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Fever. Sore arm. Flu-like symptoms. These are the COVID-19 vaccines’ side effects, which now also include possible rare blood clots in the brain, and maybe even shingles.
But are the side effects worse than getting COVID? For roughly 5 million Americans, they are concerned enough to skip that second dose, according to the CDC.
Even as we learn about the possibility of these side effects, others are no longer a concern. Bell’s palsy, for example, which was noted during clinical trials and at the FDA meetings as something to watch, has now been determined following an analysis to be no more likely than with other viral vaccines.
So which side effects do we need to be on the lookout for, and which ones will pass just as quickly as we felt them? In this episode, Dial Hewlett Jr., MD, medical director for the Westchester County, New York Department of Health and fellow with the Infectious Diseases Society of America, joins us to explain. Dr. Hewlett also previously worked at Pfizer with their global medical product evaluation team.
Following is a transcript:
Serena Marshall: Dr. Hewlett, J&J — Johnson and Johnson — their one dose shot. It has now gotten the green light to start distribution again. So let’s start there, with what exactly happened. What is CVT [cerebral venous thrombosis]?
Hewlett: Yes, well, this is an adverse reaction, as we call it, that was encountered by roughly 15 individuals who would receive the Johnson & Johnson vaccine. This is a type of, we would call it a coagulopathy or a coagulation problem. A blood clotting problem, if you will. And it is very closely linked to another type of a well-known problem, known as heparin-induced thrombosis.
And what seems to have happened in roughly 15 individuals, all women, was that they developed clotting in blood vessels of the brain — cerebral veins as they call it. And that was what happened.
Marshall: Dr. Hewlett, you said 15. Most people heard about this when it went into effect, that pause, of only being six …
Hewlett: That’s correct. And I think subsequently when the FDA called upon the nation to have a pause, they reviewed data from many, many individuals. They found that, I believe, it was a total of 15 cases, which seemed to meet their definition for this clotting disorder.
Marshall: Let’s put that into perspective. It’s 15 out of how many shots?
Hewlett: This was out of, I think, over 7 million doses of the vaccine that had been administered.
Marshall: So not really a big or high number or percentage of overall doses. I mean, why would they even need a pause for such a small amount of cases?
Hewlett: Well, the reason for this is very, very clear. And I think that Dr. Fauci elucidated this very well, because vaccines are being administered to people who are previously well, we take an abundance of caution, whenever we see things that are occurring that are what we call serious adverse reactions, which might be associated with death, or that might be associated with a severe disability that would require hospitalization.
And so in the first roughly six cases, these six cases met the definition. And although it was only occurring at a rate of one out of 1 million, it was felt that there should be a pause, so that the cases could be very closely studied, so that there could be advice given to practitioners so that when we did start to administer the vaccine again, that we would be able to advise the practitioners about things that might be occurring that might prevent the disorders from progressing.
These measures were being taken out of an abundance of caution. I think that what should be gained from this, for the public, is that there should be a reassurance that the FDA and the CDC and the medical community are taking safety very, very seriously. And so when these things are noticed, and even though it was in a very, very small number of patients or individuals, these measures were taken again to try to understand everything that they could about the syndrome that was caused.
Marshall: When you talk about other medications, like blood clot risks for birth control, for example, are those the same kind of blood clots and the same concern that exists when you’re talking about birth control versus a COVID vaccine?
Hewlett: Well for birth control, it’s a bit different. One of the things that people should understand about the blood clots that were associated with the J&J, or Janssen vaccine, is that these clots were occurring primarily in the blood vessels of the brain, and they were not blood clots that would occur in the lower extremities.
We typically talk about deep vein thrombosis occurring in the legs. And so this was quite different. We also had some reports of blood clots that were occurring in what we call the splanchnic level of circulation, and these are the blood vessels that serve the intestinal tract of the body.
And so it was a rather unique type of situation that was occurring. And so I think that it is different, but certainly we know that there are going to be risks associated with many types of medications, including oral contraceptives. We certainly agree with that.
Marshall: When you look at how rare these types of blood clots are, is that why they were able to tie them as a causation to the vaccines and not just a correlation?
Hewlett: Well, yes. I think the rarity of this particular type of clotting in the blood vessels of the brain, the fact that clotting was occurring at the same time that we were seeing a decrease in the number of what we call platelets — a condition known as thrombocytopenia. And so it’s unusual to see both blood clotting and low platelet counts at the same time in the same person, and so this was rare.
Also the thing that triggered the investigation and the concern was the temporal relationship between the administration of the vaccine and the occurrence of these blood clots. The fact that these events occurred within roughly the first few weeks, I believe, within the first 3 to 4 weeks following the vaccine. All of these things really tipped us off that this was essentially some sort of a causal relationship.
Marshall: Do we know why that’s happening yet? Is the research already coming out yet on why that may be related?
Hewlett: We don’t really know exactly why. One of the things that we do know is that this syndrome that is occurring is very similar to another very well-known disorder, known as heparin-induced thrombosis. And that is a condition that occurs rarely in people who have received an anti-clotting medication called heparin. In some individuals, very rarely, there is an autoimmune type of a disorder that develops.
It seems to be closely linked to a factor known as platelet factor-4. Platelet factor-4 is a small cytokine, as we call it, that actually is usually involved with the management, or I should say, response to injury. It is believed that in these individuals, they have this unusual autoimmune response that has resulted in both the lowering of the platelet count, or thrombocytopenia, and thrombosis — which is the development of a blood clot, which potentially blocks the blood vessels.
Marshall: Now, Dr. Hewlett, J&J’s vaccine isn’t the only one that has had this associated blood clotting risk; AstraZeneca has as well. Now they haven’t themselves submitted yet for emergency use authorization. But we do know other countries like Sweden and Latvia did block the use of that vaccine until the EMA [European Medicines Agency] — their version of the FDA — could make a determination.
Why are we seeing that same effect with a different vaccine? Is it because they are both adenovirus vectors?
Hewlett: We believe that that might be the case, both the AstraZeneca vaccine and the J&J vaccine operate on what we call a viral vector platform. So there are certainly similarities in terms of the mechanisms of action or the platforms that are used.
Marshall: So what’s the bottom line for concern here, should people who have a risk of blood clots, who have had a blood clot in the past, be concerned and avoid this type of vaccine or these types of vaccines … or COVID vaccines in general?
Hewlett: No. That’s not really the recommendation. The recommendations that came out of the meeting were that practitioners should have this warning that would be attached to the labeling indicating that in very rare cases this has occurred. And that the practitioners would be made aware of the early manifestations. It is important for consumers or for patients to rely upon the advice of their doctors. We need to keep this in proper perspective — that we’re talking about something that has occurred in roughly one out of 1 million cases. We do know that there is a predominance of involvement, or the impact seems to be, mainly in young women between the ages of 18 and 50.
We still don’t know all the answers in terms of the predisposing factors. And I think it’s the hope that as more research is being conducted, that there may be some sort of a genetic factor that predisposes some people to this particular reaction. But we still have a lot of information that needs to be uncovered.
Marshall: Dr. Hewlett, I want to switch gears a little bit. The mRNA vaccines — we’ve been learning about another side effect that has come of those ones, like shingles. Now there was a study that suggested that at least six patients with comorbid autoimmune inflammatory diseases may have or experience shingles associated with receiving the Pfizer mRNA vaccine. Can you tell us about that and why, perhaps, there wasn’t a pause there after six cases, where there was one with the J&J?
Hewlett: What we do know about shingles is that shingles may occur quite often in individuals who are older. And so I believe the stats are something like maybe 10% of individuals who reached the age of 80 will have an episode of shingles.
We know that it can occur also in individuals who may be immunosuppressed. For individuals who have autoimmune disorders, connective tissue disorders, where they may require treatment with anti-inflammatory medications or immunosuppressant medications that suppress their immune system, and this might trigger shingles. Now, I don’t know at this time the actual mechanism or the actual causality between the vaccines and the development of shingles.
With regard to whether there should be a pause for shingles, one would say absolutely not. And the reason why, is that shingles, although it is a painful type of disorder and causes a great deal of discomfort in those who develop it, it is not generally viewed as a life-threatening adverse event.
Marshall: Unlike the blood clots, which were?
Hewlett: That is correct. And so that would be the reason why you wouldn’t want to have a pause.
Marshall: But if you can get shingles from the vaccine, is it just because you’re activating your immune system?
Hewlett: In all likelihood, yes. Because shingles develops in people who previously had chickenpox as a child. And so it’s a reactivation of an infection that was already present in the person’s body.
Marshall: Are there going to be more of these kinds of random reactions or side effects as we continue to vaccinate more and more people?
Hewlett: Yes. Most definitely. I think that any time we are talking about something that is being given to literally millions and millions of people around the world, we are going to see a variety of reactions. Most of which, we hope, and most of which I think predictably will be mild to moderate reactions, which are self-limited.
I think the hope and expectation is that the occurrence of life-threatening, dangerous adverse reactions, that this will be rare. As was the case with this type of thrombosis or clotting abnormality that has been described, the so-called vaccine-induced thrombotic thrombocytopenia, or VITT, as they’re calling it.
Marshall: Let’s broaden this conversation even more, Dr. Hewlett. When we look at these vaccines, we know people get mild side effects with the first dose. And then with the second one, it seems to knock you out more. We’ve heard anecdotal reports that if you’ve had COVID, your first shot would actually be like other individuals’ second shot. So can you explain the science behind what’s happening here?
Hewlett: Yes, this is due to what we call a memory response. One of the terms that is used is an anamnestic response. Your body’s immune system remembers that you have been exposed to this particular agent or antigen, as we like to call it. In this case, it is a piece of the virus that causes COVID, the spike protein.
So your body recognizes this. So if you’re receiving your second dose, your body is actually already poised to react to it. And so it develops a condition that we call reactogenicity, which can be associated with fever and with causing fatigue and other types of things that are associated with an inflammatory response.
And this is actually a good thing because it is actually showing that your body is defending you against this particular antigen. And because you are being exposed to this the second time, your body remembers, and that is why some people have significant symptoms of a short duration, usually. If you have already had COVID, however, when you receive the first dose, your body actually had natural responses to that first encounter with the virus, and so it’s almost like you’re receiving the second dose of a vaccine, and that is what we call the memory response.
Marshall: That seems a little counterintuitive, though. You would think that when your body first receives that first dose, it would need to build up a more robust response. So that would be the more upsetting shot?
Hewlett: You would think that, but it’s actually the opposite. The first time the spike protein is being injected into your body, you are forming antibodies. You are also forming what we call memory cells being stimulated. So, in most cases, people have not been exposed to this particular virus or antigen, as I should say, before. And so that’s why the response is really not as robust as the second time.
Marshall: Okay. So now some have reported, though, missing their second shot because they don’t want to have those side effects. Even saying, one may be sufficient enough for me.
Hewlett: We are very troubled by that. I think that some of the reports have indicated, and I think there was a report in the New York Times, that indicated that up to 8% of individuals have missed their second dose. So this is troubling …
Marshall: And that’s a pretty high number.
Hewlett: Yes, this is troubling to me as a physician and as a person in public health, because we know that the data on protection and effectiveness, when we talk about the 94% to 95% effectiveness, that that’s based on people who have received two doses. And we know that for those who have received only one dose, the level of effectiveness is significantly lower. Possibly only in the less than 80% range or possibly even lower than that.
So it is troubling to us and we hope that individuals will be very vigilant about this and be serious about this and go in to get their second doses because the danger, we think, is that if there is a predominance of variants that are in the environment, it may be that they will be even at a lower rate of being protected against those variants that are out there.
Marshall: So it could actually leave you more susceptible to these new variants that are coming around?
Hewlett: That is correct. Yes.
Marshall: Now, most of those effects, though, are short-term side effects. So when we look at long-term side effects, is that what would actually — those blood clots from J&J or shingles be classified under, or are those also considered short-term side effects?
Hewlett: These are effects, or adverse events, that occur usually within a few weeks of the vaccine. So we should not mistake these for the long-term side effects that people have described associated with COVID — the so-called long haulers. That is something that is entirely different. Most of the, I would say, I can’t give you an exact percentage, but I would say it’s well over 90% of the adverse reactions that are experienced after one receives the vaccine occur within the first roughly 24 to 48 hours of receiving that vaccine.
Other delayed types of responses over a period of several days to say 3 to 4 weeks, those are in the distinct minority. And so by the time you get out to the 2-month timeframe, you’re very unlikely to see adverse reactions to the vaccine.
Keep in mind, however, that the studies have been set up to look at individuals for safety signals for out to 2 years. One of the things that has been reported, and I would have to check this for accuracy anecdotally, is that some people who have had long-term symptoms resulting from COVID, some have actually reported improvement after they receive the vaccine.
And so I think that that’s something that should be looked at more closely. I haven’t read those reports personally, but it’s something that I’ve heard anecdotally and it does make a lot of sense.
Marshall: Why would that make sense?
Hewlett: Well, it would make sense because these individuals … their natural immune systems naturally may not have been able to mount an adequate response to totally clear the infection. And so, possibly, the vaccine may have given them that boost so that their immune systems were able to sort of totally squelch the infection, in their cases.
Marshall: Oh, that’d be good news for a lot of people.
I’m really glad you brought that up, Dr. Hewlett, because one of the things we’ve heard from folks is that they’re worried about long-term side effects from the vaccines. Now we know the vaccine itself doesn’t really stay in your body long. It’s your immune response that’s activated and stays in your body.
But if we can get a blood clot anywhere from, you know, 3 to 6 weeks after receiving the vaccine because of the immune response, are there going to be other things that can be activated by your immune system from this vaccine at that 2-year mark that we’re not going to learn about until we get there?
Hewlett: We really don’t believe so, although certainly anything can happen. One of the things that seems to be occurring is that this is occurring within a short period of time. So with the J&J events and with the AstraZeneca events, these occurred within the first 3 to 4 weeks following the vaccine. We are not aware of events like this that are occurring farther out.
And so this critical period of time, if you think back in terms of it takes roughly 2 weeks after you’ve received the second dose of the vaccine before you have achieved a level of full immunity or protection, and it is during this period of time that your body is developing the immune response, which is in many ways an inflammatory response, and so from a scientific standpoint, if things are going to occur like this, it’s most likely to be occurring during this time when your body is building up to its level of immunity or to the antibody levels and memory cell levels that are required for full immunity. And after that period of time, it would be unlikely.
Marshall: Are there any other vaccines that we could look at and say, “oh well, there are long-term effects from an antibody response at the 2-year mark,” or when you look across the vaccine spectrum, they all pretty much hit that 2-month mark and nothing?
Hewlett: That’s a good question. I think that in order to compare apples to apples, we would have to look at other viral vector vaccines, if we are looking for something to compare with the experience with Johnson & Johnson.
Marshall: But overall, when you look at vaccine profiles, after your immune response is built up, it protects you against the virus, but doesn’t have any other kind of random side effects?
Hewlett: As best we can tell, that’s true. Yes.
Marshall: Okay. So what is the bottom line here? When people look at these vaccines and they look at the short-term side effects and the long-term side effects, and in some of these cases, the new side effects, and they say that vaccine may not be for me because I don’t want to experience that versus the risk of getting COVID?
Hewlett: Well, I think the bottom line and the big picture for people is that we have to look at the benefits of any of the vaccines, any of the three. And I’m very comfortable with recommending any of the three vaccines to anyone in any age group. That’s my position medically.
COVID is still something that is very, very common. We know that we are rapidly approaching the 600,000 mark in terms of deaths in this country. We know that there have been literally millions of deaths worldwide. We know that there’s a 2% mortality rate for COVID, and we know that anywhere between 10% to as high as 40% of individuals may go on to develop the long-hauler types of situations, which is long-term symptoms and disability from COVID. So, with that in mind, we then look at the vaccines. And when we look specifically at the serious life-threatening types of adverse reactions from the J&J vaccine, for example, we’re talking about something that has occurred in roughly one out of every million doses.
And so clearly the benefits of all of the vaccines far outweigh the risks. When we think about the second doses and the side effects that people may experience from that, for possibly not feeling very well for a day or maybe a day and a half, that pales in comparison to what happens to individuals who were actually infected with COVID who go on to require hospitalization and possibly suffer — if not death — suffer from long-term side effects as a result of the infection.
Source: MedicalNewsToday.com
