The Ob-Gyn's Key Role in Influenza Prevention
Originally presented on Wednesday, October 22, 2014 at 12-1pm ET
** Please note: This webinar contains information specific to the 2014-2015 influenza season, including the influenza virus strains contained in the 2014-2015 influenza vaccine. Please view the 2015-2016 Influenza Season page for updated information including the 2015-2016 influenza vaccine virus strain components.**
Download presentation slides. The presentation slides available for download are the original slides that were used in the presentation on October 22, 2014.
This webinar, “The Ob-Gyn’s Key Role in Influenza Prevention,” covers the 2014-2015 influenza immunization recommendations, including the importance of vaccinating pregnant women, the 2014-15 vaccine formulations, vaccine safety, burden of disease and strategies for integrating immunizations into standard practice. With Influenza season upon us and the recent publication of ACOG Committee Opinion 608, which urges Ob-Gyn's and other health care providers to improve the rate of influenza vaccination among pregnant women, this webinar is the perfect opportunity to learn more about how you can improve influenza immunization rates.
Upon completion of the presentation, participants will be able to:
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.
Hello everyone and thank you for joining us today. My name is Joy from Blue Sky Broadcast and I will be the operator for the presentation today. Today's webcast organized by the American College of Obstetricians and Gynecologists is the first in a series of four immunization webinars from ACOG. Future webinars will include Integrating Immunizations into Ob-Gyn practice on December 3, 2014; Tdap Vaccination on January 21, 2015, and Human Papilloma Virus Vaccination on March 4, 2015. Today's webcast is entitled the Ob-Gyn's Key Role in Influenza Prevention and will focus on the importance of influenza immunization and the provider's key role in protecting their patients.
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Now please let me introduce our program faculty for today's webcast. Dr. Flor Munoz is an Associate Professor, in the Departments of Pediatrics and Molecular Virology and Microbiology, Section of Infectious Diseases, at Baylor College of Medicine and Texas Children's Hospital and a member of ACOG's Immunization Expert Work Group.
Dr. Kevin Ault is a Professor of Obstetrics and Gynecology at the University of Kansas Medical Center (KUMC) in Kansas City, Kansas. He is Division Director for General Obstetrics and Gynecology and a member of the KUMC Institute for Reproductive Health and Regenerative Medicine. Dr. Ault is a Fellow of the American College of Obstetricians and Gynecologists (ACOG) and a Fellow of the Infectious Society of America. He is currently the liaison member for ACOG to the Advisory Committee on Immunization Practices.
Here are the learning objectives for this presentation today (displayed on the slide). And now ladies and gentlemen without further Dr. Flor Munoz I'll turn it over to you.
Flor Munoz, MD:
Good morning everyone. Thank you for joining us today. It is my pleasure to speak with you today about influenza, a very timely topic as we are preparing to face our current influenza season.
And it's always a good time to remind everyone that vaccines are not just for children. Vaccination is a key component of our dealing with influenza season every year. And it is clear that adult vaccination is very important. It saves lives. When we understand how influenza impacts infections in our country every year and that many thousands of deaths are attributed to vaccine preventable diseases, particularly pneumonia and influenza.
It's one of the main leading causes of death in the United States. What we will be discussing today regarding immunization comes from routine adult vaccine recommendations from the Advisory Committee on Immunization Practices and also supported by ACOG which is information that you can find at the ACOG Members' web site and also immunizationforwomen.org.
What is influenza? As many of you might have experienced in person, influenza is not just a cold. It is far more severe than a cold. And we know that it is presented in different ways at different ages. Typically one has a high fever, body aches, a lot of fatigue, headaches. Typically one has a cough, a sore throat, and may or may not have upper respiratory symptoms such as runny nose or stuffy nose. It is important to know especially in this climate of being more aware of infectious diseases that influenza is one of the most contagious diseases out there.
The incubation period is one to four days. So that means that after being exposed to someone with the flu you are potentially able to develop symptoms within one to four days, the average being about two days. So it very quickly can be passed from one person to another and spread within a household or within a community. And when you think about the fact that a person that is infected can potentially shed the virus for about a week or so and be ill for up to ten days you understand how quickly this particular infection can spread and how contagious it can be.
The flu season varies every year. We do have early activity. Probably in some places already you have seen a little bit of the flu. This is not yet the full season. The majority of times we see influenza circulating is from October to May. But the peak of the influenza season tends to cluster around the months of December to February with February usually being the month where we see the most.
And you will see how CDC will keep us up to date. There is information that comes out in real time on a weekly basis during the season telling us about how influenza is spreading in the community and what months we are seeing the most cases. It is important to know though that for an influenza vaccination to be effective it needs to be given before the season starts. And so it is important to start vaccinating before the influenza starts and as soon as the vaccine becomes available.
When we talk about the flu there's also information that helps us understand who is potentially at risk. And this is an excerpt from a graph that is available from CDC that talks about influenza associated hospitalizations during the previous season, 2013-2014. And clearly we have different risk factors. For example in children we know that up to 40 percent of those children that are hospitalized might not have any underlying conditions. But when they do, asthma is an important disease or, cardiovascular disease.
For adults we have understood that if again cardiopulmonary disease, obesity, and diabetes for example, are potential risk factors. But I wanted to point your attention towards pregnancy. Pregnancy in and of itself is a high risk condition for hospitalization and severe influenza illness. And in this particular figure you can see how out of all those individuals that had laboratory confirmed influenza associated hospitalization last year 23 percent were associated with pregnancy.
And pregnancy is a condition where the changes – physiologic changes – that occur, especially in the later part of pregnancy with changes in volume of distribution, changes in the way that our heart and our lungs are functioning during the late part of pregnancy makes us more prone to have more complications from influenza and more severe disease. It is clear from history that influenza and pregnancy have a combined effect that is deleterious for the patient.
We know that from pandemic and also from inter-pandemic periods – so both pandemic and seasonal influenza can be adverse– causing adverse effects for pregnant women. I have here a couple of data from the previous pandemic, starting from 1918 when during that Spanish Flu pandemic the mortality associated with acquiring influenza, especially in the third trimester of pregnancy, was high. About 50 to 60 percent of women who were pregnant died from pneumonia.
In the 1950s with the Asian flu women who died of influenza also had severe pneumonia. And it is important to know that pregnant women and women of child bearing age were over-represented in the group that had mortality and complications from influenza. Then since 2005 we have seen other epidemics with not quite a pandemic for the H5N1 but clearly a new virus strain that particularly affected pregnant women – this is the bird flu or Chinese flu that we saw from the late '90s where clearly women had died of influenza.
Or those who survived had adverse advents to their pregnancy with spontaneous abortions. As I mentioned before we have learned that even between pandemics there has been good data from the U.S. and other countries showing that women in the third trimester, especially of pregnancy, are more at risk of having pneumonia and hospitalization and other complications from the flu. And for those of you who remember the 2009 pandemic the data was very clear coming out really early after the pandemic that pregnant women were at higher risk to be hospitalized, four times higher risk of being admitting to the ICU, requiring mechanical ventilation and dying from influenza especially if they were in the second or third trimester of gestation or if they had other underlying conditions.
And pregnant women again were over-represented in the mortality where five percent of all the deaths that year with the pandemic were in pregnant women. Young women are the ones who are usually affected, women of child bearing age. And even those who survive; their severe illness results in an increased rate of adverse effects for the infant. So prematurity up to 30 percent was also documented. It was important to note that we learned as well during the pandemic that it is key to have an early diagnosis and treatment because if we don't we would have an increased risk of mortality in the mothers as well.
Other data that talked to us about how important influenza is widely available. Here is some information about the fact that in a given season – this is now not pandemic, just regular influenza season – there is a potential for up to 20 percent, so one out of five United States residents can have influenza every year. That is just the usual attack rate – 20 percent of people. It can go up to as high as 30 percent. Again numbers on average from different seasons about 200,000 people are hospitalized.
Obviously this is a huge cost to the economy, to businesses, to work being missed by people who work and get the flu. And certainly we have talked about mortality which can vary. But as we put things in perspective again in the face of new epidemics it is very important to keep in mind that influenza in and of itself is the cause of death in thousands of people every year.
I wanted to talk to you briefly about vaccination. This is the main method of defense and the main method of prevention against influenza every year, influenza vaccine. And this is a figure from the CDC that shows us influenza vaccination rates from 2009, so since after the pandemic until 2014, and you can see that although the vaccine is recommended for all ages regardless of underlying conditions we do have about half of the population vaccinated.
The top line is children, and children have a vaccination rate of about 60 percent. When you look at the bottom line that would be adults about 40 percent and this is on average because truly actually people over age 65 have much higher rates and there's about 60-70 percent. And then pregnant women are in the middle. Pregnant women vaccination rate was about 52 percent last year. In the last three years we've been over 50 percent for the first time. And note that it's been relatively steady since the pandemic.
But it is important also to know that before the pandemic the vaccination rates for pregnant women were relatively low and they were only about 15 percent. So the pandemic did raise awareness about the impact of influenza in pregnancy and has resulted in better coverage and relatively steady coverage. But as you can see we still have room to go. Ideally at least 90 percent of pregnant women should be vaccinated.
The flu vaccine for this year: we have many options available. We have many more than we have had before. As you can see we have the inactivated influenza vaccine. That is the one given as an intramuscular shot. We have both quadrivalent and trivalent options this year. And I'll tell you about that in a moment. The inactivated vaccine comes in high dose for elderly and intradermal presentation for adults. There are also cell-based vaccines. All of these vaccines are not live. So this is not even a full virus that goes into it. It's a protein hemagglutinin protein from the virus that makes this vaccine. And all of these are available even for pregnant women.
The nasal spray is a live, inactivated vaccine. That one is contraindicated in pregnancy. As I was telling you we have this year for the 2014/15 influenza season different formulations. All the vaccines have the exact same strains. But trivalent vaccines contain two Influenza A virus strains and one B as you can see there. The quadrivalent vaccines also contain as second B strain and therefore will have two A and two B. The movement towards having more quadrivalent vaccines available continues. And so even though this year you will have both types of vaccines out available for people in different settings eventually most influenza vaccines will be quadrivalent in the future. And the reason for this is to decrease the variability of the matching of the vaccine with the circulating strain so that there is a better chance that we will be able to cover with the vaccine everything that is circulating.
Certainly the B strains don't vary very much. So those will be covered. And the A strains do vary but they are selected based on portability of circulation every year. The recommendations for influenza vaccine again come from ACIP from the Centers for Disease Control and Prevention, and also are supported by ACOG. And the bottom line is what you see on the top which is that routine annual influenza vaccination is recommended for everyone six months of age and older and especially those who do not have contraindications which are relatively few contraindications mainly reactogenicity allergic reactions to the vaccine.
So what you see there is that as I mentioned before it is important to start vaccinating before influenza starts circulating in the community and that especially healthcare providers as those of us who have the option to educate our patients; we should be able to offer it as soon as the vaccine is available to us or in the community. And as the vaccination should continue throughout the season – so don't stop just because flu started hitting already. We need to continue during the season and even until May if necessary because sometimes we see late influenza activity appearing as well.
We also have some guidelines from CDC available as well regarding the concern of egg allergy. This relates to the fact that the live vaccine and the inactivated vaccines are traditionally prepared based on growing the virus on eggs. But this is not a contraindication. People who are able to ingest eggs and people who have a mild history of egg allergy could still receive the vaccination.
This is something that is important for you to note if you are members of ACOG. ACOG also has this information for you, a committee opinion specifically related to influenza vaccination. This is updated as of September 2014. And again it is available to you through the web site or through immunizationforwomen.org. And really it points the fact that influenza vaccination is an essential part of prenatal care and preconception care for all women and that we understand the importance of influenza in terms of causing morbidity and mortality during pregnancy as well as the potential benefits of the vaccine for both moms and their babies as we will discuss in a moment.
So this is a good reference for you to have. In terms of additional comments regarding the recommendations it is important to note that influenza vaccine – the inactivated influenza vaccine – can be given to pregnant women throughout pregnancy at any trimester, so regardless of the trimester of gestation. We should not give the nasal spray, as we mentioned before. Women can get the trivalent or the quadrivalent vaccine. And women, after they deliver, if they choose to breastfeed their baby they can also receive the influenza vaccine. As we will see shortly the flu shot protects both mom and baby.
It is important to note, again from my side as a pediatrician, that by vaccinating pregnant women we are also protecting the infants, even up to six months of age. Babies cannot receive a flu vaccine until they are six months old or older just simply because before then the vaccine is not very effective in those babies. And so we have also good information that when you vaccinate a pregnant mother the antibodies to influenza will be produced and will be able to cross the placenta and protect the newborns.
We also have a way to project babies by making sure that everyone else at home: father, siblings, and caretakers are also vaccinated.
And that is a way to cocoon if you will or protect the infant in addition to having the direct protection from antibodies that are transferred from the mother to the baby. So it's really, really important as we educate moms and future parents to emphasize the fact that in addition to vaccination for them other household members need to be included in the protection efforts as well.
And I wanted to share with you the results of a study and a couple of other updated information regarding really good data showing the effectiveness of influenza vaccination during pregnancy both in the mother and the child. This is a study that was published in The New England Journal of Medicine recently that was carried out in Bangladesh and was during the 2004-2005 influenza season where women in the group that you see in red – influenza vaccine – received a vaccination with influenza during pregnancy and a control group of mothers received a different vaccine.
When infants were followed through their first few months of life, the number of cases of influenza in babies whose mothers were vaccinated with influenza vaccine during pregnancy was lower than the number cases of influenza in babies of mothers who did not receive the flu vaccine (in terms of having laboratory confirmed influenza). It was very important in this study because for the first time we noted that infants did receive a benefit and reduced the risk of influenza illness that was laboratory confirmed by about 65 to 69 percent when mothers received the vaccine. When you look at reduction in respiratory illness of clinic visits, that was also documented in the babies. Importantly, this study also looked at maternal illness and documented a reduction by 36 percent of respiratory illness with fever which was considered to be potentially associated with influenza in the mothers who also ended up having fewer clinic visits because they were protected against infection. And this is data that has also been found in the United States.
The figure that you see there – the table – shows you the study from Bangladesh at the top with its effectiveness on the infant. But the fact that observational studies in the U.S., at least three that have been published recently; these were case control studies looking at the efficacy or effectiveness if you will of maternal immunization and infant disease. You see that depending on the outcome – so either by influenza PCR, viral culture, or serological outcomes it was possible to document a reduction that went from 40 percent to 90 percent in infant influenza in the first six months of life when mothers received their vaccine.
So again this is all good information and I think it enforces the fact that we can talk to moms about receiving their vaccine for themselves and also for their babies. And what I would like to do now is pass the phone – or I'm sorry – the microphone to Dr. Ault who will be talking to you a little bit more about the Ob-Gyn's role and additional data. Thank you.
Kevin Ault, MD:
Thank you very much Dr. Munoz. And thanks everybody for joining. These next few slides I think in a way are some of the most important slides of the presentation. And there are lots of factual data and I'm going to go over some of it about improving obstetrical outcomes and maternal outcomes with flu vaccine. But of course the patients have to get it. Study after study has shown that provider recommendation: the midwife, the obstetrician talking to the patient about getting a flu vaccine is the most important reason. I've always found that reassuring because that does show that patients do listen to our recommendations. Ob-Gyns and all the Ob-Gyns that are logged in and listening know that we provide primary and preventative healthcare to women and certainly there are statistics to back that up. About half – about 44 percent – of all preventative care visits for adult women are seen by Ob-Gyns. Pregnant women see their Ob-Gyns at least a dozen times during pregnancy as well as postpartum.
So there are multiple opportunities to talk about the vaccine, to give the patient the vaccine and to make sure our patients receive this important intervention. And this slide just emphasizes what's on that previous slide. This is from the MMWR, the Morbidity and Mortality Weekly Review. And again this is a very important slide – maybe the most important slide. And the take home message is that that blue bar on your left where it says recommending an offer – This is a survey of pregnant patients and pregnant patients who are recommended by their provider to get the vaccine and offered the vaccine in the office.
About 70 percent of them are vaccinated. The people that were recommended to get the vaccine but were not offered are lower than the national average by about 20 points. But the people who were recommended and offered are higher than the national average by about 20 points. And of course if it's not recommended it's not going to happen. So you can see that very small bar on your right side as well.
Reasons for not receiving the vaccine among pregnant women in the last flu season: clinician did not recommend the – Or reasons for. I'm sorry, reasons for receiving the vaccine, clinician recommended the influenza vaccine as you can see is an important reason; protect themselves from influenza. Of course that's the traditional reason that we've given the flu vaccine to prevent pregnant women from getting ill. But protecting the infant from influenza is a growing reason. Again that data is relatively new. That's the data that Dr. Munoz just went over a few slides ago. And I think certainly pregnant women will do lots of interventions to have a healthy pregnancy and to have a healthy newborn. So that's not surprising.
Many of you are probably getting your flu shots right now. I actually have a picture of me getting my flu shot on my cellphone that I have shown patients while counseling them. You really need to make sure that you and your staff are vaccinated. About 75 percent of healthcare providers were vaccinated in the last flu season. It keeps trickling up. I suspect the reason that it's trickling up is where I work and where a lot of us work it's mandatory. So coverage was the highest among healthcare providers working in settings where flu vaccination was a requirement. As you can see almost 100 percent so make sure you and your family are vaccinated. Make sure the staff around them is vaccinated as well. I think the other little take home point here is that one staff member saying – And my nurse just actually said this to me the other day, if you tell the patient, "Well my sister got the vaccine and she was sick for a week," or some of the other myths we're going to talk about, that can undo a lot of counseling for you. Make sure that all your office staff is on board with the message so somebody doesn't undo your work later on down or even at intake when they come into your office.
There is lots of data about the safety of influence vaccine. There's been an explosion in this area and there was pretty good data before. But I think there's excellent data – iron clad data – now. And other than the medical literature we get that data from several different places. The Vaccine Adverse Event Reporting System or VAERS for short is managed by the CDC and the FDA and is a passive way of gathering data about the safety of VAERS data. Anybody can file a report about that a parent, a patient or doctor.
The Vaccine Safety Datalink system is a group of researchers that are across the United States that get together and discover vaccine safety and talk about vaccine safety and design trials. The data we're talking about today is generated from that group. The Vaccine and Medications in Pregnancy Surveillance System is a somewhat similar system from the CDC that's mostly patient input. But all three are robust systems and all of them look at the problem with a little different context.
The observational phase as I said – VAERS – about two million women, about 50 percent of pregnant women – were vaccinated in the study that the VAERS people are talking about in the flu seasons from 2000 and 2003. And then upwards of 11 million when you include 20 years' worth of flu seasons and then the – and then of course everybody that was around for the pandemic in 2009 know that we had a special monovalent vaccine for that. The take home message from the VAERS system and the studies that you see quoted there and by the American College of Obstetrics and Gynecology is that there is no increased risk of adverse events or pregnancy outcomes versus the background rate. That's very good news. And then here's a whole list of studies. And most of these are pretty recent. When Dr. Munoz was talking about that 1957 pandemic there was an article in 1964 – which is probably older than a lot of people listening on the phone – that talked about the safety of flu vaccine and pregnancy. It was in the Journal of Obstetrics and Gynecology. So we have at least 50 years' worth of safety data and we have about a half a dozen or more studies here on this slide that summarizes that. Basically what I'd like you to do is kind of look at the columns. I'm not going to go through these studies in any detail. But you can see a wide variety of studies in the vaccinated pregnant women column and a wide variety of formulations, monovalent vaccine, adjuvented vaccine and so a pretty wide variety of formulations were given.
In the control groups of course we have unvaccinated pregnant women as well as more normal controls. But maybe the most interesting column to us today is that far right hand column where there's no increase in adverse events, no increase in obstetrical problems, and maybe even a hint in one of those studies I'm going to talk about in a slide or two about decrease in obstetrical complications, but very robust data, dozens of studies dating back five decades saying that this vaccine is safe during pregnancy.
And so this is data referred to on that other study. This was in The New England Journal of Medicine I think almost two years ago at the beginning of 2013. Scandinavian studies have an advantage – this is a Norwegian study of being able to link registries together. So they looked at 113,000 pregnancies during the year of the pandemic and about half of their women, similar to here, were vaccinated with the pandemic version of the flu. And they looked particularly at an adverse event – probably one of the adverse events for our patients and ourselves: fetal death. And they found some interesting findings. One of the findings they found, and this is in other studies as well, is that vaccination during pregnancy substantially reduced the risk of influenza – 70 percent in this study of an influenza diagnosis in pregnant women. There are beginning to be more studies published about this. So there are two this year. And one was just in The New England Journal of Medicine a few weeks ago from South Africa. So again a lot different setting than Norway but somewhat similar data including both HIV positive and HIV negative women.
And then here is the interesting data as far as obstetrical outcomes. Among pregnant women with influenza the risk of fetal death was increased as you can see there – almost twice as much. And the risk of fetal death was reduced with vaccination with the intervention. There are other related – I think this is a good selling point as well as interesting data. There is other data, and there will be a lot of data published over the next few years, about decreasing preterm delivery and decreasing small for gestational age newborns.
This will be an interesting topic when we start talking about some of these worst obstetrical outcomes as far as stillbirths and preterm delivery and decreasing them by something as simple as just getting a flu shot.
Again, a lot of people probably on this webinar have had their flu shot already. Sore arms are a common side effect, redness, swelling at the injection site, fainting. The picture I have on my phone I was standing up and it occurred to me if I fainted that would not make a very good picture. In adolescents, in my daughters, there can be headaches, fever, and nausea sometimes.
The nasal spray – I've never had that and I know some people have had that. But I think mostly rhinorrhea, runny nose, is the main side effect of that vaccine. But it's squirted in the nose. I'm sure that you have seen it given or somebody that you know has gotten that. Those are common side effects for that. The more severe side effects are the side effects really of any medication and this is why you have a code cart in your office is what I was thinking with this. This could probably happen with any IM medication: difficulty breathing, hoarseness, hives, paleness, swelling, racing heart, dizziness, behavior change, weakness, and high fever of course would all cause us to activate our emergency system.
The other thing that's in the smaller print down here at the bottom is you should report these kinds of adverse events to the VAERS system – these various side effects. And it's not hard to do. It's a few pages worth of paperwork. And the contact information there is at the bottom of the slide as well as a link to the VAERS web site. This is a pretty complicated flow chart. And similar to what Dr. Munoz said I would encourage you to go to the www.immunizationforwomen.org web site and download this.
We've seen a little bit of Influenza B already in Kansas City so I know this is hanging in our labor and delivery. But it's how to treat pregnant women with flu like symptoms with antivirals, Oseltamivir in particular. And the title kind of says it all. Pregnant women experiencing flu like symptoms should be treated early and liberally. Pregnant women who are ill during the influenza season should be treated presumptively with Oseltamivir the anti-flu, antiviral medication regardless of their vaccination status.
The vaccine is not 100 percent as I said on the previous slide. And one of the more common things I see in women who get very ill is somebody waited two or three days to see the test results from an influenza swab. And you shouldn't do that. Patients should be treated empirically. There is really robust data around this too mostly from the pandemic that you really decrease a woman's chance of those very severe complications like an extended ICU stay, intubation, and some of things that we really dread in this population but we see frequently because of the severity of flu in pregnancy.
Again I'm not going to go through this whole algorithm but I would suggest you download it. Post it on labor and delivery. Post it in your office and certainly have it available to review.
Okay I want to go through these common myths with you. And I think we just started doing vaccine here a few weeks ago so I think I've heard all of these. So I think I'm prepared to talk to patients about this.
"I got my flu vaccine last year and I don't need it this year." As Dr. Munoz said the flu vaccine is made up every year based on what we think is going to be circulating. The vaccine may be slightly different from year to year. So you really do a need a flu shot every year to protect yourself even though this year the components are similar to last year.
"I'll get sick from the vaccine," which is probably the most common of these myths I would guess. Discuss the common side effects that I went over with a few slides. The flu vaccine is made from a killed, very weakened virus so you won't get the flu from the flu vaccine. But you may get some nuisance side effects.
"Flu vaccine causes autism." There are multiple studies about this, and again some of them predate the pandemic. So multiple studies have been conducted reviewing mercury containing vaccines, influenza, and autism. Those studies have never shown a positive correlation between the influenza vaccine and autism. And most flu vaccines don't contain this (mercury) either. That's the other kicker in there. That's a pretty easy one to get around 'cause most vaccines don't contain that.
"I'm healthy and I never get the flu so I don't need it." You're going to hear this from pregnant women because in your early-20s when you're pregnant and you've never been sick and don't miss work, women don't realize that they're really at risk. So even healthy adults, healthy pregnant adults I would say, can become severely ill from the flu. And the flu vaccination is recommended for everybody six months of age and older. Usually what I tell the office staff is anybody that's old enough to walk into the clinic, is old enough to get the flu vaccine.
"I can't get vaccinated in the first trimester of pregnancy." That's not true. The vaccine as I said has a robust safety track record and it's safe in all trimesters. Since 2004 the CDC and ACOG have recommended the influenza vaccine during any trimester and that's certainly the most recent data that is available from ACOG.
"The flu vaccine will cause birth defects or miscarriage." You'll hear this frequently. I mean pregnant women think that a lot of things cause miscarriage. And of course miscarriage is very common and that has been shown again in these robust safety studies that that doesn't happen. And so I think that's good news. And if anything, fetal loss is less common. I went over that Norwegian data to kind of disprove that myth for you.
Some of the upcoming webinars touch on some of these topics I'm going to finish up with here in the last few slides. As far as very practical recommendations how to get flu vaccine and a lot of other vaccines into your office; there are resources available from ACOG that are pictured there on the right. It's also a nice opportunity to talk about Hepatitis B vaccination in newborns and a lot of other vaccines that we give early on that Dr. Munoz maybe can answer some questions about during the Q&A.
There are scripts. That's actually I think one of the most popular things that practices use from ACOG as well as toolkits. I would certainly recommend that you have these things available to you and that will increase uptake in your patients and make things smoother in your office both. As far as your responsibilities patient vaccine records should be kept up to date. And in the era of electronic records of course there is usually a separate system for that.
However the vaccine logic and electronic medical records may not reflect OB-GYN needs. I think my experience is that they are good for general adult populations but not so good for pregnant women. I believe Dr. Munoz has actually published a study that standing order is the best way to go as far as uptake. And that's similar to what I said kind of humorously a few slides ago. You know if you're pregnant and it's flu season you should get a flu shot and there shouldn't be a separate doctor's order for that, and that will increase your uptake as well.
I have found the Vaccine Information Statements to be a good source of patient education too because they're pretty short, to the point, and worthwhile, and the patients can sign them right there in front of you. And those are downloadable from the CDCs web site and available in multiple languages depending on your clinical setting.
You should report to VAERS and I kind of mentioned that when we were talking about the most severe adverse reactions related to influenza vaccines. You would record those types of reaction in the chart too. I hope that goes without saying. Most states – I think every state – has a vaccine registry and in the era again when patients move around from state to state or different parts of the state and they get part of their care one place or the other I think that's a very good idea. And you can see the need for making sure there's not duplication and to verify that people have gotten vaccinated. And as you can see there are contact registries for your state if you follow that link down there in the last bullet point of the slide. Some of these topics – and these are barriers that we need to talk about and we need to acknowledge – are our business practice or reimbursement. ACOG has anticipated that for us. And I've gone to seminars at the Annual Clinical Meeting. That's usually covered then which isn't flu season of course. But as far as reimbursement, vaccine purchasing resources, vaccine for children, and registries; you can get information about those types of things again at the web site as well as watching the webinar – a previous webinar – buy following that link. And certainly that is a barrier I think. And a lot of single specialty offices as far as providing the vaccine. So I would encourage you to look into that if you feel like that's a barrier.
We did have an item, an objective about pneumococcal disease on one of those first slides so I'm just going to touch on this a little bit. Strep and pneumoniae is certainly is a major cause of death and illness in the general population. And some of the guidance for giving the pneumococcal vaccination has changed a little bit. It's recommended in persons over 65 which of course is not the pregnant population. But those three risk factors down there: smokers, asthmatics, and diabetics are a lot of our patients.
And so those patients – and that's one of the fairly recent changes – should get the pneumococcal vaccine. The way that electronic medical records work I think is good here because it'll frequently pop up when a patient comes in for a visit that they are not up to date on their pneumococcal vaccine. And ideally that would be done in a preconception visit but can certainly be done during the pregnancy or postpartum.
This is maybe a little more detail than we're interested in but I'll go over this in a little bit. Immune competent patients should receive the 23-valent polysaccharide vaccine. And then there's a combination of two vaccines that immune-compromised patients should be given. Providers should make every effort to vaccinate high risk women before they’re pregnant. I said that on the previous slide. And then for pregnant women who have never been vaccinated the 23-valent polysaccharide vaccine for the asthma, diabetics, and smokers which there will be a lot of those and then the two dose regime for the women who have asplenia or who have immune deficiencies. And again I think the most common one of those would probably be HIV.
This is a busy slide and again probably a little more details than we want but this nice graphic for the National Foundation for Infectious Disease I think is useful. Influenza vaccine should be given to all women that are pregnant. Tdap and HPV which are on that long list on the left are the topic of upcoming webinars. And I went over the pneumococcal vaccination and recommendations, but again that appears on the web site. So I'd encourage you rather than me go through this whole list, to go to the website and have those resources available to you. This ties to highlight some of the things.
This is the immunization schedule from the CDC that's updated. It usually comes out in January, so this is this year's schedule. It shows influenza one dose every year as we've said several times. And then it talks about some other vaccines in the red there that we're going to have in future webinars. And then the pneumococcal vaccine is kind of midway through there down here as you can see. Let me go on to the next slide.
This is a little bit more complicated slide because it's vaccines that are indicated based on medical conditions and pregnancy is that column that's the far left column that's right next to the type of vaccine. I think the take home message for this is there are several vaccines that are recommended during pregnancy and influenza and Tdap are at the top there. And there are some that are contraindicated. None of these that are contraindicated are associated with birth defects but they are a live virus vaccine so we generally try to avoid them during pregnancy. You can print this off the CDC's web site and I think that's very useful. Again we have a laminated copy of this in our office so it's nice to have it around.
Conclusions: all persons six months or older should receive influenza vaccine every year. Pregnant women are at increased risk of complications including death, to be blunt about it, are at increased risk of complications from influenza infection. Influenza immunization during pregnancy protects the pregnant mother, their baby, and maybe from some of the obstetrical complications as well. Influenza vaccines are safe and as I said previously, and Ob- Gyns have a responsible to integrate influenze immunization into their routine practice.
I think we have time for questions so when we were talking beforehand, Dr. Munoz and I know each other fairly well. So down here on the bottom right I think Carl S. had asked what is PW? I was actually looking at that question while Dr. Munoz was talking and I think that was pregnant women on some of the slides. Dr. Munoz do you want to handle that question from Andrew B. or do you want me to?
Flor Munoz, MD:
Absolutely I can start and I will welcome your comments as well because this is a very common question. Andrew is asking, “does the efficacy of the vaccine or any of the vaccine options decline before the end of the flu season, especially when you give it before or early in the season?” I think that I can speak for many who work on influenza in general and that this is definitely a question that needs an answer. There is work being done towards trying to decide that. And there are many aspects of it.
So it depends on who you are vaccinating, what their risk is, and what kind of a season we are having. I say that because there is data clearly showing that when you receive an influenza vaccine you have an antibody response that usually starts after a week and peaks anywhere between two to four weeks after the vaccination. So that's the time when you have the highest levels of antibody. And the antibody level will come down to a plateau if you will usually in the first six months or so after vaccination.
So there is definitely a decline in antibody concentration over time that occurs within the first six months after vaccination to a year. Whether that relates to a decreased efficacy or not is a question. So does that decline in antibody result in a decrease in the vaccine working? And I have to tell you based on the fact that we know that antibody levels correlate with protection, so an arbitrary level of greater than 1 to 40 for example has been considered to be associated with protection in more than 50 percent of people.
So a lower level might potentially be less efficacious. But there is variability in the antibody response to a particular individual. There is variability depending again on exposures and previous history of antibody or antigen exposures. So it's not an answer that I could give you that applies for everybody. There is data in elderly individuals in whom yes the antibody level is very important and they do decrease for example. And there is also data in children and in younger adults that even if you don't receive a flu vaccine every year there's enough memory that you do have protection in a second season where you did not get vaccinated that might not be either a 60 to 70 percent. It might be closer to 40 percent but there is still some protection later on. So this is kind of a convoluted answer to tell you that there is variability, that we do know the antibody levels are important, that there is a decline in antibody concentration, but that once you have been primed with a vaccine you would also expect to have an antibody response once you get exposed to the flu. And that the results are the issues of opportunities and not missing opportunities.
So for pregnant women in particular they will be coming to the office for their prenatal care at least monthly and eventually every two or one week towards the end of pregnancy. And so if you have a regular follow up and you are able to track the activity of influenza in your community you usually will be able to start giving the vaccine anytime between September/October. And if you think of the fact that most of the flu activity will occur between December and February you are still within those six months.
And there would be no concern I think in giving the vaccine to pregnant women between September and October if you are indeed going to want to protect them throughout the season. If you have women who are in their third trimester of gestation I would try to vaccinate them as early as possible because we don't know when the flu is going to hit and they would be at higher risk. And so even those cases that we're seeing right now in October; those could be prevented with early vaccination.
So I think that's – Again if you have all this information think about we don't know really when flu occurs. We're counting on surveillance to know and we also want to make sure we don't miss opportunities to vaccinate. And then the specific academic issues of when the antibody goes down and how the efficacy is affected are also something that we are looking at in some clinical studies. So this will be important to consider as we go.
Kevin Ault, MD:
I would just emphasize what you said. I mean the women who are pregnant now and in early pregnancy are going to be in their second and third trimester which is when they're at the most risk for complications. But the patients who are pregnant right now who are 36 weeks pregnant are going to be breastfeeding and plus they're going to be at risk for cardiovascular problems at least six weeks after pregnancy according to some of that nice data from the CDC, and maybe even longer.
So yeah I think the answers we're giving just emphasize what we said – to give the vaccine now to protect mothers – is really who you're going to protect, but also the babies that are being born later on.
Flor Munoz, MD:
Kevin Ault, MD:
One of the people that's typing in wants to know if a flu vaccine can be given with other vaccines, for example Tdap. Do you want to answer that Dr. Munoz or do you want me to answer it?
Flor Munoz, MD:
I would say yes they can be given at the same time. They have different time recommendations and so Tdap is supposed to be between 27 and 36 weeks of gestation. So it's not a first trimester vaccination. But if you have a woman that is at the second or third trimester they can be given at the same time. Is that what you do Dr. Ault?
Kevin Ault, MD:
That's what I do. Yeah it just came up yesterday because then you have two sore arms rather than one sore arm. But yeah – I kind of alluded to this before. Once you explain to pregnant women the advantages to the newborn of giving this vaccine – giving both vaccines for that matter – most women are willing to put up with two sore arms. And the women who have a little pain, who don't want two sore arms, can get their Tdap in a couple of weeks is what a couple of people have chosen to do – a couple of my patients.
Flor Munoz, MD:
Well I do appreciate the fact that you mentioned the baby because it is clearly, as we have been discussing today, a huge advantage is protection of the baby. And so yeah if you have babies born around Christmas time or even between Thanksgiving and Christmas or thereafter their best chance of protection is going to be if mom gets vaccinated. So I would definitely encourage everyone to try to vaccinate their moms now before Halloween.
Kevin Ault, MD:
Well I mean I think that's the data that really made us go from 15 percent to 50 percent because that study was in 2008 and then the pandemic was right on the heels of that study. Back in the '90s and before the pandemic women would say, "I'm willing to take the risk of getting the flu because this shot might harm my baby," or some of those myths. "I don't get sick," or "I'm not sure this is safe." All of those things have kind of disappeared and that's why we've had more uptaks. I mean we could certainly do better than 52 percent but I think that's a good selling point just as far as counseling patients. We've got time for a few more questions.
Thank you Dr. Ault and Dr. Munoz. I'll give a reminder to everyone if you'd like to ask a question the Q&A pod is located at the bottom of your screen. To send a question click in the text box and type your text. When finished click the send button. And if our presenters have any final thoughts while we wait for any other questions that may come in?
Kevin Ault, MD:
Well one of the things I thought about when we were developing this webinar, and this is going to come up I bet in the next few weeks in your practice, is if a patient – There are measles going around in the United States and so if somebody gets a measles vaccine, a MMR vaccine or gets a nasal vaccine for flu now and then two weeks later, a month later, you find out they're pregnant those vaccines have not really been associated with birth defects.
Just in an abundance of caution we usually don't give those vaccines to pregnant women. But if it happens inadvertently, which it does of course, there haven't been shown to be problems. Do you agree with that Dr. Munoz?
Flor Munoz, MD:
Absolutely. Inadvertent vaccination to a pregnant woman is something that has allowed us to gather data on that. And even some of those live vaccines have not been associated with birth defects or any other specific event. So I think that is important. I also wanted to mention related to that we do give MMR. We give rubella vaccine to postpartum women and therefore at the postpartum period that is another opportunity to bring moms up to date with their vaccine.
And even the live vaccines are not contraindicated. It is also a high risk period for mom for flu. And it's a high risk period for the babies. And so ideally we are going to be increasing our coverage of pregnant women because of all the wonderful things, the wonderful benefits for moms and babies. But if moms are not given the flu vaccine it's not too late, it's not too late to give it postpartum. I would also encourage that.
Kevin Ault, MD:
Right and that'll be coming up right now when the vaccine is first available. And I bet a lot of people listening in have dealt with that. One of the participants is asking: “Is the flu contagious during the one to four days after exposure before the affected person has symptoms?” I think I know the answer to that but do you want to answer that?
Flor Munoz, MD:
Yes. This is very interesting. Especially young children, before they start having a fever or before they start getting really sick they can be potentially contagious. But certainly the one to four days after exposure; that's the latency, the incubation period if you will. So that means there's already virus replicating in your nose and you can potentially pass it to others. But the highest contagious period, highest increase of transmission obviously is going to happen once you start having the runny nose and the congestion and all that. That's how the virus spreads to others.
Kevin Ault, MD:
Right and this is one of the more contagious diseases known to man really. Measles and flu are very contagious in that kind of prodromal and just after being exposed situations. So yes that's a situation where the virus is getting passed around asymptomatically.
Flor Munoz, MD:
Kevin Ault, MD:
According to my watch we've got one more minute. Do we have one thing that we left out that we want to talk about Dr. Munoz?
Flor Munoz, MD:
I think this is covering. There's a lot of vaccine, that's another thing. There are no potential issues with supply so hopefully everyone is able to have vaccine at their offices and vaccine is being given in pharmacies and different clinics. It is important to make sure pregnant women do get included and they receive their vaccine no matter what the location of the vaccination is.
Kevin Ault, MD:
And I agree and that's something that's change pretty dramatically over the past few years. There was a shortage just a few seasons ago. But now when we have that universal recommendation it seems like there are less of those glitches.
Okay great. Well 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 firstname.lastname@example.org. This concludes our program for today. Please join us for the next webinar on Integrating Immunizations into Ob-Gyn Practice on December 3, 2014 from 12- 1 PM EST.
Thank you for joining us and we'll see you next time.
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