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Vaccine and Allergic Reactions; Kids Safer in School? It’s TTHealthWatch!

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

0:40 Potential for allergic reactions after Moderna vaccine

1:39 Previous history of allergic reaction

2:41 Resuscitation with epinephrine

3:40 Over 23 million doses so far

4:01 Two IUDs for emergency contraception

5:01 Non-inferiority trial

6:01 As effective as copper IUD

6:30 COVID transmission in schools

7:31 Compared with community transmission

8:28 Could kids be safer in school?

9:16 Resumption of cardiac activity after life support withdrawal

10:17 Incidence and timing of resumption

11:15 Some cardiac activity in 14%

12:15 All electrical activity ceases

13:15 Neurological definition of death

14:04 End

Transcript:

Elizabeth Tracey: Using IUDs for emergency contraception.

Rick Lange, MD: COVID-19 transmission in schools.

Elizabeth: Spontaneous cardiac activity after withdrawing life support.

Rick: And allergic reactions after the first dose of the Moderna vaccine.

Elizabeth: That’s what we’re talking about this week on TT HealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, why don’t we turn right to MMWR — Morbidity and Mortality Weekly Report — taking a look at the potential for allergic reactions following vaccination? I think this is a top-of-mind issue for many.

Rick: It is, Elizabeth, and as our listeners know we have two vaccines that have been at least emergency use authorization granted by the FDA, the Moderna vaccine and the Pfizer vaccine, and they’re both two-dose vaccinations. We reported previously that associated with the Pfizer vaccine, for every million doses there are about 11 anaphylactic reactions. Those are the most severe reactions, where people can actually present with shock.

So this is the report after the administration of 4 million first doses of the Moderna vaccine and what they report is a little bit lower incidence, about 2.5 anaphylactic reactions for every million doses of Moderna vaccine administered.

A couple of interesting things about this. This was 10 anaphylactic reactions in over 4 million doses. All of them occurred in women, by the way. Nine out of 10 of these individuals had a previous history of some type of allergic reaction, mostly to medications, occasionally to contrast material, and one person had a food allergy. Almost all of the allergic reactions happened in the first 15 minutes, so it seemed like the recommendations after someone has received their first vaccination dose is to monitor them for 15 minutes. By the way, if they have a history of previous severe allergic reactions or anaphylaxis to something else, it’s observed over 30 minutes instead.

Elizabeth: No deaths, though, related to any of this, right?

Rick: That’s true, neither with the Pfizer vaccine or with this one. These individuals received epinephrine. Approximately half of these individuals were hospitalized. The other half were just treated where they received their vaccination. Now, there are also some non-anaphylactic reactions that occur to about 2 or 3 out of a million, and these are things like itchy skin or flushing, a little scratchy throat, even a little difficulty breathing, not true anaphylaxis.

I guess what I want our listeners to know is these are incredibly rare events, at least after the first dose. By the way, if someone’s had an anaphylactic reaction at the first dose, they shouldn’t receive the second.

Elizabeth: Oh, I was going to ask that. Of course, let us be honest, being resuscitated with epinephrine is not a fun event, so probably most people don’t really want to have that experience. There are, of course, a host of other reactions — these are what are so-called reactogenic vaccines — that people can expect to have.

Rick: These are systemic side effects that occur within the first 24 to 48 hours. They’re not allergic reactions. They’re your immune response, so people will experience fatigue and headaches, chills, fever, some muscle aches or joint aches, and again, 75% to 80% of individuals will experience those after the first or second dose.

It can be treated with an anti-inflammatory medication like naproxen or ibuprofen or Tylenol and they go away in the first 24 to 48 hours. It’s your immune response responding to the vaccine, so it’s actually a good sign.

Elizabeth: The latest data that I’ve seen on this suggests that right now the so-called vaccine hesitancy rate has really plummeted, with more than two-thirds of Americans saying, “Yes, indeed. Bring it on.”

Rick: We’ve administered over 23 million doses across the United States already and I think people are realizing it is safe.

Elizabeth: Yeah. The other advantage, of course, to the mRNAs is their ability to adapt in case one of these variants turns out to be a problem.

Rick: We can flip on a dime and make booster shots that address the new viruses that we see.

Elizabeth: Okay. Let’s turn to the New England Journal of Medicine, something not related to COVID. This was taking a look at two different types of IUDs — intrauterine devices — for emergency contraception one of them utilizing copper and the other one a hormonal method with levonorgestrel. We’ve talked about Plan B — so emergency contraception — before, but I had no idea that IUD placement could be used in this capacity.

This was performed at six clinics in Utah. It included women who sought emergency contraception after at least one episode, but frequently more than one episode of unprotected intercourse within 5 days before presentation. They had to try to recruit people to the study for quite a while and they ended up, finally, with 317 who got the hormonal-method IUD and 321 who got the copper IUD, and they looked at 1-month outcome data.

Basically, they found out what this was, was a non-inferiority study, so the levonorgestrel IUD was non-inferior to the copper IUD for this emergency contraception indication. There was, in the hormonal group, one pregnancy in the follow-up and in the copper IUD group, no pregnancies.

What the authors point out in this study, and I think it’s really important and definitely something that I became sensitized to as a result of reading this, is the idea that when women seek emergency contraception, if they use hormonal methods, they do have a higher failure rate than the placement of an IUD.

The other huge advantage to the placement of an IUD is that it’s ongoing contraception, so they can choose a family planning method right there at the same time and not be lost to follow-up later, so I thought this was pretty powerful.

Rick: And as you pointed out, Elizabeth, we have two oral medications approved by the FDA for emergency contraception, and the copper IUD, although it’s not approved, observational data has suggested it’s very effective, that its failure rate’s 0.1%.

Now, most women don’t prefer to use the copper IUD, so the next question is, what about using the hormonal IUD? Is it as effective? That’s why this study was really effective in showing that it’s just as good as the copper IUD, and as you mentioned, there’s ongoing contraception.

Elizabeth: Right. Then the other thing is that the levonorgestrel IUD helps to reduce menstrual bleeding and discomfort for women who have really heavy menstrual bleeding or cramps at the time of their periods.

Rick: Which is why they prefer it to the copper IUD.

Elizabeth: We got educated, didn’t we?

Rick: I’m glad you picked this article.

Elizabeth: Back to MMWR, to your second one.

Rick: Let’s talk a little bit about COVID-19 transmission in schools. This was a study done in 17 different schools in Wisconsin. The concern is, can you send kids back to school and is it safe for them and for their teachers and for their families? There are 18 schools in this particular county and 17 agreed to participate, and what they did is between the end of August to the end of November, they examined COVID spread at the schools.

Now, here’s what the schools did. They were actually enforcing the precautions that we know that reduce the risk. They had everybody wear a mask indoors. If they were outdoors, they had them wear a mask if they were going to within 6 feet of one another.

They tried to keep the classroom size manageable, 11 to 20 kids. They tried to keep cohorts together so there wasn’t a lot of intermingling, and if somebody developed COVID — and that is, one of the kids did — they took the kid out and quarantined them, and their brothers and sisters as well.

At the end of the day, they said how effective were these particular measures? They looked at almost 5,000 students and over 650 staff members. This is K through 12, and by the way, they compared the incidence of COVID infection there to the community.

There were 191 individual students and staff that ended up getting COVID infection. By the way, that was 37% less than the community spread rate. Of this 191, how many were spread among individuals in the school? Less than 4%. Most of the infections occurred outside in the community.

This suggests that if you have the proper measures, you can have the kids go back to school, and by the way, the cases of transmission were children-to-children, no children-to-teacher transmission, so if you do the proper things you can bring kids back to school and educate them and do it where it’s safe for the children and for the teachers as well.

Elizabeth: Of course, this falls right into line with a previous study that we looked at that looked at in families, who is it who gives COVID to whom? It was the adults giving it to the kids rather than the other way around.

Rick: You could argue that this is actually a safer practice because you’re taking kids out of the community, you’re bringing them into school where actually face masking is enforced, and all the other proper measures, and even among the elementary school kids, face mask-wearing was extremely high, overall about 92% compliance with face mask-wearing. Perhaps sending kids to school is safer for the kids rather than having them running around the community not following the protocols.

Elizabeth: I guess now that we’re vaccinating teachers, this possibility becomes more practical.

Rick: Unfortunately, the amount of vaccine, the only teachers getting vaccinated, at least in our community in the state of Texas, are those over 65 or under 65 with a lot of comorbidities. There are some teachers like that, but many of them are just out of school and they’re in their 20s and 30s. They won’t get a vaccine till later in the summer. This study would suggest is that if we do what we’re supposed to be doing, the kids could safely go to school and the teachers will be protected.

Elizabeth: Probably help everybody out. Let’s turn back to the New England Journal of Medicine, again an unusual study, taking a look at spontaneous resumption of cardiac activity after somebody is terminally extubated or they have withdrawal of life support.

The reason this is important, and I hear lots and lots and lots of discussion about this in the chaplain role, is that if we have somebody who’s going to be a candidate for organ donation, we need to make sure that before we go take them to the OR, that they have been declared dead, and there’s just a huge amount of discussion about this.

You’re aware of both this idea of circulatory death as well as neurological death, so I thought this was a really interesting study. It took place in Canada — probably one of the only places where it could have taken place, for the most part — in 20 adult intensive care units, also 3 sites in the Czech Republic and 1 site in the Netherlands.

This was called the Death Prediction and Physiology after Removal of Therapy study. It sought to describe the incidence and timing of resumption of cardiac electrical and pulsatile activity in critically ill adults who died after withdrawal of life-sustaining measures.

They had clinicians at the bedside who, if they observed it, reported resumption of circulation or cardiac activity. They also had EKGs, arterial pressure catheter monitors, and they palpated their arterial pulse. Also, they took a look, of course, at breaths and physical movements after withdrawal.

There were 631 patients who were ultimately included. Of that number, 205 or 32% were eligible for organ donation after circulatory determination of death, of whom only 33% became donors and had at least one organ retrieved. Those are a little bit daunting statistics for me because it just suggests that there’s an awful lot of potential organ donation that’s not happening.

They found that there was spontaneous resumption of some kind of cardiac activity in 67 of their 480 patients, or 14%. That always took place within 4 minutes and 20 seconds, but most of it took place significantly earlier, and in none of these patients did spontaneous continuous cardiac activity resume.

Rick: Most protocols for organ donation, after we’ve determined that the person has passed away, recommend that we have 5 minutes of observation of where they’re not breathing and they haven’t had a pulse, and this is the period that you’re talking about.

Unfortunately, over the years as a cardiologist, I’ve witnessed death in organ donation as well and there’ll be periods for a minute or a minute and a half where you won’t see any activity, then you see just an EKG spike, no pulse associated with it, and some people call this autoresuscitation. But as you pointed out, it’s not autoresuscitation at all.

None of these individuals actually survived afterwards, but it does lead credence to the fact that if we wait for 5 minutes, then at that point all electrical activity and even a minimal amount of pulse — here the pulse was just 5 millimeters of mercury, not very much — but that will cease and confirm that the person is in fact, qualified to be an organ donor.

I think it’s important for those of us who are at the bedside of loved ones and they appear to have passed away and you see an occasional EKG spike, the person’s not coming back to life. This is a very common occurrence and it occurred in 14% of the individuals in this particular study.

Elizabeth: Right, and that’s my hope because I think sometimes family members who agree to organ donation have this concern that somehow this person could possibly have survived and that they were sent off for organ retrieval and should not have been. And I think this is informative in that regard.

Rick: I wholeheartedly agree. In our almost 20 years of reporting, we’ve not seen a study like this, so I’m glad you brought it to our listeners’ attention.

Elizabeth: It’s going to be interesting to see the neurological definition of death, which as you know, there’s international energy behind trying to create a more uniform definition of when we can actually say that that has taken place, and I haven’t seen anything compelling about that yet, so maybe that will be the next one.

Rick: The other thing that’s important to our listeners, and I’m glad you pointed out, is we are certain when we ask people to donate organs that life has ceased for those particular organ donors, and this confirms that.

But the importance of organ donation for those that are alive and need kidneys, or sometimes they need corneal transplants, or hearts or lungs, you can make a significant impact on somebody that needs those organs. If people that are listening aren’t organ donors, in the future please sign up to be so.

Elizabeth: On that note, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.

Source: MedicalNewsToday.com