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>> good morning. welcome to the october2016 acip meeting. we are very happy to have youall here and we welcome you. we have a really packedmeeting for the next two days, so i hope you will allbe able to stay with us. but since it is so packed,i'm going to turn it over to dr. cohn right away. >> great. thank you. good morning.

the proceedings of this meetingare accessible to people not in attendance viathe world wide web. welcome to those who cannotattend the acip meeting in person. several people will bewith us for the duration of this acip meeting toassist with meeting functions. natalie greene is sittingin the table at the back. and jean clare smith issitting at this front table. we have a full agendatoday until we adjourn

at approximately 5:45 pmtoday and 3:30 tomorrow. and handouts of slides to bepresented have been distributed to the acip members andare available for members of the public on the tableoutside this auditorium. so slides presented atthis meeting will be posted on the acip websiteapproximately three to four weeks after the meeting. after the figures on the slidesare sufficiently described in words to enable them tobe accessible to all viewers.

that is they are made accessibleto the visually disabled. the live webcastvideos will be posted in approximately four weeks. and meeting minutes are postedto the acip website generally within 90 days of the meeting. the minutes from the 2016meeting will be available soon on the acip website. members of the mediawho are interested in conducting interviews

with acip members should contactian branam for assistance in arranging interviews. and he is sitting on thisback wall to my left. the next acip meeting will beconvened at cdc on wednesday and thursday, february22nd and 23rd. registration for allmeeting attendees is required and will be open thisfriday on the acip website. the registration deadline for non-us citizensis february 1st, 2017.

and for us citizens, registration closesfebruary 13th. registration is not requiredfor the webcast viewing. as a reminder for non-uscitizens attending acip meeting, completion of several formsis required for each meeting at the time of registration. it's important theseforms are submitted with in the required timeframe. stephanie thomas, the acipcommittee management specialist,

will be able to help with anyquestions about the process. and i'm going to turn it backover to dr. bennett who's going to introduce ourfour new acip members who will be servinga four-year term from july 2016 throughjune 2020. >> thank you, dr. cohn. it's a great pleasure to introduce our newmembers and to welcome them. we had a pre-meetingyesterday and got

to know them a little bit. i'd like to tell you a littlebit about each one of them. robert atmar, professor atthe department of medicine at baylor college ofmedicine in houston texas. dr. atmar is board-certifiedin internal medicine and infectious diseases. has served joint appointmentssince 2006 as professor of medicine and professorof molecular virology and microbiology at thebaylor college of medicine.

he has served since2007 as chief of the infectious diseasesservice at ben taub hospital. in addition to his strong recordof basic and clinical research, dr. atmar has contributedgenerously to the administrative, clinical and educational missionsof the college. paul hunter, associateprofessor, department of familymedicine and community health, school of medicineand public health

at the university ofwisconsin madison. and also associate medicaldirector of the city of milwaukee health departmentin milwaukee, wisconsin. big jobs. dr. hunteris board-certified in family medicine andhas served since 2009 as associate medical directorof the health department of milwaukee, wisconsin'slargest and most ethnically diverse city with public health problemsrelated to disparities

within the city's population. he's also associateprofessor in the department of family medicineand community health. dr. hunter has completedmany projects related to population health,health disparities and immunization initiatives. dr. grace lee, associateprofessor of population medicine and pediatrics, departmentof population medicine at harvard medicalschool in boston.

dr. lee is boardcertified in pediatrics and pediatric infectiousdiseases, and is the director of the center for healthcareresearch in pediatrics at harvard medical school, whereshe has been conducting analyses for more than a decade onclinical and policy issues in immunization andinfectious disease. she served on an institute ofmedicine committee on priorities in the national vaccine plan. and the iom board on populationhealth and public practice.

dr. lee has alsoparticipated extensively in activities relatedto immunization safety, including the vaccinesafety data link project. and dr. szilagyi. peter szilagyi is professor andvice chair for clinical research in the department of pediatricsat the david geffen school of medicine, university ofcalifornia at los angeles. dr. szilagyi is board-certifiedin pediatrics and was on the faculty of thedepartment of pediatrics

at my hometown for many years. he brings extensive experience as both an immunizationdelivery researcher and a primary care clinician. dr. szilagyi has carried outa large body of work over more than 25 years dedicated to immunization practicesand policy. he is also an expert on children's healthinsurance plans.

so please join me inwelcoming our four new members. [ applause ] >> so i would also liketo make an announcement. we would like tointroduce dr. allen craig who recently joined ncirdas the deputy director. dr. craig was most recently part of cdc's global immunizationdivision where he serves as the africa team lead in the polio eradicationbranch since 2013.

after completing hismedical residency, dr. craig joined the indianhealth service where he served as the acting chief medicalofficer from 1993 to 1995. in 1995 he joined thetennessee department of health and later became a stateepidemiologist before returning to cdc in 2007. and dr. craig actually was anacip member for a short period of time before he joined cdc. so he will now be onboth sides of the table.

welcome. this is dr. craig. we also have several guestsattending and we would like to welcome ourvisitors from china who are sitting inthe first row. and if you all could pleasestand when i announce your name. dr. lu ming is theepi division director in the ministry of health. dr. feng zijian thedeputy director of china cdc. dr. an zhijie is the vaccineevaluation division director

of china cdc. dr. xu keming isthe external affairs and communication divisiondirector of the national health and family planning commission of the people's republicof china. and dr. xia wei is thenational professional office of who china office. we also have with us dr. lancerodewald who was previously with us at ncird and is nowthe cdc medical officer working

at who in china. and we welcome all of you. i was just told by lance that the chinese birth cohorti think he said was 14 million. so they vaccinate many, many more childrenthan we do each year. thank you. so we have some membersubstitutions for this meeting. for the ex officio members,

dr. kathleen pittman isrepresenting the us department of veterans affairs. and dr. gus birkhead isrepresenting the national vaccine program office. we have some liaisonrepresentative substitutions. dr. corey robertson isrepresenting pharmaceutical research and manufacturersof america. dr. bonnie maldonado isrepresenting the american academy of pediatricscommittee on infections disease.

dr. greg frank isrepresenting biotechnology innovation organization. and dr. susan lett isrepresenting the association of immunization managers. topics presented at today's acipmeeting include open discussion with time reservedfor public comment. public comment period isscheduled immediately preceding each acip vote and at theend of the meeting day. registration for publiccomments is solicited

in advance of the meeting. people who plan to makepublic comments should plan to visit the registration tablein the rear of the auditorium and complete the public commentform and leave it on the table. we will collect these and logyou in for public comment. we'll record you name and provide informationon the process. people who make public commentsshould provide three pieces of information before yourpublic comment begins.

you name, organizationif applicable and any conflicts of interest. registration for public commentwas also solicited in advance of this meeting throughthe federal registry. given time constraints,each comment will be limited to three minutes in total. comments not presented atthis meeting may be submitted in writing for inclusionin the meeting minutes. at every meeting weupdate you on the status

of acip recommendations. there has been oneacip publication since the june 2016 meeting,and this was the prevention and control of seasonalinfluenza recommendation and report. recommendations and immunizationschedules can be downloaded from the acip website. acip has a policy that every3-5 years each recommendation is reviewed and then renewed,revised or retired.

the spot on this screenshows the acip website where detailed instructionsfor submission of names for potential candidatesto serve as acip members may be found. applications for acipmembership are due no later than august 1st 2017 forthe four-year term beginning july 2018. to summarize conflict ofinterest provisions applicable to the acip, as notedin the acip policies

and procedures manual,members of the acip agree to forgo participation incertain activities related to vaccines during theirtenure on the committee. for certain other interests that potentially enhance amember's expertise while serving on the committee, cdc hasissued limited conflict of interest waivers. members who conduct vaccineclinical trials or serve on data safety monitoringboards may present the committee

on matters relatedto these vaccines, but these members are prohibited from participatingin committee votes. i would like to remind everyone to please turn off their cellphones and we will hand it back over to dr. bennettwho will do roll call. now i'd like to askthe committee to please state your conflictsof interest and i'm going to go around the table.

dr. atmar? >> i would say the researchreport from takeda vaccines. >> thank you. dr. stevens? >> no conflicts. >> dr. kempe? >> dr. szilagyi? >> dr. walter? >> dr. belongia?

>> i have a conflict for rsv due to research supportfrom nova vax. dr. riley. >> dr. riley, no conflict. >> dr. lee? >> ms. pellegrini? >> dr. hunter? >> paul hunter, no conflicts. >> dr. moore.

>> dr. ezeanolue and dr. romero? >> i have a conflict ofinterest for [inaudible] based on non-vaccine-relatedresearch funding. >> and dr. bennett, no conflicts. now i'd like to askthe ex officio members to introduce themselves. let's talk startwith dr. birkhead. >> i'm dr. gus birkhead,national vaccine program office, representing bruce gellin today.

>> i'm narayan nair, the division director for the division of injury compensationprograms at ursa. >> hi, wellington sun,director of division of vaccine-related productapplications at fda. >> hi, i'm kathleen pittman. i'm representing dr. jane kim from the departmentof veterans affairs. >> amy groom, indianhealth services immunization program manager.

>> i'm kimberly thompsonrepresenting the national vaccine advisory committee. >> david weber representingshea. [ inaudible ] >> okay. amy middlemanrepresenting the society for adolescent healthand medicine. >> pat whitley williams,national medical association. >> corey robertson,pharmaceutical research and manufacturers of america.

>> ian gemmil, chair of canada'snational advisory committee on immunization. >> matt zahn, nationalassociation of county and city health officials. >>kathleen neuzil,the infectiousdiseases society of america. >> bill schaffner, nationalfoundation for infectious disease. >> christine hahn,council of state and territorial epidemiologists.

>> stan grogg, americanosteopathic association. >> stephan foster, americanpharmacists association. >> susan lett, association ofimmunization program managers. >> jack reynolds, americannurses association. >> kent schmader,american geriatric society. >> sandra fryhofer,american college of physicians and the americanmedical association. >> kevin ault, american college of obstetriciansand gynecologists.

>> carol hayes, the americancollege of nurse midwives. >> susan even, americancollege health association. >> good morning, my name ismarie-michã¨le lã¨ger american academyof physician assistants. >> david kimberlin, americanacademy of pediatrics, red book. >> bonnie maldonado, americanacademy of pediatrics, coid. >> margot savoy, americanacademy of family physicians. >> thank you all,and welcome again. and i think we'll get startedwith dr. romero and hepatitis.

>> so the hepatitis workgroup of the acip met and used as terms of reference forthis presentation five current recommendations, three of whichare from the acip and three of which are from thecdc spanning 2005-2015. the objectives were to vote onremoving the permissive language for hepatitis b vaccinebirth dose to be administered after hospital discharge. and also to vote for approval of revised hepatitisb vaccine statement.

the considerations werecarried out by the work group from february toseptember of 2016. we met five times, deliberatedand made recommendations on these topics viateleconferences. the work group and acipmembers reviewed and commented on the draft statement prior tothe october '16 acip meeting. the key updates to the hepatitisb vaccine recommendations are shown on this slide. the first is the removalof permissive language

for delaying the birth doseof hepatitis b vaccine. second is to provide examples of chronic liver diseaseincluding recommending hepatitis b vaccine for individualswith hepatitis c infection. we also want recommendations or desire the committeemake recommendations for post-vaccinationserologic testing of infants whose mother'shepatitis b surface antigen status remains unknownindefinitely.

and lastly, testing of hepatitisb surface antigen positive pregnant women forhepatitis b viral dna. the members of the workgroup are shown here and we really thank our leadnoele nelson and sarah schillie for the time and effort they'veput into this presentation and the work that they'vedone on the committee. thank you very much. today i will be discussingrevisions to the acip hepatitis bvaccine recommendations.

this morning's presentationwill include an overview of existing hepatitis b vaccinerecommendations, a brief review of hepatitis b virus background,epidemiology and prevention, a review of existing hepatitisb recommendations and revisions to the acip hepatitis brecommendations deliberated upon by the work group. i will now provide the overview. the hepatitis work group hasdrafted a revised statement for hepatitis b vaccinerecommendations.

the revised statement is asingle document containing guidance for hepatitis bvaccination of infants, children, adolescentsand adults, testing of pregnant women for hepatitis b surfaceantigen or hbsag. and if positive, hbv dna. hepatitis b pre-vaccination and post-vaccinationserologic testing and hepatitis b viruspost exposure prophylaxis

for occupational andnon-occupational exposures. the revised statementincorporates previously published reocmmendations fromacip and cdc and is augmented by the american associationfor the study of liver disease'srecommendation for antiviral therapy toreduce perinatal transmission of hepatitis b and hepatitisb surface antigen positive pregnant women withhbv dna greater than 200,000 internationalunits per milliliter.

the single revised statementwill update the two existing acip hepatitis b vaccinestatements for infants, children and adolescents publishedin 2005 and for adults publishedin 2006. the revised statement willalso incorporate previous acip guidance for hepatitisb vaccination of adults with diabetes, publishedin 2011. cdc guidance for ensuringhepatitis b protection among healthcare personnelpublished in 2013.

and cdc guidance forshortening the interval for post vaccination serologictesting for infants born to hepatitis b surfaceantigen positive mothers, published in 2015. i will now reviewhepatitis b virus background, epidemiology and prevention. hepatitis b virus istransmitted via percutaneous or mucosal exposure toinfections blood or body fluids. the virus is highlyinfectious and remains viable

on environmental surfacesfor at least seven days. hepatitis b can be transmittedin the absence of visible blood. approximately 3,000 cases ofacute hepatitis b were reported to cdc in 2014, accounting foran estimated 19,200 new cases when considering under ascertainmentand under reporting. it is also estimated that 952perinatal hepatitis b infections occur annually. according to an analysisfrom the national health

and nutrition examinationsurvey, approximately 850,000 persons in the united states havechronic hepatitis b. other studies have yieldedhigher estimates. persons with chronicinfections serve as the main reservoirfor transmission. imported hepatitis baccounts for approximately 95% of new cases in theunited states. the rate of reported acute hbvinfection has declined by 90.6%

since recommendations for hepatitis b vaccinewere first issue in 1982. the rate has been fairlystable from 2010 through 2014, although increasesoccurred in some populations such as white persons age 30-39years reporting injection drug use in kentucky,tennessee and west virginia. this slide depicts the declineof acute hepatitis b since 2000. note that the rate is lowestfor persons aged 19 years and younger, likely a resultof routine vaccination.

chronic hbv infectiondevelops in approximately 90% of infected infants, 30% ofinfected children age less than five years, and in fewerthan 5% of persons infected at age five years or older. the risk of prematuredeath from cirrhosis or liver cancer isapproximately 25% for persons infectedduring childhood and 15% for persons infectedafter childhood. perinatal transmission occursprimarily from mucosal exposure

to infected blood and otherbody fluids during delivery. without post exposureprophylaxis, perinatal hbv infectiondevelops in approximately 90% of infants born to mothers who are hepatitis bsurface antigen positive and hepatitis b eantigen positive. and in 5-20% of infantsborn to mothers and hepatitis b eantigen negative. the world health organizationrecommends all infants receive

their first dose of hepatitisb vaccine as soon as possible after birth, preferablywithin 24 hours. countries in which thehepatitis b birth dose has been implemented in the nationalimmunization program are depicted here in green,reflecting 49% of countries. post-exposure prophylaxisshortly after birth is efficacious in preventing perinatalhbv transmission. hepatitis b vaccinealone is 75% effective,

and hepatitis b immuneglobulin alone is 71% effective. the combined efficacy is 94%. serologic evidence of vaccine-induced protectionis assessed by the level of antibody to hepatitis bsurface antigen measured 1-2 months after thehepatitis b vaccine series. antibody to hepatitis b surfaceantigen greater than or equal to 10 milli international unitsper milliliter corresponds to vaccine induced protection.

protection exists for 30 years or more among immunocompetentvaccine responders. the three-dose hepatitisb vaccine series results in protective antibody tohepatitis b surface antigen in 98% of health infants and90-95% of health children and adults age youngerthan 40 years. lower seroprotection isassociated with prematurity, advanced age, diabetes, obesity,chronic illness and smoking. antibody to hepatitisb surface antigen

after vaccinationwanes over time. however, even whenlevels wane to less than 10 milli internationalunits per milliliter, breakthrough hepatitis b virusinfections are uncommon among immunocompetent vaccineresponders. i will now review existinghepatitis b recommendations. the national strategyto eliminate hepatitis b in the united states encompassesscreening all pregnant women for hepatitis b surface antigen

and providing prophylaxisconsisting of hepatitis b vaccine andhepatitis b immune globulin within 12 hours of birthfor all infants born to hepatitis b surfaceantigen positive women. universal vaccination of allinfants beginning at birth, that is before hospitaldischarge as a safety net. routine vaccination ofpreviously unvaccinated children and adolescents ageyounger than 19 years. and vaccination of adults atrisk for hepatitis b infection,

including those requestingprotection without acknowledgementof a specific risk factor. to identify hepatitis binfected pregnant women, all women shouldbe tested routinely for hepatitis b surfaceantigen during pregnancy, during an early prenatal visit. testing should occurduring every pregnancy, even if the woman has beenpreviously vaccinated or tested. for infants born to hepatitisb surface antigen positive

mothers, acip recommendshepatitis b vaccine and hepatitis b immune globulinwithin 12 hours of birth. for those infants with birthweights less than 2,000 grams, the birth does is not countedas part of the vaccine series. infants born to mothers with unknown hepatitis b surfaceantigen status weighing greater than or equal to 2,000 gramsshould receive the hepatitis b vaccine within 12hours of birth. and infants weighing less

than 2,000 grams shouldreceive both hepatitis b vaccine for those infantswith birthweights less than 2,000 grams, the birthdose is not counted as part of the vaccine series. infants weighing greaterthan or equal to 2,000 grams who are born to hepatitis bsurface antigen negative mothers should receive hepatitisb vaccine before hospital discharge. for infants weighing lessthan 2,000 grams born

to hepatitis b surface antigennegative mothers, the first dose of hepatitis b vaccine should bedelayed until one month of age or hospital discharge. the existing recommendationscontain permissive language to delay the birth dose. the language states that ona case by case basis and only in rare circumstances, thefirst does may be delayed until after hospital dischargefor an infant who weighs greater than or equal to 2,000 grams

and whose mother is hepatitisb surface antigen negative. a physician's order to withholdthe birth dose should be present along with a copy of the original maternalhepatitis b surface antigen laboratory report. the birth dose should beadministered by two months of age and should not bedelayed in high risk situations, such as high riskmaternal behavior or expected poorcompliance with follow up.

the hepatitis b vaccine seriesis completed at age six months for infants born to hepatitisb surface antigen positive or unknown mothers. and at age 6-18 monthfor infants born to hepatitis b surfaceantigen negative mothers. post-vaccination serologictesting consisting of testing for antibody to hepatitisb surface antigen and hepatitis b surfaceantigen is recommended at age 9-12 months or 1-2months after the final dose

of the vaccine series ifdelayed for infants born to hepatitis b surfaceantigen positive mothers. three dose revaccinationfollowed by repeat post-vaccinationserologic testing is recommended for infants with antibody tohepatitis b surface antigen less than 10 milli internationalunits per milliliter. hepatitis b vaccination isrecommended for all children those not previously vaccinatedshould be vaccinated routinely at any age using anappropriate dose and schedule.

adults recommended for hepatitisb vaccination are those at high risk forinfection by sexual exposure such as sex partners ofinfected partners and men who have sex with men. those at risk for infectionthrough percutaneous or mucosal exposure to blood,such as injection drug users, healthcare and publicsafety workers, persons with end stage renaldisease and those with diabetes. international travelersto regions

with higher intermediatehbv indomicity, defined as a hepatitis b surfaceantigen positive prevalence greater than or equal to8% and 2% respectively. persons with chronicliver disease and persons with hiv infection, and allpersons seeking protection from hepatitis b infection,even without acknowledgement of a specific risk factor. all adults in certainsettings are also recommended for hepatitis b vaccination.

settings include sexuallytransmitted disease treatment facilities, hiv testingand treatment facilities, facilities providingdrug abuse treatment and prevention servicesand other settings as depicted on this slide. vaccination of personswho are immune to hepatitis b infectiondue to either past infection or vaccination does not increasethe risk for adverse events. however, pre-vaccinationserologic testing might reduce

cost by avoiding vaccinations ofpersons who are already immune. pre-vaccination serologictesting is recommended for household needlesharing and sex contacts of hepatitis b surface antigenpositive persons, persons born in regions of highhbv indomicity and hiv positive persons. existing recommendationsalso state that pre-vaccination serologictesting might be cost effective for injection drug users,incarcerated persons,

men who have sex with menand persons born in regions of intermediate hbv indomicity. the first dose should typicallybe administered immediately after the collection ofblood for serologic testing. post-vaccinationserologic testing for immunity is not recommendedafter routine vaccination of infants, children,adolescents and adults. post vaccination serologictesting is recommended mothers, healthcare personnel,chronic chemodialysis patients,

hiv infected and otherimmunocompromised persons, and sex partners ofhepatitis b surface antigen positive persons. testing is recommended 1-2months after the final dose of the vaccine series, or atage 9-12 months for infants. revaccination isrecommended if antibody to hepatitis b surfaceantigen is less post-exposure prophylaxisrecommendations following occupational exposuressuch as those sustained

by healthcare personnelare depicted here. unvaccinated healthcarepersonnel exposed to blood or body fluids from asource patient positive for hepatitis b surfaceantigen should receive one dose of hepatitis b immune globulinand initiate revaccination. those exposed to asource patient negative for hepatitis b surface antigenshould initiate vaccination. a previously vaccinatedhealthcare personnel who is a known vaccine responderrequires no post-exposure

prophylaxis, regardlessof source patient status. previously vaccinatedhealthcare personnel who are known non-respondersafter three vaccine doses and exposed to a positive sourcepatient should receive one dose for hepatitis b surface antigenshould initiate revaccination. who are known non-respondersafter six vaccine doses and exposed to a positive sourcepatient should receive two doses of hepatitis b immune globulinseparated by one month. for hepatitis b surfaceantigen require no prophylaxis.

post-exposure recommendationsfollowing non-occupational exposures are depicted here. an unvaccinated person exposed to a hepatitis b surface antigenpositive source should receive the hepatitis b vaccine seriesand hepatitis b immune globulin. a previously vaccinatedperson exposed to a hepatitis b surface antigenpositive source should receive a dose of hepatitis b vaccine. an unvaccinated personexposed to a source

with an unknown hepatitis bsurface antigen status should receive the hepatitisb vaccine series. while a vaccinatedperson exposed to a source with unknown statusrequires no prophylaxis. i will now discuss revisions to the recommendationsdeliberated upon the work group deliberatedupon and supports guidance for testing hepatitis b surfaceantigen positive pregnant women for hbv dna.

dna testing identifiesinfants at greatest risk for perinatal hepatitis binfection and prioritizes women for referral forantiviral therapy. in accordance withaasld suggestion for maternal antiviraltherapy, to reduce the risk of perinatal transmissionwhen maternal hbdna is greater the work group also deliberatedupon and supports guidance for infants whose mother'shepatitis b surface antigen such as infants surrenderedanonymously shortly after birth.

note that all 50 states havesome form of a safe haven law to reduce the riskof infant abandonment and that medical data onthese infants is lacking. the work group alsodeliberated on removal of the permissive languagefor birth dose administration note the existing language onthe left, the bottom portion which states that on acase by case basis and only in rare circumstances thefirst dose may be delayed proposed revisedlanguage is on the right,

which reflects removal ofthe permissive language for delaying birthdose administration. included in the work group'sdeliberations was a study demonstrating an increasein hepatitis b infections for infants born to hepatitis bsurface antigen positive mothers with increasing age atfirst dose of vaccination. the suggested odds ratio for anincrease in infection was 4.3. birth dose coverage in theunited states is currently 72.4% and has remained relativelystable in recent years.

note that current coverage isbelow the healthy people 2020 target of 85%. the work group also discussedthe safety net provided by birth dose priorto hospital discharge, including when infants born to infected mothers are notidentified due to errors in maternal hepatitis b surfaceantigen testing or transcription or reporting of test results. note that the work group did notreach consensus on the removal

of the permissive language. for providing examplesof chronic liver disease and the statement: the existingguidance recommends hepatitis b vaccination for personswith chronic liver disease, and the work groupsupported providing examples of chronic liver disease such ascirrhosis, fatty liver disease, alcoholic liver disease,autoimmune hepatitis and liver function tests greater than twice the upperlimit of normal.

three-dose hepatitis bvaccine coverage among adults with chronic liver conditions,slightly less than 30%. lastly, cdc supportsexplicit language for recommending hepatitisb vaccination for persons with hepatitis c infection. an increasing incidenceof hepatitis b and hepatitis c virusinfections have been noted in young non-urban adultswho inject drugs in kentucky, tennessee and west virginia.

current hepatitis b virusinfection may increase the risk for liver disease progressionamong hcv infected persons. i would like to acknowledge thework group members listed here and those listed here. now for discussion and vote, does acip approve removingthe permissive language for the hepatitis b vaccinebirth dose to be administered after hospital discharge? and does acip approve therevised hepatitis b statement?

questions? yes, dr. belongia. that was very helpful. do you have any insight as to why the originallanguage was ever put in there regarding a permissivebirth dose prior to discharge? and what would be a circumstance that would have been consideredreasonable to not give it prior to hospital discharge?

>> so i don't reallyhave any insight on why that language wasoriginally placed in there. that was from the2005 recommendations. but some of the work groupdeliberations in favor of not removing the permissivelanguage was for mothers who feel that they knowthat they are negative for hepatitis b. that perhapsthose mothers shouldn't be required to have theirinfant vaccinated before perhaps they should beallowed to have the choice

to have the infantvaccinated later in life. >> dr. hunter. >> paul hunter. thanks for the presentation. i have a questionabout, are there any data that would suggest that removingthe birth dose permissive recommendation after dischargewould change the overall completion rate of thethree-dose infant series? and if not, are there anyplans to study this question?

>> so there have been studies, and these studies are10 or 15 years old. they're fairly old now, but those studies did showan association with receipt of the birth dose in thehospital and timely completion so there is data to supportbirth dose administration in the hospital is associated with timely completionof the series. >> go ahead.

>> i would like to speakfor some others i've spoken to about the birth dose,and they have concern about vaccinatinga child at birth, that their immune systemis not ready for a vaccine. and there is parentalconcern that we should wait until the infant's immune systemis more mature before we begin to vaccinate. so those are parentalconcerns i've heard. kelly moore.

although they may have concerns, is there any scientificevidence to support that? i don't believe so. so one of the thingsto remind folks is that having a clearrecommendation does not mandate anything. people all the time make theirown choices about whether to refuse somethingthat is recommended. so i can't see that removal

of the permissive languagewould result in a compulsion of parents to immunizewho are resistant to that, any more than any otherrecommendation does. however, there is a lotin my experience practice where clinicians may chooseto have the patient come on and get their vaccineat the doctor's office at the two week visit whichmay be for convenience of the clinician, andalso the clinician is paid for that visit insteadof something

that the hospital takes care of. so there may be other issuesthat come into play in terms of pediatric practice anda clear recommendation without the permissivelanguage may make it easier to make it routine in thehospitals prior to discharge. >> yes, dr. walter. >> yes, i had one slightlyunrelated question too, regarding the recommendationsfor babies under 2,000 grams bornto serum negative moms.

and the question is, thelanguage there says delay does of hep b vaccine until age onmonth or hospital discharge. what's the intent there? especially if you have a childwho's around 2,000 grams or just under who may get dischargedat two or three weeks of age? >> so among pre-term infants,vaccine response is lower when it's administeredearly in life. and the vaccine responseamong low birth weight infants improves quite a bit whenvaccination is delayed

until about one month of life. so to give you some numbers, when low birthweight babies areimmunized in the first couple of days of life, 60 or65% of those might end up achieving serumprotective antibody levels. but when vaccination in thoseinfants is delayed starting at one month of life, 90or more percent reach serum protective levels. >> so do we want them toget vaccinated at one month

or at hospital discharge,which may be before one month? i think the language isa little confusing there. >> so the language shown onthe slide is taken verbatim from the existing recs whichdoesn't specify a preference. it just says either one monthof life or hospital discharge. we can certainly entertaina preference for either of those time periods or someclarification to that language. >> that would be good. i think it's confusingfor providers.

>> yes? >> i have a question abouttesting post-vaccination for infants born tohepatitis b surface antigen positive mothers. one of your slides illustrated that the recommendation is9-12 months or 1-2 months after the final dose of thevaccine series if delayed. it used to be 9-18 months. can you comment onwhy it changed

from 18 months to 12 months? >> sure. in 2015 cdc issueda recommendation to shorten that interval from 9-18months to 9-12 months of life. two reasons werebehind that decision. one, we had new data that showedthe decline in surface antibody over time, when postvaccination testing was done at increasing intervalsfollowing vaccination. so infants were falselyidentified as being a non-responder

and were being revaccinatedunnecessarily due to this decline insurface antibody over time. and the other is com vaxproduction was discontinued. and with com vax the last dosewas given at age 15 months. so that's one reasonthe interval extended out to 18 months, was to accommodate intervalscompleting vaccination with com vax. i might point out that

in the 2015 sti guidelines itdoesn't specifically state this, but it points to the 2005 mmwr. it does not point tothat 2015 document. if you have a living documentwith the sti guidance, it might be worthadding that in. >> dr. messonnier. >> hi, actually first just when you all make comments canyou please announce yourselves so our recorders canfigure out who it is?

and i guess i felt tooi was going to comment, so i have to ask you,does cyd have language around this issuein the red book? and is there agreementabout removal or an opinion about removal of thispermissive language? >> dr. maldonado? >> yes, so i can comment. dr. kimberlin can talkabout the red book language. we discussed this on aconference call last week

and we were in agreementwith the recommendations. we didn't have anyproblems with it. >> dr. kimberling? >> david kimberlin,aap red book. currently we also havepermissive language in the red book but we'reworking very actively on the 2018 editionand would be delighted to incorporate this in,should acip vote in favor of removing permissive language.

>> sorry, i'd like tomake one other comment and again this ishistorical evidence, because as you mentionedthe document from 2005. many of us, we're noton governing committees, but the discussion at least atmany of the local levels was around the difficulty ofpractitioners at hospital to develop a birth dosewithin their systems. and the idea being that it wouldbe very hard to get every child. and so the idea was toallow some permissive.

i think since that pointit's been 11 years. most hospitals and practiceshave really been able to make that switch. but i think it was madeprimarily for the wrapping up of the ability to dothis at the hospital level. >> dr. thompson? >> yeah, thank you. excellent presentation. i had a couple questions.

one is, what do we knowabout the fraction of births that occur outside of whatwould be captured as hospitals? are hospitals capturingevery birthing facility, every kind of facility? or are we missing somepart of the population, even if it's small thatmight be relevant to uptake? and picking up on the commentearlier, what are we doing to figure out how to improvethe uptake in this area? you know, again, lookingat who are the kids

that are being missed. >> so as far as births thatoccur outside the hospitals, we didn't really address that. i mean we're focused primarilyon infants born in hospitals, but certainly we are concernedabout infants born outside of the hospital as well. but i don't have dataon the proportion of infants born outsideof hospitals and their hepatitis bbirth dose coverage rates.

and then you had one otherquestion about what are we doing to improve rates of birthdose before discharge. i mean there are educationalefforts going on to try to educate you know, mothersand providers of the importance of birth dose as a safety net. it also is a nationalquality for a major, so it is a quality metric forhospitals who choose to use that measure of birth dosecoverage before discharge. >> dr. schaffner.

>> yeah, bill schaffner,national foundation for infectious diseases. first, compliments toeveryone on their hard work. and i am certainly supportive of changing the permissivelanguage regarding the hepatitis b birth dose. i'd like to have us discussjust briefly adult immunization. because frankly iwas disappointed in the committee's report,the working group's report.

because i think we'vemissed an opportunity here. you know, one of the titlesof the document is a strategy to interrupt transmission,and as was demonstrated, we've had flat rates largely in the adult populationfor some time. and indeed, rates areincreasing in some parts of the country insome age groups. so this is an opportunity tomove forward this strategy to interrupt transmission

in a more innovativeand assertive way. let me make severalpoints quickly. after the 19th birthday, in away that's different from all of our other vaccinerecommendations, you actually have -- for themost part if you're an adult -- to acquire risk before you'reeligible for immunization. we don't wait foryou to be exposed to measles before weuse measles vaccine. second, we know that thisrisk-based strategy is honored

most often in the breachrather than the observance. so it's really a strategy that'sstuck i might even say failed. you know, it's beenabout 15 years plus since we have recommendeduniversal immunization of everyone up tothat 19th birthday. i've never understood whyonce you get 19 plus one day, you're no longer eligiblewhereas you were before. why don't we take that universalrecommendation with that cohort and move it forward with them?

this is an opportunity tomove universal immunization up to age -- i don'tknow, you decide. 35, 40, 50? that would be innovative. that would be strategic,rather than lethargic. so i would urge the colleaguesto go back, redeliberate and really do somethinginnovative regarding this continuing concern about hepatitis b acutelyoccurring in adult age groups.

>> you raised anexcellent point. certainly there are areas where hepatitis b is increasingamong young adult populations. so 30-39-year-olds for example. universal vaccinationof those would help to address the increasinghepatitis b prevalence among those populations. >> dr. wexler? >> hi, deborah wexler,immunization action coalition.

the question aboutwhy did we develop that permissive language,actually it was developed as restrictive language. i've been comingto acip meetings since before the year 2000, so i've been following the wholehepatitis b birth dose issue since actually 1991. initially before thethimerosol controversy, we had very high rates

of hepatitis b vaccinationat birth. it was approaching 80%. with vimerisol, ratesdropped down into like zero, and then up to 40% was aboutas good as we could get after the 1998 thimerosalfiasco if i could call it that. in 2002, acip recommended thebirth dose for every baby again. i mean, that came back. and rates started to go upagain, but they weren't going up very quickly, soin 2005 this language

which you're calling permissive,but actually it was restrictive. the purpose of it was to say, "do not give thebirth dose later. give it at birth, exceptin rare circumstances and on a case by case basis." and actually whatwe've seen as a result of that is the birth doserate actually has been going up gradually. and so now we hear of it today,but it's only at 72% and that's

within three days of birth. that's not meaning thatthey're getting it before so i just wanted to set thatstage for how important it is to give this birthdose in the hospital. i just got an email from a perinatal hepatitisb coordinator who has been to every hospital in herstate, and she is just fighting to get the birthdose implemented and the private doctorsare still delaying the dose

and giving it in their practicesyou know at the week visit. and she's just hungry for,"could we please help?" what should she do? so in light of the formerrestrictive language and perhaps moving towards thislanguage of everybody give it, i think programmaticallyit would be very helpful to perinatal hepatitis bcoordinators if you said, "what does it mean to give thedose before hospital discharge?" to give it eitherbefore 12 hours of age,

or before 24 hours of age. and i think that wouldhelp perinatal hepatitis b coordinators be veryclear what they're trying to implement ratherthan just saying before because we've plateauedon the birth dose. we're not increasing it. and it would helpeverybody with clarity about what beforehospital discharge means. dr. decker?

>> yeah, i also like dr.wexler, have been coming to meetings a long time. there's another factor thatplayed into this that fits in her history thatshe didn't mention and it was an economicpolitical issue. at the time there was theoriginal recommendation, and as she said, hospitalswidely adopted this. but vimerisol came up, hospitalsleapt at the opportunity to kick this outof their program

because it was anunfunded mandate. when it happens during thebirth process they're capitated for the birth of themother and nobody was paying for the injection to the baby. so that's part ofwhat drove it out. that's another reason why therewas the language from 2005 that exists because it was inpart a political compromise. but this is 11 years later. and if you want to makeprogress, you really have to go

to the mandatory language. and i agree that rather thansaying before discharge, saying something withinthe first 24 hours of life. be very specific, very concreteif you want it to get done. yes? >> sandra fryhofer for americancollege of physicians. i note on page fiveof the handout, when you mentionadults recommended for hepatitis b vaccination,that you did not give an example

under the heading personsat risk for infection by sexual exposure, the havingmore than one sex partner in the last six months. and this sort of goes towhat dr. schafner was facing. i think you were mentioningthe patients in their 30's. but i think you know,patients in their 50's, 60's and up may experiencechanges in their situations. and that may apply to them. so i assume that's stillin the recommendations,

because i saw it in thebackground materials. also i want to applaud the groupfor highlighting fatty liver as an indication as an examplefor chronic liver disease. because we're seeing more andmore patients in our practices with this obesity crisis. yes, dr. hunter? >> it's paul hunter. i just wanted to followup in that same section. i have a question as aclinician why the cutoff

for the upper limit of normal asa risk is twice the upper limit of normal rather than threetimes the upper limit of normal. because i'm familiar withthe three times upper limit of normal being whatmost clinicians use as decision factor in othersimilar clinical situations. >> that number waschosen fairly arbitrarily. there are some clinicalguidelines which use greater than two times the upperlimit of normal in some of the decision factors.

we sort of unrelatedlyissued and algorithm for prenatal testing andwe got some comments. we used an alt cutoff thatwe received some comments on was a little bitperhaps too low. so we want to be carefulto capture you know, a level that's nottoo low or too high. but we are certainly openfor feedback on that level. >> i'm just arguing in generalfor primary care physicians to try to make thingsas uniform as possible

so that you actually getwhat you say implemented. that's just my point. >> dr. o'leary. >> yes, sean o'leary withthe pediatric infectious disease society. the 2005 guidelines have fairlyextensive guidance for hospitals on policies to increase theuptake of the birth dose and also screening, et cetera. including recommending theuse of standing orders.

will that be in thesenew guidelines? >> yes. >> john ward, director of thedivision of viral hepatitis. going back todr. schaffner's comments, the big gap in hepatitis bvaccination coverage is among adults and that's obviously where you're seeingmost of the cases now. in states like tennessee we'reactually seeing increases in hepatitis b incidenceheavily related

to the opioid abusecrisis and the injection of those medicationsor of heroin. and i think we havean elimination goal. it's not a specific one, butit's one that has been proposed without a numerical target ever since the infant hepatitisb vaccine was recommended by acip back around 1992. and this eliminationtarget has really taken on some renewed interest.

the national instituteof medicine, now known as the nationalacademies of sciences, has convened a panel toset elimination targets for hepatitis b andhepatitis c elimination. and framing it asthe elimination of hepatitis b transmissionand disease, as a public healththreat in the us. so that's proposed to becoming out from that committee in the spring of 2017.

so i think a more ambitiousphase being vaccination policy for the most vulnerableparts of the population, in this case youngto middle aged and maybe even older adults,would be very appropriate. so we can ask the work groupif they agree with reconvening and looking at strongerrecommendations for adults while stillhopefully having acip agree on what's already infront of them today. dr. lee?

>> thanks. actually i'm going to --three questions or comments. one is it would be reallyhelpful on the measurement end to understand whether or notthose rates, the 72% rates in terms of the birth dose,exclude premature populations. so if 10% are actuallypremature, then maybe the vaccinationrates are higher. it also might giveus a better sense of where we can targetimprovement efforts number one.

number two, i think it does seem like from a systems levelperspective, what we're trying to do is just bridge the gaps. and minimizing thepermissive use would be helpful in that instance. and the third point, iguess i would mention that it might be helpfulto actually have models to take a look at the impact of alternative vaccinationstrategies

on particularly theadult disease burden. and so i would iguess suggest or ask if the work groupwould consider that. yes, dr. moore. >> kelly moore. i completely support the ideaof having the working group look at age-based recommendationfor those adults. being the programmanager from tennessee, we are one of the three statesthat is struggling mightily

with this, and risk-basedstrategies just have not helped us. but also i would like tosay that as i've thought about the fact that ourlanguage that we're looking at here proposed,specifies hospitals. and we understand that thisis excluding in fact children who are born in settingsoutside of a hospital. our concern is notabout the setting. the concern is aboutprotecting the infant at birth.

would there be oppositionto proposing then especially from a programmatic standpointthe clear-cut communication message that rather than sayingthat the proposed language state that the first dose of vaccineshould be administered before hospital discharge, instead saythat it should be administered within 24 hours of life. for example, that wouldthen eliminate the setting of that birth from consideration and the protectionof the newborn.

i have a point of information. the acog website says thereare about 35,000 births outside of the hospital every year, which is about .9%of the births. dr. ward. dr. romero, doyou want to comment on that? on changing the wording? >> i think you canmake the motion if that is the motion you want. but it may be easier toapprove this and then try

to add the motion afterwards. but you can make the motionif you think that is the case. >> yes, dr. belongia? >> i just want to speakin support of that also because i think itgets at the issue of whether the birth occursin the hospital or not. it doesn't matter,it's within 24 hours. so i see it as an improvement and i would support theamendment in the language.

>> then may i officiallymake a motion? i'll look to youfor point of order. >> so we have not yetmade a motion at all, so perhaps hold thatas an amendment. dr. messonnier? >> we just want to point outthat actually the language within 24 hours of birth isconsistent with what who says. any further discussion. dr. romero, would youlike to make a motion?

>> so i make the motion thatwe accept the current revision in the recommendation foradministration of the birth dose of hepatitis b vaccine priorto discharge from the hospital. >> do you want to include in the motion acceptingthe overall hepatitis recommendations? or would you likeit to be separate. >> it's up to you,madame chairman. but i would be more than happyto add it to that motion also.

>> dr. messonnier? >> i'm sorry, butit would be helpful as we move towards avfc vote if actually at this juncture you specifiedthe language that you want around hospital dischargeor around 24 hours of birth. it makes it much easierto go on to the next. >> i think we are going todo that as an amendment. so okay, let's restatethe original motion. >> so the original motion isto accept the revised language

as it states, "for all medicallystable infants weighing greater than or equal to 2,000grams at birth and born of vaccine should beadministered before only single antigen hepatitisb vaccines should be used for the birth dose." that is a motion to accept that. and then we're also going to -- >> can i have a secondto the original motion? thank you, dr. atmar.

and dr. moore, do youhave an amendment? >> yes. thank you. dr. moore, i'd like toamend the proposed language to remove the statementreferring to hospital discharge, and instead recommendingthat the first dose of vaccine shouldbe administered within 24 hours of birth. is there a second. yes, dr. blunt.

okay. any further discussion? yes, dr. lee? >> just a point ofclarification for myself. are there any implementationissues we'll need to worry about with the change to 24hours versus at discharge? i just want to make sure. if there's no implementationchallenges, then it seems to me it would be fine. >> is there anyone who wouldlike to comment on that?

dr. o'leary? >> yeah, i would argue thatit would make things clearer for hospitals and cliniciansbecause there's confusion between whether theyshould wait till 72 hours if it's a c-section? so in this case it'sjust very clear for every infant it shouldbe less than 24 hours. other discussion? sorry, dr. riley.

>> i started waving. i'm sorry. laura riley. so i think that from aprogrammatic standpoint, i think it will just meanchanging standing orders and i don't think that that'sreally that big of a deal. i think thought that i wouldn'tbe wildly optimistic that people who deliver outside ofthe hospital are going to be the ones who all ofthe sudden get vaccinated.

because the very peoplewho deliver outside of the hospital generallyare not people who are tremendously excitedwith organized medicine and needing to get vaccine. any further comments? then i'd like to ask fora vote on the amendment. and i'd like to startwith dr. moore. >> kelly moore, yes. >> ezeanolue, yes.

>> jos㨠romero, yes. >> bennett, yes. >> atmar, yes. >> stephens, yes. just as a brief commenti want to continue to keep dr. schaffner's point about universal vaccinationon the table. >> kempe, yes. >> szilagyi, yes.

>> walter, yes. >> belongia, yes. >> riley, yes. >> lee, yes. >> pellegrini, yes. >> hunter, yes. >> thank you, so the amendmentwas accepted unanimously and the wording will bechanged to "first dose now can we vote onthe overall motion?

is there any furtherdiscussion of that? no, okay. dr. kempe,would you start us? with again underlining thefact that we should return to the adult recommendationsat a later time. >> and szilagyi yes andi want to second that, that risk-based strategiesare not usually effective. >> moore, yes. >> romero, yes. >> thank you, so the motionwas accepted unanimously

and we have new language. okay, the last finalthing is voting on the overall recommendations,and dr. romero would you like to make that motion? >> yes. i motion thatthe acip group vote to accept the overallrecommendations >> is there a second? at this time i'd like to ask ifthere's any further discussion. yes, ms. pellegrini?

>> i realize we'vealready had the first vote, but is public comment going tobe occurring at some point here? >> thank you for thatreminder, and yes, we would like to havepublic comment at this time. >> pat stinchfield from napnap. i just want to add in terms ofimplementation considerations, we'll need a lot of education. if a birth center says,"well we're at hour 25. what do we do?"

and i don't thinkyou need to build that into the policy statement,but accompanying education on what to do whenyou're not meeting this. >> hi, my name ischristina hildebrand. i'm from a voicefor choice advocacy. i'm a little concernedabout the 24 hours of birth. i know you've already votedon it before public comment. but the us has the highestrate of infant mortality within the first day of birth.

we're also one ofthe few countries that has the hepatitis b given within the first24 hours of birth. and i wonder if the cdc or anyone else has done theresearch behind that and looked into that, becauseit does concern me that there is a correlationthere. and so i just ask that you lookinto that before you mandate or not mandate, before youmake that recommendation.

any further comment? public comment or fromthe committee members? is there somebody i'm missing? >> thank you for that comment. we continually monitor thesafety of hepatitis b vaccine, including when administeredshortly after birth. it is a very safe vaccine. anaphylaxis occurs in aboutone out of a million cases, but it's something wewill continue to monitor.

also, with the issue of itgiven so shortly after birth, there have been data to supportthe safety of that as well, including it doesnot increase the work up for sepsis in young infants. but thank you. then i'd like to vote onthe overall recommendations. oh, dr. riley? i don't know why ikeep missing you. >> it's okay.

i just want to point out inaddition to the safety data, i think it would be importantto point out that most of the infant mortalitythat we see in the us in in pre-term infantswho are note the babies who are getting vaccinatedwithin the first 24 house. because they are lessthan 2,000 grams. just to put that out there. >> thank you for thatclarifying point. anyone else?

so we will move to the vote onthe overall recommendations. can i start withyou, dr. belongia? so we passed therecommendations unanimously. thank you very much tothe hepatitis work group for this excellent presentation. and now we're going tomove on to pertussis. i wanted to mentiondr. riley is going to introduce the pertussissession, but i wanted to mention what i should havementioned before, which is vfc.

i apologize. this is dr. santoli who willwalk us through the vfc vote which i didn't realizewe needed to take. >> so hello there. and i think this is justan opportunity for us to align the vfc resolutionwhich has been created and updated many times withthe new recommendations. so it actually justbrings it all together just like the hepatitis group did.

so the eligible groups forthis resolution are children and adolescents birththrough 18 years of age. and the recommended schedule and interval includesa couple of tables. these tables come directly fromthe draft of the recommendations that you all have reviewedand discussed and approved. we will make the changethat was just discussed such that birth id replacedwith within 24 hours, and we actually can do thatthrough all parts of the table

because in some places birthalready has a specific hour range associated with it for infants born topositive mothers. this is the first half ofthe table for the infants who are greater than or equalto 2,000 grams at birth weight. and this is the second halfof the table with the less than 2,000 gram infants. there's also a table that comesalso out of the recommendations that include theacceptable schedules

for children and adolescents. the only thing that's been addedto this table from the draft that you all have seenis the final schedule, which will be added ifthe accelerated schedule that can be used whenadministering trinrics and it's at the very bottom of the adolescentsection of this table. it does apply tothose 18-year-olds who are covered bythe vfc program.

there's also informationabout the resolution about interrupted schedulesand minimum dosing intervals. this comes from the currentversion of the recommendations that was voted andapproved and actually comes from prior versions of therecommendations as well. covering interruptedschedules, minimum intervals, the four-day graceperiod, et cetera. finally there's guidanceabout revaccination to make sure those doses areincluded in the vfc program.

and again, this is takendirectly out of the statement in various categories where revaccinationwould be recommended. and then lastly recommendeddosage and contraindications and precautions are referredto the package inserts. finally as a statementgets published with the specific details,that's actually incorporated into this by referenceand we will do that following thepublication of this statement.

>> thank you, dr. santoli. would someone make a motionfor the vfc resolution? >> i motion. >> i think dr. stephensthis time. and a second? dr. romero? >> second. and is there any discussion? dr. hunter?

just a point of clarification. i thought i heard you sayingthat you'd change at birth to less than 24 hours, but i assume you meant you'dkeep everything that's less than 12 hours asless than 12 hours? >> okay, just wantedto make sure. any further questionsor discussion? then let's move forwardwith the vote. dr. riley, wouldyou like to start?

>> kemp, yes. and with that we unanimouslypass the vfc resolution. thank you very much,dr. santoli. now onward to pertussisvaccines. dr. riley is going topresent to us the session in dr. reingold's stead. and i should have mentionedearlier that dr. reingold's not with us today forinescapable reasons. we miss him, but wegive great thanks

to the other work groupmembers who have stepped up to present on his behalf. >> thank you and good morning. it is impossible to stand in dr. reingold's shoes,but i'm going to try. so this is the workgroup members and i'd like to thank all of them. and obviously thank outcdc lead, jennifer liang. and our terms of referencehere on this slide,

and i would just point outthat the term of reference that is highlighted in bluepresenting the drafted updated statement will be done today. next. oops. so this is just a reminderthat there are two types of pertussis, tetanusand diphtheria vaccines. and just to bring toyour attention dtap, which is the pediatric vaccine. and today what we'retalking about is tdap

which is the adolescentand adult vaccine which is licensedfor single use only. so today's session we willtalk about guidance on the use of tdap on pregnant women aswell as updated acip statement for pertussis, tetanusand diphtheria which will be voted on. so in the time sinceacip has recommended tdap for pregnant women, additionalstudies have assessed the safety as well as the immunogenicity

of tdap vaccination duringpregnancy and the effectiveness of preventing infant pertussis. so it was timely and criticallyimportant for the work group to review these data, given theupdated statement for pertussis, tetanus and diphtheriavaccines was being prepared for acip's reviewand affirmation. so tdap coverage among pregnantwomen has steadily increased. the current estimate, you cansee several different estimates. but the current estimateduring flu season

from an internet paneldone by cdc was 48.8%. with regards to theupdated statement, here is a historical backgroundof the acip statements to date. and you'll see in 1991 the firstacellular dtap vaccines were licensed by the fdaand recommended by cdc for a fourth and fifth dose. and then in 1997 theacip recommended dtap for all five doses inthe childhood schedule. and then in 2005, tdap wasfirst licensed by the fda

and recommended byacip as a single does for adults and adolescents. since the 2005 tdaprecommendations, acip has also expanded as well as updated the tdaprecommendation which is listed here,which were published as policy notes in the mmwr. so as you can see, vaccinationrates among children are quite high.

unlike tdap coverage amongadults and adolescence, tdap immunization has increasedsteadily since its introduction. so in today's session we willdiscuss guidance on the use of tdap in pregnant women aswell as updated acip statement for pertussis, tetanusand diphtheria for a vote. >> thank you, dr. rileyfor that introduction. and good morning. before focusing on thetopic of the timing of tdap administrationduring pregnancy,

because the pertussis workgroup has not presented to acip in over a year, i will give anoverview of the epidemiology of pertussis in theunited states, the current acip tdaprecommendation and guidance for us in pregnant women,as well as the safety of tdap administration tomothers and their infants. following the introduction ofwhole cell pertussis vaccines in the late 1940's, therewas a dramatic decline in cases reported through thenational notifiable diseases

surveillance system, or nndss. in the 1990's the united statestransitioned from whole cell to acellular pertussisvaccines or dtap. by 1997 all five doses of thechildhood series were dtap. tdap vaccine wasintroduced in 2005. since the late 1980's the burdenof disease has been increasing with notable epidemic years in2004, 2010 and most recently in 2012 with over48,000 cases reported. the increases inreported pertussis cases

over the last two decades arelikely the result of a number of factors including improvedsurveillance capacity, changes in diagnostic testingand reporting, increased public and provider awareness, and probably mostimportantly waning protection from acellular pertussisvaccines. looking at the reportedpertussis incidence by age group, infants,represented by the red line, continue to have thehighest risk for disease.

historically, rates of pertussishave remained about the same for all other age groupsuntil more recent years when we have observedthe emergence of disease in 7-10-year-olds,shown in beige, and 11-19-year-olds in purple. a growing body ofevidence which is presented to acip throughout theyears strongly suggests that the change invaccines from whole cell to acellular pertussis vaccines

in the childhood vaccine serieshas caused the age-specific increases due towaning immunity. published studies have found that acellular pertussisvaccines provide protection within the firstyear of receipt, but that effectivenesswanes over time. vaccine effectiveness for dtapin blue was evaluated by time since the fifth dtap dose. tdap vaccine effectivenessin purple was evaluated

in adolescents who received onlyacellular pertussis vaccines for their primary dtap series. as previously mentioned,infants continue to have the highestrisk of disease. this graph shows thenumber of reported deaths by age group and year. infants less than three monthsof age here in beige account for the greatest number ofreported deaths from pertussis. of reported infant pertussiscases that were hospitalized,

more than 50% were lessthan two months of age. and of those who died, 86% wereless than two months of age. these infants were too youngto have received any doses of pertussis vaccines. and because younginfants are vulnerable to pertussis infection andhave the highest morbidity and mortality rates,as a strategy to prevent infant pertussis, acip first recommendeda single dose of tdap

for pregnant women in 2011. prior to this recommendationtdap was recommended to be given to womenpost-partum. in 2012, acip expanded therecommendation to a dose of tdap during every pregnancy. this is the aciptdap recommendation for pregnant womenand guidance for use. the focus of thework group's review and discussion is thehighlighted language.

to maximize the maternalantibody response and passive antibody transferto the infant, optimal timing of tdap administrationis between 27 and 36 weeks gestation. although tdap may be givenat any time during pregnancy. as a reminder, two tdapvaccines are available in the united states. sanofi pestrus adacel,and gsk's boostrix. both provide protectionto pertussis,

diphtheria and tetanus. for pertussis antigens, bothproducts contain pertussis toxin or pt, filamentus hemoglutinen,fha, and protectin, prn. adesol also containsfembrae or fem. when acip first recommended tdapto pregnant women, safety data, although reassuring,were limited. the committee stated theneed for enhanced monitoring and safety studies of tdapgiven during pregnancy, especially to women who havereceived prior tdap vaccination.

in response to thecommittee's comments, the cdc immunization safetyoffice developed an immunization safety plan for this population through three establishedpost-licensure vaccine safety monitoring infrastructures. the vaccine adverse eventreporting system or vaers. vaccine safety data link, vsd. and the clinical immunizationsafety assessment project, or cisa.

activities include ongoingmonitoring through vaers. vsd provides available coveragedata as well as surveillance and research on safetysignals including those listed on the slide. vsd also has access toelectronic medical records and medical recordsto validate cases and denominators for rates. cisa currently has two projects. tdap safety in pregnantwomen, and the safety

of simultaneous tdap and inactivated influenzavaccine administration in pregnant women. safety data from thesemonitoring activities have been presented to acipat past meetings. safety data collected inthe united states on tdap and pregnant women and infantscontinue to be reassuring. the pattern of adverseevents observed in vaers and pregnant womenreceiving tdap

and their infants isconsistent with expectations. studies of over 50,000 womenreceiving tdap during pregnancy in the vaccine safety datalink show no increased risk for adverse maternal orinfant health outcomes. and the clinical study in the cisa project showstdap was well tolerated in both pregnant andnon-pregnant women, including pregnant women whoreceived a repeated tdap dose. although pertussis specificantibodies would likely confer

protection and modify theseverity of pertussis illness, when acip first recommendedtdap for pregnant women, the effectiveness for tdapvaccination during pregnancy to prevent infantpertussis was not known. since then, effectiveness data and additional immunogenicitydata have become available. recent immunogenicity studieshave assessed the optimal timing of tdap administrationduring pregnancy to provide maximal transfer ofmaternal antibodies to infants.

but before presenting asummary of these studies, i wanted to highlight thefollowing information. for pertussis, there areno well-defined serologic correlates of protection. pertussis toxin orpt is suggested to be the most importantviral inspector. after receipt of tdap, aminimum of two weeks is needed to mount a maximal immuneresponse to vaccine antigens. during the course of pregnancy,active igg transport begins

around 17 weeks gestation andincreases with gestational age. with accelerated uptakestarting around 34 weeks. the immune responsein pregnant women to tdap immunization issimilar to non-pregnant women. and vaccine induced pertussisantibodies are efficiently transplacentally transferredfrom woman to fetus. studies report higherantibody concentration in infant cord bloodcompared to maternal serum. this australian studyfrom naidoo et al examines

and compared cord bloodpertussis antibody levels for pertussis toxin filamentushemoglutinen and protactin in infants of unvaccinatedand vaccinated mothers. note that the cord bloodantibody levels here are presented as logtransformed values and not as geometric meanconcentrations. compared to the no-tdap group, cord antibody levelswere significantly higher in the vaccinated group.

by multivariableanalysis, when adjusted for maternal pre-vaccinationlevels, pertussis toxin approachedsignificance and protactin was significantlyhigher in the early versus late vaccination group. naidu et al also found a modest to significantly positivecorrelation between the number of weeks exposed to tdapand infant cord blood levels for the three pertussisantibodies.

only anti-pertussisantibody is shown here. these findings suggest longerexposure to vaccine allows for higher vaccine inducedantibody levels produced by the mother andtransferred to the infant. supporting earlier vaccinationwithin the 27-36 week window. as with the previous study, this study from abiretaet al found both maternal and infant cord blood serumconcentrations were higher in the tdap vaccinated groupversus the unvaccinated group.

within the 27-36 week windowof tdap administration, the cord blood gmcfor pt was higher in infants whosemothers received tdap at 27-30 weeks comparedto 31-36 weeks. it is unclear why the gmc's arehigher for tdap after 36 weeks, but this is from a smaller group and the findings are notconsistent with other studies. a study by dr. maryhealy from baylor college of medicine looked atanti-pt specific igg levels

in cord blood frominfants born to women who received tdap duringweeks 27-36 weeks gestation. and compared it to infantsof unvaccinated mothers. as part of this study, dr. healyassessed the optimal gestation for tdap administrationbetween 27-36 weeks. this figure shows infantcord blood for anti-pt gmc's by gestational age of thewoman's tdap administration. immunization earlier within the27-36 weeks appears to allow for maximal anti-pt iggantibodies in infants.

the aim of this swissstudy by eberhart et al was to determine whethertdap vaccination as early as 13-25 weeks wouldillicit non-inferior gmc's of infant cord blood antibodies,compared with immunization after 25 weeks gestation. within the currentacip guidance, infant cord blood gmc's forpt and fha tended to be higher for infants whosemothers received tdap between 26-33 weeks compared

to infants whosemothers received tdap after 33 weeks gestation. eberhart also found thatthe gmc's were non-inferior for infants whose mothersreceived tdap earlier than 26 weeks. from the same study, these curves representthe distribution of individual anti-pt antibodygmc's at various time intervals between the maternal tdapimmunization and delivery.

i've put a red box aroundthe days that would fall within the 27-36 week window. compared to no vaccinationand less than 15 days before delivery,the pink and blue lines, a longer time betweenmaternal tdap and before delivery resultedin similar distribution of anti-pt infant cordblood concentrations. antibody concentrations markedlyincrease with intervals greater than 14 days, reachingoptimal gmc with intervals

between 31 and 120 days. in summary, infantsof mothers vaccinated with tdap duringpregnancy were born with significantly higheranti-pertussis antibodies compared to infants ofunvaccinated mothers. within the 27-36 weekwindow, the concentrations of anti-pertussis antibodies in infant cord bloodwere generally higher when mothers werevaccinated earlier.

and longer exposureto vaccine allows for higher vaccine-inducedantibody levels produced by the mother andtransferred to infant. and one study found infantcord blood concentrations of anti-pertussisantibodies non-inferior when maternal tdap wasadministered before 27 weeks. although the methodologiesdiffer in these various studies, these studies have shown that vaccinating women duringpregnancy is very effective

at preventing infantpertussis from 78-93%. the majority of women fromthese studies were vaccinated within the current guidancewindow of 27-36 weeks. a retrospective cohort study from california evaluatedwhether infants born to mothers who received tdap duringpregnancy had less severe pertussis compared to infantsborn to unvaccinated mothers. infected infants ofvaccinated mothers were older when they developeddisease and were less likely

to have classic pertussissymptoms. they were also atsignificantly lower risk of hospitalizationand icu admission. none of these infantsdeveloped seizures, required intubations or died. after review of availabledata on immunogenicity and effectiveness, thework group was cautious with how these immunogenicitydata might relate to effectiveness.

again, the minimalconcentration of antibodies to confer protection is unknown. and because of thisunknown, the work group noted that it is importantto ensure enough time between mother's receipt oftdap and infant's birth to allow for maximizing the concentrationof maternal antibodies. this may be betterachieved by vaccinating at an earlier gestational age,for example before 27 weeks. however, vaccination too earlyduring pregnancy may not allow

for sustained levels ofantibodies to provide protection through the infant's firstdtap dose at age two months due to maternal antibody decay. data are not yet availableto address this concern. based on review ofthe immunogenicity and effectiveness data, the workgroup considered the following options to modifyingthe current window. first, expanding the window to include earliertdap administration,

for example as earlyas 22 weeks. second, narrowing thewindow to 27-32 weeks. or the third option, to notchange the current window but emphasize earlieradministration within the windowof 27-36 weeks. when reviewing thesethree options, the work group consideredwhat impact any modification to the guidance window wouldhave on the current program. acip has been recommending tdapfor pregnant women since 2011.

and since then tdap uptake in pregnant women hassteadily increased. as dr. riley presentedearlier, the current estimate from the 2015-2016 fluinternet panel survey was 48%. during the previous fluseason, tdap coverage was 23%. the work group did not want topotentially disrupt this trend. earlier administration of tdapmight increase the opportunity to educate and vaccinatepregnant women and increase protectionamong preterm infants.

vaccinating pregnant womenearlier might provide protection to these earlierpre-term infants, but the greatest majority of pre-term infants areproviding protection under the current27-36 week window. and when consideringnarrowing the window, the work group was concernedthis would decrease the opportunity to vaccinatepregnant women. the work group is encouragedthat vaccinating pregnant women

with tdap is effective inpreventing pertussis in infants. the work group was alsoreassured that if infected with pertussis, infants born to vaccinated mothersare less likely to develop severe pertussiscompared to infants born to unvaccinated mothers. although there is variationbetween immunogenicity studies and the studies are limited bysmall to modest sample size, these studies have shownthat vaccinating earlier

with in the 27-36 week window or even before 27weeks may be beneficial at optimizing theproduction and transfer of maternal antibodiesto infants. however, at this time it isunclear how the immunogenicity data from earlier administrationwill translate to effectiveness in protecting infant pertussis. the current strategyis effective at preventing infant pertussis

and so the work groupwas reluctant to modify the current window. again, the work groupwas cautious not to equate higher concentrationof maternal antibodies from earlier vaccination tosimilar or better effectiveness without knowing whether thedurability and concentration of maternal antibodieswould be maintained until an infant is old enough toreceive his or her first dtap. without effectivenessdata specific

to vaccinating womenearlier during pregnancy, the work group is cautious to over-interpret resultsfrom these studies. after consideringthe proposed options, the work group did notsupport expanding the window to include earliertdap administration. although the workgroup thoughtthat vaccinating earlier within the current windowwould likely provide maternal antibodies for themajority of infants,

including those born pre-term,work group members differed in how to modify the currentguidance of 27-36 weeks. a minority of the work groupssupported narrowing the current window to 27-32 weeks, whereasa majority supported no change to the current window of 27-36weeks, but include language to emphasize earlieradministration within this window. this option was alsosupported by our acog and acnm work group members.

therefore the languagei will be presenting was modified accordingly. as a reminder, here's thecurrent acip tdap recommendation for pregnant women alongwith the guidance for use. the underlined sentenceis the language that the work group is updating. the drafted change to theguidance for use is highlighted and reads tdap should beadministered between 27 and 36 weeks, althoughit may be given

at any time during pregnancy. currently available datasuggest that vaccinating earlier in the 27-36 week window willmaximize passive antibody transfer to the infant. this guidance languagewill be included in the updated acip statementfor pertussis, tetanus and diphtheria vaccines which will be presentedfollowing this discussion. so i think we're goingto have some discussion

on this before we move onto the updated statement. so questions, comments. dr. kempe? >> i realize you don't havespecific data about duration of antibody on the maternalside, if it's given earlier. but i guess i wouldn't expectthis to be very different from other situations. can you talk a little bit about what your subject expertsthought about the duration?

for example, the comparisonbetween 22 weeks or 27 weeks? >> thank you, dr. kempe. that's a good question. i think the concernwas in part -- to address what you're asking, the concern fromthe work group was that these immunogenicityshowing equivalent or non-inferior concentration to earlier administrationwe're promising.

i think the concernwas whether or not -- without knowing in terms ofthe durability and the timing of maternal antibody decay. would that higher concentrationthen translate to durability from time of birthto the two-month -- when the infant wouldbe recommended to receive the firstdoes of dtap? i think that is where thework group was concerned. i think we don't knowyet specifically what

that durability is and howlong the duration would be. and so i think thatthe work group wanted to be more conservativeabout that. >> dr. walter. >> was that the workgroup's main consideration in narrowing the windowto the earlier time? >> that was one ofthe considerations. the other concerns were in terms of potential programmaticdisruptions.

any change couldpotentially cause confusion. i think that we've heardanecdotally that even with the current guidancewindow that we have that providers aren'tnecessarily targeting between the 27-36 weeks. and so any other changewould potentially result in misinterpretation. and at this time becausewe don't have the data, the work group did not wantto change it drastically.

and you know, dr. riley, ifyou would also like to comment on some of the work groupdeliberations as well. >> so you know, oneof the options was to, if we didn't change thewindow to earlier and get rid of 27 weeks and goto something like 22, the other questionwas should it be 22-32 or something to move it up? and the concern was thatas jennifer says, you know, we're making anothersmall change.

we're only at 48% with afairly new recommendation. and to tweak it seemed likeit could cause more problems with confusion. and unfortunately what we'veseen before in other areas of obstetrics, andi don't know -- i can't talk about otherareas of medicine -- but when you tweak it andpeople don't understand, they just don't do anything. and so the concern was wewanted people to get vaccinated.

so even if you get vaccinatedat 35 weeks, it was better than not gettingvaccinated at all. so one thing that we'regoing to do on the acog end, because we're trying toshift the vaccinations more to the earlier part of thisis to tell obstetricians and midwives that youknow, if you pair this with the glucose loadingtest, which everyone has around 27-28 weeks, it is theideal time to also give tdap. that way we're hoping thatpeople will actually you know,

now vaccinate earlierin the window. because the otherconcern obviously is that when you vaccinate at34 and 36 weeks, you miss all of those you know, late pre-terminfants who get nothing. >> and i just want toadd another comment. i think in terms of also thedurability and immunogenicity, because again we don't knowthe serological correlates to protection and howmuch concentration would provide protection.

i think that given thatthe various studies that have evaluatedthe effectiveness in preventing pertussisin an infant -- because those evaluations weredone within the current window of administration, thatthe work group felt that that was reassuringand showed that the currentprogram was working. and whether or not to shiftit to make it earlier, that they didn'thave these data.

i think the other piece toowithin the united states, the evaluations that we'rehaving, the coverages, we're still learningabout the impact. we know that it works onthe individual infant. but in terms of the impactof the overall numbers of cases reported in infants,we're just starting to be able to evaluate that ascoverage increases and as we move forwardthrough time. >> yes, thank you for anexcellent presentation

and the thoughtfulnessof the options. do you have any healthcareutilization data about if the window werenarrowed, what percentage of pregnant women arenot even seen at all? so we would miss any opportunityto vaccinate these women? >> we don't have those data. you know, for us atleast it's difficult. we know that there areproviders who administer tdap, but we don't know

when specifically they'readministering it even during pregnancy. we've heard variabilityaround that as well. one of the limitations tothe coverage data is we know that pregnant womenare receiving tdap. but when during pregnancythey're receiving that, we don't have those data. >> yeah, that was goingto be my question. could you get data onfrequency by week of pregnancy?

but i did notice on one ofyour slides that there was data in a small group about that. if you looked at the ends, itlooked like it was between 27 and 30 weeks and then itdropped off after that. and i assume that has to do withthe protocols of when you do it and what group by group -- whenyou decide how you're going to set things up in yourclinic, how to do that. would that be the rightimplementation issues? >> yeah. i think that that'sprobably what that reflects,

is how people areimplementing it. but i think that's whyour thought is that if in our own acog statementwe really stress earlier in the window is better for x, xand x reasons and people pair it with the glt, i think you'llsee many more people get it at 27 and 28 weeks. the concern about --we actually talked about maybe making it 26 weeks. but you know, littlechanges make people do really

weird stuff. so we didn't want to do that. >> yeah, i just wanted to comeback to something you asked, which is studying this is veryhard and there isn't a lot of variability in our data sets about when peopleget vaccinated. and so we have data on overallvaccine efficacy of the program, but we don't have data thattakes into account timing. and you also have to remember

that through twodifferent vaccines. and there is some data thatsuggests that the kinetics of the vaccines are different. we understand that the ukactually will be changing their window. and so this is a case wherewe may within a couple of years have the advantageof a country with really, really high maternalimmunization levels giving us additional data.

>> dr. platt, you'vebeen waiting for a while. >> yeah, as well, you know,i think the recommendation to maintain 27-36 weeksis a reasonable public health recommendation. but i would just liketo object to the mantra that we don't know what thecorrelates of protection are. obviously we do. the fact that maternalimmunization protects infants shows that in fact antibody isthe correlate of protection.

the thing that we don't haveis an absolute threshold for the antibody. but that antibodies to ptto fimbrial aglutinogens and to protactin areprotective is very clear. personally i do thinkthat vaccinating early in the third trimester isbetter than vaccinating later because of the antibody data. but again, i think it'sa reasonable compromise under the current circumstancesto maintain the breadth

of the recommendations,particularly since the impact on later vaccination of theinfant is something that has to be taken into account in making the overallrecommendation. dr. neuzil? i'd also like to complimentyour deliberations. you certainly took intoaccount the science, the principle of simplicity. i think the human factor.

you know, i also believehaving reviewed the data as the working grouphas, that it is appearing that earlier is better. and how early, we'renot quite certain. i'm not sure though that thisstatement actually reflects what you intend it to reflect. that it may not bestrong enough. while i do appreciate theissue of not wanting to tweak, did you considersomething along the lines

of it should be administeredduring the first visit in the third trimesteror as early as possible in the third trimester? and then putting that 27and 36 in parentheses. because, laura, as you've said,it's very protocol-driven in ob. so if we can get it right there with that first third-trimestervisit, that might accomplish thiswithout causing confusion. >> yeah, i'd justlike to support that.

i think you could takethe second sentence and say something like vaccineshould be administered as early as possible within that window. and that would i thinkmake a stronger statement than what you have here. >> others? i'm sorry, dr. hayes? >> hi, carol hayes withthe american college of nurse midwives.

just to reiterate whatdr. riley said a moment ago, the working group really didfeel like we need to be careful about recommendationfatigue, and that was one of the main reasons thatwe didn't change this. and also we havea working group. to someone's questionabout data and utilization, we have a maternalimmunization working group that is trying very hard to get a quality datameasurement on this.

and they almost had agiant conniption fit, because we've been working for ayear and a half on this language and that's what wewere going to measure. and please help changethat language was sort of the unspoken requestfrom the working group. so there's a coupleof things moving. we felt that even though thedata indicates it could be helpful earlier, i do howeveragree with your statement that we could be stronger here.

dr. riley? >> so i am perfectly fine with saying earlierwithin this window. i would caution againstsaying the first visit in the third trimesterbecause that definition is a moving target. some people say the thirdtrimester is 24 weeks. some people say 26 andother people say 28. and if we're too literal, i canjust imagine someone showing

up at 25 weeks and, "oh,it's not your turn." and then you don't getit until god knows when. so i just think we probablydon't want to use that. i think it's fine to say earlierin this 27-36 week timeframe. >> so can i just clarifywith the work group? it appears that our plan was tovote on the updated statement, not on this particular wording. are we all on thesame page about that? i think it's great to discussit, but i just wanted to be sure

that we're not actuallyvoting on this wording. okay. good. dr. friedland? >> hello, leonard friedland fromgsk, one of the manufacturers of one of the tdapvaccines that's being used i'd just like to mention that inaddition to the safety programs that were outlined by dr. liang, of course gsk maintains apregnancy registry for the use of boostrix in the united statesand in other parts of the world.

and of course we have ongoingpharmacovigilance systems in place to monitor thesafety of the use of boostrix in pregnant womenaround the world. >> yeah, just relatedto the window. using the language "earlier inthe window" is a little vague. i wonder, did you discusswhether it would be helpful to be specific? so 27-30 weeks or27-29 or something? just thinking aboutthe protocolization.

earlier leaves it kind of lose. >> from a programmaticstandpoint, i think if you time it withyour glucose loading test which we know obstetricians doat a certain time all the time, that probably is going toget us where we need to be, earlier in that window. >> what's the wordingon the glucose testing in your recommendation? is it tied to a trimester?

>> it's generally given26-28 weeks gestation. it's very specific. dr. wexler? >> debra wexler,immunization action coalition. we do get a lot of questionsabout the very last statement for women who have notbeen previously vaccinated. tdap should be administeredimmediately post-partum. what they want to know is why, even if they have beenvaccinated as an 11-

or 12-year-old, why notprotect them immediately with a dose of tdap? and that would be veryhelpful to address because providersare asking, you know, if they didn't getit during pregnancy, why shouldn't i protect thatmom now to provide protection for the newborn after it's born? yes, dr. belange? >> just a quick question,what do we know

about co-administrationabout flu vaccine and tdap in pregnancy? do you have any data? is there any specificrecommendation and do we know if there's any evidencethat the receipt of one might influencethe immunologic response to the other? >> so in terms ofco-administration with flu, so at this time there'sa cisa study

that is just beginningto look into that. currently the recommendationis there's no language to say to not co-administer tdapwith the flu vaccine. so in terms of the data, thereis one study that has looked at non-pregnant populationsthat have looked at the co-administration. i believe that in terms of the co-administrationthere was a slight decrease in the response in one ofthe pertussis antigens.

but again, we don't quite knowwhat that translates to in terms of the clinical outcomeor the impact on response. >> i think we're goingto ask dr. liang to move on to the updated statement. >> so just in brief,this is the outline of this last presentationto review the effectiveness of the updated statement. review the currentepidemiology of pertussis, tetanus and diphtheria.

a list of the current pertussis,tetanus and diphtheria vaccines. an overview of theacip recommendations and guidance for acip's vote. so this updated statementcompiles and summarizes all previouslypublished recommendations from acip regarding preventionand control of pertussis, tetanus and diphtheria in theunited states, specifically after the introduction ofacellular pertussis vaccines and does not containany new recommendations.

this document alsoprovides an overview of the current epidemiologyof tetanus, diphtheria and pertussis. and as previously stated, theupdated list of current vaccines and recommendationsfor routine vaccination and guidance for use. this statement also describesthe process undertaken and the rationale used insupport of these recommendations and is intended foruse by clinicians

and public healthproviders as a resource. the statement is the productof the review of published dtap and tdap vaccinerecommendations, peer reviewed literature andsurveillance data from nndss and the enhanced pertussissurveillance or aps. the work group reviewedthe draft statement and provided comments. and prior to this meeting, acip voting membersreviewed the draft statement

now this is the summaryof the updated statement. after the introductionof universal immunization with tetanus toxin containingvaccines in the mid 1940's, the incidence ofreported tetanus in the united statesdeclined by more than 98%. deaths from tetanus alsodeclined similarly during this period. currently tetanus israre in the united states and occurs primarilyamong older adults.

from 2004-2015 an average of 28 tetanus casesper year are reported. in the united states,reported diphtheria cases from all anatomical sitesdeclined from over 200,000 in 1921 to over 15,000 in 1940. this decline continuedafter the introduction of universal childhoodimmunization in the late 1940's. and in 1980, only two casesof diphtheria were reported. during 1996-2004, 11cases were reported.

and from 2004-2011, nocases were reported. but in 2012 therewas a probable case of non-toxigenic diphtheria. and in 2014 a confirmedcase, positive by culture with non-toxigeniccorynebacterium. and as previouslypresented, this is the number of reported pertussis cases in the united statesfrom 1922-2015. listed here are thecurrently licensed

and available dtap vaccines,combination vaccines with dtap and dt vaccines inthe united states. and this is a list ofthe currently licensed and available tdap and tdvaccines in the united states. note that in monovalent toxoidtetanus vaccine manufacturing was discontinued andhas not been available in the us since 2013. this consolidated updatedstatement will contain the routine recommendations fordtap, dt when indicated,

tdap and td whichwere last published in separate statements. the statement also includestdap recommendations made after the 2005 recommendationsand published in mmw or policy notes. again, there are no changes to these previouslypublished recommendations. this statement also containsupdates such as dtap vaccines that became available afterthe 1997 dtap statement.

and updates to label indications from various dtapand tdap products. also included in this statementare the following updates. mention of the discontinuation of monovalent tetanustoxoid vaccine. the contraindicationsand precautions for dtap are now consistedwith the aap's red book. and for persons age 7-10 yearswho received a dose of tdap as part of the catch-up series,

an adolescent tdap dose maybe given at age 11-12 years. this guidance is now in linewith guidance given on children for which tdap isinadvertently administered. today's acip vote is toaffirm the updated statement which does not contain anynew vaccine recommendations. the statement will be updatedwith the modified guidance for language for pregnantwomen that was just presented, along with a summaryof supporting data. we will also include a tablesummarizing safety studies

on the use of tdap in pregnantwomen and their infants. before the vote, i wanted torecognize and acknowledge all of the work group membersfrom past and present who have been part ofthis process since 2009. i would also like to thankthe previous work group chair, dr. mark sawyer, and ourcurrent work group chair, dr. art reingold,for their leadership. i'd also like to acknowledgethe following cdc groups and cdc contributorson the work group

for providing subjectmatter expertise. again, today's acip vote is toaffirm the updated statement. >> thank you, dr. liang. any comments, concerns? >> i just want to be clear. so the guidance is part ofthese recommendations, right? so aren't we in fact voting onthe language of the guidance? >> so we're separatingout recommendations from guidance for use.

so the guidance for use arereally cdc recommendations about how to implementthe recommendations that acip votes on. and so that's where thatlanguage will be contained. but it sounds like the workgroup can incorporate some of the discussion from todayand modify that language. >> other questions, comments? do we have a motion? i see one back there.

all right, motionfirst, then comment. >> is there public comment? i have a question. a very common question we get that i didn't hear discussedwas an adolescent showing up who's not had anydtap, no primary series. and they're now wantingto "catch up". has there been anydiscussion or change with what to do with that situation?

>> there is catch up languagethat does include if a child or an adolescent or even anadult were to present and wanted to start receiving anypertussis containing vaccines. the catch up series doesinclude one dose of tdap. so could we have a motion? >> public comment is goingto come after the motion. >> okay, thank you. >> before the vote. >> before the vote, got it.

>> yeah. >> anyone care to make a motion? yes, dr. walter. >> i'll make a motion thatwe vote on the statement for pertussis, tetanus anddiphtheria containing vaccines. is there a second? dr. riley, thank you. further discussion? anybody? and now we'd liketo have some public comment

and we have -- sorry. go ahead. could you say yourname and your organization? >> yes. i'm christinahildebrand. i'm with the voicefor choice advocacy. i was just very interestedin what was presented today, and i thank you for allowingme to give public comment. i have some questionswhich seemed to be left unansweredby the presentation. you say that you'regoing to give a summary

of tdap safety studies. the vaccine package insertsfor both tdap studies state that there have been noclinical trials or studies on pregnant women forboth of those studies. so i'm just curious to getthose tdap safety studies that you mentioned. the studies that were outlined in the presentation haveextremely small sample sizes. so i would hope that thestudies that you're referring

to have larger sample sizes. i also wonder whetherthere's been review of the number of miscarriages. the studies that i'veseen actually took out stillborn deaths. and i wonder if we haveany studies on the number of stillborn deaths andmiscarriages that happen after vaccination versus thosepeople who are not vaccinated. the other piece that i wouldask that you address is

that both tdap vaccinesinclude aluminum. we know aluminum crosses theblood-brain barrier and whether that has been studied infetuses and whether the aluminum from the tdap vaccinedoes impact across the blood-brain barrierand what that does to the fetus. and then the other questionthat i have for you is that there have been studiesin baboons that have shown that the tdap and dtapvaccines actually show that you can be an asymptomaticcarrier of pertussis

and you can actually givepertussis to someone else. and so i wonder whetherthat has been addressed and whether the giving oftdap and dtap among infants, specifically tdapamong the parent, whether they can be anasymptomatic carrier to their infant. and then that as well as whethergiving the tdap actually stops the infant from gettingpertussis. in that first six months oflife, whether those infants

that have the higher antibodieshave actually been stopped from getting pertussis. also because we know right now,most people and most adults and most teenagers that aregetting pertussis are getting it, having been fullyvaccinated. so thank you. dr. messonnier, wouldyou like to comment? >> thank you very much for yourcomments and your questions. i think one of the thingsis that actually a lot

of the information that you'reasking about was presented at a previous meeting. and many of the acip members, or all of the acipmembers have seen that data and had deliberations on it. that information is online. but in addition our subjectmatter experts are happy to talk to you during the break andshare a lot of the data. i know a lot of pharmaceuticalcompanies also collect data

around some of thosepoints, and if it's not clear in the package insert,i'm sure they're happy to provide more informationas well. >> hi, james grundick, freelancejournalists of new york city, epoch times, financial times,foreign directive magazine. my green investors would like toknow why zika wasn't discussed with this particular vaccine. it was an acronym problem. but apparently themicrocephaly problem,

northeast brazil has not beenconfirmed yet whether it's zika, whether it's other toxins,or whether it was the vaccine that was given downthere to pregnant women. >> thank you for your comment. we do focus our attention on vaccine recommendationsin the united states. we are going to have anupdate on zika tomorrow. any other comments, questions? okay, then i'd liketo move to a vote.

could we start with dr.hunter and go to your right, just to change the direction? >> thank you very much. so we have unanimouslyaffirmed the updated statement for pertussis. and thank you to the pertussiswork group and to dr. liang for an excellent presentation.