Special Episode: COVID-19 & Pregnancy Update – What to Know About Vaccines and Treatment

This week one of my lovely listeners asked me on Instagram if I could update my COVID-19 & pregnancy episode from earlier this year. With the announcement that multiple vaccines will become available soon, I thought it would be a wonderful idea to provide some updated information about COVID and pregnancy (as of December 2020). As always, make sure you check out resources from the CDC and ACOG for the most up-to-date info.

In this episode I give a quick refresher on what we know about COVID-19 and pregnancy, including risk factors for severe illness, whether your  baby can get COVID while you are pregnant and what to expect if you contract COVID while pregnant. I'll also walk you through what to expect if you are COVID-positive at the time of your birth.

Then I talk about the upcoming COVID-19 vaccines, how they were developed and what you should consider when deciding whether to get vaccinated while pregnant. 

In this Episode, You’ll Learn About:

  • A quick overview of what we know about COVID-19, preventing the spread, and treatment
  • What we've learned about COVID-19 in pregnant and birthing people
  • What you can expect if you test positive for COVID-19 while pregnant or if you are positive while giving birth 
  • What we know so far about how COVID-19 could impact your baby if you test positive while pregnant
  • How vaccines are developed and why the COVID-19 vaccines have been developed so quickly
  • What to think about when deciding whether you want to get the COVID-19 vaccine while you are pregnant


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Transcript

Ep 94a: COVID-19 & Pregnancy Update & What to Know About Vaccines and Treatment

Nicole: This is a special episode where I am giving an update about Coronavirus and pregnancy, including the Coronavirus vaccine.

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. Well, hello hello. Welcome to another episode, a special episode of the podcast. Thank you for being here with me today. So today's episode of the podcast was inspired by an email from Monique. She sent me an email that said in March, you did a podcast about being pregnant with COVID-19. Is it possible to do a follow-up podcast since a lot has changed since when you did the original podcast. Possibly how does your care differ when you were diagnosed with COVID? Um, what is it like delivering as a COVID positive mama? What happens to the baby? Can you still breastfeed? Have I myself delivered babies of COVID positive mamas. Is there a higher risk of preterm labor? Well, I'm going to answer all of those questions in this episode. And then of course, I'm also going to address the COVID-19 vaccine that was recently FDA approved. I'll talk about how vaccines are developed in general, how this, these particular vaccines, the ones that are going to be available in the U S work.

Nicole: And then of course, I'll discuss how these vaccines relate to pregnancy and lactating people. So of course, the information in this episode is for educational purposes only, it comes from the CDC, the American College of Obstetricians and Gynecologists, the Society for Maternal Fetal Medicine, articles published so far, and it is up-to-date as of the date that I'm recording this episode, which is December 11th. Things are being updated all the time. So check those sources for the most updated information. All right, so let's get into the episode. First, let's start off with a general overview of just what Coronaviruses are. So they are a large family of viruses that are common in people in many different species of animals, including camels, cattle, cats, and bats, rarely animal Coronaviruses can infect people and then spread between people like with this virus, the COVID-19 virus. It actually had its origins in bats, and there've been other Coronaviruses in the past, like SARS was a Coronavirus as well. This particular virus, actually the official name of it is SARS-C O V-2, the disease that it causes is Coronavirus Disease 19, abbreviated COVID-19. But of course we use all of those terms sort of interchangeably.

Nicole: So the COVID-19 Disease was first detected in Wuhan, China in December of 2019. I cannot believe it has been a year since this virus first showed up. And of course it has since spread all over the world. When I did the episode in March, there were 94,000 infections and 3000 deaths, about 3% of people had died from COVID. The majority of those infections and deaths were in China. Of course now it's worldwide. And as of this recording, there are 69.7 million cases worldwide. So that's between March and today, March 94,000. Now 69.7 million and 1.58 million deaths. So 2.3% of people who have been infected have died from coronavirus. The U S leads with cases, 15.7 million cases in the U S with 293,000 people having died from it. So that's 1.9% of people who have contracted coronavirus in the US have died. When we look at pregnancy numbers for, and this is from the CDC between January 22nd and December 7th of this year, there have been 44,183 cases reported in pregnancy, of those 8,511 people have been hospitalized.

Nicole: So that's 19% and there have been 57 deaths. So 0.13%. And I'll talk about in more detail, how Coronavirus seems to affect pregnancy in just a moment. So just a review of how it's transmitted the virus is spread mostly from person to person. It spreads very easily through respiratory contact, respiratory droplets, people who are in close contact with one another, an infected person coughs or sneezes, and then the droplets travel and people can get infected very easily. It is possible that you can get coronavirus or COVID-19 by touching a surface or an object that has the virus and then touch your mouth, your nose, or maybe your eyes. But that is not how we think it's mainly spread. Mainly it is spread through respiratory droplets. The most vulnerable groups are the elderly, especially elderly men, and then people with underlying conditions like heart disease, lung disease, and diabetes. Pregnancy does not appear to put you at an increased risk for getting infected with COVID.

Nicole: It doesn't make you vulnerable, which is different than other Coronaviruses in the past. Now, as far as symptoms, and I'm speaking specifically of symptoms and pregnant people, the symptoms are actually the same, whether you're pregnant or not pregnant and symptoms typically appear within two to 14 days after exposure. And those are, and I should say a lot of pregnant people are asymptomatic. We don't know the exact percentage of how many pregnant people are asymptomatic because we haven't really been catching that data, but many people are. But if you have symptoms, they're going to appear within two to 14 days after exposure of those who had symptoms. These are the symptoms that they had. So cough, 50% of pregnant people reported having a cough, 42% headache, 36% muscle aches, 32% fever, 28% sore throat, 26% shortness of breath and 21% a new loss of taste or smell.

Nicole: So you may have one or more of those symptoms, two to 14 days after exposure. The most common ones, again are cough, headache, muscle aches, fever. So let's talk about the effects of COVID-19 on pregnancy and birth. I myself have taken care of just a handful of pregnant people with COVID. We haven't had a lot at our hospital. Thankfully, all of them have been women who contracted COVID in the second or early third trimester. None of them had any pregnancy complications. They were admitted to the hospital for short hospital stays, less than a week for treatment with COVID and then none of them needed to be delivered. They recovered and went home and were fine. I have not delivered any COVID positive moms, but there are positions in my hospital that have, we probably only had two or three. So again, my hospital has not had a particularly high number of COVID positive patients.

Nicole: I think other hospitals in the area have seen things a little bit different, but at my hospital, it hasn't been a lot. At other hospitals in the area haven't been terribly high either. And I'm in the Richmond, Virginia area for reference. Now in terms of how like you're treated during pregnancy, that was one of the questions that Monique asked is how you're treated, if you are COVID positive. And I think in the beginning, we were certainly worried. We felt like we didn't have the proper PPE. There was definitely some fear with treating COVID patients. I think, I mean, we obviously did it and still do it, but there was definitely a level of discomfort. I think now we have better PPE. We have a better understanding. And I don't think now that it's nearly as fear-based as it used to be and pregnant people, or even anybody with COVID in general, isn't like ostracized or, you know, left alone in the room for hours or things like that.

Nicole: I think we have evolved thankfully in the way that we care for all COVID positive pregnant people or all COVID positive people in general. So as far as how pregnancy affects COVID, it does not appear to increase susceptibility to infection again, which is unusual or different than other Coronaviruses like SARS and actually most infected mothers, greater than 90% of pregnant people who get COVID will recover without needing delivery or having any long-term problems. Now, if a pregnant person does get COVID, they are at an increased risk for developing severe disease compared to people who are not pregnant. So although pregnancy doesn't make it more likely for you to get it, if you do get it, you're more likely to have severe disease that requires that you need to go into an intensive care unit and may require mechanical ventilation. And in rare cases, something called ECMO, which is extra corporeal membrane oxygenation.

Nicole: Part of that may be be, I think that we probably in pregnancy are going to be a little more aggressive with treatment because we're treating two patients. So that may be part of it. But the data shows what the data shows and that is that if you get it while pregnant, you're more likely to have severe disease. Other risk factors or risk factors, rather for severe disease include age greater than or equal to 35, obesity, hypertension in pre-existing diabetes, not gestational diabetes, pre-existing diabetes. And I mentioned that, yes, there have been some deaths reported 57, but it is very low the number, and it's not an excess. As a matter of fact, it's lower than those in non-pregnant women of reproductive age. Now, as far as delivery, infected women do have an increased frequency of preterm birth and Cesarean birth, especially those who develop pneumonia.

Nicole: But we really believe that that's not because of the virus itself. It's more so that delivery helps facilitate care of the mom. When you had things like pneumonia or lung conditions in general, having a pregnant belly or pregnant uterus is going to decrease the amount of space and capacity of the lungs. So delivery may help with that. Also, if you're pregnant and fighting off an infection and you're having to take care of the pregnancy and your body's also fighting off this infection, if we can reduce the stress or the workload on your body, by delivering the baby, then that may be a reason to deliver. So that's why we think there's an increased frequency of preterm birth and Cesarean birth, not because of the virus. But just because it's better to help care for mom. Now, if you do get COVID during pregnancy, once 14 days has passed, and every hospital, every place is a little bit different.

Nicole: Everything's changing all the time, but roughly once 14 days has passed from that positive test result, you're treated like everyone else. So if you have COVID during your pregnancy, once 14 days has passed, when you come in for labor, you're treated like anybody else. So no difference or changes there. Now, if you are positive or you have active COVID at birth, there are some things that are slightly different. Some things that are still the same. So you can definitely still have a vaginal delivery. There is no data that shows that Cesarean birth is necessary just because of a positive test. You can still get an epidural, if you want an epidural. You cannot, however, do nitrous oxide, nitrous oxide is an inhaled medicine to help with pain control. And we can't guarantee like, you know how the equipment is sterilized, how the equipment is clean specifically for COVID.

Nicole: Is it like being aerosolized into the air? So you can't do nitrous oxide. Now, one of the biggest things is can you have a support person? And we're leaning towards, or most facilities, recognize that a support person is important. So there can still be one support person who can stay with the laboring woman. They can't leave the room and return. They have to stay and stay with the person the whole time. They can't be going back and forth. They also can't have any symptoms. They also can't themselves have had a positive test within 14 days. Some places may also say if it was someone who was exposed to a confirmed case within 14 days, they can't come in. That can be tricky because if it's your partner and you're positive, then they have likely been exposed to you, a confirmed case. So there may be a role for your partner getting a rapid COVID test.

Nicole: And if their test is negative, then they should be allowed to come in. But we haven't said that you can't have any visitors or support people at all. When you're laboring, they just have to be screened appropriately. And it has to be one person in stay the whole time. Okay? So there's a question of whether or not your baby can get infected if you have COVID, that's still under investigation. There is no definitive evidence that the Coronavirus crosses the placenta and can infect a baby. There are a few cases of placental tissue or membranes that have tested positive for the virus and a few cases that may suggest intrauterine infection, but it's really not definitive at all. And then we also think some of the neonatal cases may be false positive results, or it may be that the baby got it shortly after birth. Even if babies get it shortly after birth, um, reports of infection have been very mild.

Nicole: All right. So what happens postpartum? If a mother has known COVID 19, this has been, um, a big deal in terms of both separating moms and babies and breastfeeding. I'm going to talk about both of those. So of course, if mom is positive, baby is going to be tested and isolated from other healthy infants. Until we know the results of the test. As far as mother newborn contact in the hospital, this is an area where I disagreed with my hospital's initial stance. We have since changed, and most facilities, I think have come around and have changed. But initially there were certainly a lot of separating moms and babies with very little evidence, no evidence that it made a difference. However, now we're recommending not separating mom and baby or making an individual choice and discussion about it. It should not be automatic to separate mom and baby.

Nicole: The baby's risk of getting coronavirus from the mother is low. And data suggests that there is no difference in risk of neonatal infection, whether the baby is cared for in a separate room or remains in the mother's room. I think a lot of that is because even if you separate them in the hospital, how are they going to remain separated when they go home. Like that doesn't make any sense to me. So instead we should like do things to help them exist in the same space as safely as possible, because it's not going to be possible that you're going to be separated from your baby for a long times when you're, you know, you just had a newborn baby once you go home. Now, even if moms and babies together, if mom is, is COVID positive, mom should wear a mask. Practice, of course, good hygiene during contacts with their baby, and then physical distancing, where possible between the mother and the baby.

Nicole: So place the baby in like a crib, uh, away from mom when mom is not breastfeeding. And I'll talk about breastfeeding in a second. Now there are some factors to consider in terms of rooming in, like I said, we know that rooming in helps with breastfeeding. It helps facilitate bonding. So again, it should be recommended, but separation may be necessary if mom is too ill to care for the baby at the time, or if mom needs a higher level of care. For example, moms and babies being in the same room is something that can happen on the regular postpartum floor, because that's what they're used to. But if mom needs to be like in an ICU or what's called a step-down unit, a unit outside of the postpartum floor, then babies can't go with moms to those other units. Those other units aren't equipped to take care of babies.

Nicole: Their separation may also be necessary if the baby is, um, needing more care. So for a preterm baby that needs to go to the NICU, the mom and baby may be separated. That's going to be the case. If you have a NICU baby in general, or if the baby has some underlying medical conditions, they may need to be separated. Now we do know that separation doesn't make sense. And of course this, this makes sense. If the baby tests positive for coronavirus, then there's no need to separate mom and baby. That's not going to be useful. And then of course, if separation happens, then the baby should be away from other healthy babies. So if mom after discussion decide, you know what, I, I don't, you know, I want to be separated from my baby. If that's what you decide, then the baby is going to be separate from other babies in the full term nursery.

Nicole: So usually it's like a smaller room where the baby is. And then finally, if there's another healthy family member who does newborn care. So if dad is providing care or you know, another family member, then they should use masks. They should use gloves. They should wash their hands in order to reduce any possible risk of getting it. If the baby happens to have it. And then finally, if another healthy family member is providing that care, like diapering, bathing, feeding those things, then they should use appropriate protective equipment in that small chance that the baby is positive. So they should wear a mask. They should wear gloves and wash hands. Now, how long does a symptomatic mom who has COVID have, well, I should say how long does a mom who has COVID have to be separated from her baby or do all of these, I shouldn't say separated, do all of these measures with the mask and distancing before you can stop doing those? And it varies a little bit whether or not mom is symptomatic or asymptomatic. So if a mom is symptomatic, then there should be at least 10 days since the symptoms first started, it could be up to 20 days, if mom has more severe disease. Also, there should be at least 24 hours since their last fever, without the use of anti fever medications. So you can't still be on medications to bring your fever down, 24 hours of no Tylenol, no ibuprofen or Motrin, those medications to bring your fever down. And then other symptoms have improved. Okay? So you're not coughing anymore. You're not short of breath anymore. Your taste has come back. Those symptoms have improved. So all of those things have to be the case for a symptomatic mom in order to not do the mask and things.

Nicole: When you're in contact with your baby for an asymptomatic mom, it really just needs to be 10 days since the positive test. So that's a little bit more simplified. Okay. So what about breast milk? The general consensus is that breastfeeding should be encouraged even for moms who are COVID positive because it has benefits for both moms and babies. We do not know whether or not it can be transmitted through breastmilk because very few breastmilk samples have been tested. But from what we've seen so far, I mean, I'm going to say fewer than a hundred samples have been tested. It has not shown up in breast milk. You do need to take some precautions, like of course, washing your hands, wearing a mask, washing your breast before breastfeeding, but breastfeeding should continue and be encouraged. The other option is that you can pump breastmilk, express breastmilk, and then a healthy caregiver can give the breastmilk to the baby.

Nicole: Of course, mom has to, you know, use, um, wash your hands and still wash the breasts before pumping and then even wear a face mask during pumping. All right. So how do we prevent transmission? And I'm going to talk about the regular things and then the vaccine. So the best way to prevent COVID-19 is to avoid being exposed to the virus. So the CDC recommends that everyone should wash your hands often, either with soap and water for 20 seconds or hand sanitizer that contains at least 60% alcohol. Of course, avoid close contact with people who are sick, socially distance of maintaining a distance of at least six feet, cover your mouth and nose with a mask. When you are around other people cover your cough or sneeze with a tissue and then throw the tissue in the trash, clean and disinfect frequently touched objects and surfaces daily.

Nicole: And then also with the mask wearing them, especially in public settings or when around people, I'm sorry, in public settings. And when around people that are outside of your normal household, you don't have to be inside your house wear a mask, obviously, but if you're out and about you're in public settings, wear a mask, especially when social distancing is difficult to maintain. And what we've seen is that masks help prevent people who have COVID-19 from spreading the virus to others, from people who have mild symptoms or no symptoms, it prevents them from spreading the virus to others. All right. So let's talk about the COVID-19 vaccine. There are actually numerous vaccines in development. According to the New York Times vaccine tracker, there are 57 vaccines in clinical trials, 86 vaccines in preclinical development. I am going to focus on the two most likely vaccines that are going to be available.

Nicole: First in the U S, one is from Pfizer, and one is from Moderna. The Pfizer vaccine is two doses that are given three weeks apart. It's a muscle injection. It has an efficacy of 95%. And I'll talk a little bit more about that in a second. As of this recording, it was just FDA approved for emergency release use. It does require storage at very cold temperatures, minus 94 degrees Fahrenheit. Um, so there are some logistics in terms of shipping and stores that are going to have to be worked out, but they have been actively working on this for quite some time. The Moderna vaccine is two doses that are four weeks apart. It is also a muscle injection. It has an efficacy of 94.5%. It also has to be stored in cold environments, either refrigerated or minus four degrees Celsius. So again, there are some things with transportation and storage that have to be worked out and they have been working on this for quite some time as well.

Nicole: There is an FDA hearing on December 17th for emergency use of the Moderna vaccine. Now both of these vaccines use a new technology using something called mRNA, which is messenger RNA. So let me explain how that works. So vaccines in general, work by giving your body a piece of the bacteria or virus, not the whole thing. So just a piece of it. And typically your body recognizes it and makes something called antibodies. Okay, those antibodies will help attack the virus or bacteria if you're exposed to it in the future, because you have those antibodies already build up. If you're exposed to it again, those antibodies quickly pop on to that, that virus and attack it before you can even get sick. So all of that happens without you actually ever having the full disease. That is how vaccines work now, traditional vaccines, like the flu vaccine actually uses an inactivated virus.

Nicole: The pertussis vaccine, the hepatitis B vaccine use a part of the virus that triggers an immune response. This particular vaccine uses messenger RNA. So let me try to explain, or let me explain how this works. So messenger RNA is genetic material that our cells read in order to make proteins. Now, the Coronavirus has something called spiked proteins on the outside. And literally, if you see a picture of it, it looks like spikes all on the outside and those spikes are proteins. So what this vaccine does is it wraps a piece of that Coronavirus, mRNA that codes for those spike proteins. So it wraps that piece of Coronavirus mRNA in a protective material. And that is the reason why the vaccine has to stay so cold because it helps to keep that mRNA in that protective material, until it can be delivered into your body cells.

Nicole: So you get the vaccine and then the particles get released into your body. And what happens is those particles bump up against the cells in your body. They fuse with the cells in your body, and they release that messenger RNA inside the cell. Your cell will read that messenger RNA genetic material, and then make those Coronavirus spikes. So your body makes just the spikes, but not the whole virus. Okay? So those spikes then migrate to the surface of the cell. As cells die, pieces of those spikes will be in your system. Those spikes will then migrate to the surface of the cell. Also, as cells die, pieces of those spikes will be in your system. Your body's going to recognize those spikes as is foreign and make antibodies to them. And then those antibodies will be available to attack Coronavirus cells, if you're exposed to them in the future.

Nicole: Okay. That's sort of a simplified version of how messenger RNA works. There is a couple other things about how it works to stimulate your immune system, to be able and ready to attack a Coronavirus if you're ever exposed to it again. But that's a simplified version of how it works. Now, one question that people have is how did the vaccine get approved so quickly? Because usually it takes 10 to 15 years to develop a vaccine. This has come out in under a year from, you know, starting to look at this to production. So a big part of it. And there are several key reasons. A big part of it is that the U S federal government invested billions of dollars into Pfizer, into Moderna so that they would start producing the vaccine before the development stage was complete. So the government said, hey, we're going to pay you for producing this vaccine.

Nicole: Even if it turns out that the vaccine that you produce doesn't work. So the government, the federal government, we, the taxpayers took on the burden, the risk of these companies being able to produce this vaccine before it was completed. So when the companies had this financial reassurance, they started manufacturing this vaccine before the clinical trials were even complete. So vaccine has been already manufactured for a while. Now, another reason that it was able to come to market so quickly is that scientists have already been studying other Coronaviruses like SARS for a while. So they already had some understanding of these types of viruses. There was also a really big international effort in global cooperation and sharing information to help get these things moving quickly. And then another reason is that, uh, the trials have been conducted in areas that have high numbers of COVID-19.

Nicole: So when you conduct trials in areas that have high numbers, it doesn't take long to reach the number of cases to show a benefit or to show efficacy. They also made it so that efficacy was defined by any case of COVID-19 not just whether or not it was severe. So any case of COVID-19, so that made it so that they needed fewer participants in order to show a benefit. Okay. And then the final reason is that how this came to market so quickly is that they did a little bit of combining phases of the vaccine trial. So vaccine trials typically happen in four phases, the preclinical to, I guess, almost five, really the preclinical phase, where they test a new vaccine on cells and they give it to animals like mice or monkeys. And they're actually, as I said, in the beginning 86 preclinical vaccines, still in development, then there are phase one safety trials where they give the vaccine to a small number of people to test the safety, to come up with the right dose, also confirms that it actually does what they say or want it to do.

Nicole: Then the phase two trials scientists give the vaccine to more people, hundreds of people. And then they typically split it into different groups. So it could be like children, the elderly, women, to see if the vaccine acts differently in different groups. This gives more information about safety and the ability to stimulate the immune system. Now, in the case of this vaccine, the phase one and two trials were combined in a lot of cases. So that helped to speed things up in terms of getting it to market. Now, the final phase before, like post-marketing survey phase is phase three or efficacy trials, and this is what all the talk has been about recently is the results of these efficacy trials. So the way these work is that scientists give the vaccine to thousands of people and participants are randomly assigned. That means like flipping a coin to either receive the experimental virus vaccine or a placebo, which is just normal saline.

Nicole: Then they wait and they see who develop symptoms of COVID-19 and test positive. Now, an important thing about these trials at phase three is again, they're randomized and they are double blinded, meaning the participants don't know what they got, the people taking care of the participants don't know what people get. The investigators don't know what people get, they are blinded or masked to what groups people are in. The data is kept in a separate place it's firewalled and stored away from any of those people. And then analyzed separately in order to protect the integrity of the results. So when you do trials like this, gold standard, randomized, double-blinded, controlled placebo trials, this determines if the vaccine protects against the Coronavirus, it measures the efficacy rate, which is, you know, how well is it at reducing, um, COVID-19 disease, any disease, not just severe disease.

Nicole: And they're usually, uh, big enough to show any evidence of like rare side effects that might have been missed in some of those smaller phase one and two studies. Now for the Pfizer vaccine, the phase three trial began in July of this year, and they have enrolled over 43,000 participants. Now, according to the press release and the now data revealed, um, at the FDA hearing, the vaccine is 95% effective, beginning 28 days after the first dose or seven days after the second dose, that's based on 170 confirmed cases of symptomatic COVID. And again, it could be any severity anywhere from a mild, you know, cough or fever to more severe disease. And 162 of those cases were in the placebo group. Eight of those cases were in the vaccine group. So again, 43,000 participants, there were 170 cases across all 43,000, 162 people in the placebo group and eight people in the vaccine group.

Nicole: And a confirmed case was someone who had a CDC defined symptom and a positive PCR test. So a positive test to look for the actual Coronavirus itself. Okay. There were 10 severe cases of COVID-19 in the trial. Nine of those were in the placebo group. And one was in the vaccine group. Pfizer has reported that the vaccine was equally effective across gender, ethnicity, race and age, it's over 94% effective in adults aged 65 years and over. That's important because there are really vulnerable population, about 42% of global participants. And 30% of US +participants were from racially and ethnically diverse backgrounds. And anywhere from 41 to 45% of participants were 56 to 85 years of age, again, that vulnerable older population, but all of these trials continue afterwards to continue monitoring data participants will be monitored for two years, following the second dose to look for any long-term safety issues or effectiveness.

Nicole: Now, keep in mind that this trial, like all of these trials, um, was not big enough or long-term enough to rule out or look for like very, very rare but serious events. And of course it doesn't look for any events that could happen months to years after vaccination. Now, the Moderna phase three trial, that's the other vaccine that's going to come to market in the U S, had 30,000 people in the phase three trial. They state that their vaccine is 94% efficacy against COVID-19 and a hundred percent efficacy against severe COVID-19 starting two weeks after the second dose of the vaccine. Of the 30,000 participants, there were 196 cases of COVID, 185 of those cases were in the placebo group. And 11 were in the vaccine group. Of those 196 cases of COVID, overall 30 were severe. And all of those severe cases occurred in the placebo group.

Nicole: Ooh, y'all, I'm trying to get through these numbers. I hope you are understanding everything. All right. So the Moderna vaccine reports that the efficacy was consistent across age, race, ethnicity, and gender, and the most common adverse events. Oh, actually I don't think I've talked about the adverse events in the, um, Pfizer trial, the most common ones, and they were small, less than 5% were, were fever and, um, like muscle aches and fatigue and for the Moderna it's injection site pain, fatigue, muscle aches, headache, and then redness at the injection site. And that's typical of most vaccines that we see in terms of side effects or adverse reactions. Okay. Now I do want to say a couple of quick things about efficacy in particular vaccine efficacy measures, how well a vaccine works at preventing disease in vaccinated people compared to unvaccinated people under ideal clinical trial conditions.

Nicole: Okay? So these are going to be the most ideal circumstances. We have to keep in mind that it may be a bit different when the vaccine is introduced in quote unquote, the real world. We just don't know yet. There's also the fact that we don't have research on whether or not the vaccine actually reduces transmissibility of the virus, meaning whether or not it can reduce your chances of passing on the virus to a vulnerable family member or passing it on to somebody. So we know that the vaccine can prevent symptoms of COVID-19, but there has been some concern that the vaccines could lead people to become asymptomatic spreaders, especially if they don't wear mask after they receive the vaccine. So this is still something that we don't know yet. Research is still coming. It's just too early to conclude that the vaccine both prevents symptoms and protects close contacts from catching COVID-19.

Nicole: Okay. So last thing I want to end with are what are some things that pregnant and lactating people should consider if they are offered a Coronavirus vaccine. I believe especially that pregnant healthcare workers are going to be offered the vaccine. So I'm going to give you some advice or things to consider when making the decision about whether or not to get it. Now, the first thing that I'll say is that no pregnant or lactating people were in any of the studies or in any of the studies on the vaccine trial. So we have literally zero data on what happens in pregnant and lactating people. Okay. We have zero data on short-term outcomes, long-term outcomes. We have nothing that is actually very, very common that pregnant people are excluded from studies, like pregnancy and lactation are conditions of exclusion. A lot of that revolves around legality and not wanting to be sued.

Nicole: If there is an adverse event that happens, there's definitely a lot of push within, um, scientific organizations, the NIH, um, uh, I don't know, necessarily the NIH, I should say ACOG, SMFM, which is the Society for Maternal Fetal Medicine to open up studies and allow pregnant people to participate in clinical trials. If they want to. Now I do get a little bit frustrated because although there's a lot of talk about opening up studies, there's very little talk about like the practicality of enrolling pregnant people in studies and how to manage some of those legal risks if they occur. So, yes, although I do believe that pregnant people should have the option if they want to be in the study. Yes, of course they should be permitted to make a study, be in a study if they want to, that that decision should be made for them.

Nicole: We have to do some more like investigating because I think even if we suddenly said like sure pregnant, people can be in a study, there are a lot of other things like, how are we going to recruit? What assurances can we provide? All of those things. And honestly, practically I don't think a lot of pregnant people will want to participate in studies unless it's something that's really, really serious that affects them just informally. I did like an Instagram poll and something like 90% of people said that they would not participate in a clinical study while pregnant. Again, that doesn't mean that they should have the choice taken away from them, right. Because 10% of people said they would. So that's an ongoing sort of debate within our, our specialty in our field. Okay. So whether or not you get the vaccine, think about whether you have health or medical problems that put you at an increased risk for getting severe COVID-19 disease during pregnancy.

Nicole: So although most people recover again, 90% will recover during pregnancy. They won't need hospitalization. They won't need anything major. There is a small subset who experienced more severe disease. So if you have underlying heart disease, if you have underlying lung disease, if you have diabetes that existed before pregnancy maybe you want to consider, whether or not it's worth it to you, or whether you want to accept the risk and get the vaccine while you're pregnant. You also want to talk about whether or not or think about whether you have an occupation that puts you at an increased risk of infection. For example, like I said, healthcare workers or people who work in long-term care facilities and are pregnant, may be more likely to benefit from getting that vaccine. And then maybe also consider, you know, if you're healthy, you're able to socially distance, you're fine with wearing a mask and wearing it properly and wearing it at work.

Nicole: All of those things, some healthy, pregnant people may prefer that approach over taking a vaccine that doesn't have safety data yet for pregnancy. And then finally, if you've already had COVID-19, then you may have some natural immunity. We don't know yet whether or not that happens. We don't know how long it lasts. We don't know how much protection it confers. If you've had COVID-19 before, we don't know if it's like the flu where you can get it repeatedly. So we just don't know that information, but you may want to decide, or, you know, hey, I had this cold earlier in the year, could that have been COVID and get tested and see if you have antibodies and make a decision like that. We don't have a lot of data to guide us, but that is something to consider. If you already had COVID, whether or not your benefit from the vaccine, having had COVID-19 before was an exclusion criteria.

Nicole: You can not participate in the clinical vaccine trials. So it really is an individual decision. You have to think about it and you have to do what you believe works best for you. Either way you're taking on risk. It's just a matter of what risk you're willing to accept. Now for me, and I'm going to talk about this in the context of if I was pregnant, of course, I'm not pregnant because I've had two children and they're 11 and 13 and I'm 46 years old and there's no way I'm having any more children, but, but if I were pregnant, I'm gonna be honest. And I'll be honest because, and I'm saying it from my own perspective, because people ask me about my own perspective. I think sometimes we shy away, especially medical professionals from, you know, wanting to sway people with our own perspective. But I'm just going to say my perspective.

Nicole: I'm not swaying. This is just my thoughts. Y'all ask. So I'm gonna say for me, it makes me uncomfortable that this hasn't been studied in pregnant or lactating people at all. Like we have zero data and that this particular messenger RNA vaccine technology hasn't been used in pregnant people either. It's not like there's another vaccine that's developed that was similar to this that has been used. Now, this vaccine has been used or this type of messenger RNA has been used in cancer treatment. So we do have some information that it has been used before, um, and been used very safely. So there is some reassurance there, but it hasn't been used in pregnant people and the vaccine, again, hasn't been studied at all. I'll also be honest as a black woman, I still have some lingering thoughts about, you know, there's a long history, complicated history, in the past of scientific research and mistreating black people in horrific ways.

Nicole: Okay. And that does not happen today. It really doesn't. But some of that thought that just linger and sorta kind of lingers in the back of my mind. So if for me, if I were pregnant, I would probably not get the vaccine if I'm honest. And if I did that, then I would be accepting the risk that I could get COVID. Now, I don't know. I can't say that I wouldn't change my mind or that if, uh, you know, in the beginning of pregnancy or if it's been out for a while, I'm saying like, if right now, today and the vaccine was available tomorrow, and if I was pregnant, what I may may do. So that's what I'm saying like today. But again, there is accepting that would be accepting that risk that I could get COVID okay. Now, on the flip side, you could be someone who that 95% efficacy is really important to you.

Nicole: You work in a high risk environment, you have really bad asthma, or you have really, you know, difficult time controlling your diabetes. You feel that you are at a higher risk. Well then in that case, maybe it may feel more comfortable for you to accept the unknown risk of the vaccine. We know that based on other vaccines, vaccines in general are very, very safe. They have minimal or no side effects even in pregnancy. So the likelihood based on the data that we have, that anything serious is going to happen is very, very low. So you may be comfortable accepting that unknown risk. You may decide something like, um, you know, maybe I'll wait until after the first trimester. We know that that's when most of the organogenesis or everything forms. And then after the first trimester, everything's just getting bigger. So maybe you want to wait until after the first trimester to theoretically reduce any risks, but you may be willing to accept that risk perfectly fine.

Nicole: So I do think it should be the choice of the pregnant or lactating person. It's not a decision that should be made for them. Also a pregnant or lactating person should not be coerced to have the vaccine. So if you're a healthcare worker, you should have the option. You shouldn't have to have it as a requirement for you to work, but if you want it, then you should have access to it actually. So far in the UK, pregnant people cannot get the vaccine. It's a reason to exclude people from getting the vaccine, and that has been causing a little bit of discussion. And it's actually not uncommon like what they're doing in excluding pregnant people is not unusual. That's typically how vaccines are rolled out and administered. So it's not different. It's just that some people are saying that, hey, this is different for pregnant people that they get.

Nicole: It can be more severe, so they should have access to it. Again, give pregnant people to make the choice for themselves. Okay. And the last thing is like, if you do want it, when can you get it? So it's been estimated there'll be enough vaccine to vaccinate about 30 million people in January in the U S. 50 million people in February more thereafter. Pfizer is planning to produce 1.3 billion doses in 2021, Madonna expected to produce 1 billion doses. First doses will likely go to healthcare workers and residents who live in long-term care facilities. That is about 24 million people. So January we'll be focused on getting those people vaccinated. And then after that, the CDC, CDC is probably going to recommend that, um, essential workers like teachers, police, food workers, get vaccinated next, and then followed by adults with underlying conditions that put them at higher risk, like diabetes, hypertension, and then seniors, age 65 and older.

Nicole: So once all of those groups come through, we believe that the general public roughly will probably have access into February, March, April, or April at the latest. We really don't know when anyone who wants it can get it, but roughly they expect March or April. Again earlier, if you fall into one those different populations. Now that timeline of course could get changed. If there are any manufacturing difficulties or shipping difficulties or storage difficulties, but that is just a rough guideline. Okay? So just to recap, COVID-19, as we know is a serious public health problem. Pregnant people have the same symptoms as non-pregnant people. Typically cough, headache, muscle aches, fever, shortness of breath, loss of taste. Pregnancy does not appear to increase susceptibility to infection. Most infected mothers, greater than 90%, will recover without any problems, but they are at an increased risk for severe disease that requires ICU admission or more intense care.

Nicole: It does not appear to be transmitted from mom to baby. If you are positive at birth, you can still have a vaginal delivery. Separation is not recommended. Breastfeeding is encouraged. You can prevent transmission the same way everyone else does. Wash your hands, wash your hands, wash your hands, avoid sick people, wear masks in public places, wipe down surfaces. And then finally getting vaccinated is a personal choice. If you want it, you should have access to it. And there's nothing to suggest thus far that anything about this vaccine is going to be harmful. And then my final reminder is if you have not gotten the flu vaccine, the flu is still around. So get the flu vaccine, if you haven't got it. All right. So there you have it. Be sure to subscribe to the podcast on Apple podcast or wherever you're listening to me right now, Spotify, Google play.

Nicole: And I would love it if you leave an honest review in Apple podcast in particular that helps the show to grow. It helps other women to find the show and get all of this good, great information. Do also come check me out on Instagram. That's my favorite social media platform. And I'm doing more and more there like live Q and A sessions, actually answering some of these other questions in this episode came from folks DM-ing me after the, um, after I posted a story poll. So I definitely take suggestions and ideas and interact with people on Instagram. So do check me out there. Oh, and I'm at Instagram @drnicolerankins. I should say where you can find me. That's @drnicolerankins. Okay. So 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.

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