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Dr Warner Huh: Hello, everyone. My name is Dr. Warner Huh, the Chair of the Department of OB-GYN at the University of Alabama Birmingham. I'd like to welcome all our listeners to our inaugural podcast on women's health. Today's topic is a topic that we've been asked about a lot recently. It has been in the news quite a bit. It's the topic of COVID-19 vaccination in pregnancy and lactating women. Then I want to introduce our two speakers today, two guests. First one is Rachel Sinkey, who is an assistant professor in the Division of Maternal Fetal Medicine here at UAB in the Department of OB-GYN as well as Dr. Audra Williams, who is in the Division of Women's Reproductive Health, also in the Department of OB-GYN here at UAB. So welcome, Dr. Sinkey. Welcome, Dr. Williams.

Dr Rachel Sinkey: Thanks, Dr. Huh. We're happy to be here.

Dr Audra Williams: Yeah. Thanks for having us.

Dr Warner Huh: So, it goes without saying that there's been a lot of confusion and interest in this topic related to COVID-19 vaccination in pregnancy and lactating women. So I just thought we'd go ahead and just start with you, Dr. Sinkey, and maybe have you comment on what is specifically the concern related to COVID-19 infection, particularly in pregnancy.

Dr Rachel Sinkey: Thanks so much, Dr. Huh. We're still learning about COVID-19 in pregnancy, but information we have so far suggests that symptomatic pregnant patients with COVID-19 have higher risk of more severe disease than non-pregnant women. The absolute numbers are low, but there is an increased risk for ICU admission, life support, including mechanical ventilation and ECMO and death.

Additionally, there were several really nice COVID presentations at our annual society for maternal fetal medicine meeting that we held virtually last week. The highlight of the COVID presentations was one presented by the Maternal Fetal Medicine Units Network. It included data from 33 US hospitals across the country, and they reported on 1200 COVID-positive pregnant patients. And of these 1200 COVID positive pregnant women, about half of those were asymptomatic and a small percentage of those were quite ill. About 8% had severe disease and 4% had critical disease.

And so the take home points for that were the vast majority were either asymptomatic or mild, but among those who were sick, they found that they were often older, had higher BMI, had medical co-morbidities like asthma, diabetes, and hypertension. And there were four maternal deaths noted in that cohort. Additionally, there was an increased risk for preterm birth among pregnant women with COVID-19 and about 1% of their babies tested positive for COVID-19 before hospital discharge.

Dr Warner Huh: So, let me just make sure that we summarize as well for our listeners. So in your opinion, Dr. Sinkey, that serious illness is more likely to occur in a pregnant patient versus a non-pregnant patient, would that be correct?

Dr Rachel Sinkey: That's right, Dr. Huh.

Dr Warner Huh: Okay. All right. So let's talk a little bit about of COVID-19 vaccination in pregnancy and lactating women. So Dr. Williams, what is currently recommended and who is making those recommendations?

Dr Audra Williams: Yeah. So right now several of our kind of governing organizations in medicine have recommendations about COVID vaccination in pregnancy. So the Centers for Disease Control, the American College of Obstetricians and Gynecologists, and the Society for Maternal Fetal Medicine, all have similar recommendations saying that the vaccine should not be withheld from pregnant women. They should have the opportunity to make that decision for themselves based on kind of shared decision-making with their partner and with their healthcare providers.

Dr Warner Huh: And I know a lot of our listeners are--you probably already can predict my next question to you, which is-- so last week the world health organization came out with a pretty vocal stance on not offering particularly the Moderna vaccine to pregnant women. I think they made a similar recommendation, right, when the Pfizer vaccine came out. Could you explain to our listeners why they would make that stance? And it's my understanding that they've actually backtracked a little bit and now saying that, yes, they agree that we should offer to women.

Dr Audra Williams: Yeah, absolutely. So like you said, their initial recommendations actually stated that pregnant women should not be offered the vaccine unless they were high risk based on their exposure. And really that thinking really comes from that there were not pregnant women included in the vaccine trials. So we don't have any clear data that the vaccine is safe. However, we also, based on how we know the vaccine works and experience with other vaccines, don't have any data to suggest that this vaccine would be harmful for pregnant women either.

And so I think after some advocacy from Centers for Disease Control from ACOG, there was a change in their statement, that they now say we don't have any specific reason to believe that there will be risks that would outweigh the benefits of vaccination in pregnant women.

Dr Warner Huh: And your thoughts on women who are actively trying to get pregnant or conceive? Do you have an opinion one way or the other about vaccination in that group?

Dr Audra Williams: We have some pretty great guidance from the American Society of Reproductive Medicine that state that women who are thinking about conceiving or actively trying to conceive should receive the vaccine to protect themselves for their current health and for a future pregnancy.

Dr Warner Huh: So I think this is really what our listeners want to know. I'm going to ask you both, Dr. Williams and Dr. Sinkey. do you both feel that the vaccine should be offered to our patients?

Dr Audra Williams: Absolutely. A hundred percent.

Dr Rachel Sinkey: Yeah.

Dr Warner Huh: Okay. I think that's an important message to get out because I think it's confusing in terms of what our patients read. And I think that we need to be very clear about where we stand in terms of vaccination and COVID. So, you know, I appreciate you're making those comments.

So Dr. Sinkey, can you tell me just vaccinations in general, during pregnancy, I think It's been well-described that both for the Pfizer maternal vaccines that the registration trials include pregnant patients, but I thought maybe it would be interesting to our listeners for you to comment on the role of vaccination during pregnancy.

Dr Rachel Sinkey: Absolutely. So during pregnancy, we routinely recommend vaccines, including Tdap and the flu vaccine. These have a long profile of safety and efficacy in pregnant patients. We don't give live vaccines in pregnancy because it could potentially cross the placenta and harm the fetus. And I think it's really important to point out that the COVID vaccine is not a live vaccine. So we don't know of any mechanism that it could cause harm to the baby or cause birth defects or anything like that.

It is a really personal decision for some patients on whether or not to get the vaccine in pregnancy or not. And so, certainly your providers are available to answer any questions that you may have about it. And we also encourage you to discuss it with your family or your support persons, and we are happy to discuss any of those questions at any of your visits.

That being said, we don't want it to be a barrier that you have to see your doctor before getting a vaccine. And so if you are pregnant or thinking about becoming pregnant and you want the COVID-19 vaccine, then you should definitely be able to get it without any permission from a doctor or a doctor's note or anything like that.

Dr Warner Huh: So I'm sure that this question comes up frequently is, if a patient says, you know, I'm not quite ready to get the vaccine for whatever reason, is it reasonable for that patient to just socially distance, mask up as we were doing presently?

Dr Rachel Sinkey: You know, we do recommend that whether or not you get the vaccine, it is safest to continue to socially distance and mask up. However, we don't think that that replaces the efficacy of a vaccine, and that really seems to be the best way to prevent this really terrible disease.

Dr Warner Huh: Great. No, thank you. I appreciate that. So, Dr. Williams, let me ask you, so there's been a lot of information particularly on the internet related to the vaccination affecting an individual's fertility. And so my question to you is can you share with the listeners what we know actually scientifically about the relationship between the impact of fertility and COVID-19 vaccination?

Dr Audra Williams: Yeah, absolutely. I think there was a lot of widespread misinformation that came out very early in the days of the vaccine that isn't based on any science. So we know again from the American Society of Reproductive Medicine, that the vaccine will not cause infertility in men or women that received the vaccine.

And although again, pregnant women weren't included in the trials, there were some women that did conceive during the course of the vaccine trial. And there were no difference in pregnancy rates between the group that got the vaccine and the group that got the placebo. So I think that also kind of gives us some additional reassurance that the vaccine does not cause infertility.

Dr Warner Huh: Yeah, absolutely. I mean, I would think that considering all of the rates of COVID-19 infection globally, if there was really an effect on fertility, you would think that you would start seeing it now, irrespective of whether or not the vaccine has any impact. An I don't think that we've seen that signal.

Do you have any thoughts about whether or not there's any risk of the fetus being exposed to the COVID-19 vaccine? And again, it's a unique vaccine because it's an mRNA vaccine. So do you have an opinion one way or the other regarding that?

Dr Audra Williams: Yeah, there's really no evidence that there would be a risk to the fetus from what we know about the mRNA that's actually injected as part of the vaccine. It's very quickly degraded by the body. So we don't think that it's something that would be passed in the placenta or even in breast milk for lactating women.

Dr Warner Huh: All right. So Dr. Sinkey, what's next? What do you think what's going to be happening next related to research related to vaccination and COVID-19?

Dr Rachel Sinkey: Sure. So there are several research studies that are launching to study the COVID-19 vaccine in pregnancy nationally and globally. I believe Pfizer is doing a trial in pregnant women. Nationally, the Maternal Fetal Medicine Unit Network is starting a registry. UAB is going to be involved in two CDC studies investigating the impact of COVID-19 vaccine in pregnancy. And so I think we have a lot of opportunities here to put some data behind this. So that way we can give the best production to our patients possible.

Dr Warner Huh: I think it goes without saying it's an obviously a rapidly changing space. So I mean, obviously we'll provide updates as they come along. And, you know, again, we learn a lot every single day and so I'm sure that we'll have a lot more information related to vaccination, particularly in this population in the next three to six months.

Dr Rachel Sinkey: I totally agree.

Dr Warner Huh: So, you know, Dr. Williams, Dr. Sinkey, any parting comments to our listeners and perhaps patients that are listening to this?

Dr Audra Williams: I just think it's great that our patients have the opportunity to make this decision for themselves, you know, in conjunction with their family members, their partners, their healthcare providers. I think women just need to really think about what their personal risks of COVID is. We know from what Dr. Sinkey was telling us, the risk of COVID is very real for pregnant women. And right now, there are theoretical risks for the vaccine, and it's really just a matter of where that falls for each individual patient.

Dr Warner Huh: All right. Great. Well, I guess in summary again, I think all three of us, it's important to highlight that we do recommend that the vaccine be offered to pregnant and lactating women, and we wanted it to be very clear about that. But as I think Dr. Sinkey and Dr. Williams had mentioned, it's a very much a shared decision-making process with multiple people and it's about risk and benefit, but we do think the benefits outweigh the risks.

Well, thank you Dr. Sinkey, Dr. Williams, appreciate it. So this concludes the first podcast episode on COVID-19 vaccination in pregnant and lactating women. For more information on resources available at UAB Medicine, please visit our website at uabmedicine.org. And please don't forget to subscribe, rate and review this podcast and all other UAB Medicine podcasts. I'm Warner Huh. Have a good day. Thank you.