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ACIP Recommends HPV Vaccination

June 29, 2006, 1:00 p.m. ET

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OPERATOR:  The briefing will begin momentarily.  Our speaker today is Dr. Anne Schuchat.  As she makes her way to the podium, you will hear room noise from the auditorium or silent moments until she begins.  We would like to remind you if you would like to ask question during the call, please press star one on your touch-tone phone.  If you would like to withdraw your question, please press star two.  As a reminder, if you are on a speakerphone, please pick up your handset before registering your question.  All participants are in a listen-only mode until the question-and-answer segment.

This call is being recorded.  If you have any objections, please disconnect at this time.  Please stand by. And thank you.

GLEN NOWAK, MEDIA RELATIONS DIRECTOR, CENTERS FOR DISEASE CONTROL:  Welcome to the CDC.  I’m Glen Nowak.  I’m Director of Media Relations at CDC.  And this morning – or this afternoon - we’re going to do a press conference focusing on the recent ACIP vote on the human papilloma virus vaccine.

The press conference will be led by Dr. Anne Schuchat, who is the director of the CDC’s National Center for Immunization and Respiratory Diseases.  We also have available to us a number of other experts.  And Anne will call upon them as necessary.

They include Dr. Lauri Markowitz, who’s the medical epidemiologist who has led the CDC’s representative on the ACIP working group.  Dr. Janet Gilcrest, who has chaired the ACIP working group – Gilsdorf.  I’m sorry, Janet Gilsdorf, who chaired the ACIP working group on the HPV vaccine.  She’s from the University of Michigan Medical School and School of Public Health.  We have Herschel Lawson, who’s a senior medical adviser for our division of cancer prevention.  And we also have Dr. Lance Rodewald, who is here from our Immunization Services division. And finally Dr. John Iskander, who represents our Immunization Safety Office.

And so, depending on the questions, Dr. Schuchat may direct the questions to one of those available experts.  They will probably have about 25, 30 minutes for this press conference.

And with that, I will turn it over to the doctor.

DR. SCHUCHAT: I guess it’s good afternoon.  I’m delighted to talk with you today.

The big news today is that the Advisory Committee for Immunization Practices made a historic vote today to recommend the routine use of the human papilloma virus vaccine for girls (age) 11 to 12.  The recommendations also include permissive use of the vaccine down to age nine and up to age 26.

This vaccine targets human papilloma virus or HPV.  HPV is the principal cause of cervical cancer. The vaccine has four types in it. Two of those types prevent – are considered the cause of about 70 percent of cervical cancer.  So, this is a huge breakthrough for women’s health, for prevention and for cancer prevention. It’s a very exciting day.

The recommendations involve a three-dose schedule and involves trying to prevent – trying to provide the vaccine to girls before the onset of sexual activity.  The vaccine’s been studied in thousands of people around the world and has been shown to be safe and effective at preventing the precancerous lesions that are precursors to cervical cancer.

As you know, cervical cancer is a leading health problem.  It’s also – the vaccine, in addition to being highly effective at preventing precancerous lesions also is expected to help with prevention of genital warts as well.

The way that the ACIP vote works is that the Advisory Committee for Immunization Practices provides advice to the CDC director and to the Department of Health and Human Services.  And so, from this vote will go recommendations that are reviewed by the CDC director and HHS and then final recommendations will follow.

The other historic event today was that the Advisory Committee for Immunization Practices recommended that this vaccine be included in the Vaccines for Children Programs.  The Vaccines for Children Program provides vaccines for free for children who are Medicaid eligible, uninsured, who have – who are American Indian or Native Alaskan, and basically provides a tremendous safety net to children in the country.  It covers children up to the age of 18. So, anyone who is eligible for the Vaccines for Children Program in that age group would be – would have access to this vaccine for free.  It’s a very important day as a breakthrough for women’s health, for prevention, and an exciting expansion of the childhood immunization schedule.

So, I think I can probably answer questions at this point.

QUESTION:  The CDC’s issues with pregnancy and your admonition exactly regarding pregnant women or women who are going to become or thinking of becoming.

DR. SCHUCHAT:  Thank you.

We’re going to – the ACIP recommended that pregnancy be considered a special circumstance, that details will be provided to the clinicians about women who are found to be pregnant after receiving the vaccine.  The vaccine is – the ACIP recommendation suggested the vaccine not be given during pregnancy, but that if pregnancy is detected after the vaccine has been given that one delay continuing the series until the pregnancy is completed.

And both the company and, would say, the CDC are interested in enhanced surveillance around use of the vaccine unintentionally or inadvertently during a pregnancy so that we can long-term follow what happens.

During the clinical trials some women actually were pregnant – were found to be pregnant during the course of the trial.  And those women have been followed.  So far there are no excess adverse events or complications with pregnancy in the women who received the vaccine compared to the control group, but that’s a relatively small number.  And so, it’s important when a new vaccine comes out even if we don’t expect it to routinely be given to pregnant women sometimes pregnant women will get it.  And so, we want to make – keep a close eye on what happens.

QUESTION:  Did it have to do with the five birth defects?

DR. SCHUCHAT:  No.  I think the issue on the ACIP recommendation relates to the complexity for the program.  Are we concerned about safety of vaccines in pregnancy?  That’s always a concern.  This particular vaccine is considered category B by the FDA because there actually was already a good deal of animal work that was done to understand how this vaccine behaves in animals that are pregnant.

On the other hand, it wasn’t studied in a large-scale trial of pregnant women, so it can’t get a higher rating.  But – so the idea is to keep an eye on things.

The data so far is pretty reassuring about the adverse events in pregnancy, but none of those trials were designed to answer that question.

I’ll take another question.

QUESTION:  Did you receive any import or comment from either organizations or individuals who are opposed to the recommendation of the HPV vaccine for pre-adolescent girls?

DR. SCHUCHAT:  The – of course, there have been many official comments made in the public meetings.  And I would say I don’t recall any comments at the public meetings about the use in the younger age groups.

I think it’s important to understand why the committee recommended the routine (INAUDIBLE).  We know that this vaccine is designed as a preventive vaccine.  It prevents infection with HPV after exposure.  It is not designed to treat an HPV infection after you’ve already gotten it.

It turns out from national studies that HPV is very common, that women – girls or women - can acquire HPV fairly soon after the onset of sexual activity.  And so, it was important to the committee that the recommendations offer the vaccine before most girls would have the onset of sexual activity.

The other thing we know is that the vaccine antibody response or immune response is much higher in younger teens than in older teens or women.  So, the vaccine may be even more effective when given at that age.  There, of course, are unanswered questions.  But to have the maximum preventive impact, the decision was to target 11 to 12 year olds.

On the other hand, there are many girls and women over 12 who could benefit from this vaccine.  At the start of the program, it was very important to the committee to recommend the vaccine be given to anybody – any woman 13 – girl or woman 13 to 26 who had not yet been vaccinated so that they could take advantage of this vaccine.

So, next I want to take a call from the phone, I guess.

OPERATOR:  Thank you, doctor.  And at this time if you would like to ask a question, please press star one on your touch-tone phone. Our first question comes from Christy Feig with CNN.

QUESTION:  Hi.  Thanks for taking my call. I’m curious. This is three shots that, I guess, are costing about $120 a shot.  When the ACIP makes a recommendation like this, does insurance tend to cover those?

DR. SCHUCHAT:  In general, when the ACIP makes a recommendation for routine use, insurance companies and managed care organizations follow.  We are hopeful that the insurance companies and the managed care organizations will cover this vaccine and allow the great preventive benefits that it has to be accessed by many women.

Another question from the phone?

OPERATOR:  Thank you.  David Brown with Washington Post, your line is open.

QUESTION:  Hi. Thanks. Was there any discussion about whether the committee would recommend that states require this for school continuation or for moving from elementary school into middle school, something like that?

DR. SCHUCHAT:  Thank you. School entry laws for immunization are not federally mandated.  Those are state or local issues.  And those will be decisions that state and local entities will take over.

Another question from the phone?

OPERATOR:  Thank you.  Robert Bazell with NBC News, your line is now open.

QUESTION:  Hi.  In the Vaccinations for Children Program, do you anticipate that the government will be paying the $120 a dose that Merck is charging for this?

And this cost of these three shots will come close, if I’m correct, to doubling the cost of the entire course for the 16 diseases.  Isn’t that correct?

DR. SCHUCHAT:  Thank you for that question.

The Vaccines for Children Program involves first a resolution.  And today we got a resolution that this vaccine be included on the VFC – within the VFC Program.  The next step involves negotiation of a contract price.  So, the CDC would be pursuing a negotiated price that is usually discounted from the private sector price and a fair price.  So, that is a process that will be ongoing in the future.

Another question from the phone?

OPERATOR:  Thank you.  Todd Zwillich with WebMD News, your line is now open.

QUESTION:  Hi.  For those of us who didn’t have a chance to be there, what was the actual vote, the score?  That’s my first question.

DR. SCHUCHAT:  The votes today were unanimous in support of the routine recommendation for girls 11 to 12 and the recommendation that the vaccine could be started as early as nine year olds who had not yet …

ZWILLICH:  And could you …

SCHUCHAT:  … be offered the vaccine.

ZWILLICH:  It could be started as early as nine at a physician or parent’s …

SCHUCHAT:  At the provider’s discretion, right.  Sorry.

And then the VFC vote, the Vaccines for Children vote, was also unanimous in support of that, including this vaccine, within that program.

A question from the room?  I think back here.

QUESTION:  William Ryan with NBC News.  Another regarding cost. Do you – are you concerned that a lot of people might fall through the cracks when it comes to being able to afford this?

DR. SCHUCHAT:  Vaccine financing is an enormous issue.  The Vaccines for Children Program provides a tremendous safety net for the most impoverished and for special vulnerable groups in the country.  State governments also help.  There’s also something called the Section 317 Program for the federal government that provides support to states to help with financing of vaccines.  But these are strained system and – the VFC Program is not sustained, but the other, the state and the 317 programs, are challenged.

The other thing to mention is that the VFC Program really only goes up to age 18.  And so, for women in the 19- to 26-year-old group, there could be a gap.  I think people heard Merck’s announcement about efforts they’re trying to make to bridge the gap in people over 18 who are within 200 percent of the poverty level.

So, I think working on assuring access is very important.  We really would like to get high coverage of this vaccine.  It’s a tremendous opportunity for prevention and it won’t be that if we don’t get the vaccine into the people that need it.

Here in the room.

QUESTION:  Hi.  I’m Beth Galvin with FOX5 here in Atlanta. What would you say to parents of young girls who might be a little bit uncomfortable with the idea of vaccinating them against an STD at, say, 11 and 12, before they’re ready to talk about sex?

DR. SCHUCHAT:  You know, I think this is an incredible opportunity for parents and an incredible opportunity for our country.  This is a cancer prevention vaccine.  It also turns out to prevent the most common sexually transmitted infection in the country.  And this is a great opportunity for us to make advances in prevention.

The other opportunity we have is with adolescent health.  As you know, there’s a lot going on in adolescents, a lot of risk taking, a lot of issues.  We now have several vaccines that are routinely recommended for adolescents at 11 to 12 years of age, new opportunities for a health care provider/ adolescent interaction, new opportunities for parents to talk to their children.  So, I think this is really exciting on that front as well.

I think on the phone, do we have another question?

OPERATOR:  Thank you, Christine Gorman from Time Magazine, your line is now open.

QUESTION:  Yes.  How did you come up with 26 as the upper limit for the recommendation?

DR. SCHUCHAT:  Well, thank you.  The committee recommended that the vaccine be given up to that age group, first, because that’s what the FDA label had.  The FDA label went up to 26 because the studies went up to that age group.

The company is doing studies ongoing in older age groups as well as in men.  And so, there may be alterations and recommendations in the future.  But I think it’s important that we use a science base on our recommendations.  And this vaccination set of recommendations really followed that guide.

Another question from the room?  Up here again.

QUESTION:  (INAUDIBLE) the cost for the VFC Program.  I believe you’ve already explained that that’s going to be (INAUDIBLE).  (INAUDIBLE) an estimate of the annual cost of the VFC will be?

DR. SCHUCHAT:  You know what, I don’t think I could say that.  The – probably better not to.  But we’ll be negotiating a price and expect to have the price be much less than $120 per dose.  There’s a large group of population that may be included.  I’m trying to – maybe I should ask – jumping up here – about the number of children that might be included in the VFC program.  Sorry.  I don’t have that actual number for you.

LANCE RODEWALD:  Lance Rodewald in Immunization Services Division.

About 40 to 45 percent of the U.S. child population is included in the VFC.  And there used to be three things that we didn’t know in order to predict what the cost of the government will be.  They were the breadth of the recommendation, the cost of the vaccine and the uptake or the acceptance of this vaccine.  Now there are only two things left, but there are two missing pieces of information in terms of really projecting the cost.

We tend to think of about – in the first year of a recommendation about a fifth of the population that’s recommended getting it.  And then usually after several years we like to see up to around 90 percent coverage.

DR. SCHUCHAT:  On the phone another question?

OPERATOR:  Thank you.  Denise Gellene with the Los Angeles Times, your line is now open.

QUESTION:  Yes.  I was wondering if you could talk about the cost effectiveness analysis that you looked at for the vaccine. And I also wanted to clarify if that VFC would be paying for children nine to 18, not as opposed to 11 and 12.

DR. SCHUCHAT:  Yes. Thank you.

The VFC resolution did include the nine- through 18-year-old age group.  At the meeting this morning, many, many models of cost effectiveness were presented with a lot of different assumptions.  There were models that took into account indirect protection, what we call a herd effect. There were models that took into account different levels of effectiveness.

And the bottom line was that almost every way this was assessed, this was a cost effective intervention.  We think of cost effectiveness as how much money we’re putting in with how much return. So, the vaccine model both for 11 to 12 year olds and for the catch-up schedule or the women up to age 26 all was considered cost effective within the reasonable estimate for a recommended health intervention.

There’s lots of nuances there and lots of technical issues that will come out in the various papers, but that was – I think people know that the ACIP considers many factors.  They consider efficacy, safety and cost effectiveness as well.  And on all three fronts this vaccine looks very good.

Other questions from the phone?

OPERATOR:  Thank you.  John Reichard from Congressional Quarterly, your line is now open.

QUESTION:  Yes.  I wonder if you could comment on the procedure after these recommendations are voted.  You mentioned that CDC would look at them and then HHS after that.  How often does CDC or HHS revise or change the recommendations?

DR. SCHUCHAT:  The process, as I mentioned, is that these recommendations will now go to the CDC director and the Department of Health and Human Services usually within a few months or the recommendations will come out in the MMWR.  And that’s what we’re anticipating here.

The issue of the recommendations being overturned I actually don’t know if that’s a – we’re not anticipating that.

OK.  Another question from the phone?

OPERATOR:  Thank you.  Macon Moorhouse with People, your line is open.

QUESTION:  Thank you. I was just wondering if you have any idea of when this might actually show up in pediatricians’ offices, when girls might start getting the vaccination?

DR. SCHUCHAT:  Well, we’ve been told that the company has a very ample supply.  And they were anticipating as broad recommendations, as we’ve – as the committee has recommended and that shipment to offices should be happening quite soon – underway.  I think I have some company people in the room.  So, maybe – it’s in the mail, I think.  Under well-controlled conditions.  Right.  OK.

Another question here.

QUESTION:  Mike Huckman, CNBC. Could the recommendations change if Glaxo’s vaccine shows that it’s effective on additional strains, works differently, larger age group, et cetera?

DR. SCHUCHAT:  Thank you. As people probably know, the GlaxoSmithKline is researching a different HPV vaccine.  We are very excited about the research and development around HPV vaccines and look forward to multiple vaccines making it onto the market.

The ACIP recommendations apply to the Gardasil, the Merck vaccine, which has been licensed by the FDA.  And we look forward to the additional data that will be forthcoming about other products.  So, these recommendations are really specific to the one licensed product that exists right now.

Another one from the phone?

OPERATOR:  Thank you.  Paul Weingarten with Chicago Tribune, your line is now open.

QUESTION:  Thank you. I just want to follow-up on one thing.  (INAUDIBLE).

OPERATOR:  Excuse me (INAUDIBLE)…

SCHUCHAT:  I think I actually got the question.  I’m going to answer a question that I want to.

No, actually I believe – that was sort of marbled for us.  But I think you were asking is there some place people can read what this recommendation is even before it’s finally approved or accepted by the CDC and HHS.

What typically happens following an ACIP meeting is that the provisional recommendations, what the ACIP actually voted on, will be posted on the CDC’s Web site under “Provisional Recommendations.”  It’s also usually easy to find on the American Academy of Pediatrics Web site.  Those are provisional.  They’re not yet official policy of the CDC or HHS, but the details of the key recommendations are usually made available through that venue.

I think we have time for one more question from the phone.

OPERATOR:  Thank you.  Randy Meads with AFP, your line is now open.

QUESTION:  Yes.  I wanted to know if these – there – is there any other country where this vaccine is already in use?

DR. SCHUCHAT:  I’m looking at the audience.  OK.  Apparently in Australia the vaccine is already – well, there are a couple countries where it may be licensed.  I don’t know if they are routine policies now.  Not yet.  No.  It’s been licensed in more than the U.S., but I believe we’re either the first national recommendation.  So, as I said at the beginning, today is a historic day.

Thank you very much.  And I think if people have additional inquiries they’re referred to our press office probably. Thanks.

OPERATOR:  Thank you.  This does conclude today’s conference call.  We thank you for your participation.

END

####

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