As US vaccine distribution expands to include younger healthier populations, questions about vaccine safety in women of childbearing age have become more urgent. University of Texas Southwestern Medical Center's Catherine Y. Spong, MD, and Emory University School of Medicine's Denise J. Jamieson, MD, MPH, both eminent obstetrician/gynecologists, join JAMA's Q&A series to discuss the safety of the Pfizer-BioNTech and Moderna vaccines in pregnant and nursing mothers, and in individuals trying to get pregnant. Recorded February 8, 2021.
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>> Howard Bauchner: Hello and welcome to conversations with Dr. Bauchner. Once again, it is Howard Bauchner, Editor in Chief of JAMA. And I'm delighted to be joined by two preeminent physicians, both who work in obstetrics and gynecology, Denise Jamieson, formerly of the CDC. She was named the James Robert McCord, Professor of Gynecology and Obstetrics at Emory and Vice-Chair for Population Health in 2017. She is currently professor and chair of the Department of Gynecology and Obstetrics. Welcome Denise. And my other guest is Cathy Spong, and Cathy was at NICHD, and she's now the Gillette Professor of Obstetrics and Gynecology at UT Southwestern. Welcome Cathy.
>> Cathy Spong: Thank you.
>> Howard Bauchner: So we're going to talk about a pair of viewpoints that are being published simultaneously with this presentation. And Denise, why don't we start with you talking a little bit about your co-author Sonya. The title of your JAMA insights is Caring for Pregnant and Postpartum Individuals during the COVID-19 pandemic. So, Denise, can you tell us a little bit about your co-author.
>> Denise Jamieson: Sure. Sonya Rasmussen is a dear friend and colleague. We've known each other and worked together for almost 20 years now. She is a professor of Pediatrics. She also has an appointment in OB/GYN and in Epidemiology at the University of Florida in Tampa -- I'm sorry in Gainesville. And she and I at the CDC really worked together to try -- starting with pandemic influenza -- to try and plan for what to do about pregnant women when there are novel pathogens, emerging pathogens, to try and figure out how pregnancy issues should be handled. And so we worked together on pandemic influenza and then Ebola, then Zika, and then we both left the federal government. We were at the CDC together for many years, and continued to collaborate on COVID-19.
>> Howard Bauchner: Thanks Denise. And your experience about flu and flu during pregnancy as a vaccination. We'll talk about that in a bit. And then, Cathy, you're co-author's Emily, COVID-19 Vaccination in Pregnant and Lactating Women. Can you say something about your co-author?
>> Cathy Spong: Yea. So Dr. Emily Adhikari is an Assistant Professor here at UT Southwestern, and she's also the Medical Director for Perinatal Infectious Disease at Parkland Health and Hospital System. And she is the go-to person for COVID-19 here at UT Southwestern and sat Parkland, and has been on-call 24/7 since the pandemic began, really caring for the sickest of our sick, and really navigating the incredible onslaught of COVID that we've seen on our very busy Labor and Delivery Service.
>> Howard Bauchner: Before we get to vaccination, let's talk about a few other issues that actually are really important to inform the potential of vaccination of pregnant persons. So either of you, and we'll alternate back and forth, what's do we know about the risks of COVID-19 for pregnant persons, the fetus and the newborn? So, Denise, why don't you go first?
>> Denise Jamieson: So I like to think about pathogens in term for the mother, for the maternal risks, in terms of susceptibility and severity. And in terms of susceptibility, how transmissible to pregnant women is COVID. We really don't have any information. We know that the same risk factors that put people at risk for acquiring COVID are the same whether you're pregnant or nor pregnant, but we really don't know whether pregnant women are more likely to get COVID. What we do know is that once pregnant women get COVID, they're more likely to have severe disease. They're more likely to be hospitalized, to require intensive care, to require ECMO, to be ventilated, and to die, unfortunately.
>> Howard Bauchner: The fetus?
>> Denise Jamieson: In terms of risks to the fetus, we know that there seems to be an increased risk of preterm birth among women who are infected with COVID. There may be an increased risk of stillbirth. I think the jury's still out whether or not there's increased risk of stillbirth. So basically, we know that particularly among severely ill pregnant women, their babies don't do as well. And that's the same as in most pathogens.
>> Howard Bauchner: Cathy, do you read the literature and reach the same conclusions. And not to create a debate, but sometimes it's confusing literature. JAMA's actually published extensively because of Jody Zylke. We've published an extensive number of research letters and other types of articles. Is your reading of the literature the same as Denise's.
>> Cathy Spong: Yea, so I do read the literature [laughter], and in fact, we have Dr. Adhikari's first author on a JAMA network open paper, specifically related to our experiences with COVID in pregnancy. And we have a slightly different population that is published in other reports because ours is more of a population based publication rather than just those who are hospitalized. So what we found was that -- because we were doing universal testing -- and women who had COVID-19 in pregnancy had about the same rate of hospitalization if they were pregnant or not pregnant. So it was about 5% to 6% required hospitalization. Now I will say that those who have severe or critical illness, we also found a much higher rate of pre-term birth. In fact, I think the literature is about 10% to 40%, we found about 60% delivered pre-term. I will say that it is hard to know for certain that impact on the fetus. There certainly have been case reports of vertical transmission. The vertical transmission that we have seen have been predominantly from asymptomatic women. And I think, you know, the literature is a little bit difficult to discern whether or not pregnancy itself increases your risk, but clearly women with critical illness have much higher risks when they're pregnant.
>> Howard Bauchner: Now Denise, around Zika it was very clear we were seeing adverse effects on the fetus and the newborn. Is the data less clear around COVID-19?
>> Denise Jamieson: So with Zika there is clearly a congenital syndrome. First of all, Zika was more easily passed transplacentally. as Cathy was saying. There are cases where COVID is being -- SARS COVID-2 is being transplacentally infecting fetuses, but it's much less common than with other pathogens such as Zika. And interestingly enough, people don't realize, but even influenza can be passed transplacentally. Almost all viral infections under the right circumstances can be passed transplacentally. But with COVID, it doesn't happen very often. And so with Zika you got a congenital syndrome similar to other congenital infections. It was a very specific pattern of abnormalities that was noticed fairly early on in the outbreaks in the South Americas. By contrast, we are not seeing concerning patterns of either frequent congenital infections or congenital syndrome. So I don't think that that is likely to be -- with all the women that are now infected, all the pregnant persons that are now infected -- I think it's very unlikely that we're going to see a specific congenital pattern.
>> Howard Bauchner: Now Cathy, your department oversees quite a few births. You mentioned 40,000 before we started. I knew it was large, I didn't know it was quite that large, but questions keep coming up around the peripartum processes and protections that need to be put in place. So for a woman who comes in to deliver, you screen them, and they're generally healthy, and they're COVID-19 positive, what are you doing at your institution?
>> Cathy Spong: So when a woman comes in, every woman who's admitted to Labor and Delivery is screen for with questions and then all are tested. Those who are symptomatic are initially put into an isolation room and all of the protective gear is used for each interaction. Some will come back as asymptomatic COVID positive, and again, you will take those extra precautions. As long as they are asymptomatic, they are allowed to room in with the baby and do all the normal things.
>> Howard Bauchner: Breastfeeding?
>> Cathy Spong: Absolutely.
>> Howard Bauchner: Okay. Thank you.
>> Cathy Spong: Absolutely. Yea.
>> Howard Bauchner: And for those that are symptomatic, what happens if the mother is symptomatic at the time of delivery and presumably the baby's well?
>> Cathy Spong: So that's evolved over time because, you know, we had to learn, you know, how risky the transmission was. And I think that that's also kind of come out with some of the publications, looking at the risk of transmission with breastfeeding. And that, in fact, is very low as long as the mom is very cautious and careful and does good hygiene and wears a mask to try to reduce that risk of transmission. So it is definitely evolved over time.
>> Howard Bauchner: So, Denise, the same question to you. The symptomatic/asymptomatic woman who's been admitted to Emory and is delivering, how do you deal with both the asymptomatic person as well as the symptomatic person?
>> Denise Jamieson: Almost identical to that Cathy described. So we test everyone now. If they're positive, we make sure that all the healthcare providers in the room have the N95 masks, that the patient is masked, take all the usual precautions. And then, like Cathy, our thinking has also evolved over time. And based on basically a fairly large case series from New York City where infected moms safely breastfed their infants using careful hand and breast hygiene, masking with every contact, we now know that the babies can remain safe even with breastfeeding and moving in. The only other thing they did in New York City that I thought was interesting in the case series that was reported is the infant stayed in a closed isolette rather than an open isolette. That is now something that we have done, but I thought that detail was interesting.
>> Howard Bauchner: One question already came in, and then we'll move quickly to vaccines because I know that with 3.7, 3.8 million births a year and WHO's announcement and then change, it's on everyone's mind. Do either of you at UT Southwestern or Emory, are you testing for vertical transmission or not normally?
>> Cathy Spong: So it's not routinely done. If an infant is experiencing any symptoms, then we will test, but it is not routinely done.
>> Howard Bauchner: And when you do that, Cathy, how do you test or what do you test for?
>> Cathy Spong: I'm not exactly certain for.
>> Howard Bauchner: Okay, Denise?
>> Cathy Spong: Because I would assume it's the same.
>> Denise Jamieson: Yea, so if there's a suspicion then the babies are tested. So they generally do a full workup with oropharyngeal swab, cord blood. The pediatricians do a full workup of the baby.
>> Howard Bauchner: Okay. So now let's go to the question that everyone keeps asking me, and have asked, and since I can't answer it, I've asked the two of you to come on the program. I appreciate that there's no definitive answer, so I'm willing to begin the conversation that way. Cathy, how do you think about advising pregnant persons about being vaccinated? And which vaccine, the timing of the vaccine, would you avoid the first trimester, would you tend to get in the second trimester for people who anticipate trying to get pregnant next year, would you really try to get those individuals vaccinated? How do you even think about this?
>> Cathy Spong: Right. So I think the difficulty and the reason you're asking the question is, of course, neither pregnant nor lactating women were included in the studies of the vaccines. Right? And so without that data then how do you decide what to do given what we know that pregnant women, certainly with severe disease, have very, very high risks, both for herself and for the baby. And so how can we mitigate that? You know, even though they were not included in the studies, both the FDA and the CDC's Advisory Committee on Immunization Practices left open the door to allow pregnant women and lactating women access to the vaccine. And the American College of OB/GYN and the Society for Maternal-Fetal Medicine have been advocating that pregnant women should have access to the vaccine. And I think, you know, it's really important that you consider what is the risk to the woman of COVID-19. So in an area where there is active transmission and she is in a high risk group, she should certainly have access to that vaccine. And we are offering all of our women in our Maternal-Fetal Medicine Clinic the COVID-19 vaccine and making certain that it is available to them because of those risks.
>> Howard Bauchner: Denise, I mean you are at the CDC, you're one of the world's experts on influenza and vaccination during pregnancy, how have you thought about this?
>> Denise Jamieson: So I review all the same information that Cathy does, but I also emphasize that there are risks of not getting vaccinated, real and meaningful risks of not getting vaccinated. And so if you're a healthcare worker and you would otherwise receive the vaccine if you were not pregnant, then I am fairly supportive and a little bit more directive about the fact that I think the vaccine is a good idea. You know, the flu vaccine was so different because the Surgeon General first recommended flu vaccine for pregnant women in 1960. So we've had many decades of experience, and we had a little kerfuffle with trying to figure out whether we should be offering in the first trimester, but as it turns out, regardless of trimester, women should receive the flu vaccine. So I think about all the years of maternal vaccination and immunizing pregnant women, and I think that it's likely that in the end, the benefits will greatly outweigh the risks and theoretical risks, none of which we've seen yet.
>> Cathy Spong: I absolutely agree with Denise. I too am incredibly supportive and encouraging, and I think the difficulty is this nuance that we have to walk through.
>> Howard Bauchner: So if a friend or a relative calls you, and I suspect this may have happened over the last six or seven months, if a friend or a relative calls you and goes, my friend or relative is pregnant. I have a pregnant person in my family, and that person is asking me and I'm asking you if they should be vaccinated, would you tell them yes, wait until the end of the first trimester, or would you say, if they can get vaccinated, they should get vaccinated. Cathy, I'll go with you first, and then I'll let Denise think about what she's going to say while you answer first.
>> Cathy Spong: Absolutely. So I will talk with them first about vaccinations in pregnancy. And as Denise mentioned, we do this commonly. We recommend them. We have shown that it improves both maternal and fetal outcome. Influenza pertussis, what not, we've got data to show that vaccination is commonly done. I will talk with them about this type of vaccine, the MRNA vaccine, that you cannot get COVID from the vaccine itself, that it is immunogenic, it is not infectious, it is not an integrating vaccine, right? So we have knowledge about this type of vaccine. And then I'll talk with them about the risk of COVID-19, and that, you know, clearly we see across the country it is a significant cause of morbidity and mortality. And if you get severe COVID-19 in pregnancy, your risk is very, very high. So, yes, I will go through those things and say vaccination has the potential of preventing COVID-19, which would be beneficial for you and for your pregnancy, and I would not differentiate by trimester.
>> Howard Bauchner: And Denise, you get the same telephone call?
>> Denise Jamieson: I counsel in much the same way except I have to say I take into account practical considerations as well. So if you're a healthcare provider and today your health system is offering you the vaccine, think really carefully about declining the opportunity to get vaccinated because that same opportunity may not be available next week or next month. And so, I really think that delaying, given that we have not even theoretical concerns about the vaccine, may carry a heavy cost. Not to mention as long as rates of transmission are high, if you're a healthcare worker in a healthcare setting, you're at risk every day. So I would advise to get vaccinated soon and not delay regardless of the trimester.
>> Cathy Spong: Absolutely. If I can add into that, I think it was a recent conversation that you had with Dr. Fauci where he talked about that since that emergency use authorization went to play for the two vaccines, that over 10,000 pregnant women in the United States have been vaccinated. And to date, there have not been red flags. So, you know, that is also reassuring I think in that conversation.
>> Howard Bauchner: Denise, are vaccines, for people who are not in the high risk category at age or other comorbid conditions and essential healthcare worker, are vaccines available in Georgia for pregnant persons?
>> Denise Jamieson: Not unless they're healthcare providers. In some prioritization schemes, they're in the high risk medical conditions category, pregnancy is included, but not available yet widely in Georgia unless you're a healthcare worker.
>> Howard Bauchner: Cathy, and in Texas?
>> Cathy Spong: So at UT Southwestern and at Parkland, if you are pregnant and you're at high risk, and so our Maternal-Fetal Medicine Clinic kind of encompasses that, we are offering and they are getting vaccinated.
>> Howard Bauchner: So again, it's so interesting to see the variability across the country, fifty states, District of Columbia, Puerto Rico. I've always wondered if we would have been better off with kind of a singular approach, but I fully recognize that we still live in a country with states' rights. Just to followup on vaccination, a number of questions have come in. Right now it's only Moderna and Pfizer, both MRNA vaccines. I think we can anticipate that the J&J, an adenovirus vector vaccine, will be approved sometime in February. Is there any reason to think about differentiating between the vaccines? Cathy, you can go first on this one.
>> Cathy Spong: So I think between Moderna and Pfizer, I do not differentiate between them, and I appreciate that the WHO really kind of called that question, right, when they put out their report on the 26rh saying that pregnant women should not be vaccinated with the Moderna vaccine. But there was no additional data to support that, and on the 29th, they reverse that saying that pregnant women who are at increased risk for COVID-19, as an example, as Denise said, you know, healthcare workers, should be offered the vaccine. So I do not differentiate between the two. I'm going to have to wait to see when J&J comes out to determine that.
>> Howard Bauchner: Denise, any sense of the different vaccines or similar to Cathy?
>> Denise Jamieson: The adenoviral vaccines are interesting in that that same platform has been used for Ebola vaccines. And I don't know if you remember, but we went through the same thing with Ebola where pregnant women, even in high risks spots in West Africa, were excluded from vaccination efforts. Many pregnant women ended up getting inadvertently vaccinated, and then they were added into trials. And so we do have more data on the adeno-platforms in general than we've had on the, you know, novel MRNA vaccines.
>> Howard Bauchner: Can I assume -- since you didn't add, but can I assume they were safe with the Ebola vaccine?
>> Denise Jamieson: Yes.
>> Howard Bauchner: Okay.
>> Denise Jamieson: Yes, they were safe. So again, in the absence of any theoretical or real risks, I'm not sure how we're going to decide whether or not to differentiate on the basis of safety for pregnant women.
>> Howard Bauchner: Now both of you are members of numerous professional societies, particularly professional societies who are being queried about vaccination during pregnancy. So, Cathy again, I'll start with you. What are your professional societies saying about vaccination during pregnancy?
>> Cathy Spong: So, both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine are advocating for making COVID-19 vaccines available to pregnant and lactating women. The exact verbiage differs slightly, and I think Denise really outlined that nicely in her viewpoint where she kind of put side by side the different recommendations. And some are more positive, and some are more negative type statements. You know, should not be withheld versus should be offered. Did I say that fairly, Denise?
>> Denise Jamieson: Yea, and I think that's a great summary.
>> Howard Bauchner: A question to both of you because it came up. You know that Phil Fontanarosa and I added the two pieces, and Ed Livingston helped on the insight piece. Everyone always wants a child to be born healthy, and legal liability always comes up. It's such a difficult issue for obstetricians. I'm a pediatrician, you know, and I've delivered a number of infants, but it's so difficult for obstetricians and families who really want a healthy child. And so we have these vaccines, MRNAs had really limited use before this. It was interesting, Denise, I hadn't realized that Ebola also had a adenovector vaccine. How do you think about the notion of legal liability when you're trying to talk with families, or you're going to give the vaccine, and you're nervous about it. Denise, how do you think about that?
>> Denise Jamieson: I mean I think it comes down to the same risk/benefit analysis. When COVID is circulating widely, there are real risks to not getting vaccinated. We know the risks of being infected with COVID, and to me -- and if the mother doesn't well, the baby's not going to do well. And so to me I think it's just a risk/benefit analysis.
>> Howard Bauchner: Sorry, Cathy?
>> Cathy Spong: I absolutely agree. With respect to these vaccines, it's a risk/benefit of what your risk of COVID and getting the vaccine is going to markedly reduce that risk. I think the idea and the concern about liability is why the pregnant, lactating women were not included in the studies or in the trials. I mean, that's the major reason, right?
>> Howard Bauchner: Has it been your experience, and it's always hard to generalize, that for pregnant persons they tend to want the vaccine because of the concern that they could get infected and the implications where they don't want the vaccine because they're nervous about introducing something that could threaten the health of the fetus? Or is it hard to generalize? Denise, I'll start with you on this one. Is it hard to generalize? I'm trying to figure out how it would shift in pregnancy for people.
>> Denise Jamieson: One thing I'll say is that pregnant individuals often feel very passionately one way or the other. And there's very little middle ground. So you have particularly pregnant healthcare workers who are at the front of the line clamoring to get vaccinated, and then you have another group that's very concerned and really is very hesitant to do anything that they perceive might adversely affect their baby. And, you know, I think one of the other things that's really important is just because we think the benefits outweigh the risks, that doesn't let us off the hook in terms of describing the risks. And I think that's one thing that I'm concerned about is that, you know, 15,000 women have been vaccinated, pregnant persons have been vaccinated, and yet we really have stunningly little safety information. And that's not okay.
>> Howard Bauchner: Cathy, what's been the experience at your institution about families wanting to be vaccinated or passionately concerned about the risks.
>> Cathy Spong: It's a great question, and I think Denise summarized it very well. I will say that it's not only with the COVID vaccine, we get the same question with the flu vaccine and with TDAP. You know, education is really critical and talking about what are those risks and why you might want to get this vaccine. I think we're capturing some of this information actually in our patients trying to understand are they willing to accept the COVID vaccine or not, and trying to get at some of that nuance and looking at, you know, did they get the flu vaccine. Or is this that person who just is not interested in vaccines? Do they understand what type of vaccine it is, that, in fact, there is no virus that is entering your body, you cannot get COVID from this vaccine. So those are all things that are part of the education process. I think the other piece that's really important about it is the discussion with her about the side effects, because those side effects when they occur in pregnancy could be very concerning, right? And so trying to reassure that these are side effects and these are reasons why we want you to return if these things happen. So I think it's really important that education piece when you're talking about the COVID vaccine, and any vaccine.
>> Howard Bauchner: Not surprisingly, there are many questions. So I'll read them, and you can alternate answering or you could echo someone else's response. If a pregnant woman recovers from COVID-19 from a mild case in the first trimester, what would you recommend for followup? And I'm assuming the corollary of that question would be, say they are infected in the first trimester, it's now the second trimester, would you recommend that they get vaccinated? So, initially followup for someone who's infected during pregnancy, what would you recommend?
>> Denise Jamieson: So the -- go ahead Cathy.
>> Cathy Spong: No, it's okay.
>> Denise Jamieson: So the good news is that it seems that the biggest risk is infection and illness closest to the time of delivery. So the good news is that if you're infected in the first trimester, we would anticipate that you do fine. I would still recommend that you get vaccinated even with prior infection for a variety of reasons.
>> Cathy Spong: Absolutely, your followup care is going to be similar to if you had not had COVID during pregnancy, but I think both Denise and I would recommend that they get vaccinated.
>> Howard Bauchner: Can you speak, or either of you, can either of you speak to anticipated safety of having vaccinated relatives who visit or help with the newborns?
>> Denise Jamieson: And that's an interesting question about this whole concept of cocooning, that you want to make sure that who's ever around your infant when the infant is too young to be vaccinated, that they're protected. And if you're going to have people in the house, you know, helping with the newborn, it's a great idea to have them fully vaccinated. And several weeks after in the case of MRNA vaccine several weeks after their second vaccination.
>> Cathy Spong: I would still encourage them to adhere to all of the practices that you want. Just because you've been vaccinated doesn't mean that you should no longer wear a mask or do good hand hygiene. You continue those practices because we all know that the vaccine is not 100%, right? And so it's really, really important even if vaccinated that you continue to adhere to all of the precautions.
>> Denise Jamieson: Unfortunately, we don't know about the role of variants either.
>> Howard Bauchner: Yes, I mean I had a chance of talking with Tony last week and I think we're both guardedly optimistic in the next couple of months. The numbers have really come down dramatically in the U.S. We had 130,000 admitted to the hospital, you know, as much as a month ago, and now it's down to about 80,000 or 85,000. And obviously, the deaths have come down. The deaths related to the number of people hospitalized, and more and more people are getting immunized, 1.3, 1.5 million a day. But the real issue is what do the variants ultimately mean? I'm not quite sure they'll play out that quickly in the U.S. in the next six or eight weeks, but beyond six or eight weeks, they may really impact how we think about which vaccination and the timing of vaccination. Any risks to a breastfed baby if the mother gets vaccinated?
>> Cathy Spong: So the data has not shown that there is a risk to a breastfed baby from mom being vaccinated. In fact, the American Academy of Breastfeeding Medicine fully supports breastfeeding, and it is anticipated that the vaccine would not transmit into breast milk, and even if it did, it would be digested by the baby and not enter the baby's --
>> Howard Bauchner: For the individuals who are admitted to the hospital at the time of delivery and are COVID-19 positive, are those pregnant persons being allowed to breastfeed?
>> Cathy Spong: Yes, absolutely.
>> Denise Jamieson: The other thing to mention about postpartum vaccination among breastfeeding women is we give a live viral vaccine, measles, mumps, and rubella, to pregnant women who are breastfeeding routinely. So the whole fact that pregnant and lactating women get lumped in together really doesn't make any sense.
>> Howard Bauchner: Okay. Denise, both of you have been at this a long time. I mean, Cathy, you were at NICHD and Denise, you were at the CDC, two preeminent institutions. Is it disappointing that somehow pregnant women were once again excluded from this trials?
>> Denise Jamieson: Absolutely.
>> Cathy Spong: Absolutely. I mean I think if you look over the last several decades, there have been huge groups that have worked towards including pregnant and lactating women in research, in clinic studies. In fact, Congress, of course, proposed and passed the Cares Act, which included PRGLAC, the task force including pregnant and lactating women in clinical research. And that task force met for years and came up with recommendations on how to include these two groups in clinical studies and trials. Then went through another cycle to identify how to implement those recommendations. And yet, still, again, they were not included in something where clearly they are at high risk.
>> Howard Bauchner: Denise, your comments about this I'm sure echo Cathy's, but I'm curious.
>> Denise Jamieson: I agree. I think the other piece of this is really CDC's piece as well. I think now that we have thousands of women, tens of thousands of women, vaccinated, we really need to beef up our surveillance of pregnant women who've been vaccinated, and really learn as much as we can from the many women who are coming forward and getting vaccinated. And I don't think we're collecting that information nearly as quickly as we should be.
>> Howard Bauchner: Do you know if there's any trials that are ongoing for women who are pregnant to be enrolled in a clinical trial? So we do know that trials for adolescents have begun, and then ultimately, they're going to drop that down to pre-pubertal children. Do you know if there's any ongoing trials with pregnant women?
>> Denise Jamieson: It's going to be harder and harder to enroll pregnant persons in placebo-controlled trials now that the vaccines are rapidly becoming available. So my hope for this vaccine and other COVID vaccines are that we really look carefully at observational safety studies. Be Safe, a CDC surveillance system has a module for pregnancy, but I think we really need to enhance our efforts to very rapidly gather information about this vaccine in pregnancy. I think we owe it to pregnant persons.
>> Cathy Spong: Absolutely. I mean, this is the time for that proactive data collection to not only get at vaccine-related symptoms, but also obstetric outcomes given that so many women now are being vaccinated because we have to create that evidence base so that we can replace the expert opinion and give people the evidence.
>> Howard Bauchner: I just want to return to a few more questions because I know this topic is so clinically meaningful to people. Can a caregiver who is fully vaccinated still carry the virus to a baby or the mother if she is not -- so can a caregiver who is fully vaccinated still carry the virus to a baby or a mother if she is not vaccinated? So I assume this question is really -- a grandparent gets vaccinated, can they visit their pregnant person or the baby?
>> Cathy Spong: It goes back to the previous question, right? Again, just because you're fully vaccinated doesn't mean that you can't get COVID-19, and the variants play into that role as well. So we cannot let our guard down. And it is critically important that we adhere to all of the masking and the hygiene and recognize that, yes, you could be asymptomatic and have COVID even if you were vaccinated.
>> Howard Bauchner: Right. Lots of questions about passage of vaccine-induce antibodies via breast milk in the infant. Is it protective?
>> Cathy Spong: It's a possibility, right?
>> Denise Jamieson: It's a great question, and I don't think we know enough about the transplacental passage of antibodies and antibodies in breast milk and all the other issues. So we need more information. There have been some early initial studies, but we don't know nearly enough yet to be able to say, we hope so, we hope it's like influenza or pertussis, and that by vaccinating the mother while pregnant you provide protection to the infant. Fingers crossed.
>> Cathy Spong: That's the hope.
>> Howard Bauchner: Both of you over your careers have participated in studies that studied the issue itself about vaccination and pregnancy and the threat of illness during pregnancy to the fetus and the newborn. I'll start with you, Denise, what has struck you about COVID-19? When you look back over the previous year, in your area of expertise, what have been the surprises?
>> Denise Jamieson: I mean it's surprising, you know, when I was at the CDC doing emergency preparedness planning, we thought about respiratory pandemics. We thought about pandemic influenza. But I don't think we -- I did not foresee how completely this pandemic would affect every facet of our lives. And I think it's been really hard on pregnant persons and mothers in a way that I did not appreciate.
>> Howard Bauchner: Cathy, you know, when you reflect on -- now it's 14 months, sadly, it's 14 months in the U.S. and we're approaching half a million deaths, there's 3.7 or 3.8 million births a year, so we know this affects an enormous number of individuals as well as their related families. What's your perspective when you look back over the last year?
>> Cathy Spong: So there's a couple of things that come to mind. One is before I get to the impact on the family, I think it's very interesting on the hospital system where many, you know, elective cases, surgeries, things change. Other services had a decrease in volume. In obstetrics we certainly did not have that. In fact, in some ways we had an increase in volume. And this gets into the family situation where COVID has impacted stress and mental health and the role of the woman, especially in socioeconomically disadvantaged populations is even higher. And you've now got perhaps someone who doesn't have a job at home. You've got the children at home. You need to educate the children, online schooling, all of that stress. I think I would not have anticipated that. That was surprising to me.
>> Howard Bauchner: This is Howard Bauchner, Editor in Chief of JAMA, and I've been joined by Denise Jamieson, formerly of the CDC. Denise is the James Robert McCord Professor of Gynecology and Obstetrics at Emory University, and Cathy Spong, formerly of NICHD, and Cathy is the Gillette Professor of Obstetrics and Gynecology. I want to thank the two of you for joining me today. Pregnancy, immunization during pregnancy, pregnant persons, it's always emotional and difficult. There's never certainty, and I think that lack of certainty makes it a much more difficult discussion. And I want to thank the two of you, Denise for your JAMA insights entitled Caring for Pregnant and Postpartum Individuals During the COVID-19 pandemic, and Cathy for your viewpoint entitled COVID-19 Vaccination in Pregnant and Lactating Women. Thank you so much for joining me today.
>> Cathy Spong: Thanks for having me.
>> Denise Jamieson: Thank you.
>> Howard Bauchner: And to both of you, stay healthy, and thanks for answering all the questions and there were quite a few.
>> Cathy Spong: Of course.
>> Denise Jamieson: It was a pleasure.
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