TWiV 848 COVID-19 Clinical Update #95

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 01 January 2022

pdf of this transcript available (link)

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

From MicrobeTV, this is TWiV, This Week in Virology, Episode 848, recorded on December 30th, 2021. I’m Vincent Racaniello and you’re listening to the podcast all about viruses. Joining me today, not from New York, Daniel Griffin.

Daniel Griffin: Yes, from the Nevada Desert. This will be the first time I’m recording without a bow tie. I’m very casual. I’m sort of on vacation.

Let’s get right into it. We really have a lot to cover today and a lot of stuff that I know is generating lots of questions. I’m going to start off with my quotation. “Hope is being able to see that there’s light despite all the darkness.” This is by Bishop Desmond Tutu who, unfortunately, we lost this last week. He was the Nobel prize-winning Anglican cleric. He’s described as having wonderful good humor, inspiring messages, and he really was a tireless worker for civil and human rights. He died at 90 and that’s quite a loss.

All right, let’s start with our update. I think everyone is aware we are setting, I think, records no one thought we would actually set. We’re setting new daily case records with almost 500,000 new cases per day and the deaths have increased again where we are seeing days with over 2,000 deaths in a single day. Here in New York, actually, we’re doing our part. Unfortunately, we’re approaching 70,000 cases per day. We’re already three times the highest number we ever saw before. We only hit 20k once last January of 2021. We’re already more than three times above that.

We saw 175 deaths in a single day from COVID on December 29, 175 in a single day just right here in New York State. Just for a perspective, our last winter seven-day moving average peaked at 205 on January 15. Even though vaccines are available here, we’re actually headed really in a negative direction. Vincent, do you have any thoughts?

VR: Well, people are always saying to me it must be the variant and I say, “No, people are back to their lives more than ever in the last year, plus there are a lot of unvaccinated people. Plus the vaccines don’t prevent infection, they prevent disease.” That’s why we’re in this situation, but if more people would be vaccinated, there would be fewer hospitalizations, don’t you think?

DG: I think vaccination is the most important thing here. We’ll make sure we touch on that, as well as some of the other issues. One of the biggest changes this past week were some CDC changes to isolation and quarantine. We’re going to go through these a little bit slowly because it was a march through this. I’m going to jump right ahead because I started suggesting that this was something that needed to happen. We’ll discuss the pros and cons, I guess I will say.

Via a press release, the CDC announced on Monday, December 27, given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation from 10 days for people with COVID-19 to five days if asymptomatic – I want to stress that “if asymptomatic” – followed by five days of wearing a mask when around others. People who test positive should isolate for five days and if asymptomatic at that time, right, so you reach day six, if you’re feeling better, if you have no symptoms, then they may leave isolation if they continue to mask for five days to minimize the risk of infecting others.

In the CDC press release, the CDC goes on to explain that the change is motivated by science demonstrating that the majority – I’m going to throw in “but not all” – the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the one to two days prior to onset of symptoms and the two to three days afterward.

I’m going to make a few comments here before we get to quarantine. One is, they’re really very straight in saying the majority. I’ve seen a lot of Twitter posts, a lot of interviews where people have said they’re worried that the CDC is now sending out infectious people. They are. They are saying that. They are saying the strategy of Tetris, of COVID-Zero, that’s no longer what we’re doing here. We’re coming up with something that we hope from a public health standpoint is reasonable.

Yes, day six, you do not go visit your 90-year-old mother with numerous health issues because you may still be infectious but there’s a balance here. When you have half a million people getting infected every day, we like to think healthcare workers were essential but then other people say, “That’s great, Dr. Griffin. How are you going to get to and from work? Who’s going to run the trains? How are you going to eat? Who’s going to run the supermarkets and grow the crops? Who’s going to police the streets? Who’s going to come if there’s a fire?” A lot of people are essential. I think this is a balance but I think it’s really important to realize that at day six, you’re not magically not contagious. Any comments there, Vincent?

VR: As we have said for a year now, there’s never an abrupt dividing line between one phase and another. Because people are genetically varied, it’s different and it’s hard to put a number on it. If you wanted to be absolutely certain we’d be still at 14 days, right?

DG: I think that’s, yes, we would still be at 14 days. We would even, as some countries have done, we might even be testing at the end. We might even be doing PCR which is I’ll say overly sensitive. A lot of people criticized wanting there to be a test at the end of this. Some employers that we work with have still said, okay, I see what you’re doing here but I don’t want those workers coming back into a workplace where there’s vulnerable people until they’ve got a couple of negative tests. There is going to be a lot of nuance here. It’s going to be a lot of subtlety. I think people have to be smart. We are not magically non-infectious at day six. That is not what the CDC is saying here in their guidance.

Quarantine also got updated and I know that UnitedHealth Group are going through this. I was working with John and a few others. I said, “John, we need two separate slides that run through this because there are lots and lots of questions.” What about quarantine? There’s certain parallels here but there’s also I think an important change. Here’s where they start.

For people who are unvaccinated or are more than six months out from their second mRNA dose or more than two months after the J&J vaccine and not yet boosted – right, so they’re lumping the unvaccinated with those that have gone out the stretch with someone like that. I just thought I’d pause there for a second. We’re now talking about people that are not necessarily infected, they’ve been exposed. Isolation for the infected, quarantine for the exposed, the CDC now recommends quarantine for five days followed by strict mask use for an additional five days. This period of ten days when you may turn positive, you may start becoming contagious, but then they even water it down. Alternatively, if a five-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure.

Now, individuals who have received their booster shot, they do not need to physically quarantine following an exposure but should wear a mask for 10 days after the exposure because there’s this concern that even vaccinated people can get infected, can spread, and then they do say best practice would also include a test for SARS-CoV-2 at five days after exposure. If symptoms occur then individuals should immediately, they say, quarantine until a negative test confirms symptoms are not attributable to COVID-19.

I’m not sure quarantine was the right word at the end there but I got this question even again today. It was a physician that I know, found out one of the people working in his office had symptoms for a couple of days, finally went and got tested, found out they had COVID. We said, “Hey, the guidance says since everyone there is boosted and vaccinated to get a test in five days. You might as well get a test right now because it’s been enough time that you may also be infected and infectious at this point as well.” Now, I’d like to pull you in on this, Vincent.

VR: Daniel, what if everybody is triple vaccinated and some people are testing positive, whether or not they have symptoms? Why do you have to quarantine them? They’re all triple vaccinated. Let’s say they’re all young and healthy, not very old, not very young people, why do we have to take them out of the workforce at all?

DG: We’ll look back on this and we’ll wonder why it took us so long to get to different points. We don’t quarantine after an exposure to flu. We don’t protect those who decide not to get vaccinated for influenza. At some point, we are going to, and we are moving, this was a pretty rapid move in this direction to say, “You’ve had your choice, you can make your decision. Do you want to get vaccinated?” If you’ve decided not to get vaccinated, I’m not sure we will continue to make all these Herculean steps to protect the unvaccinated. Because that’s what we’re seeing. That’s who’s dying, that’s who’s filling the hospitals.

VR: Yes, absolutely. I do think that we are at the point now where we have multiple highly-effective vaccines, amazingly effective, right? In the 90s against hospitalization and death. It’s about time to stop thinking about those people who are never going to be vaccinated, it’s their choice. They’ve made a choice and so I don’t see why we have to stay home from work to protect them. It may sound cruel, but I think we will eventually get there, don’t you, Daniel?

DG: I think we’ll get there. What are the last few steps? The last few steps may be moving those vaccines down to the youngest among us so that they can feel– I have a neighbor across the street, Al, super nice guy. He has very young children and he is just continuing to be really careful, really trying to keep those kids safe. I think that that will start to complete this move.

As we know, we also have those among us who do not have immune systems that allow them to get that full protection. We do need to ramp up, get these people the pre-exposure monoclonals, nice to have some medicines for those individuals as well. I think we’re moving in that direction.

The last in our beginning here, the FDA EUA for molnupiravir was announced. We’ll touch on this a little bit more, but now we have an EUA for two oral antivirals.

Children, COVID, and mental health. To reinforce, children are at risk for COVID. I hope that this is a message that people have all gotten at this point. Case numbers are often children hospitalizations are rising, children are dying every week, as I mentioned last time. I did get an alert this week from our local Cohen Children’s Hospital about the growing concerns with children being hospitalized. There has been a fivefold increase in pediatric admissions in New York City just this month. Nationwide, pediatric hospitalizations are up 50% in just the past week. As Paul often repeatedly shared, these children are getting hospitalized, they are dying. These are almost exclusively the unvaccinated.

A reassuring bit of news we got from vaccine safety. This was MMWR, COVID–19 Vaccine Safety in Children Aged 5–11 Years – United States, November 3–December 19, 2021. After authorization of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years during October 2021, and administration of approximately 8 million doses, local and systemic reactions after vaccination were reported, no serious adverse events, serious adverse events were rarely reported. We are not seeing myocarditis. We are seeing this being incredibly well tolerated.

The pre-exposure transmission testing, never miss an opportunity to test. As my wife says, this is a great way to go bankrupt, but maybe not. A single sentence from the FDA that was updated on their website, Tuesday 12/28/2021 created a bit of a stir. “Early data suggests that antigen tests do detect the Omicron variant but may have reduced sensitivity.” Really not much information there. We didn’t get to see any of the data, but they basically go on to state if you do an antigen test and the person, in your clinical suspicion, has COVID or has symptoms consistent, don’t let that one negative test rule them all.

Go ahead, either get a next test. Go ahead, get a molecular test. Really important to realize that particularly now I have to say with triple vaccinated people. A lot of them, I’m not sure they ever really reach those high levels where they’re contagious, where they’re going to transmit it onto the next person. If this is a high-risk individual, let’s say an overweight individual, someone with diabetes, maybe older with comorbidities, you really got to know what’s going on because maybe that second week, they’re going to end up in hospital. Go ahead, take that extra step.

Otherwise, as I was on a call just yesterday with our urgent care providers, if you think they have COVID, if there’s a good story, even if that antigen test is negative, we’re often going ahead and recommending they stay home for five days, wait until they feel better. Treat it as if they had COVID, reinforced mask-wearing. Now that we are seeing people triple vaccinated, now that we’re seeing just how effective these vaccines are, you can start making subtle clinical decisions.

We also heard that a couple of the molecular tests are failing to detect the SARS-CoV-2 Omicron variant. The FDA keeps track as to let people know. Meridian Bioscience has a test, Applied DNA Sciences has a test. All of the other tests are still working so the FDA really keeps track. I think this is really part of their job and really important.

Another, I’ll say we’re getting a little more information, really starting to understand Omicron, the kinetics, and the manifestation. Investigation of a SARS–CoV–2 B.1.1.529 (Omicron) Variant Cluster — Nebraska, November–December 2021. This was an early release. Here, the authors describe a household outbreak of Omicron. One patient experienced reinfection after having been fully vaccinated, four patients experienced reinfection, and one person experienced their first infection. I guess at some point, this will be rare for people who’ve never been infected to get a novel infection without vaccine or prior infection.

They did observe a shorter incubation period. They said this further evidence suggesting a shorter incubation period, and of course, adding existing evidence suggesting an increased potential for reinfection. They comment, like we saw in a Norwegian study and much like we are seeing here in New York, whereas the median time per SARS-CoV-2 incubation had been initially described as greater than or equal five days down to four for Delta, now we’re seeing about three days from exposure till people are testing positive and getting symptoms.

We also saw, and I like this one, this was a preprint, SARS–CoV–2 Omicron variant of concern, VOC Transmission in Danish Households. This one took a little time to go through and really get at what they were saying. Here, the authors reported on 11,937 households, 2,225 with the Omicron variant. You’re going to get a comparison here between Omicron and Delta, and then they identified 6,397 secondary infections during this one- to seven-day follow-up period.

The secondary attack rate was 31% and 21% in households with Omicron and Delta respectively, 31% in households with Omicron, 21% in households with Delta. This is one person is infected, and this is other individuals in the household getting infected. They found increased transmission for unvaccinated individuals. I’ll go into numbers there, a reduced transmission for booster vaccinated individuals compared to un-boosted but vaccinated individuals.

Comparing households infected with Omicron to Delta, they found a 1.17 times higher secondary attack rate for unvaccinated, 2.61 for fully vaccinated, and 3.66 for boostered. What are we seeing here? We’re actually seeing, not that there’s more infections, but that there’s more, I’m going to use that word, breaking through of the vaccine, the vaccine efficacy against infection was lower. You’re getting really great protection with three shots against Delta, really not getting as great protection vaccine efficacy against infection.

They observed that booster-vaccinated individuals generally had a reduced generation of secondary attack rates of 0.72 and that unvaccinated individuals had a higher rate of producing secondary attack rates, 1.41. They’re actually suggesting here that this data supports the rapid spread of Omicron may be ascribed, in part, they actually say primarily but I’m going to say in part due to the immune evasiveness rather than any necessary inherent increase in the basic transmissibility.

I think this is actually what we’re seeing. We are unfortunately seeing lots of re-infections and we’re unfortunately seeing lots of people who were previously vaccinated get infected on top of that, but what we are certainly still seeing, and this is really encouraging, is that individuals that were recently infected with Delta, now got infected with Omicron, people who are vaccinated or even triple vaccinated, the outcomes are much better.

VR: I think the Norwegian study made the same conclusion that immunization is, and what they said, immunization is responsible for the increased fitness, not any change in the intrinsic transmissibility of the virus, which is what we have been saying for over a year now.

DG: Keep saying it, Vincent, keep saying it.

Active vaccination. This is actually exciting. Never miss an opportunity to vaccinate. Peter Hotez, I think people know Peter, we heard Texas Children’s Hospital and Baylor College of Medicine COVID–19 Vaccine Technology Secures Emergency Use Authorization in India. This is the Peter Hotez, Tito Vodka-financed vaccine. This is a traditional recombinant protein-based vaccine, that I actually understand is a receptor-binding domain. It’s not a full-length spike vaccine. This is just the receptor-binding domain portion of that 1,273 amino acid-long spike from SARS-CoV-2.

The initial construct and production process of the antigen, it was developed at Texas Children’s Hospital COVID Vaccination Development, led by co-directors Dr. Maria Elena Bottazzi and Dr. Peter Hotez, and then licensed to the Hyderabad-based vaccine, and pharmaceutical company Biological E. Limited. They now have an EUA in India based upon two Phase III clinical trials where they did not look at efficacy, they looked at neutralizing antibody geometric mean titers, and then they calculated an efficacy.

I’m going to pull in on this, Vincent, because this is interesting. We talked about this idea, and I understand, but since this is a receptor-binding domain, I do the mother test. Would I give this to my mother or would I request that I get a Pfizer or a Moderna shot? Perhaps we’ll get Peter to come on and discuss. Vincent, you want to jump in?

VR: We don’t have a correlated protection. How do you know what antibody level is going to be protective? Now, I understand that in these trials, where we have already vaccines and you can’t withhold standard of care, you need to do this. We don’t know yet whether neutralizing antibodies are actually the ones, it could be non-neutralizing antibodies, or it could be T-cells that are more important. I think this is not really well-advised. I don’t understand why you’d focus only on the receptor-binding domain because that makes the assumption that all the protection is by antibodies that block attachment. From a basic virology viewpoint, that’s just wrong. I hope it works out well for India but I’m not very enthusiastic.

DG: I share your concerns because, in a sense, I’m going to say it’s almost rigged. If you make antibodies against the receptor-binding domain, you’re basically making neutralizing antibodies in general. You’re not targeting the rest of this 1,273 amino acid-long protein. All the ones that require Fc-mediated and other effects. Areas that are, I’ll say, under less selective pressure for changing over time, I’m a little concerned. I’m not as comfortable with this as I would like to be. I would like to see efficacy trials. They’ve really doubled down on this. It’s going to be incredibly expensive per dose, but nothing is more expensive than giving someone a vaccine that doesn’t work.

VR: Daniel, do they need this or is it a problem that they can’t have enough of the other vaccines that are available to them?

DG: In all honesty, Vincent, I don’t know if they need this. I like the idea of this being this inexpensive vaccine that they can make for ₹250 per dose, which is not a lot of money. We have incredibly effective vaccines that have really proven efficacy and growing knowledge regarding safety and efficacy against different variants. I’m not sure about this decision.

Let’s move into the period of detectable viral replication. I have been saying this is the time for monitoring, the time for monoclonals with some twists there recently, but now antivirals. I also wanted to add another thing in here, and I’ll touch back on this. Also, the time to consider enrollment in clinical trials. We still don’t have this nut fully cracked. We’re still not sure what the best thing to do during this first week is. Let’s talk about the two medications, PAXLOVID and molnupiravir.

The big question we’re getting now is– these medicines are becoming available, but the logistics, how do you actually get these medicines? They’re in incredibly limited supply. What have we heard? We’ve heard that a couple of pharmacies have been selected as dispensing pharmacy partners. This is really to our clinicians out there, because patients, you’re going to really have to be working with your clinicians to access this.

Walmart actually has set up a nice website. You just Google “Walmart COVID medications” and then you go to this website, www.walmart.com/cp/2766660. This will hopefully be in our show notes, link to that. I sent this to you, Vincent. This can help you find out which Walmarts locally might have these. CVS has also been selected as a dispensing pharmacy partner. Again, there’s a CVS website, www.cvs.com/content/coronavirus. At this point, that website is still a little bit primitive, but I’m sure these will improve. What we’ve really done is try to have local physicians know which pharmacies have these. For instance, here in Nassau County, we know that the CVS Glen Cove, CVS Hempstead, CVS Freeport has this.

Now, one of the bits of advice, in addition to knowing where you might be able to find these medicines, is we anticipate that PAXLOVID will be in significantly limited supply even though it is considered the preferred medication. Logistically, this’ll be hard, but the suggestion is you write a script, PAXLOVID 150mg, two tabs PO b.i.d dispense number 20, with ritonavir 100mg PO b.i.d dispense number 10. Now, this should come as an EMR thing that you click on, but these three tablets will be packaged together and then all three are taken as a single dose twice a day.

What you’re supposed to also put on this script is, if unavailable, may substitute, this is your choice as a prescriber, molnupiravir 200mg tablets, four tabs PO b.i.d. That’s four tablets by mouth twice a day, dispense number 40. The idea would be, our EMRs or electronic medical records will have these built-in so that this script is generated with the flow-through. You can check or uncheck a box if you want to go. This is the idea. If it shows up, they have no PAXLOVID, time matters, they can default to molnupiravir. It’s a little tricky, but we’re going to learn.

I did also want to bring up at this point, the importance of our clinical investigations in understanding what therapeutics might be helpful. Despite the incredible excitement about ivermectin, fluvoxamine, inhaled steroids, and the number of other therapies, we still don’t really have the data that most of us consider compelling. If you tested positive, you have COVID-19 and you’re excited about some of these, don’t start yourself on that chocolate-flavored ivermectin paste designed for horses.

When I take care of patients, they bring this up. Apparently, it tastes like chocolate. We have trials where we’re really trying to figure out the role of these. I don’t think any of us want people taking horse paste. There are people who think that ivermectin has a role, and some of them are my friends still. I think we’re still friends. One of my friends, Ken Cohen, is running the COVID-OUT trial with the University of Minnesota. This is www.covidout.umn.edu. They’re looking at ivermectin, they’re looking at fluvoxamine, they’re looking at metformin.

Dr. Susanna Naggie is the PI of the ACTIV-6 trial. That’s just www.Activ6study.org. They’re looking at ivermectin, fluvoxamine, inhaled fluticasone. If you are feeling like those medicines might be something you’re interested or you’re a clinician and you have a certain interest in those medications, we have the opportunity to get the answers here because there are still several months ahead of us before these other medications are going to be aplenty. Right now, there’s a vacuum, there’s lots of passion, we need more science.

I’m going to jump right ahead to, COVID is not just a two-week illness. We’re doing a great job with the vaccines of reducing the risk of Long COVID, but it is not zero. Just to reiterate that. Then, a final, no one is safe until everyone is safe. We’re starting to hear promising things about vaccines throughout the world. We talked a little bit about Peter Hotez’s vaccine there, but continuing to do everything we can to push forward for equity.

Then I will close here by saying November, coupled– December will be over. This is going to drop on January 1. During the month of January, we will continue to support MicrobeTV. I think we’re going to be able to be much more generous, even at $40,000 that we initially thought we would cap this at. If you want to, go ahead and donate $1,000 or more. Vincent will send you a signed Virology textbook, and PWB will cover the shipping costs. Doesn’t matter where you are in the world, we’re there and excited to send that to you.

VR: Thank you, Daniel. Before we get into a few questions, here in my home, we have a holiday tree and people decorate their trees in different ways. I just wanted to show you how we decorate ours.

DG: I like that.

VR: This is a poliovirus Christmas ball, right? That is a single poliovirus receptor and of course, the TWiV logo there. Isn’t that great? It’s 3D printed.

DG: That’s exciting. Well, I should say in our house where we celebrate one of these holidays, that people’s stockings were hung by the chimney with care and filled with N95s, TWiV mugs.

VR: Excellent. Excellent. All right, it’s time for some questions for Daniel. You can send yours to [email protected]. Kip and Laura write, “There are two PharmD’s in San Francisco, they’ve been with us since February. A couple of cases representing what we’re hearing and seeing out there. First, a 24-year-old woman, double vaxxed, began exhibiting COVID symptoms on December 20, has tested positive on rapid antigen starting on 12/21. It’s now 12/28. She continues to test positive on daily rapid antigen tests. Her symptoms have begun with a mild head cold resolving, nearly gone, just dry cough, but her rapid antigen is still positive seven days after the initial.

Case 2, another similar case. A 16-year-old boy with the same disease course as case 1, same non-contributory history, symptoms nearly gone and yet too continues to daily test positive. Now day seven with rapid antigen. Question: isn’t this continuing infectiousness unexpected in a young person without any risk factors? I thought these vaccinated and healthy young people would not retain infectious amounts of virus for these lengths of time, or maybe it’s no big deal and these few represent the random results we can expect to see in the wide diversities of immune systems found within a diverse population.”

DG: All right, perfect. There’s a lot in here which is really great. Because this I think factors in with this whole discussion of isolation periods and testing to come out of that. Let’s say you have an individual and it’s day six, it’s day 11, whatever the day is, if you go ahead and you get a negative antigen test, I think all of us can feel pretty good that this person is no longer contagious. What if you get a positive antigen test? What if you get a positive PCR? What we’ve seen, and what’s clearly being described here is some individuals can continue to test positive for longer than those five days, longer than those 10 days.

What we don’t know is the level, right? An antigen test is a yes or no test, I guess you could watch how quickly does that line come up and how dark does it get. With PCRs, we can get CT values which correspond to RNA copy numbers, but we do know from a lot of research, time is a significant component in predicting whether or not we’re going to get live viral culture independent from the RNA level. If you tell me an RNA level is five million, but it’s day one of symptoms, you’re probably going to be able to get some live virus or some viral replication and culture. If you tell me it’s day 10 and there’s that same five million, your chance of actually getting viruses out of there is going to be low.

There’s two factors here, there’s a lot of variability. This is why the isolation talks about continuing to wear that mask. There’s no line in the sand, there’s no plexiglass at day five or day 10 when those tests will turn negative or when a person becomes 0% contagious to the population.

VR: Phillip writes, “I’m doing a T-Detect test. Hopefully, it will tell me if I’ve had actual COVID. My antibody tests have been eight, 20, and 150. My only conclusion from the antibody test is that the vaccines have produced a response. Do you have an opinion on the T-Detect test?”

DG: Yes, the T-Detect test is a T cell. It’s made by Adaptive. It’s a T cell assay for trying to determine if a person’s immune system has seen SARS-CoV-2. It’s great for that purpose. There’s no ability to look at that and get any sense of levels of protection, et cetera. We use it to an individual, let’s say they have symptoms that seem consistent with COVID, they weren’t able to get a test upfront, we’re not sure. Maybe they don’t have antibodies, and that happens with some of our assays. A T-Detect test can help us with putting together that post-acute COVID sequelae diagnosis.

VR: Charlotte writes, “My husband and I were vaccinated with Moderna on 1/18 and 2/15 and boosted on 10/25. When should we be considering a second round of the vaccine? I haven’t seen anything about the timeframe. It’s no doubt pertinent that we are both in our 70s.”

DG: Yes. I think this has come up several times so this’ll be a repeat. There’s a certain idea that the vaccine efficacy against infection may only have a durability of about four months, very dependent upon antibody levels at mucosal surfaces. Are we going to continue to vaccinate people every four months, three times, four times a year, depending on how you do the math or don’t do the math here? This will be an interesting thing going forward. Right now, you don’t have any guidance yet here in the U.S. on a fourth dose, but boy, people are certainly talking about it. Israel is actively discussing this.

VR: Lastly from Lynne, has a question about the CDC’s guidelines this week, and not one everyone is asking. “I’m concerned about how the guidelines impact the 12 to 15-year-old population who were vaccinated as soon as it was authorized, and now we’re six months out from their second Pfizer shot. According to the last part of the guidelines, it seems that this group are now being treated the same as the unvaccinated when it comes to exposures, they need to quarantine for five days, following every close contact.

Given the current and growing prevalence of Omicron, for kids in full-time school and out-of-school activities, that’s a lot of potential exposures and quarantining. Unlike those 16 and up, this group doesn’t have the option to remedy the problem by getting a booster shot. I have three kids in this situation. Thankfully, my oldest just turned 16 and is boosted. Can the CDC really have intended to leave them in this limbo? Are we really saying a 12-year-old with two mRNA shots should be treated the same as an unvaccinated adult? It seems like the guidance makes life easier for everyone else but sends this group back to 2020. Would be grateful for your thoughts.”

DG: Well. The good thing is I hear that next week, the FDA is meeting to discuss boosters in these individuals. If that’s the case, then we’ll be able to get rid of this limbo, but now, that’s exactly what’s happening. The timing is pretty tough here because people are getting ready to go back to school. I think it would be pretty nice if we can get that decision next week. We can get this news, but now, you picked up on a really important subtlety in that area there.

VR: That’s COVID-19 clinical update number 95 with Dr. Daniel Griffin. Happy New Year, Daniel, and thanks again.

DG: Now, it’s been my pleasure, and everyone, be safe.

[00:37:35] [END OF AUDIO]