The Power to Prevent Cancer: Important Updates on the HPV Vaccine
Originally presented on March 4, 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 March 4, 2015.
The fourth and final webinar of the series, “The Power to Prevent Cancer: Important Updates on the HPV Vaccine” reviews the burden of disease caused by Human Papillomavirus, and explains the importance of immunizing patients, particularly those in the target and catch up ages. The presentation details ACOG and ACIP’s HPV immunization recommendations, describes the safety and common side effects of HPV vaccination, and explains the importance of and optimal timing for HPV immunization.
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. 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 last in a series of four immunization webinars from ACOG. Today's webcast is entitled The Power to Prevent Cancer: Important Updates on the HPV Vaccine, and will detail ACOG and ACIP's HPV immunization recommendations, describe the safety and common side effects of HPV vaccination, and explain the importance of an optimal timing for HPV immunization.
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Now, please let me introduce our program faculty for today's webcast. Dr. Jennie Yoost is an assistant professor of pediatric and adolescent gynecology at Marshall University, department of OBGYN, in Huntington, West Virginia. Dr. Yoost earned her medical degree at the University of Louisville, School of Medicine, and completed her residency at the Medical University of South Carolina. She completed a fellowship in pediatric and adolescent gynecology at Kosair Children's Hospital in Louisville, Kentucky, and has a master's in clinical investigational science from the University of Louisville. She is a member of the ACOG Immunization Expert Work Group, and serves as a liaison to the ACIP Work Group for Childhood and Adolescent Immunization.
Dr. Barbara Goff received her MD at the University of Pennsylvania, and completed her residency at Harvard Medical School. She completed her gynecologic oncology fellowship at the Massachusetts General Hospital, and then joined the faculty at the University of Washington in Seattle. She became the director of the division of gynecologic oncology at the University of Washington in Seattle Cancer Care Alliance in 2005. Her major research focus has been in early detection of ovarian cancer, surgical skills training, novel therapeutics and patterns of care, cost-effectiveness and quality outcomes research in the treatment of ovarian cancer. Dr. Goff became the president of the Society of Gynecologic Oncology and the Foundation for Gynecologic Oncology in 2013. She has collaborated with the CDC to provide education about HPV vaccinations to pediatricians and primary care physicians.
Here are the learning objectives for this presentation (displayed on slide). And now, ladies and gentlemen, without further ado, Dr. Goff.
Barbara Goff, MD:
All right, well, thank you very much for the introduction. And we'll go ahead and get things started so that we make sure we have plenty of time for questions and answers, because there's a lot of new information that we're going to present today. So, I think this audience is completely familiar with what is HPV? Human papillomavirus (HPV) is the most common sexually transmitted infection, worldwide. And there have been more than 150 types of HPV that have been identified, with 40 of these distinct types that can cause infection of the genital tract.
Most HPV infections, about 90 percent, are completely asymptomatic when people get them, and they resolve spontaneously, within about two years, as our immune system kicks in and clears the virus from our system. But some people do develop persistent infection, and it's persistent HPV infection that's not cleared by our immune system that can cause cancer and other benign diseases.
HPV is so common that almost all sexually active men and women will get at least one type of HPV at some point in time in their lives. And I think we are all aware, as Ob-gyns that HPV can be passed even when an infected person has no signs or symptoms. So HPV exposure can occur with any type of intimate sexual contact. And I think it's really important to understand that intercourse is not necessary to become infected. And it's one of the reasons that condoms don't provide complete protection against HPV infection.
We know that the HPV vaccine is most effective when given prior to the onset of sexual debut. And we also know that nearly 50 percent of high school students have already engaged in sexual intercourse. In one study, they found that one third of ninth graders and two thirds of twelfth graders had engaged in sexual intercourse, and about 24 percent of high school seniors have had sexual intercourse with four or more partners. And of course with each additional partner, you dramatically increase the risk of getting a human papillomavirus infection.
The overall burden of disease from human papillomavirus in this country is pretty substantial. It's estimated that right now approximately 79 million people are infected with HPV, and it's estimated that about 14 million new infections occur every year among persons aged 15 to 59. And approximately half of the new infections occur among our adolescents and young adults aged 15 to 24. And it's been shown that after the initiation of sexual intercourse, there is a very rapid acquisition of individuals contracting HPV.
There's 13 HPV types that have been designated as human carcinogens, and HPV types 16 and 18 are the most oncogenic, and they account for about 70 percent of cervical cancers worldwide, and are also associated with other types of anogenital infections, as well as oropharyngeal infections, and we'll talk a little bit more about that in a second.
Among the non-carcinogenic types, HPV 6 and 11 are probably the most prevalent in terms of genital infections, and of course as I think everyone on this phone call knows, they account for about 90 percent of the genital warts that we see. Each year, there are over 350,000 people who contract – who get genital warts. And each year, approximately 12,000 women in the United States get cervical cancer. So HPV has a dramatic effect on the women that we treat. Cervical cancer of course for women is the most common HPV related cancer.
Statistics from the American Cancer Society in 2011 showed there were over 12,000 women who were diagnosed with cervical cancer, and over 4,000 women died. And I really look at these cancers as truly preventable cancers, either through screening or, as we now have the power to prevent cervical cancer with our HPV vaccination. Mean age of cervical cancer is approximately 48 years old in this country. But 25 percent of cervical cancers will occur in women who are between the ages of 35 and 44. And 14 percent will occur between age 20 and 34.
HPV really has the potential to (through the causation of cervical cancer), really has the ability to impact fertility rates as well as prematurity rates. And so really has implications, HPV has implications even beyond cancer, particularly for Ob-gyns. This slide shows the attribution of HPV to HPV related cancers in both men and women. So if we look at the female side, you can see that for females, the most common cancer is cervix cancer, and approximately 90 percent of cervical cancer is attributable to HPV infection.
And then you can see for cancers of the anus, oropharynx, vagina, and vulva, that these cancers – the attribution rate is between 80 to 90 percent for these cancers. For men, the most common HPV related cancer is cancer of the oropharynx. For whatever reason, I don't think people quite understand why, but men are much more prone to developing cancer of the oropharynx than women are. And you can see that HPV accounts for approximately 72 percent of oropharyngeal cancers of men, and then you can see for cancers of the anus and the penis, that again 80 to 90 percent of these cancers are related to HPV.
If we look at the economic impact related to HPV infections, it's pretty substantial. In 2010, we spent about $8 billion on HPV. Most of that was in relationship to cervical cancer screening, but you can see that we spent $400 million in the treatment of cervical cancer, $200 million in treating other anal-genital cancers, $300 million in treating oropharyngeal cancers, and $300 million just in treating warts alone. And so there is a huge economic impact, and the burden of disease disproportionately affects women.
There are three HPV vaccine options that have now been licensed by the FDA. The first is the bivalent HPV vaccine, which prevents two types of HPV – 16 and 18 – and, as we know, these account for approximately 70 percent of cervical cancers, and the other cancers that we've already discussed. The quadrivalent HPV vaccine protects against four HPV types; 16 and 18, and then also HPV 6 and 11, which cause 90 percent of genital warts. And the quadrivalent vaccine has also been shown to protect against cancers of the anus, the vagina, and the vulva.
And then at the end of 2014, the 9-valent HPV vaccine was approved by the FDA. This protects against nine types of HPV, including 6 and 11, which cause genital warts, 16 and 18, which we've already talked about, and then there's five additional oncogenic strains, which include HPV types 31, 33, 45, 52, and 58. And so with this addition of five – protection against five oncogenic strains, we get an additional 15 to 20 percentage point protection in preventing cervical cancer.
With this 9-valent vaccine, we're looking at almost 90 percent, the possibility of 90 percent prevention of cervical cancers, which I think is incredibly exciting. All vaccines are to be administered as a three-dose series, at zero, two, and six months, and the target age is 11 to 12, before there has been any sexual contact. The HPV vaccine rates in this country have slowly been increasing, but the United States has, for a developed country, the lowest rates of HPV vaccination, of both its boys and its girls.
In most developed countries, like Canada, Australia, the UK, vaccination rates are above 80 percent, and this would be for completion of the three-vaccine, the three doses of the vaccine. So in the US, you can see that from 2012 to 2013, at least initiating the vaccine was at least one dose of HPV vaccine, has gone up from 53 percent to 57 percent for girls, and 28 percent to 34 percent for boys. When we look at completion of the three vaccine series, which is of course going to give children the best protection against HPV in their lifetime, again, this is embarrassingly low.
In 2013, only about 38 percent of girls were vaccinated, or completed the vaccination series, and just about 14 percent of boys completed the vaccination series. I think just an interesting comment – in Rwanda, which is of course a developing country, they have a mandatory school-based vaccination program for girls, and they've been able to achieve a 95 percent vaccination rate in that country. So clearly we have an issue in terms of getting our kids vaccinated.
One of the main reasons that people don't – or parents choose not to vaccinate their children – is they're not getting recommendations from physicians. And this seems to be due to gaps in physician knowledge about recommendations and missed opportunities. There are many opportunities where children are getting other vaccines, such as meningococcus, Tdap, influenza, where they're getting shots anyway, and there would be an opportunity to give the HPV vaccine, because it can be given with other vaccinations.
Less than 50 percent of parents report that their child's clinician didn't recommend an HPV vaccine. So it's not that they were saying, "No, don't get it," but they just never brought it up in the visit. And there's a very interesting study that was done that showed that had HPV vaccines been administered to adolescent girls born in 2000 during healthcare visits between age 11 and 12, when they had received another vaccine, that vaccination coverage by age 13 for this cohort would have reached 91 percent.
And this is really critical. Because when we have HPV vaccine rates above 80 percent, as Dr. Yoost, will show you later, we have extremely high efficacy within our population, and it's been estimated that for every year that we don't get our HPV vaccination rates above 80 percent, then an additional 4,000 women will end up developing cervical cancer in this country.
Studies have shown that the provider recommendation is the most influential factor in a patient's decision to receive immunization. More parents of vaccinated teens, approximately 70 percent, report receiving a recommendation for vaccination, compared with patients of unvaccinated teens. And the percentage of parents who report that they received recommendation for HPV for their children, in 2013, was about 64 percent for girls, and about 41 percent for boys. And this should be 100 percent, given what we know about the safety and efficacy of HPV.
There was another study that was done that looked at – what were the main reasons why parents decided not to vaccinate their children? And this was a survey, and they split things up between girls, and boys, and the girls are represented in pink, and the boys are represented in blue. But the top five reasons were, first, that it wasn't recommended by the child's physician. Parents had no knowledge of the HPV. They didn't really know what it was. Many felt that it wasn't necessary because their children were not at all at risk for developing HPV. Some had concerns about safety and side effects. And then also many parents said they didn't want their kids to get vaccinated until they were sexually active – when, of course, that's exactly the wrong time to vaccinate your children. It needs to be done before the onset of sexual activity.
Current HPV recommendations for the bivalent and quadrivalent vaccine are that both of these vaccinations are recommended for female’s age 11 or 12, and the quadrivalent vaccine is routinely recommended for boys. Either the quadrivalent or the bivalent can be given to girls. The vaccine series can start as early as age nine, depending on when one expects the onset of sexual activity. A vaccination, in terms of catch-up, is recommended for 13 to 26 year old females, and 13 to 21 year old males who have not started or completed the vaccination series.
As I said earlier, at the end of 2014, the FDA approved the 9-valent vaccine. And last week, on February 26th, 2014, the Advisory Committee on Immunization Practices, or what we call ACIP, met to come up with their preliminary recommendations. These are provisional recommendations, because they ultimately need to be signed off by the CDC, but we felt with the timing of this webinar that it would be appropriate for us to bring you information that came out of that meeting last week.
For the 9-valent vaccine, ACIP recommends – the recommendations are pretty similar as to what we see for the quadrivalent. The vaccination can begin as early as age nine, but the target age is 11 to 12. Catch-up can be done for both females and males up to age 26. And the vaccination can be given, as I said, either to men or to women. All three of the vaccines, the bivalent, quadrivalent, and the 9-valent, protect against HPV 16 and 18, which is the most important oncogenic viruses to prevent. The 9-valent has the advantages of adding an additional five oncogenic strains, and so we're looking at possible protection from cervical cancer from somewhere between 75 to 90 percent with that vaccination.
They also addressed interchangeability. If you started with one type of vaccine, and say your office switched over to the 9-valent, would that be a problem? And basically they said no, you can start with one vaccination, and you can finish up with the other. These vaccines should be considered interchangeable.
All three vaccines should be administered in a three-dose schedule, with the second dose being administered at least one to two months after the first dose, and then the third dose being at least six months after the first dose. And, again, it's important to remember that if the schedule is interrupted, the vaccination series doesn't need to be restarted. Just if somebody goes a year, you just go ahead and you complete the doses on as close to a schedule as you possibly can.
Now, the HPV vaccination is not recommended during pregnancy. Dr. Yoost will address a little bit about safety. It has not been shown to be harmful. But it is not recommended during pregnancy. And with the 9-valent HPV vaccine, there is a new registry that's been established, so that if somebody does get this during pregnancy, it's important to report that, and report if there have been any adverse events with this. But to date, this has been one of the safest vaccines that has been produced.
So with that, I'm going to go ahead and turn things over to Dr. Yoost. And she's going to talk about efficacy. She's going to talk about safety. And she's also going to touch on what are some of the common myths about the HPV vaccine.
Jennie Yoost, MD:
Great, thank you, and thanks to everybody for joining us today. Right now, we're going to talk a little bit about vaccine efficacy. And this slide addresses the bivalent and quadrivalent vaccine. We know that the HPV vaccine is cancer prevention, and it certainly saves lives. Millions of HPV vaccine doses have been given over the past eight years, and have proven to be effective and safe.
As Dr. Goff mentioned, our coverage rates are pretty low, and, according to the CDC, if we as healthcare providers increase our HPV vaccination coverage to 80 percent, it's estimated that an additional 53,000 cases of cervical cancer could be prevented during the lifetime of those younger than 12. Our clinical trials showed vaccines are effective. They provide close to 100 percent protection against pre-cancers. And for the HPV-4 vaccine, close to 100 percent protection against genital warts.
Since the vaccine was first recommended in 2006, there's been a 56 percent reduction in HPV infections among teen girls in the United States, even with our very low vaccination rates. So just think what we could do if our coverage rates increase.
The 9-valent has shown a very similar high efficacy. It offers about 97 percent protection against HPV types 31, 33, 45, 52, and 58. And similar protection against HPV 6, 11, 16, and 18. That was tested in a randomized double-blind study that compared quadrivalent to the 9-valent. And that study is listed at the bottom of this slide. Just published recently in The New England Journal of Medicine a few weeks ago.
Non-inferior immunogenicity has also been demonstrated. Antibody responses to HPV 6, 11, 16, and 18, among participants receiving the 9-valent, were non-inferior to those receiving the quadrivalent. And good antibody responses and zero conversion were demonstrated for all nine HPV vaccine types in adolescent females and males compared to adult females, and in adult males compared to adult females. It can be administered, the 9-valent can be administered, with other vaccines, such as the meningococcal vaccine, the Tdap vaccine, and the combination Tdap-polio vaccine, and that's important because a lot of these vaccines are administered around the same age.
Other parts of the world have had a greater success in HPV vaccine uptake. Australia was one of the first to have a nationally funded program. And because of this, 80 percent of school aged girls in Australia are fully vaccinated. And because of that high uptake, high grade cervical lesions have declined by 38 percent in women in this cohort.
For vaccine eligible females, the proportion of genital warts has declined dramatically, by 93 percent, and the boys are benefiting as well. Genital warts have declined by 82 percent among males of the same age, and that indicates herd immunity.
The CDC uses three systems to monitor and evaluate safety of vaccines after licensing. One of these is the Vaccine Adverse Event Reporting System, or the VAERS system. It's an early warning public health system where people can report vaccine concerns. It helps the CDC and the FDA detect possible side effects or adverse events following vaccination. It doesn't look at causal relationships, but it can identify new trends in adverse events and see what needs to be investigated further.
The Vaccine Safety Data Link is a collaboration between CDC and several healthcare organizations, which uses de-identified health records to monitor and evaluate adverse events following vaccination. The Clinical Immunization Safety Network is a collaboration between CDC and several medical research centers in the US to conduct research into how adverse events might be caused by vaccines.
HPV vaccines have been well studied, and shown to be safe. This slide discusses the safety of the bivalent and quadrivalent vaccine. Both the bivalent and quadrivalent were studied in thousands of people around the world, and these studies showed no serious safety concerns. Side effects reported in these studies were mild – such as pain at the injection site, fever, dizziness, and nausea. Vaccine safety is something that continues to be monitored by the CDC and the FDA.
As of June of 2012, more than 46 million doses of these HPV vaccines have been distributed in the United States. Fainting is an event that has been reported through the VAERS system. Fainting obviously can occur after any medical procedure. It is more common in adolescents than adults after vaccination. It has been noted after HPV vaccination. Adolescents and adults – because of this, it's recommended that they should be seated or lying down during HPV vaccination and remain seated or lying down for about 15 minutes after vaccination to prevent this side effect.
The HPV vaccine is not recommended during pregnancy. But if it's inadvertently given during pregnancy, the vaccine has not been determined to be harmful. Similarly, the 9-valent vaccine has – safety has been demonstrated. It was generally well tolerated in over 15,000 recipients. The adverse event profile is similar to the quadrivalent vaccine across age, gender, race, and ethnicity. There were some more injection site related swelling and erythema in the females who received the 9-valent, compared to the quadrivalent, but most of these are mild or moderate in intensity.
There were lower frequency of adverse events in males compared to females, and that's similar to the quadrivalent studies where males had fewer adverse events compared to females.
Despite the thorough safety monitoring, there are many myths that still persist, and you will see these in practice. So right now, we'd like to address a few common ones that you're likely going to hear in your practice. This number one – "It's still a new vaccine, I don't want my child to have it until it's proven to be safe." The truth is, millions of doses of HPV vaccine have been given with no serious side effects. The CDC continues to monitor the safety and efficacy of the vaccines over time, and, to date, they've proven to be very safe and effective.
Myth number two is, "My child is not having sex, so they don't need the vaccine now." The truth is HPV vaccines are most effective if given before the onset of sexual activity. If your child is not sexually active, now is the ideal time to vaccinate them to provide them with protection they need in the future. Additionally, studies have shown that the immune response is the greatest for vaccines given around the 11 to 12 year range, which is why other vaccines such as Tdap and meningococcal are recommended at that time. It's also very difficult to predict sexual debut in adolescents. So waiting until an older age, or until sexual activity is more of a concern, is not recommended.
Myth number three. "If I vaccinate my child against HPV, they'll see that as permission to become sexually active." The truth is the HPV vaccine has not been linked to early onset of sexual activity. A recent study in 2012 in the American Academy of Pediatrics Journal, they looked at 1,400 girls and found that HPV vaccination was not linked to sexual activity related outcomes in girls.
Myth number four. "My child can't receive the vaccine because they have a cold or a chronic medical illness." The truth is, mild illness is not a contraindication to HPV vaccination, and your child can still be vaccinated. If your child has a moderate or severe illness, they can wait until they're better to receive the vaccine. It's important to note with this myth that patients with chronic medical conditions, including those that are immunocompromised are candidates for vaccination, and it's important to recommend this vaccination in those populations.
And then myth number five. "Boys don't need the vaccine." They absolutely do. The quadrivalent HPV vaccine has been recommended for use in boys since age 11, or, excuse me, at age 11 or 12, since 2011. The vaccine prevents HPV types that cause oral, penile, and anal cancer, and genital warts that can be spread through skin contact.
Obstetrician gynecologists have a unique role with HPV vaccination. Provider recommendation again is of utmost importance. And remember to give a strong recommendation. You may not be seeing those 11 and 12 year olds routinely in your practice, but you're certainly seeing the catch-up range and their mothers. So it's important to talk to mothers during their annual Ob-Gyn visit about vaccinating their children. Address the concerns with parents, myths that we've reviewed, myths that it's not safe, or, "My child is too young," or, "It's too new of a vaccine."
And then a reminder and recall is critical with this vaccination, as the vaccine is most effective when all three doses are received. So go ahead and make their appointments to complete the series when they receive that initial injection. Having a reminder system through your electronic health record is also very helpful to help them keep their appointments.
ACOG has a committee opinion available on HPV vaccination. It was published in March of 2014. In this, it notes that Ob-gyns have the opportunity to educate mothers about the importance of vaccinating their children at the recommended age. Ob-gyns are critical to vaccinating girls and young women during the catchup period. It notes that HPV vaccination is not recommended during pregnancy, although inadvertent administration is reassuring. It can be given to lactating women. That's important to know. If you have some teen pregnancies in your practice, you're hopefully giving them other vaccines during pregnancy – like flu or Tdap – so it's a good time to bring up that discussion about HPV vaccination. And if they haven't received it, go ahead and make a plan to give it to them post-partum.
In regards to integrating vaccination into practice, here are some practical recommendations. As a reminder, just give a strong recommendation for HPV immunization to your patient. Talk to moms about immunizing their families. And then use scripts and toolkits that can be found at the Immunization for Women website. It's a really helpful website that has a lot of different resources. There's some frequently asked questions about HPV vaccination, a physician script that can help you have the conversation with the patient or parent, some information about coding and billing as well.
Providers do have responsibilities in providing vaccines. Vaccine information statements should be given to all patients before each injection. Those forms can be found on the CDC website. They've been translated into multiple different languages as well. The VAERS system that we talked about earlier, the Vaccine Adverse Event Reporting System, it's important to be familiar with that in case you do have an adverse event that needs to be reported.
Documentation is important also. Recording it in the patient's chart, along with the immunization information system or state registry, requirements will vary by state. Many times, electronic health records can link to state registries, and that can be helpful to verify immunization history, where vaccines may have been given in other settings, and to avoid unnecessary duplication of vaccines. If you have questions about your state registry, the contacts can be found at the CDC website.
When we talk about HPV vaccination, the conversation often steers towards dialogue about sexual activity, when really we need to change the focus. And the real goal is cancer prevention. High risk sexual activity really should not be associated with vaccination, and this has been supported by the medical literature. A recent study looked at the incidence of sexually transmitted infections after HPV vaccination among adolescent females – that was just published in JAMA Internal Medicine just last month.
And those authors looked at incident STIs in a very large cohort. And they compared girls vaccinated versus those not vaccinated. And the authors stated, "We found no evidence that HPV vaccination leads to higher rates of STIs. Given low rates of HPV vaccination among adolescent females in the United States, our findings should be reassuring to physicians, parents, and policy makers that HPV vaccination is unlikely to promote unsafe sexual activity."
So when talking about HPV vaccination, it's important to have effective messages. ACOG recently conducted research about what messages are perceived as effective among different groups. These messages are based on medical literature, and then they were tested among focus groups such as parents of teens, providers, and then young women. So the next few slides I'm going to review what messages were perceived as effective by the different groups.
So with this slide, when talking to parents, try using these messages. "The HPV vaccine can reduce your son or daughter's risk of certain HPV related cancers by up to 99 percent when they are fully protected with three doses." "Approximately 79 million people in the United States have been infected with HPV, and 14 million new infections occur every year, leading to around 11,000 cases of cervical cancer per year, with over 4,000 deaths." Physicians are making sure their own children get the HPV vaccine before they are at risk. Try using an I statement. "I made sure my children received the HPV vaccine to protect them against HPV related cancers."
When talking to young men and women in the catch-up group, here are some messages that were found to be effective. "HPV is a common disease that has potentially serious consequences such as cervical, vaginal, vulvar, penile, anal, mouth, and throat cancers, genital warts, infertility, and pregnancy complications. You are the key to HPV cancer prevention. Make sure you're protected with the HPV vaccine. Encourage your partner to get vaccinated. The HPV vaccine is not just for women. Men can stop the spread of HPV viruses by getting vaccinated, too. Not only is he protecting others, he's also protecting himself from the 9,300 HPV-related cancers in men each year." "Even if you've been sexually active, the HPV vaccine offers protection against different strains of the virus that can lead to several types of cancer and other HPV-related diseases."
When talking to other providers, such as pediatricians, family practitioners, or other colleagues, try these messages. "You are the front line doctors in the fight against cervical cancer and other HPV-associated cancers, even though you may never see a case of it. HPV vaccine is cancer prevention, and you are the key."
Recommend the HPV vaccine series the same way you recommend any other adolescent vaccine. For example, you can say, "Your child needs these vaccines today," and name all the vaccines – meningococcal, Tdap, and HPV. Recommend whatever is recommended for the child's age, so it's not presented as optional. Your recommendation is the number one reason why someone will get the HPV vaccine and be protected from HPV-associated cancers and disease.
ACOG has several resources for business practice. There's the on demand webinar that's free. There's immunization resources for Ob-gyns, a comprehensive toolkit. There's a committee opinion about integrating immunizations into practice. The Immunization for Women website has a ton of very helpful information. And for business practice, it has information about reimbursement, vaccine purchasing resources, standing orders, utilizing electronic health records, and then routine forms, such as the VIS form, the VAERS reporting system, and there's the state registry contacts as well.
Patient resources include the Immunization for Women website. There's patient-friendly HPV information section, frequently asked questions. The CDC website has You are the Key to Cancer Prevention, handouts for patients and parents. And there is the National Foundation for Infectious Disease Adolescent Vaccination HPV section that's patient-friendly.
ACOG has other provider resources. ACOG just distributed a Practice Advisory on HPV vaccination that was just distributed via an email blast last week about the 9-valent vaccine that can also be found on the ACOG website. Again, the Immunization for Women website has a ton of information. The committee opinion that we mentioned earlier. And there is an HPV vaccination toolkit available.
The CDC has a lot of information for providers as well about HPV. The Morbidity and Mortality weekly reports are also great resources. Information from these reports has been summarized in this presentation, but should you want further information about the clinical trials or safety studies, these are very good resources to read.
Ob-gyns have a lot of opportunities to vaccinate women. And vaccination should really be a part of routine preconception planning, prenatal care, postpartum care, and routine well women care. As just a reminder, influenza vaccine is recommended for all women, including those who are pregnant. The Tdap vaccine is recommended for all adults who have not been vaccinated, and all women during each pregnancy. The pneumococcal vaccine is for high risk women, including those who are pregnant. Hep-B is a vaccination for all at risk women, including those who are pregnant.
The MMR vaccine is for women who were not previously vaccinated, and it should be given before or after pregnancy. Similarly, the Varicella vaccine is for women who were not previously vaccinated or who have not had chicken pox. It should be given before or after pregnancy. And, again the HPV vaccine is recommended for girls and women age 9 to 26. It's not recommended during pregnancy, although inadvertent administration is reassuring.
This is just a reminder of the adult immunization schedule. This can be found on the CDC website, or the Immunization for Women website. And just a reminder that the HPV vaccine can be given in other – with other chronic medical problems. The only category where there's not a recommendation is in pregnancy.
This is the information for the ACOG's Immunization Department. If you have other questions, there's contacts that you can reach out to. So this actually concludes our presentation. And right now we're going to go ahead and just answer a few questions.
Thank you, Dr. Goff and Dr. Yoost. We will now open the line for questions for both of our presenters. You can submit a question by using the question block on the bottom of your screen.
Jennie Yoost, MD:
I'm looking at the questions. Having a little difficulty enlarging them.
Barbara Goff, MD:
My computer just – I got kicked out of the room, so I actually can't read the questions, although I read some of them before, as you were talking. And there were a couple of questions about the age recommendation for boys. And when the 9-valent vaccine was licensed, it was licensed for boys from 9 to 15, but the ACIP – they are the body that makes recommendations to the CDC. And so their preliminary recommendations are – which will be formalized by the CDC – are that this can go up to age 21 for catch-up, and they're saying that boys age 21 to 26 may be vaccinated.
There was another question of whether boys over age 21, whether insurance will cover that. And I think the answer is we don't know the answer to that question right now. Usually when the CDC makes a recommendation, most insurance companies would follow their recommendation, but I think we have to wait and see. This information is so preliminary and so new. It just came out last Thursday. And I think they'll be – ACOG will be putting out more information as things become finalized.
Jennie Yoost, MD:
I'm able to see some of the questions now. Sorry about that. There's a question about – most vaccines given in adolescents are just one dose. So how to make sure kids come back for all three doses? That is definitely a barrier to receiving all three vaccines. And I think that explains why the completion of this series is so low, why it's more common for girls and boys just to receive one dose and then not complete the series.
One of the things that can be helpful with that is if you have some sort of reminder or recall system within your electronic health records – that can remind patients when to come back. Otherwise, stressing to them at their initial visit how the vaccine is most effective when all three doses are given.
Barbara are you able to see any of the questions now?
Barbara Goff, MD:
If you can, if there's a question you'd like me to answer, why don't you read it for all of our participants, and then I can answer the question. I'm sorry.
Jennie Yoost, MD:
Here's one – I can field this one. "If 80 percent of school aged girls are vaccinated in Australia, why have the high grade HPV lesions only decreased by 38 percent in that country?" That's a good question. That study is with actually an ecological study. They were reviewing a cytology registry. The program was implemented in Australia in 2007. And that study looked at incident high grade lesions in different age groups before and after vaccination implementation. And that decrease was within three years of implementation of the population wide program.
It was in girls who got the vaccine under the age of 18. So pre-cancers are still kind of a long-term outcome. So that does – I understand why that percentage may seem a little smaller, but that decrease was found to be progressive and different from previous linear trends before the introduction of the vaccination program.
Barbara Goff, MD:
Okay, I'm on now. But go ahead.
Jennie Yoost, MD:
Well, here's one. It says, "Why do you say HPV causes infertility?" Do you want to get that one, or?
Barbara Goff, MD:
Sure. Why do I say that HPV causes infertility? It is, if you have to take out someone's uterus. So that's what – the answer to that question is if you are doing cone biopsies, or you're having to do trachelectomies, or you're having to do a hysterectomy, you often take away a woman's opportunity to have children, because we talked about that 40 percent of cervical cancers will occur in women during their prime reproductive lifetime. And so that's what that comment referred to.
Jennie Yoost, MD:
Here's another question. "For patients who received the full three-dose series of the quadrivalent, is there any guidance on if they should receive a booster of the new version?" That's a great question. The ACIP hasn't voted on repeat vaccination yet, but likely there's not going to be a recommendation for all of those patients who either received the bivalent or quadrivalent to get re-vaccinated. Re-vaccination is safe, but at this point, the focus is on getting any kind of vaccine.
Barbara Goff, MD:
And it's probably not going to be cost effective. Because the vast burden of disease comes from HPV 16 and 18, which is the most important thing to prevent against. The next question is, "Is there a way for males to be tested for HPV?" Generally, no. And there really isn't a strong reason to do that for males. So why are the bivalent or quadrivalent vaccines given instead of the 9-valent? Well, the 9-valent just became available, and I think it's a discussion that you would have with your patients and their families.
I would agree that it's very attractive to have the additional five oncogenic types, and the protection that that provides. So I would agree that for many people that that makes a lot of sense to do that. And I don't know – one of the questions was, "What's the name of the new vaccine?" It's Gardasil 9, and I don't know what Merck's plans are to do with the quadrivalent, whether they will phase it out – I think that's likely – but I don't know that we know for sure what they're going to be doing with that.
Jennie Yoost, MD:
Here's a question about – does the HPV-9 sting upon administration as much as the HPV-4? The answer to that would be, yeah, it does sting a little bit, like any other vaccine. In the clinical trials, there were a few more site-related reactions, some redness of the skin, some tenderness, that's somewhat to be expected. There's a little more of the adjuvant in that vaccine that can cause that kind of inflammatory response.
Barbara Goff, MD:
"So I was pleasantly surprised to hear about the high vaccination rates in Rwanda. What is currently being done to distribute the vaccine to developing countries where greater than 95 percent of all cervical cancers can occur?" And the World Health Organization has a program in place for, depending on the economic conditions of the country, to provide vaccines at very low cost. And in Rwanda, I think they were able to provide the vaccine for under $10.00 per dose of vaccine. Don't quote me on that, but it was a very, very low rate that they were able to provide.
But the World Health Organization, along with the Gates Foundation, is very – is actively involved in promoting HPV vaccine, because screening is so difficult in these developing countries.
Jennie Yoost, MD:
There's a question here about price. "Is it the same price?" It's going to be very close. I believe it's going to be very close to the same price as the quadrivalent, and it should be covered under the Affordable Care Act. There's also the Vaccines for Children program that any provider can sign up to be a Vaccines for Children provider and have free vaccines – for those that are eligible, those that are 18 years of age or younger, and qualify for Medicaid or have no insurance.
Barbara Goff, MD:
So here's an interesting comment. I think this is for people who are on the front lines giving this vaccine. Somebody said that adolescents including college students tend to be dehydrated, giving them as little as 8 ounces of a fluid will almost always prevent fainting, and I think that's a great suggestion, and thank you for providing us with that information.
Jennie Yoost, MD:
I think some of these we've already – there's a couple more about boosters, or repeating the vaccine. Those, I think we've answered.
Barbara Goff, MD:
So there's a question – "You're saying that vaccines are interchangeable if you start with one type of vaccine and finish with another. Why do you need a series of three vaccines?" And I think when we said they were interchangeable, you still need three doses. But whether you get – whether you start with one or finish with the other. But three doses have been shown to provide the highest amount of serologic conversion, and the highest amount of protection.
There is some research going on looking at whether two could be substituted for three. But at this point in time, three doses of the vaccine are what is recommended.
Jennie Yoost, MD:
Here's a question about the role of vaccinating adult men and women beyond the recommended age. Have we already addressed that one? I can field that one.
Barbara Goff, MD:
Yeah, why don't you go ahead?
Jennie Yoost, MD:
It's not licensed for over the ages of 26, so it would – currently there's no recommendation for those age groups. Likely would not be covered as well by insurance. So I think it would be fine in a case by case basis, but it's certainly not licensed for those over a certain age.
Barbara Goff, MD:
Here's a question. "Doesn't the quadrivalent vaccine have cross-coverage among some high risk types?" Not a lot of cross-coverage, which is why the 9-valent vaccine was developed. And so I wouldn't rely on that for great coverage against the other oncogenic types.
Jennie Yoost, MD:
Here's a question. "How can we better recommend or encourage boys to get the HPV vaccine, given that the prevalence of anal and penile cancers in heterosexual populations is much lower?" Is it not – I'm not sure about the prevalence of those specific types of cancers in heterosexual populations, but as far as messaging, I would stick to some of those messages that we talked earlier about, in talking to young men and women, just their risk of cancer in general, just kind of reiterating some of those messages that were perceived to be effective.
Barbara Goff, MD:
"And what are some specific ways to tell patients that HPV is spread, and it's not always through sexual contact?" I mean I think that that's something that's really important. And we, as Ob-gyns, need to emphasize that information as we go to conferences and we talk about HPV vaccine, that it doesn't require sexual intercourse in order to contract. And even touching of the genitals can result in an infection, and I do think that it's a really important point to get across to parents, to physicians, and it's certainly one of the main messages of the CDC's campaigns is – and why it's so important to have 11 and 12 year olds, before they even start experimenting and exploring, because this is the best way to prevent them. But I think it's a constant messaging thing, and we all need to be on the same page with that information.
Thank you very much to our presenters and attendees. As a reminder, you will be automatically redirected to the post-event evaluation upon conclusion of this webcast. 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 visit ACOG's immunization website – ImmunizationForWomen.org for HPV vaccination updates, additional adult immunization information and links to past webinars. Thank you for joining us.
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