[SPECIAL EPISODE] COVID Vaccine Update

Ep 111a: [SPECIAL EPISODE] COVID Vaccine Update

Nicole: In this special episode, I'm giving you an update on the COVID vaccine in relation to fertility, pregnancy, and lactation.

Nicole: Welcome to the All About Pregnancy & Birth podcast. I'm Dr. Nicole Calloway Rankins, a board certified OB GYN, who's been in practice for nearly 15 years. I've had the privilege of helping over 1000 babies into this world, and I'm here to help you be calm, confident, and empowered to have a beautiful pregnancy and birth. Quick note, this podcast is for educational purposes only and is not a substitute for medical advice. Check out the full disclaimer at drnicolerankins.com/disclaimer. Now let's get to it. Hello. Hello. Welcome to this special episode

Nicole: Of the podcast. Thank you for being here with me today. It's been almost four months since I did a COVID update, and I figured that it is time to do another one. I'm getting lots and lots of questions about the COVID vaccine. So today we're going to dive in and you're going to learn all about the most recent evidence as of the date of this podcast. I'm recording it on April 12th. You're going to learn the evidence about the COVID vaccine in relation to fertility, pregnancy, and lactation. So I'm going to cover again, all the available data that we have so far, including what I get the most questions about, and that's that CDC V safe COVID-19 vaccine pre pregnancy registry. That was a bit of a mouthful. And as always, I will present the information. I'll give my thoughts where I think it may be helpful.

Nicole: And then you can make conclusions for yourself about what you think works best for you. So let's go ahead and dive right in. So the first thing we're going to talk about is the COVID vaccines as they relate to. And I say, I may say vaccine vaccines, interchangeably, but I really mean vaccines. There are three FDA approved vaccines in the United States. Uh, one is from Pfizer. One is from Moderna and one is from Johnson and Johnson. The Pfizer and Moderna versions are M RNA vaccines and the, uh, Johnson. And they are two shots. They require two shots each. And then the, um, Johnson and Johnson vaccine is a single dose and it works by using something called adenovirus vector technology. Okay, so let's start off first with fertility. This is probably one of the most, um, the things that I get the question about the most, the most, the most.

Nicole: So let me unequivocally say that there is no evidence, there's zero evidence that any of the three COVID vaccines affect fertility. This has been one of the most rampant rumors and falsehoods about the COVID vaccines. So let me explain where this came from. So, as I said, the Pfizer and Moderna vaccines are based on MRNA technology and MRNA is messenger RNA, messenger ribonucleic acid. It's a component of ourselves. So what those vaccines do, and that's the Pfizer and Moderna versions. Again, they give instructions for ourselves to make a harmless piece of what's called the spike protein. The spike protein is found on the surface of the Corona virus. Okay? So the spike protein is found on the surface of the Corona virus. So you get that vaccine and you get it in a muscle like most vaccines. And what happens is those instructions, those MRNA instructions get inside your immune cells, the cells then turn around and use those instructions to make the protein piece.

Nicole: So they make that spike protein. After that protein piece is made, then the cells break down the instructions, break down that MRNA pretty quick quickly and get rid of those instructions. So then what happens is that your immune cell displays that protein piece on the surface. Okay. So immune cells get that protein piece. They make it, they display it on the surface and then your immune system recognizes that, Hey, that protein does not belong here. And then your body begins building an immune response by making antibodies. And those antibodies are similar to antibodies that happen in natural infection against COVID, except in this case, you're not getting the whole entire virus. So you don't have any consequences of getting sick from COVID. All right. So at the end of this process, your body has learned how to protect you against future infection. It's made those antibodies, but you have not gotten COVID.

Nicole: All right. So that's how the MRNA vaccines work. Now, how this relates to the fertility piece is that in December, 2020, a German doctor and epidemiologist, who has admittedly himself been skeptical about vaccines, he and a former Pfizer employee wrote a letter to the European medicines agency. That agency is the European union counterpart to the FDA. All right. So it's similar to the FDA except it's in Europe. And what they asked for in this letter was delaying the study and approval of those MRNA vaccines specifically, in this case, the letter was about the Pfizer X Pfizer vaccine, because there was a concern that there's a protein in the placenta called syncytin- one. And I don't even know how that if that's how you pronounce it, but it's S Y N C Y T I N hyphen one. That protein in the placenta shares similar genetic components to the spike protein. All right. So the spike protein is similar to the syncytin-one protein. And the concern was that if the body makes antibodies to the spike protein, then it may make antibodies to this placenta protein. And it will cause the body to attack and reject the part of the human placenta. And if that happens, then women would be infertile. So I hope that that makes sense. Now, the reasons that this is not true in practice of why this is false, a couple, a couple of things, number one, that spike protein and that placenta protein share very small stretches of the same genetic code, but they are not close enough that the body would look at them as being similar. I saw one instance where it was compared that it's similar to, if two people have a phone number and both of the numbers contain the number seven, you can't dial one number and reach the other person, even though both of their phone numbers have a seven in them.

Nicole: Okay. So they share a tiny stretch of something that's similar, but nothing that's similar enough that the body would do this cross-reaction all right. There's similar on a very tiny level. And even in that letter, that doctor wrote, there's no indicate, and this is a quote, there's no indication whether antibodies against spike protein would also act like anti-syncytin-one antibodies. Okay? So even in the letter, he said that there's no indication that this would happen. However, that letter gets circulated and circulated, and that formed the basis of the falsehood that the vaccine causes infertility. Now, some more reasons why that theory, like some practical data that we have, that it's not turning out to be true. In the Pfizer trial, there were more than 37,000 people. At the beginning of the trial, women were given pregnancy test before they were accepted into the study.

Nicole: They were excluded if they were already pregnant. So you had to have a negative pregnancy test in order to be in this study. However, during the trial 23 women conceived, you know, maybe my accident, maybe they were trying, but 23 women conceived. 12 of those pregnancies were in the vaccine group and 11 of those pregnancies were in the placebo group. So if we thought that the vaccine, we know that they were not pregnant at the beginning, if we thought the vaccine would have caused issues with pregnancy, then we wouldn't have expected to see folks in the, those people in the vaccine group get pregnant. Okay. So that's one piece of evidence. And then the other, probably bigger piece of evidence is remember that this spike protein, that the MRNA vaccine in codes for is similar to what is in the naturally occurring Corona virus.

Nicole: So if it was possible that the body making antibodies to the spike protein, when they made it, and these antibodies cross-reactive with the placenta, for people who naturally get infected with COVID, then you was six-pack suspect that they would make antibodies. That would be against the placenta as well. Okay. Cause it's the same protein. However, we have not seen in people who are naturally infected with COVID, that there is a drop in fertility. So again, I hope that all makes sense, and I hope that we can please please put it to rest. That there's any evidence that the messenger RNA vaccines in particular cause and fertility, there's just no evidence of that. There's also no evidence about the Johnson and Johnson vaccine as well. So let's talk about pregnancy. Now. The reason we even worry about COVID in pregnancy is because we know that pregnant people are at an increased risk for severe illness from COVID-19, although the overall risk of severe illness is low.

Nicole: All right. So you're not likely to get very sick if you're pregnant and you get COVID-19. They are at a, pregnant people are at a increase risk when compared to non-pregnant people. And what severe illness means is that it puts you at an increased risk of hospitalization, intensive care, or needing a ventilator or special equipment to help you breathe. That can be made worse by having certain underlying medical conditions like diabetes or hypertension or any type of lung disease like asthma. Okay. Not as you know, or if you don't know now, you know, pregnant people and lactating people as well have been excluded from all of the vaccine trials. Okay. All the vaccine trials. So all of the data that we have is from pregnant people, getting the vaccine and then following them to see what happens. Now, we know that there's data from animal studies and then those small number of pregnant people who were inadvertently enrolled in the vaccine trials.

Nicole: We know that those animal studies and those small number of people have not shown any harmful effects. There haven't been any safety concerns or red flags from those. But the evidence from those randomized trials is really limited. Again, what we're basing our data on is from people who have gotten vaccinated. And then we're just following them to see what happens. The biggest source of information is the V safe pregnancy registry. The V safe pregnancy registry is just one of the several vaccine monitoring systems that the centers for disease control and the FDA have put in place to get information about COVID-19 vaccines in pregnancy. Now, the safe. So there's V safe pregnancy registry, and then there's V safe. So V safe itself is a smartphone-based tool, meaning that you have to have a smartphone, in order to be in it. They use this text messaging, uses internet surveys in order to do health check-ins after you receive a COVID vaccine. Anyone can participate in V safe.

Nicole: The only requirement is that you have a smartphone and that you have, you had to have gotten vaccinated in the last six weeks. So if this is something that you want to participate in, uh, you can do so I will link it up in the show notes, but it's Vsafe.cdc.gov. You just have to have the vaccine within the last six weeks and have a smartphone. Okay. Now the V safe COVID 19 vaccine pregnancy registry is for those V safe participants who self identify as pregnant. So you register for V safe, they ask you questions. One of which is if you self identify as pregnant at the time of vaccination or within 30 days of vaccination. Okay. And so you get additional questions in addition to what's in the regular, V safe, vaccination, healthcare, check-ins you get more questions. All right. You get contacted to answer questions about your pregnancy, your medical history.

Nicole: And some folks are being asked for permission to contact their healthcare providers. So participants in the V safe COVID-19 vaccine pregnancy registry, they're contacted once per trimester, then after birth. And then when the baby is three months old, again, they do those phone surveys. Um, they've reviewed medical records. And the things that they're looking for, the outcomes of interest are miscarriage of interest rather are miscarriage, stillbirth, pregnancy complications, like preeclampsia or gestational diabetes, whether or not you as the maternal person was admitted to the ICU, poor birth outcomes, like pre-term delivery and poor growth, whether or not there's a newborn death, infant hospitalization, or any birth defects. All right. So those are the things that they are looking for in the V safe registry, all of the protocols for how everything is done with the V safe pregnancy registry are right on the CDC site.

Nicole: I will link that as well in the show notes, if you're interested in learning more details about that. Now do note that participants are not paid for their participation. All right. And they're not going to contact everyone who reports pregnancy. Okay. So they're just contacting a subset of people and participation is voluntary. You can opt out of it at any time. Okay. All right. So as of April 5th, 2021, and that is the date that I have is when I'm recording this podcast episode on the 12th, 77,960 V safe participants have indicated that they were pregnant at the time that they received the COVID 19 vaccine. And then of those they have contacted or who were enrolled in that pregnancy registry with the more detailed information, 4,218. All right, now, obviously that's a big difference. 77,960 people who have indicated they were pregnant at the time they received the vaccine and then 4,218 people so far who are enrolled in the COVID 19 vaccine pregnancy registry.

Nicole: And the big difference in those numbers, there are a couple of factors that they mentioned. One is there was a delay between the roll out of the COVID-19 vaccine, and then the launch of the pregnancy registry. Specifically, it also takes time for the registry to contact people who self identify as pregnant. Again, not everyone who identifies as pregnant will meet criteria to be in the registry. And then the registry is only enrolling a certain number of people who are vaccinated at different points during pregnancy. All right, now the data collected from this registry will be regularly presented at the ACI P meetings. ACI P is the advisory committee on immunization practices, and these meetings are open to the public, and they also are they provide published reports after the meeting. The last meeting was March 1st, and I'm going to talk about the data from that meeting.

Nicole: And then the next meeting is on May 5th. All right. So, um, the data from, from the March 1st meeting and these slides are available completely online, and I'll link that in the show notes as well. If you're interested in looking at that. So here's a summary of the V safe data as of February 16th. Like that was the date that they put in the March 1st meeting. Now the high level summary of the data is no, and this is a quote, no unexpected pregnant or outcomes have been observed or related to COVID-19 vaccination during pregnancy. Now where people have gotten tripped up about this is this unexpected part alright? No unexpected pregnant or infant outcomes. And I'm going to explain what that means in just a minute, but first, let me go through a few of the numbers. So again, as of February 16th, people have self-reported that they were pregnant in V safe, 16,000 people reported getting the Pfizer vaccine 14,000 or so, the Moderna vaccine for about 30,000 total. Of those 30,000 in V safe as of February 19th, and remember those, those 70,000 numbers, those numbers were as of April. So a lot more people between February and April enrolled. I'm talking about data from back in February when the meeting happened, or when they collected data. There were 30,000 at that time and in V safe and 1,815, were in the V safe pregnancy registry. Of those 1,815, there were 275 completed pregnancies, including 232 lab births. Okay. All right. So let's look at some of the outcomes from the V safe pregnancy registry. And again, this is as of February 18th, 2021. Now, understandably. So people have been concerned that there have been any reports of miscarriage, still birth complications with pregnant people who have had the vaccine. However, you cannot look at those numbers and look at those who have had a miscarriage, for instance, who have gotten the vaccine. You cannot look in those numbers and look at those numbers in isolation.

Nicole: And that is because miscarriage, stillbirth, pregnancy complications were happening before COVID. Miscarriage is very common. It happens all the time. Unfortunately, it happens in those who don't get the vaccine. Again, that's been happening before COVID was around. So this is a really important point. You can't look at those V safe numbers and say, Oh my gosh, this number of people who got the COVID vaccine had a miscarriage. You have to look at that number and compare it to what we call the background rate of those things happening outside of the COVID vaccine or under normal circumstances. So to speak. I hope that makes sense, because that's a really important point. All right, you can't just look at the numbers and say, here is how many people that have had the outcome. You have to compare it to those background rates of things that happen outside of COVID times.

Nicole: Okay. So that's when they say no unexpected pregnant or infant outcomes. So what that means is that the rates of things happening in the V safe pregnancy registry are similar to the background rates of things happening outside of COVID. So for some more specific numbers for miscarriage, and that's less than 20 weeks, the background rate is roughly 25% of known pregnancies will end in miscarriage in those who've had the COVID vaccine, the V safe pregnancy registry, that number is 15%. For stillbirth, that's greater than 20 weeks, it's 0.6% background rate 1% in V safe pregnancy registry. That is not a statistically significant difference for pregnancy complications. Gestational diabetes can happen anywhere, anywhere, depending on the sources of data and in the slides, they talk about where they get these background rate numbers from. So you can look at that data. I'm not going to go through those sources in detail, but gestational diabetes, seven to 14% in the background rate, 10% in the V safe pregnancy registry. Preeclampsia, or gestational hypertension, 10 to 15% in the background rate, 15% in the V safe pregnancy registry.

Nicole: Okay. Um, for neonatal outcomes, preterm birth, 10% in the background rate, 10% in the V safe pregnancy registry. Congenital anomalies, 3% in the background rate, 4% in the V safe pregnancy registry. Neonatal deaths, 0.38% in the background rate 0% in the vaccine registry. So again, very close numbers, no difference when you compare the V safe pregnancy registry to those background rates. Okay. Now there's another source of information about the vaccine in pregnancy. And that is called V A E R S. And that is the vaccine adverse event reporting system. This is a national early warning system that detects possible safety problems in us, licensed vaccines. So V A E R S is co-managed by the centers for disease control and the food and drug administration. Now they accept and analyze reports. These adverse events, after a person has received a vaccination. Anyone can report an adverse event to VA ERs.

Nicole: So if you have an adverse event from any vaccine, you can report it, you can report it online, or you can print out a form and mail it in. And I can link that in the show notes as well. Healthcare professionals are actually required by law to report certain adverse events and vaccine manufacturers are also required by law to report all adverse events that come to their attention. So this is the VA ERs system. So in the VR V A E R S system through February 16th, 2021, 154 people have reported adverse events related to pregnancy specifically. So 154. The maternal age, the median number right in the middle is 33, with the range being 16 all the way up to 51. Gestational age in weeks at the time of vaccination, when they reported an adverse event was 13 weeks and median again is the middle number with a range from two to 38 weeks.

Nicole: As far as the trimesters, um, 51% reported being in their first trimester when they got the vaccine 31% in the second trimester and 19% in the third trimester, 63% got the Pfizer vaccine, 36%, the, um, Moderna vaccine. Now, as far as adverse events, okay, again, it was 154 and the most common one was miscarriage. And that was reported at 29 of those 154 reported miscarriage. And that was 18% overall pregnancy or neonatal specific adverse outcomes. There were 42 people of those 154 that reported adverse outcomes. That's 27%. Again, miscarriage was the most common, but some three people report a premature rupture of membranes, one premature delivery, one gestational diabetes, vaginal bleeding, one stillbirth. So those a long list of other things. And then quite a few, 112. Um, so 73% reported a variety of adverse effects that were not related to pregnancy. Okay. So 31 reported headache, 29 fatigue, 21 chills, 17 pain in the arm.

Nicole: These are all things that are related to the vaccine outside of pregnancy as well. So not unexpected. Okay. All right. So just to recap, that little piece, the V safe registry is through the CDC, the V safe registry looks at anyone who's had the COVID vaccine within the last six weeks. Anybody can register for it. And the V safe pregnancy registry takes those people who self identify as pregnant and collect additional data from them. That data has not demonstrated any difference in outcomes between those who have gotten the vaccine and are pregnant, and those who have not okay. And then the VA ERs system, which is a self reporting system for adverse events has also not identified any red flags among pregnant people who have gotten the COVID any of the COVID-19 vaccines. Okay. Now, so where does this information leave in terms of recommendations regarding the COVID 19 vaccine in pregnancy. Well ACOG and I tend to fall back to AyCOG because that's our specialty organization recommends, and ACOG is the American college of obstetricians and gynecologists.

Nicole: They recommend that the COVID night, 19 vaccine should not be withheld from pregnant individuals who choose to be vaccinated. And then it says in the interest of patient autonomy, ACOG recommends that pregnant individuals be free to make their own decision regarding COVID-19 vaccination. I think that this is a little bit of a cop out. They don't want to like stick their necks out and say, you know, recommend or, or not. Because the data that we have is for a short period of time, we don't have a lot of long-term data at all. But in general, I think people are starting to feel more comfortable recommending the COVID vaccine, especially if you have certain circumstances, but ACOG stance right now is that it should not be withheld. And if you want it, you can get it. Now, remember, as I said, none of the vaccine trials have included pregnant or lactating people, but there's nothing about the way the vaccines are made that gives us any suggestion that they are going to be problematic in pregnancy. We worry about lab vaccines in pregnancy and whether or not a live virus vaccine can cause an infection, but these are not live virus vaccines. The messenger RNA vaccines are not live. And the Johnson and Johnson vaccine is based on what's called replication and competent adenovirus recombinant vector. Okay. And that is not a live vaccine either. So they're very unlikely to pose a risk for pregnant people, the baby growing baby, or fetus or breastfeeding babies. Again, that data from animal studies, the small studies that we have so far have not shown any harmful effects. In fact, a recent study came out in March of this year, that demonstrated a maternal immune response and a transfer of maternal antibodies, actually that confers passive immunity against COVID and newborns after moms get vaccinated.

Nicole: And this is not surprising. This is why we get the Tdap vaccine during pregnancy, in order to confer passive immunity to babies. So in this particular study, and it was small, okay. There were 84 pregnant people, 31 lactating people and 16 non-pregnant, uh, females and of those, they had gotten the MRNA vaccine. All right. So the average of the pregnant folks that average gestational age at the first dose was 23 weeks, 13% received the vaccine and the first dose in the first trimester, 46% in the second trimester, 40% in the third trimester. And actually it was found the antibody titers were higher than those induced by natural infection. So your immune system created more antibodies than what people produce in natural infection. During pregnancy, there will also, uh, vaccine generated antibodies we're seeing in umbilical cord blood as well as breast milk samples. All right.

Nicole: So that transference of immunity to the baby. So that does appear to be, or it does appear to be the case that there may be some reduction in the risk of infant infection when mom gets vaccinated. However, we don't know if newborns still remain at risk, even if mom has been vaccinated. And we also don't know how long that protection is expected to last. So I don't want you to get this vaccine thinking that, Oh, I'm protecting my baby because we don't know. We know that there's some evidence that suggests that is possible, but not certain. Okay. And then again, getting back to people who may want to decide that they get the vaccine during pregnancy, if you're at a higher risk for exposure because of your work environment or because of where you live, or if you're at a higher risk because of diabetes, carrying extra weight, being obese or heart disease, then it may be, you may want to get it because pregnancy itself is associated with that increased risk of severe infection.

Nicole: Even though people, even though the risk of severe infection is low. Now, some people may decide that they want to wait until afterwards. They look at their personal risk. They're at home. They're not around a lot of people. They may feel uncomfortable that although the data looks promising, the data is limited. I will acknowledge that we only have a few months worth of data. We don't have long-term data, we're developing more robust data and it looks good. And there's nothing to suggest that this will change. But the reality is that it's limited. So some people may decide that they want to wait to get vaccinated. If they feel like they're already in a safe circumstance. Now, a couple of things about, if you do decide to get vaccinated during pregnancy, you want to try and space it out. So it's not within 14 days of routine pregnancy vaccinations that we recommend like tdap or flu.

Nicole: And also if you do become pregnant after receiving the first dose of the two dose series, you can get the second dose whenever it's indicated you don't have to wait or anything like that. You just get the second dose when it's ready. All right. And just a couple of final notes about breastfeeding and lactation. Again, the vaccines have not been studied on any lactating people at all V safe, in fact, does not collect any data about breastfeeding because breastfeeding is rarely a safety concern with vaccines. So they don't collect any data about breastfeeding. There's no data on the safety of COVID by COVID-19 vaccines and lactating people, the effects of vaccination on the breastfed infant, the effects on milk production or excretion. All right, there is nothing though to suggest that it should be a problem. Okay? Nothing at all to suggest that these vaccines will be a problem during or lactation.

Nicole: They're not thought to be a risk to the breastfeeding baby. Now it is the case that if mom gets vaccinated while breastfeeding, that some of those antibodies may pass into breast milk and they may have some protective effect. We don't know that yet, but it's possible. And if you're concerned that any of the vaccine itself somehow crosses into breast milk, when it's ingested by the baby, it will likely be an activated by the digestive system. The stomach has lots of acids, very powerful acids to break down food. It's unlikely that any vaccine component would survive that. Okay. So that is it just to recap, no evidence that the COVID vaccine causes infertility. The evidence that we have so far does not show any adverse effects on pregnancy from the COVID vaccines. There is some evidence that mom getting the vaccine may give some, may give baby some protection, but do not hang your hat on that as a reason to get the vaccine, we don't know how long it lasts. We don't know the baby's risk regarding COVID, but that evidence is promising. The COVID-19 vaccines are considered very safe with breastfeeding. The data is still limited, and it's still short term data, but overall, everything looks good for that reason because the data is limited. It still remains a personal decision, whether or not you get the COVID vaccine during pregnancy. So talk about it with your healthcare provider, with your unique circumstances. So there you have it, be sure to subscribe to the podcast in Apple Podcast and leave a review on Apple Podcast. I so appreciate it, it helps other women to find the show, helps the show to grow. Also come follow me over on Instagram @drnicolerankins, I do live Q and A sessions there a couple of times a month roughly where I answer all kinds of questions about pregnancy and birth. Those are great. Those are a ton of fun. So do follow me on Instagram. So you don't miss any of those. And that is it for this episode, do come on back next week. And until then, I wish you a beautiful pregnancy and birth.

Nicole: Thanks so much for listening to this episode of the All About Pregnancy & Birth podcast. Head to my website, drnicolerankins.com to get even more great information, including free downloadable resources on how to manage pain and labor and warning signs to look out for after birth. You'll also find information on my free online class, on How To Make A Birth Plan That Works as well as everything you need to know about my signature online childbirth education class, the Birth Preparation Course. Again, that's drnicolerankins.com and I will see you next week.