TWiV 755 COVID-19 Clinical Update #62

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 15 May 2021

pdf of this transcript available (link)

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

[music]

From MicrobeTV this is TWiV, This Week in Virology, Episode 755, recorded on May 13th, 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’s it going this week, Daniel?

DG: It’s mixed. Numbers are getting better in New York. We finally, the other day, got below less than 2,000 people in hospital. Imagine, at one point, we had more than that dying per day. Right now, we’re less than 2,000 in hospital. It’s amazing the way our benchmark is changing. We’re still seeing 20, 30, 40 people dying a day, but that’s not 2,000.

Still had another one of my patients die last night, so we’re still losing people. We’re still having people die of COVID here. I think people are seeing there’s a change. A lot of the hospitals are pointing out, 99% of the people that are getting admitted now are people that never got a vaccine, so that’s what we’re seeing. We’re seeing people who would rather take their chances, not do well. This is the lottery that you lose.

Let me start off with our quotation, and then we’ll go right into this. I’m going to start with a quotation from Nelson Mandela. “There is no keener revelation of a society’s soul than the way it treats its children.” We’re going to be talking, actually, quite a bit about children today, and there’s been a lot of news about kids en masse. We’ll try to hit on everything and a lot of stuff is hot off the press. I was listening to the latest TWiV right before this. I do listen to all the other TWiV and TWiX episodes by the way. I saw somebody comment, “If Daniel’s listening, I’m always listening.” It’s like Fauci on the Couchi or something. [laughs]

We’ll get right to the hot news, we’ll start off with some background. On May 6th, Moderna reported Phase II/III “TeenCOVE” study of mRNA-1273 in adolescents. The Phase II/III study of mRNA-1273 in adolescents ages 12 to 17 completed enrolment in the U.S. We got an initial analysis here of 3,235 participants, randomized 2:1, and we’re seeing here vaccine efficacy of 96% in the seronegative participants who received at least one injection.

The analysis included 12 cases starting 14 days after the first dose and based on the CDC definition of COVID-19, which requires one COVID-19 symptom paired with a nasopharyngeal swab or saliva sample positive for SARS-CoV-2 by RT-PCR. Just a little bit more about this, this is the Moderna sort of balance to the data that we’re going to talk about with Pfizer, so we’re going to talk about what Pfizer is now doing. In this study, the median duration for a follow-up in this analysis was 35 days following the second dose. The Moderna vaccine was very well-tolerated in these adolescents.

The majority of the adverse events were mild, moderate, no serious safety concerns. So what are these things? Some side pain, it hurts to get poked with a needle, people did reconfirm that fire is hot. They did also report headache, fatigue, muscle pain, there were some chills. The company reported that they’re going to continue to collect the data here and we can look forward to the Moderna vaccine, in the future, also requesting expansion down to cover adolescents if the rest of the data is in line with what we’re seeing here.

What about kids younger, what about down to six months? There’s also the “KidCOVE” study of the Moderna vaccine in younger children. This is ongoing and this, actually, is down to six months of age, so this will cover those 6 months of age up to 11 years, that’s ongoing. Just to predict the future, and this probably will not be Moderna first, it will be Pfizer, Moderna, etc. We’re thinking we’re not going to be expanding down to these younger ages until probably September, but we’ll see as we go forward with that.

VR: Daniel, can I ask you, the numbers are very small and we’re puzzled about that on TWiV. Why are they so low for the adolescent studies?

DG: Yes, there’s a couple of ways to look at this. One is we’re just slightly moving the bar here. Normally we think of vaccine studies of being about 30,000 people, minimum duration of two months. We’ve had now millions of people 16, 17, 18 just right above here. You’re just moving that down a little bit, and you’re basically saying, “Is there any sort of a different signal here?” This really builds on the– You couldn’t do this by itself. You couldn’t say, “Oh, I’m just going to do a,” in this case, “3,235-participant study and get a vaccine licensed based on that.” This is data building on the other data.

Actually, no, I’m glad you bring it up, Vince, because I get this question all the time. Parents say, “But it’s only 3,000 here, 2,000 here. We’re only talking about 5,000 people in these studies so far.” We’re actually talking about millions of people and we’re just moving that bar a little bit. What is physiologically difference between a 16-year-old and a 15-year-old? Probably, as we’re seeing, not very much except boy, this looks like an age when we get a really robust immune response. Is that good, Vincent? I’m trying to see if there’s more questions.

VR: Yes. You say millions, but the trial was tens of thousands, so are we following people who are being vaccinated in some way?

DG: Yes. There’s two main ways that we’re following people who’ve been vaccinated and I think Pfizer, actually, is the vaccine that has the most doses out there, well over 100 million here in the U.S. alone. There’s two ways we follow that. One is the VAERS, which is a passive, anyone can report. There’s also active, we call Phase IV, where we continue to follow a large cohort of these people who’ve been vaccinated, so it’s a combination. The VAERS is the broadest. And, as we saw, even something as rare as clotting with J&J, something that is maybe one in a million or so, maybe 1 in 100,000, we can pick that up. We have actually a tremendous amount of safety data in the age group just right above 15 so 16, 17, 18.

VR: Great, thank you.

DG: Transmission, as I like to say, COVID-19 most commonly spreads during close contact. COVID-19 can sometimes be spread by airborne transmission, people seem very excited that that’s been added. COVID-19 spreads less commonly through contact with contaminated surfaces. And that was where it said maybe 1 in every 10,000 case is due to contact, so we’ve really moved a lot away from the hygiene theater. This last week, I have to say, the whole outdoor transmission topic heated up, this is a moving target, and many are actually taking issue, I’m going to say appropriately so, with this number that’s being bandied about of less than 10%.

Now, I for a while have quoted that your risk of getting COVID outdoors versus indoor is about 20 times less likely outdoors, so wouldn’t that put us more down around less than 5%? Now, I want to say, there isn’t necessarily new science here that everyone’s getting excited about. It’s really rather a reaction to the updated CDC camp guidance where masking outdoors is recommended as a baseline with certain exceptions.

We talked about the CDC guidance that was updated by the CDC on April 24th, and what did they say? What got a strong reaction is they said, “All people in camp facilities should wear masks at all times with exemptions.” All right, so what are those exemptions? We talked about this, the exceptions can be certain people or certain settings or activities. Certain people, they said children two and younger. A person with a disability who cannot safely wear or remove a mask if necessary. Anyone who has trouble breathing or is unconscious. So we’re saying, certain people are exempted from this, but also certain settings and activities and so what are those? Eating, drinking, swimming, napping, involved in activities that could make your mask wet, during high-intensity activities where a mask would create difficulties breathing and now add to this, vaccinated. That’s going to bring us back to outdoor transmission.

Before we jump into that, breaking news here on TWiV, I don’t know if you heard this Vincent but today, Dr. Walensky at the CDC announced in Thursday, the day that we’re recording this episode, that people fully-vaccinated against COVID-19 do not need to wear masks or practice social distancing indoors or outdoors except under certain circumstances. This was then echoed by Anthony Fauci.

Now, there certainly are special considerations if a person cannot mount an effective immune response to the vaccine. I was meeting with a gentleman on Tuesday, 89-years-old, he has an immunodeficiency where he has to get intravenous immunoglobulins on a regular basis. He has some ongoing viral issues, that’s not a man who’s going to go to the ball game with his mask off or be in a large indoor setting with his mask off. This is certainly great news for people that have a healthy immune system, people who can mount a proper response to the vaccines. I think that this is reasonable. I think it’s responsible. I think the science is now here and clear on just how incredible protection a person gets when they’re vaccinated.

I think this is going to challenge some of the comments and concerns about “herd immunity or community immunity.” If you are vaccinated, we learn things that masks reduce risk by 80%, maybe being outdoors reduces risk by 95%. Your risk of ending up in the hospital or dying of COVID is reduced even more or most dramatically by vaccination and I think that the science is now here.

I think as people beat up the CDC a little, the CDC gives us evidence-based reliable guidance. We’ve been thinking the science has been mounting, it’s finally here and the CDC did not wait and they stepped forward and endorsed these recommendations. But let’s get back to outdoor transmission. As I said, this is not something new, but let’s go through what the data is when we hear this less than 10%.

Back in November, there was a systematic review published in The Journal of Infectious Diseases, “Outdoor Transmission of SARS-CoV-2 and Other Respiratory Viruses: A Systematic Review.” These authors conducted a systematic review of peer-reviewed papers indexed in PubMed, EMBASE, and Web of Science and pre-prints in Europe PMC through 12 August, 2020 that described cases of human transmission of SARS-CoV-2. Reports of other respiratory virus transmission were included for reference.

Now, I think it’s getting nice when I listen to the other TWiV’s, that we’re getting back to peer-reviewed literature. Hopefully, in the future, all of this analysis will only include peer-reviewed, properly-vetted research. But the authors here reported that based on five identified studies, they found a low proportion of SARS-CoV-2 infections occurred outdoors, and they say less than 10%.

Then here’s where you get that number, the odds of indoor transmission were very high compared to outdoors, 18.7 times, and they give a confidence interval to that. That’s that I say 20 and I’m rounding the 18.7 up to 20. Now, I will say though, if you don’t just read the results, but if you actually go through this whole article– and this will be posted, I think, on Parasites Without Borders– so that you can actually do this and start looking at the tables, you’ll actually see there’s two really large studies in this analysis.

One that involved 10,926 cases and another that involved 7,322. In those two large studies, the number was actually less than 1%. It is true that the risk is less than 10%, but based on the two large studies that were included, it was less than 1%. Now, there was a small study with 103 work-related cases. In that study, they suggested maybe 5%. I think it’s important to look through the data here. Yes, it is less than 10%. It may actually be less than 1%.

If you’re outdoors, you’ve probably reduced your risk by at least 95%. People get vaccinated as we’re seeing really goes down even further and that’s what we’re hearing from the CDC. So effective is vaccination that it is even more effective than wearing a mask and being outdoors at protecting you. I think the evidence is really compelling that being vaccinated and outdoors without masks is really low-risk all around and as the CDC is saying, “ Boy, if you’re vaccinated, maybe being indoors is fine too.”

Now that vaccine eligibility has dropped to age 12, this is really going to leave us a small donut hole for the summer going into this. The kid’s age 3 to 11, you combine testing, drops in community prevalence, all the many exceptions that are built into when the masks can come off, I think we’re really headed in a positive direction here.

Testing, never miss an opportunity to test. There’s been a little discussion, and we’re seeing it in our urgent care and primary care centers, people are embracing those tests at home. I wish the price point was better. It would be wonderful if there was some way of instead of these wide ranges that you’re seeing, if they were $1 a test.

They look like they’re about $1,250 a test. Some people are charging $35 a test. I guess if you buy them in bulk, 1,000 at a time, you can get that lower price point. But we’re actually getting– parents are now doing this at home. Their child wakes up, doesn’t feel well, they wake up don’t feel well, they do the test. Sometimes that test is positive, they come in for advice, for guidance. I just think the access to tests is fantastic, but boy, get vaccinated and then you won’t have to worry quite as much.

All right, active vaccination. Never miss an opportunity to vaccinate. This is the big news that I think everyone’s waiting for. This week was the FDA expansion of the EUA for Pfizer down to age 12. On Monday evening May 10th, 6:00pm, the FDA announced that they had expanded the emergency use authorization for the Pfizer BioNTech COVID-19 vaccine for the prevention of Coronavirus Disease 2019, COVID-19, caused by Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2, to include adolescents 12 through 15 years of age. I was very happy about the timing because I was going to appear on TV. I did appear on TV the following morning at Tuesday AM and I was going to discuss this expansion. It was really good timing that they squeezed that in there for me. Now, what did the FDA have to say about this decision?

They actually said, so March 1st, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age had been reported to the Centers for Disease Control. The FDA has determined that Pfizer BioNTech COVID-19 vaccine has met the statutory criteria to amend the EUA and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks supporting the vaccine’s use in this population.

We discussed the data on a prior TWiV, we discussed some data today on Moderna, but in the past, we discussed this study with over 2,000 participants. The available safety data to support the EUA and adolescents down to 12 included 2,260 participants age 12 through 15 enrolled in an ongoing, so it’s ongoing, they keep looking at these kids, randomized placebo-control clinical trial in United States. Of these 1,131 adolescents who received the vaccine, they were followed for a minimum, got to do at least two months, which they did. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred. So zero, 100% protection.

Now, on Wednesday, the ACIP voted unanimously. I have to say, I don’t know why I still get emotional about this, but I do. This was a huge– It actually brought a tear to my eye when I heard not only the votes coming in but the comments afterwards, but the committee unanimously voted to recommend the Pfizer Vaccine for adolescents 12 to 15, and there were really several important comments.

It was really interesting to hear some of the comments post-vote. Now, Apoorva Mandavilli at The New York Times did a really nice job of capturing the comments, which I appreciated. I was driving while I was listening and I was trying to decide, should I pull over and jot these things down? Fortunately, they were actually put in print. Dr. Grace Lee, a member of the committee and professor of pediatrics at Stanford University, commented that, “Sometimes we lose the importance of children and adolescents in the midst of pandemic, there’s such a focus on older adults in particular.”

Dr. Maldonado reinforced that children may be at lower risk, but they are not at no risk. She pointed out, “While children’s risk of severe illness is low compared with that of adults, the coronavirus has infected more than 1.5 million children and sent more than 13,000 children to hospitals, more than are hospitalized for flu in an average year, according to the data collected by the CDC.” There was a comment that COVID-19 is currently one of the top 10 causes of death in children since the pandemic began.

Remember, this is with full lockdown, with virtual schools, with, in the last year, camps and all these other activities shut down. I think it’s really important to remember that these numbers were what we observed with a rather Draconian lockdown with school closures, virtual learning, masks, everything else, things that I remember last February some of our health experts saying, this will never happen in America. Well, it happened in America. Despite that, we still had this impact.

Another little bit of good news. I think this is great news that we’re going to be expanding this opportunity to get vaccinated down. I’ll let everyone know, my 15-year-old son, Barnaby, is scheduled, it’ll be Friday evening. When this drops, he’ll already have had his first vaccine. I’ll be able to give some updates, maybe we’ll even post a picture if he’s willing. I’ll have to check with my wife first.

We learned about temperature stability. That’s always a challenge with a lot of these vaccines. Particularly, we think about the Pfizer with these thermal shippers. We heard from Pfizer that they actually have an updated formulation, which may allow six months in the fridge. Moderna is always right there with them, and they recently announced ongoing development data related to the current formulation that could support a three-month refrigerated shelf-life for the vaccine and also alternative formats to facilitate easier distribution to doctors’ offices and other smaller settings.

I think this is critical. I’ve talked a little bit about this is some people are happy to go to these large vaccination sites, the state-run sites. That’s where Barnaby’s going. But a lot of people want to have that conversation with their physician, particularly a lot of parents want to have that conversation with the pediatrician.

What they’ve done here in New York State, and I think it’s really ingenious, is the Pfizer vaccines come with over 1,000 in this thermal shipper. Not every pediatrician office is ready to accept 1,000 vaccines and all the commitments of getting them out, so there’s sort of a cooperative that they’ve arranged where several pediatrician groups can work together to each accept a certain number of the vaccines. They get popped in a fridge, you got five days, so basically your Monday through Friday, to get those vaccines into arms, so giving you a little bit of flexibility and thinking outside the box to get this done so that we get to that next level of people who want to have a conversation, want to ask questions.

I’m going to move to the viral symptom phase, the time for monitoring and monoclonals. We have some data on NSAIDs, so things like ibuprofen, naproxen. We have some reassuring data on the ability to safely use the non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen in COVID-19. Actually, I’d say this is huge. It may not seem huge, but when a person is suffering through that viral symptomatic phase of COVID or even starting to move into the early inflammatory, it can be miserable. It is amazing what an Aleve, a naproxen, a couple of ibuprofen can do, particularly in the evening when that person is trying to get some rest. Early on, people may remember, there was a little bit of concern as a letter sent.

This article in The Lancet Rheumatology, “Non-steroidal anti-inflammatory drug use and outcomes of COVID-19 in the ISARIC clinical characterization protocol UK cohort,” a matched, prospective cohort study.The authors reported on the results of this prospective multi-center cohort study that included patients admitted to hospital with a confirmatory or highly-suspected SARS-CoV-2 infection between January 17th and August 10th, 2020. The primary outcome was in-hospital mortality and secondary outcomes with disease severity at presentation, admission to critical care, receipt of invasive ventilation, receipt of non-invasive ventilatory support, use of supplementary oxygen, acute kidney injury. Now, what did they find?

This was a pretty robust study. They enrolled 78,674 patients across 255 healthcare facilities in England, Scotland, and Wales– where there be dragons. In this cohort, 4,211 patients were recorded as taking systemic NSAIDs before admission to hospital and they report that the NSAID use was not associated with worsened hospital mortality, not associated with critical care admission, not associated with the requirement for invasive ventilation, requirement for non-invasive ventilation, requirement for oxygen, or kidney injury. Basically, NSAID use is safe in COVID-19.

Passive vaccination. It actually looks like we’re moving closer to full-approval or licensure. Here as the data is such that recently the FDA said that the data is currently so compelling that they no longer agree with conducting placebo-controlled trials here in the United States. Basically, this is considered the standard of care and something that should be offered to patients.

A little bit of a challenge for the intramuscular, subcutaneous, and other monoclonal antibody therapies that are trying to come to market, trying to get their trials. We also have ongoing trials looking at using these agents to protect contacts and high-risk individuals unable to produce their own antibodies. Things are moving with monoclonals.

I actually was at the gym today wearing a mask. I don’t know if I need to anymore. This was before Dr. Walensky made the pronouncement. We’ll have to see when the rules change, but actually seeing an advertisement on the television, pretty exciting stuff that the information is getting out there. We need to use these more.

Now, early inflammatory phase. If room air saturations are less than 94%, that’s when we have data that steroids, dexamethasone from the recovery trial, six milligrams once a day for 10 days, improves outcomes and saves lives. There are certain situations where people are actually using a little higher doses a little bit longer.

Here’s where I want to throw in, a little bit of caution here. People following the news about India have probably heard about the black fungus or what is more properly called rhinocerebral mucormycosis. There was a nice case series published in The Journal of Laryngology & Otology. This was “Post-coronavirus disease mucormycosis: a deadly addition to the pandemic spectrum.” I don’t know if people are familiar with this. I actually have seen a number of cases of this in my career, and actually a number of cases when I was spending time in India.

Here’ the authors describe 23 cases and the association with diabetes, overzealous use of steroids, use of broad-spectrum antibiotics, I’ll add, to treat a viral disease, and perhaps unclean oxygen delivery devices. They have some great images in this article, disturbing images. They’re not the actual looking and seeing in the open mouth of a patient that black eschar, which is the fungus eating away.

If you do, if you look inside the mouth, and I mentioned I spent some time in Tamil Nadu where I saw some cases in the Indian population of this, when you look inside the mouth and on the roof of the mouth there’s this black eschar where the fungus is basically eating away the person’s face and oral cavity. It’s truly horrific. I’ve even seen where it progresses and eats away the eye.

This is really a caution. This is a viral disease, they do not need these broad-spectrum antibiotics. The steroids has somewhat of a benefit, but you do not keep these patients on steroids for three weeks. You don’t give steroids and let the glucoses go really high. We’re seeing a lot of this in India. This is really we’ll say iatrogenic, which means we’re causing this, so we need to be a little bit careful here, please.

Remdesivir has some minor impact at huge expense, I like to say. Anticoagulation for hospitalized patients. The science strongly recommends against HCQ at this point. I apologize, but that’s where we are. There was a paper published in Nature Communications, “Mortality outcomes with hydroxychloroquine and chloroquine for survival in COVID-19: an international collaborative meta-analysis of randomized trials.” Here, the authors presented a meta-analysis of ongoing, completed, or discontinued randomized control trials on hydroxychloroquine or chloroquine treatment for any COVID-19 patients.

They reported on all-cause mortality and they looked at publications, preprints. They even reached out to the investigators to get more information if needed. Looking through 63 trials that were potentially eligible for inclusion, they include 14 unpublished trials with 1,308 patients, 14 publication preprints with 9,011 patients. They included the recovery and the WHO solidarity trials, which included 4,716 and 1,853 patients. Basically, just to say, the combined odds ratio on all-cause mortality for hydroxychloroquine was 1.11, for chloroquine 1.77. Basically, they were reporting that treatment with hydroxychloroquine was associated with increased mortality. It looks like HCQ is associated with a 10% increase in mortality. I think we need to move past that.

Oxygen and pulmonary support, antibiotics are not helpful for treating viral infections. As I mentioned, experience here can increase the risk of kidney failure, progression to dialysis, death, and increase the risk of opportunistic infections, which can harm or actually, in some cases, kill our patients. We mentioned last time some data, tocilizumab added to steroids can improve outcomes and have a mortality benefit. Consider this early in patients not responding to steroids. It’s not something you want to wait to do, and this is something which has now actually been added to the ID Society guidelines.

Tail phase long COVID, post-COVID. Our listeners may have heard that Dr. John Brooks, the Chief Medical Officer for the CDC’s COVID-19 Response, let it be known that there will be forthcoming guidance from the CDC on how healthcare providers can identify long COVID and manage long COVID. There will likely be a specific ICD-10 code, a diagnosed code for long COVID. I was asked for some input on this guide and said it really looks like they’re doing a great job recognizing that not all patients have access to testing during the acute phase or test positive by serology when they come to medical attention.

I expect that this guidance will likely focus on the multi-disciplinary team approach that many of our centers are finding so critical for meeting the needs of these patients. I also think it’s really nice and this is a new model. They’re reaching out to some of these support groups. They’re trying to get input from patients. I know Survivor Corps has been asked to, basically, input on this. I really think that this is going to be incredibly helpful for sharing the knowledge, serving as an educational resource for all the many clinicians who are really stepping up and helping take care of these patients.

Now, I will finish by mentioning our fundraiser. If you’re not driving, stop what you’re doing, go to parasiteswithoutborders.com and help us support Foundation for International Medical Relief of Children. This is an organization with sites throughout the world and the patients they care for are struggling. The young volunteers who usually go out to these sites, the financial support that they usually have to do all this tremendous work, it’s not there. If you look at these places, they have a couple of sites in India, they have sites in Sub-Saharan Africa, sites in South America. They have sites in so many of these places that are being so hard hit with COVID. Please help us support them, so that we can really go beyond our borders and help address these global issues.

VR: All right. Time for some questions for Daniel. You can send yours to daniel@microbe.tv. First is from Pete. “I have just sent money to a friend in India for oxygen, $500 for a cylinder, $200 for a fill that would probably help two people. I’m thinking monoclonals would be a better option. Any idea how much and how to get them there?”

DG: These are challenges. That’s amazing that that amount of money is being taken for cylinders and these other things and really frustrating that there was not better preparation for what’s going on in India right now. I was actually told by someone I work with, actually, a lot of Indian clinicians, and that remdesivir, for instance, was negotiated, so at least remdesavir is only about $15 or $20 a dose in India. That’s better than $3,000 for a course here in the United States. Access to the monoclonals is difficult.

There actually is a bit of a black market where the monoclonals– I don’t know how they’re actually being initially procured, but they seem to be being sent over to India. I’m not going to endorse the black market. When you start looking at these price points when someone’s paying that amount of money for oxygen, then some of these other costs just don’t seem quite as high. If anything, I think this just highlights what a tragedy is going on over there.

VR: David writes, “Universities are starting to implement vaccine mandates for their students since a lot of students come from overseas. The question keeps coming up, ‘What do we do about students vaccinated with non-FDA approved vaccines; AstraZeneca, Sinovac, Sputnik COVAX, and etc.?’ Re-vaccinate them? Seems extreme given the existing manufacturing shortages. Accept non-FDA approved vaccines in the context of a mandate or just some of them? Is there formal guidance? Obviously there has to be a line drawn somewhere but I’m not sure who draws this line.”

DG: I’ve actually seen that the CDC is starting to put together guidance here. What they are saying basically is, “If it’s U.S. FDA-approved vaccines, all right, that counts.” Then you get into something like, “What about AstraZeneca?” That’s the current guidance. The current guidance, if somebody has vaccines that are FDA-approved, considered effective, then that can be considered as adequately fully -accinated, the same criteria, two weeks after the last shot in the series.

So far, the rules are if a person got vaccines that our FDA has not fully-reviewed, has not fully-endorsed, or licensed, or given an EUA, we’re in the world of EUAs, then we actually have to go ahead and re-vaccinate. I think this is tough because I’m going to say in the next sentence, we have an abundance of vaccines here in the United States. We have the capability to do that. That’s a little bit of an embarrassment when we’re talking about places like India where, ooh, those vaccines would make a huge difference. What is the cheapest way to keep someone from dying from COVID-19? It’s to vaccinate them.

VR: Tiffany writes, “I have a co-worker who has gout. She had a terrible flare-up about a week after getting her first vaccination. Is there any chance these events are connected? Her doctor told her they probably are, but it seems weird to me. She found this article on Podiatry Today connecting gout attacks to vaccinations. I was just wondering what you think? I don’t want any more reasons for people not to get vaccinated if they aren’t based on fact.”

DG: It would not surprise me. Well, as an infectious disease doctor, we often see inflammatory triggers related to gout flares. You can imagine how bad that gout flare would be if you actually had COVID. I’ve certainly seen patients who come in with COVID. I’ve certainly see patients that come in with pneumonia, urinary tract infections—the GOUT is something that is driven by an inflammatory process and something like a vaccine potentially could trigger that. Very easily treated. You treat it with ibuprofen, or Aleve, or colchicine. We have many therapeutics for this.

I think that we need to be honest. This was something mentioned on the last TWiV, is people get vaccines, they might have joint pain, they might have muscle pain. It might be more than just that 24 hours. A colleague of mine actually had really bad vertigo, world spinning for several days after a vaccine. There can be side effects. Why are we recommending these products with these horrible side effects?

It’s because, “You know what’s really horrible? Getting COVID-19. What’s really horrible is dying of COVID-19. What’s really horrible is having a breathing tube put down into your trachea because you’ve got COVID-19 and didn’t get vaccinated.” We always talk about the risk benefits. Boy, the risk and harmful potentialities of not being vaccinated, that’s why we’re vaccinating everyone.

VR: Lindsey writes, “Is there any evidence that people with a previous history of autoimmune platelet disorders like immune or thrombotic thrombocytopenic purpura are at increased risk of CVST from an adenovirus vectored SARS-CoV-2 vaccine or if given one of those vaccines, should someone with such a history be monitored for signs of CVST more closely than someone who didn’t?”

DG: That’s a great question because we have this knee-jerk reaction that, well, boy, if you’ve had a problem like that in the past, that you’re someone who should be at higher risk, we would think. What has been shocking, we continue to track this, we continue to see the rare CVST associated with J&J, I’m going to say that, I think there’s a connection there. I think we’re all comfortable saying that, rare as it continues to be. We’re, interesting enough, not seeing this connection, not seeing it occur in people with prior disorders as you’ve described, even though that would have been the population we would think about seeing it in. So, no, this group is not at any higher risk. This continues to be incredibly rare. Because it is so rare, any intervention we might do is more likely to do harm than just watchful waiting.

VR: All right. The last one, Daniel, we read on TWiV and we thought, actually, you should answer it because we didn’t have an answer. This is from Haley who is a 26-year-old, healthy woman who got Pfizer vaccine, both doses, got a lot of side effects and many of them lasting a long time. She now has daily headaches, muscle and joint pain, can’t exercise. Her doctors don’t know what to do. She’s regretting having gotten the vaccine. She says, “Please help.”

DG: I think this echoes what I was saying before, is that for not everyone is it just “I felt bad for 24 hours” or “I was sort of fortunate, I barely noticed that I was getting my vaccination.” Some individuals, like is being described here, can have wrist or joint pain. They can have muscle pain and sometimes that can last for several weeks. We’re usually recommending that people take non-steroidal anti-inflammatory medicines for these. This tends to last weeks.

We are not seeing, so far, that this turns into anything long-term. I understand the frustration and the regret here, but if you are having difficulty, that’s why we set up a lot of these centers to try to help people. As I think a lot of our listeners know, I’m always happy to answer questions and to potentially step in and help in a situation like this. Have your doctors reach out and I’m happy to, hopefully, help guide you through this process.

VR: That’s COVID-19 clinical update number 62 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Thank you so much. Everyone, be safe.

[music]

[00:41:28] [END OF AUDIO]

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