hepatitis

hopefully, this morning'sagenda made provisions. as you can see, my firsttime at the podium. first of all, i want toacknowledge and let the persons who don't no who the members ofchildhood and adolescent immunization work group are,they're myself as the chair the members are cynthia pelligrini.dr. allison kemp. and from the aap,dr. codey meissner, from the aafp dr. schlam.and cdc lead, dr. raymond strikas and the consultantsshown on the right side of your

slide.so i want to remind the members of the committee why we'relooking at it and why we're voting on it, i want to remindyou all that acip approval of the proposed schedule isnecessary to the publication in the mmwr in january and february2015. also approval is necessarybefore the partner organizes the american academy of pediatrics.american academy of physicians, and the acog, american collegeobstetricians and gienology. also approved proposed schedulesprior to the pun indications.

lastly, keep in mind, we are notestablishing a new policy. these are actually shown in theannual schedules which reflect the recommendations alreadyapproved by theacip. so, for the remainder of thepresentation, dr. strikas will discuss the proposed edit to thefoot the catch-up table.schedule that's easy to ve the e interpret by the physical healthcare provider. this years only a fewas scheduled have required attention.the acip members have

your slidenders, as well ason the meeting website. in addition, on the website, arethe full set of footnotes for your review, as well as thecatch-up schedule for revised job aids for the dtap, hib andthe vaccines. these latter documents will bepushilied by the cdc and while they don't require the acip'sapproval, we request that theeww weeks to ensure that they'reconsistent with the current childhood/adolescentimmunization schedule. now, let me turn this over todr. strikas who will take us

through the proposed slides.>> thank you, dr. romero. and when i neglected in advisingyou that the website referred to as sharepoint site that acipmembers have access to that is not the public website atpresent. so here's speaker one.the draft schedule for 2015. the changes proposed here are tohighlight the different recommendations for influenzafor children for number one, live attenuated vaccinesbeginning at 8 years of age up to which children will need onedose of vaccine up to which

they're require on one dose.therefore, the new age group is to accommodate the changes.i realize those are parsing finely, but we feel they will beuseful to the practitioner. let me walk through the closedchanges here. for his vaccine in the dose 1 to2 column, we only change the language to refer to a doseadministered before the first birthday, it seemed clear to usthan younger at age 12 months. in the 2 to 3 dose column, whichdose is to be given from the second dose.and those are active vaccines or

unknown, it may be either ofthose. for an interval of eight weeksbefore the doses and to be final dose in the hit series, wedeleted what appeared to be unnecessary where it statedregardless of which hit vaccine used.we also define for children 12 to 59 months of age to allow forone more dose. and lastly, we deleted somelanguage in the last category to read both doses with prp and ompvaccines again used before the first birthday instead ofyounger than 12 months.

in the head dose, three to fourcolumn, any child receiving vaccine before 12 years of ageshould receive one more nose. in fact, the strike out sectionwere deleted. only to say it was given beforethe first birthday. that the three doses, rather,were given before the first birthday.for the pneumococcal conjugal vaccine.and the routine childhood immunization recommendation,those three should be given four weeks after dose two if a childis younger than 12 months of

age.and the previous dose was gimp before seven months of age.dose three is the final dose that should be given eight weeksafter the previous dose. that is the second dose in theseries was given between seven and 11 months of age.and the third and final dose should be given once the childhas reached 12 months of age or older.or if the child is 12 months of age or older and received twoprevious doses before the age of 12 months, they can completethat series at that time.

in the dtap section, wording wassimplified before the first birthday.and we deleted unnecessary language where we defined thedtap doses the final dose in the series above the language thatyou see there. the last is the dose before thefirst birthday rather than before age 12 months.the minimum age for dose one for hepatitis a, hepatitis "b,"polio, meningococcal is not relevant for children in thecatch-up schedule so we indicated those are not forvaccines.

and in tvaricella section wedeleted the age and so on. let me move on to changesproposed for the footnotes. in footnote three for dtap, thelanguage generally for recommendations on immune dagsw immunization was added.which means children who already received the dtap at least fourmonths, providing the child is 12 months of age.so this change is to facilitate representative of that vaccinethat out recommendation that children should routinely getthe dose but when six months are

acceptable.in the vaccine, footnote six, we added language to follow moreclosely the language from the 2010 recommendation forhigh-risk children, 2 to 5 years of age that they should receiveone dose of this vaccine. if the child receives anyincomplete series whether the 13 valents.and also the children if they received fewer than three goesof any conjugate vaccine in the past.that's verbatim. in the influenza footnote, theonly change to update the

references and to point to the2015-2016 current dosing guidelines and recommendationsby the acip that are applicable for those in the 2014recommendations where those are currently available.there were extensive wording changes where the meaning wasmeant to be the same as in the pneumococcal note that you seehere. those were meant to be done forhigh-risk children for the three vaccines.we stratified this by condition. this is the one and the only newone here, the recommendations

public here.indicating they only need two goingses of that vaccine.the other thank is simply stratifying by vaccine and thenby the age of the children. and a similar restructuring wasdone over the language in parallel for each vaccineseparately for children with component efficiencies,otherwise, the language has what it had before.so as dr. romero said, i remind you that we request your input.and we'll take the revisions that you give us go through cdcclearance and sent it to

colleagues aafp and acog withthe latest in pediatrics and the american family physician nolater than february. and i want to thank the manysubject matter experts on the cdc, wells colleagues on therki.too many to maihere.who worked 2014 schedule as well as the2015 draft. so i leave it now up to thecommittee for questions, clarifications.and if you deem appropriate, to vote on the schedule.>> thank you, dr. strikas. open it up for questions fromthe committee.

all right.>> when i'm looking, i'm not sure what page it's from,tetanus, diptheria, 3 to the box that correctionis correct. but on all the other pages itsays a first dose of dtap was administered.i first dose of dtap was administered.i think that needs to get cut on the other copy.>> all right, thank you. thank you a comment, i justwant to say hallelujah for the team for the hib language.>> let me think elizabeth baird

and our colleagues, but on ourbehalf, thank you. dr. pickering.>> yeah, i haven't read all seven pages of the footnoteslately. but just to restress, yourchange is before the first birthday and younger than 14years of age really clarify things.but as you go through, make sure you don't use any dashes --like six dash 23 months. many people will differentiate.some people say two or four. it's very confusing.you could eliminate those dashes

that would make it a little moreclearer. thank you, we will do that.>> other comments? so, it appears that the workgroup has done a very good job with the revisions.do we have any motions for -- first of all, do we feel thatwe're at a point that we could move ahead with this?i see a lot of -- do i have a motion?dr. reuben. a second by dr. kim.further discussion? this is the last chance.i see none.

we'll go ahead and start -- thisis really difficult as it was, dr. vazquez will go clockwise.then we'll go to you. vazquez.>> yes. bow keane, yes.>> riley, yes. karron, yes.>> orange, yes, harrison yes, romero, yes.reuben, yes. pelligrini yes.>> with all this peer pressure, reingold, yes.>> as such, the motion carries unanimously with 13 votes infavor and two absent from the

meeting.thank you very much, dr. strikas, thank you.and dr. romero. i need to turn back to myschedule. it is -- we're actually ahead oftime, should we take a break here or we could -- i can't --no, if dr. riley is up for it, we could have you come up to thep introduce the adult immunization schedule.>>> good afternoon, i'm filling in for who is using herexpertise in west africa. i think i have chris here togive the updates on the good

doctor.sorry, i thought chris was going to join us to to fill us in onnew communication materials. she's not here, right?okay. there she is.i don't wand to steal her thunder.>> hi, thank you for letting me have just a minute.i wanted to call the members' attention to a folder ofmaterials that we passed out to you.we wanted you to see and have some of the direct consumermaterials that we put together

including a few of our postersand flyers, as well as some of the materials that were done forclinicians. specifically, the series on theadult standards. i also wanted to mention thatcdc is currently working with the iic on aset of adultstandards. to cover assessment,recommendation, administration and documentation.the assessment futures be available online.and the recommendation feature will be available soon.this feature will include

examples from patients aboutvarious vaccines and monitoring how to answer those questionsclearly and distinctly. i just wanted to give you aheads-up with those materials. make sure you know it'savailable. that's it.thank you. thank you.>> wonderful materials, are they available in spanish?>> we do have a couple of the pieces currently available inspanish. and we're going to be working tomake more of themselves also

available in translations aswell. other questions?all right. thank you so much.>> okay. i'm going to press forward aseveryone was asking for. so, this is the adultimmunization work group, and i'd like to acknowledge all of thepeople who made this group work. and it's a very interestingprocess that is -- has gone over very, very carefully, and wethank all the representatives, as well as the consultants fortheir work.

and obviously, we greatlyappreciate our fearless leader david kim as well as carolynbridges. so just as a reminder, acip, asyou know, updates the adult immunization schedule everyyear. and represents and summarizesall of the acip policy. the group meets positively andgoes over, along with consultation.some are experts to recognize changes over time.the updates approved policy changes from additional acipmeeting on august 13th.

and those published in the mmwron december 19th were discussed in great detail and we workedmultiple times which you buys will see shortly.the 2014 adult schedule is also approved by accp, aafp, acog andothers. and now i'm going to turn thisover to david kim. thank you very much,dr. riley. before we get started again, ijust want to mention that our acip representative kathy hharriman as you got the information earlier, she wasdeported to west africa.

and she got training and itlooks like she broke her foot. and that prevented her fromdeploys to africa. she's back in california and wecertainly wish her a speedy recovery.just in a nutshell, this is what we're -- what we are faced with,in terms of revising the 2015 adult immunization schedule.we are doing three things we did three things.the first is we're doing figure one.and basically, that meant we placed the purple bar whichbasically recommended if there's

risk involved with the yellowbar. that's why we're recommendingthat. recommending that for pcv13 foradults age 65 years and older. along the way, because thesefigures are accompanied by footnotes, we needed to addpvc13 for adults 65 and older just for the recommendations inthe extra session in august for acip.and our charge was to basically make it as user friendly aspossible. so for the work group, we for tformatted the footnotes from the

vaccine-focused approach topatient-focused approach. and from the contraindicationstable we added changed associates with laiv and iiv incontraindications and precautions.so on that last point, on the contra indications.those changes were based on the recent article that summarizedrecommendations on the seasonal influenza vaccines that waspublic lehred in august 2014. and in it, there were changesand contraindications and we adopted those changes.the first adoption being the

inclusion of severe allergicreaction, that is anaphylaxis with any vaccine for laiv or iivas contraindications. in addition, acip recommendsthat laiv not be used in the following populations.and we included the material that was present before.pregnant women, immune know suppressed persons, persons withegg allergy and children with asthma or wheezing episodewithin the last year. and also includes patients withprecautions of chronic health conditions.so, looking at the 2014 adult

immunization schedule, with therecommendations that are currently in place, we havethree each representing a vaccine, pcv13, ppsv23, andrevaccination of the peoppsv23. in terms of population groups,we invited them into two age groups, one greater than orequal to one year of age. those 65 and older.and the recommendation -- the previous recommendation of age65 years and older needing to receive one dose ppsv23obviously was in place. and i wanted to specificallybring out the younger age

grurngs 19 years old or older.because the common revaccination that we as workers get from thefolks within cdc, folks outside of cdc, from anybody who readsthe acip recommendations. it's complex.and from this morning, the pneumococcal vaccinations arecomplex. the adults, ppsv23, two dosesand the enter ral, two vaccines, and the fact that theyed me toget both, we have different combinations of possibledelivery and the interval between the two vaccines aredifferent.

for example, ppsv23, you need towait at least one year before you're given pcv 13.and the ppsv23 to another dose of ppsv23 you have to wait atleast five years. to go from pcv 13 to ppsv23, theinterval is at least six weeks. that makes it complement.on the other side, if the person has anatomic as meania, butpeople with csf leaks and cochlear in-plants they only getone p c "v" 13 and ppsv 23. people with chronic healthconditions, they get one dose of ppsv23 and a population thatconstitutes a large segments

smokers residents of long-termcare facilities get ppsv23. so it say complex schedule thebeginning the scheduling and the intervals between thepneumococcal vaccine with two different types.so we had quite the challenge in trying to incorporate thepneumococcal vaccinations in the 2014 schedule because inaddition to the ppv 13, in persons 65 years of age orolder, the set of recommendations get even morecomplex. so depending on age andconditions, and i'm going to

point out some of these that arekind of obvious and have contributed significicantly to edifficulty in comprehending the recommendations for thepneumococcal vaccine. i menged that ppv 13 for ppsv 23interval for the younger population was at least sixweeks. and in addition to the ppv13 foradults 65 years of age and older, that interval is now 6 to12 months. so same dosing schedule, butdifferent dosing intervals. so greater than eight weeks forimmunocompromised and 6 to 12

months for adults 65 years ofage or older. and i mentioned that personswith csf leaks and cochlear implants with one dose of pvc 13and the added rare complexity also stems from the fact thatthose younger adults who are 19 to 64 years of age, who receivedpneumococcal vaccines, they age into that latter group of kindof years of age or older. and their schedule will get --will become complicated with the addition of pcv 13 on top ofppsv 23. if you're a busy health careprovider and you're trying to

vaccinate older persons in thoseconditions, it becomes a tall order to make sure you'regetting everything straight for the right vaccine at the righttime for the right person. so the figure is actually --there's very little change to the figure.but the footnotes became paramount in importance intrying to relay the message that -- relaying the messagethat it's simple and useful. so, in the 2015 adultimmunization schedule is really -- there's really verylittle change.

so you can see here, that thered we have changed that, that purple bar, for 65 years of ageand older for the pcv13 from purple to orange.and you'll note that the -- you'll note that the gap isactually -- it's actually a continuous line, as opposed to abroken yellow line and the purple line.vaccines for particular populationsxa b based on theirmedical and other conditions, that has not changed.so for 2014, the adult immunization external, by addingpcv 23 on top of 13.

and that when indicated only onedose of pcv 13 is indicated for adults.the other three points listed here have already been stated inprevious versions of adult immunization external footnotes.the interval for adults now as i mentioned became a little morecomplex with the addition of pcv13, needing to beadministered for those adult stage, 65 years and older.so these intervals between pcv13 and the subsequent ppsv23 shouldbe 6 to 12 months. in contrast to at least eightweeks for the same -- same

schedule for the persons 19 to64 years. who are immunocompromised orhave some aspleenia or csf leaks or cochlear implants.like i mentioned earlier, the bottom line is we are taking --what we tried to do was, take the take the biloadrecommendations and the set of recommendations if the footnotesto go from the specific set of guidelines or set of informationto patient-focused set of information.meaning for a busy provider, they're not -- there's a thingyou cross as a patient.

as an individual, who has -- whohas so many years old. who has certain conditions.so the idea is that providers find it's easier to work withwith patient characteristics as opposed to the specifically thevaccine. so the footnotes changes areproposed in the 2015 adult immunization schedule footnotes.so you see here that the population has been divided intothree. adults who are 65 years of ageand older. and adults who are 19 to 64years, with immunocompromised

positions and with csf leaks oras meania. and other conditions, csf leaks,cochlear implants being one group.chronic health conditions another group.and a population for those who reside in long-term carefacility. the difference being, this islike talking about unknown unknowns.and known unknowns and so on. so forgive me for playing alittle bit of a mix and match game with what's the differentcombination of the vaccines

here.but for adults 65 years of age and older who have not receivedpcv 13 or ppsc23 or unknown pneumococcal history, they arepcv13, and as you see here, the footnote -- for the footnote,i'm sorry about that. so 6 to 12 months after pcv13,they should be getting ppsv23. for the 65 years and olderadults who have not received ppcv 13 but did receive ppsv23at 65 or older they can simply get pcv13, but that should be atleast one year removed from the most recent yet, ppsv23.again, adults aged 65 years of

age and older who did notreceive pcv13 but did receive one dose of ppsv 23 from age 65.and they should be getting pcv 13 which is at least one yearremoved from the most recent dose of 23.followed by another dose of 23. that is six to 12 months after.at least from the most recent though because of ppsc23.if those adults did pcv 13 but not ppsv 23, they simply get ittwo to six months after. that's for adults 65 years orolder. if they received pcv 13 or oneor more doses of ppsv, they

simply get ppsv 23 at least fiveyears removed from the most recent dose of ppsv 23.it's basically an algorithmic approach.it's to identify the patient by age and by health condition andfollow through a simple menu site, what the patient needs interms of pneumococcal vaccine. and obviously, what i had herefor persons 19 to 64 years of age, immunocompromised and withasplenia, it goes through the possibilities of what they mightor might not have received during their pneumococcalimmunization odyssey.

for adults 19 to 64 years, thebottom -- the bottom three small bullets, there's really nochange. but the ideal for us as a workgroup to make it easier for the busy provider to follow and makesense. and so the schedule, the adultimmunization schedule for vaccine, the changes in thefootnotes. so the next step is for us,based on your recommendations and discussions, obviously, forus to revise the adult immunization schedule for 2015which will undergo another round

of scrutiny by the subjectmatter people in this case, the influenza folks and thepneumococcal folks. and then get the approval fromthe professional colleagues, aacp, and the acog and the nursemidwife. and i'd like the child andclearance schedule, the clearance process and the mmwr,and at the same time, we will be publishing, in the annuals ofinternals. we'll do that coaccord with themmwr. that is all i have.and i'll be happy to take any

questions.we would certainly welcome your comments.>> thank you, pretty much, dr. kim, dr. kissinger.>> hi, david, thanks very much. i really like that simplifiedalgorithmic approach you that have.i have a plea for the committee and a question.and the plea would be first if you could simplify the intervalbetween pcv 13 and ppsv 23 so there's one interval, regardlessoffing a that would make programming for the tools muchsimpler.

and i would you askdeciding whether the intervals would be eight weeks or 6 to 12months. that's very helpful.that's my plea. my question is for a 65-year-oldpatient who is pneumococcal vaccine naive.who hasn't had either one. who didn't becomeimmunocompromised, which schedule do we follow do theyget just once pcv 13 and the ppsv 23 once or do they get twodoses of ppsv 23? so that's a gap there.>> that is not specifically

identified in this slide.however, in the previous slide, we indicated that.so when indicated only one pcv 13 is needed for adults.and more additional ppsv 23. you might make it clear evenif immunocompromised the guide dance for immunocompromisedpatients may not be as what it was before.that may be confusing. thank you.>> i don't think we're able to change recommendations from thepneumococcal by virtue changed in thele.however with dr. bennett sitting

here and listening verycarefully to your words, i think she will take it back to thepneumococcal working group for your consideration.>> i can make a quick comment why this came out this waybecause there wasn't a lot of discussion about it.and we weren't happy. there was nobody happy.it's sort of back and forth for making recommendations on whatwas the most possible recommendation.and people w compromised, some who were over 65 who arehealthy.

and to say a greater than witheight s. and the concern was that wereally needed more leeway.so the minimum of that, but obviously it can be extended.and we were fully aware this was not there.but we will discuss it. thank you.>> i suspect there's an inverse relationship between complexityand successful implementation of guidelines like this.and just maybe a talking point, you can look at sort of each oneat the time, make certain.

then you look at the wholepicture and, my gosh, how can people keep track of this.perhaps a more specific thing, i wonder if it would be helpful tocreate a flowchart or a couple flowcharts one forimmunocompromised, one for not, one for over 65.at least for the practitioners it would be good to see good andread all the footnotes. if i may, we are -- we willbe submitting a writeup of this to the mmwr for publication infebruary. and we'll do this withsimultaneously publication in

the animals of internalmedicine. and in the an newlies we do havean opportunity, but the real die yam is appropriate.even the real dates, with the pressure, on the footfootnotes,before the schedule, we simply were not able to did that.but a flow diagram, i think, makes perfect sense.>> miss pelligrini. this is a comparative minoredit. on the fifth slide you have alist of contraindications for laia.i suggest that you pasted in the

entire list.the fourth bulletin or ages 2 to 4 years and it is probably notpart of the immunization issue. thank you.>> i have just a quick question. i think we can go back to thepneumococcal vaccine. almost the last slide,actually -- actually, keep on going.number 11. thank you.yeah, go back. two suggestions, one fromdr. pickering to make sure if age 19 through 64 years in boththe bottom bullet points.

the second one is in terms ofclinicians out there, heaviness in order of likely to be seen.so the adult 65 and ordinary like on top, falls by adults 19to 64 with the more common things out there.and then the more complicated maybe at the bottom which is,again, less common in regular care.>> dr. kemp. i was just going to follow upto the idea of a flowchart. maybe ray can respond to thisbut in the childhood, the attempts to make all of thosesupport catch-up documents, they

did some really nice pilotingwith providers and found, in fact, the flowcharts were hardin general to understand, compared to the patient-focusedthings. it's a good idea to pilot that.that was really effective. any comment?>> from the minnesota department of health.i know this is really a minor detail, but having alreadygotten some questions like is it okay if we can give ppsv23 twotimes a year apart for psv13, and in the footnotes you talkabout adults 65 years of age or

older in ppsv 23 and pcv 13first. and we thing we need to bespecific, pcv 13 followed by ppsv 23 12 month it's later.even though it's specific, it looks like you end up givingthem together. and i know many that will dothat. thank you for your comments.>> yes. follow up on the question, is the minimum thenfor a 65-year-old patient who received ppcv 13 they would neeto dose? if that can be spelled out inthat lovely catch-up table in

the pink book, that's what mostof us are trying to glean, what is the maximum level?so it is eight weeks. great, thank you.>> dr. bennett. just to make a last comment.i think we gauge you a pig's ear and you made a silk purse out ofit. this is very difficult.and i'm impressed with the way you compressed all of thisinformation. so thank you.>> dr. schner, on behalf of my colleagues on the working groupthanks to david, had led us

through the pneumococcalwilderness and he always had good composure and a great senseof humor. so, thank you, david.>> any other comment out there? and again, if there is nocomment, this is also a topic that we need to vote on.do you have a comment? oh.after the vote? okay.doctor. i have one other comment,back to the contraindications of the purple table.we notice that things have been

harmonized in terms ofantivirals to continue with the language in the flu statements.now there's a little bit of subboardence for the others,live vaccines in the percussis column.and i was sent an e-mail literally two minutes ago withall the experts here, it's probably something that mightneed to be -- oh. but, you know, i don't knowlike, you know, if we vote today, if that can be furtherclarified after the work. where we really are voting onthe language.

so the issue is that now withthe laiv statement. and for laiv, is now says foranabolic use. it's a contraindication for theantiviral. for the varicella and zoster,it's in another column. so for -- it's a precaution forlaiv, but it's a contraindication for zoster andvaricella. they're veryand that is in agreement with the the statements, correct?>> it is, the way it's in the table now.>> it was just said it will

cause confusion.those things, when there may be scientific reasons why they arenot the same anymore. but people tend to keep it justin mind. more ease ly in terms of what isa precaution. just to know if there's anopportunity for more discussion among the subject matter.experts about harmonization for that.further comment? yeah, i am just not sure thatwe have -- if it's something that we can resolve todaywithout the other working

groups.particularly foster being able to weigh in.>> my understanding is for the adult schedule, it's apresentation of existing policy and not an opportunity to createnew policies. so, suffice it to say, the workgroup has done a fabulous job of capturing the changes.i think the doctor at the mic. thank you, if you could go tothe slide that he says footnotes 2.there's inconsistency, it's the first time i'm seeing the slide.so forward please.

one more.that one. some of the bullets are writtenhave not received x but received y and some are written, havereceived x but not ymp and you may want to standardize thoseand i think, i defer to dr. kuemper.i see people, the ones that deal with clinicians more than i do,you think of what they have received from the record andthat tell thes you what is missing and that sequence mayhelp them. hi.sit back at the microphone

please.>> so i would always, i know we talked about the dash with thehyphen of course for the footnote to the footnote.it says is 6 to 12 months. i would make sure it's clear.it's 6 to 12 months not through 12 months.people may think after a year, they should no longer give thisvaccine. thank you.other comment? doctor?>> just about that have not received versus the hasreceived.

i think you the a good job withthe adults over 65 where they have not received pcv13, thefirst three bullet withes are essentially all people 65 andover, so the majority case is being addressed first, beforeyou continue on. and it would be difficult toscan down there for the have not received pcv -- you know, ithink it makes sense is the way you did it, i would not changethat. sorry, just a quick, i agreewith dr. shooket because pcv is a single dose, versus being two.just from a perspective of it's

easier to think of the pcv in abinary way first and use it as the first screen before you lookat whether or not they have gotten one or two doses.>> thank you. again, we are beingconsidered to ask a vote to approve this schedule, sothere ?dr. bennett, and a second? dr. riley.discussion and we are keeping from dr. fryhoffer for after thevote. discussion?then, let's go ahead and go counter clockwise this time.starting with dr. container.

container, yes.ballange, yes. dr. ballange, you failed yourfirst test here. okay.i need the remedial on clockwise versus counter clockwise and iwill athat soon. dr. kemp?>> yes. riley, yes.>> openie yes. vaskus, yes.>> reingold yes. pellegrini yes.>> reuben yes. bennett, yes.>> formedo yes.

harrison, yes.>> and the -- ballange, yes, again.that's not two votes. and i will remind you, thisis not chicago. but no offense to anyone fromchicago here. the motion carries 13 votes forno votes against and again, two absent from voting.so this passes. and we thank the adult workgroup for a very complete presentation.with this, i guess we move on to the hepatitis.-- oh -- i'm sorry, dr.

fryhoffer.>> thank you. on behalf of the -- of internalmedicine, students, and resident fellows and on behalf of thepatients we want to thank the acip for voting on the new adultschedule. and i want to give a specialthanks to the working group for putting together the knewpneumococcal mega footnote and i prefer the new title.with goal being to help practitioners more easilyimplement the new schedule. as we all know in the room, k. wthis disease kills as many as

4,000 people each year, mostlyadults. old adults are increased risk.so, you have done your work, and now, it's in our hands.and just to let you know, we will be stepping up to the plateto help get the wordout about this new schedule.we have an adult immunozation, we have a dedicatedimmunoization portal. and we will implement our newprograms. and it will have the guide andapp. we have ongoing qualityimprovements initiatives,

including a cdc funded program.and we plan to have a special coaching call on pneumococcalvaccine protocol on these programs.just to let you know, the most recent impact factor for it is16.104, which was the highest of any specialty journal in thegeneral and internal medicine category.this new recommendation is both comprehensive and complicatedbut our patients will benefit from our collected i eed immunoand implementation efforts. thank you very much.dr. strickus.

just a quick announcement.i don't think it's been mounsed. the emery vaccine dinner club ismeeting specially oent and they are having dr. stanley plotkinspeak tonight. latch on your favoriteperpendicular and we will take you over there.thank you. thank you very much.okay. if we can move then to dr.reingold for introductory comments on the hepatitis a andb vaccine. do you want a break?>> oh, thank you.

before i get to hepatitis a, iwanted to update people, one quick thing about the discussionthis morning about pertussis vaccine, we have had a callinforming us that mft the vaccine is covered by medical incalifornia and has been for some time.he acknowledged that many providers have a hard timegetting reimbursement. but it is in fact covered.so that is just a brief update from what you heard thismorning. so, i have the pleasure ofsharing the hepatitis-a working

group.we have a robust working group with people from a variety ofareas and again, dr. nelson from cdc here is doing the lion'sshare of the work on behalf of the working group and i wouldlike to thank her for that that. ands, just to acknowledge that naddition to dr. nelson, a variety of people in thedivision of viral hepatitis have been involved in developing theworking group. just to go back.so this is simply to remind you that the working group has beentasked with updating the

recommendation s hepatitisvaccines, a and b, and we decided to go in order, so weare working on a first. there's been statements abouthepatitis a previously. i will show you the terms ofreference in a minute. since the june meeting, we havehad a number of telephone conference calls, focused oncoverage and burden of disease and the presentations today willlargely focus on hepatitis a and burden of disease and thepopulation that may still require protection.so, basically, as it says here,

in the short-term, we arediscussing updating the hepatitis-a vaccination stastatement. talking about types of coveragethat will be covered. and catch up vaccines for olderchildren could be worth considering.in the long-term, discussing the question of post exposer,profolaxis in adults over the age of 40.when you efrom nelson's presentation, you will see thatwhile the burden of disease from hepatitis-a is lower than itused to be.

there's gaps in immunity, andcertainly with the importation of food that poses a risk, wehave not quite finished the job. anyway, dr. nelson?>> thank you, dr. reingold. i'm going to give an update onhepatitis-a burden and population protection.the outline of the talk is hepatitis-a vaccine history inthe united states, epiemiology, vaccine coverage, and the viralprevalence. and help tpatitis-a outbreak anfood exposer risk and summary. hepatitis-a vaccine wasintroduced incremental in the

united states.in 1996, vaccine was recommended for children at age two years incommunities with high rates disease.in 1999, vaccine was recommended in 11 states, showing in darkpurple. and in six states, with ratesabove the national average hone in light white.number 11 states the rate 2 times the national average.a burden equal to 20 cases. where in the six states thepopulation was 100 cases per 100,000.in 2000 and and six, universal

childhood vaccination wasintroduced. it was recommended for age ages12 to 23 months in all states and it was recommended thatvaccination programs for ages 2 to 18 years be continued.catch up vaccination should be considered in outbreaks and inareas with increasing disease rates and vaccines wererecommended for any person wishing to the obtain immunity,no routine recommendation was made for children greater thanage 23 months. in addition, vaccine isrecommended for groups at

increased rifb of hepatitis-aviral infection or severe disease.such is as travelers, men who have sex with men, users ofinjection or noninjection drugs. persons that work with nonhumanprimates. persons who anticipate closepersonal contact with an international adoptee, andpersons with chronic liver disease.it's recommended for post now, i'm going talk abouthepatitis-a, data collection for hepatitis-a started in 1966.the first case was reported in

1971, where 60,000 cases.in 1996, as mentioned, vaccine was recommended, there was about31,000 cases at that time, decreasing to 2011 to about1,398 cases. the rate also decreased duringthis time from 11.7 cases per 100,000 population to .4 casesper 100,000 population. this represents from 1996 to2011, a 95.5% decrease in reported cases.had sli this slide shows the number ofcases reported, from 2008 to 2013.as shown in the previous slide,

in 2011, the number of ofreported cases in the united states reached an all time lowof 1,39 'cases. in 2012, the number of reportedcases in the united states increased to 1,562 cases.>>> representing the first increase in cases since 1995.in 2013, the number of errored cases in the u.s. increasedagain to 1,781 cases. though these increases are notlarge at this point, and most of the increase in 2013 isattributable to the multi-state outbreak that i will describelater, the increases from 2011

to 2013 the represent a reverseovertrend of on over two decades.we have initiated the reason for the case increase.and explored the geographic nature of the cases.which i will show on the next slide.this slide shows the rate of hepatitis-a cases by u.s. regionin 2011 to 2013. increases in the rate of casesfrom 2011 to 2012, reported in four regions.increases in the rate of cases from 2012 to 2013 was reportedin six regions.

with a decrease in one region.the multi-state outbreak in 2013 was reported primarily in themountain and pacific region along eight constituents.however, increases from 2012 to 2013 were observed in otherregions as well. when looking at the data at thestate level, it occurred in states not involved in theoutbreak, suggesting multiple causes in the reason for numberof cases and rate. this slide shows the agedistribution of the reported cases from 2007 to 2012.the decline for all groups in

2012, only 2007 to 2012 areshown here much rates were similar and low, among personsin all age groups in 2012. in less than one case per100,000 population. in 2012, the rates were highestfor persons ages 20 to 29 years. that's the top line shown inin .the lowest rates were among children, age less than nineyears at .15 cases per 100,000 population, as shown in thebottom blue dash line. starting in 2007, children lessthan nine years of age had the lowest rate of infection in anyage group.

the healthy people, 2020 targetis .3 cases. only the 0 to 9 years hasdeclined to that rate. of note, the rates increasedfrom 2011 to 2012 for ages 20 to 29 years, and ages 40 and above.looking at the data separately, by decade of life for children.0 to 9 years and 10 to 19 years and all adults, age greater than20 years, from 2008 to 2012. it is clear that the largestpercentage of hepatitis-a cases are occurring in adults.>> taking a further look at burden of disease.a recent paper analyzed

hospitalization trends fromwould thousand and would to 2011, using primary dischargediagnosis data. icd-9 codes from the nationalinpatient sample. though a decrease inhepatitis-amp hospitalization rates increased overall.to .29 hospitalizations per 100 in 2010 and 2011.the mean age for persons hospitalized for hepatitis-a hasincreased significantly. the mean of 36.7 years of age.compared to 45.5 years in 2010, and 2011.this table hoes information from

case surveillance, nationalnotifiable disease system data regarding hospitalizations andreported hepatitis-a cases. the first column showshepatitis-a cases reported. same numbers as shown onprevious slides. the second and third columns arethe number and percentage of cases with available data onhospitalization. as can be seen, many cases arereported without hospitalization information.35 to 45% of cases do not have data on hospitalization 2009 to2012.

therefore cases hospitalized islikely under estimated. in the last two columns, caseshospitalizationed. the number and percentage ofcases hospitalizationed is shown.39.3% of hepatitis-a case s hoppized in 2009.since is 2000 and mine, ations increasing.so hepatitis-a hospitalization in-patient sample d overall byprimary diagnosis code data. the surveillance did vaisr-- shows the numbers increased from 49% in 2009 to 46% in 2012.looking further back, this data,

this trend of increasing n ratecases that have been observed since 2005.in 2005 the rates were looking at hepatitis-a deaths,from 1990 to 2012. we can see the deaths havedeclined since vaccine introduction for all age groups.the number of deaths now approaches zero for age groupsless than 50 years. the total number of deaths in2012 was 23. with 21 deaths in the 50 plusgroup and two deaths in the 20 to 49 year age group.these numbers increase slightly

when multiple causes of deathare considered. so who is getting infected withhe hepatitis-a, patients were askedthat the exposer prior to on set of symptoms.data was collected, via passive surveillance, which wasvolunteer voluntary reporting.of the case reports. they received by cdc during went12, a total of 568 or 36% of cases did not include a responseto any questions about risk behaviors and exposer.making assessment of risk ame

aassessment and exposer.of those that had a response, 80% indicated no risk exposersfor hepatitis-a and 20% had one of the risks for acutehepatitis-a, two weeks previous to on set of illness.among the factors, travel was the most identified and directcontact was second. of the case reports that hadinformation on travel, 13% involved persons who hadtraveled outside the united states and canada.food bou food born or water born exposerwas increasing.

because risk factor informationis often missing, in other words, no response to a riskfactor is given when cases are questioned.select health departments are conducting enhanced populationbased surveillance. an analysis of these data doneby clevins and aul, data from 2005 through 2007, they lookedat six emerging infection programs or eip sites, coveringan estimated 30 million population.this graph shows the risk factors reported by cases in theeip sites during the time

period.there are less missing data and funded sites compared to thedata. however the distribution of riskfactors was comparable. travel was still the mofrequentreported. including persons with directinternational travel and those that had contact with someonewho traveled. this is higher than the 13% thatwas reported. in much higher and observing the80 to 90s, about 4%. the characteristics of thesample of cases confirm they

were travel related the strengthrelated to he ed to hepatitis-a. it's believed that the data issimilar today. of note, over 35% of cases areshowing in the last column and are reported an unknown riskfactor. food born risk exposure may --however, based on did it a collected no significantassociation between risk factor and the increase inhepatitis-amp cases from 2011 to 2013 can be made at this time.>> hepatitis-a vaccine coverage. the wider use of vaccine islarge lly responsible for the r

market decrease morbidity, in2012, the vaccine coverage for children 19 to 35 months of agewas 85.1% and 53% for greater to equal to 1 and great than orequal to two doses substantially.this is less than the target of 80% for two dose coverage levelin this age group. in 2012, coverage amonged edadolescents, is estimated to be 48% for greater than equal to 1and two respectively based on preliminary did it a.only greater than equal to three dose has hpv coverage.of the vaccines routinely

recommended there's norecommendation for children greater than 23 months.while hpv, and -- are routinely recommended for adolescents.>> greater and equal to two dose coverage for adults is 12.5%overall. the vaccine coverage for personschronic liver disease is 17% and vaccine coverage is 20% fortravelers outside the u.s. to countries other than japan,australia, or other country cief europe.the age groups with the highest death rate have the lowestvaccination coverage.

as far as national healthinterview survey, they collect health and health care and havebeen noninstitutionalized representative sample. anti-body to hepatitis-aprevalence. the change in prevalence by agegroup is shown, from 1989 to 2000 in light blue and 2009 to2010 in dark blue. significant increases asindicated by the note occurred in the proportion of childrenwith protection of ages 6 to 11 years and 12 to 19 years.this is most likely due to

vaccination.the minimal change occurred in prevalence among adults, 20 to29. and 30 to 39 areas.however, significant decreases occurred in the proportion ofadults with protection for ages 40 to 60 years.the prevalence was the same between the two surveys, kitingthat only 1/3 of the u.s. population had protectionagainst hepatitis-a protection. the prevalence inanti-body was among adults. --[ inaudible ]

exposer and adultsusceptibility, there were 165 cases in ten states, eight ofthem were in western its. most are 93% of cases in theoutbreak were ages greater or equal to 18 years.40% of cases were hospitalized and two cases developedhepatitis and one required a liver transplant.addition, multiple recent outbreaks in europe have beenreported. and of note, the percentreported hospitalized in the out d break, 44% is consistent withthe percent of hepatitis-a cases

in 2011i hospitalized.this side shows a trend in u.s. imports of fruits andvegetables. based on surveillance data.travel is the most reported risk factor for hepatitis-had a,there's a growing risk from contaminating food.the volume of imported fruits and vegetables has increased.last year, the u.s. imported over 12 million tons of fruitand almost 9 million tons of vegetables.these fruits and vegetables are originating from countries wherehepatitis-a is if you look at

the next sloiide, you see theprevalence of the hepatitis-a virus in the you know can.the green is high in country. and as you can see, mexico andsouth america both considerconsidered intermediate countries.in summary, in increasing portions of adults in the unitedstates are exposed to hepatitis-a, significantdecreases in the anti-body in oldered a uses and the adultsgreater and equal to 40 years. low dose vaccination coverageamong adults, including high

risk adults, travelers and thosewith chronic liver disease for example.and as mentioned, morbidity and mortality increases with age.and there's suboptmimal coverage.hepatitis -- increases in the viral cases is noted.occurred in 2012, and 2013. these are the first increasessince 1995 and 1996. addition, hepatitis-a viralinfection rates have increased for ages 20 to 29 years and agesgreat than 40 years. the -- hospitalization rates arereported hepatitis-a cases have

increased a ed from 2005 to 201.hepatitis-a virus is andemic for a risk of travelers in riskcountries. and as mentioned, there's noroutine or catch up hepatitis-a vaccine recommended.hepatitis-a, the work group is currently focusing on updatingthe statement, which was left in two sdmou six.the work group is discussing strategies to address theincreasing number and rate acute hepatitis-a cases and continuingprogress toward the healthy people of .3 cases.the work group is discussing

catch up vaccinations age 2 to18 year years. -- the reason would be forfuture protection of the adult population, and to maximizeimmunity from childhood vaccination.and the work group is discussing other strangs for catch up.such as vaccination for other ages.additional information and needed before the work groupconsensus can be reached. additional information thatwould be helpful in support of expanding the age range,includes monitoring the cost.

planning is under way for suchis a study. hepatitis-a one and two dose,long-term protection, a he review is in progress.and evident from the multi-state outbreak, the response two weeksafter first dose to consider vaccine among adults age greaterthan 40 years is important. planning surround way for such astudy as well. i would like to thank thedivision of acip work fwrup for theircontributions. thank you, dr. nelson.open for any questions here.

dr. karen?>> so, i have a couple of seconddose. and the first question i haveis, back to the slide 21. when you talk about incompletecoverage, particularly saying travelers, i suspect given theinterval twan first and second doses this that there'stravelers that go to travel clinic, get a dose and thennever return. so i was wondering, my firstquestion is, do you -- so for that data, do you haveinformation coverage on one

dose, as opposed to two dosesinful tin travelers?>> i do not have the one dose based on this survey.>> okay. and then, my second question hasto do with what we understand about the protective efficacyfor one dose versus two doses. the teaching that i had alwayslearned was that we give two doses to sustain butoften you receive protective levels after the first dose.i want to check if that understanding is correct?>> yes, and it's protective

immunity after one dose, studieshave delayed booster dose and over two years of age, haveshown that you know, up to 31 month delayed booster, you havecomparable results. in terms of one dose efficacy,there's a five years of follow-up data right now onchildren. that's all we have right now.and i know for two doses that modelling long-term protectionwe believe it's at least 25 years or more.>> dr. reingold, yeah, i think noel has it right.when i was sage, we based on the

argentina data gave thecountries permission to go with a one-dose scheduleall they could afford. i think the data is convincingthat one dose is effective, but the duration of the date issomewhat uncertain. dr. kemp?>> i have a question about the use of "catch-up" here, on thehe schedule, it's recommended for catch up now, after two allthe way up through adolescents, right?>> it's to be considered. catch up can be considered.>> i don't know, in all the

catch up things, it gives you ifminimum age of 12 months and then it says, dose 1 to 2.i guess, i agree that education and focused encouragement ofthat needs to happen. but is that actually not part ofthe schedule right now? the schedule is for 12, 12months to 23 months. and then, the recommendation asstated now, catch up can be considered.>> dr. bennett. just a quick question inconsidering strategies. you gave, you he showed us dataabout the potential source of

infection or risk factors.i wonder if we have any ability to look at the data by age?>> that was it. right there.>> this one. do we have data by age orthis is all ages, correct? yeah, this is all ages.i am not sure about that. i'm not sure if you can breakit down by age to identify the most, the potentially greateststrategies for decreasing the rates of disease.>> dr. sheffner. thank you, dr. nelson, first,for a nice presentation and to

follow-up on that point, i'mticked interested in the unknowns.i wonder what the age and sex distribution of that group is?>> i don't have that. but thank you, it's an importantpoint. and you know, the unknowns inthis survey and the other are quite high.so, we are looking in to -- i'm looking back at the analysis nowcurrently to try to get at what -- try to further definewhat the group is. but i don't have the indicate --i don't have the data right now

to present.>> thank you. my questions deal with thereporting issues. this is a reportable disease, doyou have any idea how under reported it is?>> well, in children you know, no children are very symptomaticup to 5 years. we have right now, division ofhepatitis-report, we are two times -- not two times -->> maybe i can hone that question down to be one that isanswerable. is there a difference betweenyour spontaneous reporting and

your augmented reporting on theeid centers? there's a difference in therates of the hepatitis reporting went the two kbrups?-- the two groups? not that i'm aware of.>> the reason i ask that, if we had a 95% reduction and while itdoes look like it's end frtrend slightly, it may be that webutched against bottom. as people become rarer, peopleare less likely to report it, because it's unusual.i'm not saying that is what is happening, but it's a concern ihave.

and this is from a unscientificof three, adult children from the ages of 20 to 29 who happento share my last name, all three have traveled to high riskcountries, whereas i think, and that may be a more common eventin the generation between 1995 and heand 2012 than it was beforehand. that could be that they areexposing to more risk factors than there being a vaccinationrelated episode. thank you.>> all right, similar type question.i'm curious, as to what we know

in terms of the patients withmore severe disease and hospitalization and how many ofthem are have chronic liver disease as a risk factor.i -- last figures i saw, we do a horrible job of immunoizingpatients with hepatitis-c and the alcoholics with hepatitis-c,i wonder how much that contributes to the severe cases?>> i'm not sure how much the -- how many of the seer cases arein chronic liver disease. we have looked at transplants.and they are not seeing a trend over time.i'm trying to get to slide here.

here it is.so, this is looking at liver failure and liver transplant inhepatitis-a cases from 2002, 2011.and really, we -- the numbers sort of go up and down overtime. that's like one of the best wayi can answer that question right now.>> thank you. ms. pellegrini.>> we were talking about the fact that another barrier forthe group, motie i noting that s the single most identifiablecause, is that travel related

vaccines may not be covered byhealth insurance. even if you think you need avaccine before traveling, most people don't, you will have is aheavy cost out-of-pocket. dr. pickering?>> the follow-up on what dr. kemp said a minute ago.at age 2 on, the range of recommended ages during whichcatch up is encouraged and for a certain high risk group.so it's not recommended routinely for 2 and over.so that way of handling things does not seem to be working.because kids are not getting

immunized and the adults thatdevelop the condition after being adults, drug drug use andso o what percentage of them are immunized?a low percentage of them a protected.>> other comment? okay, thank you, dr. federal onand dr. reingold. and dr. smith, dr. coming backtomorrow morning? yeah.>> okay. tomorrow morning.so, he was your last hope of extending schedule out foranother 45 minutes or so.

and seeing that -->> [ inaudible ] we have not had registeredpublic comment. i'm looking to the back table ifthere's and i see none.so, i think -- i'm -- oh, dr. orensteen?>> i wanted to say that it was mentioned the vaccine club, ithas wine and cheese at six and the talk is at 6:30 and it's inthe school of medicine building. if you walk down clifton road,it's the second building on the right after you cross therailroad tracks.

thank you very much, and iwould be remiss in two other announcements. first, i was informed that it'salways macy's 50th anniversary, so congratulations to ourcousins to the north. and if you didn't notice ongoogle yesterday, yesterday was the 100th birthday of -- googlehad a nice graphic in memory of that.so, with that, i think we stand adjourned for the afternoon andwe will be picking it up right at 8:00 tomorrow morning.thank you.