COVID-19 Update 2/10: Vaccines, Side Effects, ITP, and More
On this week's COVID-19 update, Dr. Bishop talks about Johnson & Johnson's emergency use authorization request, the side effects after getting a vaccine, the relationship between vaccines and ITP, and more. Watch the video below and read on for the full recap.
Johnson & Johnson Requests FDA Approval
Johnson & Johnson has submitted for FDA approval for an emergency use authorization for their vaccine. This vaccine, according to the initial data reports that have come out, it's still very effective. It's not quite as effective in their initial reports as Pfizer and Moderna appear to be. But it's still very effective.
And the benefit is it's a single dose of vaccine, which is much simpler to administer. You're getting about 70-some percent effectiveness out of the Johnson & Johnson vaccine after one dose. That's actually comparable with Moderna, which has 80% effectiveness after one dose.
So I think it's still a win. And because it's simpler to administer, I think it's still a good thing to do for many people when that comes available. If that's the one that's available to you, I would take it, of course, pending reviewing all their other data.
I could not find their whole data submission like Moderna and Pfizer had for their FDA submission yet. I'm guessing that's going to be posted somewhere whenever the FDA schedules their hearing for this vaccine. So hopefully that'll be out soon.
One other good thing about the Johnson & Johnson vaccine. It does appear to cover the South Africa variant, and I believe most of the other variants that are out there currently. So that's also good news as well.
My suspicion is that we're going to need to take boosters for COVID at some point to continue to deal with the variants that are going to pop up from time to time. And it'll probably end up being something akin to the annual flu vaccine. Something along those lines. That's just my guess at this point, based on the rapidity with which these variants seem to be popping up here and there. That's what I'm expecting to happen.
Vaccine Side Effects
Alright so let's talk about vaccine side effects. I know as more people come around the bend here to getting the second dose available to them, there's a lot more worry and concern about the side effects from the second dose of the Pfizer and the Moderna. Totally legitimate thing to be worried about.
I actually had my second dose of Moderna on Saturday and had some body aches and, you know, felt a little tired Sunday a little bit into the afternoon. But it wasn't significant. Didn't have a fever or anything else.
Now I did take Aleve and Tylenol as well to kind of minimize those potential side effects just because the first one left me feeling a little crummy. So I did do that. If you want to do that, that is okay. It's not going to affect whether the vaccine works or not.
About 40% of the patients in the trials for both Pfizer and Moderna took some sort of anti-inflammatory after both doses. So it's not going to keep the vaccine from working. If you want to take something like that after you get your vaccine, that is perfectly all right. It's not going to harm you in terms of whether the vaccine is going to work or not. So go ahead and do that, if you want to, to minimize your chance of having side effects.
You are more likely to have side effects with the second dose. That is for sure, so just be prepared for that. You probably will have some side effects, but that doesn't mean anything bad. It just means your immune system is responding. And for the most part, a little bit of Tylenol, a little bit of ibuprofen, Aleve, something like that should take care of the side effects that you get from the second dose, either Pfizer or Moderna. So that is that.
Vaccines and ITP
I did want to talk about one significant side effect, potential adverse effect from both the Pfizer and the Moderna vaccine that you guys may be seeing out in the news and this is something called ITP or immune thrombocytopenia.
I've gotten several questions about this the last few days. And there was a news article about a month ago from a physician who actually got vaccinated in Florida and unfortunately he did die from ITP not too long after he was vaccinated. And so there's speculation about whether the ITP that he developed was from the vaccine or not.
But let me just tell you a little bit about what ITP is and unpack it from there. Immune thrombocytopenia is when your body makes antibodies against your own platelets, and then the body destroys the platelets.
Platelets are the central component of the blood that keep you from bleeding. They are the clotting agent, when you cut yourself, that's one of the main things that comes in and plug the holes and heals up your cuts and different things. Same thing internally, right? If you have any injuries, damage internally, platelets are one of the major components that stop the bleed.
So what happens when you have destruction of those platelets, you're much more at-risk for having spontaneous bleeding, having strokes, that sort of thing. So, unfortunately, that's what happened to this physician down in Florida. He developed ITP, his platelet count went extremely low and had a stroke and he passed away. It was a couple of weeks after he got his first dose of Pfizer.
They don't know for certain yet whether the vaccine actually caused it or not. It seems like it probably did. That being said, this is actually a risk with many, if not most, vaccines. Many vaccines can cause immune thrombocytopenia. The flu vaccine, hepatitis vaccines, these vaccines probably will turn out to have that risk as well.
It's not unusual, in terms of, you know, it doesn't surprise me. I think it's something they're going to have to monitor, and they do need to make people aware of that.
That being said, virus and viral infections also cause ITP. So on balance for almost every vaccine, the number of cases of ITP caused by the vaccine are way less than the number of cases that would be caused by actually getting the viral infection. So like everything, there's risk and benefit, but on balance, the cases of ITP are less with a vaccine versus getting the viral infection because your body can still misrespond to a viral infection and cause antibodies to be created against platelets and things of that nature.
The same thing is thought to be related to type one diabetes. You get a viral infection of some kind, then your body creates antibodies against portions of the pancreas. On balance, the vaccines in terms of that side effect are likely still to be way less concerning than actually getting COVID.
Just want to put that out there. That is something that is out there. Just something to be aware of. But this is still a rare issue and not going to be a concern for most people, but did want to talk about it because it's out there in the news.
"Can you say more about the quantity and quality of scientific evidence about masks wearing and mask mandates? Last week, you discussed the relative lack of good studies on these topics and the need for additional research. CDC just published two studies suggesting mass mandates are correlated to reductions in infection. Today, they released data from experiments. Do these new studies by better evidence supporting mask guidance even before they had some saying they supported their guidelines?"
Yeah, I still think that the data — I saw that they released a couple of things and I saw one of the epidemiologic data sets they had released studies last week as well. The problem is they stopped studying the outcomes data back in like the late summer or fall before we had a big surge.
So for the epidemiologic data, I don't think it actually provides us with anything that's helpful, because I think what's going to end up happening is we're going to find the virus is seasonal. So I really would like to see the data extend through October and November and December in terms of mask mandates versus non.
And I know when I've looked at data, comparing different states in different areas where some places have mask mandates and some don't, the infection curve is similar. Whether that's just an artifact of the data, whether it is people wearing masks differently, I don't know.
But the Annals of Internal Medicine does a rapid review pretty regularly and I check that. It's a very comprehensive review of all the published data on masks. I'm sure they will do an update after these new studies have been released, but from the last update that annals did, which looks at all the available data on masks wearing, their conclusion was that there was no conclusion. They could not really say one way or the other whether masks helped or not.
And I think that's kind of still where I am at this point in terms of the scientific evidence. That's concrete evidence that's there.
That being said, like I've said all along, mask wearing for the vast majority of people is a harmless intervention and I don't think there's any reason to not do it when you're around other people unless you have a medical issue, because it's such a low risk intervention and there's the strong potential that it may help. But I don't think the scientific evidence is there to support it and say, this definitely works. I just don't think we're there yet. They may get there. But I don't think we're there yet.
Rashes Around Injection Site
"I've heard that some have gotten rashes and swelling around the injection spot after the first dose. Would that suggest you should not get the second dose?"
No. That's actually a normal and expected reaction to vaccines. Most vaccines have that reaction, same thing with the COVID vaccine. It's not uncommon to get, and I had to have a little bit of redness and very mild swelling after both vaccines and my arm still hurts a little bit actually from the second one that I got on Saturday.
That would not be considered a severe reaction or an abnormal reaction, or even an allergic reaction. That's a normal reaction to a vaccine and is a sign that the vaccine is doing what it's supposed to do. So unless the swelling gets extremely extensive or spreads to other parts of the body, it's generally not something that to be concerned about.
Side Effects and Immune Response
"Does lack of side effects suggest less immune response from the vaccine?"
Maybe, but I think it's still going to be enough. There are people that have had minimal effects from the vaccine. I think that's great. They're still going to develop antibodies for the most part and be fine, especially after two doses. So I wouldn't worry if you don't have side effects. It doesn't necessarily mean that you're not developing antibodies against the virus in that case. So I wouldn't wouldn't worry about that too much. Count yourself lucky if that happens to you.
"If you don't get side effects from the second dose, does that suggest a weak immune response?"
Same idea. No, I don't think it does suggest that. I think everyone's immune response is a little bit different, so don't be alarmed if you don't have side effects or reaction or something like that. That's fine. Again count yourself lucky. And you will still develop antibodies and that will be fine.
Remember too, if you look back to the data, even though a fair percentage of people in the trials had side effects to vaccine, it wasn't a hundred percent, right? It was still only, of each side effect, it wasn't a hundred percent of people had each side effect. There were people that had no side effects whatsoever and still after the second dose, 95% of people had protection. So don't be alarmed if you don't have side effects. That's a good thing.
Back to Normal in Summer?
"Assuming that all who wants to be vaccinated do so by mid to late summer, at what point can we let the vaccines do their job?"
Yeah, that's a good question. And I think what is really going to dictate this — I'm guessing you're talking about the mask mandates and keeping things closed and social distancing and all that sort of thing — I think that's really going to depend on this assumption is when can we get these vaccines to people.
And so far the rollout continues to be abysmally slow in most places, Virginia not withstanding. Things have gotten a little tiny bit better in Virginia but not much. People are still scrambling trying to hunt and find vaccines, and it is a logistical mess.
And it's not much better than it was last week. There was a rollout of some doses at CVS, and that kind of turned into a mess too, because they told people to register on February 9th, then they said, no, we're going to do it on the 11th, and then they opened up registration anyway, but only to certain people.
People are confused and I understand why they're confused. And unfortunately the state governments are going to have to do a better job is the bottom line. And at this point I don't have a lot of confidence that they're going to get things moving a whole lot faster anytime soon. So I think we're going to see, I think mid to late summer to get kind of everyone who wants a vaccine one, is optimistic because things are just so slow.
Deaths After Vaccination
"Is there any data yet showing how many people have passed away due to getting the vaccine?"
No. Certainly some people have died after getting vaccine. That's true. But we don't know if it caused it.
You got to think, too, we're giving the vaccine, we prioritized giving the vaccine to the old and the frail to begin with. There's certain just random chance of them passing away in general all the time.
A lot of the folks who have passed away shortly after getting the vaccine, of course, it needs to be investigated and make sure that it's not vaccine related, but more than likely, it's sort of random happenstance in most cases.
Just because when you're talking about people who are 94-95 years old and have medical problems, they're likely to pass away anyway because of their age and medical issues. So it's hard to tease that out. And I think it is going to take some time to sort these things out.
Vaccines and ITP
"I actually had ITP 17 years ago and have not had another occurrence since then. Would I possibly be at a higher risk of it reoccurring due to the vaccine, compared to someone who has never had ITP?"
I think probably the answer to that is yes. Just based on my gut instinct. But I don't know for sure.
What I would do, I would talk to your either primary care doctor or your hematologist and find out if they think this is a significant issue for you.
But again, I think that, you're probably on par all things being equal. There's a worst risk of you getting COVID and having ITP from COVID compared to getting it from the vaccine. But I would talk with your hematologist or your primary care doc about that. But my gut tells me, yes, I don't have any data to back that up.
Warm Weather and COVID
"Was there ever any any conclusion about the "warm weather helps kill the virus theory?" Thinking about the weather starting to warm up in March, and if that could further bring down cases and hospitalizations, or is it probably the result of people spending more time outside?"
Yeah, I think it's a little bit of all those things. And I think we're just going to discover that this virus has a certain level of seasonality to it, and it's going to come and ebb and flow over various seasons as well.
Even though we still haven't vaccinated that many people the last several weeks, the numbers of cases and hospitalizations have continued to kind of just drift down and I'm hoping that's going to continue to be the case as we get into March and April and June, of course, but time will tell there.
There definitely is activity of UV light against the virus and warm weather is better. People are outside. There's less congregation. I think all those things play into the seasonality. But there's not been any sort of definitive conclusions about that, but I think we're going to see that the virus is seasonal. Some of the reasons for that will be what you indicated there.
If We Don't Reach Herd Immunity
"What will happen to the course of the pandemic and the need for infection mitigation if we don't reach herd immunity after all who want the vaccine have been vaccinated?"
I suspect that the virus will continue to circulate pretty heavily at that point, but hopefully what would happen is everyone who's really at risk for doing poorly will have gotten vaccinated.
So even though the virus may continue to circulate pretty widely, hopefully the hospitalization and the death rate will continue to decline dramatically, even if a large portion of the population ends up choosing not to get vaccinated at some point along the line here. That's what I would expect to happen. Case numbers will stay high, but hospitalization and death rates will hopefully go to very low or as close to zero as we can get.
How do you feel about infusion treatment of monoclonal antibodies for people who are not hospitalized? Under what circumstances?
Yes. And we're doing it. We're referring people out to Henrico doctors and there's a few other places in the area that are doing this as well.
Yeah, if you meet the certain list of criteria, if you're high risk and you're symptomatic with COVID, you can get monoclonal antibody treatment. I think it's a good thing to do. It's been helpful for a lot of our patients. So I do recommend it for folks in those categories, if they're high risk and want to do it.
If the U.S. Reaches Herd Immunity First
"Let's suppose the US is one of the first countries to reach herd immunity. What would be the implications of the pandemic that other countries have not yet reached it? For example, if it takes years and years to vaccinate the poorest countries, does that mean viral replication could generate virus mutation that could threaten us?"
Yes, of course. Yeah, absolutely. And that's why I think ultimately what's going to happen is we're going to end up with boosters for the vaccine probably on an annual basis.
That's my guess, because these mutations are going to continue to happen just like flu. I think it's here to stay and we'll be dealing with this indefinitely in some way or another. But hopefully we'll keep the infection well-controlled or at least more well-controlled and be able to treat it more like the annual flu in the future with just boosters and things like that.
Vaccines and Essential Thrombocythemia
"Would you believe an individual with essential thrombocythemia to be at higher risk for serious side effects from vaccine?"
No, I don't think so. It's hard to say though. If you have ET, I would talk with your hematologist very specifically about. That that's a fairly uncommon diagnosis, so I would ask them about it and see what their opinion is. You may be at higher risk, but probably not more so than anyone else.
Johnson & Johnson Approval
"What is the anticipated timeline for the J and J vaccine approval and distribution?"
Good question. I would love to know that myself. I know they submitted their request for approval to the FDA this past week and the last I checked, they had not yet scheduled the hearings to review the data and vote on it (Editor's Note: The FDA meeting to review the J&J data is set for Feb. 26).
So I don't know yet. I would hope that it would be scheduled in the next few weeks. But haven't heard just yet on that. And then it should be, I would assume available pretty rapidly after that, just like it was with Pfizer and Moderna. They did the approval and then the vaccines were being distributed about a week later.
So as soon as that's done, I would expect it would be approved. I would hope that by no later than early April that would be starting to go out.
"What's your opinion on the Novavax?"
I think it's another potential tool in the tool belt. The more vaccines, the better. If they're at least 60-70% effective, I think they're good to consider and I wouldn't necessarily shy away from using any of them if they have efficacy rates in that category or higher. So hopefully we'll see data on that as well.
Variants in the United States
"Any new info about variant prevalence in the US? What should we expect if a more highly transmissible strain becomes dominant by the end of March as Fauci says this is likely?"
Yeah, I think that's likely, too. I think most likely the UK strain, I saw something where it was doubling or quadrupling in prevalence every few days, which, which pretty much matches with my expectations.
That's how viruses work, right? Once one of the more dominant, a more transmissible strain is almost always going to become dominant. So I would expect it'll become the dominant version that's around in the next few months.
It's kind of the same thing as we've been saying the last few weeks. We're racing these more transmissible strains in terms of vaccine delivery. So in terms of how things play out is going to depend on whether our state and local governments get the vaccine out.
If they get the vaccine out, then we're probably fine. Pfizer and Moderna both work fine against the UK variant and Pfizer seems to work fine against the South Africa variant. The Moderna one, maybe not so much or not as well. I know they're already working on a booster for that, but I think we're pretty much just in a race to get the vaccine to the vulnerable before the strain becomes dominant, because I think that's inevitable at this point.
Antibodies Developing After Second Dose
"Could you please comment on how quickly antibodies are developed after the second vaccine dose?"
Yeah, so, first of all, many people will have antibiotics after the first dose. I know I did. I checked just out of curiosity about two weeks, exactly two weeks after I had the first dose of Moderna, and I had antibodies already.
And so that'll be true for about 80% of people with Moderna and about 50ish percent of people with Pfizer, you'll have antibodies two weeks out by the time you get the second vaccine.
Generally, a rule of thumb is 14 days. So 14 days after you've had the second dose, there's about a 95% chance that you are protected at that point. So that's a general rule of thumb.
Boosters — mRNA or adenovirus?
"How will the boosters be made if you received an mRNA vaccine, would you need an mRNA booster or would an adenovirus booster be compatible?"
That's a great question and is not addressed yet. I don't think it would matter as long as the new booster was effective against the variant. So I don't think it would matter one way or the other whichever one.
Now, the only boosters I'm aware of being made are Moderna at this point and that'll be mRNA platform again. And that's probably going to continue to be the case, that the mRNA platforms are able to make the boosters faster and easier.
That's the nature of mRNA technology, so they'll come out first before other like adenovirus or DNA vector vaccines, things like that. So the the mRNA platforms, they're always going to be probably first to market in terms of boosters, because it's such a rapidly flexible platform.
If that makes sense. But theoretically it shouldn't matter down the line, you know, a couple of years from now when there's plenty of options available. I don't think it would make a difference, which one you used as long as the immune system responds and creates the antibodies it needs.
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