•Audio recording (MP3, 6.61MB)
Operator: Welcome. Thank you for standing by. All participants are in listen only mode until the question and answer session of today's conference. At that time you may press star one to ask a question. I would like to inform all particiaptns that today's conference is being recorded. If you have any objection you may disconnect at this time. I would now like to turn the conference over to Mr. Tom Skinner. Sir, you may begin.
Tom Skinner: Thank you, Jennifer. Thank you all for joining us today for this telebriefing where Dr. Anne Schuchat is going to give us an overview of some recommendations made today by the Advisory Committee on Immunization Practices to vaccinate all 11 and 12–year–oldmales against HPV. Dr. Schuchat is the director of the National Center for Immunization and Respiratory Diseases here at CDC. Her name is spelled a–n–n–e, last name is spelled s–c–h–u–c–h–a–t. She's an MD. She will provide some opening remarks. Then we'll get to your questions and answers. Doctor?
Anne Schuchat: Good afternoon, everybody. Today is another milestone in the nation's battle against cancer with the Advisory Committee on Immunization Practices recommending to CDC that boys also be protected from HPV. What I′m going to do in the next few minutes is provide a little bit of background about HPV and the quadrivalent HPV vaccine. I will review committee recommendations as well as the basis for those recommendations including a deliberative review of vaccine safety, efficacy, trends in disease and coverage. Then I will give you a sense of what the next steps will be and take questions.
So first some background about the disease and the vaccine. About 20 million Americans are currently infected with human papilloma virus or HPV. HPV has been associated with several types of cancer.
Cancer of the cervix, vulva, vagina, penis, anus as well as head and neck cancer. Each year in the U.S about 18,000 HPV associated cancers affect women. Cervical cancer is the most common type of cancer that HPV can cause in women. About 7,000 HPV associated cancers each year affect men in the United States. Cancers of the head and neck are the most common type of cancers in men. HPV can also cause most cases of genital warts in both men and women and about one in 100 sexually active adults in the United States has genital warts at any one time. So these are common conditions. Men who have sex with men and people who are infected with HIV are at the highest risk for HPV–related disease. The HPV vaccine is a strong weapon in cancer prevention. The quadrivalent HPV vaccine prevents the types of HPV that cause cervical cancer in women as well as anal cancer and genital warts in both women and men.
A little bit of a timeline. In June 2006, the ACIP recommended HPV vaccine for 11 to 12–year–old girls and also for teen girls and young women through age 26 who hadn't already received the vaccine. In October 2009, quadrivalent HPV vaccine was also approved for use in boys and young men. The quadrivalent HPV vaccine is covered for both girls and boys through the Vaccines for Children Program. ACIP's recommendations today result from a several–year process where the committee has been reviewing quite a bit of information. The committee recommended that routine vaccination of males aged 11 or 12 years with three doses of quadrivalent HPV vaccine be given to prevent HPV infection and HPV–related disease. They recommended that the vaccination could begin as young as age 9 and that boys and young men 13 to 21 years of age who hadn't already received the vaccine should also be vaccinated. These recommendations to CDC resulted from a careful review of data that's been going on for the past few years. Much of the data became available after the initial permissive recommendation in back in 2009. The new data included clinical trials that have shown quadrivalent HPV vaccine to be very effective for males. The greatest impact can be had when the vaccine is given at ages 11 or 12 where there is a better immune response compared with older ages. The vaccine is most effective when it is given before there is exposure to the virus which occurs through sexual contact. So that's the rationale for recommending this routinely for 11 or 12–year–olds.
Part of the deliberation the committee made was to review trends in cancers associated with HPV types that could be prevented by the quadrivalent vaccine. As I mentioned, this vaccine can prevent several different types of cancer. More than 80% of anal cancers are caused by the HPV types included in the vaccine. There have been increases in head and neck cancers and in cancers of the anus over the past few decades. Cervical cancer trends have been decreasing over the past few decades, but the increasing trends in these other cancers was something that was important to the committee. The committee also reviewed the trend in HPV vaccine use among girls. HPV vaccine is not being highly taken up by teenage girls. There's been a disappointing uptake among teen girls we reported earlier this summer. HPV vaccination of males offers an opportunity to decrease the burden of HPV related disease in both males and females. So in addition to providing direct benefit to boys by preventing future genital warts or anal cancer there is also the potential that vaccinating boys will reduce the spread of HPV from males to females and reduce some of the HPV–related burden that women suffer from.
The committee reviewed a variety of models that looked at the cost effectiveness of different vaccination strategies. This is an important component of what the committee reviews for every vaccine recommendation, but there is no threshold that they use. Male vaccination is most cost effective when coverage of females is low and unfortunately here in the U.S. coverage of females is currently low. The committee also undertook extensive review of data on vaccine safety. Through middle of September nearly 40 million doses of HPV vaccine have been distributed in the United States. The clinical trials that have been carried out in smaller numbers have shown the quadrivalent HPV vaccine to be safe for males as well as for females. The most common adverse events or side effects that can occur following HPV vaccination include injection site reaction, headache and fever, and those reactions have tended to be mild or moderate in intensity.
So the committee reviewed the effectiveness, the disease trends, the cost effectiveness, safety and also considered practical implementation issues for the providers, parents and the programs. Where do we go from here? The ACIP recommendations are delivered to the CDC and there will be a development of written recommendations that will be subject to approval by our agency. Once approved the ACIP recommendations will end up being published in the MMWR. Before I take questions I want to make a couple final comments. Immunizations have dramatically reduced the occurrence of infectious diseases in the U.S. And it′s truly exciting to have vaccines that can also tackle cancers. We hope today's deliberations will be a reminder to parents and health care providers about the opportunities we have to protect a generation today from the cancers of tomorrow. So I would be happy to take questions now. Operator?
Operator: If you would like to ask a question, please press star one and record your name clearly. To withdraw your request, you may press star two. Once again, to ask a question, please press star one. Our first question comes from Sapna Parikh from ABC News.
Sapna Parikh: Hi. Thank you for taking my question. Can you please clarify the upper age limit for recommendation for both boys and girls? Is it 26 or is it now 21?
Anne Schuchat: Thank you for the question. The recommendations for girls and women are for vaccine to be given routinely at 11 or 12 and for those who haven′t already been vaccinated to go up to age 26 for girls or women. For boys and men, the recommendation goes up to age 21. Routine use at 11 or 12 and for those who haven't already been vaccinated to go up through age 21. The difference –– there were also recommendations that for those 22 to 26 the vaccine may be given. A permissive recommendation. The committee differentiated between those up to 21 and those older based on the preventable impact of vaccinating younger people and also in reviewing the cost effectiveness.
Sapna Parikh: Thank you.
Operator: Our next question comes from Meredith Wadman from Nature.
Meredith Wadman: Thanks for taking my question. I have two. One is does the CDC ever in practice not implement ACIP recommendations or have you ever in memory not done so or is pretty much a done deal now?
Anne Schuchat: The ACIP process is a very careful, deliberative, science, evidence–based review. Something I forgot to mention was this particular vote incorporated an extra level of evidence–based review, something we called grade that makes transparent the nature of the quality of evidence available and the strength of recommendations. So in general, the ACIP recommendations are founded on a strong science base and the agency typically does adopt them. But there is a difference between the recommendation as issued by the committee and what the agency's final wording would be.
Meredith Wadman: Okay. But the difference is not likely to be substantive? Are you saying that? At least if history is precedent here.
Anne Schuchat: Most of the ACIP recommendations in the past have been fairly straightforward. There have been one or two times where they weren't. I think looking forward we're certainly appreciative of the hard work the committee has done to deliver graded recommendations to us with the quality of evidence available in support of the different components.
Tom Skinner: Next question, Jennifer.
Operator: Our next question comes from Emma Hitt of MedScape.
Emma Hitt: Thanks for taking my question. What do you expect the uptake of the vaccine will be among
young boys and how will it compare to the low uptake among young girls?
Anne Schuchat: There are a lot of different views of this. Some providers think by having a recommendation that's universal uptake in boys and girls may improve substantially. We might ever see better use of the vaccine in girls. I think based on the kind of survey data we have we don't expect quite as robust an initial uptake in boys as what we saw in girls. Of course, we have a lot more room for improvement in uptake in girls and part of our challenge has been some misunderstanding. There's been a lot of confusion about when you should give this vaccine. It turns out that the age of 11 or 12 is a very good time to be vaccinated. Antibody or immune responses are the strongest and that's well before girls or boys would become sexually active. So the vaccine works most well when given at the younger age. We know parents are confused about when they ought to vaccinate their daughters and we hope to improve that messaging going forward.
Emma Hitt: Thank you.
Tom Skinner: Next question, Jennifer.
Operator: As a reminder, if you would like to ask a question, please press star one and record your name. Our next question comes from Dena Bunis of CQ HealthBeat.
Dena Bunis: Hi. My question is similar to the last one but I′m curious. Even in the political campaigns, as you know, there's been this issue of the HPV vaccine, what happened in Texas with the law. Are you concerned at all that the timing of this will kind of get into that debate and reignite it? And exactly what strategies do you have planned for trying to get the uptake to be better in both boys and girls and my call cut out a little bit. You said in the next steps that this goes to a CDC. How long do you think it will be before a statement comes out from CDC and this will become the officially recommendation of the agency?
Anne Schuchat: Sure. I think you mentioned some political question. The thing I would like to stress is how carefully the Advisory Committee on Immunization Practices reviews data. We in fact webcast live the meetings and they are attended by the public. Almost an agonizingly detailed review of information that the committee takes before a decision is made. Particular deliberation has been going on since 2009 when the FDA first licensed the vaccine for use in boys and men. The original FDA approval for the vaccine was to prevent genital warts in boys or men and the FDA in December 2010 expanded their approval, the licensure of the vaccine to also include prevention of anal cancer in both males and females. And so that FDA expanded licensure was really a cue to the Advisory Committee on Immunization Practices to look into the database that was available and make recommendations about routine use of this vaccine. This has been going on for a very long time. In fact –– so I don't think there was any kind of timing in terms of the issuance of this committee vote. There were extensive presentations in February, June and again today in October. Now, in terms of going forward, we're really keen to do a better job of communicating and address accurate information and understand the barriers that are out there. So we'll be working closely with the health care community, the providers, doctors, nurses, and programs that deliver vaccines and try to get a better understanding of what's going on for parents so we can address their questions. I do think some people had been holding back in the first couple years of vaccination because it was a new vaccine. But now nearly 40 million doses have been used and they have a very good record for the vaccine.
Dena Bunis: When is CDC going to make it final, do you think?
Anne Schuchat: Thank you. I forgot to answer that. I would say the process usually takes a couple months. So sometimes we're quicker and sometimes it's slower. I think we'll need to see how things go. It's usually the order of months.
Tom Skinner: Next question, Jennifer.
Operator: Our next question comes from Liz Szabo from USA Today.
Liz Szabo: Hi. I just wanted to ask the doctor to go over more the difference between the permissive recommendations of two years ago to the routine recommendation of today. I would like to clarify for readers what the change is from two years ago to today.
Anne Schuchat: Two years ago the committee had a permissive recommendation that basically said males 11 or 12 or males 9 to 26 actually could be given the vaccine or may be given the vaccine. Today the committee is recommending something much stronger. They are recommending routine vaccination of males age 11 or 12. The principle reason they strengthened the recommendation is the review of new data that were not available in 2009. In 2009 there were data about genital wart prevention and there was an FDA label in support of that. Since that time, clinical efficacy data on prevention of the precursors of anal cancer have come out that were very striking, highly effective against that very severe type of cancer for which we don't have routine screening and for which we don′t have very effective treatment. The idea that we could prevent cancer with the vaccine was really motivating much of the ACIP's thinking. There were a few other factors for them. Part of that was an expanded safety database. Part of that was the extensive review of cost effectiveness information. Part of that was the disappointing uptake we have seen in girls in terms of teenage girls because of the greatest impact of the male recommendation is in these circumstances when there is really pretty poor uptake in girls. Though it's a much stronger routine recommendation than what they had in 2009 and the reason they have strengthened it is because of additional data that weren't available back then.
Liz Szabo: So before the vaccine was permitted for boys but now it will be in the regular pediatric vaccine schedule?
Anne Schuchat: Absolutely. So it was sort of like a footnote and now it's going to be a routinely recommended vaccine. But it's important to point out that when ACIP makes recommendations for routine use these don′t constitute a mandate or force anybody to be vaccinated. These are essentially the expert committee and CDC's prescription pad for docs sort of distilling an awful lot of information into the best scientific and medical advice. Parents having a good conversation with doctors or nurses about their child and the risks and benefits of vaccinating are always important. But a routine recommendation usually helps providers have the confidence to make a strong recommendation to the families that they are caring for.
Tom Skinner: Next question, Jennifer.
Operator: Our next question comes from Leticia Stein from St. Petersburg Times.
Leticia Stein: Thank you very much. Can you talk about the level of the insurance coverage now available for this vaccine for boys and how the recommendation may change that?
Anne Schuchat: Yes. Thank you for that question. In 2009 public insurance for children, the Vaccines for Children Program, has included HPV vaccines for boys through the age of 18. Though many teens are eligible for Vaccines for Children have had access to free vaccines since then. The VFC program covers children who are Medicaid eligible, American Indian or Alaska Native. Understand that many or perhaps even most insurance companies have been covering the HPV vaccine as well as girls but this very much varies depending on a person's coverage and the particular plan they opt into. Affordable Care Act actually –– ACIP recommended vaccine and inclusion in a insurance plan without co–pays and so that a routine recommendation usually will translate into insurance companies going forward, being expected to include the vaccine without a co–pay. There is some question about whether permissive recommendations do or do not carry the same weight.
Tom Skinner: Next question, Jennifer.
Operator: Our next question comes from Richard Knox from National Public Radio.
Richard Knox: Hi, thanks very much. Two things. One a question of equity and how that figured in today's discussion. Namely not placing the entire burden on females and the parents of females to carry the HPV burden. And how you think that might change sort of the political ecology of this vaccine and then I will ask another one if I may.
Anne Schuchat: Thank you. The concept of equity was something the committee considered of the list of factors, the idea that males as well as females should be protected against HPV for equity reasons was one of their concerns. Both that the source of the virus might be a male or a female and that the burden of consequences of the virus could occur in a male or a female. So I think that we are interested in seeing whether a universal recommendation makes it easier for providers to remember the vaccine and offer it routinely or perhaps even makes it more acceptable to parents because they are thinking about it for their sons and daughters. But we don′t know yet. That's the kind of thing we'll be tracking. I can tell you that with the permissive recommendation since 2009 we have had very little uptake of HPV vaccine in boys. We estimate 1.5% through the 2010 teen coverage for 13 to 17–year–old boys. You had another question, I think.
Tom Skinner: Dick, do you have a follow–up question? Okay. Jennifer, we can go to the next question.
Operator: Our next question comes from Molly Peterson from Bloomberg News.
Molly Peterson: Thanks for taking my question. Just a quick question on the cost effectiveness issue. I′m wondering what does it typically cost for a patient to get the vaccine and has the cost changed at all since 2009 or was the finding, the benefits justify the cost. Was that based on the data in terms of the new data you talk about that's come in?
Anne Schuchat: The cost has not gone down since 2009. The current public sector cost for the quadrivalent vaccine is $108. And the private sector cost runs in the range of $130. We haven't seen costs really dropping in the time that the vaccines gone into wider scale use. The cost effectiveness, certainly the cancer end points in males do have an impact. It turns out some of the cost effectiveness of vaccinating males is the benefit you have indirectly on cervical cancer reduction through the expected reduction in spread of the virus to girls and women. So cost effective analysis have been done with a number of different inputs and scenarios and I think your question gets to the concept that if the cost of the vaccine or the price of the vaccine was much lower it would be much more cost effective to give this vaccine in different circumstances.
Tom Skinner: Jennifer, next question.
Operator: Our next question comes from John Roberts of Fox News.
John Roberts: Hey, Anne and Tom. Two questions really. How much of the weight of the committee's decision was placed on the potential for blocking transmission male to female as opposed to development of head and neck cancers in males? We know not all of those are caused by sexual activity? Secondly, and this is a question raised since we got the story on our website. Adverse outcomes. CDC reports 34 confirmed deaths from Gardasil. In getting the word out about immunizing boys will you also alert parents as to that potential?
Anne Schuchat: Let me take your questions in reverse order. I do want to stress how carefully the committee reviewed safety data. They have reviewed safety data at multiple meetings and had an extensive discussion today about that. The passive surveillance systems that track adverse events that can follow vaccination had identified a certain number of deaths. As you mentioned, I think only 34 of them have been confirmed. But the key point about the evaluation was that the current and reporting of deaths following vaccination was not at all greater than expected in that population and the nature of causes of death were a number of different things. So car accidents and so forth. So we don't believe there is any evidence to support severe life threatening outcomes associated with this particular vaccine, but safety is an important concern for the advisory committee and we review this regularly. The first question you had was about how important the indirect benefit for girls and women was versus the direct potential benefits for boys and men.
John Roberts: Correct.
Anne Schuchat: I would say both were important considerations. The committee did feel the burden of disease in males justified routine vaccination. They thought that there was likely to be additional benefit to girls and women by reducing the spread of the virus but they did think that the burden of disease in males alone was sufficient to recommend the vaccine. They really looked at a number of factors. As I mentioned, the disappointing coverage in girls, the idea of equity, the safety and effectiveness. Frankly the idea of having a vaccine that can prevent cancer is a pretty compelling argument to support its use.
John Roberts: One more thing came to mind. One of the earlier questioners asked about the negative publicity this has gotten via the presidential campaign. When you have a candidate go on national TV and repeat several times that she's heard a report that the HPV vaccine can, in her words, cause mental retardation, how big a hill do you have to climb to get the word out? There are many people though there is no scientific evidence to back up what the candidate said, many people believe it.
Anne Schuchat: Accurate understandable information for parents and families is critical to us. The CDC is committed to doing the best job we can in having clear information available. Parents have a lot of challenges these days with so many recommendations. Frankly, there are a lot of vaccine recommendations out there. We're committed to get good information out in ways that people can understand them and make them accessible so people can make the best choices for their families.
Tom Skinner: Jennifer, we'll take a few more questions.
Operator: Our next question comes from Richard Knox of National Public Radio. Sir, please check your mute button. We are unable to hear you at this time.
Richard Knox: All right. You got me now?
Anne Schuchat: We can hear you now.
Richard Knox: Sorry. I got cut off as you were answering my first question. I′m sorry if you covered this because I had to dial back in. On the question of boys who are later going to become those who have sex with men I wonder if you could talk a bit about how the committee felt about these recommendations in reaching that group? Obviously once you wait until they have become in that group it's too late. I wonder if you could talk about the rationale for the recommendations.
Anne Schuchat: Yes. Thank you for the question. The risk of anal cancer in men who have sex with men is very high. That's important now that we have a vaccine that appears to prevent those occurrences to be able to do the best job we can. The HPV vaccine, the quadrivalent vaccine should have benefit to both MSMs and other males. The committee was keen to be able to offer vaccine protection to a broader group than just MSMs and there was the concern that sexual identity is not usually fully recognized at the early ages when we recommend this vaccine. So a broad recommendation for all boys 11 or 12 is what the committee went for, both for the future MSMs and for the general population for benefitting men directly and for benefitting women indirectly by less spread of the virus from males to females. So I think it was a concern. They felt historically risk–based strategies have not been very successful and age–based strategies are more effective. We know from the antibody results that an 11 or 12–year–old responds much better to the vaccine than 25–year–olds.
Tom Skinner: Jennifer, one more question, please.
Operator: Our last question comes from Dr. Sapna Parikh of ABC News.
Sapna Parikh: Can you please clarify the recommendations in terms of the brand or type of vaccine? It sounds like it only refers to the quadrivalent vaccine. Are you only recommending the quadrivalent Merck vaccine, not the bivalent vaccine by GlaxoSmithKline? Could you clarify that?
Anne Schuchat: The quadrivalent vaccine that Merck produces, Gardasil, has been approved for use in males by the FDA. These recommendations for males only apply to the quadrivalent vaccine. The bivalent vaccine produced by GlaxoSmithKline, Cervarix, has not been licensed for use in males and we understand the company isn't intending to file for licensure. Both vaccines are recommended for use in girls and women.
Either one is fine. But for males, only the quadrivalent vaccine is recommended.
Sapna Parikh: Thank you.
Anne Schuchat: The vote is based on the quadrivalent vaccine.
Tom Skinner: Okay. Thank you. That concludes our call. Thanks for joining us. We'll have a transcript available from this telebriefing up on the CDC media relations website as soon as possible. Should you have follow–up calls you can call the main CDC press office at 404–639–3286. So thank you all for joining us.
Operator: That concludes today's conference. Thank you for your participation. You may disconnect at this time.
CDC Online Newsroom - Press Briefing Transcript: October 25, 2011
No hay comentarios:
Publicar un comentario