TWiV 778 COVID-19 Clinical Update #70

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 10 July 2021

pdf of this transcript available (link)

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

[music]

From MicrobeTV, this is TWiV, This Week in Virology,Episode 778, recorded on July 8th, 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: I understand that we have a slight uptick in cases in the U.S. due to a few states where there are a lot of unvaccinated people.

DG: Vincent, have you left the echo chamber? It’s the delta variant, of course.

VR: Oh, all– I’ve forgotten.

DG: It has nothing to do with a lack of vaccination, a lack of masking, nothing to do with human behavior. It’s all the virus. We’re all doing the right things.

VR: Got it.

DG: Now, I have to say, I think I went through stages of frustration and I’ve come out the other side. Earlier today, I was listening– It’s actually Carl Zimmer talking about how he’s welcoming people into the delta club. He knew this was coming. It would be the end of the world. Vincent, what you say is exactly true. You look at a map, and where people did not get vaccinated, they’re getting COVID.

VR: The hospitalizations and deaths are not going up, right?

DG: I don’t understand, no. That is something that I– I was doing a talk yesterday, actually, talking about what is the story with the delta variant? What is this concept of transmissibility? Actually, I will tell everyone I little shamed that I didn’t get TWiV 777, but I did really enjoy TWiV 777. I think it’s important because sloppy language, I think, puts us all at risk because there’s this concept– I did a thought experiment in this talk I did yesterday. I said, “What does transmission mean to you?” Then I had asked some people before the show, and one of them was like, “I heard it’s so transmissible that two people were walking in the street, and one person walked by the other and got COVID.” I’m like, “Let’s be honest, they were having an affair. I mean, they did not walk passed someone–“

[laughter]

I think then people start, “Oh, the masks don’t even work, why do I bother? The vaccines don’t work, why do I bother?” The reality is that, yes, there is a fitness advantage to the delta variant. That’s fine. We keep seeing different variants. No one ever raised the specter with flus in the past year, so I’m not sure why science be damned during times of COVID, but I’m sure we’ll get into that.

I mean, the vaccines, as we’ll talk about, continue to be very effective. Areas with excellent vaccination coverage have low rates. Areas like Nevada, Missouri, other areas where they’re not getting vaccinated, lots of COVID. Suddenly, if you look at the numbers across the country, we’re not seeing suddenly that the hospitals are getting full again. It’s all regional. It all corresponds to poor vaccine uptake. Our quotation will hit right on to this, “It may be said that natural selection is daily and hourly scrutinizing, throughout the world, every variation, even the slightest: rejecting that, which is bad, preserving and adding up all that is good: silently and insensibly working.” That’s right out of On the Origin of Species by Charles Darwin. I would say, it’s good. You want to quote Charles Darwin right out of his writing because there are so many misquotes of Darwin out there.

VR: Yes, indeed.

DG: Some of them even etched in marble that were never said by Charles Darwin. I know that when we do science communication, people think that the intelligence level of the genuine population is about fifth-grade level or such, but I don’t think that’s true and, particularly, the TWiV audience. I think people can understand survival of the fittest, and the concepts that the viruses are competing against themselves, and we are just behaving poorly, but okay.

Children, COVID and mental health. As I like to say, children are at low risk, but they are not at no risk. Really nice discussion. I think people are realizing COVID is becoming endemic, so really, the selection a parent and adolescent is making is, “What is the risk of vaccination versus what is the risk of eventually getting COVID?” Really nice conversations having yesterday with a colleague of mine, Michael Amala, just about there may be an increased incidence of cardiac inflammation after vaccination. This in no way compares to the incredibly high incidence and severity that we see when these kids actually get COVID.

All right, so let’s move to transmission, pre-exposure period transmission. Still, never miss an opportunity to test. We’re falling down quite a bit on this. One of the things I get a lot of questions about, and we had a nice MMWR early release about this, is, “What about these air purifiers?” The early release entitled, “Efficacy of Portable Air Cleaners and Masking for Reducing Indoor Exposure To Simulated Exhaled SARS-CoV-2 Aerosols,” – United States, 2021.

Now, I have to say, this sounds like it was a fun project, so let me go through what the authors did. The authors reported using a breathing aerosol source simulator to mimic a meeting participant exhaling infectious particles. That was the source. And then there were three breathing simulators used to mimic a speaker to participants exposed to these aerosol particles. Interesting enough, these simulators were actually head forms with elastomeric skin from Hanson Robotics, used to do these experiments.

They set them up, set to either 15 liters per minute or 28 liters per minute, and then they use these optical particle counters to collect aerosol particles. There’s a figure in the paper, but I have to say, I wanted to see the video. I’m going to have to admit, this must have been cool. They did report that based upon this investigation, using two HEPA air cleaners close to the aerosol source reduced the aerosol exposure of the uninfected participants and speaker by up to 65%, and a combination of the HEPA air filters and universal masking reduced exposures by up to 90%.

There’s a few comments. I mean, this is a big topic, but a few comments. First, just this was really a simulated, basically air cleaning procedure. There’s no SARS-CoV-2 in this paper. This paper actually doesn’t really tell us anything about the actual transmission of SARS-CoV-2. It just tells us about how you might keep droplet particles, aerosols out of the air. I think that’s important.

When people ask me about the HEPA air cleaners, I say, “Sounds great.” There’s no magic barrier at six feet. You get in that suburban home with poor airflow, you get in that office, you start getting a lot of people in there, and I think that it’s reasonable to consider these air purifiers, reasonable to open those windows. Your risk does not go to zero when you hit six feet. This is interesting, but realize I’ve seen a lot of retweets of this, “Look, we’ve been saying this forever.” I’m not sure what you’ve been saying forever. This just tells you that air filters do filter the air.

All right, active vaccination. Never miss an opportunity to vaccinate, and vaccination is how this pandemic ends. We are seeing that across the country. Last week, I talked about the preprint, “Serum Neutralizing Activity of mRNA-1273 Against SARS-CoV-2 Variants.” That’s the Moderna vaccine. This suggested that the Moderna mRNA vaccine produced antibody levels with neutralized activity against several SARS-CoV-2 variants, including the delta variant.

I also mentioned the data from the UK suggesting the Pfizer-BioNTech vaccine, 88% effective against symptomatic disease from the delta variant. Then the AstraZeneca, about 60%. This week, we had some data on the J&J vaccine in the form of the preprint, “Ad26.COV2.S elicited neutralizing activity against Delta and other SARS-CoV-2 variants of concern.”

Similar to the Moderna preprint, the authors tested sera from recipients who’d gotten a single dose of the J&J. This is the J&J vaccine. They tested this for neutralized activity against several SARS-CoV-2 variants. All tested variants demonstrated susceptibility to the induced serum neutralization. There was reduction compared to the B.1 strain. Most pronounced reduction was observed for the beta that was about 3.6, the gamma that was 3.4. Now, there was only a 1.6-fold reduction observed for the widely spreading delta variant.

Couple comments here. This work was done using pseudotyped virus. Again, this is looking at antibodies. This is not looking at T cells. This is also not giving us real-world experience as far as the ability of the J&J vaccine to reduce our chance of getting sick, to reduce our chance of getting infected, but I do know I get lots of questions.

We got all these people wanting to top off their immunity after J&J with an mRNA vaccine. This does not support that. That is not currently recommended. If anything, this would give people, I think, maybe a little bit of confidence that even just looking at the antibody levels, and we really think that J&J’s power is in a T cell response, that we’re maybe better off from a J&J standpoint with a circulating delta, relative to the gamma or the beta.

Now, last week, I also discussed, “Effect of Vaccination on Household Transmission of SARS-CoV-2 in England.” That was where they reported their vaccination was associated with a 40-50% reduction in transmission of SARS-CoV-2 in household context. As Vincent brought up, most of the vaccinated index patients in this dataset (93%) had only gotten their first dose of vaccine. I know when I discussed this with my wife, her comment was, “That’s useless.” Remember, [chuckles] this was the UK. There had been a significant period of time where people had only gotten one dose. We’re hoping that after the second dose, that that reduction is even more. I just want to point that out.

We did get a little more information in this realm. The New England Journal of Medicine had a paper, “Prevention and Attenuation of Covid-19 with BNT162b2 and mRNA-1273 Vaccines.” This is the Pfizer-BioNTech and the Moderna vaccine. I think this paper is also helping to build the story that people who get vaccinated not only are protecting themselves, but there may be an impact on interrupting transmission. These were a number of participants. They excluded participants with laboratory documentation of SARS-CoV-2 infection prior to the start of the study. Then they went ahead and conducted a prospective cohort study on 3,975 healthcare personnel, first responders, and other essential and frontline workers. They looked from December 14th, 2020 to April 10th, 2021.

I have to say, this is great. The participants completed weekly SARS-CoV-2 testing, mid-turbinate nasal swabs for qualitative and quantitative PCR testing. Now, 796 or 20% of these individuals were completely unvaccinated. About 636 had received at least one dose. 2,543 had gotten two doses. They report that they detected SARS-CoV-2 infection in five of those that were fully-vaccinated, 11 partially-vaccinated, 156 unvaccinated. Now, remember, different denominators down. I break this down into what percent are we looking at. About 0.2% of the fully-vaccinated, 1.7% of the partially-vaccinated, 20% of the unvaccinated got infected. You’re about 100 times less likely to get infected, about a 2-log reduction in even testing positive after the vaccination.

They then went one step further to look at the level of the viral mRNA, not actually looking at live or infectious or active virus, but looking at viral mRNA. They also looked at the duration at which you can detect this. In the vaccinated, their data showed lower levels of viral RNA and a lower percentage of individuals still had detectable viral RNA for greater than one week. I think this is compelling. This is data showing that people who are vaccinated are less likely to get infected. I always point out that if you can’t get infected, you can’t spread it to others. Also, suggesting as we’ve seen, that if you do get infected after vaccination, it looks like there’s less viral RNA. Also, looks like that is present detectable for a shorter period of time.

Now, one of the big things that keeps coming up is, “What is your altruistic, your civic virtue to getting vaccinated?” I’m going to share a story because I think if people think these things through, “Let me see. Yes, I guess I should get vaccinated.”– This was a call I got on Thursday evening. The story was, it was a three-year-old. I got the call from the grandparents who are physicians. This three-year-old, who’s most of the pandemic isolated in the home, now has the opportunity to go off to a day camp, and the mom’s excited. She’s pregnant. Has another child under the age of 10, as well.

On Thursday morning, everyone’s ready for the July 4th exciting weekend. It could be the two sisters, the grandparents, the two grandchildren. The three-year-old starts to feel not well, runny nose, and they get a call that morning from the camp, “I’m sorry, but the camp counselor that has been taking care of your three-year-old just called us to let us know that they have COVID.” Unvaccinated camp counselor, the three-year-old gets tested, and the three-year-old has COVID. Let’s look at the impact of that counselor’s decision to not get vaccinated and work around children. That counselor transmitted the virus to the three-year-old. We now have a pregnant woman at home with a six-year-old. We have a three-year-old, who’s got COVID, who now can’t go back to camp, finally had had some social interaction.

The six-year-old is in quarantine. The six-year-old can’t go to camp. The pregnant woman’s sister had come out for the four-day weekend to be together. She leaves immediately. The two grandparents leave. What a disaster. Just think about the fact our decisions affect our community, they affect others. If you’re going to work around young, unvaccinated, vulnerable children or other vulnerable populations, your decisions doesn’t just affect you, they affect others. I think this is just a story about how that person’s decision really had a significant impact. Let’s think about that when we make our decisions.

The period of detectable viral replication, the viral symptom phase, the time for monitoring in monoclonals. I like to say, where you get your test is ideally where you should get your monoclonals. I have to say, anticipate in the next couple months, I’m very optimistic, we’re going to have some exciting small molecule inhibitor results, an option going into the fall and winter when we will still have COVID-19, but some less exciting data on ivermectin with the publication of the paper, “Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial,” in BMC Infectious Diseases.

A lot of people were waiting for this. This was nicknamed the Corrientes Trial. This was a randomized, double-blind, placebo-controlled study conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 hours of that positive test by telephone to invite them to participate. The trial then randomized 501 patients between August 19th, 2020 and February 22nd, 2021. The patients were randomized to receive ivermectin. It was weight-based dosing with an N=250, the placebo, N=251. This treatment was for two days with this weight-based. The efficacy of ivermectin to prevent hospitalizations was evaluated as the primary outcome. The mean age was 42 years, and the mean time since symptom onset to inclusion was four days. This was actually quite early.

The primary outcome of hospitalization was met in 5.6% of the individuals in the ivermectin group, 8.4% in the placebo group. The p-value on this difference was 0.227. Time to hospitalization was not statistically different between the groups. The mean time from study enrollment to invasive mechanic ventilatory support was 5.25 days in the ivermectin, 10 days in the placebo group. That actually, interesting enough, was statistically significant. People in the ivermectin group, on average, ended up on a mechanical ventilation in about five days versus 10 days in placebo, and that’s a p-value of 0.019. I know there’s a lot of people who are really passionate about ivermectin. There’s this buzz that it’s a crime against humanity that not everyone is getting ivermectin, but I have to say, so far, we are not seeing the science to support that degree of excitement.

At this point, still, we’re not recommending use of ivermectin outside of clinical trials. If anything, I think this also gives us a boundary of how potentially effective ivermectin could even possibly be if we have a larger, powered study, so put that in context. I’m sure I will get some fairly friendly constructive comments.

[laughter]

The early inflammatory phase. The publication, “Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19A Meta-analysis,” and this is out of REACT, so that is the WHO Rapid Evidence Appraisal for COVID-19 Therapies, the REACT Working Group. There’s a couple of these. I think I’ve shared that I sit on the American Society of Hematology Working Group looking at anticoagulation. A number of individuals sit on this WHO group. What they’re doing is they’re looking at data that we have. Actually, there’s a lot of communication even ahead of time with the researchers prior to things being published. This paper was published in JAMA and just reinforces the role in select patients of IL-6 antagonist therapy.

This is Tocilizumab that we’ve talked about. This was a prospective meta-analysis of 27 randomized trials, including 10,930 patients of whom 2,565 died by 28 days. The 28-day all-cause mortality was lower among patients who received the IL-6 antagonists compared with those who received usual care or placebo. I want to break it down because I think this is really critical and I want our listeners to catch this. The summary odds ratio for the association of IL-6 antagonists treatment with 28-day all-cause mortality was 0.78, so a 22% reduction with concomitant administration of corticosteroids. It was 1.09, so about a 9% increase in mortality if the patients did not get corticosteroids.

I think this really enforces this paradigm now in a lot of our treatment guidelines. Patient comes to the hospital, their oxygen saturation is less than 94%, we start them on steroids, they progress to a higher level of oxygen requirement, then we look at adding the IL-6 antagonist Tocilizumab. If you do not give them steroids, do not give them Tocilizumab. This is not a treatment for everyone, it’s a select group. If they escalate to that higher level of oxygen, you have a window of only about 48 hours to jump on board. If you wait to day three, we actually see that we make things worse. This should be done with someone who knows these fine details.

The tail phase, long COVID. This, I have to say, was the excitement of my week. I really enjoyed seeing this Lancet preprint, “The impact of COVID vaccination on symptoms of Long COVID. An International survey of people with lived experience of long COVID.” Now, the authors invited patients with long COVID to complete a web-based questionnaire. 900 people were invited to participate, and several were excluded for different reasons. Ultimately, we end up analyzing 812 individuals. Following vaccination, 57.9% of participants reported improvement in symptoms, 17.9% reported that they felt worse, 22.2% said they were really just about the same. There was a considerable individual variation in these responses. Larger improvements in symptom severity were seen in those who received the mRNA vaccines compared to the adenoviral vector vaccines.

This is the UK, so think about that. A few comments. Since this was the UK, only 130 of these individuals had received a second dose of vaccine. Here, we’re actually seeing a 57.9% of participants reporting improvement after just a single dose of vaccine. I think I’ve shared that a lot of these had the experience that we pick up more responders with a second dose. This was an online survey, so it recruited participants via social media and is not really representative of the entire population of people with long COVID. Most of the respondents identified as white, and by most, I mean over 90%. Over 80% were female. There was no control group here. I will say that there was a great figure too, and I want people– This will hopefully be linked to on the Parasites Without Borders website. You can go to this right after you donate.

There’s a great figure too, and figure 2 is nice to look at. What is getting better? Because people always ask me that. Is there a profile of who gets better? We saw individuals with fatigue reporting improved fatigue, brain fog improved, my allergies improved, shortness of breath improved, insomnia improved, chest pain. A lot of these individuals have ongoing chest pain that improved or resolved. Gastrointestinal symptoms may be underappreciated earlier in the pandemic, but a lot of these individuals have ongoing reflux, diarrhea, discomfort that improves. The inability to smell, interesting enough, we’re seeing improvement after vaccination. The autonomic dysfunction, the pot that we’ve all heard about, even these individuals that have chronic cough, fever, rash, or other vascular issues.

The authors comment a little bit about the fact that there was no control group. They do point out that the majority of patients had been experiencing symptoms for at least nine months when they enrolled them, and there was a return to baseline for at least half of the patients within one month of vaccination. There’s a nice timing here suggesting that for the majority of long COVID patients, receiving a vaccination not only offers protection against reinfection but also may potentially improve their symptoms.

I will finish there today, and just remind everyone, throughout the months of May, June, and July– We’re in July already. I was shocked that we’ve already gotten there. We are going to continue to take your donations. We’re going to match them. We’re going to continue to help Foundation for International Medical Relief of Children. I think one thing that is maybe clear to everyone, as good as things are getting in parts of the United States, you look at areas like Sub-Saharan Africa. Only about 1% or 2% of those individuals even have access to vaccines. Hear all these discussions in the U.S., “Should I get a third dose? Should I top off my J&J?” Just remember, so many parts of the world, they don’t even have access to that first dose. We want to work with these groups and try to help support them so they can get back in these areas, help with the vaccine rollout, and you can be part of that. Thank you.

VR: Time for some email questions for Daniel. You can send yours to daniel@microbe.tv. Kerry from Southern California has arranged monoclonal antibody treatment for over 40 patients in the last two months, but there are still high-risk patients who are eligible. “However, resources in his area have been reprioritized and the monoclonal infusion clinic is being closed with referral of high-risk patients to community sites, but the problem is we haven’t found any.

The HHS and Regeneron websites have extensive list of REGEN-COV infusion sites, but every one of them in our area have ceased operation. County and state funding appears to be drying up. There don’t seem to be any alternatives for patients in our community. Have you found a similar problem in your area? Are there any national efforts to allow continued treatment with monoclonals? I’m interested in your thoughts. Thanks for all you do.”

DG: That’s disturbing, disheartening. I have to say, I was actually just on the phone earlier today with Adam Fiterstein. He’s the head of our ProHEALTH urgent care. Just talking, are they having any issues? I always try to keep this on my radar. We continue to be very fortunate in the New York tri-state area. Our partners, the Catholic hospitals, you can send an individual right over. Few hours later, they’re on their way home having already received their monoclonals. The large healthcare system Northwell is jumping in with their tents as well. We really have good access here, locally. What you’re saying is, actually– I’ve heard that this is starting to be a problem nationally.

There’s no profit here. We live in a capitalist society. The number of COVID cases are dropping down. A lot of people are returning to business as usual. There isn’t this huge demand for monoclonals in many parts of the country. There certainly should be in some others. This is a problem. I remember in my previous incarnation, I spent some time in Washington, actually, training lobbyists. If you can believe that, and one of the things is you’ve got to create, in a capitalist society, a model that really makes people encouraged to do this.

I hate to say that, “People, you should all just do this because it’s the right thing.” These medicines, the Regeneron products, are bought by the government. Maybe you can charge an infusion, but there really isn’t a big market driver to get this done. They continue to be one of our most effective, if not, our only most effective, during that first week. We’re lucky in the New York State area, but yes, this is a problem and hopefully, the word– People are listening and we can get this addressed.

VR: Darcy writes about an experience with his first AstraZeneca jab. He has had a prior history of anaphylaxis to contrast agents used during an MRI scan. Initially, he was okay but had an arrhythmia bad enough to need the emergency room and had had several since—“Taking me there since each time discharged with no insights. I had a history of palpitations in summer. Arrhythmia’s nothing significant for years, could be entirely coincidental that it happened within five days of my first jab.

I’m awaiting a variety of tests to see what might be going on, but in the meantime, I keep getting contacted about my second and now overdue AstraZeneca jab. The doc told me not to get the second one until I had some cardio investigations, but with the delta variant and pressure from social and familiar sources to be fully-vaccinated, I wonder if you can comment on your experiences regarding arrhythmias and COVID vaccination, whether a second jab could exacerbate arrhythmia symptoms.”

DG: There are several things here. This is a great email, great question. What we are doing in the U.S. if someone had an issue with one vaccination, and here, let’s say, it was Pfizer, Moderna, those are two-dose, we might look at switching over to a different vaccine. It is the mRNA vaccines that really have this connection. We’re saying it’s about one in 100, one in 200,000 risk of myocarditis. I don’t know if that’s what’s causing the arrhythmia. I’m not even sure it’s causal certainly here. A lot of this is going to depend where you are in the world.

If you had an issue with that first AstraZeneca vaccine, do you have the ability to switch to a different vaccine to complete this? Can you go ahead and do a Pfizer two-dose? Which would be actually how we would approach that. We wouldn’t just give, at this point, heterogeneous or mix-and-match. That’s going to depend where you are. If you do not have a choice, and this is going to become that risk-benefit of, are you going to risk getting COVID, or are you going to risk potentially having arrhythmia cardiac issues after that? That’s a tough call, and I see why they’re saying you should go see a physician, you should see a cardiologist, they can get to the root of this. Hopefully, they can even get a sense of whether or not it makes logical sense. Then this is related. The five days after, there’s a causal suggestion.

I have to say, this is going to be the last– Is the delta variant– What is the only good thing about the delta variant is we actually are seeing an uptick in people coming in and saying, “I wasn’t going to get vaccinated, but now, with everything I’m reading about the delta variant in the media echo-chamber–” I’m not a huge fan of the end justifies the means. I think we need to be honest, but I’m always happy to hear people coming in and getting vaccinated.

VR: My view, Daniel, is that at least people stop using the word ‘strain.’ They’re using variant now.

DG: [laughs] Okay. We’ll take what we can, Vincent.

VR: Ken writes, “I just watched a presentation where several medical doctors have hypothesized, based on clinical studies, that long-haul COVID is caused by the presence of non-classical monocytes containing S1 protein fragments located on or near epithelial cells of blood vessels. These cells apparently engender various inflammatory conditions in the vascular system presenting as common symptoms of long COVID. The doctors have also presented evidence from their own practice that the use of statins and ivermectin have benefited patients by presumably shutting down overactive monocytes or somehow blocking the effect of residual S1. I’m not a doctor or scientist, but I would love to hear your thoughts on this hypothesis.”

DG: I’m going to comment. I hope those physicians didn’t use the word evidence when they were describing their anecdotes, their clinical anecdotes. The way science is supposed to work, and I really am a little troubled by what happened during the COVID-19 pandemic, is you may make some observations in the clinic, and that’s really what drives you to say, “We need to study this. We need to find out if it’s true.” It is very easy to be tricked by our observations, by our selective memory of things.

Normally, you would have a theory. You might do some basic science to get a sense of whether or not that’s true. If that seems consistent, then you would look at a small trial to get a sense. Then you would talk to your statisticians about how many people do we need to have in this trial because you don’t willy-nilly start getting medicines to lots of people. Unfortunately, the last 18 months has been the Wild West. I’m hoping we’re getting away from influencers, thought leaders, spreading of anecdotes. I think we got to get back to science. What is science? Science is really just asking in a way that you can find out the truth, what works, what doesn’t work, and then the risk-benefit of making different choices and different recommendations for our patients.

VR: What is it that Mark Crislip says the three most dangerous words that a doctor says?

DG: “In my experience.”

VR: There you go.

DG: I’d like to say the plural of anecdote is not data.

VR: That’s a good one. That’s a good one, too. Ken, by the way, said he had long-haul COVID in November, and then it got better after his first dose of Moderna.

DG: That’s fantastic. We are seeing that. I know Akiko up at Yale is working on studying this, but having issues recruiting enough patients. We are seeing this. It’s nice that we had this UK investigation. Just more support, right? Again, this is an issue. We have observations in the clinic. We have to do these in formal ways to really turn those anecdotes into information.

VR: All right, one more, Daniel. I think we’ve covered this. Danielle got her first J&J in April, and then decided to get a dose of Pfizer. “I listened to your podcast last week about a person who got two more doses of a vaccine, even after Sputnik. She wants to know whether it’s safe to go ahead, get the second Pfizer dose, or whether I would be subjecting my immune system to too much immune stimulation?”

DG: I think there’s two topics here to touch on. We’ll start with the safety issue. The U.S., as far as recognizing someone as fully-vaccinated– There is the list of not only EUA, so U.S. FDA, EUA approved but also now WHO-approved vaccines. You look at that list, and if you completed the series, you can be considered recognized all the rights and privileges of being fully-vaccinated. We certainly have seen a lot of individuals that didn’t meet that criteria and ended up getting a couple more doses of a U.S. FDA, EUA approved vaccine even though they already had received some other unrecognized, unapproved vaccine outside the country.

From a safety point of view, not been formally studied, we do now have experience with thousands of individuals who have gone through this. We’re not seeing any reports [unintelligible 00:36:40] or anything else. From a safety standpoint, I’m not concerned. I am concerned about the logic here. The J&J is a very effective vaccine for doing what we want it to do. I’m not sure you really need to be topping things off with an mRNA series.

VR: That’s COVID-19 clinical update number 70 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Thank you, Vincent. Thank you, everybody, and be safe.

[music]

[00:37:23] [END OF AUDIO]

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