Maternal Immunization: Understanding Safety and Efficacy, and Making a Strong Recommendation

About the Webinar

This webinar emphasizes the safety and efficacy of maternal immunizations, provides updates on current recommendations for maternal immunizations, shares tips for talking to patients and making a strong recommendation, and identifies and locates resources for providers and patients regarding immunizations.

Learning Objectives

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

• Discuss the scientific evidence supporting maternal flu vaccination safety and monitoring
• Educate pregnant patients about the importance of an annual flu vaccine
• Name three components of a strong recommendation
• Use CDC, ACOG, and ACNM messaging and resources to address patient questions and concerns regarding flu immunization

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, thank you for joining us today. This is Don from Blue Sky. Today's webcast is entitled Maternal immunization: understanding safety and efficacy and making a strong recommendation. We’ll be focusing on the current recommendations for maternal immunization, providing an overview of the available safety and efficacy of maternal immunization, and offer methods to address the topic of maternal immunization safety with patients.

This webinar is supported by cooperative agreement from the Centers for Disease Control and Prevention and the Association of State and Territorial Health Officials. Its contents are solely the responsibility of ACOG, ACNM and do not necessarily represent the official views of the CDC or ASTHO.

Before we get started I'd like to take a moment or two 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 you may have. We ask that you please hold all of your questions until the end of the presentation. On the bottom of your screen you'll see the Q and A window. There's a large window, which holds all of your sent messages and a smaller text box at the bottom where you'll type in all of your questions. To send us a question, please click in the text box and type your text. When finished click the send button. I'd 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.

Before we move further into our presentation 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.

If you experience technical difficulties at any time during this webcast, please use the help button that is shown on your screen. The faculty and planning committee wish to disclose the following information.

Now please let me take a moment or two to introduce you to our program faculty for today's webcast. Dr. Lakshmi Sukumaran is a medical officer for the Immunization Safety Office at the Centers of Disease Control and Prevention, Atlanta, Georgia. The Immunization Safety Office conducts post-licensure safety monitoring of U.S. vaccines. Dr. Sukumaran's primary work focuses on maternal vaccine safety studies in the vaccine safety data link. She earned her M.D. and MPH degrees from Stony Brook University. She completed her pediatric residency at the Albert Einstein College of Medicine. And pediatric infectious diseases fellowship at Emory University. And also completed a T32 fellowship in vaccine safety at Emory University atthe CDC. She's board certified pediatrics and pediatric infectious diseases.

Ms. Ashley Brooks is a health communication specialist serving as the lead for adult and maternal immunization communications at the CDC in the National Center for Immunization and Respiratory Disease. Prior to her time working on adult and maternal immunization communications, she worked on seasonal influenza communications in the CDC NCIRE. She has a master's degree in public health from the University of Tennessee at Knoxville.

And we ask you to please take a moment to review the learning objectives for today's presentation.

And now with no further ado, I will turn the audience over to Dr. Sukumaran.

Dr. Lakshmi Sukumaran: Hi, everyone. My name is Lakshmi Sukumaran and today I'm going to be talking to you about the safety of vaccine's and pregnancy. Before I discuss the safety of vaccinations in pregnant women, I want to just start off by reminding everybody why vaccination during pregnancy is an important issue.

As you may recall, the 2009 H1N1 swine flu pandemic was especially dangerous during pregnancy as there were many deaths in pregnant and post-partum women both in the United States and worldwide. In 2010, we also experienced a pertussis epidemic in which many young babies died before they were old enough to get their infant vaccines. These tragedies have highlighted the importance of vaccinating pregnant women. So in today's talk, I will review influenza and pertussis infections during pregnancy and recommendations for vaccination during pregnancy. I will describe the CDC vaccine safety monitoring process. I will discuss results of inactivated influenza vaccine or IIV and Tdap vaccine safety studies in pregnancy. And I will provide a brief recap.

So vaccinations during pregnancy protect the mom and the baby. Influenza and pertussis infections are more severe in pregnant women and neonates. For influenza, there are physiologic changes during pregnancy including altered cardiopulmonary mechanics and cell mediated immunity that lead to more severe disease in pregnant women. And there is approximately a five times increased risk of death from flu especially during the second and third trimesters. Infants are unable to get the flu vaccine until six months of age and require two doses, one month apart. So they aren't fully immunized until seven months of age at the earliest. They are also more susceptible to severe disease and can only be protected via antibodies from maternal vaccinations during this time period.

Infant pertussis is also more severe and potentially fatal. In the United States, infants typically get vaccinated at two, four, and six months and get a booster of the pertussis vaccine at 15 to 18 months. However, most pertussis deaths occur in infants less than three months of age and they rely on passive antibody transfer from maternal vaccination for protection.

So this figure further demonstrates the changes that occur in mom's immune system during pregnancy. As estrogen and progesterone levels increase during pregnancy, the mother's immune system shifts to increase humoral immunity, seen in blue, and decrease cell mediated immunity, seen in red. That helps to protect the fetus. However, these changes also lead to an increased susceptibility to severe influenza infection.

This figure shows the potential impacts of exposures during pregnancy. In the pre-implantation period or the zero to two weeks gestation, injury to a large number of cells can lead to spontaneous abortion. In the embryonic period from two to nine weeks gestation, exposures can lead to major birth defects and altered functions of organs. And in the fetal period from nine weeks to term, exposures can lead to small for gestational age, inter-uterine growth restriction, fetal death, minor malformation, and altered function of organs. And these are all important to keep in mind when we study the safety of exposures during pregnancy.

So now I'd like to review our current recommendations for influenza vaccine during pregnancy. The first recommendations by the Advisory Committee on Immunization Practices or the ACIP were in 1960. 1957 was actually a pandemic influenza year in which there were deaths in pregnant women that prompted a specific recommendation in 1960 that included pregnant women. Between 1960 and the 1990s pregnant women were not mentioned in the general influenza vaccine recommendations. But in the '90s, the second and third trimester pregnancy were noted to be high risk periods. And a recommendation for vaccination during pregnancy reappeared. In 2004, this recommendation was expanded to include first trimester pregnancy as well. And most recently, in 2017, the recommendations read that any licensed, recommended, and age appropriate vaccine can be administered during pregnancy. And this includes the newer recombinant influenza vaccine.

So for Tdap vaccine, in 2006, the ACIP first recommended a Tdap booster to post-partum mothers and family members. And this is following a 2005 epidemic year that impacted young infants. In 2011, the ACIP first recommended Tdap during pregnancy for previously unvaccinated pregnant women. And then most recently in 2012, Tdap has been recommended for every pregnant woman during every pregnancy regardless of her prior immunization status. And ideally between 27 and 36 weeks gestation to maximize antibody transfer to the fetus.

So at the CDC, maternal vaccine safety is a priority. This figure demonstrates the vaccine licensure process in the United States. And after the pre-licensure clinical trials, a vaccine is licensed by the FDA and then recommended by the ACIP, our advisory committee, and that's where the CDC safety monitoring begins and these are considered phase four trials. So why is post-licensure vaccine safety monitoring important? Well, pregnant women are often excluded from pre-licensure clinical trials. In addition, these pre-licensure trials may be too small to detect rare events. And finally, safety standards for vaccines are high. They're generally given to healthy individuals and so adverse events are less tolerated.

So at the CDC, our vaccine safety monitoring occurs in the Immunization Safety Office or ISO. The ISO has three core programs, the Vaccine Adverse Event Reporting System, or VAERS, the Vaccine Safety Datalink, or VSD, and the Clinical Immunization Safety Assessment, or CISA. So VAERS is a front-line passive reporting system that's co-managed by the CDC and FDA. And VAERS receives reports from patients, providers, and manufacturers and study these reports to detect vaccine safety signals. The VSD is a collaboration between the CDC and eight participating healthcare organizations around the country. The VSD actually has specific ways in which we identify pregnancies and study the safety of vaccination during pregnancy. We're able to use the validated algorithm to identify pregnancy outcomes, start and end dates from electronic health records, and we can link pregnant women and their infants.

As part of our annual cohort, we also have information on approximately 125,000 pregnancies per year and 90,000 live births per year. In addition, for our live births, we're able to get additional information such as mother's height and weight, education, prior pregnancy history, smoking and alcohol use, and pregnancy information that we can use in our vaccine safety studies. CISA's a collaboration between the CDC and seven participating healthcare organizations, consists of vaccine safety experts that assist U.S. healthcare providers with complex vaccine safety questions about their patients, and CISA also conducts clinical research.

So now we'll discuss the influence of vaccine safety studies focusing on the mom, the baby, and the pregnancy. As for the general safety of maternal influenza vaccine, a few studies have been conducted using data from the Vaccine Adverse Event Reporting System (VAERS). One study looked at the safety of inactivated and live influenza vaccines from 1990 to 2009. And another study looked at the safety of monovalent H1N1. And more recently a study has evaluated IIV through 2016. I just wanted to remind everyone that even though live attenuated influenza vaccine is not recommended during pregnancy because of theoretical safety concerns from a live influenza vaccine; we do have reports in VAERS which can be a result of the patient's lack of awareness at the time of vaccination, lack of awareness of being pregnant at the time of vaccination, or provider errors.

For influenza safety studies looking at adverse events in the mom, a couple of studies in the Vaccine Safety Datalink (VSD) have looked at allergic reactions. Local reactions such as fever and arm swelling, and neurologic reactions have found no increased risk of these events following IIV or H1N1 monovalent vaccine. A CISA study looked at text messaging as a way of monitoring the safety of influenza vaccine in pregnancy and found that post-vaccination fevers were rare and other outcomes occurred as expected.

For pregnancy outcomes, we have had two completed studies in the VSD looking at spontaneous abortion. The first study evaluated the 2005 through 2007 influenza seasons and found no increased risk of spontaneous abortion in the 28 days following influenza vaccine. More recently, a follow up study including the pandemic H1N1 strain found an increased risk of spontaneous abortion in the 28 days following an activated influenza vaccine during the 2010 through 2012 seasons. This risk was seen in women who had been previously vaccinated in the prior influenza season. Many other studies have not shown an increased risk of spontaneous abortion following influenza vaccine. And currently a follow-up study is underway within the VSD to look at subsequent influenza seasons. We have also had VSD studies looking at medically attended adverse obstetric events in the VSD and have not found an increased risk of hyperemesis, gestational hypertension, gestational diabetes, proteinuria, and urinary tract infections following IIV or monovalent H1N1 vaccines. We've also not found an increased risk of pre-term delivery or small for gestational age following an activated influenza vaccine.

Now as for the infant outcomes, we've had a couple of studies evaluating birth defects and have not found an increased risk after IIV. And also there was a study looking at infant mortality and hospitalizations that found no increased risk of infant death or hospitalization in the first six months of life following exposure to maternal influenza vaccines. So thus far my talk is focused on CDC influenza studies. But I just wanted to mention that our CDC studies are consistent with many other studies that have been done on influenza vaccine safety and pregnancy. I don't have time to go into these studies today but I did want to highlight a few systematic reviews of meta-analysis to give an overview of some of the safety literature.

So one review looked at 19 studies, found no increased risk of fetal death, spontaneous abortion, or congenital malformations following flu vaccines. Another review looked at seven studies and actually found a lower risk of stillbirths following influenza vaccine, and no increased risk of spontaneous abortion. A third review found that in 15 studies, there was no association between congenital defects and influenza vaccine at any trimester of pregnancy but also specifically after the first trimester.

So I'll briefly mention thimerosal as there have been claims in the past that exposure to thimerosal can lead to autism. Currently, this compound is only used in multi-dose vials of influenza vaccine as a preservative to prevent dangerous bacterial contamination of the vaccine. Many studies have disproven this theory. And in 2004 the Institute of Medicine reviewed the literature and rejected a causal association between thimerosal-containing vaccines and autism. Furthermore, a CDC study evaluated prenatal exposure to thimerosal and in this case control studies found that prenatal exposures did not increase the risk of autism.

So now I will discuss the Tdap vaccine safety studies again looking at the mom, the baby, and the pregnancy. There have been a couple of studies in VAERS that have looked at safety of Tdap vaccine and pregnancy. The first was before the recommendation for routine vaccination, and the second was following the recommendation. Both of these studies have been reassuring. A few studies have looked at adverse events in the mom following Tdap vaccination. Within the VSD we have looked at local reactions, allergic reactions, and neurologic events following Tdap vaccine but also specifically following concomitant Tdap and influenza vaccines and pregnancy and following repeated doses of tetanus-containing vaccines during pregnancy. Furthermore, a clinical prospective study in CISA found that Tdap was well tolerated and there were similar reactions to the vaccine in women who were receiving their first Tdap dose compared to a repeated Tdap dose.

A few studies have evaluated pregnancy outcomes. One VSD study found a small significantly increased risk of chorioamnionitis following Tdap vaccines without an associated increased risk of pre-term delivery. A follow-up study was conducted looking at infant outcomes which I will describe on the next slide. Another study in VAERS that was a follow-up found that chorioamnionitis is rarely reported after maternal vaccinations. And other studies have looked at pre-term deliveries, small for gestational age, and have found no increased risk following Tdap vaccine and pregnancy.

As for infant outcomes, one study found no increased risk of microcephaly or birth defects following Tdap vaccines. This was prompted by concerns in Brazil when Zika virus was first discovered to be related to birth defects that the increase in microcephaly they were seeing may have in fact been due to Tdap vaccine, which was introduced around the same time. The study in infant morbidity was a follow-up to the chorioamnionitis study that previously mentioned and found no increased risk in the listed infant outcomes associated with chorioamnionitis despite the increase in diagnosed chorioamnionitis. And another recent study found no increased risk of hospitalization or death following exposure to Tdap vaccine in pregnancy looking at infants through the first six months of life.

Similar to influenza vaccine, these Tdap safety studies from CDC are consistent with the other Tdap safety studies. So now I'll provide a brief recap. Pregnant women and neonates are increased risk of complications from flu and pertussis disease. Vaccination during pregnancy is an important tool to protect pregnant women and their infants. Pregnant women are often excluded from drug and vaccine pre-licensure trials and post-licensure monitoring is crucial. The CDC has a comprehensive mechanism for monitoring vaccine safety and our studies support the use of influenza and Tdap vaccines in pregnancy and are consistent with a larger body of safety evidence. So I'd like to end my talk just by pointing out that your recommendation matters. And it has consistently been shown to be the most influential factor in a patient's decision to receive immunization and I believe that this is especially true of pregnant women and her obstetrical provider. Thank you.

Moderator: Alright, excellent. Ashley?

Ashley Brooks: Alright, thank you. So as mentioned, my name is Ashley Brooks and I'll be following Dr. Sukumaran's presentation with some maternal vaccination communication strategies. So, during my presentation I will discuss some ACIP recommended immunization schedules for pregnant women. I will discuss CDC research surrounding maternal immunization communication and the role of the healthcare provider. And then also the use of CDC, ACOG, and ACNM messaging and resources to address patient questions and concerns about immunization. So first, let's recap on ACIP's recommendation for pregnant women.

This chart lists key vaccination recommendations for before, during, and after pregnancy. It is a quick reference table summarizing important contraindications and recommendations related to maternal vaccinations. As you can see here, I have highlighted two routine vaccines that are recommended during pregnancy.

As Dr. Sukumaran mentioned, live vaccines that are administered to pregnant women pose a theoretical risk to the fetus. Dr. Sukumaran presented on some of this information that I'll go through next during her presentation but as a recap I'm going to go over some information about influenza and pregnant women also pertussis and pregnant women.

Severity of influenza diseases in the U.S. can vary widely and is determined by a number of factors including the characteristics of circulating viruses, the timing of the season, how well the vaccine is working to protect against illness, and how many people got vaccinated. Influenza infections are associated with substantial medical cost, hospitalizations, lost productivity, and thousands of deaths every year in the U.S.

Just to give you a better perspective on the seriousness of flu, on average, more than 200,000 people in the U.S. are hospitalized each year for respiratory and illnesses associated with seasonal influenza virus infections. CDC estimated that from the 1976 - 197777 season to the 2006 - 2007 flu season, 3,000 to 49,000 deaths occurred. During the 2010 - 2011 season to the 2013 - 2014 season, CDC estimates influenza associated deaths ranged from a low of 12,000 to a high of 56,000. During the 2015 - 2016 flu season, the overall burden of influenza was substantial with an estimated 25 million illnesses, 11 million flu associated medical visits, 310,000 hospitalizations, and 12,000 deaths associated.

So as Dr. Sukumaran discussed during her presentation and as a review, flu is more likely to cause severe illness in pregnant women than in women who are not pregnant. This is contributed by the changes in the immune system, heart and lungs during pregnancy making pregnant women more prone to severe illness from flu. Flu may also be harmful for a pregnant woman's developing baby. The flu shot given during pregnancy has been shown to protect both the mother and her baby for several months after birth from flu. Pregnant women have protective levels of anti-influenza antibodies after vaccination. Passive transfer of anti-influenza antibodies that provide some protection from vaccinated women to their babies has been reported. Vaccination of women while pregnant reduces risk for flu infection and hospitalization among infants younger than six months of age.

We know this is important since infants younger than six months are too young to get vaccinated. CDC, ACOG, ACNM, AASP, and ACIP recommend influenza vaccination for women who are or will be pregnant. Here we have the flu vaccination coverage among pregnant patients. The coverage as you can see has remained around 50%. So while we can look at the glass half full, these rates still imply that half of pregnant women and their babies are not protected against flu. Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a lot of evidence that flu vaccines can be given safely during pregnancy though the data is limited for the first trimester. CDC and ACIP recommend that pregnant women get vaccinated during any trimester of their pregnancy. It is very important for pregnant women to get the flu shot by the end of October if possible to help ensure protection before flu activity begins to increase.

So now on to pertussis in pregnant women. Pertussis is a nationally notifiable disease. Clinicians should notify the appropriate health departments of all patients with suspected pertussis. Since 2010, CDC sees between 10,000 and 50,000 cases of whooping cough each year in the U.S. There are cases reported in every state. In 2015, there were 21,000 cases with 22% of those among adults aged 20 plus. Provisionally for 2016, there were more than 15,000 reported cases. Whooping cough disease is most severe for infants. Pertussis in infants causes them to stop breathing and turn blue. About half of babies who get whooping cough end up in the hospital. Hospitalization is most common in infants younger than six months of age. Of those infants with pertussis who need treatment in a hospital, approximately 61% will have apnea, 23% get pneumonia, 1.1% will have seizures, and 1 % will die. Other complications can include anorexia, dehydration, difficulty sleeping, hernias, and urinary incontinence.

In 2012, the Advisory Committee on Immunization Practices or ACIP voted to recommend that ACPs administer a dose of Tdap during each pregnancy. Tdap vaccination provides direct protection for mom and indirect protection forbaby by passive antibody transfer. Getting Tdap during gestational weeks 27 to 36 weeks is 85% more effective at preventing pertussis in infants younger than two months old. Post-partum Tdap administration only provides protection to the mother, it does not provide immunity to the infant. It takes about two weeks after a Tdap receipt for the mother to have protection against pertussis. Thereby if vaccinated post-partum, she's at risk for contracting and spreading the disease to her vulnerable newborn during this time.

To maximize passive antibody transfer to the infant, healthcare providers should administer Tdap during the early part of gestational weeks 27 to 36. The level of pertussis antibodies decreases over time so you should administer Tdap during every pregnancy in order to transfer the greatest number of protected antibodies to each infant. ACOG and ACNM also support this recommendation. Cocooning alone may not be effective and it is difficult to implement. ACIP has recommended cocooning since 2005 but full implementation of cocooning has been proven to be a challenge. Thereby limiting its impact as an independent prevention strategy. Cocooning in combination with maternal Tdap vaccination and administering childhood DTaP series on schedule provides the best protection to the infant. So there's the recommendation.

So what are the bottom lines? It is recommended that pregnant women get influenza and Tdap during every pregnancy but vaccination coverage remains low. Healthcare providers recommendations have big impact on vaccination decision, so a focus on effective messaging and communication strategy is needed. So what does the communication research tell us? CDCs’ research helps us develop communication strategies and materials based on information that both general consumers and healthcare providers are seeking. The goal is to get a better understanding of knowledge, attitudes, and behaviors regarding maternal vaccines and also to provide a better understanding of provider needs and recommendations.

In 2014, CDC conducted mixed methods research comprised of surveys, focus groups, and in-depth interviews. The survey of pregnant women was an online survey of United States women aged 18 to 45 years. There were 487 respondents that were eligible and completed the survey. Additionally, CDC convened focus groups with pregnant women. There were a total of 28 focus groups of pregnant women in high pertussis incident and low pertussis incident locations. The groups were segmented by parity and language; so English and Spanish. And participants were also a mix of trimester, race, ethnicity, and socioeconomic backgrounds. There were two rounds of focus groups conducted. For the provider audience there was a survey of OB/GYNs. This online survey was sent to over 32,000 members of ACOG. Respondents all offer prenatal care and over 2,300 respondents completed the survey. In-depth interviews were also conducted with OB/GYNs and these interviews were 60-minute telephone interviews nationally. Respondents all offered prenatal care as well.

Findings from this research gave CDC a better understanding about both of these audiences regarding maternal vaccinations. And as you can see on this slide, the guiding principles for each audience may contribute to the information gaps. We want to continuously look at the most up to date data. So in the winter of 2016, CDC conducted additional research with both pregnant women and healthcare providers. An online survey, which included message testing, was administered to pregnant women. We had 251 women aged 18 to 45 years of age who were receiving prenatal care. They came from mixed household income, age, and experience with pregnancy and they had a range of intentions for flu and Tdap vaccines. In addition to the online survey with pregnant women, in-depth interviews were also conducted with healthcare providers. There were 16 OB/GYNs and eight certified nurse midwives who participated. They were from across all regions of the United States and we included those that provide Tdap on-site and those that refer.

The key findings from the research were that pregnant women were evaluated in three main buckets. Vaccine recommendations, vaccine acceptance, and vaccine decision making. For vaccine recommendations about 60% of those who received recommendations for flu vaccine and or Tdap vaccine reported they were told the vaccine was extremely or very important. For vaccine acceptance, while more respondents had gotten or intended to get flu vaccine than Tdap, there were 28% who decided not to get each of these vaccines. And for decision making, similar to what we saw for the 2014 research, pregnant women want information on safety, side effects, and ingredients of vaccines. And they also want and trust information from their providers.

In the in-depth interviews, CDC learned how providers talk about maternal vaccines to their pregnant patients. Most providers use similar flu and Tdap messaging with their patients. Most discuss Tdap and flu vaccination concurrently during the initial intake visit. Some of the key message themes that facilitated their vaccine conversations are disease, susceptibility, and severity. As well as vaccination benefits and vaccine safety. Certified nurse midwives, we included them in the interviews this time instead of just focusing on OB/GYNs, and from that we learned that they were more likely than OB/GYNS to feel uncomfortable making a strong recommendation for either vaccine as they view that as the patient decision. We also identified the best ways to reach pregnant women. Pregnant women get vaccine information from three main sources: their healthcare providers, internet health resources, and their families. However, most are not actively looking for information about pregnancy vaccines. Some pregnant women would be prompted by messages they see online to ask their healthcare provider about maternal vaccination.

So now that we see vaccination coverage, the importance of vaccine and some knowledge attitudes and beliefs about pregnant women in regard to immunizations, how can we encourage them to get the recommended vaccines they need? Pregnant women have several questions once they realize they need vaccines and may not have all the information. Such as: Are the diseases really that dangerous? Why do I need this vaccine every pregnancy? Is it not enough to make sure everyone around my baby is vaccinated? Basically that cocooning concept or if we just stay away from sick people. This audience tends to be high information seeking and may be looking to many, many resources for pregnancy information. It's important to note here that while most are seeking information on healthy pregnancies, most are not actively seeking for vaccine information. Because there are numerous existing sources, there is a need for clear, credible, and consistent information.

The National Advisory Committee or NVAC, revised the standards for adult immunization practice in 2013. These standards state that all healthcare providers including those who do not provide vaccine services have a role in ensuring adult patients are up to date on their vaccines. The practice standards include assessing vaccination status of all patients at every clinical encounter, so making sure there are no missed opportunities. Strongly recommending vaccines that the patient needs. Administering the needed vaccines or referring to a vaccine service provider and documenting vaccines received by patients in their records.

One thing you can do is present vaccination as a standard part of obstetric care. Provide your patients with information and resources about maternal vaccines during her first prenatal visit and be sure to mention the timeframe for each vaccine when discussing her pregnancy. You can assure your staff deliver consistent messaging about the importance of vaccines, this includes your nurses, front office staff, and managers. And last you can normalize vaccination as a part of your patient's pregnancy care. You may state something like, "It is October, and flu season is coming up, so that means it's time for your flu vaccine. Unless you need more information on flu vaccine, I'll have the nurse bring it in."

So now we're going to talk a little bit about that strong recommendation. This chart shows results from the internet panel survey of flu vaccination coverage before and during pregnancy for patients who visited a healthcare provider at least once and I want to just provide some clarification on the definition of terms. So no recommendation means that no recommendation of flu vaccine was given to the patient. Recommended but not offered means there was a recommendation of flu vaccine given but no vaccine was offered or to be administered on site or at all. And then last, offered, that means vaccination is available on site and ready to be administered to the patient. And then all these vaccine results are based on self-report. But I want to call attention to that offered category. And we can see that an offer from a provider can impact a patient's decision to get vaccines.

Though there are numerous sources, pregnant women turn to their most trusted source, which is their OB/GYN or their midwife. In our research, most providers say they recommend vaccines to pregnant patients yet we see that coverage rates continue to be stagnant. So where's the disconnect? A strong effective vaccine recommendation makes a difference. It is important for providers to talk to their pregnant patients about the importance of on time vaccination. Let's talk a little bit more about a strong vaccine recommendation. Our research indicates that some pregnant women do not feel their providers are strongly recommending vaccines. Providers should state clearly that they would like her to get vaccinated. An example of this recommendation could be, "Today, I strongly recommend two vaccines to help protect you and your baby. Again, the flu and whooping cough."

Healthcare providers can share information with patients. These tips are great for general vaccine recommendations with adults but also can be used in the case of pregnant women. Healthcare providers can share tailored reasons why the recommended vaccine is right for the patient. They can highlight positive experiences with vaccines. These experiences can be personal or in practice. You can address the patient's questions and any concerns about the vaccine. Remind your patients about the protection vaccines can help provide from serious diseases. So you may want to say something along the lines that, "Fall and winter are typically the times for flu in the United States. Flu can be especially dangerous for pregnant women. That is why I want to make sure I help protect you and your baby with a flu vaccine by the end of October." And then last, you can explain the potential cost of getting the disease. These costs include serious health defects with each disease for mom and baby. Time lost like missing work or family obligations and then of course the financial cost associated.

What are some resources and tools available to assist in vaccine conversations with patients? CDC has several digital resources available targeting pregnant women. The maternal CDC website frames maternal vaccinations as a part of a healthy pregnancy. These pages cover vaccines that pregnant women need before, during, and after pregnancy. We also have several web pages geared towards provider audiences about making recommendations to pregnant women. Our webpages are home to several resources including a maternal vaccine quiz that tests knowledge about vaccines during pregnancy. A motion graphic that highlights how to have a healthy pregnancy. A list that CDC developed titled “Vaccines and Pregnancy” lists the top seven things you need to know and that explains the information pregnant women should know about vaccines and how they contribute to protecting mom and baby. Also, not listed here we have web buttons that can be placed on websites to connect visitors with CDC's online resources. And one of our newer products is we have a digital toolkit that is specially aimed at prenatal care providers and it's basically a comprehensive toolkit that covers all things maternal vaccines.

We also have several print resources including fact sheets and posters. These resources can serve as a patient education tools for providers. Patient education materials include posters and videos for waiting rooms, low literacy materials, materials for diverse audiences and language needs, answers to commonly asked patient questions, and tips on providing a strong recommendation especially when making vaccine referrals. We found that moms are responsive to messaging about the importance of vaccines for protecting babies. ACOG also has several resources available including the immunization for women website, which has information on several diseases and their appropriate vaccines, and pregnancy information and resources. ACOG also has several patient and provider resources for addressing clinical guidance, frequently asked questions, vaccine recommendations, vaccine safety, coding and reimbursement, and practice management.

ACNM resources include up to date talking points for providers about immunization and pregnancy, position statements on immunization status of women and their families and on immunization in pregnancy and postpartum, frequently asked questions, posters and coloring books, a free evidence based curriculum on immunization for midwifery students and other healthcare professionals. And the “Be a Super Mom” materials that feature a superhero character and succinct information on the benefits of immunization and that's used to engage your clients. And other resources can be found on the website that's listed on this slide.

So with all the information, what can you do? The most important step is to get vaccinated. What great example you set as an individual or organization by staying up to date on your own vaccines. Next, we want you to talk to pregnant patients about maternal vaccines. We want maternal vaccines to be a part of a healthy pregnancy. Be sure to make your conversation and your recommendation effective, memorable, and compelling. Administer the indicated vaccine in your office if possible and then follow-up to ensure receipt. Use and promote the resources available and encourage others to do the same. You can promote resources and products through social media channels and you can include maternal vaccine resources in prenatal information packets. We ask that you educate your staff about maternal vaccines. You can identify someone or you yourself serve as a vaccine champion in your practice. You can encourage pregnant women to ask questions and last but not least, tell us what you need to help communicate about vaccines. You play a major role in raising awareness about the important of vaccines and CDC, ACOG, and ACNM would like to continue to support you in that effort.

That concludes our presentation. Thank you.

Moderator: Alright, thank you Ms. Brooks and Dr. Sukumaran for the presentations today. We'll now open up the line for questions for both of our presenters. You may submit your question by using the question block on the bottom of your screen. Type in the text box at the bottom and when you are finished please click enter. Alright, we'll jump right into questions here.

Our first question, if the women does not get the Tdap vaccine in pregnancy, does getting it in the early postpartum period still help even if they received it in recent year prior to pregnancy? Are any of the Tdap immunity factors passed to a baby via breast milk?

Ashley Brooks: This is Ashley, I can answer that question. So, we are encouraging women to get vaccinated in that gestational period of the 27 to 36 weeks. And as I mentioned in my presentation that we see that if women get vaccinated for Tdap postpartum, it does take two weeks for antibodies to appear. So unfortunately, if they're getting vaccinated postpartum, there is still a chance they could contract and spread that illness to their child. We mentioned earlier as well that the immunity does wear off. So that's why it's very important to get vaccinated each pregnancy. And then also Tdap immunity antibodies are passed via breast milk as well as flu vaccination.

Moderator: Alright, excellent. What is cocooning?

Ashley Brooks: So cocooning is going to be the practice where instead of just the mother or the baby getting vaccinated, you kind of rely on those around you to get vaccinated. So you know that could be grandparents, visitors, and siblings. But cocooning we see is not as effective because not everyone is going to get that vaccine. So there is still a chance you spread that illness to your developing baby - to your newborn excuse me.

Moderator: Are there any other vaccines being considered?

Ashley Brooks: So there are other vaccines that are being looked at for pregnant women. One of those being the RSB vaccine. I don't really have a lot of information. I know that might be a vaccine coming up. And actually I failed to mention but in our research that we did in 2016 with pregnant women and providers, we did ask about what's the threshold of too many vaccines during pregnancy. And most said that actually the two vaccines that are recommended are kind of where they would have their cutoff. But we did imply that other vaccines will be coming down the pipeline as they're developed and tested.

Moderator: Alright, I just want to give you a heads up that Dr. Sukumaran got disconnected from the phone and she's going to be dialing back in shortly. So at this point, we'll just continue along and we'll allow her to join us once she gets reconnected.

Our next question, anything on the progress of the group B streptococcal vaccine?

Ashley Brooks: And that actually might be a question for Dr. Sukumaran instead of me.

Moderator: Okay. Sounds good. And just a heads up for the doctor if you could please dial back in using the previous number and then hit star, 45, 45, pound we will return you to the conference. And we can revisit that question that we just presented. And the doctor is back with us. We have an attendee doctor wondering if you have anything on the progress of the group B streptococcal vaccine.

Dr. Sukumaran: The group B streptococcal vaccine is one of the vaccines that is being developed in the pipeline that would target pregnant women, but I don't have any specific information on when that is expected to be ready for use in pregnant women.

Moderator: Alright, excellent. Next question is: I'm wondering what doctors are telling patients about influenza vaccine in the first trimester especially in light of the recent studies showing possible association with SAB.

Dr. Sukumaran: So I'm happy to talk more about the spontaneous abortion and influenza vaccine finding. If you see the slide, I can just give some background on the study and then I can talk about what the CDC recommends for talking to pregnant women. So background rates of spontaneous abortion range from 10 to 22% and as a result miscarriages following influenza vaccine not necessarily attributed to the vaccine are expected. We do have limited data on first trimester influenza vaccine exposure and as I mentioned there was a systematic review that looked at seven studies that showed no elevated risk of spontaneous abortion. Unfortunately, observational studies do have limitations. So even if we find associations, we can't prove that flu vaccine was the cause of the miscarriage. And as I also mentioned previously, the original study from 2005 to 2007 seasons found no risk.

The follow-up study is expected to be available in 2019. So the CDC has some guidance on how to talk to patients about SAB and states that healthcare decisions should be an ongoing discussion between the provider and patients and that providers should use clinical judgment based on factors including the patient's health status, the local influenza activity, as Ashley mentioned, we try to vaccinate by October before the flu activity increases. And also the benefits and risks from flu vaccination when deciding whether and when to immunize their patients against influenza.

Moderator: Alright, thank you very much. Up next, for family members, how often should they get boosters? At a recent OHSU conference in Portland, the panel suggested every five years.

Dr. Sukumaran: Is this for flu or Tdap?

Moderator: The questioner can follow up and give us a heads up on which one they were referring to. And in the meantime, we'll move on to another question. And that question is when is the optimal postpartum time for VZV and MMR vaccines if indicated?

Dr. Sukumaran: As far as I know, they can be given any time after the delivery. So often they're given prior to discharge from the hospital.

Ashley Brooks: That's correct.

Moderator: Alright, excellent. And why isn't single agent of pertussis offered instead of a multi agent Tdap? Once again, the question. Oh, go ahead.

Ashley Brooks: I was going to say I think I'm trying to understand. I think I'm understanding is why is pertussis not offered alone instead of it being put in with tetanus and diphtheria? I think that's correct. And that's actually a question that I can find out the answer for and follow-up to you on. I'm not actually really sure about the compounding of that vaccine. But Dr. Sukumaran you might have some more information.

Dr. Sukumaran: Yeah, this is Lakshmi Sukumaran, we don't currently have a single pertussis vaccine. So the only pertussis vaccine we have available is with the tetanus and diphtheria components. And also in response to your question about the Tdap boosters for family members, for everybody who is not pregnant, only one Tdap vaccine is recommended. So family members are not indicated to get boosters. Only the pregnant women is supposed to get vaccinated every pregnancy.

Moderator: Alright, thank you. What's the rate of getting pertussis even with the Tdap vaccination?

Ashley Brooks: That's actually a good question and I actually have that information not included in my presentation. I will have to pull those numbers, because it is nationally reported, that they do report on the numbers of those that have received Tdap and then also still have the disease. So I can pull that information and we can follow up with you Lorena.

Moderator: Alright, excellent. Patients ask a lot about how low the efficacy has been for this year's flu vaccine success, less than 15% is that accurate? Based on your knowledge.

Ashley Brooks: So currently, I know there's lots of speculation especially in the news, but actually I've touched base with our influenza division and those numbers are not going to be finalized until later in the summer. But as of right now there are some mid-range numbers now but with flu activity still continuing, those numbers are not hard yet.

Moderator: Alright, we thank our audience for all the great questions. We've got a few more questions in the queue here to work through. Our next question: so just to clarify the answer to a prior question, we should still recommend Tdap in early postpartum period if the mother did not get it in the third trimester because there could be some protection to the baby via the breast milk?

Ashley Brooks: Ideally, we would like pregnant women to get vaccinated in that gestational period. Yes, technically there is some protection that could be passed through that breast milk but it's not going to be as effective and there's not as much protection passed as if she had would have got it while the baby was in utero.

Moderator: Alright, and I believe we have one final question in the queue here and we invite and encourage participants to continue to send in their questions if they still have them. And this question reads: No vaccine manufacturer wants to do the research and development for a single pertussis vaccine. I think that may be a comment rather than a question. Your thoughts?

Dr. Sukumaran: This is Dr. Sukumaran I'm not aware of that.

Moderator: Alright. Excellent. I believe we have gotten to all of the questions we have in the queue. We have about 90 seconds remaining. So I think at this time I will defer to our panel for closing remarks and perhaps we will start with Dr. Sukumaran and then we will go to Ms. Brooks.

Dr. Sukumaran: I just wanted to remind everyone that pregnant women and their young infants are just very susceptible to these infections and that their infants are relying on these vaccines during pregnancy to protect them in those first few critical months.

Ashley Brooks: Yeah, I was just going to say in following up with what was just stated, as well. You know as a healthcare provider, you play a major, major role in patients getting vaccinated. They trust you for that health information so we encourage you to let your patients ask questions but also just strongly recommend those vaccines so we can raise these vaccination rates and continue to protect women and their babies.

Moderator: Alright. Thank you so much to our presenters and attendees. If you have any outstanding questions that were not answered today, please contact ACOG's immunization department at [email protected]. That's [email protected]. This concludes our program for today. Thank you for joining us and we'll see you next time.