On this week's COVID-19 update, Dr. Steven Bishop analyzed the recently released data from the Moderna vaccine, discussed an at-home COVID test that the FDA just approved, and took questions from viewers. Watch the full video below and read on for a full transcript.
First I'm going to put here a link to Moderna's data. It's another one of these big 54-page documents that Moderna submitted to the FDA, their data, and this is what the the advisory committee will review. We'll kind of go through some basic stuff about what's in the data and then kind of delve into a few of the specifics in the data charts that they have. And then give my overall take of things at the end of that part.
The bottom line is that the Moderna vaccine is really pretty similar to the Pfizer vaccine. It's an mRNA-based vaccine. It's a two-shot series. The only difference is that I believe this one is given four weeks apart instead of three weeks apart like the Pfizer vaccine. So it's a little bit different in that regard, but otherwise they're very substantially similar.
One thing that is very different, that is important in terms of distribution and availability that the Moderna vaccine has going for it as opposed to the Pfizer vaccine, is the Moderna vaccine does not have to be stored at extremely low temperatures. My suspicion is that all things being equal, should the FDA find that the efficacy data and the side effect data are similar, I think they'll approve it.
And I think that the Moderna vaccine will eventually become more prominently used just because of the much simpler method of distribution. The Pfizer one is sort of the first mover. They have an advantage there. So it's going to be used first and going to be used in the most critical places that have access to more storage facilities, like big hospital systems, academic medical centers, things of that nature, and then it'll start rolling out to nursing homes and other places.
But I think as the vaccines become more mainstream and we start seeing it available, hopefully in regular doctor's offices and pharmacies and things like that, my guess is that the Moderna vaccine will be the more common one used just because it doesn't require that extremely low refrigeration temperature where many practices, if they want to carry the Pfizer vaccine, like we're having to do, we're having to source and find some of these minus 80 degree freezers. And they are not easy to come by. My guess is most places we'll probably end up using the maternal vaccine just for simplicity sake.
I'm diving into the data here. Their study is I think is done equally well to what Pfizer's has done in terms of the demographics, the type of people that are in the study including both older people and people who are at high risk for a bad outcome from COVID.
This study, just like the Pfizer one, did exclude pregnant women when they discovered that they were pregnant. And of course they had a few patients in there that were pregnant and they haven't reported any adverse problems to date, but remember these are still not studied in anyone who's pregnant. And I believe, let's see, the young, I think this was the same, they were studying no one younger than 16. Let me just double check that. I believe that it was 16 and up, same thing as the Pfizer study. So let me see here.
Just diving into the efficacy data. They kind of looked at everything based on two weeks out from these... Actually, I think, sorry, excuse me. 18 was the youngest age in this, in this study, not 16. So this one would probably just get approved for ages 18 and up.
But going back to the efficacy data, if you want to go to page 23, if you're following along, table nine is the interim analysis for primary efficacy endpoint. 14 days after the second dose. And they're reporting essentially a 94-95% efficacy rating for their vaccine, which is, is excellent. You know, very good.
And I think that's fantastic and the efficacy was actually higher in older patients than in younger patients, so that's sort of interesting. Might be just a fluke of the data, but that's kind of an interesting finding. That's a little bit different from the Pfizer vaccine, but I don't think it's substantially going to affect anything.
If you look at, if you go down to page 27 and we're looking at table 14, the efficacy rate for preventing severe COVID was a hundred percent. So it was excellent. No one who got the vaccine got severe COVID disease. And if you go again back to table nine, only five people in the vaccine group out of 10,000 got COVID at all. And none of them got severe COVID so good results there from the vaccine. Of course, this is just a couple of months of follow-up but still very, very positive outcome.
If you look at figure two, which is on page 28, you see these nice cumulative incidents curves, which shows that over time the patients who had the vaccine had almost no incidents of development of disease and people who did not have the vaccine, their curve in the placebo group just keeps going up and up as more and more people got the virus over time without the vaccine. I think this is good, again, it's really promising.
The question, as everything else, is going to come down to to side effects and things of that nature. So just looking through, they reported their side effect data a little bit differently than Pfizer did, but their side effects are substantially similar. So after the first dose, there are very few, if any, side effects, other than local sort of pain at the injection site, some arm soreness, and maybe some lymph node swelling and things of that nature.
Those things were pretty common. Sort of local site reactions, little lymph node swelling on the side of the vaccine. And after the first dose, people got fewer side effects than the second dose, which was pretty common.
The most common side effect for most people after both the first and second dose was fatigue and about the same number of people got body aches and fever and things like that compared to the Pfizer vaccine after both the first and the second dose. After the second dose, about 17% of the patients had a fever of any kind. Only a few of them had a high fever. Most of them had a low grade fever, and most people did get a headache as well. And again yeah, a number of people got body aches and things like that.
Now there was in this vaccine, which is a little different than the Pfizer vaccine, about 10 to 20% of the patients did get some nausea or vomiting after this vaccine, both after the first dose and the second dose, but it's a little tough to make out what if the vaccine actually caused that or not in my view, because if you look at the placebo groups, after dose one of the vaccine, about 9% of the patients had nausea and vomiting, but about 8% of the vaccine group also had nausea and vomiting. So it's a little tough to sort that out.
The second dose, I think probably there was definitely more. 21% of the patients reported nausea and vomiting in the vaccine group, only 7% in the placebo group.
So there's something odd there, a little bit off with the placebo data and a lot of these patients having nausea and vomiting just in the placebo group, so something's a little different there. I'm not totally sure if it is primarily from the vaccine or not, but it's just something to be aware of.
That was the only real difference in terms of side effects that I could see between what Pfizer had reported and what Moderna is reporting. And then similarly to Pfizer, the Moderna vaccine has actually fewer side effects in older patients, which is good.
In the Pfizer vaccine, I think the the sort of hypothesis behind that and the concern was that, well, maybe it's not working as well. And the efficacy was a little lower for older patients in the Pfizer vaccine, but the efficacy data for older patients in the Moderna vaccine seems to be just as robust or even better than in the younger group. So I'm not sure that I would worry too much about the efficacy.
And if I were 65 or above, given that the side effect profile is good, or perhaps even better with the Moderna vaccine, I might opt for that one if it becomes available instead of the other. So that that's something interesting to note about that.
They did note and the FDA did submit a little sort of blurb update on things. There has been a few, there were a few cases of Bell's palsy in the vaccine groups. But there were some in the placebo groups as well, both with Moderna and Pfizer. So FDA basically has said you know, docs and nurses, you guys, please, please watch out for cases at Bell's palsy and people getting the vaccine. We don't know if it's related, but do monitor for that.
And for those who don't know, Bell's palsy is a paralysis of one side of the facial nerve. It's not life-threatening but it can be very debilitating and difficult to deal with. But in most patients and in most of the patients in the vaccine groups here who did get Bell's palsy, it did resolve after a few weeks and that's pretty typical.
And Bell's palsy is something that happens to people all the time. We don't always know the cause. Sometimes it's a viral infection, sometimes it's random. It's something that happens out in the world, and the rates at which people developed Bell's palsy, even in the vaccine group, really were not substantially different than the rate at which people develop this sort of out in the world in general, so I'm not convinced that there's a huge risk there. But it is something to know about.
Something that both Pfizer and Moderna did note pretty substantially in their side effect data was a lymph node swelling, particularly on the side where the vaccine was given, but also sort of head and neck lymph node swelling.
Again, that makes sense. The vaccine's purpose is to develop an immune reaction, right? And that's what your lymph nodes are designed for is to develop an immune reaction. So it's not totally surprising that there was some lymph nodes swelling in the vaccine group, but that is something else to be aware of as a side effect that you likely will experience, especially after the second dose of the vaccine, but also perhaps after the first dose.
So there's no really serious events reported much that were felt to be related to the vaccine per se. There were a few odd things, serious adverse events reported, but it's hard to say if they're related to the vaccine or not. It was mostly things like you rheumatoid disease, arthritis, things like that, some autonomic problems and other things like that, that it's just hard to know whether the person was going to get those things anyway if they're related to the vaccine or it's something completely completely different.
I think overall, this vaccine looks as safe as the Pfizer vaccine. In general, I expect they will probably approve it pretty quickly here. And then that will will become a much more common vaccine in the coming weeks and months, mostly again, because it's just easier to transport store and administer it compared to the Pfizer vaccine. So that's the Moderna data.
"What's your opinion? Fast forward, six months, most folks are vaccinated. Are we still going to see lots of positive cases and will we need to continue being diligent, wearing masks, washing hands and managing distance?"
I'm not sure. I think that it's going to depend on how many people really do get vaccinated. I think if we really get to that magic number of 70 to 80% of the population being vaccinated within six months, then I think we will stop the transmission of the virus pretty effectively. And we won't have a need to necessarily continue doing all of those things.
That being said, I don't think that we're going to have that fast of an uptake of the vaccine for a couple of reasons. I think first of all, it's just going to take a while to roll out the doses.
And second of all, I think a lot of people are going to want to wait and see how things go with the first few rounds of the vaccine before they commit to doing it themselves. And I understand that concern.
So I think it's gonna take more than six months to get to that magic 70, 80% number. Time will tell, but I think once we get to that number, then the disease transmission will fall off pretty precipitously. And we won't see the need for all of these things to be maintained.
"Can you comment about how mitigation measures can safely be reduced as the population is vaccinated? I know it isn't simple as 10% vaccinated means we can reduce mitigation 10%. Does this mean we need to keep all our most mitigation in place until we reach herd immunity from vaccination toward the end of 2021?"
Yeah. So this is sort of a related question. I think the problem is going to be what we don't know from the vaccine studies is whether the vaccines prevent infection or if they prevent symptomatic infection.
So what we don't know is whether the patients can have asymptomatic infection with the virus and still be sort of carriers and transmitters of that virus, but don't really get sick with it, or if it prevents any kind of infection from being set up. And we just don't know that yet.
I think that's going to be a key part of this piece. I think the mitigation strategies are going to have to stay in place until we get all the highest risk people vaccinated.
So again, healthcare workers, nursing home patients, patients 60 and up, especially patients 60 and up who have chronic health problems. Until we get the vast majority of those people vaccinated, I think that the mitigation measures are gonna have to stay in place.
And I think that they are probably going to have to do some follow on studies and see if the vaccines actually prevent a transmission or if they just prevent symptomatic infection. And I know that's a little bit of a fine distinction there, but I think we have to just get a little bit more data before we can commit to doing anything differently than what we're doing now.
"Are the side effects expected to be similar to Pfizer? Feeling like you've had a cold for about 24 hours?"
I would describe it a little bit stronger. I think most people are going to feel like they have the flu, and probably a moderate flu, for probably two days after the second vaccine dose that they get for both Pfizer and Moderna. They will have a lot of fatigue. They will have bodyaches. They will probably have a headache and then many of them may get a fever of some kind. So I think probably most people are going to feel like they've got the flu for a day or two after, after the second dose in particular.
"When might we know how long immunity lasts from the vaccine? What data will we use to understand this?"
Yeah, I think that that is going to just take time. I suspect it'll take a year. What they will probably do in, again, the post rollout studies, is they will probably start following people's antibody levels and T-cell immunity markers. There's a number of companies developing T-cell immunity markers for COVID. So I think they probably will follow that information out for a year or more and see what happens with people's immunity levels.
And I think if they find that it continues to wane, or if we continue to see people get infected or we see a renewed surge of infections, then that will probably be the indication we're going to have to have boosters of the vaccine at some point. I think it's going to take a year before we really know about that.
"Will PartnerMD be prescribing remdesivir or any other medication to your patients with COVID since there's a surplus of this free medication, which is a proven cure of some symptoms to prevent hospitalization?"
So remdesivir in the data does not really show much benefit in early disease. It's not actually being used for that. It is being used in hospital for people who are sick enough to be in hospital. It's not something that we can prescribe like a pill or something like that, a normal prescription, because it's a series of five fusions that you have to get over several days, which is why it's being used in the hospitals.
I'm wondering if you're asking about ivermectin rather than remdesivir. We have actually been using a protocol from Eastern Virginia Medical School that's called MATH+. And I can actually post a link to that. And we have started using that recently due to the data that is surrounding it and the fact that it appears to potentially help people with their COVID illness.
And the mainstay of that is an anti-parasitic medicine called ivermectin. And we've opted to start using this in some patients because it's quite safe. And it's safer than the hydroxychloroquine that was being used by a lot of folks. So we are using that in many of our patients when they get sick, and for some people, if they have high risk exposures, we are using that protocol. It's primarily ivermectin plus vitamin C, D, and zinc, and some melatonin and aspirin.
So it's a bit of a cocktail but the primary piece is the ivermectin. We have recently started using that in some patients at the discretion of their physician if they think it's safe and appropriate to do so and have been having good success with that so far. Again, based on the data that's out and in what we've reviewed and our clinical experience with the medicine, ivermectin has been widely used for 50 years for parasitic illness all over the world. It's quite safe. So we have been using that over the last few weeks.
"What happens if people choose not to get vaccinated and we don't reach the critical 70, 80% vaccination rates?"
Yeah, good question. So I suspect that the transmission of the virus will continue and those who are at risk will continue to be at risk. What I'm really hoping is that 70 to 80% of the high risk population gets vaccinated very quickly.
And that will cut our burden of disease and the fatalities substantially you know, especially in our older patients, 70, 80-year-old patients and in our 60 and up patients with medical problems, if we can get those populations to get to that 70%, 80% mark, I think we'll be well on our way to getting toward a brighter end to this tunnel.
If we have a lot of trouble with getting those groups to take up the vaccine, then I think we're kind of still in for a world of hurt if we can't convince people to do that.
"I've heard that the COVID-19 vaccine only masks the symptoms, doesn't kill the virus, you can still spread COVID-19."
Yeah, that's what we were just talking about a few minutes ago. We don't know whether the vaccine prevents symptomatic illness or symptomatic illness AND transmission. So that is a concern we just don't know. Even if it just prevents symptomatic illness, I'm happy with that. That's fine. That's still a huge win. If it prevents transmission as well, that's fantastic. Time is going to tell. We just don't don't know quite yet.
"Is there any data regarding the vaccine and infertility? My cousin is frontline healthcare and wants the vaccine, but she is younger and worried about infertility."
We just don't have any data on that yet unfortunately. I wish we did and I wish we knew more but I think it's going to be several years before we really can say whether anything long-term like that is of concern with the vaccines.
There's no intrinsic reason why that should be the case. But we just don't know. I think that's going to be a really tough decision for a lot of folks because we don't know the long-term side effects of these things and these are new vaccines. And we just don't know what they might do in the long-term.
That being said, I can't see or foresee a specific mechanism that will cause a problem like that. But we just don't know. And I think that's the most honest answer is we just don't know.
So I think, you know, unfortunately she's going to have to weigh the risk of the small chance of that being a problem versus the much higher likelihood that she's going to get exposed and may get the disease and be sick in the meantime.
I think it's just, she's going to have to unfortunately sort of do that calculus and see how she feels with the decision knowing that we may really not know for a decade, you know, whether these vaccines have other untoward effects that we have no way of predicting. So, yeah, sorry, Michelle. I wish I had more sort of cut and dry answer for that.
"What is the cocktail that those associated with the White House get when they are hospitalized? Are they really that sick or do they get it before being really sick?"
What some of them have been getting is either Regeneron or something similar to that, which is, it's an antibody cocktail. And that's available to other folks too. That's been being used in other places. They're getting a number of different things.
The president, I think got a whole smattering of things, but for most people at this point, there's a number of medications available.
The antibody cocktails, the plasma, the remdesivir, the steroids when necessary, are being used at most hospitals in the area. And there's some other medicines, too, and a couple others that are still sort of under investigation, so to speak.
But I think they're getting similar to what other people are getting around the country at this point. If you have a more specific question or had specific question about one of the components of that cocktail, let me know.
"Does PartnerMD have any sense when the vaccine might be distributed to their offices?"
Not yet. We actually just finished talking to the health department again this morning and they took all our information. We provided them all the details of what we would like and how we can administer the vaccines and things like that.
And it was sort of, you know, "Okay, great. We'll call you when we're ready to give you the vaccine." So we're sort of in a holding pattern waiting to hear back from the health departments, plural because we're in multiple states, about when we might get the vaccines.
I think it's my guess is it's going to be several weeks to a month before we get any vaccine doses that we are allowed to give to our patients
It's from Ellume health and it is a at-home COVID antigen test. It's a nasal swab and the test kit is sort of a little, it almost looks like a pregnancy test, so you have a little solution that you add to it and it detects the antigen for COVID and then it gets reported on a phone app that you can see and tell you right there, if you're positive or negative. It's just been approved. I don't see where it's available to purchase just yet, but I suspect it'll be available in the coming weeks.
That'll be something to sort of keep an eye on and watch for if that's something that you want to get and keep in your home just for use in the coming months as we wait for the vaccine rollout to happen.
It looks like the cost for each test is going to be around $30 and it takes 15 minutes to do. It seems to be a very accurate test based on the data they have published. So I think it's a promising addition to things and might make testing a little bit simpler for folks, especially because I know it can be challenging to get access to testing, right? Even now.
"I wasn't tested for COVID back in March because I didn't put my symptoms together until more was publicized detailing them, had an antibody test more than a month later, but it was negative. Is there a more definitive test now? I believe that I am a long hauler."
What you might want to do is actually just repeat the antibody test. There's not a more definitive test available just now. The problem is, of course, we don't know how long the antibodies will persist. So you could have had COVID and you just didn't create enough antibodies to be detected. And they may still not be enough to be detected at this point. So it's a little hard to say.
There are companies coming out with T-cell tests to check for COVID, past COVID infection, so that may come out soon and be helpful to you. But at this point probably just need to talk with your doctor and probably can maybe consider, based on all your symptoms and everything, whether you likely just had a clinical diagnosis of COVID without necessarily a test showing anything.
And I think that's perfectly reasonable. I think that's probably happened to a lot of people especially early on February, March, April, when testing was really difficult to come by.
So yeah, I might suggest repeating an antibody test to see if they're there at this point, and if not then either waiting for one of these T-cell tests to come out or just chatting with your doctor about being considered as a COVID long haul or just from a clinical standpoint, based on your symptoms and such.
"Are there any trackers showing the number of people who have been vaccinated similar to the tracking of positive tests?"
Not yet. I bet the CDC will be putting that out soon. Probably in the next few weeks as they start to track how many vaccines have been given across the country. But I have not seen that just yet. Good question though. I bet. I bet that'll be coming.
(32:04)
Alright. What other questions? So you guys have lots of good ones today. I've got time. So let me know if there are others. I'll hang on the line here while you guys type those up, if you have any and you know, while we're doing that, I'll just go ahead and kind of repeat my general encouragement to folks.
"Do you recommend the trackers we have on our phones?"
Yeah, I think that can be helpful. All the states have slightly different versions of the contact tracing apps, so I'm not familiar with all of them, but yeah, I think they can be helpful for you if you're wanting to see if you've potentially been in contact with anybody.
"Is the news still dire for COVID deaths over the next few months? Any good news there? The daily deaths numbers are staggering. When can we hope they might improve?"
Yeah, honestly, I don't think they're going to improve until people start taking the vaccine. I'm hopeful that over the next four to six weeks as we start vaccinating our healthcare workers and the folks in the nursing homes, that we will start blunting the deaths, because those are the people at higher risk for death. So I'm hoping as we prioritize those people, that we will see some positive news.
But it's going to take four to six weeks before we really start seeing those trends turned around because that's how long it takes for the vaccine to take hold. It's four weeks or so. So again, I'm hopeful about that, but I think it's going to be mid-to-late January before we see anything substantially different in that regard unless, you know, something else changes. But I doubt it.
"What do the antibody tests show? Is it a binary result or does it show the level?"
It's just a binary yes or no at this point. It doesn't show us levels of antibodies.
"Should we call in and get put on a waiting list for the vaccine for those of us over 60?"
I would hold off just for now. Maybe another week or two until we get some more information from the health department about when we may even have the vaccines. We haven't even started putting together lists yet just because we don't even know how many doses we're going to get or when at this point. So I would hold off on that for now just because we're not really in a position to take the list yet, but hopefully soon.
"What do you suggest that we can say or share with people in our lives who still debate the effectiveness of masks? Is there a specific phrasing or study that you suggest?"
Yeah, I think that's a tough question. I think the data is still, is not good on masks. We just don't have high-quality data. And I think my sort of party line on that continues to be if you're in a space where you can't distance from people, wear a mask because the risks of wearing the masks are pretty low and they may help.
So I think that's kind of my party line on that piece. There's not any definitive data that we can share with people because the studies that have come out have not shown anything. The data haven't shown that they like super effective as of yet, but there are design flaws with the studies and things like that.
So I think it's just, it's hard to point to any one specific thing and say, this study shows that they work and so therefore you should do it. But I think we're still in that sort of risk benefit area where we have to say, okay, look, the risk of wearing a mask is pretty low. The potential benefit is high, especially in crowded spaces where you can't get away from other people. So I think that's probably the best you can do right now.
"How long do you expect us to be wearing masks since vaccinated people may still be contagious?"
Yeah, I think we'll still be wearing masks until the transmission rates drop off. And until the death counts come way down. So my guess is at least the next six months.
"When will PartnerMD get the vaccine? Will you contact your older patients?"
Yeah, we're waiting. Like we said, we are waiting to hear from the health department on that. I suspect we'll hear something in the next couple of weeks.
And then after that, based on how many doses we get, we'll probably come up with a a way of prioritizing our patients and contacting the older patients and the higher risk patients who are probably going to be in the first tiers of vaccine.
Most likely the health department is going to tell us who we can give the vaccine to at first. So we'll have to wait for that guidance as well.