TWiV 695 COVID-19 Clinical Update #41

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 20 December 2020

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

VR: From MicrobeTV, this is TWiV, This Week in Virology Episode 695, recorded on December 17th, 2020. 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: Historic week, Daniel.

DG: It is actually, and this time the voting was a little bit quicker, but I’ll get to that. Yes, let’s start because I’ve got a lot to say and we want to keep this under 30 minutes, for all the busy folks that want a quick update. My quotation, “At this historic moment, surely not one of us is too busy, too young, or too old to play a part,” and that was actually King George VI, the father of Elizabeth II. He was actually speaking about D-Day.

I think this is appropriate. We are now launching massive vaccination campaigns, and this is going to take a lot of effort, a lot of coordination, and a lot of people are going to need to be involved to make sure that this actually goes from manufacturing to actually people’s arms.

Start a little bit with some patient updates. I think everyone realizes that the projected post-Thanksgiving rise is what we’re seeing. We’re setting records, numbers of people who are getting sick, numbers of people who are dying per day. It’s quickly approaching 4,000, it’s well over 3,500. I’m not in the best of moods when my patients die. I had, earlier this week, a gentleman, no medical problems in his 30s who died. I just had another gentleman die today. I have a teenager in the ICU who I don’t think she’s going to make it. This is a horrible disease. Each one of these people who die is someone that people love, someone that people care about.

The vaccine is here. I just heard about an ICU nurse who just got diagnosed today. The vaccines are here. I know it’s Christmas. I know everyone’s hoping to get together, but I’m going to be the Grinch and I’m going to say, “Please, postpone Christmas.” Can we do that? I just want people to be safe. I’m going to try not to be judgy, but when I see this many people dying and I see families, they got together, they were doing nothing wrong. This is not a moral issue. It’s really dangerous.

All right, let’s go to the pre-exposure period. I always like to touch on testing and a little shout out here to Rachael, the special assistant to the NIH Director of COVID-19 Diagnostic. She let me know that they appreciate the updates because for them, it’s nice to get some feedback on what’s happening on the ground. Happy to hear that, and I’m going to give some feedbacks here. Feedback, yes, no plural on that, just feedback.

[chuckling]

DG: This is an update. The FDA updated its FAQs on testing, and I was communicating a little with one of the New York Times reporters who may drop a story on this but I told her that she has until Saturday morning when this episode drops. Actually, the FDA basically went ahead and said “Okay, these tests are not approved. These PCR tests are not approved for quantitative,” saying the quantity of virus, “But go ahead and you can share those Ct values with clinicians.” There’s a bunch of caveats in there, but for me as a practicing clinician, this is exciting. This is a helpful update, and there’s a number of qualifications. I think those qualifications are appropriate.

What are the things? I give some background here. We use a measurement of the amount of virus, of the viral load, so to speak. We look at these cycle threshold values when we manage a number of viral diseases. CMV – cytomegalovirus – we use it for HIV, the virus that causes AIDS, we use it for Hepatitis. We’re used to some degree of variability. We’re actually careful to say like, “Oh, are these for treating something over time? Is that being done in the same lab?” Because there can be some inter-lab variability.

There’s also an extra bit of variability here. We’re used to doing blood tests and someone draws a certain amount of blood, and a certain amount of blood is then put on the machine, but here we’re actually doing swabs and those swabs could be taken from different sites. It could be one of those deep brain biopsy swabs where it’s really pushed in there and it’s twirled around, sort of a blind procedure. It could be left in there for a proper 15 seconds, an appropriate number of twists, or it could be in and back out.

It could be taken from the front or just inside the nose. Fifteen seconds on each side, making sure you get a good sample or not. It’s operator-dependent. It could be actually a swab from the mouth or even the back of the throat. The collection can actually affect these things.

We know a few things. We know that you tend to get the highest amount of virus if you swab deep in, that middle turbinate swab, the NP swab that we started with. If you do the front of the nose, it comes up about three cycles later, so about a 10-fold difference. If you do it in the mouth, it’s actually about 10 cycles different.

There’s a lot of caveats and we’re going to have to do a little bit here to make sure we interpret that, but at the ends of the spectrum, I think, we can make sense of this. If you get the report that that Ct value is less than 24, that you’re translating that into millions of RNA copy numbers, you’re probably dealing with someone in that height of infection. You’re probably dealing with someone who’s very infectious. This is someone, rush home, don’t pass go, don’t go get those groceries, you can order them.

At the other end of the spectrum, let’s say, it comes up 37, 38, so past 36, then we want to ask a few more questions. Was it collected properly? Where was it from? Here we want to calculate is this due to poor sample procurement or is it actually really that they’re at either the tail end of illness or right in the beginning? The ends of the spectrum, I think we can really work with this.

There’s going to be gray areas in the middle. It comes up at about 30, that might be a little harder to interpret, but for us as clinicians, this is helpful. I had a case, well, I have a case, a gentleman from Nigeria. One of the few people who actually appreciate that I own cows. I showed him a couple of cows and then he wanted to know how many wives I had. He [chuckles] had actually been sick really for several weeks. The two-plus weeks, and at first, he tried Azithromycin and then he tried Bactrim, and then he wasn’t getting better and then ended up in the hospital. His first test was negative but it just didn’t seem right. It really seemed like this was a viral syndrome, retested again, and this time it was positive. My suspicion is that it’s right on the edge here of detection, probably high 30. Being able to get a Ct value in a context like that’s actually helpful.

By the way, just one wife.

VR: The Ct values are going to be available for all nucleic acid test?

DG: This is actually an excellent question, Vincent. Not all the machines actually allow you to get those values. It’s actually cheaper to buy a machine that just gives you a, yes or no, basically, just at the end of, we’ll say 40 cycles says, yes or no. The more sophisticated machines, apparently the ones that the Broad Institute or the ones that Fauci is using, those actually give you Cts all the time.

I hate to say, we call then this gentleman the machine that the sample was run on did not have access to the Ct values, but again, it shows you it would be great to spend that little bit of extra money and give us something that helps us in figuring this out.

As I mentioned, we’ve tried to move a little bit away from those deep NP swabs, the brain biopsies, but in some settings, we’re doing those NP swabs, particularly with kids. We like to do it in the anterior nares, particularly if we’re going to be doing repeat testing because of the blind procedure, we’ve had issues with triggering migraines, with bleeding, trauma, and things like that.

Actually, some pretty exciting stuff here. We’ve really moved ahead with access to rapid testing. I don’t know if I had mentioned it last time, but some of our sites are doing over 6,000 tests a day. When you start seeing, oh, 5%, 6% of tests are positive, we’re picking up hundreds of infected people per site, and then we’re actually getting them from spreading it to other people. It’s really tremendous. I have to say I’m excited to see this happening. Testing saves lives.

As far as what tests do, we have access to– the BD Veritor is in reasonably good supply. We can get reagents; we can get access to that. We have quite a bit of the Abbott ID NOW machines, but I have to say, I’ve talked to a lot of my colleagues who– those are back-ordered. It’s hard to get those now there’s such demand. There’re also some other tests that people are hearing about, the Abbott BinaxNOW. That’s supposed to be this $5 test. The government has heavily invested in that. Most of us in the private sector are not getting access to that but now an approved at-home over-the-counter test, no prescription needed, and I think that’s fantastic. I don’t think a doctor needs to be standing between you and your ability to get a COVID test.

This is by Ellume and it’s a rapid antigen test and it actually has this Bluetooth connection, and it’s really neat. If you’re not driving after this, just go ahead and Google E-L-L-U-M-E COVID test. For, they say, $30, you’re going to be able to walk into your local pharmacy, you’ll get this little kit. There’s a video, so you need a smartphone, but you provide that. You go on your smartphone, you watch a little video, it shows you how to do this. There’s a little sterile nasal swab, you’re going to swab your nose.

They actually say in the kit, it’s going to be an NP. They’re actually going to expect you to put that back in there so that’s going to be interesting to see how tolerated that is. There’s a little dropper, some processing fluid, it connects via Bluetooth to your phone, and it walks you through it. In about 15 minutes, you get an answer.

We’re now increasing the number of options and making it cheaper for testing in the home. We talked before about the Lucira, a little battery-powered molecular test. Now we have this, hopefully soon-to-be-available $30 over-the-counter antigen test. There’s actually some talk about the BinaxNOW being an at-home option as well. We’re moving in the right direction. We’re not quite there at the price point a lot of us are looking at, but I think this is exciting stuff.

Schools. I was going to talk about schools. Really, a nice piece in the CDC Morbidity and Mortality Weekly Report (MMWR) and this was titled Estimating Resource Costs for Implementation of CDC’s Recommended COVID-19 Mitigation Strategies in Pre-Kindergarten through Grade 12 Public Schools – United States, 2020-21 School Year. Actually, it was really interesting. They went through– And to point out, this is not free. If you’re going to say “We’re going to open our schools,” or “Send kids to schools,” you can’t just do it like it’s 2019. You’ve got to do it like we’re in the middle of a pandemic if you’re even going to consider this.

They actually went through and they made estimates. You need to invest an average of $55 per student minimum but then it goes up to about $440 with increased staffing, shields, mask, hand sanitizer, wipes, the pulse oximeters, signage. There’s a lot involved. This is not just you say, “Oh, we’re sending kids back to school, we hear it’s safe.” If you’re thinking about doing it, there are ways to approach this challenge but it takes money, it takes a plan.

I always try to reinforce the point that in-person schooling is a goal but you can’t just jump there. You get there with education, you get there with resources and financial assistance. We dumped a lot of money, I would say, into the stock market. If we think we’re going to send kids to school, if we think we’re going to ask teachers to go there, then we’re going to actually have to put the money in. I think there was good analysis so schools can really understand what those costs should be. Hopefully, we’ll say, policymakers can make the decisions to make this happen because you look at $440 per student and you think about that enabling parents to work, enabling that child to get the benefits of education. I’ll leave it there.

All right. Vitamin D and Ivermectin. Seems lots of people want me to discuss this. [chuckles] Here’s what I’m going to say. I’m doing a better job of remembering to take my Vitamin D and if this podcast goes viral, and we get above 20,000 YouTube views, I promise to discuss Ivermectin next week, but we got way too much other stuff for today. Why do we have too much other stuff? Vaccines. This has been an exciting week for vaccines.

Last week, at Long Island Jewish hospital– This is where I did my training, also where I see a lot of patients. The first person– an ICU nurse received the Pfizer vaccine. This was exciting. I’m always critical and so I’m looking and the fact is it’s an ICU nurse and not a physician. I thought that was pretty cool. The fact that the physician was given the vaccine seemed a little odd because I’m not sure we know how to do that. That’s actually nurses are much better at that, so.

[chuckling]

DG: But somehow that doctor did well and the nurse claimed it didn’t hurt so we’ll take her word for that. There was the tall Irishman, Michael Dowling, the head of Northwell was there. That was nice that there’s the Irish there. We’re always on the side of history, so that was exciting.

VR: Were you there Daniel, did you go?

DG: No. I actually was busy taking care of patients.

[chuckling]

DG: I did make the comment like, “Yes, this is great that you’ve got the media appearance, but come on, let’s start pushing out the vaccine. It’s here. Let’s get it into arms.” [chuckles] Last week was all about Pfizer and this week, the focus changes to Moderna. What do we know about Moderna? As people may remember, last week, when Vincent wanted to start TWiV, I was like, “I can’t. I’m watching, it’s the vote.”

[chuckling]

DG: I did watch it again today. I guess, if people listen to TWiV, they should have been tuned in if you want to hear a bunch of really smart nerds talk about stuff. It was great. I was loving it. Really these are brilliant scientists and it’s not just scientists and people looking at the whole equity aspect, et cetera.

What do we know? We got efficacy data out of this and it’s right about the same as Pfizer. It’s right about 95% for preventing people from getting the disease. I’ll talk a little bit about what I mean. They really said it would look like it’s close to 100% at preventing severe COVID-19. I’m going to go a little bit into that.

People also are always interested in the immunological data, I guess they’ll say, so T-cell responses. We know that we’re getting great antibody responses, but they also commented that the CD4-positive T-cells responses were strongly biased as we wanted towards Th1 cytokines, minimal Th2 cytokine expression. This is reassuring because this is our way to predict the future. Are we going to have any issues, vaccine-induced disease?

As far as reactogenicity, hopefully, our listeners remember this. This is not a side effect. This is, “I got the vaccine and this is evidence that my immune system is working and evidence that I can feel when people poke me with a needle.” It was pretty similar. The majority of people said, “Yes, it hurt when they stuck it into my deltoid,” unlike the nurse who claimed the doctor poked her with minimal pain.

It’s funny, the majority of people, that two days afterwards, said they feel tired. “That’s not funny, Dr. Griffin.” What was funny is that, actually, if you ask the placebo people, somewhere between 1/3 and 1/2 said, “Yes, I feel tired.” Just to say, “I haven’t gotten my vaccine yet, and I feel tired.” Fatigue was very common but only lasting usually a day or two. Headache was reported, muscle pain, some joint pains, some chills, and then a minority of people had a fever but again, this was more after the second dose than the first dose. Interesting enough, the older you are, the less you complain, the less reported side effects. This seems very similar when I went through the numbers with Pfizer.

What came up a bit in the discussion today was the issue of Bell’s palsy. There are a few cases of this in the Pfizer study. There were three cases of this in the Moderna vaccine group and one in the controls. There was a whole discussion about whether that is really background. Can we really say that with confidence? That’s something that will be monitored.

Another part of the discussion that was quite interesting– And this will be addressed going forward, was the issue about correlates of immunity. What they’re hoping the Moderna vaccine trial will do, is actually give us the ability to do blood tests to tell, do we have to worry about someone getting infected again? Also, it may help us with timing about revaccination. It was a slightly different discussion than Pfizer because really, this trial is being financed by the U.S. Government. This is very much under Operation Warp Speed. Several times they’d say, “We are paying for this trial, so this is what we would like.” Very interesting.

Here is our vocabulary for today. We have three words. I want people to learn about infection, disease, and severe disease. I’m going to throw in– We got a little bit of information about infection. I think this is important because this is going to tie in with transmission. The endpoint was not whether or not people got infected. The secondary endpoint was not whether or not people got infected. It was whether or not they get the disease, and whether or not it was a severe disease.

What’s infection? Can you get an infection without getting the disease? This is, I think, an important point. Our TWiV listeners probably know this, but it’s good to go through, so you’ve got the elevator response ready to go. Sometimes a pathogen, a virus in this case, can actually infect us. I use the same word, and could actually go and start replicating, but we don’t know it. We have no symptoms, we have no fever, we have no headache, we are infected asymptomatically.

The concern there is that if that happens, if the vaccine does not prevent that you could have people getting infected, walking around, feeling fine. They’ve got the virus replicating in their nasal pharynx. They might wipe their nose, they might talk. They might potentially transmit it and they feel fine, they’re coming to work. There actually was a little bit of suggestion, some data here as discussed on the last TWiV if people want to listen to that, that there may actually be a protection against infection, and that’s ideal if we’re ever going to look at herd immunity.

The second is the disease. This is, you get sick. This is a subset of infected. You have the virus doing its thing, and you either have a sign or a symptom. Either you have a sign such as a measurable temperature, an abnormal chest X-ray, or you have a symptom. You feel bad, you’ve got a cough. Severe disease in COVID really means that your oxygen level drops, that you require hospitalization.

In this study, we saw some preliminary suggestions that there may be a decrease in infection. We saw some really compelling evidence about a 95% reduction in disease. We saw what looks like close to 100% protection against severe disease. This is exciting and they actually talked about moving forward. We talked about this at the meeting today. They’re planning a transmission study with the Moderna vaccine, this fall at university campuses, which I thought was really interesting. They’re going to take a campus. These will be individuals who maybe have not been vaccinated yet, and they’re going to have 1/2 of them get vaccinated, 1/2 of them not get vaccinated, so we blinded all the rest and then going to do a really close contact tracing. They’re also going to do repeated swaps looking at levels of virus.

Very important questions when we talk about herd immunity because if a vaccine protects you against disease, but not infection, if it doesn’t knock down levels and interrupt transmission, then we really have to step back when we talked about herd immunity.

VR: Daniel, what was the percentage in the prevention of asymptomatic infection? You didn’t give us that. You gave us the disease.

DG: I know. I believe it was 67%. Is that correct? Am I remembering?

VR: I think it’s– Yes. It’s not great. A lot of people are still going to not be protected from infection, right?

DG: Yes. Actually, I’m glad you– So 67%. That’s a problem because if it’s only 67% and it’s a binary system, is that enough to get us herd immunity? If you say, 100% of the population agrees to get vaccinated, I’m not sure what planet that occurs on, and it’s 67% effective at blocking infection, that’s like right at the edge of giving us herd immunity. You drop down to 90% and you’re probably below herd immunity, so this is a problem.

I think maybe, in the transmission, research is so important because infection is one thing, but let’s say you get infected but it’s at such a low level you can’t transmit, that’s okay. I think that’s what we’ll get hopefully this fall.

Now it’s actually people probably wanted to know that 67%, so thank you.

Alright. We’re getting lots of questions. The vaccines are out there. The first question I always get is, “Dr. Griffin, which is better? Is it Pfizer or Moderna?” We were joking about this because saying, “Well, it’s like the Android phone versus the Apple iPhone. Which one do I get?”

It’s like, “I like the Moderna. I think it’s got nicer packaging. The way Apple does that thing.” I said, “To be honest, if someone calls me right now and said, hey, Dr. Griffin, we’ve got your Pfizer dose. Come running down.” I was like, “Yes, probably will just go get it.”

Of course, that day, I got the call like, “Hey, Dr. Griffin, you want to schedule your Pfizer vaccines?” I said, “Yes.” [chuckles]. I think the data is pretty compelling. They’re very, very similar as far as efficacy, as far as safety. I think when you get your golden ticket, as we say, the doctors or nurses and staff they’re getting their vaccines. Go ahead, take the opportunity, get the vaccine.

“What about pregnant or breastfeeding?” This is an EUA, it’s not a fully FDA-approved vaccine. I don’t think we should be fighting with anti-vaxxers and anti-vaxxers shouldn’t be fighting with anyone at this point. We have not tested this vaccine technology in pregnant or breastfeeding women, humans, or even animals for that matter. It’s unknown. There’s no mechanism to think this is an issue. There’s no signal to think this is an issue as we talked about last time.

The Scientific Advisory Board and the FDA has made it really clear. This is a woman’s decision. This is not a man’s decision. It’s not the FDA’s decision. The information is there and women have the ability to make this choice. As we move forward, we’re going to learn more.

If you’re an ICU nurse and you’re involved in people getting intubated and you’re in high risk, or maybe you work in an ER, or an urgent care, you may decide, “I want to go right now,” or you may decide, “Hey, I’m doing more administrative stuff. I have limited patient contact.” You may decide you want to wait a little bit. Again, that’s what we have and I think it’s important that we respect people’s decisions here.

“What about autoimmune disease?” We have seen no signal suggesting there’s a problem here. Again, the encouragement it seems that the scientific evidence in totality favors vaccinating, getting vaccinated.

“What if I previously got infected?” I’m going to talk about that a little bit, but I think it was very clear in the discussion today by the Independent Scientific Advisory Board, I just quote, “We know people get reinfected. We sometimes see the reinfection is worse than the primary infection.” Actually, had people get a mild case and then died the second time, so the encouragement was that you should go ahead and get vaccinated. We have no correlates of immunity. There’s no blood test that we can do right now to tell you you’re going to be okay.

“What about distribution?” I was asked about this. Right now, we still don’t have as much product as demand, but we expect to quickly change. Particularly, it sounds like we’ll have six million doses of Moderna vaccine coming out next week. Another three million of Pfizer will ship, and so I think pretty soon we’re going to get to the point where we can meet that demand. There’s really a lot of people as I mentioned, all hands on deck to try to make this happen.

VR: Has there been some reports? I think three allergic reactions to the Pfizer vaccine. Can you illuminate?

DG: Yes, the one in the U.S., I think that got a little bit of press as they gave it to an individual up in Alaska. There were a couple in the U.K. that early on– there is that warning that we say that if you’ve had a previous anaphylactic reaction to a vaccine, you should speak to your physician, consider pre-medication. Don’t just run in there and get the vaccine. I think that’s important. It is a previous severe reaction to a vaccine. It’s not an egg allergy, it’s not, “I have issues with pollen,” it’s not peanuts, it’s not an antibiotic issue. That’s the question. “Have you had a previous severe reaction to a vaccine?” If the answer is, no, you can move ahead.

VR: After you get a vaccine, shouldn’t you be observed for 15 minutes to make sure nothing happens?

DG: Yes, they’ve actually extended it in a lot of the places here to 30 minutes, but the recommendation is observation for a minimum of 15 minutes. As we learn more, we’ll see. Yes, that’s recommended.

The two shots, the Pfizer and BioNTech is a 0.3-ml shot given 21 days apart. You get a second shot so it’s two shots. An interesting thing, people have probably heard about is, “Oh my gosh, there’s more doses in that vial than we know.” I’ll talk a little bit about that. I was asked– One of our pharmacists who’s been actually reconstituting this today.

These vials, when you actually saw them, there’s about .2 milliliters of liquid in there, about .2. There’s a certain amount of the product in there, and there’s a certain amount of volume that comes up. You add 1.8 milliliters, could do the math that gives you about 2 milliliters. They’re always slightly overfilled, so you say, “Well, I’m going to do the math in my head here, Dr.Griffin: .3 times 5, 1.5. That leaves 1/2 milliliter of fluid in every vial or so,” and that’s what was actually noticed.

Pfizer was alerted. Pfizer said, “Listen, we’re not going to give any specific recommendation, but your hospital might make a decision about this.” What a lot of the hospitals have done and the health care system where I’m working has actually said, they will draw an extra dose out of that vial, if possible, if there’s an extra .3 in there, which there always is. Sometimes there’s even another dose in there because we say about .2, so sometimes it’s about 2.1 at the end. They do say, “Don’t draw a little bit out of one, a little bit out of another, worried about cross-contamination, infection risks.” That’s the mystery there.

The Moderna is actually a slightly larger volume. This we’ve always talked about from a nursing point. We have to be careful that people are just straight with how much they draw. The Moderna is 0.5 ml, so it’s a little bit larger amount that goes in. Again, two shots about 28 days apart.

I guess just to wrap that off, Pfizer’s being sent around in those cool thermal shippers. They monitor them until they arrive and then switches over, and someone else monitors it. They can actually be kept in those thermal shippers. We’re not going to necessarily need everyone in the world to have an ultra-cold. Moderna can be shipped around at -20 and then kept in a fridge. We think it’s going to be for about a month, so good stuff there on access and getting it around.

All right, incubation period. I want to make sure I hit this. Remember, a test does not predict the future. Just on the phone again with a dad who said his one son got sick, tested positive, isolated for his 10 days. He and the other boys had a test a couple of days after the first son tested positive, so his comment was, “We should be all good to go.” I was like, “Actually, your last contact was 10 days ago, so you’re still within the 14-day quarantine. That test a couple of days after your son got sick, that doesn’t quite work. Naturally, CDC has said you can finish that quarantine at day seven with a negative test within 48 hours, your state’s still sticking with its 14-day quarantine.”

I have to say, we’re being really strict. I got another call from the National Hockey League (NHL) where there was this question about, do they have to be PCR-negative, or can we switch over to this 10 days, 21 days? I don’t know if people are familiar with this, but in youth hockey, something about the dynamic of the ice makes it the highest risk situation for transmission of virus from one person to another in a sporting context. Still sticking with a really strict COVID policy for professional hockey. Expect another great season next year.

“Period of detectable viral replication.” Here I’m going to talk about the other type of vaccination, passive vaccination. This is the type of vaccine that the President, Ben Carson, Chris Christie, Rudy Giuliani, and now many, many other people are getting. I’m now starting to see a significant number of people who go for this. Some of them end up in the hospital. This is not 100%.

The first person I saw was a gentleman, got it on day four, two days later felt great. Another gentleman got it on day nine, didn’t really notice much, ended up in the hospital. We’re seeing a lot of people get this. The earlier they get it seems to be consistent with what we knew from before. The suggestion is if you get these monoclonal antibodies within the first week, there’s about a 70% reduction in progressing to hospitalization. The U.S. Government is actually distributing 65,000 doses every week, but only about 20% of them are getting used. There’s a problem here. Hopefully, people are listening to this, let’s get the word out. The Bamlanivimab, the BAM BAM, is really widely available, but people don’t know about it, actually to the point where even people that don’t qualify are actually getting it through a lottery system because the hospitals are sitting with these vials not being used. Eli Lilly has a place; you can actually go to the Eli Lilly page. There are numbers and actually here in New York, I get lots of calls. I send them the hotline. There’s a hotline, you call.

I just had another patient today, actually, a fellow clinician, elderly gentleman, or a senior gentleman– I don’t know if elderly is the right word, but an older adult above 65. He was being arranged to get the Bamlanivimab infusion today. This is one of those tools. This does have some data behind it. As people may know, I’m working on a trial post, EUA trial to really get solid data. This is still EUA based on Phase 1, 2, we’re hoping to get more solid data to move forward with this.

“What about reinfection?” I wanted to ask this question. I wanted to say, “Okay, so what about reinfection?” What I wanted to really be curious about, do people get reinfected and potentially shared it to others? We now have a lot of cases in the literature of really well-documented reinfections. I wanted two things. I wanted them to be young and I wanted them to be in their 20s with no medical problems. Two, I wanted them to be healthcare workers.

I wanted to be in a situation where potentially, they got it, they got it again, and they also– You’re ready? My last was I wanted Ct values. I wanted to know, did they have enough virus that I would be concerned that they would transmit?

I found a nice article by Gupta, V. et al, Asymptomatic Reinfection in 2 Healthcare Workers from India with Genetically Distinct SARS-CoV-2. One was a 25-year-old man, PCR-positive, 5th May 2020. Ct value at the time 36, so a few 1000 bits of RNA when he is initially diagnosed. They isolate them, they wait till his PCR is negative, they get him back at work. August 17th, now he’s got a positive PCR with a Ct value of 16.6. That would be millions and millions of RNA copy numbers, so something we would think that we’d be worried about for transmission.

The other 28-year-old woman, found PCR-positive also back in May, Ct value at that point in the 20s. She did the institution; she became PCR-negative. September 5th, Ct value of 16.9. Again, very high levels of RNA. This raises a couple of issues that we got back to our vocabulary. This was an issue of reinfection, they were asymptomatic, so there was no severe disease, but they had really high levels, suggesting potential for transmission in these settings.

Early inflammatory phase. I want to re-enforce the timing of steroids. I got a call the other day, it was like, “Dan, the steroids seem to be doing really well for our patients in the hospital. I got a person who just got COVID. Should I call in a script for steroids?” Steroids are the second week, they’re in select individuals who are hypoxic, who are starting to develop more significant disease. They’re not for everyone. It’s not COVID steroids. It’s just like people, it’s a select dose. A little judgment here.

Secondary infection phase. We talked a little bit about the ferritin/procalcitonin ratio, but I want to point out that the timing seems to me to be the most helpful. Just had a woman today, procalcitonin was less than 0.05. The FPR, the ferritin/procalcitonin ratio, was super high, suggesting not bacterial, but she had a staph aureus in the blood. The white count went up, she was looking right. I still find that you want to be vigilant, you want to understand the phases of the disease, and when something starts to change, think about the complications that happened in that phase of the disease.

The tail phase, which often ends up with the long COVID. I was actually speaking with a nurse this week. It’s really tough. We’re seeing individuals who are now six, seven, eight months out, really getting pretty far out from initial disease, still suffering. Some of the employers are starting to get tired and say, “Hey, what’s going on here?” I think we talked about this a little last time. There really isn’t a great chronic diagnosis here, puts these people in a really tough situation. It’s very clear, COVID is not just binary. You can get sick, you can die, you could get sick, you could not die, and you might have prolonged suffering, you might have a prolonged disability. I’m going to leave it there.

I want to thank everyone for all the hard work everyone’s doing. Hang in there, keep doing it. For everybody who’s coming to www.parasiteswithoutborders.com in helping us. It’s fantastic. Thank you. We’re continuing to help the Peace Corps HIV and AIDS programs because remember, that virus has not gone away.

VR: All right, Daniel, a couple of quick questions. First one is Alan from Johns Hopkins, “Assuming one has been vaccinated and then becomes infected with SARS-CoV-2. One, do we know the degree to which that person’s virus shedding is infectious? Two, can that person become a long hauler?”

DG: Oh, that was fantastic because that hits right into what we were talking about. We don’t know yet. We’re going to get this data. This is actually the plan transmission studies that we heard about. They’re going to be taking individuals and vaccinating, comparing them to non-vaccinated individuals. They’re actually going to be doing quantitative viral load testing, and coupled with transmission contact tracing. We’re going to get answers, just we don’t know yet. I think this is really critical.

A lot of people– I saw this early on in the pandemic, they get the COVID, they’d say, “Oh, I’m fine.” The mask would be off, they would feel like they had some special invisible magic shield. We don’t know the vaccine may protect you from infection. We’ve seen evidence for that. It seems very compelling that it protects you from disease and severe disease, but we don’t know. You could very well get infected. You could have high enough viral level that you could then infect your loved ones or your patients. Until we know that, you got to keep washing your hands, you got to keep wearing your mask, you got to keep acting like we’re in the middle of a pandemic.

VR: Alan asks about allergic reactions after vaccination. We already covered that, so we can skip it.

Dr. Hasa Nein says, “Can someone like President Trump, who received monoclonal antibodies, get the vaccine now, or will he have antibodies that may neutralize the spike protein once formed?”

DG: Yes. We think that that’s a concern and we’re actually recommending that people wait 90 days. That’s based upon, we’ll say the half-life of the monoclonal Bamlanivimab by Eli Lilly is 21 days, so we’re waiting for that to get low enough. Otherwise, the concern is you get the vaccine, and you actually will not get the benefit of vaccination. The half-life is pretty similar for the cocktail for Regeneron. The GSK product hasn’t made it to market yet. That is even a longer half-life. That may really prevent you from getting active vaccination for some time, but the current recommendation is to wait 90 days.

VR: One more from Nicolas. “As a health care worker myself on the frontlines every day who has suffered from COVID-19, what are the recommendations for vaccination? Should I move myself to the back of the list since I may have antibodies? Are there any concerns for someone to get the vaccine after having suffered from COVID-19?”

DG: There’s two questions here that I’ll tease out. One is, there’s no risk that we’re aware of that a person is going to get the vaccine and have a problem because they had COVID before. Pfizer had a number of people who had been previously infected get vaccinated. The ChAdOx study, the Oxford-AstraZeneca also had a similar, where people were fine to get the vaccine.

The other is a prioritization issue. “Should I get this? Should I wait and let all my colleagues get it first?” The hospitals and healthcare systems, this is a monumental challenge to get everyone vaccinated. I’ve basically been telling people “If they call your number, if your golden ticket comes up and it’s time to get vaccinated, go ahead and get vaccinated.” Try to get all the healthcare workers at least their first dose this month. Just go ahead, keep the logistics flowing. “Make sure you jump in the lifeboat before we run out,” type thing. Don’t wait. Just go ahead, get vaccinated. I’m encouraging people to do that.

VR: That’s COVID-19 clinical update number 41 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Thank you. Everyone, take care and be safe.

[00:41:37] [END OF AUDIO]

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