TWiV 713 COVID-19 Clinical #47

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 30 January 2021

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 713 recorded on January 29, 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: How’d your immunization go, Daniel?

DG: It went incredibly well. We’re getting consistently 12 doses per vial.

VR: Nice.

DG: I actually got even a little bit extra last night. I was able to, with five vials, vaccinate 62 people.

VR: Wow, good job.

DG: There’s something for me, like I am exhausted, but then I vaccinate that many people and I’m full of all this energy. I can’t sleep. I have to settle down. It’s okay.

VR: Nice. Very good.

DG: All right, well, we’ve got a lot to cover today, so let me start with my quotation, “There are no problems, only solutions,” and I think that’s from a song by John Lennon. I have my three rules and I keep updating these, ”Never miss an opportunity to vaccinate, never miss an opportunity to test, and never waste a vaccine dose.” My view is, every vaccine dose is a chance to save a life. We got to get those into arms.

We have a lot of exciting new information to share, so I’ll start with active vaccination. A quick update on the Novavax protein-based vaccine candidate. We have some interim analysis in the form of a press release. We’re getting used to that. It’s funny because you read it through and obviously the PR department was involved.

What is this Novavax vaccine? “It contains a full-length, prefusion spike protein made using the Novavax recombinant nanoparticle technology.” Now, I’m not getting paid by them… “and the company’s proprietary saponin-based Matrix-M adjuvant.” Basically, what they do is they’ve got the spike protein that they purify. It’s made in insect cells, which is actually interesting because I know my two daughters are pretty much vegan, so this might be something they can use. There’s no replication, it’s really just the protein and think of it as like a flower, with spikes all sticking out from the center.

This study enrolled over 15,000 participants from 18 to 84 years of age. About a quarter of them were over the age of 65. The primary endpoint was PCR-confirmed symptomatic – mild, moderate, or severe – COVID-19. It had to be seven days after the second study vaccination. This is something we’re going to talk about. When do you start looking, when do you say it’s time to judge the efficacy? I would say seven days seems to me a little bit early, but I think they were very confident. They wanted to get some data out here. The preliminary data suggested that the Novavax protein-based vaccine efficacy, and they break it down by strain– it’s calculated to be 95.6% efficacy against the original COVID-19 strain, 85.6% against the U.K. variant strain, but only 50% against the South African strain. We’ll talk a little bit more about the terminology strain and variant, but that’s what they’re saying.

This first interim analysis was based only on 62 cases. This is a preliminary interim analysis. Fifty-six of those cases of COVID-19 were in the placebo group. Six of them were in the people that got this protein-based vaccine. Overall, you had an efficacy of about 89.3%. There was only one severe case, and that was in the placebo group.

We’re starting to see this consistent, really good efficacy if your endpoint is keeping people from ending up with severe COVID, keeping people from dying from COVID. This is one of, I’ll say, tried and true technology. This is the vaccine technology that’s used for the new SHINGRIX, the new Shingles shot, so more to come. Also, my gosh, this was vaccine day. Maybe I forgot to give my, “get off the flight if you don’t want to hear about vaccines.” This is not for you, spend your time somewhere else. If you want to send those angry anti-vaxxer emails, www.peterhotez.com, I think is where you send those.

[laughter]

J&J vector vaccine. I’ve been waiting for this. I thought I was going to have to wait till Tuesday. I was excited to have this come out. We keep getting these questions and I think I was joking with one of my colleagues today. When is the normal vaccine coming out? When’s the one where you just get one shot and you’re done? Yes, we’re getting information here. J&J reported that they had met their primary endpoints in the interim analysis of Phase 3. Again, we got a press release, so we’re going to get peer-reviewed. We’re going to get more data and this is going to go, we think, to the FDA soon. Safety and efficacy data based on 43,783 participants. Here, we have 468 symptomatic cases. This is pretty robust data.

Many more cases here compared to some of the other ones, right? We were talking about 100, 118, or so. Here, we have data four weeks after vaccination. I do want to remind people that what we learned about from the J&J vaccine, it really takes about eight weeks to get those antibodies up at 100% of people. What’s the data going to be here? J&J vaccine, they report, was 85% effective in preventing severe disease across all regions studied. I’m pointing out that’s what we are really concerned about. If someone gets a little bit of the sniffles and more or less, or the mild disease, so looking at keeping people from ending up with severe disease, keeping people from dying.

Eighty-five percent at efficacy in all the regions studied as early as 28 days, and then efficacy against severe disease increased over time to 100% at day 49, so about seven weeks. We’re only seeing very limited information in this press release. I’ll get back to this when we get more, but what’s success writing here is this is inexpensive, it’s established vaccine technology that’s been used. Hundreds of thousands of people have received vaccines with this technology. Basically, the safety data, there was nothing there, the reactogenicity profile. This is what people were saying. “I want to get a shot, like the flu shot, where the only reason I know I got it is because one poked me with a needle and they put a sticker on my card or something,” but we’re going to get more data as we go forward.

But I have to say that it was nice to get this data this morning. Before I do FAQs on vaccines, frequently asked questions, I really want to get a little bit into the weeds. I always want to remind people that primary for me, the way this started was using this as a chance to get all the tri-state physicians, the ProHealth New York and other physicians, Riverside and ProHealth Connecticut providers up to speed on what we need to know, but I’m going to call this part here, I’m going to call it the Elizabeth Warren, Bernie Sanders approach. You need a plan. You need to make sure one gets the vaccine, but also I’m going to call it the Biden-Buttigieg vaccines for everyone who wants them only at this point.

Before you order any vaccines, you want to have a vaccine reaction kit. You want to have your Benadryl, you want to have your epinephrine, and then you want to have a plan. If you’re going to be opening a vial, you’re going to get 10 or 12 doses. You want to make sure you have a plan for who’s going to get those and you also want to have a plan if someone has a reaction. With the mRNA vaccines, about one in 100,000 people are having reactions. You want to have a plan for what you’re going to do, so let’s go through.

Part of this, I’ll say, I have conversations with people, and of the nurses I’ve been working with were saying actually just a week ago when we started doing some revaccinations, “We’re thinking about getting this in the office, but we just don’t have a freezer, so we’re not sure.”

Let’s go through. You don’t need a freezer, you need arms. The Moderna, it arrives frozen. You just put it in the refrigerator. Yes, a normal medical office refrigerator. It can stay in there for up to 30 days. I’m not sure there’s any reason with the supply relative demand that any vaccine should sit for 30 days in that fridge, but it can, no freezer required. Once in the refrigerator, just leave it there. Don’t put it back in the freezer. It can, in a couple of hours, defrost in the refrigerator, but if you’re ready to start vaccinating, you can just take it out, let it sit at room temperature for an hour. It’s ready to go. Once it’s been in the fridge, you only need about 15 minutes out before you’re ready to go.

Once you pull out the vial, again, reinforce, have a plan. If you’ve got 10 people scheduled and only eight show up, have a plan for what you’re going to do with those last two. If you got a couple of doses, have a call list and plan, don’t be like, “Oh my gosh, I got to leave at 9:00 for some important date.” Don’t let those vaccines go to waste, have a plan. Call on the phone, make sure people are going to come. Once you pull that vial out of the refrigerator, we’re talking about Moderna here, you have 12 hours just keeping that at room temperature. Once you puncture the vial, you have six hours. Puncture the vial, you’ve got your syringes ready to go, use 1ml syringes. I’ve been posting on Twitter and if anyone follow me on Twitter, and you’ll get my posting on the weeds here, which are the best syringes to buy, which are the ones so that you get 12 doses per vial instead of 10, that’s a 20% increase in the number of doses. That’s huge.

Once you put these shots in arms, you observe people for 15 minutes. It doesn’t have to be one person at a time. You can actually look at multiple people at the same time. Last night we did, as I mentioned, 62 individuals. This is actually for a lot of us the biggest logistical challenge. Where do all those people wait, so you can keep an eye on them? Most people were telling them, set your iPhone, set your smartphone, it’s okay if you have an Android, for 15 minutes. When your alarm goes off, that’s great. A little bit of an oddity. The expiration date is not on the bottles or the box. You actually have to go to the website and input the lot number and then you get this date and you get the expiration date. A little bit odd, but listen, you don’t need a freezer. All you need is a medical-grade refrigerator.

Well, what about Pfizer? Oh my gosh. That’s the ultra-cold, right? That’s these thermal shippers. It arrives frozen and it can stay frozen in that thermal shipper for up to 30 days. All you have to do is add a little bit of dry ice every five days. If you take those vials out, you can put them in a normal refrigerator and they can sit in that refrigerator for up to five days. They shouldn’t be sitting in that fridge for up to five days because we should be getting those into arms. It’s painful to say, but you can actually keep those for 35 days from the time you receive the thermal shipper.

Every five days, you’re adding some dry ice, and at the very end, you put them in the fridge for the last five days. Once you put them in the refrigerator, it takes a couple of hours to thaw, so give yourself an amount of time and pull them straight out of the freezer. If you put them at room temperature about 30 minutes, once they’re thawed, you can pull them out. Once you pull them out, you have about two hours before you do the dilution, and again, you’re going to run into that same– once you’ve diluted them, you’re going to get six doses per vial if you use the proper syringes. You’ve got six hours once you mix them up and load your syringes, ready to go.

All right, now we’ve got our FAQs. Some of these are fun. I have to say, I’m entertained by the questions, but some of them actually speak to a little bit of, I’m going to say carelessness.

“What do we do if a person gets a vaccine and they feel crummy for one day, for two days, for three days?” That’s a magic rule. We have been noticing, unfortunately, that some people come in and they actually have already been exposed and on day three, they’re still feeling crummy. At that point is when you say we can’t just chalk this all up to reactogenicity and you want to do that COVID test.

We’ve actually had some individuals– actually several times this has happened. We were talking about this on the urgent care call where the whole family comes in, and then they all are there to get vaccinated and it turns out someone in the group feels crummy, comes back later that day or the next day, and then tests positive. The rule we’re using, test as often as you can. This is an opportunity to test. We know 5% to 10% of people that are getting tested are coming back positive, so think about, you open two vials, probably one or two people that you’re vaccinating is already positive. They want to know that so that they don’t spread it to their families. We can prevent infections.

Once they get the vaccine, 48 hours is typical. If they’re feeling crummy at day three, then you want to evaluate why are they feeling crummy. It may not be from the vaccine.

All right. “I got vaccinated, but my antibody test came back negative.” This is TWiV, so you’re going to get a little bit of nitty-gritty science here. When you’re getting vaccinated, you are getting the spike protein so that you can make antibodies against the spike protein. Now, the end protein is actually the most abundantly produced immunodominant protein. Most of those tests out there, those serology tests like the Roche, for instance, they’re testing for antibodies against the end protein, so let’s think about it.

If I give you spike protein and you make antibodies against the spike protein, but I send you for a test looking for antibodies against the end protein, the nucleocapsid protein, it’s going to come back negative. Just to throw it out there, we do not recommend checking serologies. We certainly don’t recommend checking the wrong serologies. [chuckles] If you do want to check serologies for some crazy reason, send them to someone with a little bit of a sophisticated understanding, and then they’re going to need a quantitative S-protein antibody test.

“Do I still need to wear a mask if all my friends have been vaccinated?” This is a quarantine issue. I ran into my buddy Jay Berger the other day, and I ran the scenario by him. I said, ”Jay, I know you want to hang out with me, but what if this– what if you and I, and our buddy Conan, we get together because Conan bought a liquor store and he’s going to treat us to this great new scotch. We sit around and we’ve got our mask off because we’ve all been vaccinated and we’re so excited.” Then Conan ends up getting a test the next day because his mother-in-law’s coming to visit and, he’s positive. I’m like, “Jay, you and I, we’re quarantined, we’re out of work.” That’s part of the issue. We do not know if people who’ve been vaccinated, we don’t know about transmission yet. We really need to know about that.

“Why are healthcare workers not required to get vaccinated?” If people listen to the previous TWiV with Dickson, he was getting pretty emotional about this. He obviously feels really strongly about this, but where are we with the science? Dickson was suggesting, and this gets back almost to that first question that we just talked about. Dickson suggested that an unvaccinated person was more likely to transmit the virus to others, or the corollary that vaccination reduces the chances of transmission by a person who’s been vaccinated. Now, here, we actually need to stop and say that we do not know the answer to this question, but we really do need to know the answer to this question.

We have very limited data from the vaccine trials with PCR surveillance in hundreds, not thousands of participants suggesting there may be a reduction in infection and potential transmission. We still do not know if our current vaccines prevent viral transmission. There was a plan to do a major study on transmission with the Moderna vaccine led by Larry Corey, a virologist at Fred Hutchinson Cancer Research Center in Seattle, but they did not get the federal funds and currently, my understanding is that the study is not going forward. The other issue is that these vaccines are not FDA-approved. Even if we knew the answer to the first question and we try and hopefully, we will get the answer too about transmission. There’s a major issue mandating something that’s not FDA approved, so throwing that out there.

“What about these syringes with less dead space?” What is that? I think Rich was talking about that. I’ve been tweeting a bunch about this for a while. If you use the right syringes, you get an extra 20%. Pfizer, five doses. If they send out their vials with the right syringes that do get six doses, then they count it as six. If they’re sent out with the crummy syringes, they don’t get to count extra. I guess I’ll say the same with Moderna in that Moderna right now is sending out with the idea that there are 10 doses per vial, but again, if you use the right syringes, you can get 12, maybe even sometimes more.

This is not common knowledge, I have to say. If you’re thinking about vaccinating, you’re moving forward with vaccinating, reach out, get some guidance, use the right syringes because 10% to 20% extra vaccine, that really adds up. Instead of 10 million vaccines, you got an extra one or 2 million thrown on top.

All right. “What about school openings?” I always get in trouble when I talk about this. The MMWR Early Release came out on the 01/26/2021, COVID-19 Cases and Transmission in 17 K through 12 Schools in Wisconsin. This study involves students, staff members in 17 K through 12 schools in rural Wisconsin under the district and statewide mask mandates.

They found that the teachers in the study reported the students had very high masking compliance. Despite widespread community transmission, the rates in the schools, 37% lower than in the surrounding community. A couple of things I want to say. The mask use was reported at greater than 92%. They were using 11 to 20 student cohorts. They were doing physical distancing. They were doing the quarantine after exposures, and of note, they received funds from a foundation to support this strategy. We all want our kids to go to school but we want the kids, we want the teachers, we want everyone, all the staff involved to be safe. This takes planning, it takes a strategy. It takes money. You can’t just make it happen.

Incubation period, post-exposure. I just always want to remind everyone the test doesn’t predict the future. Don’t go have a test and then think that you don’t have to worry. If you’re in the incubation period, a test can be negative today, it can turn positive tomorrow. Now we have a lot of exciting data. This week, passive vaccination. Monoclonal antibodies for COVID. From Eli Lilly, we have the paper SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with COVID-19 in the New England Journal. That was a 75% reduction in COVID-19. That was the BLAZE-1 study. From Regeneron, we had the original paper in the New England Journal, the REGN-COV2, A Neutralizing Antibody Cocktail with a 50% Reduction.

Then we’ve recently discussed the BLAZE-2 study where Bamlanivimab decreased infections by 80% in long-term care facility residents, and the only deaths were in the placebo arm. This is when we were doing it pre-exposure, but we got a couple of new things today. We have cocktail data from Eli Lilly. This was the Effect of Bamlanivimab as Monotherapy or in Combination with Etesevimab. Now, they should have thrown an L and it could have been e-telsa-vimab, but it’s not. It was better, I think, on viral load in patients with mild and moderate COVID-19.

Really what this was is they continued a second part of the BLAZE-1 study data, and they were looking at the proportion of patients with COVID-19-related hospitalizations or ED visits – 5.8% for placebo, 0.9% for the cocktail. An 84% reduction in COVID-19-related hospitalizations or ED visits. There were no deaths in this study, so we can’t really assess that as well. Regeneron has got more to tell us. Another press release about their cocktail. This is using the cocktail to prevent you from getting COVID-19. Who wouldn’t want to have a cocktail and not get COVID-19?

They looked at 400 individuals. They were randomized to receive the passive immunization with the Regeneron CoV-2 cocktail, and this was subcutaneous. What we hear from this press release is passive vaccination with the Regeneron cocktail resulted in 100% prevention of symptomatic infection, and a 50% lower rate of any infection at all. There actually are some pretty exciting things I’m going to go through here. The lower number of infections that did happen in the REGN-COV2 therapy, they were all asymptomatic, so 100% prevention of symptomatic in this study. The infections that did occur in the placebo group had on average more than 100-fold higher peak viral load in the placebo group than in the vaccinated group, so a two-long difference.

The infections that did happen in the people that got the cocktail, none of them lasted more than a week, whereas the people in the placebo group, 40% of them were lasting three to four weeks. No infected individuals in the cocktail group had viral loads above 10^4 compared to about 62% in the placebo group. REGN-COV2 cocktail given ahead of time was associated with fewer total viral shedding weeks, fewer total high viral shedding weeks. For a recap, the data on the monoclonals is pre-exposure. We have it post-exposure. You don’t want to give it late; you want to give it early.

Here I think you’re seeing some interesting suggestion that 10^4– We’re actually thinking that may be below the level of transmission. People who get high antibodies, whether they’re being given in a cocktail or we’re hoping with vaccines, we are hoping that even if they get infected that it’s going to be resulting in interruption of transmission. Now, this, I was so excited about this, but then I became less excited and then less excited. This was the COLCORONA Study which we finally saw as a preprint. Some really clever person did a little tweet, and they’ve got this really like muscle-bound ripped man.

That was the press release, and then they had the abstract which was a guy who maybe hadn’t been hitting the gym quite as often. Then they had the results and it was a guy with the belly hanging over the belt, and that’s how I’m feeling here. This was a study looking at the efficacy of Colchicine in non-hospitalized patients with COVID-19, and as mentioned, we’re looking at a preprint, so not peer-reviewed. This was a randomized double-blind placebo-control clinical trial conducted in Canada, the United States, Europe, South America, and South Africa. It was designed to determine whether Colchicine would reduce the risk of severe complications associated with COVID-19.

There’s some interesting, I’ll say, background theory on all kinds of ideas about how Colchicine might work, might interfere with the microtubules, might affect the virus, might do immune modulation. But they enrolled 4,488 COVID-19 patients, non-hospitalized at the time of enrollment. They ended up analyzing 4,159 patients with a diagnosis of COVID-19. In those patients with a proven diagnosis of COVID-19 on Colchicine versus placebo hospitalizations, 4.5% versus 5.9%. The need for mechanical ventilation, 0.5% versus 0.9%. Deaths, 0.2% versus 0.4%.

Nothing reaching statistical significance until you start lumping stuff together, but then I will add that 13.7% of the Colchicine seen patients develop diarrhea, and that had a P-value of less than point 0.0001. We did reach statistical significance in giving people diarrhea, but a little disappointing looking at over 4,000 patients and seeing this 0.2% versus 0.4% as far as death, so I was a little bit disappointed. I was pretty excited that we were going to see something here based on the press release.

Now, there’s a lot of data coming out and I’m getting the preliminary stuff on the ATTACC, the ACTIV4a, and the REM-CAP studies looking at anticoagulation. I’ve had a chance to look at the interim data so far, but I’m going to put that on the back burner, that’s something we’re going to talk about next week.

To finish off with the tail phase, I always want to talk about the tail phase. More information about how Long COVID patients have autoantibodies suggestions that this may be tied into some of the symptoms. This is evolving, so we’ll get back to that when I know more.

Our fundraiser, this is our final episode encouraging people to help us support the Peace Corps HIV and AIDS programs, thank you so much for all the support we’ve gotten. I look forward to supporting them. We have a very exciting upcoming fundraiser that will start February and March, but I’m going to leave everyone in suspense and we’ll announce that next time.

VR: Daniel, after the last tweet where we talked about immunization of healthcare workers, I got an angry email saying, “How dare you think that we don’t know how to prevent getting infection? Weren’t the healthcare workers on the priority vaccination group and wouldn’t you want them to stay healthy so that they can keep working?”

DG: I think that’s really interesting. Isn’t getting vaccinated the way and washing your hands? I have to say it’s really a shame, there’s a large healthcare system bias. It’s made of a lot of different hospitals– and each hospital has a different culture also, I’ll say. In that healthcare system, the majority of the people working there don’t want to get vaccinated which shocks me. I remember the time their flagship hospital got scolded because nobody washes their hands. I mean it’s just like, “Come on.” All right, send us the angry emails. Remember that’s at peterhotez.com.

[laughter]

VR: Okay, all right. We have an email from Bhavna in Delhi, India whose parents got COVID in November, and he’s concerned– His parents are doctors, they’re going to get vaccinated, AstraZeneca, but he’s concerned about his dad taking it so soon. “I can’t find any substantial data on how people who had moderate-to-severe disease a few months ago react to the vaccine.” Some advice for Bhavna.

DG: Yes, we talked about this a little bit last time and this goes into my, “never miss an opportunity to immunize.” If your dad has the opportunity to get a vaccine, go ahead and get that vaccine for your dad. The CDC recommends no minimal interval between the time you’ve been vaccinated and the time you’ve been infected, and when you get a vaccine. Now, I know some of my colleagues say, “Oh, wait a few months.” Do not miss the opportunity to vaccinate. We’ve now vaccinated millions of people, lots of them had COVID before. I’ve personally vaccinated lots of people that had COVID. They’re fine.

We are not seeing any signal to suggest that people who’ve been infected before are going to end up having problems with the vaccine. Last night, I vaccinated a gentleman who was on the ventilator for 55 days. He’s now better. When I vaccinated him, he cried tears of joy. He and his wife were just so relieved. This was his second dose. I said, “Give yourselves two weeks, you’re almost there. Keep going.” Particularly, oh my gosh, people who’ve been sick before, let’s get them vaccinated because you do not want to have a second infection.

We’re seeing the data, yes, you’re unlikely to get infected in the first three months. Your chance increases by six months, and as we go farther out, we’re seeing people get reinfected. Let’s make sure we vaccinate these people. The CDC says there’s no reason to wait. I say there’s no reason to wait. The science says there’s no reason to wait.

VR: David in the U.K. asks, “With further trial showing advantage and survival for tocilizumab, do you think your clinical practice will change? Reading between the lines it seems to be in combination with steroids as you have long suggested.”

DG: Yes. My practice hasn’t necessarily changed, interesting enough. We’ve talked about this early on. Our experience is that you don’t want to give it without steroids, you want to give it in a background to the people who have been on steroids. If that person escalates to high-flow nasal cannula, they’re heading towards the ICU, you think they’re going to require intubation. I think our experience, and now the science is pretty clear, that the right patient, the right time, tocilizumab reduces people that require mechanical ventilation. It reduces your chance of death. Actually, there’s mortality benefits if used in the right patient with the right background of steroids at the right time.

I have to say it’s really difficult. We talked about this on the ASH Guidelines Meeting this week. A lot of people are suddenly put into positions of power and decision-making that they were not used to, that they did not have before, and maybe didn’t have the experience for. People that never sat on a Guideline Panel. They see guidelines and they say, “No. No these are the rules.” We are really careful when we’re talking about when we publish our guidelines coming up, that we’re going to actually put in the line where we say the qualification. We feel like people don’t quite understand the guidelines and saying, ”These are guidelines,” but you should be caring for your patients based upon the most recent, the most available, the most up-to-date data.

I had a painful conversation about a weekend back. I ended up with a medical director at a hospital where I don’t spend a lot of time and either an endocrinologist, renal doc, I forget his specialty, and he was aware of some of the latest and he said, “We’re aware of there is stuff out there. We’re going to probably meet next month and discuss it. I really haven’t taken the time to go through it, but I’m not going to authorize tocilizumab on this patient,” who actually later that day ended up ventilated in the ICU.

It’s a little bit difficult I have to say, from my perspective as a specialist to see that a lot of institutions want one-size-fits-all and decisions are being made about patient care, I think not really appreciating what is the latest data, right? If my family member is in the hospital and there’s an expert in the field who’s keeping up on the literature and making decisions, that’s quite a bit different than something being managed by an administrator.

VR: Carson writes, “Is there any known correlation between a person’s reaction to a vaccine and the strength of that person’s immune response? Should a person who gets vaccinated and has no side effects be concerned that perhaps they didn’t have a significant immune response?”

DG: I like that because we always– when the person has like a warm arm on the seventh day and we say, “Oh, you’re having a really strong robust immune response.” People respond really well to these vaccines whether or not they have any kind of local reactogenicity or not, so no reason to check anything. These are vaccines with really high efficacy against severe disease. Yes, whether or not you have a strong reaction, you should not be concerned.

VR: All right one more from Julia who says, “Can you give us an update on Kawasaki-like symptoms in children. I haven’t heard much about it. Are we seeing it? Do we have any more information? How are the affected kids six months out from infection?”

DG: Yes. Some of the nice things that have developed over time here is that CDC has really provided good guidance, good links, and actually if people are concerned, we had a recent case where it was an adult with multi-inflammatory syndrome, multi-inflammatory system adults, so MIS-A versus MIS-C. You can get on the phone; you can reach out to the CDC. There aren’t enough cases to say anything in general, but some of these children have had cardiac issues. They’re being followed by cardiologists on a regular basis. We’re learning a lot. We still only have, as mentioned, about six months of data. We’ll learn more. This is something we’re still seeing, and unfortunately, there’s a lot of cases of COVID in children and this is one of those, though not common, you start having a really large population affected and you start seeing more of these cases.

VR: All right. That is COVID-19 Clinical Update Number 47 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Oh, thank you so much, and everybody, be safe.

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