Best Practices to Improve Maternal Immunization

About the Webinar

This webinar emphasizes the importance of maternal immunizations, provides updates on current recommendations for maternal immunizations and the future of maternal immunizations, shares practical tips to incorporate immunizations into your practice, and identifies and locates resources for providers and patients regarding immunizations.

Learning Objectives

Upon completion of the presentation, the participants will be able to:

• Emphasize the importance of maternal immunizations
• Update on current recommendations for maternal immunization and the future of maternal immunization
• Discuss practical tips to incorporate immunizations into your practice
• Identify and locate resources for providers and patients regarding immunizations

This webinar is supported by an independent educational grant from ASTHO. ACOG does not allow companies to influence ACOG’s programs, publications, or advocacy positions.

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Video Transcript

Moderator: Hello, everyone, and thank you for joining us today. My name is Gary Lee from Blue Sky. Today's webcast is entitled "Best Practices to Improve Maternal Immunization" and will focus on the importance of maternal immunizations as well as practical tips to incorporation immunizations in your practice. This webinar is supported by cooperative agreement from the Centers for Disease Control and Prevention (CDC) and the Association of State and Territorial Health Officials (ASTHO). Its contents are solely the responsibility of ACOG and do not necessarily represent the official views of CDC or ASTHO.

Before we get started I would like to take a moment to acquaint you with a few features of this web event technology. At any time you may adjust your audio using any computer volume settings that you may have. Please hold all questions until the end of the presentation. On the right side of the screen you will see the Q&A window. There's a large window which holds all of your questions. To send a question click the text box and type your text. When finished, click the Send button. All questions that you submit are only seen by today's presenters. Your questions will be responded to in the order in which they are received and will be addressed at the end of the presentation.

I would also like to remind everyone that you can download the slides from the presentation website today by clicking on the file in the Downloads box on the right-hand side of your screen. If you experience technical difficulties at any time during this webcast, please use the Help button that is shown at the top of your screen. The faculty and planning committee wish to disclose the following information.

Now, please let me introduce our program faculty for today's webcast. Dr. Geeta K. Swamy is Associate Professor in the Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine at Duke University and serves as Director for Obstetrics Clinical Research. Dr. Swamy has extensive experience conducting both epidemiologic and clinical trials involving pregnant women. She has a particular interest in maternal immunization during pregnancy and the postpartum period, and has led several trials involving influenza, Tdap, GBS, and RSV vaccines during pregnancy. She is the co-PI for Duke's NIAID-funded vaccination treatment and evaluation unit and the CDC-funded clinical immunization safety assessment project. She has served on numerous advisory boards involving the conduct and ethics of research in pregnant women and other vulnerable populations and serves as the lead chair for the Duke University health systems institutional review board. She was recently appointed as the Associate Dean for Regulatory Oversight and Research Initiatives at the Duke School of Medicine and will be leading new initiatives in e-consent and biobanking.

Also joining us today is Dr. Linda Eckert. Dr. Eckert is Professor of Obstetrics and Gynecology and Adjunct Professor of Global Health at the University of Washington in Seattle, Washington. A Carlton College graduate, she completed medical school at the University of California San Diego and residency in obstetrics and gynecology at the University of Texas in Houston. She worked in Nicaragua and Kenya before joining the faculty at the University of Washington in 1992. She went on to complete an infectious diseases fellowship in the Department of Medicine and engaged in research in vaginal and uterine infections. With the advent of multiple vaccines for our patient population she transitioned her focus into OB-GYNs as immunizers. In 2009 she had a sabbatical at the World Health Organization in the Department of Immunization where she was the HPV vaccine focal point. Since returning to the University of Washington she has continued to serve as a consultant to WHO and other global health organizations on HPV vaccine and cervical cancer screening, as well as other immunization efforts including maternal immunization. Dr. Eckert has published in numerous journals, including The New England Journal of Medicine, has authored multiple guidelines, including CDC treatment guidelines, WHO cervical cancer screening, and HPV immunization guidelines. She is active in ACOG, including the expert immunization advisory committee, and on the ACIP HPV vaccine workgroup. She is currently serving as the obstetrics lead for GAIA, Global Alignment of Immunization Safety Assessment, in pregnancy project.

Please review the learning objectives for this presentation.

And now, without any further ado, please welcome Dr. Geeta Swamy.

Geeta Swamy, MD: Thank you so much. I'm very glad to be here today, and thank you for all the participants. We hope that you'll, in addition to the learning objectives, get a sense of how important vaccines are for our providers for ob-gyns to take care of the women that we serve each day.

So, as stated here, vaccines are not just for children anymore. If you look at the World Health Organization (WHO) and the CDC, or Centers for Disease Control and Prevention, you'll find that vaccines are actually only second to clean water as providing the greatest public impact on protecting human lives. And that goes to say that it's the same for maternal vaccination, which is indicative of giving vaccines or immunizations during pregnancy. There are routine recommendations for children, adolescents, and adults, and those recommendations are reviewed and reaffirmed or updated on an annual basis by the Advisory Committee on Immunization Practices, or ACIP, which is a committee that is managed by the CDC. And here is a link to the ACIP immunization practices website, and you can see the recommendations that are updated each year.

In addition to that, ACOG has developed and supports a website specifically focused on immunization for women, immunizationforwomen.org, and covers the adult, maternal, and childhood or adolescent immunization schedule, as well as many resources, provider tips, information for patients as well to focus on the work at hand.

When we think about maternal vaccination, we really look at it as the important strategy that we have to try to protect against infectious diseases that particularly threaten newborns and young infants as well as the mother. The three areas that have gained much focus over the last few years are in tetanus, influenza, and pertussis. There are also new vaccines on the horizon in development to administer both for maternal benefit as well as potentially for infant benefit also. And the two infectious diseases that have vaccines furthest down the line towards licensure are for group B streptococcus, or GBS, and for respiratory syncytial virus, or RSV.

So, there are many benefits of vaccinating mothers during pregnancy. We know that maternal vaccination enhances immunity for both the mother and baby because vaccines administered during pregnancy will produce antibodies that not only protect the mother from the infection but also cross the placenta and provide protection to the newborn and young infants. Antibodies that are transferred therefore provide protection during this particularly vulnerable period when a young infant or neonate cannot adequately respond to a vaccine if it was to be administered directly to him or her. And that has mostly to do with the way that the immune system works early on in life. And it's not that they're necessarily immunocompromised, but more so that they just can't generate enough antibodies yet for it to be protective. Also, we know that breast milk provides significant protection to the infant, and so antibodies that could be transferred through breast milk could also contribute to protection against those infectious diseases.

So, let's switch gears and talk specifically about some vaccines that are recommended directly for pregnant women, and we'll start with influenza. So, we know now, particularly from influenza pandemics, we've learned that influenza infection itself is associated with significant morbidity and mortality during pregnancy. In the influenza pandemic in 1918 mortality was associated with infection mostly during the later part of pregnancy: about 50 to 60 percent mortality incidents in pregnant women who had influenza. In the pandemic that occurred in the late 1950s, about 50 percent of women of childbearing age who died of influenza were pregnant. And ten percent of all influenza deaths that season occurred in pregnant women, and again towards the end of pregnancy.

Since 2005 we have had additional pandemics. If we start looking at the H5N1, which is one of the avian flu strains, we have documented data on six affected pregnant women, four of whom did not survive. And among the two survivors, they both had spontaneous abortions, or miscarriages. In postmortem studies there actually was some evidence to suggest maternal to fetal transmission by the placenta of those infectious pathogens. We also know from interpandemic case reports that complications have occurred from influenza in pregnancy even during nonpandemic seasons, and the majority of the complications, particularly around mortality, occur in the later stages of pregnancy or immediately in the peripartum period.

So, many of you very likely remember, as it was not that far off, the influenza H1N1 pandemic of the 2009-10 timeframe. And at that time we have lots of data supporting the concerns and complication risks of influenza in pregnancy. We found during that pandemic that pregnant women were at high risk to be hospitalized, to be admitted to the intensive care unit and require mechanical ventilation, and suffer death from influenza infection itself, particularly again in the later stages of pregnancy, or among those women who might have other comorbid conditions like asthma, chronic hypertension, and so forth.

Five percent of all reported 2009 H1N1 deaths in the United States occurred in pregnant women, which is of course disproportionate to the general population, when only one percent of the population of the US is estimated to be pregnant at any one time. The median age of mothers who died was about 25 years, but that ranged from 14 to 43 years of age, and a severe illness in the postpartum period and increased rates of prematurity were also documented. Clear evidence showed that delayed diagnosis and treatment increased the risk of death.

So, what do we know about the newborn infant benefits of vaccination? So, we certainly have evidence to show that vaccinating mothers with influenza vaccines prevents influenza infection in the mother. But what can it do, then, for the fetus and newborn-to-be? So, we know that in women who get influenza vaccines during pregnancy there is a decreased risk of acquiring the influenza in their infant for the first six months of age, and that decreased risk of influenza-related hospitalizations follows as well among those young infants. There also appears to be improved pregnancy outcomes that have been reported in varying rates across studies, such as a decreased risk of prematurity as well as low birthweights.

So, what are the recommendations, then, for influenza vaccination? So, in line with the CDC recommendations from the ACIP, the ACOG Committee Opinion #608 specifically describes influenza vaccination as an essential part of prenatal and pre-pregnancy care. It's documented that pregnant women have increased morbidity and mortality from influenza, and that neonates are also at those same risks but unfortunately cannot be vaccinated until six months of age simply due to lack of efficacy of the vaccine. So, we know that keeping mothers healthy during pregnancy overall protects the fetus and young infant from overall morbidity and mortality, and certainly hope to decrease that chance of early delivery or prematurity.

So, the recommendation for influenza vaccine during pregnancy is it should be given to every pregnant woman unless they have a specific contraindication, which are very few. Pregnant women should receive the inactivated vaccine and not the nasal spray, which is a live vaccine. They can receive the trivalent or quadrivalent vaccine, whatever is in supply or easily obtainable in your area. And the flu shot is certainly okay, and actually recommended, to be administered, even while breastfeeding. The flu shot has, again, been shown to protect both the mother and her baby up to six months of age from getting influenza.

As I mentioned before, children younger than six months of age cannot receive the flu vaccine, so protecting the mom therefore can protect the baby. Again, maternal antibodies cross the placenta, therefore providing protection to the newborn. An additional way to protect that newborn/young infant is by vaccinating family members and caretakers, which is a concept known as cocooning, by providing a surrounding lower risk of getting exposed to the infection itself. So really, everyone who will be around a newborn baby or young infant, such as siblings, grandparents, babysitters, other caretakers, should really be encouraged to get vaccinated. And we should always promote good handwashing practices, in general for overall health care but certainly to decrease risk of exposure to those young infants.

So, here's some data to support some of the information I described earlier on efficacy and effectiveness. So, this is data from a study that was published in 2008 from a group that did a randomized trial in Bangladesh looking at giving women either flu vaccine or a controlled pneumococcal vaccine to see what impact it had on infants' health. In this study maternal influenza vaccine was associated with a significant reduction in influenza illness in the infants, which was about 65 percent, as well as a 29 percent reduction in any respiratory illness, and a 42 percent reduction in overall clinic visits for those infants. Specifically in the mothers, maternal influenza vaccine was reduced as far as respiratory illness and fever and fewer clinic visits in those women who received the influenza vaccine directly.

So, this figure from an article that was published in 2012 in The American Journal of OB-GYN provides some data on some additional studies following the one I just described from the Bangladesh study, provides additional data from case control and observational cohort studies that are not necessarily always thought of at the same level of evidence as a randomized trial, but as you can see, support of that data showed the same thing, that infants whose mothers received influenza vaccine had a lower incidence of having laboratory-confirmed influenza infection.

Additional data looking at the potential protection or decreased risk on adverse pregnancy outcomes has come from several studies, some being observational, some being randomized trials. The data shown here describes the effects specifically on preterm birth. The figure on the left, or figure A, describes the data from several studies shown as the adjusted odds ratio, with the 95 percent confidence intervals around it. And figure A demonstrates the data looking at any influenza vaccine, any strain that was given, and the data in figure B specifically focused on vaccines that did not contain the 2009 pandemic strain. And as you can see that overall the studies demonstrated there either is no association, given that the confidence interval crosses one, or a modest decreased risk of premature birth, especially if you look at the one, the figure that contains the strains during the 2009-2010 pandemic season, or figure A. So, the way that would be interpreted is that the overall force plot value is less than one, and therefore demonstrates that there potentially could be a decreased risk. But the good take-home message here is there certainly is not any increased risk or concern of influenza vaccine having a negative impact on premature birth.

Similar results are shown here, looking at studies that evaluated the risk of low birthweight. And these studies actually are fairly more convincing that maternal influenza vaccination is associated with a decreased risk of low birth weight. Now, whether the vaccines directly do anything to impact the growth of the baby or the timing of delivery is certainly up for debate, and more likely the case that by improving the overall health of the mother we're improving the health of the pregnancy itself.

So, let's shift the gears just a bit and think about what is our role as ob-gyn providers, and how can we be a part of the vaccination administration that pregnant women should be receiving? So, studies today continue to show that provider recommendation is the most influential factor in a patient's decision to receive immunization. Ob-gyns have a longstanding role of providing primary and preventative care for women, and we serve as a major source of ambulatory care provision for women, accounting for 44 percent of preventative care visits in adult women. Pregnant women regularly see their ob-gyn through the course of prenatal and postpartum care, thus allowing for multiple opportunities to offer vaccinations.

So, the data shown here is from the CDC's flu surveillance data, and this is going back to the 2015-2016 influenza vaccination season. And they collected data from pregnant women through a survey asking them where they received their flu vaccine. And you can see here the majority of them actually received their vaccine in a doctor's office, with nearly 37 percent receiving that in their ob-gyn or midwife's office and about 28 percent or so receiving that in their family physician or some other physician's office. But it's important to note that a significant number still received it, say, at a pharmacy or drug store kind of setting, at a hospital which likely could factor in women who might have been admitted to the hospital during the season at their workplace, and at health department settings. But clearly, ob-gyns are playing a significant role, and we hope that that will continue to increase given our emphasis and need for providing this service to our patients.

So, this figure actually demonstrates, again, looking at vaccine coverage. This is data, again, from the CDC, as you can see the links at the bottom to find these figure online. The orange line actually demonstrates vaccine coverage or uptake. So, in the '15-'16 season, the most recent data shown here, approximately 50 percent of pregnant women reported having received influenza vaccine during that season. But you can see that over the last five years or so that provider recommendation, which is shown in the blue line, is the recommendation and offering of vaccine has certainly increased, and that the gray line is women who reported receiving no recommendation from their provider about influenza vaccine uptake or that they should be getting the vaccine. So, we hope that the blue line and those orange lines will continue to increase as our efforts and educational resources are increased for both providers and patients.

And in addition, the pregnant women were asked in that same survey about why they might have chosen to accept or receive influenza vaccine, and the majority of women, again, chose it either to protect their baby from influenza or to protect themselves from influenza. And obviously, I think we would all agree that those go hand in hand. But still, around 14 percent or so said that they accepted the vaccine or received the vaccine based on provider or medical professional recommendation. So, you can see that there's still a significant potential for us to impact that just by including it our routine prenatal care and recommendations.

So, I would argue that health care personnel really should be the example. We should be out there ourselves talking about how important it is for us to get vaccinated as well as our patients. It's important to make sure that all of our staff members are vaccinated. During the 2015-16 season that the CDC has that same data published, they reported about an 80 percent coverage rate for health care personnel. But we do know that the coverage or acceptance of vaccine is highest among health care settings where vaccination is actually a requirement, and then we're reaching upwards of 96, 97 percent of vaccine coverage. So, it's important to make sure that both you and your family are vaccinated and to make sure you're educating your clinical staff on the importance of vaccinating themselves as a way to demonstrate support for their patients.

So, lastly, I just want to touch on any questions about safety. We talked a lot about the benefits of vaccination, but as with all things that we provide and recommend for our patients we always have to think about that in a balance of looking at safety at the same time. And so, how is safety monitored for vaccines, for influenza vaccine in particular? It really is not necessarily different across the United States, which is good, and there's not necessarily specific differences by vaccine, although there some specific differences in how we survey and monitor safety in pregnancy. So, VAERS, or the Vaccine Adverse Event Report System, is a national program that's managed by the CDC and the FDA, or the Food and Drug Administration, which monitors the safety of all vaccines licensed in the United States. Anyone can provide or file a VAERS report, and that data is readily accessible by the CDC and can be queried by bodies such as ACOG or research sponsors such as NIH and so forth.

In addition, the Vaccine Safety Data Link is also sponsored by the CDC, and it is a vaccine safety system that is built upon a large electronic health record system from a significant managed care organization in the United States, and it's used to both monitor for safety events as well as assess specific queries of adverse events that may be of question or concern.

And lastly, VAMPSS, or the Vaccines and Medications in Pregnancy Surveillance System, focuses on specific targets or new vaccines that may be coming out, and looking specifically in pregnant women.

So, if you look specifically at influenza vaccinations and safety in recent studies over the last two decades, data coming out of VAERS reports that covers several million women vaccinated, there have been no concerns or questions of any increased risks of adverse events or pregnancy outcomes versus what we would expect from background rates.

And lastly, it's clear looking at the comparison between influenza vaccination versus influenza infection that vaccine is certainly safer than infection during pregnancy. The Norwegian Birth Registry and other national registries out of the country published data back in 2013 looking at well over 100,000 pregnancies during the 2009-2010 pandemic. About 54 percent of women in the registry were vaccinated again, mostly in the second and third trimester. And of those women that were part of the registry there were about 492 fetal deaths, which is about 4.3 per 1000, in Norway at the time, and outside or off-pandemic years that rate is about 4.1 per 1000. So, slightly increased. Vaccination during pregnancy substantially reduced the risk of influenza infection diagnosis in pregnant women, and among those with influenza the risk of fetal death was significantly increased, while the risk of fetal death was reduced with vaccination. Among those that had live birth there was no association of vaccine with preterm delivery, low birth weight, or low Apgars.

So, I'd like to turn things over to Dr. Eckert. She will pick up with things related to tetanus and pertussis recommendations.

Linda Eckert, MD: Thank you very much, Dr. Swamy. So, now we are going to shift gears and we're going to move forward talking about one of the other vaccines that we recommend in pregnancy, which is the tetanus, pertussis, diphtheria vaccine.

So, what is Tdap? This contains tetanus, diphtheria, and pertussis antigens so that you will develop protection against all three. And there are different combinations that can be used, so it can be confusing of Dtap versus Tdap, diphtheria-tetanus, tetanus-diphtheria, what does a capital letter or what does a small letter mean? And essentially, the capital letter is the dose strengths that are given to children under seven, and the lowercase letter means that there is a dose strength that's used more in adults. And so, what we use is Tdap. In contrast, if you have small children, they will get Dtap. And so, just to clarify, for pregnant women and maternal immunizations, in adults what we use is Tdap.

So, what is pertussis or, the whooping cough? Pertussis is an infection that's caused by Bordetella, which is a gram-negative bacteria, and this has a very subtle incubation, meaning that you won't realize that you're that sick. You have kind of a runny nose, a little bit of feeling like a mild cold for seven to ten days, and during this time you don't feel ill enough to stay home, but you're very infectious. So, you go to work doing your job because you don't want to take days off, and you are quite infectious. The incubation time is seven to ten days. But then you start to develop the cough, and it's the cough that causes the major challenges. And this is very strong paroxysms of cough, or coughing spells, that continue actually for four to six weeks.

There is a clinical case definition essentially that a cough illness that lasts at least two weeks with either the paroxysm of coughing, the whoop – which is that you're coughing so hard it's hard to get your breath, and so when you breathe in you get that "whoop" sound; this happens more in small children or you can be coughing so hard that you get vomiting; sometimes you actually get low on oxygen. And so, the clinical case definition is when you have a cough of at least two weeks that's quite a severe cough without another apparent cause. This cough is a very significant one. It can lead to rib fractures, weight loss, pneumonia, seizures, incontinence, even death. And I think that it's important to realize this is a cough that is not just a cough associated with the common cold.

Pertussis is one of the leading causes of vaccine-preventable deaths worldwide. We may not hear about it that much in our country in adults, but 5 in 100 adults who have it are hospitalized, and it remains a serious infection in young infants. I became interested in Tdap actually, in vaccines in pregnancy more in 2006. I had a pregnant patient who was 26 weeks pregnant who acquired pertussis, and she coughed so hard that she broke her rib. She had to be hospitalized, she went into preterm labor, and she delivered her infant at 28 weeks. And it was during this time that ACOG was coming up with their initial recommendations for Tdap, as was ACIP, and her story and caring for her and seeing how hard she coughed, witnessing the pain that she had when she broke her rib from coughing certainly is one of the factors that's led me to be a huge advocate for this vaccine.

And while we talk about Tdap in adults as causing significant challenge, really it's the infants that die. There is a large number of studies that show this, that the real risk of death from pertussis comes in the youngest. And what we do when we give the vaccine is we try to protect those youngest. And this is a study that looks at pertussis cases or, this is an accumulation of data from the CDC, and what you can see in this graph is that there is an increase in pertussis cases that happened from 2010 to 2015. And during this time is when we've been trying to get the most word out about Tdap and Tdap vaccines. Again, this is data that shows who dies from pertussis, and when you look at this slide you see that there's a large burden of cases in those under one year of age. That's where the majority of people get the cases that lead to death. There may be more cases in the 11-to-19-year-olds and in those who are over 20, but the ones where the deaths occur are the infants aged less than one. And these are the groups that we can target when we give the Tdap vaccine.

Again, this shows the same type of data, looking at pertussis incidence by age group. And the red line is those children less than one year of age, and you can see that they acquire pertussis at a much higher rate per 100,000 than older individuals.

So, how are we doing as far as pertussis cases go? Some states are doing better than others. Some states show that there is a decreasing rate of pertussis, and this is in the light green – so, you can look at your state and see where you are versus an increasing rate of pertussis in the dark green. And despite all the press that has been given about pertussis and Tdap, we can see that there still is a lot of work to do and we still do have pertussis cases increasing compared to 2012 in many areas, including in the Washington, D.C. area.

So, what does ACOG say? Well, the ACOG Committee Opinion #566 (currently revised and replaced by Committee Opinion #718) states that a dose of Tdap vaccine should be given to all pregnant women, preferably between 27 to 36 weeks of gestation, and this should be given during every pregnancy. Now, Tdap has had an evolving history. Initially, when it was recommended it was given to postpartum women, but now the recommendations are to give it in the third trimester, and it needs to be given during every pregnancy. This is because the transplacental transfer of antibodies from the mother to infant provides protection against pertussis in early life. And again, if you remember the data, it's the early life where people are the most vulnerable to death from pertussis. We know that the immune response to the vaccine peaks at about two weeks after administration, and so it's recommended to give it preferably between 27 and 36 weeks to optimize the antibody transfer and the protection at birth.

We also know that the vaccine pertussis antibodies wane over time, or decrease. And therefore, in order to get a high enough level in the mom that she can pass the level on to the baby and protect the baby, we boost the mom with a pertussis or Tdap injection during every pregnancy, and that way we can guarantee that the infant receives the high level of protective antibodies. In our practice we routinely do Tdap when we offer and do the glucola in all our patients. Those are orders that just go together so that way, we try to get the vaccine in everybody early in their third trimester.

We do know that immunizing pregnant women does protect the infants. In England there was a large pertussis outbreak in 2011 to 2012, and they had many deaths in newborns less than three months. England has a national health system and they were able to quickly change policy based on this data and mobilize and initiated a program to immunize all pregnant women between 28 to 37 weeks. They found looking at their data that they were 92 percent effective in preventing infant pertussis if the mother receives a vaccine at least seven days before birth. And they also were able to do safety monitoring and found no safety issues for these 23,000 infants whose mothers received Tdap in their third trimester. So, this was a great nationwide effort that definitely showed the benefit of Tdap in pregnancy.

And this is a graph that shows this, and you can see how if you look at the spikes on the right side, those cases of pertussis are increasing in all age groups, but especially the less than three months of age. And then, the drop in the spike is the time when they started initiating the Tdap vaccine to all pregnant women. So, within a short period of time they were able to markedly lower the cases of pertussis that were occurring and to save many lives.

There are several studies that have been looking also at Tdap vaccine safety data during pregnancy, and there has not been any association with an increased risk or preterm birth or small babies. Similar to what Dr. Swamy discussed for flu vaccine, we have the vaccine safety data link that we've been using to assess the risk of maternal Tdap, and this has been very reassuring. And there also has not been any association with Tdap with other pregnancy complications such as hypertension in pregnancy. And so, similar to the flu vaccine, everything that we're seeing for Tdap is quite reassuring. In contrast, acquiring pertussis as an infant or as a pregnant woman can be quite devastating.

So, we are continuing to monitor this. Because pregnant women are receiving the vaccine during each pregnancy that's the recommendation some pregnant women will be receiving several vaccines in a short period of time, and therefore it is important to continue monitoring safety. And what I usually tell my patients is that we are looking hard. We are looking for patterns of adverse events; we're not seeing anything. We're looking at the vaccine safety database and not seeing any increased risk. And we're also looking for side effects and showing that it's well-tolerated in both pregnant and non-pregnant women, including those pregnant women who are receiving a repeated Tdap dose. So, again, the evidence is compelling that this is not causing adverse effects for pregnant women and their babies. And we are continuing to look, as Dr. Swamy talked about, this is ongoing surveillance assed carefully and commonly. And so, I feel like we are able to offer quite a bit of reassurance to our patients when they ask us about safety.

We do know that when babies receive or, when moms are given the pertussis vaccine that there have been effects on the severity of pertussis in the infants infants. If the infants do happen to acquire pertussis because no vaccine is perfect, and so some infants may acquire pertussis even though their moms receive Tdap, those infants are older when they develop pertussis. They're at 45 days versus 35 days. And this may not sound like much difference, but actually it is clinically significant, and statistically significant as well. And so, giving the Tdap vaccine to the mom will help delay the amount of time before the infant will acquire pertussis, and they have less severe symptoms, they have a lower risk of hospitalization, and lower ICU admissions. And there have not been any deaths due to pertussis in those infants born to vaccinated mothers. So, again, this just reinforces the idea that you are doing your babies a big favor by vaccinating the women and the mom.

And so, what is our role? Again, we are the most influential factor in a patient's decision to receive an immunization. We do provide primary preventative care to women. We account for a lot of preventative care visits for women over 18. And of course, we see our pregnant women regularly over the course of their prenatal and postpartum care, so we have multiple opportunities to vaccinate. And in some ways, though, these multiple opportunities can be a challenge because you say, "Oh, if I didn't get it in this time, I can get it next time." And so, that's for instance in our practice why we routinely give Tdap at the same time we do the glucola.

Cocooning, which is an idea that Dr. Swamy mentioned also for influenza, has certainly been a strategy for pertussis, which is the idea that you can protect the infants by vaccinating all those close to them. In pertussis we know some of the cases that infants acquire most cases come from family. They can come from grandparents. They come from siblings. They come from parents. And so, in 2005, ACIP recommended cocooning, which is giving Tdap vaccine for all those who come into close contact with their infants younger than one year of age, including care providers such as day care centers or nannies. And it's shown that when you do the cocooning and you do the maternal Tdap vaccination and you do the childhood Dtap series, that that certainly is the best protection for the infant.

We as providers also have an opportunity to educate our pregnant women and tell them to have their dads, their grandparents, other caregivers be up to date with pertussis, and I would add flu vaccine as well. And I routinely talk to all of my patients in the mid-third trimester just to say, "Hey, has everybody – have the grandparents who are coming, who's coming to help you after the baby, have they immunized against flu and Tdap?" And I've had a lot of patients actually tell their grandparents, "You can't come until you get your vaccine."

So, how then do we go about trying to incorporate immunizations into our practice? It is not always easy to change a culture in ob-gyn, to see ourselves as immunizers. And there are a few things that have been published as far as increasing immunization rates in practice. One of them has been to offer an educational seminar on the value of vaccines. If you have a practice where you use interpreters or you use people outside your own office staff, it's very helpful to educate them on vaccines. We did this during H1N1. We have a lot of interpreters in our clinic and we held a series of teaching sessions with them on the value of the H1N1 immunization so that in their own communities and as they translated they would feel comfortable why we were recommending the vaccine to our pregnant women.

We also offer a lunchtime seminar in our clinic every August and September as the flu shot comes out to nursing and clinic staff to highlight the importance of flu vaccines so that everybody has a chance to ask questions. There is data definitely showing that if your office staff, when they're checking patients in, is not a proponent of vaccination, that will influence your vaccination rate. And so, it's really helpful to just share information to give people a chance to ask questions, to share safety information with everybody in your office.

You also need a vaccine champion in your office. This is the person that will order your vaccines, that will make sure that your refrigerator is working where you stock the vaccines, that will make sure you have your vaccine information handouts. And on the ACOG immunization website there are excellent resources for what it means and how to become a vaccine champion. And it definitely is helpful to have that point person in your office. It's also helpful to have a secondary point person for when that vaccine champion goes on vacation or is sick. And certainly, requesting that your staff have to opt out of flu vaccine and Tdap vaccine and that those who opt out need to watch an educational video or sign a paper, Dr. Swamy showed the data that if you have requirements for flu vaccine unless you do these steps, you have a 96 percent vaccination rate in your office. I work in a hospital setting, and so we have very strict opt-out criteria, but I think there is compelling data to show the impact of flu vaccine on staff as well as educational opportunities for staff. And so, I would consider changing the culture in your practice if you don't have that already to really encourage everyone in your office to become vaccinated.

Lastly, you can use standing orders for flu vaccine and for Tdap so that you don't have to actually remember every time to write the orders yourself. We place a sign on our front desk when the flu vaccine is in, and it says that the flu vaccine is available and it's strongly recommended. We have a multicultural practice, so we have the sign translated into several different languages. And we also hang signs in our bathrooms, like "Help prevent your baby from catching the flu or whooping cough." Again, I think as providers who care for pregnant women, one of our main benefits that we can tell our pregnant patients is the benefit they offer to their infant when they themselves get vaccinated. So, we really try to publicize this in our office. And many of us with our electronic health records now have reminders about vaccines that pop up in our patient charts for us to see. We also could have the opportunity to send out messages to our patients.

And so, at this point we will stop and we will have the opportunity for questions. And feel free to be typing your questions in. I can see some of them already.

Moderator: Dr. Eckert, let me just if I can, just before we get into the Q&A portion, let me just remind folks how to submit questions. If you would like to ask a question, you'll find the Q&A window on the right side of your screen. There's a large window which holds all your sent messages and a smaller text box at the bottom where you will type in your questions. To send a question, click on the text box, type your text. When finished, just click the Send button. So, let me throw it back to you, Dr. Eckert and Dr. Swamy, for the Q&A portion of today's program.

Geeta Swamy, MD: Okay. Hi, this is Dr. Swamy. I think that I'm going to take the first question.

The question reads: "For the flu vaccine, does the pregnant woman have to have the preservative-free vaccine?" So, the easy answer to that is no. Preservative-free is simply the issues that get around concerns in the public related to things like thimerosal or other preservatives that might be in a multidose vial vaccine product so as to prevent contamination from, say, bacteria every time you insert a needle in to draw out the product. Instead, what many places will choose to do simply to avoid that issue, which has not been scientifically proven to be a concern but still could make it difficult for you to counsel your patients and their acceptability, if you utilize the single doses where they're already packaged and you essentially attach the needle to administer, those will not contain preservatives. But again, it's not required that you do that. It's perfectly fine to administer vaccine that comes out of a multidose vial. It's really more of a workflow process and the choice you may make in your practice.

I think I'll take the next one too, if that's okay, Linda. So, this is from Patti that says: "If a woman is pregnant through two flu seasons, spring and fall, should she receive flu vaccine during both seasons?" So, the first answer is probably yes, and it has more to do with the fact that the flu vaccine itself changes from season to season. So, seasons are defined by the timing that flu virus is circulating through your area or your community, and we generally follow the recommendations from WHO that come from what's circulating in the southern hemisphere and then sort of migrate upwards north. So, from one spring to the next fall the strains of the vaccine may very well change. So, in general you should just plan that women should get one vaccine during the flu season so, it doesn't matter how recent that may have been that they just got vaccinated.

Linda Eckert, MD: Okay. I will take the next question from Deborah which says: "Since the CDC recommends only one Tdap, what do we suggest for the dads?" And we do suggest actually that the dads get the same vaccine that they get. If they've not been vaccinated, they should definitely get the Tdap before the infant is born.

And then, the next part of this question is: "Currently, with more same sex couples adopting newborns, I feel we are missing this population as adoptive parents." And I think that's a very good point. Adoptive parents also should be immunized. Again, all people who are going to be caring for the infants should be immunized against Tdap and flu, and that this is a very important component of caring for the baby. And that word definitely needs to be spread through adoptive parents.

So, the next question is: "In addition to screening pregnant women from rubella immunity, should we be thinking about screening pregnant women for measles immunity? I worry about young women who never received MMR vaccine giving birth to babies with no maternal protection to measles." And I think this is a good point and it's one that will be getting more interest now that we're having more measles in our country. Measles is very infectious. You need wide herd immunity. You need about 95 percent to 90 percent of people to be immunized against measles to keep your population base intact. And we definitely have been seeing measles cases sporadically around the country.

At this point, we aren't recommending doing measles antibody testing routinely, but I think if you have patients that you are particularly worried about and you're in a pre-pregnancy setting, they don't know that they've ever received the measles vaccine, I think this is a very reasonable idea.

So, this is a question from Carla that says: "Has ACOG partnered with WIC Program to promote and reinforce prenatal vaccines?" I don't know that ACOG has actively partnered with WIC Program to promote and reinforce prenatal vaccines, but that is certainly something we can learn more information about and provide that back as feedback later after this seminar is over. I think the question, that was a really good one, which is partnering, and how can we partner as broadly as possible to increase the amount of people that are using vaccines and the message, and so I really appreciate that, actually.

This is a question about: "How often should day care workers get the Tdap vaccine?" Currently, it's recommended that they have the vaccine at least within the last five years. And so, that's the recommendation that we are using.

Geeta Swamy, MD: So, the next question, it asks: "Do adjuvants and additives of the vaccine cross the placenta?" So, that's a very good question. At present we don't have a tremendous amount of data to support whether it does or not, partly because adjuvants and additives are very small particles and for the most part are local effects. So, the way adjutants are supposed to work is they're supposed to stay when you give that intramuscular dose they're supposed to stay there in the muscle and help to increase that immune response. So, to actually be able to find it is difficult in any human studies, but those studies are actually being conducted presently in animal models to date. Right now we don't have any data to suggest that they absolutely do cross the placenta. And if they did, remembering it's something that goes through metabolism, through the mother, then potentially something that crosses the placenta, it would have to be in literally extremely small amounts and therefore possibly not even detectable.

I'll take the next question as well. It's a question that says: "There is a different in the vaccines between Dtap and Tdap from Honduras, and we just have Dtap for children. I don't if I can use that one for pregnant women." So, there are actually differences between the two vaccines. The actual antigens within them are the same but it actually goes about the amount or the dosage. Dtap itself has higher antigen amounts than Tdap. So, what could happen is it would not be necessarily abnormal or overly detrimental to give the Dtap vaccine, except that it could cause a higher response or reaction, even a significant local reaction, because the antigen load is much higher.

If you are able to get Dtap, it is possible that it's the same manufacturers who make Dtap who make Tdap, at least in the United States. The only manufacturers are GlaxoSmithKline and Sanofi. Those are the only two producers, but they make both vaccines, so it is possible you could get it from the same manufacturer.

Linda Eckert, MD: Okay. I'll take the next question that says: "I didn't know cocooning was a recommendation now, in California at least." So, the primary recommendation is absolutely to vaccinate the pregnant mom, to vaccinate her against Tdap and to vaccinate her against flu. And this definitely should be the emphasis that you place in your practice and the emphasis of the message that you give to your patients. And it's very consistent with what ACOG and ACIP recommends. Cocooning as a strategy, however, is also a good strategy. It's simply the idea that whoever is going to be around this infant should also be protected against flu and pertussis.

And so, I would say that we are not saying not to cocoon. We are definitely saying to emphasize immunizing the pregnant woman, but that cocooning itself is still a term that is talked about and is encouraged, simply because we'd like everybody who is around this baby to be protected against these diseases.

Okay, so then the next question is: "Are consent forms needed for vaccines in the OB office?" And the answer, I think, might depend on your particular practice. We certainly don't use consent forms, and I know, Geeta, you could potentially add on to this. Legally, I think you need to ask the patient and you need to talk to her about it. And it is recommended and required to give her an information statement that the CDC puts out on every vaccine called "Vaccine Information Statements." But as far as signing a written consent we certainly don't do that. Geeta, do you do that in your practice?

Geeta Swamy, MD: No. The same here: We do not have any required consent. I think that pediatric offices might have consent forms, but we do not have any such in our adult clinics or in our obstetric clinics. And as Linda mentioned, the VIF sheets are great information to provide your patient. What we usually do in our clinic is that the nurse provides that information sheet even before giving the vaccine because if often has FAQs or answers questions they may have. And those are available publicly and for free on the CDC's website, and are often in additional languages. I know they're in Spanish and they may be in a few other languages as well.

I think we have a couple minutes. I'm going to go to the next question or two. The first one is: "What is the earliest age to immunize a pregnant mother for flu and Tdap?" So, in actuality flu vaccine can be given to any individual it's universally recommended now at six months of age and up. So, there's no difference except for the first time that a child would receive its vaccine dose. And for the first two years of life the vaccine dose is a smaller amount than it is in adults. So, really, any age that we would be seeing young adolescent or adult women who are pregnant could get flu vaccines during the season.

As far as Tdap it would be the same, as long as they would have gotten their adolescent dose of Tdap, most likely. But again, if they're pregnant, it wouldn't matter if they had gotten that or not. So, they would get the Tdap vaccine, because it is the same vaccine administered to adolescents and adults. So, there really is no earliest age for women we'd be seeing who would be pregnant.

I think I will try to answer this one more question so, a question from Gregory Lewis says: "Can polysaccharide 23 vaccine be used during pregnancy – for example, an asthmatic pregnant patient?" While we didn't cover this in the talk today, there are recommendations on polysaccharide pneumococcal vaccine for use in pregnancy. And it should be given if you think that there are conditions that are indicated by the adult recommendation schedule, such as asthma or lung disease, cardiovascular disease, diabetes, and so forth. So, in our clinic where we are seeing maternal fetal medicine, where we see high risk patients for various medical conditions, we routinely administer pneumococcal vaccine to our patients that have a medical indication.

Moderator: All right. We are out of time, so I'd like to thank – very much thank our presenters, Dr. Swamy and Dr. Eckert, and you as well, our attendees. This concludes our program for today. Again, we thank you for joining us. Have a great rest of the day and we'll see you next time.