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1B COVID Vaccine Expansion Includes Pregnant Women. Should They Take The Shot?

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(AP Photo/Charles Krupa)
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In this Thursday, May 7, 2020 file photo, a pregnant woman wearing a face mask and gloves holds her belly as she waits in line for groceries with hundreds during a food pantry sponsored by Healthy Waltham for those in need due to the COVID-19 virus.

The expansion of the 1B phase of COVID-19 vaccinations includes pregnant women. While the Tri-County area isn't yet expanding eligibility, other areas of the state may choose to begin that expansion starting Thursday.

Tim Shelley spoke with Dr. Michael Leonardi, a maternal and fetal medicine specialist at OSF Saint Francis Medical Center, about the risks and benefits for pregnant women--and their unborn children--if they roll  up their sleeves to take the shot.

Tim Shelley: The governor announced pregnant women will now be eligible to get the vaccine in phase 1B on Feb. 25.  In a sort of informal survey I've done, I know there's some pregnant women, in my own life, who are skeptical about getting it. What were the pros and cons of getting the vaccine if you are pregnant?

Dr. Michael Leonardi: Just a little background, right. So pregnancy has been put into tier 1B. And the reason for that is, we're trying to give vaccine based on people who are at highest risk. So that's why they started with nursing home patients and health care workers and that sort of thing. And there has been recent work, as we get more experienced with COVID, to understand that one of the comorbidities that makes an otherwise typical patient higher risk for having complications is pregnancy.

So yes, most women who are pregnant, if they were to get COVID, would do fine and not have any adverse consequences. But we know that if we compare pregnant women to identical non-pregnant counterparts, say, identical twins, one's pregnant, one's not, both get COVID. The pregnant patient is about three times more likely to be admitted to the hospital, three times more likely to be need to be in an intensive care unit, a couple of times more likely to be on a ventilator, and actually one and a half times more likely to die than the non-pregnant person. And we know that, you know, the pregnant women also are more likely to have other factors that can complicate management of viral infection, like obesity, hypertension, diabetes, those sorts of things.

So as far as any medication and pregnancy goes, it's always important to say, What are the risks of the medication? But what are the risks of the disease if we don't treat it? Right. So if you have a blood pressure medicine, for example, there may or may not be risk associated with it. But what's the consequences of untreated hypertension, which might be stroke or heart attack, which are also not desirable.

So the vaccine is a new type of vaccine based on messenger RNA. There are not human studies of safety in pregnancy for the vaccine. But what most of your listeners probably don't know is that no drug is tested for safety in human pregnancy. So, the antibiotic that somebody's given the blood pressure medicine they're given, etc, has not been tested in human pregnancy, because we can't figure out an ethical way to do that.

You know, as an example, there's a new drug out for seizures. And somebody who's thinking of getting pregnant, nobody's going to say, well, you don't have seizures, but would you mind taking this drug, so we can see if your baby comes out abnormal? Because clearly, that's not ethical. And that's the same problem.

So the way we figure out if drugs are safe in pregnancy or not, is animal experiments. They give them to pregnant rabbits or pregnant mice, that sort of thing. There are developmental and reproductive toxicity studies that get done prior to drugs going on the market. And you look at the structure of the drug, or is it similar to other medications that either have a favorable or unfavorable safety profile?

And then it's a wait and see, basically, so you know, people who have a disease who are on a medication who happened to get pregnant, or people who develop a condition during pregnancy who get started on a medication, and then it becomes sort of collective experience. Does the drug seem safe or not? And I totally agree that that's not optimal. But we can't think of a better way to do it in an ethical way, that we're not potentially harming fetuses who didn't sign up for research.

TS: So the lack of clinical studies was one of the things I was going to ask about. That's one thing I've actually heard. So the point you brought up about, the fact that no medication really is tested in clinical studies on pregnant women specifically, I think it's an interesting point. So, and I believe Dr. Fauci said, that they were now aware of 20,000 pregnant women who had gotten the vaccine and hadn't had any major complications. Correct?

ML: Yeah, so that number will change every day. But if you look at what frontline health care workers, so not the administrator who sits in an office, but the people at the bedside, they are overwhelmingly... nurses, respiratory therapists, housekeeping, dietary, all of those people who contribute to taking care of patients, they're overwhelmingly reproductive age women. So there's an awful lot of pregnant women who have been immunized because they work in health care. So they had a reason other than pregnancy to get immunized, because they're high risk because they're exposed to it so often. And there's not been any increased risk for our incidence of side effects, or from the vaccine.

You know, I think that one of the normal human nature kinds of concerns, and one of the reasons why moms are so amazing, is, you know, there's concern about birth defects, for example. Well, we know that development of the fetus when birth defects can happen as a short period of time really early in the first trimester. So patients who are getting immunized after 16 weeks, and pregnancies 40 weeks long, all the organs are formed, they just need to develop and become bigger and that sort of thing. So vaccines administered later aren't going to cause birth defects, as an example.

And I think the really important conversation that pregnant women should have with themselves, with their partners with their health care providers is, is the big picture of what's my risk of catching COVID. If you're an intensive care unit nurse who's at the bedside with people with COVID, on ventilators, that person's risk is exponentially higher than somebody who's working from home in their basement and hasn't seen another human being for six months.

And so those two people might make very different decisions about whether they want to take the vaccine or not, and be perfectly legitimate and well reasoned, because they have different risk profiles. And you know, it's a personal decision. But I think an important consideration is, you know, do I want to wait until 100,000 or or a million people have had the vaccine who were pregnant?

Optimally? Yes. But what happens to me if I get COVID, prior to that threshold being reached? And then I think we have to reinforce to people the way we keep babies healthy fetuses healthy, is by taking care of the mother who's carrying that fetus around. And so it's a it's complex, there's no right answer. And I think people are generally unsettled by either choice, because if this is the best choice for me, but maybe not the way I would pick, if I was talking in a theoretical sense.

TS: You mentioned, like 16 weeks, right around that mark, is when organs are fully developed. So let's say a mother is eight weeks. So should she consider getting the vaccine now, when it's available? Or should she say, I'm going to wait a few weeks on this?

So that's a great question. And not a simple answer, because there's a lot of moving pieces there.

So, what I would say to a patient who asked me that is I would say you have to look at, or I would encourage you to look at, what is your risk? So getting vaccinated does not eliminate the need for masking, social distancing, hand hygiene, and that sort of thing. And if the patient, again, if we go back to the example of the ICU nurse, or the person who has vulnerable family members, and they're worried about bringing the infection home to their family. So, the person needs to figure out what their individual risk profile is, and what their risk tolerance is, and, and the patient may say, you know what, I'm able to control my risk. Because I'm good about masking social distancing. My work environment is not that high risk. And I would personally feel more comfortable waiting till 14 or 16 weeks.

And having said that, I think that's very appropriate. I wouldn't disagree with it. But the additional factor that is clearly changing every day is if there's vaccine available today because of your risk category or because you work at a hospital or whatever, will there necessarily be vaccine of supply available to you when you get to the point in pregnancy that you're comfortable getting vaccinated with?

And I don't think we know that for sure. Because you know, where I work, for example, we're dependent on the supply of vaccine that we get from the Illinois Department of Public Health. And they're doing the best they can with the vaccine supplies that they're getting. And so I think it makes it a really difficult decision for families and pregnant women.

TS: One thing I've been wondering, and this might be an example of the jury's still out on it. But I know, there's been some studies that show that a pregnant woman who has had COVID-19, the baby will be born with the antibodies, also. Do we think is there going to be a similar effect if a pregnant woman gets a COVID-19 vaccine, that her child will also be born with some form of immunity?

One of the additional benefits of the vaccine, whether it's COVID, or, and we've had this discussion for years with patients about flu vaccines. So, anything that a mom has been exposed to in her life, either because she had the disease, or because she got vaccinated against it. So think chicken pox, measles, mumps, all those things, we vaccinate kids against all of the antibodies, which is what our body makes to fight off infection, all the antibodies that the mom has, are transferred across the placenta into the fetus late in pregnancy.

So one way of looking at it is the mom provides this cocoon of immunity that she sends her child out into the world with, and the baby has that, and it protects the baby for the first couple months of life, because the baby's immune system isn't competent to be out in the world yet.

And that's one of the reasons your listeners may have noticed that kids don't get their first vaccines in the childhood immunization world until they're 2 months old. So they're protected for the first couple months of life by something they got from their mother that we call passive immunity, because you get it from your mom. And then it sort of wears off over time, which is why you then need to get vaccinated.

So, women who get vaccinated for COVID during pregnancy and make antibodies, those antibodies go through the placenta into the baby, and help protect the baby for the first couple months of life. The other really important benefit whether vaccination is during pregnancy or postpartum is breastfeeding, because breastfeeding is critically important to kids for many different reasons.

But the way kids, young children get infections is through their GI tract and respiratory tract. And we know that breast milk is full of antibodies, the different kind of antibody that coats mucosal surfaces. And those antibodies protect the children's gut and respiratory tract, which is the way they get infections.

So, the mom who has been immunized during pregnancy, or soon after delivery, makes antibodies against COVID and lots of other things that she then transfers to the babies, you know, mouth nose, and got through breastfeeding. So, you know, not only do we want moms to get immunized when it's appropriate for their circumstances, but we really want to encourage breastfeeding. Because this is just one more great reason why it's so helpful to newborns.

TS: Just based off our conversation, it sounds like there's a there's a lot of factors for an expectant mother to consider here in deciding whether or not the COVID-19 vaccine's right for them; based off of the timing of where they are in their pregnancy, their own personal risk factors, the availability of the vaccine. Is there anything else you wanted to add or that you think people should know about this that we haven't already touched upon?

ML: Yeah, I think an important thing that I would say to my patients or my family is to make the best decision that you can with the information you have available at the time, and try to avoid the hysteria that sometimes people find on social media. Because it's not necessarily accurate. Or it may be true about the person who posted it, but not applicable to you.

And so I would encourage people to ask questions, look at reliable sources, like the CDC or IDPH websites, talk to their health care provider. And, you know, not forget the important public health measures, like masking, social distancing, and hand hygiene.

And as a community, we will get through this together. But source of information is critically important, and making the best decision for yourself. And I guess the last thing I would throw in is, is, you know, we're all thinking about our circumstances. But math is important, too. If most vaccines have a serious complication risk, the side effects or symptoms of one and 100,000 people, if you vaccinate 100 million people, you're going to have 1,000 people with really severe complications from the vaccine. And,  that can sound scary because they all end up on social media. But you have to weigh that against the fact that we have 500,000 dead people from COVID in this country, and 500,000 dead people versus 1,000 people with serious reactions, but 100 million people protected from moderate or severe infection.

And so I think, big picture, make the best decision for yourself. And be very cautious about what your source of truth is when you're making decisions.

This interview has been lightly edited for clarity.

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