actually have a science brief, and this is “Science Brief: Transmission of SARS-CoV-2 in K-12 Schools and Early Care and Education Programs.” This was updated July 9th. This is the CDC’s attempt to communicate the science that is driving these recommendations. I do encourage people to look at this information.

I was having a discussion just yesterday with a friend of mine, Dr. Lucy McBride. She was asking, “What is the science behind these recommendations?” Let me go through what is the science? The CDC is a science-driven organization. They’re not going with hunches, and these are the four points that they base this on. One, children and adolescents can be infected with SARS-CoV-2, can get sick with COVID-19, and can spread the virus to others. Those are true. That’s not something we can just deny. Two, several studies conducted during the COVID-19 pandemic suggested that the incidence rate among children and adolescents was lower than among adults.

Remember, low but not no risk. However, the lower incidence rates may have been due in part to children when compared to adults, having fewer opportunities for exposure. I do really want to point this out. People say, “Oh, only about 500 children died in the last year when we had them locked away, not able to go to school, not able to engage in all these activities.” What happens when you start having children with the same exposure opportunities? It’s an odd wording, exposure opportunities that adults have had.

Point number three, although rates of severe outcomes, for instance, hospitalization and mortality for COVID-19 among children and adolescents are low, youth that belong to some racial and ethnic minority groups are disproportionately affected similar to adults. And COVID-19 deaths among persons aged 5 to 17 years, 120 deaths among– Let me say it again, 71 COVID-19 deaths among persons aged 5 to 17. We saw 120 deaths among those aged zero to four, those were all reported to the National Center for Health Statistics through July 7th.

Just to point out, that was reducing these exposures to the children. We still were seeing deaths. The CDC doesn’t go into this, but I will point out there’s also the issue of long COVID. We’ve focused too narrowly in adults, but also in children, on just deaths and hospitalization. Think about all the children we’ve talked about with cardiac manifestations, with long COVID, who months after COVID, are still not back to normal. Number four, studies of SARS-CoV-2 transmission in schools that consistently implemented layered prevention strategies have shown success in limiting transmission in schools. I’m going to go through a little bit of the science here.

I do want to point out, there is lots of science behind these recommendations. These recommendations are based on about 100 peer-reviewed publications that one can access and read on the CDC site. We’ve talked about some of these studies before. One was the study that we talked about in the end of May. It was a study of 11 school districts in North Carolina with in-person learning for at least nine weeks during the fall 2020 semester. They reported minimal school-related transmission, even while community transmission was high. Now, these schools implemented and strictly adhered to multiple prevention strategies, including universal mask use, physical distancing.

Now, breaches in mask use likely explain the few instances of in-school spread of SARS-CoV-2. I want to point this out, this is kind of an interesting issue. I know I’ve gotten some less than friendly comments from parents. We can actually keep children safer in school, give them the social and educational interaction that is critical compared to if they stay home and they’re socially isolated. At some point, they’re going to get together with their friends, they’re going to get together in a suburban home, which is a high-risk environment. Just really good example here.

Another study of elementary schools in Utah, maybe people remember this one. This is where they implemented layered prevention strategies such as mask-wearing, cohorting, and they found very low transmission, secondary attack rate of less than one percent. I don’t think we talked about this one, but the study of the K-12 schools in St. Louis, again, multilayered prevention strategies in-place. Only 2% of the contacts of the COVID-19 cases tested positive for the virus. This was again, in a context of very high community transmission rates.

We have a nice study out of Italy that they reference. They reference a study in Swiss schools, a German school, and then they finish off their discussion with a study of private schools that reopened for in-person instruction in Chicago with the implementation of a layered prevention strategy. Again, minimal in-school transmission. I do want to point out, this is evidence-based. The CDC is not being whimsical here. We do want those kids in school.

I will just throw one quick scenario, which I encountered today. It was an outdoor learning environment. It was school, young kids, and they spent most of the day outside, but then what they do is they have snack time indoors. They all go indoors, unmask, sit around these tables, and one of the kids had COVID. What do you think happened? I was like, “Why can’t they just have snack time outdoors?” Be separated, apart, then there wouldn’t have been this exposure. There wouldn’t be a shut-down of the venue for 10 days. I want to bring up not only can we keep kids safe, but we can also keep them there in school, not in and out of quarantine and isolation.

All right, pre-exposure period transmission testing. Never miss an opportunity to test. Rates are rising, as I pointed out. These rates are going to keep rising into the fall and the winter. We need to keep testing. We had a nice article, “Comparing the diagnostic accuracy of point-of-care lateral flow antigen testing for SARS-CoV-2 with RT-PCR in primary care.” This was the REAP-2 Study, for those that were following this. It was published in The Lancet publication EClinicalMedicine. I think this was well done, taking what we know about rapid testing. This is a great diagnostic test early in disease, in symptomatic individuals.

In this study, they looked at 2,562 patients with mild to moderate influenza-like symptoms. That’s that classic that we think about with COVID, but we think about with a spectrum of other respiratory diseases; fever, malaise, cough. This was a general practice network in an Austrian district, they were looking at October 22nd to November 30th, 2020. All of these individuals, these patients, received a clinical assessment including both a lateral flow rapid test, so an LFT. Then all the patients that had suspected COVID-19 also went on to get that RT-PCR testing. They reported in this cohort an overall sensitivity for the rapid antigen test in the acute illness of 95.4%, with a specificity of 89.1%.

They talk about positive predictive value, but I’m not going to actually mention that because as we all know, the sensitivity specificity gets coupled with the prevalence, the pre-test probability, so I’m going to leave it with that. If you have a low pre-test probability, if you have a low prevalence in your community, that’s going to impact the translation of your sensitivity and specificity into positive predictive values.

What I will also say, and I thought this was really nice, they had information on my favorite value. What is my favorite value? The CT value, the cycle threshold values. They reported what we would expect our listeners are thinking. Do you think those people that had positive PCRs, but a negative rapid, perhaps they had really high CT values and low viral loads? Yes, that was exactly. The rapid testing was strongly associated with CT values less than 30 and the duration of symptoms being in those first three days.

Those first three days, the high level of RNA, that’s when we’re picking these people up. This is when we’re picking up people who are transmitting the virus or capable of transmitting the virus. I’m going to throw in a little story. I think people like our stories. This was a recent sporting event where they brought people into a cohort. They did all the right things, they tested people, 72 hours ahead of time. They tested them when they got in.

Then day five, someone started to feel ill. They tested everyone. One person, that symptomatic person, was positive. Another person was PCR positive, but in the high 30s. They pulled those two individuals out and that was the end of the spread. Think about different testing serving different roles.

Active vaccination, we had a bit going on in this realm. I thought this was going to be quiet, but no. Never miss an opportunity to vaccinate and vaccination is how this pandemic ends. The FDA updated the J&J vaccine EUA to include Guillain-Barré Syndrome. Reports of the adverse events following use of the Janssen COVID-19 vaccine under emergencies authorization suggest an increased risk of Guillain-Barré Syndrome during the 42 days following vaccination. They’re suggesting that this may be a rate of about two to three million to a two to three per million versus a background rate in the population of about one million. We hear they’re looking at about 100 individuals.

The nice thing about the media getting this out here is now clinicians and patients can report this to VAERS, the Vaccine Adverse Event Reporting System. Actually, got a call yesterday from a neurologist, a colleague of mine. He said, “I got a call from a patient. Is there a connection here with Guillain-Barré? I just diagnosed this individual with Guillain-Barré and about 40 days prior, they had gotten their J&J vaccine.” This is going to help us make that connection. I do want to point out we’re talking about a rate 2, 3 per million.

Again, as I always like to say, you are making a decision between whether you’re not going to get vaccinated, or since COVID is going to be with us, you’re going to get COVID. We saw Guillain-Barré with COVID, we see Guillain-Barré with COVID at a much higher rate than with vaccine parallel here with influenza. We also got some interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine. That’s the Johnson & Johnson Janssen and a viral vector vaccine.

The authors evaluated antibody and T-cell responses on day 239. It’s about eight months after a single shot vaccine regiment, but also six months after a two-shot regiment where they got one shot and they got another. Basically, what they were telling us is, they excluded three individuals or 10 individuals– 10 individuals, three got excluded. These are not big numbers here. One of the individuals had a breakthrough infection, nice spike in their antibodies because of that. A couple others had a big spike in their antibodies, turned out they went and got some mRNA vaccines.

After they excluded those folks, they looked at the remaining and they reported that the Spike-specific interferon-gamma CD8+ and CD4+ T cell responses showed durability and stability over this time period. The same with the antibody levels. There also was an interesting comment. This is really just a one-page or so. There’s not as much in here as one would like, but there’s a lot packed in there. It looked like the neutralizing antibody breadth was expanding over time. That’ll be interesting as we get more data on that.

I think this goes along with what we’ve seen. Those germinal centers keep churning along. People have said two to four weeks after that vaccine is when you’re protected. Well, it looks like that protection continues to evolve over some period of time. Now, we also had another paper. This was forwarded to me by my good friend, Dr. Amy Rosenfeld. The paper was “Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing COVID-19 Hospitalizations in the United States.” This was a preprint.

This was a multicenter case-control analysis in the U.S. adults hospitalized March 11 through May 5th, 2021. The authors looked at 1,210 participants. Median age was 58 years, 22.8% were Black, 13.8% were Hispanic, 20.6% had immunosuppression. The SARS-CoV-2 alpha variant was the most common variant, 59.7% of the sequenced viruses. They reported overall vaccine effectiveness for preventing hospitalizations was 86.9%. They reported that the vaccine effectiveness in patients with immunosuppression was approximately 60% and for patients with active solid organ or hematological malignancies or solid would be– like a liver cancer or a kidney cancer or a hematological malignancy, things like leukemia.

The estimated efficacy was still over 50%. I do want to point this out. I know we’ve seen a lot of these serology studies. For me, this was the really interesting part of the study, was looking at individuals with active cancer, immune suppression. Despite those serology studies, which seem to have said, “Oh, these people they don’t show this immunological evidence. Tell them that they should get vaccinated, but act like they’re not vaccinated.” We’re not seeing hospitals fill with these immunosuppressed people. An immunosuppressed person who gets a high antibody level, we don’t tell them to rush out to a big party. Still that individual who does not show a positive serology test, we’re getting growing experience as well as evidence that those serology antibodies do not correlate necessarily with immunity, and we are seeing benefit in this population.

All right, the period of viral replication, the viral symptom phase. The time for monitoring and monoclonal, and as I like to say, “Where you get tested is ideally where you get your monoclonals.”

We may be moving away from the bamlanivimab-etesevimab into other cocktails and other therapies, but we did get a publication in the New England Journal of Medicine, “Bamlanivimab plus Etesevimab in Mild or Moderate COVID-19.” This was done back before we were seeing a lot of the resistant variants. This was a Phase III trial in which ambulatory patients with mild or moderate COVID-19, who were at high risk for progression to severe disease, were randomly assigned in a 1:1 ratio to receive a single intravenous infusion of either this monoclonal antibody combination agent or placebo within three days after a laboratory diagnosis of severe acute respiratory syndrome, so SARS‐CoV‐2 infection COVID-19.

Nice and early, where we want to see it, the high-risk population, the primary outcome was the overall clinical status of the patients defined as COVID-19 related hospitalization or death from any cause by day 29. A total of over a thousand, it was 1,035 patients underwent randomization and received the infusion or placebo. By T29 2.1% of the monoclonal infuse, the bamlanivimab-etesevimab test group had COVID-19 hospitalization or death as compared to 7% in the placebo group. A relative risk difference 70%.

About 30% risk reduction here. Nice p-values, 0.001. No deaths occurred in any of the people that got the monoclonals. There were 10 deaths in the placebo group. Also, a little more data that there was a greater reduction from baseline in the viral load, people getting monoclonals versus not. This is, I think, proof of principle of the monoclonals. We are shifting to the right monoclonal for the variant that you might have, but I continue to reinforce this is incredibly powerful effective therapy.

All right. Some more negative data on ivermectin with the publication of, “Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials.” This was published in CID, Clinical Infectious Diseases. I don’t want to spend too much time on this paper. As the authors point out, themselves, based on the review, I’m going to quote here, “the quality of evidence was low or very low for all outcomes.” Their comment was that based upon available evidence, ivermectin should only be used within clinical trials.

I have to say, I was a little surprised that this paper was published in CID as the evidence they were looking at was really very low for all of the outcomes. I think if they had gone in the other direction saying we have really low, poor quality evidence suggesting you should use ivermectin, I don’t think it would have gotten published. There is a lot of ivermectin being used out there. What I take away from this is we really need a proper trial, not lots of anecdotes, not lots of small trials.

We don’t need sites with ivermectin in the URL to go to. We also know, and it’s sort of a word of warning, we have a lot of folks out there using veterinary ivermectin products. Random doses, random periods of time, no clear timing relative to infection. This just seems like a terrible idea all around. I do think that we need really clear guidance on the role of ivermectin either way. If we have clear, well-controlled trials that say ivermectin provides some benefit in some people at some time, that’s great. If it comes out the other way, we need to know that because right now this is a bit of the Wild West.

We have believers, we have non-believers. It’s very emotional. We need to know if this has a role in the disease. I think this just, if you like ivermectin, you are angry about this trial. If you are not excited about ivermectin, this is the– I’ve always said I don’t know if this adds– we just don’t have the quality data we need to guide us in this issue.

I’m going to get right here to the tail phase, long COVID. I want to say the CDC seems to have been really busy the last couple of weeks. Everyone else was celebrating the fourth, the CDC mandatory workday. On July 12th, there was an update on their Post-COVID Conditions Page. Under the ‘Prevention’ section, there were two, what I thought were, interesting comments. One, “The best way to prevent post-COVID conditions is by getting vaccinated against COVID-19 as soon as you can. COVID-19 vaccination is recommended for all people ages 12 and older, including if you had COVID-19 or a post-COVID condition.”

Now, vaccination is not 100%. We certainly have seen individuals with breakthrough infections that go on to get long COVID, but that is a relatively small number compared to unvaccinated individuals. Next, number two, I thought this was interesting, “Although media articles have reported that some people with post-COVID conditions say their symptoms improved after being vaccinated, studies are needed to determine the effects of vaccination on post-COVID conditions.” Then under what CDC is doing, they state rapid and multi-year studies are underway to further investigate post-COVID conditions.

These studies will help us better understand post-COVID conditions and how to treat patients with these longer-term effects. Now, I think this should be reassuring to the millions, and it is millions at this point here in the U.S. alone suffering with post-COVID conditions. There was a BBC episode that I listened to earlier today really talking about how the UK has recognized the post-COVID conditions, the U.S. has recognized the post-COVID conditions. Much of the world is still dismissing this and just think of all the COVID cases throughout the world and all the individuals that are going to suffer as a consequence of that.

There’s really a commitment here in the United States, I have to say. There’s funding, there’s an organized effort, there are hard-working, brilliant, committed people working on this issue and I’m hoping that this science gets accomplished and we can really help these individuals. Before we go to the emails, I want to remind everyone, we’re getting near the end of July. We’re almost at the end of our Foundation for International Medical Relief of Children fundraiser. Along those same lines, this is critical.

This is an organization that works throughout the world, working in those areas that are still being ravaged by the pandemic. The numbers are going up throughout the world. They are not going down. People are getting sick. People are ending up in the hospital. People are dying. People are recovering, but then continuing to have long COVID symptoms. This is not over. Help us and help FIMRC. Go to parasiteswithoutborders.com, click on the donate button, and help us with this work.

VR: Time for some email questions for Daniel. If you’d like to send one in, the address is daniel@microbe.tv. Now, I had one here queued up from Dee who wants to know what’s going on with ivermectin. She has friends who are trying to get it, online prescriptions, so forth. I think you answered it pretty much, Daniel. I will publish the letter in the letters part, but I think we don’t need to address it. Dee, I’m sure you got an answer from Daniel just now.

George writes, “My four-year-old son had a surgically repaired VSD and ASD at six months old. His annual checkups have shown normal heart function since then. As you know, he isn’t eligible for a vaccine yet, but as we get closer to an approval for his age group, I wanted to ask whether the recent myocarditis risk would give you pause if he were eligible today? It’s frequently mentioned that those who show symptoms of myocarditis or pericarditis post-vaccine respond well to treatment, but it seems to go unsaid of what that treatment entails and how that applies to those who have had congenital heart defects. As you know, they have a lifelong higher risk of endocarditis. I’m leaning towards vaccination, but wanted to understand the risks better – especially at this age group.”

DG: This is great and I want to say, I think it’s great that you are asking questions. There’s no problem asking questions about vaccinations. There’s no problem wanting to be informed when you make this decision. We’ve moved past the cattle approach of herding people through these giant centers. Particularly, now as we’re looking at younger individuals, there’s a different metric. You look at an 80-year-old getting COVID versus vaccination. There’s really nothing, it’s very obvious that vaccination is there. Let’s look at this case.

What we’re looking at this point, unfortunately, is COVID is here to stay. Your calculation is the risk of vaccination versus the risk of COVID. So focusing just on the cardiac issues– I think I mentioned this last time, a friend of mine, Dr. Michael Almaleh, actually, is a cardiologist, went through the risks of heart issues with COVID and it’s probably a couple percent is the low bar. Probably at least 2% of people that got COVID will have some evidence of heart issues. Some of that heart issues will continue further along.

If you do more sensitive testing, it might be as high as 50%. COVID triggers inflammation that affects the heart in a large number of individuals. I see someone like your child that you’re describing, and I say, boy, this is not a person that you want at risk for COVID. The vaccine is not zero in terms of risk, but the risk there is much lower with vaccination than it would be with having COVID. That’s the way I would weigh that decision.

Protect your child, so that they don’t get COVID. Take that tiny risk when you know potentially it’s going to happen with the vaccination. What is that treatment? It’s ibuprofen. It’s Aleve. It’s about 48 hours of taking it easy and then the child is better. Quite a bit different than so many of the children that we’ve seen with long-term effects after COVID.

VR: Now, James writes, “Dear Dr. Griffin, I’m so grateful for your podcast. To the point, the 20-something-year-old son of one of my co-workers tested positive today for COVID-19. He reported symptoms yesterday. Should he be given monoclonal therapy or is such therapy reserved for higher-risk patients?”

DG: Yes, this is almost exactly the question I was just answering earlier today. It’s a colleague of mine, had a family member who ended up– and actually in that case it was a second infection, which just troubles me. With these individuals who are 20 years old, they are considered at low risk. Even though the monoclonal antibodies are considered a very low-risk safe therapy, we still have a limit to the EUA. These are sitting on shelves, but you have to go through and say, “Is this an individual who maybe their BMI is above 25?”

Actually, and you can Google. I’m going to say Google or internet search the Regeneron monoclonal fact sheet, and there’s a list. But if there’s diabetes of any of these things, reach out to a clinician and have them help you work through this. If you’ve got a 20-year-old with a BMI of 26, they would qualify and be eligible for monoclonals and it would make sense. There’s combination here of a risk-benefit ratio, but there’s also a limited access because this is still EUA products. These don’t have quite the experience where we would start extending that off-label.

VR: Martin from the UK writes, “I’m seeking facts or merely off-the-record opinion as to whether Pfizer of other vaccinated asthma patients with occasional recourse to prednisolone run the risk of negating the benefits of vaccine effectiveness or of significantly reducing immunity by medicating with low dose prednisolone, say daily five to 10 mgs for a week or two?

I’m assuming more typical rescue dosage of prednisolone, 40 mgs daily, would certainly best be avoided, unless the degree of exacerbation presented its own major health risk. Are you aware of any research on this topic? Could you venture a generalized opinion? What are the respiratory team in your hospital advising such asthma patients to do about oral steroid use during COVID? Also, is there a similar vaccine negating or immunity lowering risk for inhaler usage where maximum licensed daily inhaled steroids have been prescribed?”

DG: These are great. This is a great line of questioning. We do have some data, at least, on the serologies that if someone gets vaccinated, and this makes sense immunologically, we would expect there to be a less robust antibody response. I don’t think steroids are going to have as much of an impact on your T cell response but we are, in general, recommending if you can stay off of immunosuppressants for a couple weeks before that vaccination, hopefully, stay off until you finish the cycle, so try to reduce that if possible.

Inhaled are definitely going to have a lower systemic level than taken orally. We would think of that as preferable. We do think these individuals are getting protection from the vaccines, but what we’re trying to do is limit the drug and other effects on the immune response.

VR: That’s COVID-19 clinical update number 71 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Thank you, Vincent. Thank you, everybody. Be safe.

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[00:41:44] [END OF AUDIO]

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