TWiV 761 COVID-19 Clinical Update #64

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 29 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 761, recorded on May 27, 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: Here we are, Daniel, in the midst of a pandemic and people are arguing about whether the virus came from a lab or not. Is this crazy?

DG: Well, you know what? You got to watch the subtleties, Vincent. Initially, it was whether or not this was created in a lab. Now they’re like, “Well, if it just had anything at all to do with the lab, we’re going to take that as a win.”

VR: I don’t get it. I really don’t get it.

DG: Yes. Well, I do. I think everyone should listen to the most recent TWiV, which I truly enjoyed, where Peter Daszak and crew, basically, the actual investigators who went there, spoke for over an hour. Really, I thought that was a great episode because so many of these headlines are out there and you find there’s secret stuff we can’t share with you and you find out the secret stuff is what we found out that during the cold and flu season, there were a few people at a large institute that had respiratory symptoms.

VR: Indeed.

DG: Oh, my Lord. That confirms it. By the way, as Peter said, “Would you tell us who they are? We could go see if that was due to COVID.” “Oh, we can’t tell you who those three people–” Come on. Yes. When you mix science and politics, what do you get, Vincent?

VR: You get politics. I love that. I thought that was great.

DG: Yes, that was a great line.

VR: Of course, clinical medicine is immune from politics, right, Daniel?

DG: Oh. The really tough thing is nothing is immune from politics. It’s all intermesh. Sometimes, it’s really interesting when people say, “Oh, we stay away from politics.” It’s hard in medicine because public health is always directly tied in with politics. All right, let’s try to avoid politics as much as we can.

VR: Okay.

DG: Actually, boy, and then of course here’s my quotation. “Never ever depend on governments or institutions to solve any major problems. All social change comes from the passion of individuals.” That was Margaret Mead. Her usual apolitical self. I think she’s actually another one of those really tremendous individuals that my dad had the opportunity to get a chance to meet and talk with. Very jealous that he had this opportunity.

Let me give you a little bit of an update on what’s going on here in New York. And what I’m going to try to do is, I’m going to intersperse some of the stories, because I am still admitting patients with COVID to the hospitals. Clearly, the numbers are lower. These individuals are, as we’re seeing across the country, they’re the unvaccinated. That’s who gets sick with COVID. The vaccinations are incredibly powerful. We’ve quoted numbers. Rich was trying to do the methods. Your chance of dying of COVID after a vaccine is one in 1/500,000. Pretty, pretty tremendous.

I will say things are going in the right direction here in New York in so many ways, but I’m going to throw little clinical vignettes, little stories, little experiences that I’m having here that I think put this into context. I will start off with children and COVID, and by the time this dropped, I’ll have been on the air Friday morning, Channel 12, again, talking about a lot of the issues that have come up, a lot of the science, and a lot of how this is being translated.

This is quickly changing. May 19th, we had updated guidance here in New York State and we had the executive order. These are executive orders, which are law. New guidance for health and safety measures at childcare, day camp, and overnight camp programs as New York proceeds with strategic reopening. I want to put this into context as I have done before, so I’m sort of repeating here.

The CDC gives us the science-based guidance. They try to interpret the science and translate that into what might affect how we comport ourselves. Ultimately, at the state level, our governors give us the rules that we have to live by. I applaud all the clinicians and other healthcare professionals that I know are donating their time to help guide everyone through this. Unfortunately, I’m finding, as someone that gives advice to a lot of these places, that the staff is getting really savvy. They’re really starting to get the science. They’ve been educated up, which is fantastic. There’s also a lot of different associations that camps and restaurants and all these childcare facilities rely on, and those associations really have tremendous people that are taking the time and getting up on the science.

With that said, what was that guidance? I’m going to tell you ahead of time. We got more guidance on the 24th, so that’s going to get layered onto. What was the initial guidance on the 19th? Facilities and programs must collect COVID-19 vaccination status and documentation for all staff and children. That’s actually kind of heavy. That’s a little bit of a thing.

We’ve talked about, HIPAA is coming up periodically, but what is really the issue here? An employer, a person running waste programs can ask, the HIPAA thing would be a person may say, “I’d rather not answer that question,” but this is an interesting challenge. They’re actually saying you must collect the vaccination status. That’s going to be an interesting challenge into this summer.

The next mandatory daily health screening practices of staff and visitors, including daily temperature checks. That is a little bit of an issue. I know we’ve discussed this at a national level. Is how much do those actually help? Particularly those daily temperature checks, because we’ve got to start thinking of COVID as the flu. A lot of individuals, particularly during those first few days when they’re shedding a lot, they do not have fevers. There’s a little bit of an issue here, but that’s New York State. It’ll be different in everyone else’s state and country.

Facility and programs need to notify the state and local health department immediately upon being informed of any positive COVID-19 test by a staff member or child at their site. Each site must implement a property-specific capacity limitation for children and campers that ensures appropriate social distancing. Staff who are not fully-vaccinated must maintain a distance of at least six feet from other unvaccinated staff. That requires you to know unless you’re going to make everyone distance. Children and campers over the age of two and staff who are not fully-vaccinated must wear face coverings except when eating, drinking, showering, swimming, or sleeping/resting.

Take a deep breath. Now, May 24th, we get an update and it hits right on some of these issues. Suddenly, it has changed. And I say suddenly, not to be judgmental, but the guidance is moving forward. Responsible parties should encourage children campers age two and older who are not fully-vaccinated to wear face covering. Young children campers, those that are not in kindergarten, do not need to wear face coverings when they’re in a childcare or day camp, program, facility, or area. It’s getting a little bit different here.

Children campers are not required to wear a face-covering when utilizing the outdoor space that belongs to and or is exclusively used by the childcare or day camp program and then restricting saying face coverings must be worn by individuals who are not fully-vaccinated during transportation. They’re actually, at least here in New York State, if you read this guidance closely, it’s not that easy to read that closely, but if the kids are there, if they’re in that camp setting, in that childcare setting, they do not necessarily need to have masks on when they’re outdoors.

I think this evolves from some of the science we have talked about. Outdoors is a very safe place relative to other places. A proper translation of the research, I think, is that transmission is less than 1% in the outdoor area. Outdoors, in the summer, dropping prevalence, particularly here in New York State. These are all going to be really positive for our kids. I don’t go that much into– I did go into it a little on previous ones, but there is a mental health and all kinds of other challenges to having kids wear masks, having all these restrictions that our kids have gone through.

I always get angry emails when I talk about the fact that we have learned a lot about how we can actually get kids in these different settings, in camp, in school, how we can do it safely. Maybe sometimes the rates of infection are even lower when kids are allowed to go to school with the proper mitigation methods. Well, let’s talk about that. There was a recent preprint that caught a lot of headlines. Let’s go through this because I think it was misinterpreted a little bit, so I want to actually go through what it actually said, if one takes the time.

This was the pre-print, “COVID-19 Mitigation Practices and COVID-19 Rates in Schools: Report on Data from Florida, New York, and Massachusetts.” This was recently posted and the authors used data from the COVID-19 School Response Dashboard. Now, what is that? This is a resource created with the organizing partners, the AASA, the School Superintendents Association, the National Association of Secondary School Principals, the National Association of Elementary School Principals, Brown University Professor of Economics, Emily Oster. This can actually be accessed. This is covidschooldashboard.com. You can go there and look at the data.

As the authors pointed out, they only looked at data from Florida, New York, and Massachusetts because, as they and the COVID school dashboard report, this resource only contains consistent data for a limited number of states. There’s actually a couple more that the COVID school dashboard has added. I will say that this paper will be much better after peer review. Despite several limitations, the authors point out, what I agree, basically finding that there does seem to be a lower rate of COVID-19 for students being in school. Suggesting that actually kids that may be safer in school then not in school.

This has been an interesting– touchy for when I discussed this with parent groups. Who would I trust with my children? Let’s see. The Port Washington School District or my wife? It would be my wife. There is a dynamic that happens socially when our kids are isolated, we’re trying to figure out ways for them to socially interact. It is hard, and the school can do it in such a way where they actually get a degree of social interaction.

One of the things that was taken away from this, I will point out, is people said this study failed to show an impact of masking. They only actually had mask mandate information for Florida. I’ll qualify that all they had was whether or not there was a mandate in place. There was no one the ground checking to see whether masks were being worn, not worn. There did to seem to be a little bit of a signal to the teachers wearing masks. I’m going to leave it at that point because we’re going to hit some other data where we actually look at when they looked at masks, ventilation. Where they’ve actually shown that, that is associated with a reduction in transmission.

Pre-exposure transmission period. I really liked another early release that came out in the MMWR. This was shadowing this. “Mask Use and Ventilation Improvements to Reduce COVID-19 Incidence in Elementary Schools.” This was Georgia, November 16 to December 11th. The authors reported that COVID-19 incidence was 37% lower in schools that required teachers and staff members to use masks, and 39% lower in schools that improved ventilation. The ventilation strategies associated with lower school incidence included dilution methods alone. That was 35% lower incidence. Or in combination with filtration methods, that was a 48% lower incidence. Using things like those HEPA filtration systems.

In this study, the authors used data from Georgia Kindergarten through grade 5. K-5 schools that opened for in-person learning during fall 2020. They reported on this huge study, 169 K-5 schools that participated in a survey on prevention strategies and recorded COVID-19 cases during November 16 to December 11, 2020. The Georgia Department of Public Health required all Georgia schools to submit weekly data on the aggregate number of COVID-19 cases among students and staff members.

This analysis was based on 1,321 public K-5 schools, 140 private K through– private schools. Prevention strategies assessed included mask requirements for teachers, staff members, students, ventilation improvements, physical distancing of desks greater than six feet apart, barriers on student desks, class size, number of students in a classroom, cohort size; small groups of students who stay together throughout the day during in-person learning, and number and locations of available hand-washing stations.

I know the paper focused on masks and ventilations as far as their conclusions, but there’s really interesting information if you go through the paper in detail, look at the tables. In addition to the conclusions, I point out a couple of things that I found interesting. The higher the county COVID-19 incidence, the higher the number of students that tested positive. I think that’s, again, what we’ve seen– the community incidence actually ties and vary directly with school incidence. They also didn’t really see an impact of that separating the desk by six feet. Basically, the schools that did it and those that did not have the same incidence of COVID-19 per 500 students.

Again, we’ve talked a little bit about, “Do you need six feet? Can you get them three feet? Is that getting what you need?” We’re seeing masks, three feet, ventilation improvements, test, all these other strategies really are showing us that schools could be a really safe place even for un-vaccinated children. Now that we’re vaccinating adolescents, now that our rates are dropping, I think the science is supporting a lot of our progress in this area with getting kids back to schools, back to social interactions in camps.

Testing. Never miss an opportunity to test. I’m beginning to think that everyone should just subscribe to the CDC morbidity and mortality weekly reports. I will say I also listened to their– they have a great weekly podcast. If you don’t like to read. You could do both. I do both. There was another release in the MMWR. This one was entitled, “COVID-19 Testing to Sustain In-Person Instruction and Extracurricular Activities in High Schools,” Utah, November 2020 to March 2021.

Now, for context, COVID-19 was associated with the cessation of kindergarten through grade 12 in-person instruction and extracurricular activities. Most of us can agree that this had negative social, emotional, and educational consequences for our children. What were they doing here? The authors reported on two high school COVID-19 testing programs that were created to sustain in-person instruction and allow for extracurricular activities. During November 30th, 2020 through March 20th, 2021, among 59,552 students who receive testing, 3.2% had positive results.

What they went through doing these programs. These programs that they put in-place facilitated the completion of approximately 95% of the high school extracurricular competition events and saved an estimated 109,752 in-person instruction student days. The authors were suggesting that school-based COVID-19 testing should be considered part of a comprehensive prevention strategy to identify SARS-CoV-2 infections in schools and sustain in-person instruction and extracurricular activities.

What did they actually do? Well, the schools implemented these two high school testing programs. Test to Play and Test to Stay. I love how catchy these are. Test to Play, this was where there was testing every 14 days mandated for participation in extracurricular activities. That doesn’t seem very often. Every 14 days. Test to Stay involved school-wide testing to continue in-person instruction as an alternative to transitioning to remote instruction if a school crossed a defined outbreak threshold. These are areas where we’re starting to see increased incidence. They’re jumping in with these testing strategies during November 30, 2020 through March 20, 2021.

As I mentioned, 59,552 students were tested through these programs at over a hundred of Utah’s public schools. They implemented rapid antigen testing. With rising rates of COVID-19 in Utah, on November 9th, statewide COVID-19 restrictions were ordered. Part of that was a cessation of extracurricular activities. That was when Test to Play was introduced. In December, 2020, Test to Stay was piloted at two high schools. Beginning January 4th, 2021, schools crossing the outbreak threshold could choose to implement Test to Stay as an alternative to transitioning to remote instruction.

A number of the schools jumped in. They took advantage of this. They were given free test kits, training– testing assistance to help implement these programs. The authors pointed out their conclusions that this approach can serve as a framework for other schools wanting to have kids back in school for sustained in-person instruction and continued extracurricular activities.

Active vaccination. Never miss an opportunity to vaccinate. I also say vaccines are how this pandemic ends. I’m going to start here with the story. I, actually, every so often, get upset. I may seem calm and level-headed at all times. Just sometimes things get me a little bit upset. This was a patient of mine. I’ve taken care of her several times in the past, so I’ve known her for a while. She is homebound. She was homebound and she was very excited to get vaccinated, but her primary care physician was not aware of how to access one of these programs to get a homebound person vaccinated. This frustrates me because I will say a lot of people are jumping into the space and trying to help.

Actually, Northwell, one of our large health care systems here, has actually set up a program where physicians can reach out, connect their patient, and personnel will go out to the residence and vaccinate these homebound people in their homes. These exist. These programs exist. If you’re taking care of patients, if you have someone you care about who’s homebound who can’t get to a vaccine site, start making those calls. Let’s get these people vaccinated.

While she’s waiting, unable to get vaccinated, she is homebound and she is being taken care of by a home health aide who happens to be an anti-vaxxer. The home health care aide gets COVID. The home health care aide infects our patient, my patient, and now my patient, who is unvaccinated, is in the hospital on steroids, on remdesivir, on anticoagulation, on oxygen. Just this very much could be avoided.

The other thing that didn’t happen there is after she was exposed, started to get sick, monoclonals were not given. I think I pointed out too, monoclonals, we have programs for delivering those in the home for homebound individuals as well. She missed her opportunity to get vaccinated. She missed her opportunity to get monoclonals. It’s upsetting to me. I understand that people want to make decisions, but when you make a decision that ends up putting someone else in the hospital, that I find very difficult.

On May 25th, we heard from Moderna with the press release. Moderna announces TeenCOVE Study of its COVID-19 vaccine in adolescents meets primary endpoint and they plan to submit data to regulators in early June to expand the EUA down to 12 years of age for Moderna. Now, this was a Phase II/III Study in 3,732 adolescent participants aged 12 to less than 18. They were randomized 2:1 to 200 microgram doses of the mRNA-1273, so the Moderna vaccine or placebo. The primary endpoint was non-inferior immunogenicity versus the Phase III adults study comparator that was met.

After two doses, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase III COV-Study. Compared to four cases in the placebo group, resulting in a vaccine efficacy of 100%, starting 14 days after the second dose. Keep in mind, those number– You don’t want to hang your hat on that. Because the incidence rate of COVID-19 is lower in adolescence, a secondary case definition based on CDC definition of COVID-19 was also evaluated to include cases presenting with milder symptoms.

Using the CDC definition, which requires only one symptom, and a nasopharyngeal swab or saliva sample positive for SARS-CoV-2 by RT-PCR, we got a vaccine efficacy of 93% after the first dose. The Moderna vaccine was well tolerated, with really the same safety profile that we saw in adults. That was really positive, kind of nice. We’re going to have some more options eventually. The FDA, also,– This actually is pretty big. They authorized a longer time for refrigerator storage of the thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution.

If people have ever worked with these, these come in a non-diluted vial, and then you have a little normal saline that you use to dilute that before you administer it. You can take that out of the deep-freeze thermal shippers. You can leave it in a normal refrigerator for up to a month. I don’t know if that’s 30 or 31 days or 28, if it’s February. But no, it’s 30 days in a normal medical refrigerator. There’s now an updated fact sheet with this modification. One still needs to get that into arms within six hours after you dilute that. That is a little different than Moderna. Once you puncture a Moderna vial, you’ve got 12 hours.

The other thing in here is that, normally, you had to order over 1,000 of the Pfizer-BioNTech vaccines in this big thermal shipper. You can order half thermal shippers, so about 600 or so. Also, we have programs, I think, I mentioned here in New York, where you can actually partner with other organizations and get as little as 40 or 50 doses where someone else is taking another 40 or 50 doses. A number of practices are working together so that we can start offering this in the pediatrician’s office, in more of the primary care setting offices. This is really huge for helping us improve access.

The period of detectable viral replication or the viral symptom phase. As I like to say, the time for monitoring and monoclonals, NSAIDs are fine for symptomatic relief. I’m going to tell another story here. This was an interesting story I saw. I see a lot of individuals who are suffering from long COVID. This person was actually interesting. I don’t see a lot of this. This was an individual who got sick in early January. This was an older man, late 70s, a number of health problems. He actually got monoclonals, maybe a little bit late, about day eight. He actually went on to develop long COVID.

I first saw this gentleman about seven weeks ago. At that point in time, we talked. I usually tell people, “Hey, why don’t we go ahead and let’s try and see if vaccination will have any impact here?” It was really, I’ll say, this was very pleasant, Tuesday in the afternoon in the office. This gentleman got on and just basically said, “Dr. Griffin, it was like switching on the lights. I am completely better. I have no more symptoms. Thank you. We don’t need to see each other anymore.”

Two issues there. One was actually, I do not often see people with long COVID after monoclonals. I have actually seen several, and we’re analyzing our data to see what the incidence is or if there is an impact on long COVID to getting monoclonals. We’ll have that data, hopefully, to share. Real data, not just this story. Also, again, really nice to see another individual who had this really nice timing of recovery after vaccination.

Another monoclonal option just got EUA this week, so more options here. GSK and Vir Biotech announced sotrovimab. This is VIR-7831. I’m not sure their name is easier to say then VIR-7831. Sotrovimab received EUA for treatment of mild to moderate COVID-19 in high-risk adults and pediatric patients. This is actually based on data that we’ve discussed before. This was the COMET trial data with an 85% reduction in risk of hospitalization or death.

I actually want to point out, this is in the EUA, and the announcement is that sotrovimab maintains activity against all known variants of concern, including that triple mutant variant from India. That is nice to say. Monoclonal access is actually now expanded. The wording now is, healthcare providers can now consider the benefit-risk for an individual patient, using the fact sheet for healthcare providers and the CDC website as guidance. Now we’re saying, you can look at giving this to your high-risk patients. You don’t necessarily have to check that box.

We talked about BMI of 25. Maybe it’s a BMI of 24. You’re going to use your judgment there. Maybe they’re not 65, but they’re 63. Is that close enough? We’re seeing a little bit of realization that there’s no reason to let these products sit on the shelf, considering how incredibly effective they can be and how safe they have been. Remember, the monoclonal cocktails are not authorized for, and probably are not a benefit for, people who have missed the window and are already hospitalized due to COVID-19, who require oxygen therapy, because they’ve gotten into that early inflammatory phase, or who have chronic oxygen needs, and now have an increased requirement.

This is that monoclonals, actually, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen, or mechanical ventilation. We go from a window of opportunity to a time when that is closed, to actually a time when we may be harming our patients by using these. This isn’t something that you want to just demand for your relative. You need an educated clinician helping make the decision about whether or not this is going to be a life-saving, a beneficial, or even a harmful intervention.

One of the management decisions that I often struggle with during this time, and I’m still going to say after this, I still struggle with this is, is there a role for aspirin in the outpatient setting? There was an article, “Active prescription of low-dose aspirin during or prior to hospitalization and mortality in COVID-19: A systematic review and meta-analysis of adjusted effect estimates.” This was published in the International Journal of Infectious Diseases. I actually spent a lot of time analyzing this paper to really see if I could come away with a conclusion.

This was a meta-analysis, which our listeners may recall is when you get– you take a whole bunch of studies and you stack them one on top of another and maybe each study isn’t so great. When you get them all together, you reach a certain height and they miraculously turn into gold. That is not the case. The author’s report found six eligible studies comprising 13,993 patients. That sounded impressive. “Oh, this is great.” But let’s be fair. When you actually start reading the article, you realize that 12,600 of those patients come from just one study. Then the other studies all have only between 48 and 638 patients, really making this a re-analysis of that huge study.

What was that huge study with the 12,600? That was association of mortality and aspirin prescriptions for COVID-19 patients at the Veterans Health Administration that was published back in February. If you look at that, what did they do? They did not actually look in that study at people getting aspirin for the treatment of COVID. They just looked at veterans in a database and said, “Who was on aspirin prior to getting COVID?”

Then they looked at their outcomes versus the outcomes of those people who were not prescribed aspirin. I’m really left without any certainty regarding a benefit or even harm with routine use of aspirin. I’m going to leave this in the clinical judgment realm. No real good science helping us. And we do, we need good science helping us with aspirin and a platelet agent’s anticoagulation.

All right, now we’re going to get to the tail. We’re going to jump way ahead here to the tail. I don’t feel I have any other new things to jump in on on some of these other areas. We have information out of the UK on children and COVID. I think this is important to get things in context. One of the things we now think we have a sense is the case– or I’ll say the infection hospitalization rate for children.

We don’t really know the case or the actual infection, we have the cases. Let’s look at this study. “Illness duration and symptom profile in a large cohort of symptomatic UK school-aged children tested for SARS-CoV-2.” This was posted in a preprint, so it hasn’t gone through a peer review yet. The authors here reported on 1,734 children with a positive SARS-CoV-2 test result. They had information on illness duration within the study time frame. They wanted to be able to ask the question of these kids who get COVID, “How long are they sick?”

We got a little bit of information on the symptoms. The most common symptom was headache. That was 62.2%. Fatigue was a little over a half, 55%, and the median acute illness duration was six days. That was a little bit different. Seven days if you were older, five days if you were younger, as far as symptoms duration. Here, what are we looking at? We’re looking at what kids went on to have prolonged symptoms. 4.4% of the children had an illness duration of greater than 28 days, more commonly experienced by the older versus the younger children. If you looked at the older, it was actually about 5.1% and the younger about 3.1%. A trend there.

The commonest symptoms experienced by these children for this prolonged period of time past 28 days was 84%, 80% of them were reporting headaches. 80% of them were reporting a lack of ability to smell. When we got out to greater than 56 days, 1.8% of the children were still experiencing symptoms. I’m going to avoid using words like only or just, but this gives us a sense of the risk here. Kids got COVID, about 4.4% of them were still having symptoms about a month out. Once we got to about two months out, 1.8% of the kids had continued symptoms.

This is suggesting that the incidence here of long COVID, or post-acute sequelae of COVID, is lower in children than adults. The symptom burden in these children didn’t increase. They did not get worse, and as we saw, as we went from 30 days to 60 days, we actually had a lower percentage of kids continuing to report any symptoms there.

I’m going to finish with one—Actually, this was a hot off the press story that I thought was interesting. I’ll just leave this for people to speculate on. I have a patient, I’m taking care of her in the hospital and she got sick back in December. She has a number of autoimmune diseases, she’s on some immunosuppressive medicine. It had been quite a period of time, and about a month ago, we decided to repeat her PCR– this time quantitatively because we’ve been positive for PCR forever and we’ve really been looking at the literature and a lot of the suggestions. Once you get past about 10, maybe 20 days, you have a positive PCR but it’s really just low-level.

In this individual, the PCR came back in the 20s. Actually, translating into about 45 million RNA copies. Quite surprised at how high this was. We discussed with her and her sons that we really had no evidence-based interventions to offer them. We then moved on to a discussion of, “What are we going to do in the future so that this woman doesn’t get re-infected?” Not clear that she’s mounting any great response. They were concerned about vaccinations.

She had had some prior issues with vaccination and we decided, as a joint shared decision making, that the safest place to go ahead with vaccination was while she was still in the hospital before she was discharged. She received the J&J vaccine, which she really tolerated without any event. Today was about 10 days after that dose. We’ve been trying to look at our options for sending this woman to different facilities.

We repeated the PCR today and it was negative. Very exciting. We’re going to repeat it again tomorrow. Sort of interesting. One of those observations, “Is it true that that’s related to the vaccine? Did we just finally get to that threshold?” For me, very encouraging after this very long odyssey, this woman is potentially going to leave the hospital vaccinated.

I will leave it there and just remind everyone, drop what you’re doing, if you love what we do or if you love what FIMRC does, we are still continuing to help support Foundation for International Medical Relief of Children. This is really a tremendous organization that I’ve worked with for years with sites throughout the world, really making a difference in so many people’s lives. Really the mission that I love, they go to these places, they ask the people there, “What do you need? What can we do to help you?” Then they work with those communities to try to meet those needs. Go to parasiteswithoutborders.com and help us support them and continue our work.

VR: Time for some emails for Daniel. If you want to send one in, daniel@microbe.tv. Bill writes, “My 13-year-old son just received GARDASIL vaccine and with the approval for COVID for kids, we’d like to get him vaccinated ASAP. Is there a waiting period we should adhere to between different viral vaccinations?”

DG: That two-week waiting period has been removed. Earlier on, I always said, “Don’t ever let that stand in the way. “Try to space things two weeks out. Now they’ve basically said, “No, we have enough of an observation. We have enough science here. We know what we see with different vaccines. Go ahead get that COVID-19 vaccine as soon as possible.”

VR: Peter writes, “I’m an anesthesiologist and dentist here in New York’s Good Neighbor Toronto, Ontario. I was thankful to have had AstraZeneca first vaccine nine weeks ago. No sequela. I was diagnosed with polycythemia vera three years ago managed with ASA and every-other-month phlebotomy because I turned 65 in late March. Protocols are to begin hydroxyurea 500 milligrams. I’ve been delaying starting my hydroxyurea until after I have my second vaccination, thinking it may probably compromise my immune response with all the changing data regarding ‘from thrombotic events after the first AstraZeneca dose, preliminary reports regarding the incident after second dose.’ Interested in your thoughts regarding a second vaccine and the timing of hydroxyurea.”

DG: I’m not sure that I thinking through the immunology would be concerned, but that’s not really the way we want to approach this. If you can go ahead and get that vaccine, if it’s fine to delay a little bit before you switch over the hydroxyurea, that would probably be my personal preference.

VR: All right. Finally from Jackie, “I’m a pediatric nurse practitioner. I do medical administration work for a large, federally-qualified health center in Philadelphia. My colleagues and I love your show.” Jackie has a bunch of questions. Let’s see how many we can get through. “Now that now that we know J&J has caused about 28-ish caches of blood clots, could you help us compare risks to the background in the general population, people with COVID and J&J recipients?”

DG: Yes, I think that’s an excellent question. When they went through the analysis of J&J, I think this is evidence again, we have a really robust vaccine monitoring system. We had the initial numbers, we’ve now seen as mentioned a number of other cases in a slightly broader demographic. The risk is still low, it is still less than one in a 100,000 people. Is it 1 in 100,000, 1 in 500,000? Probably little subtleties on teasing that out. The risk is incredibly rare. We’ve talked about that maybe even being lower if we avoid women under the age of 50. Then maybe we get into a lower risk here.

You compare that to the risk of getting COVID. The risk of complications if you get COVID. That’s what I tell people. I had a very interesting, rather long, discussion with a patient. It was actually a patient who had an adolescent son who had a developmental disorder. I said to her, “Listen, you’re making a decision either way. You’re either deciding to get the vaccine or you’re deciding to take the risk of getting COVID and the complications that come within.” The risk of any vaccine is so much smaller than the risk of getting COVID during a pandemic and all the complications that come from that.

VR: Jackie’s second question is about the guidance for 12 to 15-year-old group with regard to vaccination but that’s answered, right? Both mRNA vaccines are authorized now for that age group.

DG: Currently, just Pfizer, but Moderna is in the works for expansion. They’ve requested expansion. Pfizer is good to go.

VR: Should be any day now then, right?

DG: You know, there is a period of when you request, they have to wait 15 days and then the FDA can grant it. We’re ending May, it’ll be in June.

VR: All right. “Could you talk a little bit about giving routine vaccinations along with COVID? When will that be approved? I’d love to do 16-year-old checkups over the summer, give that meningitis number two shot along with a stray hep or an HPV plus COVID, that would be my ideal universe as a pediatric nurse practitioner.”

DG: We live in that world right here already. We’ve lifted that ‘spacing them apart.’ Go ahead. If you can get him in, if this is an opportunity to get those vaccines into arms, you do not need to space them apart. This is absolutely fine.

VR: Finally, “Could you talk a little bit more about monoclonal therapy? How do you get patients access? I know this is a mundane concern. Transportation is an issue for many patients, and now you have asymptomatic patients you’ve told to isolate. How are you going to get them from their home to the infusion center? How about therapy for children?”

DG: As I said, we’ve expanded this a little bit out, but still it’s limited, below 18. It’s really 18 and up that really is broadened. There are a certain number of indications for the under 17 crowd. We have programs where you can get these in the home. What’s going to be really exciting, and what a lot of people are working on, is IM and SUBQ injections. What can we do right now? Right now, a lot of times it might be actually going– Say here in the New York area, the Catholic Health System do a great job. You basically just show up at an ER and you can get access.

Northwell Health, one of our largest health systems here, actually, has the physician goes online, fills out some forms, and yes, the person would have to go to a tent outside of an ER. For certain individuals, you can call the number and you can actually get a set up for in-home infusion. We’re hoping this is going to be something where a call can go out to a pharmacy, something can be delivered to the home. One of the challenges still is that rare one in several thousand anaphylactic reactions. If you’re going to do it in the home, you’re probably still going to want someone who can be there to administer an EpiPen, get Benadryl, treat an anaphylactic reaction.

VR: That’s COVID-19 clinical update number 64 with Dr. Daniel Griffin. Thank you, Daniel.

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

[music]

[00:43:43] [END OF AUDIO]

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