COVID-19 Update 2/24: Johnson & Johnson, Long Haulers, and More
On this week's COVID-19 update, Dr. Steven Bishop analyzed the data from the Johnson & Johnson trial, discussed treatment options for COVID long haulers, and more. Click below to watch the full video and read on for a transcript.
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Johnson & Johnson Releases Vaccine Data
The main topic of conversation is going to be the Johnson & Johnson vaccine data, which has just been released by the FDA. They're going to be meeting on Friday to discuss this data, and their sort of subcommittee that reviews this and makes the recommendations is going to vote whether to recommend approval or not.
If they do recommend approval, it's expected to be given the emergency authorization on Saturday. And then I would expect distribution could begin as early as next week potentially. So that's very good news.
Here is a link to the data. It is a pretty long dataset. It's the longest of the ones I've seen so far. It's 119 pages. So in your spare time when you want to read 119 pages of data, it's there for public consumption, whenever you want to do that.
But we're going to talk about some of the highlights here, and I'll tell you what pages to find the highlights on here. So we're just going to talk first about two, really two main things.
A, does it work? B, is it safe?
So the question A, does it work?
Yes, it works. Does it work as well as maybe the Moderna or the Pfizer vaccine? Maybe not in general, and that's okay. And we'll talk about that.
The efficacy against symptomatic COVID-19 in the study population was still pretty high in terms of as far as vaccines go, about 67%. So that's getting COVID, symptomatic COVID of any kind, whether mild or severe.
It was actually 77% effective at preventing severe or critical COVID, meaning you're in the ICU, you need oxygen, that sort of thing, at the 14-day mark. And by 28 days, it was 85% effective. I think that's pretty good as far as vaccines go. That's about equivalent to a single dose of the Moderna vaccine. So pretty good protection in general at the 28-day mark from severe or critical COVID.
And that's the COVID that we really care about, right? That's the COVID that puts you in the hospital, that gets you on the ventilator, that is killing people. So 85% protection from a single-dose vaccine. I think that's pretty good. And I'm happy with that overall, just as a physician.
Would I like to see it higher? Of course. But the truth is that many of our flu vaccines every year are much less effective than that. And we give them routinely and don't worry about that. So, you know, I'm very happy with an 85% effectiveness preventing severe critical COVID at the 28-day mark. I think that's pretty good.
The other thing that's nice about this vaccine that I like is that they did test and get some data on its protection against the South African variant, which I know a lot of people are worried about that. That variant has shown up. And it's at 28 days after vaccination, it's 80, about 82% effective. So I think that that is really pretty good.
And that's better than the data we were seeing from the AstraZeneca vaccine, and I think probably better than the Moderna vaccine effectiveness in terms of the South African variant in particular.
So the nice thing about this, A, it seems to work, B, it's a one-dose, single, one-and-done vaccine, which I think is nice.
Is it safe?
On the other side, sort of the safety side of this vaccine, it appears to be pretty safe in general. And I would have no hesitation recommending this vaccine for my patients or my family or myself.
Just kind of a background. So this is one of the, it's an adenovirus vaccine. The protein for the spike protein, the gene for that is put into an adenovirus DNA set. And this has been used in other vaccine platforms. And Johnson & Johnson actually published this data in their data dump. They've used this vaccine platform in 193,000 patients for other vaccine trials in the past years.
So it's been pretty well-tested, this vaccine platform. So I feel good about that.
Even adding to that, the reported side effects from this vaccine in the study are pretty mild in general. There was actually a lot fewer side effects and adverse events from this vaccine compared to what we were seeing, even with the Moderna and the Pfizer vaccines, which is good.
Part of that is probably because it's a single-dose, right? So it's the second dose that was really getting people with Moderna and Pfizer, but even so, a fair number of people were having fever, headache, body aches, that sort of thing, even after the first dose of the Pfizer and the Moderna vaccine.
These side effects rates are much lower. And I'm scrolling down to them. I got to find the page again, 'cause again, it's 119 pages of data. So we'll save you a little time, and starting on page 73 is where you can find the side effects of this vaccine, Then side effects were less common in the older population, so 60 and up is where they define as older population, compared to younger participants in the trial.
Let's see, about 48% of people had a vaccine site reaction, which is pretty common. So that's the sore arm, a little bit of redness, things of that nature. So pretty common with about half of the patients, which is pretty typical for a lot of vaccines, and not something to be worried about.
The most common side effects were 38% of people had fatigue, and 39% of people had a headache, and 33% of people had some body aches. The rate of fever was fairly low compared to the other vaccines. It was about 9% of patients had a fever of any kind, any variety. So actually, pretty decent compared to the Moderna and the Pfizer.
Serious Adverse Effects?
There were no serious adverse events that were thought to be, in terms of deaths, et cetera, that were thought to be due to vaccine in the vaccine group.
There were some other odd little serious adverse events which also happened with both the Moderna and the Pfizer vaccine, which is some rare, but not unheard of neurological complications. And these things do happen with flu vaccines and other vaccines as well. So like Guillain-Barre syndrome, which is a peripheral nerve problem where you can lose the ability, usually temporarily, lose the ability to walk and feel in your legs and feet, and that sort of thing.
That can happen anytime from viral infections as well. So this happens from the flu, from cold viruses, from whatever, also happens from some vaccines. And there was one case, I believe, of Guillain-Barre syndrome in the vaccine group.
There were also a couple of cases of Bell's palsy in the vaccine group, which again, we've seen that in both the Pfizer and the Moderna vaccines as well. And then some problems with the brachial nerve, same thing. We've seen that in other vaccines. So not an uncommon set of side effects, but just something to be aware of in that data.
Overall Thoughts on the J&J Vaccine
So overall, I think what we're seeing here is a decently effective vaccine that I would be happy to take or have my loved ones take or have my patients take. And the side effect profile seems pretty mild overall.
I'm especially encouraged, given how many people have received this vaccine platform, this adenovirus platform over the years. It's pretty well-tested, so I have some confidence in that as well. So I'm going to stop here and take questions about the vaccine issues before we kind of move on to the second topic of the day.
Two doses of J&J?
"Can we not give two doses of J & J "to increase the effectiveness like the Moderna and Pfizer?"
Yes, and people are talking about that possibility, but they didn't test that in the initial trials. So they can't report that out, or any preliminary data hasn't been released on that yet. But I suspect they are probably considering that at this point.
That being said, you know, I think 85% effectiveness is pretty doggone good. I think it's good overall. And I think we should all be happy with that in general.
95% efficacy is not super common in vaccine development. So especially after a single-dose vaccine like this, I think this is good.
Eventually we may find that two doses is better than one with that, but we may not. There was actually some data that came out, I believe it was AstraZeneca vaccine early on, they were pursuing a two-dose strategy and found that it actually made the protection worse after the second dose instead of better. And this is a little bit of a mystery there, but the immune system is sometimes a bit of a mystery.
So that may not turn out to be the case, but many people think that and are thinking about that in terms of further study for the J & J vaccine.
Taking Fever-Reducing Meds to Combat Vaccine Side Effects
"Do you recommend that people avoid taking "fever-reducing meds to combat "the side effects from the vaccine? I assume fever is seen as good for immune response. So maybe you don't want to interfere with that."
I took prophylactic medication for my second dose, not for my first, but for my second dose, because I was worried about side effects. I don't think it's going to have any meaningful impact on whether the vaccine works for you or not.
About 40% of the patients in the Moderna and Pfizer trials were taking some sort of anti-inflammatory, especially during the second dose, and it did not affect their ability to create antibodies. So I don't think it's a concern, and it's okay if you want to do that.
You don't have to be, you don't have to tough out the side effects. It's all right to treat 'em, or take it prophylactically, I think.
Long Haul COVID
"In the coronavirus task force update today, Dr. Fauci talked about new studies of long-term COVID. He emphasized that preliminary evidence suggests that a significant number of mild cases "suffer long-term problems. What do we know about the efficacy of the vaccines for preventing mild to moderate infections that wouldn't put you in the hospital, but might leave you vulnerable to long-lasting symptoms?"
These vaccines do seem to be very efficacious, all of them in general, at preventing any kind of coronavirus infection. Now, this J & J one is down in the 60% range for general symptomatic COVID, so not as good as Moderna and Pfizer for that. So probably isn't quite there, but I still would say 67% is still pretty decent for preventing these infections.
"Fauci said US study of 30% of mild cases had long-lasting health problems, including fatigue, but also problems with organ function. He emphasized we don't know much about the problem and need additional research."
Yeah, exactly. And we're going to have a certain number of people that are going to have these long-term symptoms. And that's what we're seeing in our clinical experience too.
Most people, their long-term symptoms is, mostly tends to be fatigue, sort of chronic fatigue syndrome that seems to develop after the infection. You see this sometimes or many times with other viruses too. Think mono, think the flu, things of that nature, you can get this sort of chronic fatigue syndrome.
Same thing with cardiomyopathy. So it doesn't surprise me that we're seeing this with COVID.
Time will tell what the real rate of that is in terms of how many people are truly experiencing long-term side effects after the virus, because I think part of the issue remains, and this is kind of touching on what we're going to talk about in the next topic today is, we have probably, despite our very high levels of testing, we've probably way under-diagnosed the number of total cases in the population.
I suspect the number of people who actually have long-term symptoms is going to be a small percentage. Once we have had time to kind of look at all the data in terms of seeing who actually was infected at some point, meaning they have natural antibodies and things like that.
Second Dose If You Had COVID?
"Do you recommend taking the second dose of Moderna for someone who has had a mild case of COVID? I recovered from the virus in January. I took the first dose on February 5th with a significant reaction that lasted 24 hours. I've seen some new information that indicates It may be better to get only one dose."
I've seen that too, but the official recommendations from the manufacturers, from the CDC, from the Health Department, has not changed in terms of that. What I would say is that, you know, I would advise perhaps considering pre-medicating before you take your second dose since you did have a strong reaction to it, if you still want to get the second dose.
I do think it's a good idea, just because we really don't know how long the natural immunity will last. For that matter, we don't know how long the vaccine antibody immunity will last. So it's a little kind of up in the air, but we just, we really, there's no solid answer to your question, other than to say all the official data that's out there says still get the second vaccine at this point.
How Quickly for 60 & Under to Get Vaccine
"If this vaccine is approved, how soon do you think those of us that are 60 and under will be able to receive it?"
I have no idea. It's going to depend on how many doses Johnson & Johnson has already produced, and how quickly they can distribute them. I don't think there are any of the same storage issues with the J & J vaccine as we were having, say, with Pfizer, in terms of having to keep it in these ultra cold freezers and things like that.
But that being said, it's really going to be on a state-by-state basis, Virginia continuing to be kind of not distributing vaccine very quickly, but it should in theory speed up the delivery some at least.
Advil or Tylenol Before the Vaccine?
"Just so I understand correctly, do not take Advil or Tylenol before getting the vaccine as there is not enough data on how it impacts the vaccine-induced antibody responses?"
No, I think, you can take Tylenol or Advil before getting the vaccine if you want to. I do not think that it's going to affect your immune response to the vaccine based on the data that's in the trials because about 40% of people in the study trials were taking some kind of anti-inflammatory when they got the vaccine doses. So I think it's fine if you want to do that, absolutely fine.
Case Numbers Down Substantially
Next topic, I'm going to talk about good news. So we've got some good news with the vaccine, and more good news. Case numbers are down everywhere, which is fantastic news.
They're down about 70 some percent from the peak of about a month and a half ago, which is great. We have no idea why, no one knows why. Which is not so great and is kind of mystifying.
I think there's a few reasons for this, and we'll talk about that here in a second, but I want to share that good news with everybody. There's a nice article in the Wall Street Journal that kind of details what we're seeing. And it was written by an infectious disease expert from Hopkins, Dr. Makary. And I think it's a good summary article.
And their opinion is that we will reach herd immunity sometime in the spring or summer. And their theory is that we've had a lot more infections than we realize because of asymptomatic cases and because of issues with testing, particularly in low-income communities, communities of color where we just haven't had as much testing as in other communities.
And so there are likely a huge number of just undiagnosed mild cases out there. And that's consistent with every time a lot of these sort of routine antibody studies have been done, we found that there are a lot more people who've gotten sick than we realized, which is both good and bad news.
It means that, A, pretty much none of our mitigation strategies did a whole lot to prevent the spread, which is sort of disturbing on a whole lot of levels.
But, B, it's also good news because we didn't have more fatalities than we had, despite the virus spreading pretty rapidly through our communities, even unknown and unchecked. So it's interesting.
Based on the numbers that Dr. Makary has put together, they are thinking that we'll get to herd immunity sometime in the spring or summer. And I think that makes a lot of sense based on the numbers we've seen so far. And if you add in that with the fact that we've got vaccine rolling out, which is not to a huge number of people, but it's to some significant millions of people at this point who've been vaccinated.
And then you add in the fact that there is almost certainly going to be some level of seasonality to COVID just like with all respiratory viruses. I suspect the case numbers will continue to collapse in the next six to eight weeks.
And hopefully, by the spring, numbers will be pretty low. And you can look up the data on Google or anywhere else. Again, the VDH website has this. We went from a peak of having 300,000 new cases a day in the US to down to 60, 70,000 cases a day, which is still a huge number, but that is about a 70% collapse in case numbers.
And I think the other thing that we're seeing too, is that if you got, don't know if you guys think back to January, but in January, the WHO actually updated their guidance on the PCR cycle threshold in terms of diagnosing active cases. That reduced the number of false, sort of false positives in a way, meaning that the virus was there, but perhaps at such tiny levels that it wasn't really relevant. So they recommended lowering the cycle threshold on the PCR test.
I think some labs have done that. So I suspect that's playing in as well in the change in the case numbers. So there's a lot going on there. I have no idea which of these things is the main driver, what the relative contributions of these different drivers are. But I just know that I'm glad that the case numbers are collapsing. And I hope that that continues.
And you can see that bear out again in the Virginia Health Department data where we're down to, quote, "only 600 new cases a day from our peak of..." The website just crashed on me, "of about 1,700." So down pretty significantly.
Even more important than that is our hospitalizations, and even more so, our death numbers have really collapsed, which is just fantastic news. Our death numbers are actually back to where they were in April, roughly April 2020, right now. So a lot of encouraging stuff that's going on. I hope that these trends continue and that one or all these factors is what's going on here. So that's good.
How Many More Cases than Reported?
"If I recall, "the Wall Street Journal article writes the argument assumed there were a thousand percent more total cases than documented. Is that assumption plausible? I'd seen other estimates of four or five X. Hadn't seen a 10 X more cases before now."
Yeah, it certainly is plausible, I think. I don't know if it's going to be quite to the extent that she says. But the thing too, in order to break the chain of transmission, we don't necessarily have to have 80, 90% of people immune. Even if she's off by a factor of 10 or so in her assumptions, I think it would still be enough to help us get to, it would help explain where we are now, right? Which is to say, it's not gone, right?
We still have significant circulating virus everywhere. We're just kind of back to where we were in April and May of last year. So it's not that we've reached herd immunity enough that the cycle of transmission is totally interrupted, such that we're seeing a total collapse of case numbers, which is what you would expect to see in a herd immunity scenario, but we were kind of in this weird no man's land of partial herd immunity, probably in some areas, and in different pockets, in different communities, et cetera.
So we've seen a lot of case collapse, but it hasn't gone down close to zero or into very low levels at this point. So like I said, even if she's off by a factor of 10, I think it still makes some sense.
And it just makes sense in general. Even laying aside what that author is saying, if you think about the number of people who indeed have had it and confirmed to have had it, the number of people being vaccinated, and then the fact that there's some seasonality, and then the change in the PCR cycle threshold, I think all those things are kind of coming together synergistically to cause a collapse in the case numbers.
It's probably a little bit of all those things, to be honest, it's probably not one or the other. I don't think that her assertion that 55% of Americans have had COVID is accurate. I think that's probably a little bit overdone. But I could easily see something like a quarter to a third of people having had it at this point, which would be a little bit more plausible to me, so. But it's worth considering, worth thinking about.
Fewer Cases = Less Risk from Variants?
"Does a decrease in infections we're happily seeing now mean the risk of increased infections from variants has lessened?"
Hopefully, hopefully, yes. Hopefully that means that, either... It means one of two things.
Either the overall number of cases has just dropped or it's just the most vulnerable people getting it at this point. I still think eventually what you're going to see is these, like the UK and the South Africa variant, those are going to become the dominant variants eventually.
But if we can interrupt the transmission chain quickly, then it won't matter. It won't matter which one becomes the dominant because so few people will be getting it in general. So I hope that answers your question. It was a little bit of a roundabout answer to that question.
Lifting Restrictions in Virginia. Are We Ready?
"The governor just announced some lifting of restrictions in Virginia. Are we ready?"
Oh, that's good news, I hadn't seen that yet. You're ahead of me. I don't know. I think we probably are ready to change some things at this point. I hadn't seen the change in the restrictions. If you've got details, do share them. That's good, and I think that makes sense, based on the collapsing case numbers, to lift some things.
And I think it makes sense too, given the fact that I don't, I truly, I don't think the data has really borne out that our current mitigation strategies have done a whole lot for us and they have cost us a lot. So I think it does make sense to ease some of these things up and see how things go.
Especially since the numbers have come down so far, so quickly in the last six weeks or so. But yes, I think we're ready to make some changes at least. So that is good news. And I know my son's been back in school all month, which has been great for him and his friends.
And my daughter's going back in a couple of weeks to in-person, five-day a week, in-person school in Chesterfield, which is just fantastic for a whole host of reasons. A, the data continues to show that schools are not places of major transmission, for elementary, middle school in particular. And it's good for their mental health and their academic performance. So there's a lot of good reasons for the kids to go back to school. And I think it's a really good thing.
J&J Vaccine for High-Risk Folks?
"I'm late to the heart party. I was wondering if the J&J vaccine will be fine for high risk folks with other health issues."
Yes, I think so, I think it would be good to get. I mean, honestly, when it comes to any of these vaccines, assuming this one gets approved, I would take any of them.
If you're a high risk person, take any of them as soon as they're available to you. I wouldn't be picky about Pfizer or Moderna or J&J. Any of the three I think are fine, and probably equally safe to get. So I wouldn't be picky or worried about it. Take whichever one they have available.