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Press Briefing Transcript
CDC Telebriefing on HPV prevalence among young women following HPV vaccination introduction in the United States, NHANES, 2003-2010
Wednesday, June 19, 2012 at 12 p.m. ET
OPERATOR: Welcome, and thank you for standing by. At this time all participants are in a listen-only mode. During the question-and-answer session of today's call, you may press star-one to ask a question. Today's conference is being recorded. At this time I’ll turn the call over to Mr. Tom Skinner. You may begin, sir.
TOM SKINNER: Thank you, Shirley, and thank you all for joining us today for the release of a paper by CDC in the Journal of Infectious Diseases that looks at the prevalence of vaccine type human papillomavirus infection in females since vaccine was introduced in 2006. With us is the director of the CDC, Dr. Tom Frieden, who's going to provide some opening remarks. And medical epidemiologist Dr. Lauri Markowitz who will be available to answer your questions about the paper. I’ll turn the call over to Dr. Frieden right now. Dr. Frieden?
TOM FRIEDEN: Thank you very much, and thank you all for joining us today. As the director of the Centers for Disease Control and Prevention, one of the best parts of my job is announcing good news. Today we have really good news. The types of HPV, human papillomavirus, that commonly cause cervical cancer in women has dropped by about half in girls aged 14 to 19 since 2006 when we began routinely vaccinating against HPV. These are striking results. And I think they should be a wake-up call that we need to increase vaccination rates because we can protect the next generation of adolescents and girls against cancer caused by HPV. The bottom line is this -- it's possible to protect the generations from cancer, and we've got to do it. I'd like to share a little bit more information from the study and provide some context, and then I’ll turn the call over to Dr. Markowitz.
CDC scientists analyze changes in HPV prevalence over time. They use NHANES, the National Health and Examination Survey. NHANES is the gold standard. It assesses the health and nutritional status of adults and children in the U.S., and it's unique because it combines detailed, standardized interviews and physical examinations and laboratory tests. Researchers compared HPV prevalence in females age 14 to 19 before the start of the vaccination program, 2002 to 2006, and in the first four years after the vaccine was introduced, 2007 to 2010. The bottom line is that vaccine-type HPV decreased by 56 percent from 11.5 percent to 5.1 percent. Other age groups didn't show significantly significant differences over time. And this -- the research also showed that vaccine effectiveness for preventing infection was estimated at 82 percent. The decline in vaccine-type prevalence is even better than we had expected and hoped for. We'll continue to monitor NHANES data to have a better understanding of the decrease and determine to what extent it's from herd immunity or perhaps because fewer than full three-dose series- because many girls got one or two doses- may have contributed to the decline. Let me give a little more context as to why results are so important. HPV is the most common sexually transmitted infection in the U.S., and it can cause serious health problems including cancer in both women and men. As you may have read, there has been an increase also in oral head and neck cancers, particularly in men. And this increase is particularly in HPV-associated cancers. While we don't yet have definitive proof that the vaccine will prevent head and neck cancers -- so let me just go back to what I was saying -- I'm not sure quite when I was cut off.
TOM SKINNER: You were providing context.
TOM FRIEDEN: I’ll provide a little more context. HPV is the most common sexually transmitted infection. It causes serious health problems including cancer in both women and men. As I mentioned before I was cut off, there is increasing evidence that the HPV vaccine may protect against head and neck cancers which have increased in recent years in association with HPV. About 79 million Americans are infected with HPV, and about 14 million Americans become newly infected every year. Unfortunately, only one third of 13 to 17-year-old girls in the U.S. has gotten the recommended dose series of HPV vaccine. Countries including Rwanda have vaccinated a higher percentage of females in the target population than we have in the U.S. This is simply unacceptable. Our low vaccination rates represent 50,000 preventable tragedies. 50,000 girls alive today will develop cervical cancer that would have been prevented if we had reached our goal of 80 percent vaccination rates. In fact, for every single year we delay in reaching that rate, another 4,400 women will develop cervical cancer despite good screening.
Routine vaccinations started at the end of 2006. Today, two vaccines are approved in the U.S. One targets four different types of HPV. Another targets two types. Routine vaccination with three doses of either vaccine is recommended for all females age 11 or 12, through the age of 26 if not vaccinated before. In 2011, routine vaccination of males age 11 or 12 through age 21, if not vaccinated before, was also recommended in the U.S. The types 16 and 18 of HPV caused about 70 percent of cervical cancers, and the two other types that are in the quadrivalent vaccines, types 6 and 11, cause 90 percent of genital warts. As I mentioned earlier, only one third of 13 to 17-year-old girls in the U.S. have gotten HPV vaccine as recommended. There are complex reasons for this. A key reason is provider practices. Providers are not consistently giving strong recommendations for the vaccine, particularly for younger teens and are not encouraging vaccination at every encounter. So we've identified many missed opportunities. We need to do a better job of addressing these issues and also of informing parents.
Parents commonly say that they don't think the vaccine is needed or that their teen is not sexually active or that they have concerns about the vaccine. In terms of waiting until teens are sexually active, I think this really misses the point. We vaccinate well before people are exposed to an infection. We vaccinate for measles, for example, early in childhood or infancy, age 1, because that's well before a child may get exposed. Similarly, we want to vaccinate children well before they may get exposed. The study also found no change in sexual practices or sexual risks over the course of the eight years before and after vaccine introduction. As far as safety of the vaccine goes, this vaccine has a safe track record similar to what's seen in reviews of other vaccines recommended for similar age groups. To date there have been more than 56 million doses of HPV vaccine distributed since 2006 in this country and more than 170 million distributed around the world. We track all reports of any type of adverse event following vaccination, and what we've seen is occasional fainting which can occur when adolescents get vaccinated, redness or swelling or pain at the injection site as you'd expect, dizziness, nausea, headaches. But no serious long-term complications have been associated. So we're confident that this vaccine has a similar safe track record to other vaccines recommended for this age group.
I’ll close and turn this over to Dr. Markowitz, emphasizing again that the time has come to ramp up our efforts to protect the next generation against cancer with the HPV vaccine. This is an anti-cancer vaccine. With the Vaccines for Children Program and the Affordable Care Act, vaccination is easy, and the cost of the vaccine should not be a barrier. Many insurers are required to cover the vaccine at no cost to patients for both females and males. The study results that we're releasing today suggest that the vaccine is effective, and it's making a difference. I think we owe it to the next generation, our sisters, our daughters, our nieces, and to those who are our patients to protect them against cervical cancer. Thank you, and Dr. Lauri Markowitz will now take your questions.
OPERATOR: We're ready to begin the question-and-answer session. If you would like to ask a question, please press star-one. Please unmute your line and record your name clearly. If you'd like to withdraw your question, you may press star-two. One moment, please, for our first question. Our first question comes from Jonathan Serrie with Fox News. You may ask your question.
JONATHAN SERRIE: Thank you very much for holding this conference. First of all, could you give us sort of the timeline of vaccine recommendations, when it was initially recommended for girls, and then when boys were added to the recommendations? Then if you could comment specifically on just the growing evidence of protection the vaccine offers specifically for boys.
LAURI MARKOWITZ: Okay. Well, the vaccine, the quadrivalent vaccine was first licensed in the United States in the middle of 2006. And at that time, a recommendation was made, as Dr. Frieden mentioned, for routine vaccination of females 11 or 12 years of age, and for those through age 26 who were not previously vaccinated. Then in October 2009, the bivalent vaccine was licensed, and the recommendation was changed to say that either vaccine could be used for routine vaccination of females. The quadrivalent vaccine was licensed for males in this country in 2009, and it wasn't until October 2011 that ACIP made a routine recommendation for quadrivalent vaccine for males age 11 or 12, and through age 21 for those who were not vaccinated previously. So at the present time, the recommendation is that females should be vaccinated at age 11 or 12 and through age 26 with either the quadrivalent or the bivalent vaccine- and males at age 11 or 12 and through 21 with the quadrivalent vaccine. The quadrivalent vaccine is the only vaccine licensed for use in males in this country.
TOM SKINNER: Jonathan, does that answer your question?
JONATHAN SERRIE: Yeah. On the recommendations. And then if you could elaborate on evidence of protection, specifically in males from the vaccines.
LAURI MARKOWITZ: Right. So the clinical trials that were available when the vaccine was first licensed in 2009- that was based on clinical tries showing efficacy against protection of vaccine-type genital warts. Then subsequently, data became available for the vaccine was effective for prevention of anal precancer lesions in males, and the vaccine at that time received an indication from the Food and Drug Administration for prevention of anal cancer. So right now we have data in males for prevention against genital warts and anal precancer lesions.
TOM SKINNER: Next question, Shirley.
OPERATOR: Thank you, next question comes from Mike Stobbe with Associated Press. Go ahead with your question.
MIKE STOBBE: Hi, thank you for taking the question. Two if I may. Dr. Frieden, I think, expressed surprise at the results at least in the 14 to 19-year-old girls. I was wondering if you could speak a little more about that. What -- what results were you expecting? I mean, what did the premarketing studies show, and can you compare these results to your previous understanding of how effective it was. And the second question was about -- I think Dr. Frieden said that the study also found no changes in sexual practices or risks. I was wondering if you could talk a little bit more about what the numbers in this new study said about that.
LAURI MARKOWITZ: First of all, let me say that we weren't surprised that this was the age group in which we found an impact. This is exactly the age group that we would expect to first see an impact based on who's getting vaccinated in the United States. So we were looking, expecting if we would first see an impact it would be in this age group, and it would be in females. So that was expected. But what we were -- the decrease was greater than we thought we would be seeing at this point based on three-dose coverage in the United States.
MIKE STOBBE: I mean, how much greater? What numbers had you expected to see?
LAURI MARKOWITZ: Well, we didn't have an exact number. I'm just saying that because we have about 30 percent of girls that had received all three doses, this is greater than that. But it -- it could be, you know, there are several explanations. First of all, let me just comment on the issue of no change in sexual behavior. One of the things we looked at to see if it could explain the decrease is to see if there was any decrease in sexual behavior during the two time periods. We did not see that there was any difference in the percent of 14 to 19-year-olds who had had sex or the number of lifetime sexual partners in that group. We didn't see, although we don't -- couldn't look at all sexual behavior because all the questions weren't asked. For the variables we looked at, we didn't see any evidence that changes in sexual behavior could have accounted for the decrease.
MIKE STOBBE: Right.
LAURI MARKOWITZ: The other things that could account for the decrease is that if there's efficacy from less than a full dose vaccination series. Even though we have these in 2011, a year after the study was conducted, but in the most recent data we have 35 percent of girls who received all three doses and 53 percent have received at least one dose. The other thing is indirect benefit from the vaccination, what we call herd immunity. If the prevalence of infection is decreased in the population, then even people who aren't vaccinated will have some protection from the vaccination program. Those are a variety of things that could be accounting for the larger than expected decrease that we observed.
TOM SKINNER: Mike, does that answer your question?
MIKE STOBBE: Yeah. That's fine. Thanks.
TOM SKINNER: Next question, Shirley.
OPERATOR: Thank you. The next question comes from Elizabeth Weiss from USA Today. You may ask your question.
ELIZABETH WEISS: Thank you very much for taking my call. Looking at these numbers, I wonder is it possible that there is a self-selection going on in the families who are choosing to use this vaccine such that we're preferentially seeing vaccination of girls and families who might become sexually active and, therefore, in effect you're vaccinating the girls at highest risk, and could that explain partly why the number is so much higher than you expected?
LAURI MARKOWITZ: I think that -- I think that is something, and we're going to be looking at that further. Some of the data that are in the papers do suggest that. That is another explanation for why we're seeing the larger impact.
TOM SKINNER: Beth, do you have a follow-up question?
ELIZABETH WEISS: No, that will do it. Thanks.
TOM SKINNER: Shirley, next question.
OPERATOR: Thank you. Next question comes from Matt Sloane with CNN Medical News. You may ask your question.
MATT SLOANE: My question was actually answered. Thank you.
OPERATOR: Thank you. Our next question then comes from Timothy Martin with the Wall Street Journal. You may ask your question.
TIMOTHY MARTIN: Hi, thanks for taking my call. I want to -- can you guys define -- there's this number that pops up several times, a decrease in vaccine type HPV prevalence among females 14 to 19 years old. Looks like it fell from 11.5 percent in the pre-vaccine period to 5.1 percent for the more recent years. Can you define what that's actually charting?
LAURI MARKOWITZ: Vaccine type prevalence would be the types that the vaccine is directed against, HPV 6, 11, 16, and 18. We looked at the prevalence of those four types, any of those types, and any of those types in the vaccine era.
TIMOTHY MARTIN: Okay. All right. Then one follow-up. Dr. Frieden mentioned in his comments that for the target audience or target market that Rwanda actually had higher vaccination rates than the U.S. What specific rate is that?
LAURI MARKOWITZ: They achieved about 90 -- over 90 percent three-dose coverage. But it's not just Rwanda, it's been other countries. Three-dose coverage in several developed countries such as the U.K. and Australia and Denmark have achieved 70 percent or 80 percent coverage in their target population.
TIMOTHY MARTIN: Okay. Is it -- is it the similar target population as in the U.S., or the age is slightly different?
LAURI MARKOWITZ: All countries that have implemented vaccination programs are targeting about the same age group. May vary slightly, but it's about 11, 12, 13. Some are vaccinating younger.
TIMOTHY MARTIN: Great. Thank you.
OPERATOR: Thank you. Next question comes from Sabrina Cavernais with the New York Times, you may ask your question.
SABRINA TAVERNISE: Hi, I just wanted to, you, Dr. Markowitz, to just explain a little bit more what the question -- the person who was asking the question two persons ago. The question about sexual activity. If you could just sort of spell that out in a clear way, what's the connection between sexual activity, the difference in the numbers of the two groups.
LAURI MARKOWITZ: I think that what was suggested was that -- I think we were talking about this a little bit earlier, that -- that those who have been vaccinated have a higher sexual activity. So it looks like those people who are -- either are sexually active or are going to become sexually active are seeking out the vaccine. And so what we may be seeing -- again, we need to piece this out and look at this further in additional analyses, is that those women who are contributing the most, groups who are contributing most to the prevalence are those that have -- are getting vaccinated. So that's another reason we may see the larger than expected decrease. Does that answer your question?
SABRINA TAVERNISE: Yeah. Actually, it does. Thank you.
OPERATOR: Thank you. Next question comes from Michelle Costillo with CBS News. You may ask your question.
MICHELLE COSTILLO: Hi. I know you mentioned that 1/3 of the girls have received the vaccines as recommended. Do you have any rates on how many girls received just one dose and two doses?
LAURI MARKOWITZ: I don't have just one dose, as I said. We know that about 53 percent in 2011 received at least one dose. And 35 percent received all three doses. I don't have the exact one dose and two-dose figures with me, I’m sorry.
MICHELLE COSTILLO: Thanks.
OPERATOR: Thank you. Next question comes from Richard Knox with National Public Radio. You may ask your question.
RICHARD KNOX: Hi. Thanks very much. I wonder, last week the Japanese ministry of health apparently suspended their previous recommendation that -- in favor of HPV vaccine administration because of some reports of pain and numbness. Have you seen any of that? Have you been in touch with your Japanese counterparts to understand why they're taking that action? I guess it's a temporary action pending investigation. And I wanted to also ask about whether your safety record so far includes no deaths or other serious adverse events from vaccination in the United States so far. Is that the case?
TOM SKINNER: This is Tom Skinner, we have with us another medical epidemiologist from our immunization safety office, Dr. Cindy Weinbaum who's here and is going to answer your questions. Go ahead.
CINDY WEINBAUM: Hi. So the CDC is aware of Japan’s decision to pause on their promotion of their HPV vaccination program for girls age 12 to 16. The outcomes that they were concerned about are things that we have looked for in our data system here in the United States, as well. We use their -- the vaccine adverse event reporting system as our front line. That's a voluntary reporting system that anybody can record an adverse event that occurs after they're vaccinated. When we looked back at our records, we found a total of about a dozen reports that related to something like a regional pain syndrome, such as Japan was reporting. These reports were on a variety of different presentations of regional pain. And there was really no consistency among them that would suggest that this was anything that was specifically related to the vaccination. We will be continuing to talk to our Japanese counterparts and look more closely at these reports. Sorry, what was the other half of the question?
RICHARD KNOX: I just wanted to be sure that the -- we mentioned before about safety, indicates that you've seen no serious events at all and no deaths that may be related to vaccinations so far in the United States.
CINDY WEINBAUM: Okay. We can't say that we have seen no serious adverse events at all. We can never say that about any vaccine. We can say, though, that we have not established that the vaccine has caused any serious adverse events. What we get in a system like the NHANES system this is a report of any adverse events that occurs after a vaccination has been administered. So many things may happen after the administration of a vaccine that may or may not be related to the administration of that vaccine. And generally we can't -- can't impute any causality to that. We have other data systems in which we do look for causal relationships. So we have also looked at the vaccine safety record in the vaccine safety data link. A large system of electronic health records that we collaborate with managed care organizations to utilize. In that system, we have not seen anything that would be at all alarming about this vaccine. And the paper on that was published. In terms of the deaths following vaccination, there have been reports there of deaths following vaccination. There have been a total of 42 reports of deaths. However, the causes of these deaths have been very varied. Everything from cardiovascular infections, neurologic, hematologic, so again there's no consistent pattern among the deaths that have occurred to people following when they’ve been vaccinated by the HPV vaccine to give us concern at all that these deaths might be at all related.
RICHARD KNOX: Thank you very much.
TOM SKINNER: And Richard, that was Dr. Cindy Weinbaum, c-i-n-d-y, last name is spelled w-e-i-n-b-a-u-m. Next question, Shirley.
OPERATOR: Thank you. Our next question comes from Mark Crane with Medscape Medical News. You may ask your question.
MARK CRANE: Hi. Can you explain the difference between the two vaccines. The bivalent and quadrivalent?
LAURI MARKOWITZ: Yes, the bivalent is against two HPV types. HPV 16 and 18. And those two types are responsible for about 70 percent of cervical cancers and most of the other cancers that are associated with HPV. The quadrivalent also has HPV 16 and 18, and it's directed against those two types, as well as two types that are responsible for 90 percent of genital warts. And those two types are called 6 and 11. So the quadrivalent has 16 and 18 and 6 and 11. There's also some minor other small differences between the two vaccines. But both vaccines are made from virus-like particles, and the main immunogen is a surface protein of the HPV. So they're very similar in that respect in terms of how they work.
MARK CRANE: And they're both administered the same way, with a three-dose regimen?
LAURI MARKOWITZ: They’re both administered as a three-dose regimen, intramuscularly.
MARK CRANE: Uh-huh. Thank you.
LAURI MARKOWITZ: Thank you.
OPERATOR: Next question comes from Hannah Nobis with ABC News Medical Unit. You may ask your question.
HANNAH NOBIS: Hi. Thank you for taking my questions. Just have two questions. Will there be any NHANES data released regarding boys and the HPV vaccine? And also, this may have been mentioned in the paper, but were there any differences among the ethnic groups and the -- the prevalence of getting the HPV vaccine?
LAURI MARKOWITZ: Well, first of all, in terms of boys, we started monitoring HPV prevalence in females in NHANES in 2002. And we did not have -- we did not include males in that until this year. So 2013 is the first year that we are monitoring HPV prevalence in males. NHANES, there are two-year cycles that are done. So the first data that will be available in males will be in 2015.
HANNAH NOBIS: Thank you.
LAURI MARKOWITZ: You asked about ethnic differences in coverage.
HANNAH NOBIS: uh-huh.
LAURI MARKOWITZ: Those data are from a different survey--the National Immunization Survey Teen. Those data have been published -- data from the National Immunization Survey Teen are published every year in August. The 2011 data were published last August, and the 2012 data will be published this August. They -- there have been some differences, in fact, that actually one and -- vaccine initiation is actually higher in non-Hispanic blacks and Hispanics compared to non-Hispanic whites. So completion rates have been a little bit lower, but three-dose coverage is not lower in African Americans and Hispanics compared to whites. In fact, as I said initiation is actually higher in those groups.
TOM SKINNER: If you need more specific information on rates among various ethnic groups, you can call the main CDC press office, and we'll help you with that.
HANNAH NOBIS: Okay. Thank you so much.
TOM SKINNER: Next question, Shirley.
OPERATOR: Thank you, next question comes from Marcela Cortes from -- one moment, please. She removed herself from the queue. The next question comes from Elizabeth Mechcati with OBGYN News. You may ask your questions
ELIZABETH MECHCATI: I was wondering if there was a difference between different types of physicians in coverage rates, namely family physicians, pediatricians, and ob-gyns.
LAURI MARKOWITZ: We don't monitor specifically coverages and practices by specialty. I would say that most of the vaccine that's being delivered in the U.S. is by -- by pediatricians than family practitioners. Ob-gyns are not administering the majority of vaccines. But we don't actually monitor that in terms of coverage by practice type.
ELIZABETH MECHCATI: uh-huh. Okay. So there's no specific recommendations for different specialties on how to improve coverage? Or recommendations to get the vaccine?
LAURI MARKOWITZ: I’m sorry, could you repeat that question.
ELIZABETH MECHCATI: I just -- since there's some -- I wonder if there are any specific recommendations for different types of physicians to increase coverage?
LAURI MARKOWITZ: You mean what they can do practically in their --
ELIZABETH MECHCATI: Right --
LAURI MARKOWITZ: Practice?
ELIZABETH MECHCATI: Right. Increase vaccination rates.
LAURI MARKOWITZ: I think the recommendations are very similar for all practices. And that is implement systems to decrease missed opportunities, you know, reminder recalls, things like this. But I think those would apply to all practices.
ELIZABETH MECHCATI: Okay. Thank you.
TOM SKINNER: This is Tom again. If you want to call our main press office, we could probably connect you with someone in our national immunization program who can discuss further how we go about discussing with physicians how they can talk to their patients about vaccination.
ELIZABETH MECHCATI: Thank you.
TOM SKINNER: Next question, Shirley.
OPERATOR: Thank you, our next question comes from Jennifer Welsh with Business Insider. Go ahead with your question.
JENNIFER WELSH: Thank you. Quick question here. You said about 1/3 of teenage girls are getting vaccinated. What's the number for teenage boys that are getting vaccinated?
LAURI MARKOWITZ: Well this year we'll have the first data on coverage in boys since there was a routine recommendation. The routine recommendation was at the end of 2011. We do not have data yet on what coverage is after that routine recommendation.
JENNIFER WELSH: Any idea, any guesses. Is it low, the same as girls?
LAURI MARKOWITZ: We don't have those data yet, but they will be available very shortly.
JENNIFER WELSH: Okay. Thank you.
TOM SKINNER: Next question, Shirley.
OPERATOR: Thank you, if you'd like to ask a question, please press star-one at this time. One moment, please, for our next question. At this time I’m showing no further questions.
TOM SKINNER: Okay. Thank you, Shirley. And thank you all for joining us. And should you have follow-up questions or need additional information, please call the main CDC press office at 404-639-3286. Thank you, and this concludes our call.
OPERATOR: Thank you. This does conclude today's conference. We thank you for your participation. At this time, you may disconnect your lines.
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