Tdap Webinar

Tdap Vaccination in Pregnancy: A Mother’s Gift to her Baby
Originally presented on Wednesday, January 21, 2015 at 12-1pm ET

Download presentation slides. The presentation slides available for download are the original slides that were used in the presentation on January 21, 2015.

This webinar, “Tdap Vaccination in Pregnancy: A Mother’s Gift to her Baby,” reviews the burden of disease caused by tetanus, diphtheria and in particular, pertussis. The webinar will explain the importance of immunizing patients, especially pregnant women during the 3rd trimester. The presentation will detail ACOG and ACIP’s Tdap immunization recommendations, describe the safety and common side effects of Tdap vaccination, and explain the importance of and optimal timing for Tdap immunization during pregnancy.  Upon completion of the presentation, the participants will be able to:

  • Indicate the appropriate Tdap recommendations for the general adult population
  • Communicate the burden of disease of pertussis, tetanus and diphtheria in both adults and newborns
  • Indicate the appropriate Tdap recommendations and optimum timing for vaccination during pregnancy
  • Communicate the safety of Tdap vaccination for non-pregnant adults and pregnant women

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

Transcript

Moderator:     

Hello everyone.  Thank you for joining us today.  This is Joy from Blue Sky Broadcast, and I’ll be the operator for the presentation today.  Today’s webcast organized by the American College of Obstetricians and Gynecologists is the third in a series of four immunization webinars from ACOG.  Today’s webcast is entitled Tdap Vaccine: A Mother’s Gift to her Child, and will detail ACOG and CDC’s Tdap recommendations, address the most common concerns and misconceptions around Tdap, and explain the importance of immunizing pregnant women.  Join us for our final webinar in the series Human Papillomavirus Vaccination on March 4, 2015.  

Before we get started, I’d 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 bottom of your screen, you will see the text chat window.  There is a large window, which holds all of 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 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 were received, and will be addressed at the end of the presentation.  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 today (displayed on slide)

Now, let me please introduce our program faculty for today’s webcast.  Dr. Laura Riley is an associate professor of obstetrics, gynecology, and reproductive medicine at Harvard Medical School at Massachusetts General Hospital.  Dr. Riley completed fellowships in maternal fetal medicine and infectious disease.  She is the chair of ACOG’s Immunization Expert Workgroup and a member of the Advisory Committee on Immunization Practice at the Centers for Disease Control and Prevention.  

Dr. Linda Eckert is a professor of the Department of Obstetrics and Gynecology and adjunct professor at the Department of Global Health at the University of Washington in Seattle, Washington.  Dr. Eckert completed a fellowship in infectious diseases and has expertise in immunization and policy development.  She has worked at the World Health Organization in the Department of Immunizations, and continues to serve as a consultant to WHO concentrating on the intersection of immunizations and reproductive health.  

Here are the learning objectives for the presentation today (displayed on slide).  Now, ladies and gentlemen, without further ado, Dr. Riley.

Laura Riley, MD:       

Hello everybody.  Thank you for joining us.  In the next 45 minutes, we hope to educate you about the use of Tdap in pregnancy and just remind you that maternal vaccination saves lives of both mothers and babies.  We will be disclosing all of the information from the routine adult vaccine recommendations that are based on the recommendations from the ACIP at the CDC.  Please also recognize that ACOG’s website, Immunizationforwomen.org has lots of information and goes over both the maternal and the childhood/adolescent immunization schedules for your reference.  

What is Tdap?  I think this creates lots of confusion because there is the DtaP and the Tdap and et cetera, et cetera.  But really what we need to focus on is Tdap, so that is Tetanus, Diphtheria, Pertussis, and Tdap is what we’re using for maternal immunization.  Taking you back to medical school or even earlier, Diphtheria is an organism that is transmitted person-to-person, as is Pertussis.  Again, person-to-person transmission, but it’s highly infectious and we know that the secondary attack rates are as high as 80 percent or greater.  Then Tetanus, as you know, enters the skin via cuts or wounds.  

Really focusing on Pertussis today, otherwise known as whooping cough.  The causative organism is Bordetella Pertussis, and that’s a gram negative bacterium.  It is uniquely a pathogen for humans, and the incubation period is about seven to ten days, and then that catarrhal stage is followed by paroxysms of cough that can continue for four to six weeks.  In terms of the clinical case definition, this is what the CDC uses to say this is a case, a person would present with a cough illness that lasts at least two weeks with one of the following: either paroxysms of coughing and inspiratory, what’s called, whoop or post-tussive vomiting as well as apnea without any other cause for that apnea.

Pertussis can, even though people may think that it’s kind of benign, it probably isn’t for many, and it can lead to rib fractures, weight loss, pneumonia, seizures, brain damage, incontinence, and even death.  

In terms of the burden of disease, I think that this is what is really important for people to recognize is that Pertussis is one of the leading causes of vaccine-preventable deaths worldwide.  Up to 2 in 100 adolescents and 5 in 100 adults are hospitalized with this disease or have complications from this disease.  This is what we’re trying to prevent.  Pertussis remains a very serious infection, especially for young infants, and we’ll go into more of that data.  

This is a slide that comes from the CDC and it’s looking at from 1990 up until 2013.  As you can see, this is showing a high instance of infection, especially in babies, which is in children less than the age of 1, which is the pink line.  Less frequently seen in older adults, but clearly, I think the most important thing of this slide is to let you know that it’s getting worse from 1990 up until 2013.

Then what we’re really talking about and focusing on preventing today is hospitalizations and deaths in young infants.  Here you can see on the bottom of your screen is months of age.  You can see that children less than the age of two months and the ones bracketed in red have the highest hospitalizations as well as the highest number of deaths, percentages of deaths in cases.  This looks at 2001 to 2011.  

Again, looking at Pertussis deaths by age group, again we’re looking at the heavy blue bar is those babies less than 3 months of age, which is what we can prevent with maternal immunization.  A smaller number of those deaths are in 3 to 11 month old children, and then greater than a year.  This is looking over the last 12 years from 2000 up until 2012.

Lest you think we have this completely taken care of, this is data, again, looking at the reported cases between 2012 and 2013.  What it’s showing us is that the burden of disease continues to be in those small infants.  If you look on the right, the reported Pertussis deaths, there were 12 reported in babies less than 3 months of age out of a total of 13 reported deaths.  Again, what we want to remind you of is that there are increased cases of Pertussis because there continue to be epidemics throughout the United States.  This is sort of a very small map, but I think what you should take away from that is that there are cases essentially across the U.S.  The darker green is places where the disease is widespread, but it has been reported everywhere essentially.

The most recent epidemic that continues to be ongoing is in California where there are cases throughout California.  There is definitely widespread Pertussis activity.  There have been over 10,000 cases reported since 2014 and leading to a case rate of 28.3 per 100,000 population.  The incidence of Pertussis is even higher than the epidemic that was reported in 2010.  So this is quite concerning I think certainly to people in California.  But just remember with people traveling all over, it may be in California and next month it’s in Massachusetts.  

So far in this epidemic in California, there have been 376 cases that have been hospitalized and 23 percent of those actually required intensive care treatment.  Then again harkening back to those people, those babies, I should say, who are at greatest risk, 60 percent of the hospitalized patients were infants less than the age of 4 months.  We will turn this over now to Dr. Eckert, who will talk about the vaccine and our preventive methods. 

Linda Eckert, MD:

Thank you, Laura, and also thank all of you for joining us again.  So what is the historical perspective of the Pertussis vaccine? Well, the initial vaccine used against Pertussis was a whole cell Pertussis vaccine, and this is actually the vaccine that’s still used in a large portion of the world, especially the developing world.  Whole cell Pertussis vaccines are prepared from suspensions of the inactive bacterium that causes the disease, and they became licensed in the mid-1940s.  

The original studies had a high efficacy, 70 to 90 percent in preventing serious Pertussis, although there were some studies in the ‘90s that showed that the efficacy was under 50 percent.  The difficulty with the whole cell Pertussis vaccine is the adverse events.  It causes a significant amount of swelling and pain at the injection site.  Also, it is more likely to cause fever, drowsiness, and anorexia, especially in infants.  There is a higher incidence of severe adverse effects in the whole cell Pertussis compared to Tdap.

So, acellular Pertussis vaccine came on the market in 1995, and it had been developed because of these safety concerns and the adverse events.  It is definitely associated with a lower frequency of adverse events, and it’s also effective in preventing Pertussis.  In fact, in a recent study that we’ll talk more about, it’s been shown to be 90 percent effective in a big outbreak they had in England in preventing Pertussis in the newborns.

Acellular Pertussis contains an inactivated Pertussis toxin as well as three other bacterial components.  You develop an immune response to these inactivated toxins and then when you are exposed to the live bacterium, you can wipe it out because you’ve already developed this immunity.  It also contains a lot less endotoxin than the whole cell Pertussis.  Again, that’s why it has less adverse events.  

But when we look at how long antibody protection lasts for the Tdap vaccine, what you can see in these two graphs, on the left axis, these are the amounts of antibody in the human body to these various components of the Pertussis vaccine.  You can see that right after vaccine you do get this large peak, but then it wanes relatively quickly.  Even by one year after the vaccine, the amount of antibody is significantly lower and it continues to lower showing here the trend out for three years.

One of the concerns has been that once you get Tdap and then you’re pregnant, how much antibody are you going to actually have to pass on to your infant through the cord and through breastfeeding?  Because of the shape of that graph with the rapid decline initially in the first year, that is what has led the American College of OB/GYN and the ACIP with the CDC to have the recommendation that a dose of Tdap vaccine should be given to all pregnant women in every pregnancy in the third trimester.  

Now, it takes about two weeks to make antibodies to this vaccine, and so the reason to try to give it before 36 weeks if possible is in case someone delivers at 38, 39 weeks.  They’ll still have had time to make their antibody and have it be at a high level to pass on to the infant.  However, certainly, if you see someone at 39 weeks and she has not received her Tdap yet, you should go ahead and give it because, again, the advantage is to try to get antibody made. If you boost the mother, even if she’s 39 weeks, if she delivers at 41, then she’s got full level.  If she delivers at 40 weeks, she still has some.  

So I think that the take-home message is to get every pregnant woman immunized and try to do it in the third trimester so we have the highest peak of antibody right before delivery.  We definitely know that there is transplacental transfer of antibodies from the mother to infant and that this can provide protection against Pertussis in early life.  

Like I said, we know the immune response peaks after two weeks, so that’s why this third trimester gestational period is chosen to try to optimize antibody transfer and protection at birth.  Also, that’s why we are saying to give it every pregnancy because if you remember the shape of that curve of antibodies, by three years out, it’s significantly lower than if you were to get a new vaccine boost right before delivery.

We do know it works.  In England, in 2011 to 2012, there were many deaths associated with Pertussis in newborns less than 3 months.  In order to try to combat this, they mobilized quickly a program to initiate immunizing all pregnant women in 28 to 37 weeks of gestation.  This was a nationwide program and with their medical system, they had an ability to roll it out quickly, and to get every pregnant woman or high risk level pregnant women vaccinated.  When they did that, they saw this very sharp decline in infant Pertussis and found that immunizing pregnant women prevented 92 percent of infant Pertussis if she received the vaccine at least 7 days before birth.

Also, because of the large number of women that were vaccinated in England it gave us a lot more safety data.  There were over 23,000 infants whose mothers received Tdap in the third trimester and no serious safety issues or adverse events in those infants have been seen.  So this gives a lot of confidence that (a) the plan to vaccinate pregnant women works to prevent infant Pertussis and (b) it is safe.

This graph is from the same article that’s showing what England experienced.  If you look at 2012, you see this high level of Pertussis, they had this epidemic as they peak in cases.  Once they got immunization out and going broad spread in pregnant women, you can see the cases in less than 3 months nearly disappear by 2013.  Again, this strategy works and it’s safe.

So what else do we know about safety data?  Well, there’s another study that was recently published that looked at the California database because California started vaccinating all pregnant women during the 2010 epidemic that they had.  When they looked at the vaccine safety data link and the database in California and, again, this is actually 26,000 pregnant women, they found that Tdap during pregnancy was not associated with any increased risk in the pregnancy or in having a baby that was small for gestational age.  

Tdap vaccine safety is continuing to be monitored, so I think this is something that you can tell your patients.  We’re looking very closely.  There’s two systems in the United States.  I just showed you data from California from the Vaccine Safety Data Link.  There’s also the Vaccine Adverse Event Reporting System or VAERS, which is a nationwide program that monitors the safety of all vaccines licensed in the United States. 

Safety is being looked at quite carefully, and the good news is we haven’t seen any signals that makes us concerned that we should try to change the strategy.  In fact, they’re all reinforcing the strategy that vaccinating pregnant women works and that it’s safe.  So what is our role?  Well, many studies have shown that the provider recommendation is the most influential factor in the patient’s decision to receive an immunization.  This has been shown in studies all over the world, not just in the United States.  

We know as providers of care for pregnant women that we do have an opportunity to see them on a frequent basis.  We also provide them primary and preventative care, not just when they’re pregnant, but at other times.  We are a trusted provider of women, and we do account for nearly half of preventative care visits for women over age 18.  We know that when we are caring for a pregnant woman, there is a special bond.  That’s why a lot of us went into this field.  There is a trust, and I think if we take this opportunity to say, “Look, this is a vaccine that is safe, that is good for you, but most importantly is really a gift you can give your baby to try to keep your baby from getting Pertussis that that will have a large impact.

ACOG has done some work to try to make this easier for us because we’re all busy.  We don’t have a lot of time for discussion.  If you go on to the website that was shown at the beginning, the Immunziationforwomen.org, there’s a whole package of tools to be used for Tdap vaccination.  One of them is this sample for physician script.  It certainly doesn’t mean this is what you have to say, but it might give you some idea for talking points and answering frequently asked questions that people might have.

I also mentioned cocooning, which is the idea that caregivers should get the vaccine and should get it two weeks before contact with the infant.  Initially, CDC when they recommended Tdap vaccine, went for the cocooning strategy.  They’re still recommending the strategy, but now we realize too that maternal immunization is actually more effective.  Cocooning is hard to do, but it is important.  The idea of cocooning is to protect the infant from Pertussis by surrounding them with people who have been immunized, and therefore, won’t expose them to Pertussis.  

We should encourage our pregnant women to have anyone in their family or other caretakers who will be taking care of their infant to be up to date with Pertussis vaccinations.

If you look in general at recommendations for Tdap in adults since 2005, the ACIP has recommended Tdap dose for all 11 through 18 year olds, preferably at 11 to 12 year old.  We know that adolescents carry Tdap and are a source of epidemic spreading.  Also for those 19 through 64.  Then in 2012, partially recognizing that grandparents often are the ones caring for infants, ACIP recommended that all adults age 65 and older also get a Tdap.  Essentially everybody should have a Tdap.

It needs to be given once, whereas, Tetanus is TD or the traditional Tetanus vaccine is given every ten years.  But if you’ve never received a Tdap, do substitute Tdap for the usual Tetanus vaccine.  Then in wound management care, if a Tetanus booster is indicated, it’s recommended to go ahead and give Tdap as another way to increase the coverage of Tdap in our country.

As always, there are some times when you shouldn’t give the vaccine.  Certainly, if someone has had a serious allergy to any component of vaccine or has had very serious adverse events in the past like a prior coma or seizures within seven days.  Then listed are some other potential contraindications.

There is guidance for how to give the vaccine, and I’m not going to go through this.  You can’t really read this, but the purpose of this is to give you this website, Immunization Action Coalition that shows really how to give the vaccine, how to store the vaccine.  It can be very useful for an office vaccination program.

Side effects.  The most common side effects are mild, like a sore arm.  I usually tell people if they’re going to play tennis that day, you don’t want to take it in your arm that you’re going to use to raise the tennis racquet.  But it’s mild, a little bit of headache, tiredness, and a little bit of soreness, but this is quite uncommon actually.  There are some moderate problems following Tdap, which is defined as it can interfere with your activities, but they don’t require medical attention.  Again, this is pain or redness at the injection site, a little bit of a higher fever, but these are unusual.  

Of course, any time you give any medication, there’s a chance for severe problems.  With Tdap, swelling, severe pain, and bleeding are extremely rare.  Severe allergic reaction could occur after any vaccine, but it’s estimated to be less than 1 in a million doses, and this is really rare, especially in adults.

Now, we’re going to go over to some frequently asked questions, and I’m going to turn it back to Laura.  We’ll go through these and certainly, like mentioned, you will have a chance to ask your individual questions by typing into the textbox if these frequently asked questions don’t cover what you’d like to hear.  

Laura Riley, MD:       

Thank you, Linda.  These are questions that we came up with just because these are the things that we find ourselves answering on a daily basis.  One is, is breastfeeding safe after Tdap vaccination?  The answer is absolutely yes.  Breastfeeding is not a contraindication to receiving the vaccine.  In addition, Dr.  Eckert has just gone over the safety data.  It’s safe during pregnancy as well as after pregnancy.

Can Pertussis and flu vaccine be co-administered?  Absolutely yes, particularly, if this is going to be helpful to the flow in your office.  As you know, the flu vaccine should be given as early in the flu season as possible during any trimester of pregnancy.  Certainly, Pertussis has the recommendation that we give it between 27 and 36 weeks gestation so that we can have the highest antibody level just around the time of delivery.  However, if those two things coincide and 28 weeks seems like the most appropriate thing, by all means, go ahead and give two of the vaccines at the same time.

Do Pertussis vaccines contain Thimerosal?  The answer is no. 
None of the Pertussis vaccines that are currently on the market in the U.S. contain Thimerosal.

Other questions, a patient might say, “I had Tdap with my last pregnancy.  Why do I need it again with my current pregnancy?”  You saw that the ACIP recommendation is that the vaccine be given during each pregnancy between 27 and 36 weeks gestation, again, because focusing on that original graph, looking at the drop in antibody response to the vaccination, you saw a precipitous drop at about a year.  Clearly, to give the baby, this particular baby in this pregnancy the best protection, it’s important to vaccinate during each pregnancy.

How serious is Pertussis, and is the vaccine really necessary? 
Well, hopefully, I showed you enough data to suggest that coughing for six weeks could have some serious ramifications for an adult as well as we know that particularly for infants and for children, Pertussis is a particularly serious illness and associated with many hospitalizations and even deaths.  So getting vaccinated while pregnant is definitely giving the baby protection that they normally wouldn’t be able to receive until two months of age, which is when a baby is eligible for getting the Pertussis vaccine.  

This goes over a little bit more what the provider responsibilities are as Dr. Eckert mentioned.  This is clearly an important part of what we do is to prevent vaccine-preventable diseases.  It is also as part of that effort, very important that we keep vaccine records and that they’re up to date for the patient’s sake as they move from place to place.  Consider using standing orders in your office or in your hospital.  That definitely has been associated in studies when people have looked at it to be associated with greater vaccination rates because they won’t have to remember to do it.  There are standing orders, nurse can activate it, et cetera.  

It’s also important that when you’ve giving any vaccine that you also provide the patient with what’s called a VIS form, which is a Vaccine Information Statement.  It just briefly goes over what the patient needs to know about the vaccine, side effects, and things to look for.  Then also at the bottom of that sheet or maybe on the other side is the number for the VAERS, which is the Adverse Event Reporting System so that patients can actually report any adverse event as well as providers.  

Then just as another reminder, you do not need to do immune titers for all vaccines.  So, Varicella, it’s important to know whether or not someone is IgG positive at the beginning of pregnancy.  For Rubella and Measles, Hepatitis, we want to know what their status is, but not for everything.  You don’t need to try and do Pertussis antibodies, et cetera at the beginning of pregnancy.

Additionally, I mentioned the VAERS report.  Patients or providers can do the report if they have a sore arm, or if there’s some other adverse event.  Then vaccine records are important to keep.  If you have in your state an Immunization Information System, by all means, please put that information after you’ve vaccinated someone, into the state database.

The registry may be useful for verifying a patient’s immunization history and it also helps you know where they got the vaccine as well as avoid any duplication of unnecessary vaccines.  But these registries don’t exist in every state, so it’s important to sort of know what’s going on in your area.  This is the website that can lead you to that information.  

Then, of course, it’s important that we also recognize that doing vaccinations in your office, whether it be Tdap, influenza, or all of the adult vaccines that are recommended, it is part of your practice and coding should be appropriate so that you can be appropriately reimbursed.  That information actually is available on our immunizationforwomen.org site.  There is absolutely lots of information about business practice.  There’s a coding sheet there.  You can hang it in your office and just quickly refer to it. As well as, there is an on-demand webinar, which goes through step-by step how to put the business practice of immunization safely in your office and efficiently in your office.

In conclusion, hopefully, we have convinced you that Tdap vaccination is recommended for all pregnant women during each pregnancy between 27 and 36 weeks gestation.  I would also say that it is possible to give Tdap before 27 weeks if, in fact, you’re in an area where there’s an outbreak.  It may be that it’s important to give it before 27 weeks.  The timing of giving the vaccination 27 to 36 weeks is all about getting the highest antibody level, having that cross the placenta and provide protection for the baby.  It is not that we feel it’s unsafe to give it earlier.  It’s just that we’re trying to give the baby the most protection.  

Then adults who have not received a dose of Tdap should receive at least one dose regardless of the interval since their last Tetanus booster.  So, certainly, the dad, the mother-in-law, whoever is taking care of the baby, the babysitter, et cetera, they should have a Tdap vaccine if they’re going to be around that baby as part of the cocooning process.

Then Pertussis is a serious disease and is particularly dangerous for infants and young children.  Again, the highest death rates are seen in those young babies less than a year of age.  The high death rates and hospitalizations are seen in those babies less than three months of age.  They cannot get protection from Tdap themselves or DtaP for babies until two months of age.

Then, finally, Tdap vaccine is proven to be safe for use in pregnant women and in the general population, and there’s lots of safety data.  As Dr. Eckert mentioned, we continue to monitor the safety of this medication or of this vaccine.

This is also another opportunity to inform your patients that there are additional vaccines recommended for adults.  So, in your practice, in your OB/GYN practice, please do not forget about influenza vaccine, which is recommended for all pregnant women.  In fact, it’s recommended for all adults.  Tdap vaccine obviously is for adults who have not been vaccinated previously during their adult lives and for all women during each pregnancy.  

Then other vaccines not to forget about including Pneumococcal vaccine, it is important to give during pregnancy for women who are at high risk for Pneumococcal disease.  Just sort of an example, don’t forget your patients with asthma, other chronic lung diseases, smokers.  Those patients are at high risk for Pneumococcal disease and should receive the vaccine.  Hepatitis B vaccine is also recommended for all women who are at risk for that disease, even those who are pregnant.  

MMR vaccine is recommended, and so that’s Measles, Mumps, and Rubella.  Vaccine is recommended for women who are not previously vaccinated.  It should be given either before pregnancy or postpartum.  It is a live vaccine, and so we do not give it during pregnancy.  However, if it is inadvertently given in the first trimester, it’s not a reason for pregnancy termination.

Varicella vaccine is another vaccine that should be given to women who have not previously been vaccinated or who have not had chicken pox.  Again, this is a vaccine that is a live virus vaccine.  Therefore, it should be given before pregnancy or postpartum.  Then finally, HPV vaccine should be given to girls and women ages 9 to 26.  It is not recommended during pregnancy, but should be given outside of pregnancy.  

Then just so that you are aware that all this information, there is no way we can remember all of it, this is the adult immunization vaccine schedule that is put out every year by the ACIP and CDC.  There is a pregnancy column.  This can easily be accessed from CDC.gov, and it’s also on our website immunizationforwomen.org. This is just the contraindications box and the pregnancy column is on the far left.

Then, finally, these are just references.  I think that it is certainly my experience as a practitioner is that most patients are concerned about safety for these vaccines.  So we wanted to be sure that you had safety data in front of you that you could refer to and put the patient’s minds at ease, but as Dr. Eckert mentioned, we now have the experience from England as well as the experience from California where thousands of babies have been exposed to Tdap vaccine with no adverse events reports.

Then, again, other resources.  I think we’ve mentioned immunizationforwome.org a million times.  Hopefully, you find that helpful to you as well as there’s information on the CDC website, CDC.gov.  Then these are just – this is a campaign that CDC has entered into and ACOG is fully supportive of.  There are information sheets and posters and things that you can put in your office just to bring the Tdap message to your patients.  I think that that is the end.  We are more than happy to take your questions as they arise.

Moderator:

Great.  Thank you so much Dr. Riley and Dr. Eckert.  We will now open the line for questions for both of our presenters.  You can submit a question by using the question block at the bottom of your screen.  I will now turn it over to our presenters to run the Q&A.

Linda Eckert, MD:

Thank you so much.  The first question here is, “If a mother was not given Tdap in her third trimester, could the infant get Tdap at birth or first well baby visit?”  The answer is no.  Infant immune responses are not mature enough to respond to vaccines immediately after birth.  So the first time the infant gets DtaP is at two months and the second shot is at four months.  It’s really not until that second shot of DtaP that the infant has a protective level of Pertussis.  That’s why the goal needs to be to get every pregnant woman immunized.  Laura, you want to take the next one?

Laura Riley, MD:

Yeah.  So the next question is, “Why don’t they do away with Td and just immunize with Tdap?”  That is a great question.  I don’t know exactly what the policy answer is.  I imagine that the recommendation is for Tetanus every ten years.  Currently, there is no recommendation for non-pregnant adults to get anything more than one booster shot.  So I think that until there’s a recommendation for more Pertussis, I’m not sure that that’s really going to be necessary.  It’s probably better just to get Tetanus and not get vaccines that are not utilized.  Linda, I don’t know.  Do you have a better sense of – you’re more in the policy world than I am.

Linda Eckert, MD:                 

Well, I also think that Td is much cheaper than Tdap and globally Td is one that has been used to prevent neonatal Tetanus and Td is what is in everybody’s immunization basket in low resource settings.  I think that there is a much bigger global picture involved than just the protection of the infants with maternal immunization. So, I don’t see Td going away, but thanks for your question.  

“The necessity for fathers, grandparents, and other family members?”  In a sense, if you gave Tdap to every single pregnant woman, then that would protect the infants, and you wouldn’t need to cocoon.  On the other hand, that doesn’t happen, and we are seeing continuing, ongoing, in fact, worsening Pertussis epidemics in our country; the California one in 2010 and now here it is 2014 and ’15 they’re having an even worse one.  Adults, it is not fun to get Pertussis.  I have had a pregnant patient who got Pertussis and broke a rib from coughing.  If nothing else, adults should not want to get Pertussis and should get immunized.

But the main thing we’re talking about is to get the infant and newborn protected.  So as many people that are immunized against Pertussis that are in contact with that infant, the better off it is.  So that is why I at least stress to all my pregnant patients, whoever is going to be around this baby needs to get their Tdap.  Grandparents that are coming in, they need flu and they need Tdap.  It’s a conversation I start having with them really as soon as we hit the third trimester if not before.

Laura Riley, MD:

I think it’s also important to recognize that when people have looked at this, done studies, they’ve shown that when children get Pertussis, they largely get it from family members.  

Linda Eckert, MD:

Yes.

Laura Riley, MD:

We also found that cocooning is just very difficult to do programmatically, trying to figure out who is the dad, who is going to be around?  Grandma comes from out of town.  Cocooning really is difficult.  We make the effort, but we have much less control over that as well.  We do have some say in what happens to the mother.

Linda Eckert, MD:

That’s a great point.

Laura Riley, MD:

The next question is “if a patient had Tdap in the third trimester, then is pregnant a year later, does she need Tdap?”  I love this question because I asked Dr. Eckert her thoughts on a recent patient that we had.  I think that if it’s a year, I would definitely reboost.  The reason is based on that graph that we saw, you saw a precipitous drop in antibody level at about a year.  I think what becomes difficult is do you revaccinate a patient who has been less than a year?  So, eight months, nine months, something like that.  I suspect that there’s no right or wrong answer there, and I think to some extent whether or not you re-boost might also depend on where you are.  So if you’re in an area that is having ongoing outbreaks, if I was in California, I’d take it.  If I was in Washington, I’d probably take it.  In maybe a state where they haven’t seen very much Pertussis, you might seek it out, but I think once you’re at a year, it makes sense to re-boost because we know that your antibody levels are low.  Linda, would you agree with that?

Linda Eckert, MD:

I totally would agree.  I think that that’s a common conversation that I have with patients.  “Oh, I got a Tdap at work in my first trimester.  Should I get one again?”  Or if they had closely-spaced pregnancies, “When should I get one again?”  Essentially if you remember the big picture here is to get the highest level of antibody to the infant.  If you remember the graph about how the antibody level falls, if it is less than a year, I would use that graph to have a conversation with a patient, but I don’t know that there’s a right answer.  

Then the next question is, “If a pregnant patient did not receive Tdap in pregnancy, should she be given a dose postpartum?”  I hope we’ve done our best to say absolutely, yes, absolutely yes.  I mean, that baby will be protected through some antibodies that transfer by breast milk and also you do not want your postpartum woman to get Pertussis and then pass it to her infant.  So, absolutely if she didn’t get it in pregnancy, she should get it postpartum.

Laura Riley, MD:

The next question I think we answered actually.  Let’s see, I’m trying to click through.  “The patient is pregnant in the third trimester and complains of a cold, should we wait until the following OB visit to administer the Tdap vaccine or is it okay to give at that time?”  So that’s a great question.  If she’s kind of sick and not feeling well, it is fine to give Tdap at that visit.  If you’re going to see her back in a week or two, I guess you could wait, but there’s really not sort of medical reason to wait.

Actually, the same thing is for the flu.  If you have got a cold, it’s fine to give someone the flu shot.  I think the reason that we try not to do that so much is so that the patient doesn’t think we “gave them” the cold from the flu shot, but you’re not going to do any damage to the patient.  

Linda Eckert, MD:     

Then the next question, “Can you explain the difference between Tdap and DtaP?”  There’s a slide early on that talks about the capital letters versus lower case letters.  Essentially, there’s different doses for adults versus infants and children.  The capital letters tend to be for a higher dose and the smaller letters are for a lower dose.  Based on research studies on what provides an adequate immune response, the dose is chosen.  So that is the difference between essentially Tdap and DtaP.

Laura Riley, MD:

“If a grandparent is over 65, do you not recommend Tdap?”  Actually, the CDC has made the recommendation that for grandparents over the age of 65, it is a good idea to give them Tdap.

Linda Eckert, MD:

Then, “If a pregnant patient is inadvertently given two doses of Tdap in a short time, is there concern?”  No.  She may get an arm that gets a little more sore, but there isn’t a safety concern for the baby at all that we know of.

Laura Riley, MD:

This next question may be sort of a little bit of a variation on a previous one.  “Can you review what the difference is between the different vaccines, Tdap, Td, booster?”  Okay, Tdap is actually what we’re going to give to pregnant women, actually give to adults.  Then Td is just Tetanus alone.  The recommendation for Tetanus alone is every ten years or if you get a cut or a stab wound or something.  Then booster basically what we’re talking about is giving you an additional vaccine over your primary series. So all of us as children got a primary series of DtaP, so Pertussis and Diphtheria and Tetanus protection.  What we’re getting later as adults are booster vaccines so that we can enhance our antibody levels essentially.

Linda Eckert, MD:

So the next question is really interesting.  “Can you please say a few words about Diphtheria, and why is it included in Tdap?”  The traditional vaccine Td was for Tetanus, Diphtheria, and then what the infants get is DtaP, which is Diphtheria, Tetanus, and Acellular Pertussis.  I think Diphtheria, it has been wiped out in this country because of vaccines.  It is a bacteria that is transmitted from person-to-person and we don’t see it because of vaccines.  

Why was it included in Tdap?  I think because Tdap was viewed as a replacement for the whole cell Pertussis vaccine, which also tend to contain Diphtheria.  So I feel like it’s a replacement for a vaccine that was already out there that contained Diphtheria.  It boosts us against Diphtheria, but if there’s a reason other than – I don’t know if there is a different reason other than that.  I just may not have the expertise to completely answer this question about why it hasn’t been taken out.  I think because it serves a purpose of boosting us against Diphtheria and because the Tdap was a replacement for the whole cell Pertussis vaccine and what they really wanted to do with that replacement was to use less toxic protection against Pertussis.  That was the goal of changing to Tdap over the whole cell vaccine.  

I don’t know, Laura, if you have any more insights into that?

Laura Riley, MD:

No, no.  Next question is, “Why is Tdap not given during the first and second trimesters?”  We are trying to get the highest antibody level, have that cross the placenta, and protect the baby in the first two months of life.  The best way to do that is to give it as close to the delivery as possible, which is where we come up with the 27 to 36 weeks gestation, recognizing that we might miss somebody who delivers early, et cetera.  

The vaccine can be given in the first and second trimester, and I tried to sort of point out that a potential might be someone who is exposed to Pertussis or you’re in the midst of a big epidemic and everybody is getting vaccinated.  That may be why you do it in the first and second trimester, but for the most part, the recommendation is the later the better as close to the time of delivery without missing that two week widow.

Linda Eckert, MD:

Then, “If the goal is to protect the infant, what about pre-term labor?”  That’s a great question.  I think a lot of pre-term labor treatments, you would be after 26 weeks and certainly if you haven’t gotten Tdap, you should.  I know that our labor and delivery thinks about that and they give Tdap when they’re giving treatment for preterm labor, but you’re exactly right.  If you think somebody is going to deliver at 30 weeks, you wouldn’t wait.  The difficulty, as we all know, is that prospectively predicting who is going to delivery early and who isn’t is very difficult.  But if you’re really worried about it, absolutely you should give Tdap.

Laura Riley, MD:

The next question is, “What is the best response to give pregnant mothers who fear vaccines could give their children autism because they’ve heard this in the media?”  Yeah, I think that we all struggle with this.  The media is quite powerful, but hopefully we can reinforce the message that there has not been any association between vaccines and autism.  That very early association that was made between MMR and autism was completely debunked, but it’s been slow to get the debunking message out there. So I would just reiterate for parents that there’s not been any study that has never shown vaccines associated with causing autism.  

Linda Eckert, MD:

“Do young teenagers need Tdap during pregnancy?”  Yes, even if they had a booster, it’s not typically going to be within a year.  If it was within a year, I think you can consider whether to give the Tdap in the third trimester, but unless it was within that year window where the antibody really craters after a year, then definitely give the Tdap during pregnancy.  

Laura Riley, MD:

This next one I think we’ve answered, and then the next one is, “Why not develop Pertussis-only vaccine?  Is too much TD in the Tdap dangerous to the pregnant mother if she has, for example, three children three to four years in a row?”  That’s a great, great question.  There’s no data that suggests that the Tetanus component is at all unsafe.  I think at most what we would recognize is that giving Tetanus over and over again potentially very close together is that people will get a sore arm.  They’ll get sort of quite the reaction where the vaccine has been given.

A Pertussis-only vaccine, for all I know, it is under development.  I don’t know.  It may also end up being, number one, a cost issue and then the number two question is whether Pertussis alone could give you enough of an antibody response?  Sometimes they put these vaccines together almost as one gives a much more robust antibody response and can sort of boost Pertussis as well if Tetanus gives a great response.  Is that true, Linda, in terms of putting the vaccines together?

Linda Eckert, MD:

Yeah.  I think that’s true as far as multiple antigens in the vaccine.  The other thing I would say that can be reassuring about this, in the developing world where people weren’t getting immunizations as a child, the whole way to get rid of neonatal Tetanus was to give a pregnant woman five Tetanus vaccinations.  If they could give her three, then they could really get rid of neonatal Tetanus.  So there is a vast experience with giving several Td vaccinations to pregnant women that has shown it to be safe.  I think I feel very reassured by knowing this as far as doing that in the ‘80s for prevention of maternal and neonatal Tetanus globally.

Laura Riley, MD:

The next couple of questions, Linda, I think you could probably answer together: PROM and preterm labor?

Linda Eckert, MD:

Yeah, go for it.  

Laura Riley, MD:       

Basically, if there is a high likelihood of suspicion that they’re going to deliver early, I would go ahead and give it, recognizing as Dr. Eckert said, it’s really difficult to predict.  I think in terms of would you revaccinate?  I personally would probably not revaccinate someone who got it at 26 weeks and then they managed to stay pregnant at 40, 41.  I wouldn’t revaccinate them.  I think I would bank on the antibody levels still being rather high, although it would be a lot higher if I had done it just prior to delivery.  

I think that some vaccine is probably better than no vaccine, so them not missing it is probably the best thing that you can do. 

Linda Eckert, MD:

Yeah, I agree.  The next question about, “How quickly does the antibody response happen?”  Well, we know the peak is in 14 days, but what we saw in the England data was, I think, was really encouraging, which was as long as the pregnant woman had had her vaccination seven days before she delivered, they definitely saw an impact.  I think it’s even more encouraging to give that vaccine.  Just because you think, “Oh my gosh, I may not have that much time,” it doesn’t mean that you shouldn’t give it.  What we’ve seen in population-based studies such as this England experience is that seven days before she delivered protected the infant.

Laura Riley, MD:

Yep, and then the last question was, “Do you need to change the dose of Tdap for the mother that’s pregnant with multiple births?”  I’m not aware of that.  There is no recommendation for that at the moment.  The mom’s antibody response is usually very robust and probably enough to cover both babies.  That’s a great question though, and certainly one that I think in the future we probably will be able to answer because we will have vaccinated enough pregnant women, those with multiples and those without to be able to make a statement about that.  But at the moment, I don’t believe that there’s any different recommendation.   Thank you.  I think that that’s the end of our questions actually. 

Linda Eckert, MD:

Thank you for your attention.

Laura Riley, MD:

Agreed.

Moderator:    

Great.  Thank you very much to our presenters and our attendees.  If you have any outstanding questions that were not answered today, please contact ACOG’s immunization department at immunization@acog.org.  This concludes our program for today.  Please join us for the next webinar: Human Papilloma Vaccination on March 4, 2015 from 12:00 to 1:00 PM EST.  Thank you for joining us.  We’ll see you next time.   

[End of Audio]

This website is supported by an independent educational grant from Merck and an educational grant from Sanofi Pasteur U.S. 
ACOG does not allow companies to influence its programs, publications, or advocacy positions.