TWiV 692 COVID-19 Clinical Update #40

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 13 December 2020

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

From MicrobeTV, this is TWiV, This Week in Virology Episode 692, recorded on December 10th, 2020. 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, Daniel?

DG: Today was a long day. I think it’s getting pretty bad and we’ll talk about that. Let me start with my quotation, “Wise men say only fools rush in, but I can’t help falling in love with you.” Now, some of our listeners probably know who that is by, that’s Elvis Presley. What people may not know is that he is referring to the polio vaccine when he wrote that song.

VR: [laughs] Are we going to exhume him and re-vaccinate him with SARS-CoV-2 vaccines now?

DG: We probably didn’t want to do it on the show but let’s say I just want to let everyone know Elvis is actually still alive and he’s returning for a COVID-19 vaccination next week.

VR: Excellent.

DG: You can see it here. No, I’m joking on that. I wish Elvis was still with us. What a tremendous talented individual he was. Let’s start a little bit, I’ll get back to why that quotation. Why are we not quoting Winston Churchill, why Elvis Presley? We will get there. I’m really– just bring some people up-to-date patient updates. Everyone keeps seeing these numbers, but I’d like to put a face on the numbers.

Actually, Vincent and I were together on a call about a week ago, actually this last week and Shane Crotty was on and he was talking about issues with re-infection. There were a couple of physicians on. Shane Crotty’s data is really great and all, but we’re seeing reinfection. I think I’ve talked about that a few times. My partner today called me; we discussed a case. This was a gentleman who was admitted originally back in March, had a pretty severe case of COVID and now they’re back in the hospital. They’re septic. We did a COVID-PCR and it was positive, so pretty hard for me to say that, wow, what is this? Ten months later, that that’s somehow persistent from the March of 2020?

We’re seeing cases, a number of physicians were on the call saying, “We’re seeing these but we’re busy. We’re in the trenches. We don’t have samples from March and April to do the genetics.” This raised a concern. Don’t think that just because you had it, you don’t have to worry. There’s a certain percent of people that are getting re-infected. We don’t know what percent that is but we’ll see as we go forward.

I had another gentleman. This brought me back to the Irish patient, I don’t know if people remember. People who’ve been long-time listeners may remember the Irish patient, a young man in his 30s. I felt like it was back to March again, admitted another gentleman in his 30s, no past medical history, really sick. Basically, did the same things that we learned from our Irish patient. The person was so ill that we had to intubate him. We had to lay him prone. He’s really on maximal vent settings and we’re hoping that he’s going to make it through this, but really, really sick.

People have another misperception out there that, “Oh, the virus isn’t so bad this time.” It’s bad. We’re seeing the aftermath of Thanksgiving which for me is tough because now we’re admitting families. We admitted a couple of sisters, one of them died Monday morning. Her sister’s still alive, but on a ventilator. Today, I admitted a mother and she was quite upset because she said, “You know what Dr. Griffin? Don’t worry so much about me, what I’m really worried about is my daughter who’s right here in the room with me.”

The daughter went to see her mother-in-law for Thanksgiving. The mother-in-law actually fainted on Thanksgiving and then was diagnosed the next day with COVID.

They were trying to help the mother-in-law, everyone was trying to do the right thing, people were wearing masks. The mother-in-law was wearing a mask. They took the mask off the mother-in-law, sort of helped her feel better, get her to the hospital, but that whole event led to her getting sick, the mother getting sick. Basically, the whole family is sick.

I guess I’ll move right into the pre-exposure period with this. I try to keep giving people the facts so they can make their own decision. It’s difficult when people make bad decisions and I see the consequences of that.

We’re here for you, we’re going to take care of you, I’m here to educate you, to give you the information you need to make the best decisions. Just keep these facts in mind when you’re thinking about what you’re going to do. Tonight is Hanukkah. Coming up soon, it’s going to be Christmas, Kwanzaa, and New Year, so people are making plans now. We had over 3,000 people die in the U.S. just yesterday. Things are really bad out there and we’re going to get to the fact that the vaccine is really right here on the horizon, so let’s try to make some good decisions.

Also in the pre-exposure period, let’s go back to the schools. There was a nice article in the CDC Morbidity and Mortality Weekly Report (MMWR) and this was implementing mitigation strategies in early care and education settings for prevention of SARS-CoV-2 transmission. It looked at eight states in the period of September through October, and that’s the time to look. I’ve seen studies where they talk about infections between April and September and schools were closed. I don’t really know what you make up stuff with that. This was a really good article.

The CDC has been beaten up a lot, but there’s really some great people and they’re really putting some great information out there for us and this article described the role of mitigation for Head Start programs. People in the U.S. probably know about Head Start but the rest of the world– this is a really tremendous program. There’s Head Start and Early Head Start and these are programs for kids five and under and it promotes early learning, healthy development among children.

What did they do here? They provided quite a bit of guidance, information on masks, personal protective equipment, the physical setup, so you could do this in a safer situation, supplies for actually maintaining those healthy environments and operations. Actually, there was financial aid in all this, helping them get additional staff members so that they could have smaller class sizes.

When they implemented all these programs, they actually saw very few cases of transmission among the children and the staff members. Just helpful to see. We went into this, we didn’t know and we’re learning, can we do things that make it safer to be in these environments and I think just more information that we can. I always know that this triggers a wedge issue, sending kids to school or not.

So, I always try to make the qualification that, “This tells us that you can do it safely, it doesn’t say you are doing it safely.” If you’re looking at having kids in in-person learning environments, you can’t just do it. You can’t just make-believe it’s 2018 and stick 30 kids a couple of feet away from each other. This was a study showing that you can make it safer with proper mitigation with spacing.

Now we’re seeing in a lot of areas they’re really introducing testing, actually becoming a big issue here in the New York area because as people probably are aware, our rates are really climbing. I look on the map and I see that where I live, I now live in a red area, that doesn’t mean we’re socialists or communists, it means we’ve got way too much COVID.

If we’re going to ask those kids to go to school, if we’re going to ask those teachers to be there and teach our kids, we’ve got to give them the necessary resources, the necessary guidance. We can’t just send in those folks.

All right, vaccines. Vincent pulled me away. It was like, the Super Bowl had gone into extra time and then Vincent’s like, “It’s time to record TWiV.” What was going on right before I jumped in is the FDA was having their EUA meeting and discussing what to do with the Pfizer vaccine. I know a lot of people are thinking actually by the time this drops, we’ll know the outcome, the final score. It does look as though there will be an EUA for the Pfizer vaccine.

The discussion was just about what will be the definition, what will be the confines of that? We’ll go through a couple of things here. Before we get into vaccines, I want to point out we’re getting here near the end. We’re in the 11th hour. I know everyone’s exhausted. I want to tell a story and hopefully, this story is something that maybe gives people a little bit of thought about, “My gosh, I’ve got to keep safe because we’re almost there.”

This is a story that I asked my mother to retell this past week. It’s the story of my grandfather’s best friend, my mother’s godfather, Howard Miller. This takes place, it’s 1945. This is a true story. Howard Miller is at the Rhine River in Europe. It’s World War II, he’s a captain in the 2nd Armored Tank Division. I don’t know if people realize, but 1945, that was when World War II finally ended. World War II had just come to an end in the European theater. News of the German surrender is spreading across Europe. This day 1945, Howard gets up just like any other day, not knowing that the war is already over. The news has not gotten to him yet. He’s killed by a sniper after the Germans had already surrendered.

I feel like this is a message for our listeners. By the time this drops, the vaccines are here. We’re going to start rolling these out. I want people to take a moment and realize that Tuesday, November 8th, 2020, was our modern V Day, our modern vaccination day, and really this week, mankind’s war against COVID started to end. Vaccinations have started in the U.K. They’re going to be coming here in the U.S. in the coming days and weeks, so they’re going to be spreading around the world.

All right, let’s go to where we are with the vaccine. The U.K. started to administer the Pfizer vaccine, Canada approved the Pfizer vaccine, and by the time this dropped, there will be some sort of FDA EUA for the vaccine here in the U.S. Right as I got on this, there was the discussion at the FDA, not about whether or not to give approval, but what qualifications to give approval. Was the vaccine going to be just, “Go ahead, everyone can have it” or– we’ll talk about a couple of the issues that were being discussed.

One was, will there be a lower age? For instance, the first question that was put forth was 16 years of age and up. The bulk of scientific evidence supports the safety and efficacy of this, but then there were a couple of discussions about, “Well, 16, 17, should we make it 18?” Should there be something about that lower limit of age? The other was since the plans are in the U.S. to vaccinate high-risk individuals, so healthcare workers, long-term care facility people first, should the EUA be limited to those high-risk groups, allowing more data to be generated before it goes out to a wider audience?

We’ll hear what the final decision is, but little things that we’ve learned in the last few days here, there was a 92-page brief that I actually have to say, I enjoyed reading through, and then today was a full day, a lot of really hard questions asked of Pfizer, nothing surprising, nothing concerning. A couple of things we now know, the vaccine is preservative- and adjuvant-free. I almost feel like that should be on there like advertisements. People are always worried about the vaccines, “Is there some preservative in there that might cause problems? There’re adjuvants, that might cause some sort of issue.”

Historically, we think of vaccines without adjuvants as maybe being safer, maybe having less issues. A couple of things from the immunology front. The two-dose regimen elicited a robust neutralization antibody response. The titers were actually comparable and higher actually than individuals who had recovered from COVID-19. In addition, I got some questions about this the other day, it generated a strong CD4 and CD8 T-cell response. There was reduction in the risk of getting COVID-19 as early as 10 days after the first dose. There were some common reactogenicity reactions. We’re going to touch on what is reactogenicity.

Most people said, “Hey, at the injection site, it hurt, got poked with a needle, was sore there.” I would say about half the people, a little bit more, felt tired for a day or two. Headache was actually quite common, people feeling muscle aches, chills, joint pain, fever. Fever was about 14%. One of the things that I mentioned is interesting, I don’t know if a lot of people realize this, but they actually included adolescents down to the 12 and 17-year-old ages. We had data not just on the older individuals and that was why this was being discussed. There actually were adolescents included in the study, hundreds of them, so we have data there.

I want to address some of the fears here that were addressed in the last few days. It was noticed when they went through the thousands of people that got the vaccine, that there were four cases of Bell’s palsy in the over 20,000 people that were vaccinated. This is pointed out– That’s actually what we see as a background in the population, so that was not about background, so that was not considered in any way– it necessarily be associated with the vaccine.

The other which is interesting, I don’t know if people are following this, but there’s this idea that if you get the vaccine, then you’ll never get pregnant. Actually, it doesn’t– The vaccinated people went ahead and got pregnant during this short period of time. I thought that was interesting and reassuring. There’s an interesting– and I’m going to talk about reactogenicity here. Let’s define the word first, and then I’ll get more into it. Our words for today are going to be reactogenicity, anaphylactic, and anaphylactoid.

Reactogenicity is basically the evidence you get that your immune system is responding to the vaccine. That might be local redness, soreness at the site of the injection. That might be that feeling a little crummy. I don’t know if our listeners have got a shingle shot. This seems to be a very similar experience. One of the concerns that people had is, “Oh my gosh, if I get the vaccine, I’ll be out of work for two days.” I don’t think we’re seeing that. That’s not what we’re seeing, but it’ll be great to have personal experience where we can talk to people who’ve gotten it and actually say, for instance, “Dr. Griffin, were you laying on your back for two days?” because I have a really low discomfort tolerance.

There was the interesting– several young men were claiming that they got such bad chills from the ultracold vaccine that they were shaking so hard that their teeth were shattering and cracking their teeth. I tried to explain that the vaccine is brought up to room temperature before you get it, so that seemed entertaining more than anything. The other, and this has come up, anaphylactic versus anaphylactoid. I immediately got a call yesterday morning from one of the allergists in our area and there was a concern. A couple of the people in the U.K. who got the vaccine had allergic reactions.

The difference here is between anaphylactic and anaphylactoid. Anaphylactic is when you have antibodies. You get something, it triggers this severe reaction. Anaphylactoid is more along the lines of what was being described, something where they got Benadryl. It was a non-immunoglobulin-mediated allergic reaction. There is discussion here in the States, if someone has a history of issues like that, we might suggest taking Benadryl before the vaccine. The EUA was talking about that. Should there be some sort of qualification about people that have a history of anaphylactoid allergic reactions to things? Maybe just alerting people.

I will move forward from there to what is really on the top of people’s minds, actually, I have to say. I know that in the media they’re talking a lot about vaccine hesitancy, but at this point, we’re in the less vaccine relative to demand. At some point, we’ll be into some other concerns. This is an area where we’re now talking about equitable distribution. Who gets the vaccine first? The world is watching, so we want to make sure we do this the right way.

I’m going to talk specifically about New York State’s vaccination program because the way it works is the ultimate decisions are going to be based at the New York State Department of Health and we’ve been getting updates on this. High-risk healthcare workers, nursing home residents, and staff will be the first New Yorkers to receive the vaccine. What does that mean? What are high-risk hospital workers? Not everyone in the hospital is at the same risk. Emergency room workers, particularly, we’ll say nurses, non-physicians, I think they spend a lot more time.

I think anyone who has ever interacted with the healthcare profession, your nurse spends a lot more time with you than the doctor. The nurses, the doctors, all the support staff. Similar, ICU, so all the ICU staff, nurses, all the assistants, the pulmonary department staff. New York State expects all high-risk hospital staff will get the vaccine, actually, within the next week or two. We’re expecting to get the vaccine here in New York next week when the EUA goes through, which we all expect.

Then it’s going to follow. It’s going to go very quickly to the long-term and congregative care staff, the residents there, and it’s going to be interesting. Who is giving the vaccine to whom? The big pharmacy chains have stepped up across the nation, so CVS, Walgreens. I realize– correction, Duane Reade is the drugstore, Dwayne Johnson is The Rock, but– throw that in there.

VR: [chuckles]

DG: Then it’s going to move out to other physicians, other staff working in the hospital, and then it’ll move out to essential workers, general population, et cetera.

This is interesting. I’m going to tell another little story about who gets first. I was having a conversation earlier this week with the majority leader of one of the legislative bodies here in our great country. It was not Nancy Pelosi. This gentleman was saying to me, “Well, Dr, Griffin, it’s obviously a no-brainer that we got to get these vaccines to the hospitals because when you get COVID-19, that’s where people go.”

He told me a story about how a Secret Service individual, he was talking– there’s a couple of aspects to this that I think are really interesting to our listeners. One is saying, “The Secret Service person wearing the gloves, wearing the mask, he’s very safe at work,” so it isn’t that we’re thinking that it’s a risk for the hospital workers being in the hospital, though I think it is. What happened in this case was this individual’s child got infected, the wife got infected, he got infected, and now a critical person is sick and going to the hospital.

We had a little bit of a discussion. I was actually surprised, I think our listeners know this, but I pointed out that the majority of people who get COVID never actually go to the hospital, that 80-85% of people we care for in the community. Raising the issue that as we look at the critical people that we need to make sure we keep them healthy and protected, we’ve got to be looking at our primary care docs, we’ve got to be looking at the people that work in the urgent care centers, not just the doctors. Think about the receptionist who’s working there at the urgent care or the busy primary care practice. Think about the nurses, the medical assistants.

Basically saying if we don’t protect those people, if we can’t keep them healthy enough to take care of that 80% that we manage in the outpatient setting and we leave them with just the ER as a place to get care, we’re going to drown. It’s a very interesting conversation as we go forward. We’ll hear more about how this all works. I’ll be talking more about, let’s say, our ProHealth Riverside Tri-State vaccine initiative. Once we get past these easy-to-vaccinate people, I think, people working in the hospitals, urgent cares, medical practices, long-term care facilities, I say easy. More challenging is we’re going out to the communities.

When we move from phase one to these high-risk individuals, when we start moving to people that are 65 and older, when we start moving to teachers, critical workers, so police, firefighters, et cetera, you’ll be hearing more about that a lot of organizations like ours are jumping in, reaching out to the state saying, “We’ll be a solution.” We’ll produce high-throughput vaccination access sites where people can do drive-thru, like we did back with the H1N1 vaccinations. Let’s get as many people vaccinated and protected so we can move forward.

Now, let’s move– I’m going to skip a little bit past that incubation period. Actually, I won’t skip so much. The CDC updated things where they basically said, “Once you’ve been exposed, at day seven, if you’ve got a negative test within 48 hours, you can end that quarantine a little bit earlier.” We haven’t quite embraced that in New York City or New York State so we’re still stretching out the full thing or at least we’re recommending, no one’s listening, we’re aware of that. Once you actually go ahead and actually get detectable virus, what do you do or what do you if you think that’s the case?

The NIH has a nice page now, really basically pointing out that testing saves lives. When I was talking about how we’re going to roll out the vaccine, I was talking to a lot of our urgent cares. Some of our urgent care centers are doing over 6,000 COVID tests a day per site. This is really amazing. If you look at our positivity rate being 5% or 6%, I’m going to do 5%, the math’s easier, you talking about 300 people testing positive at each of these sites per day. This was huge when we went into Thanksgiving, all those people testing positive being pulled out and not going to that Thanksgiving dinner.

Think of all the contagion that you’re stopping by identifying people who are positive. This is really critical. There’s really a push now, don’t just get tested when you have symptoms. Testing saves lives. It identifies the spread before it happens. This is really critical and being embraced. Actually, a lot of people– I think it’s taken a little longer than it needed to, but embracing rapid resulting. What are we doing? This is for doctors, we’re doing rapid antigen testing at most of our sites, we do Abbot ID NOW at some of them as well. We often send off a PCR as well.

What sometimes happens, 6,000 tests, you don’t tell everyone to quarantine while you’re waiting for that PCR, but some of the time, that antigen test is coming back negative but the PCR is coming back positive. We’re catching some people in that ramp-up phase, we’re catching some people after the fact in the ramp-down phase. What we’re doing then is basically calling them up, “Your PCR came back positive,” and then moving forward with that. That’s going to happen when you’re doing 6,000 tests per site per day. A certain number of those negative antigen tests are going to be people that are early enough in disease that you’re getting a few hours before that antigen test turns positive.

The early inflammatory phase. This I touched on a little bit above and just to reiterate– It was actually interesting. When I was talking to the majority leader, he was shocked when I said that 80% of people are managed outside the hospital. He actually challenged me, “Where did you come up with that number?” I was a little surprised actually. I think that as someone told me, 80% of the focus has been on the hospitals. People are not aware of all the people out there. When you look at 240,000 people in a single day being diagnosed with COVID, they’re not all going to the hospital. If anything, we’re getting above that 80%. We’re getting better and better at managing these people outside the hospital.

So, what are we doing? We’re still recommending the first week just symptomatic management. We’ve eased up. You can take your leave, your Ibuprofen, your Tylenol to treat those viral symptoms. We are encouraging people to wait until the second week to consider steroids. We’re limiting steroids to people who have issues with their oxygen level dropping. Actually, here in New York, we’re sending people home with pulse oximeters, $15, $20. That’s a good way for us to then to manage them. I was just speaking to a physician friend of mine who’s in the second week where each day, we’re checking him to see where his pulse ox is – it’s in the high 90s still.

As long as it stays in the high 90s, he’ll continue to take his aspirin a day, try to stay active, stay off the steroids, stay off the antibiotics, and just manage him outside the hospital.

This is critical because you can’t send everyone with COVID and a fever to the ERs. You’re going to overwhelm the system. When you do that, no one benefits. We did see the formal peer-reviewed publication of the Repurposed Antiviral Drugs for COVID-19 Interim WHO Solidarity Trial results. It came out in The New England Journal on the second. Again, this is where they looked at Remdesivir, Hydroxychloroquine, Lopinavir, Interferon regimens.

Really did not show any overwhelming compelling evidence for mortality, initiation of ventilation, duration of hospital stay. This is an interesting issue because the first of those in there was Remdesivir. A lot of the hospital systems have purchased large orders of Remdesivir in the United States. I’m actually seeing people get admitted just for Remdesivir enough though they’re not hypoxic. I think this is a decision people have to make, “Is the benefit of Remdesivir enough that it’s worth hospitalizing someone just for that therapy?”

Because originally the idea is, it shortened your hospital stay. Here I have people getting admitted to the hospital without hypoxia just to get the Remdesivir. Here, it’s creating a five-day hospital stay versus shortening a hospital stay. Something to think about there. We continue to see secondary infections later on. The multi-inflammatory phase, I think I mentioned last time, the individual with the Guillain-Barré, we gave him the intravenous immunoglobulin. A few days later, he’s squeezing my hands but then he actually started to get flaccid again.

This continues to be a challenge. I have another gentleman, I’m not sure the connection here but he was a gentleman who had COVID and then at about week four, developed an expressive aphasia, and really unclear what that is but the timing is concerning for a connection there. Number of papers out there, case reports suggesting a connection. What is expressive aphasia? This is the gentleman where I ask him questions, I go for a while until finally, I hit an area, and he just can’t get the words out, he can’t tell me. I’ll ask him where he works and it comes out gibberish.

If I let him just talk on his own, he can talk, it sounds like he’s fine. Then I say, “Oh, you work at GBP. What does GBP stand for?” And when he tries to say GBP, it just comes out– I ask him, “Do you know what GBP stands for?” and he nods. He knows what– He just can’t get it expressed. So, really a challenge. I’m going to wrap out here with our tail phase. In the tail phase, I want to talk a little bit about challenges we’re having with DC Planning now. The tail phase is very recognized, continues to be a huge problem.

Actually, one of the questions I just got from this physician colleague was his wife, his son, they’re both sick. They’re in urgent care waiting to get tested, should he wait, should they bother getting that test? My advice was, “Yes, get that test. We need that objective evidence.” One of the issues that came up is currently COVID is considered an acute diagnosis, not a chronic. One of the nurses that I’ve talked about several times, is having issues getting disability coverage because they say COVID is an acute diagnosis. “You had that back in March-April, it’s not a chronic disease. If you’re going to look for any support, you need a chronic diagnosis.” It’s interesting.

This has also become an issue for oxygen. We have a number of individuals in the hospital. We’re looking at trying to discharge them, but oxygen is only paid for if you have a chronic condition requiring oxygen. Back in March, April, the early days of the pandemic, the governor stepped in. Executive orders basically said everyone has to cover and supply oxygen for COVID, interesting that we’re seeing bureaucracy stand in the way of what we recommend as good care.

I think the governor listens to us, right, Vincent? So, he can maybe jump in and give us some help on that, but before we take emails, let me just say we’re continuing our support of the Peace Corps HIV and AIDS programs. Just to point out, we are in the midst of this pandemic. I hope when we get through the other side, people don’t forget about COVID-19, so that we don’t go into this unprepared like we did this time. There’s still a huge pandemic going on. We have not really gotten through the HIV pandemic. Go to www.parasiteswithoutborders.com, help us support them, but also help us continue our mission.

VR: Daniel, have you seen an uptick in influenza cases yet this season?

DG: There are more influenza cases. There is an increase, but it is actually a much lower percent of cases, well, just lower number of cases of influenza this season than we previously– Usually, now is when we start seeing all these flu admissions. I think all the things we’re doing is keeping flu at a lower level.

VR: That’s great. That’s good. That’s maybe one silver lining, right?

DG: Yes. [chuckles]

VR: All right. We have some emails. Remember everybody, you can send an email to [email protected]. We’ve got a lot, but we’ll just do a couple here today. This is from Sean. “I’m an orthopedic surgeon in New Orleans and have a friend who’s an internist who treats COVID patients. I’m not sure that’s what he’s supposed to be doing, but he’s on regular Zoom calls, clinical updates. He told me that Dexamethasone is no longer recommended to treat COVID. This seems to contradict everything I’ve learned so far about how Dex is one of the best therapeutics we have. What do you think?”

DG: Well, I think it’s his friend, the internist who’s taking care of the people. That’s good. That’s what we want. As I mentioned, 80%, 85%, the majority of people with COVID do not need an infectious disease specialist, they don’t need to go to the hospital. This is something everyone should feel comfortable managing in the outpatient setting in most cases. We usually, as I point out, we don’t give Dexamethasone to everyone. It isn’t like connect the dots. It isn’t COVID Dexamethasone. Dexamethasone is reserved for the class, for which it was shown to make a difference and these are people who are starting to develop the early inflammatory response.

It’s during the second week and it’s people who are starting to get hypoxic. So, if you’re not hypoxic, if your SATs are still in the 90s and you’re doing well in the outpatient setting or even if it’s the first week, don’t give them steroids. Steroids are something that we should be giving to only a select number of individuals. Is the mortality benefit huge? No. The absolute benefit is only a couple percent in people with low oxygen requirement, a little bit higher in people who are more serious disease. It’s not for everyone. There’s a certain place for it.

VR: Okay. We have an email from Anonymous in Manchester, UK, who is worried about their dad in Australia. Her dad had a flu vaccine 30 years ago and developed Guillain-Barré syndrome. Anonymous wants to know, “is there a reason my dad or anyone like him to worry about any of the COVID-19 vaccines or candidates? He no longer gets flu shots. Should I worry since that’s my father?”

DG: This has come up quite a bit, questions about the vaccine. Should I worry about Guillain-Barré? Actually, I think the flu is a perfect example. When you look at people who get natural infection with influenza versus, people who get the influenza vaccine and the incidence of Guillain-Barré is certainly higher with getting natural infection from influenza, so sort of an interesting thing. In a perfect world, there’s no influenza, there’s no influenza shot, and there’s less Guillain-Barré. I’ve certainly seen it in natural infection with influenza.

I’ve also seen it after a flu shot, but is this going to be an issue for people who get the different vaccines for COVID? So far, we’re not seeing a signal. Pretty soon we’re going to be having millions of people vaccinated, so by the time it rolls out to other individuals, I think there’s going to be more data to help us with this.

VR: The next email is from a nurse in a New York City hospital who’s been trying to get pregnant for some months and wonders if she should wait until after vaccination because the vaccines, I think, are not being tested in pregnant women. What do you think, Daniel?

DG: Excellent. I’m going to say– interfere with your family planning decisions here. You can tell your husband to curse me if he wants to have a child immediately. But as we saw, they excluded pregnant women in the vaccine trials. As a nurse in a New York City hospital, you’re right here in Phase 1A, potentially going to get vaccinated in the next few weeks. After the 10 days, you’ll have some protection. Three weeks later, you get your second dose and then you’re good to go. We certainly saw people go ahead and get pregnant once they had been vaccinated.

I think I mentioned there were a dozen women that went ahead and did that in the Pfizer trial. Yeah, just wait a few weeks and then go ahead. That would make sense. You hate to go ahead and not get vaccinated when you could be– really a matter of just postponing that pregnancy by a few weeks. That’s my advice, but I’m going to leave the ultimate decision up to you and your partner.

VR: All right. The last two are the same question. We have a question from Nafisa and Catherine, whether immune compromised people can be vaccinated?

DG: That’s an excellent question. A lot of people are asking about this and there’s a certain sophistication to mRNA vaccines and concerns about people with autoimmune diseases. When you make the RNA vaccines, you’re basically taking DNA, you’re going over to RNA, and some of the products will be double-stranded RNA. The early vaccines or the early trials, when they’re going through this, they realized that you were making contaminants of double-stranded DNA. You really don’t want that. That’s potentially something we worry could trigger autoimmunity.

So, they do a really careful chromatography process, they purify and make sure it’s just straight RNA. At least what we’re seeing so far, I think, it looks like it’s going to be okay to use in these individuals. It is not a live vaccine. That’s good. It has less stuff in there, so we’re anticipating that this might be a safer approach. I throw that in. Not only am I at this point saying the RNA vaccines, but we have a couple other vaccines on the horizon. The Chinese with their inactivated Sinopharm. That’s one that was what? Eighty-six percent efficacy, they tell us. We’ll see the actual data on that. We’ve got Johnson & Johnson coming out either this month or January.

Actually, so much COVID in the states. J & J said they don’t have to have 60,000 people. It’s looks like they’ll probably stop at 40,000. Just there’s so much COVID and then we’ll see even more. As we go forward, we’re not expecting there to be a problem here. We like the idea that it’s not a, should I say, live vaccine. I’ll say active replicating virus that we’re injecting people. This is really just that sticky note with instructions for how your immune system should respond. We are thinking, and the data seems to be supporting, that this will be a safer technology.

VR: Right now, if you were, say, one of these first-line people who are going to be vaccinated next week, and you have an immune compromised, are they going to give it to you or no?

DG: It’ll be on a case-by-case basis.

VR: Okay. There’s no general rule. Very good. All right. That’s our 40th weekly COVID-19 clinical update with Dr. Daniel Griffin. Thanks again, Daniel.

DG: Oh, thank you so much. Everyone be safe.

[00:38:53] [END OF AUDIO]