Feb 29, 2024 ACIP Meeting - Meningococcal Vaccines

okay good morning um um we're resuming um our meeting and um we're going to start the minin cako vaccine section session and I would like to turn things over to Dr Lair who is chair of the Menino vaccines work group Dr Lair thank you Dr Wharton um good morning I'd like to have an introduction to the menitis vaccin workg group our presentations next slide there are two two major topics that we're going to be going over today the first at past acip meetings members asked for review of the current adolescent schedule for the menitis vaccines the work group has had a very robust discussion about the options we had over 10 options at one point and we've narrowed it down to about four um channeling Dr Cree from yesterday I'm going to do the bottom line up front what I I'd like the acip members to think about as we're going through the presentations does the acip concur with the four options that we chose for further assessment and what additional information would help the acip determine the preferred option the second major topic is much more of an informational topic as you may recall we approved the fiser pentavalent vaccine in October of 2023 and that was approved as an option when both the men acwy and the men B are recommended at the same time we're now using the same framework for the GSK pentavalent vaccine and we wanted to give you some talk about our planned present our plan considerations next slide so at this meeting we'll be going over those two topics at the June 2024 meeting will be reviewing the epidemiology of menitis disease we'll go over the disease burden the cause cases and deaths averted by the men acwy vaccine the risk factors for the c c Group B disease and then also talk about breakthrough disease and vaccinated individuals and we'll talk about our considerations of these and how they're influencing our decisions next slide in October of 2024 will present a grade in an ETR analysis and a cost Effectiveness analysis is and we hope to plan for a vote in February of 2025 next slide these are some of the considerations that we're considering but it's a non-exhaustive list of things that we're going to be reviewing as we make recommendations in the future and the next slide I'd like to thank the entire work group I want to share a lot of appreciation for all the hard work that people are putting into this and I want to appreciate their time and effort back to you Dr Wharton thank you Dr Lair uh Dr shil do you want to uh get us started good morning I will present on revising the Adolescent menja caco vaccine schedule term of reference and considerations next slide for this presentation we will review manin caco vaccine recommendations and coverage data the epidemiology of menja cockal disease duration of vaccine induced protection and options for changing the immunization schedule next slide men acwy vaccine is routinely recommended for adolescents with dose one administered at 11 through 12 years of age and dose two at 16 years of age minb vaccine is recommended for adolescents based on shared clinical decision making and is typically a twoos series the recommended agent range is 16 through 23 years with a preferred range of 16 through 18 years the doses in the minb series need to be from the same manufacturer the pentavalent men abcw vacine is recommended as an option when both men acwy and men B are indicated at the same visit next Slide the 2022 coverage for at least one dose of men acwy vaccine was 84.5% for 13year olds and 89.8% for 16year olds for 17year olds coverage was 60.8% for at least two doses as expected coverage was much lower for minb vaccine as those recommendations are based on shared clinical decisionmaking the coverage for 17-year-olds for at least one dose was was 29.4% and for at least two doses was 11.9% next slide this slide depicts the incidence of Manja cockal disease in the United States from 1996 through 2022 note that the incident started to decline before the introduction of men acwy vaccine in 2005 there is an uptick in disease incident in recent years next Slide the proportion of disease caused by Sero group varies with age as depicted here for 2020 through 2022 or during the covid pandemic next slide this slide shows the proportion of disease by S group from 2012 through 2021 or predominantly pre-pandemic data s group B accounted for more than half of cases among adolescents note the Y AIS scale on this slide differs from the previous slide next slide preliminary data reveal 416 cases of invasive menja cacal disease in 2023 which is the highest number of cases since 2014 the rates of disease are greatest in children younger than one year of age and there is a second peak in ad Ence when considering the 2021 cases for which the most recent data is available 19 of the 210 cases or 9% were among 11 through 23 year olds next slide because the decline in Manja cockal disease incidents began prior to the introduction a vaccine measuring the association between vaccination and disease incidents is challenging but has been modeled using surveillance data among adolescents 11 through 15 years old incidents decreased 16.3% During the prevaccine period and 27.8% during the post primary dose period and among adolescent 16 through 22 years old incidents decreased 10.6% during the post primary dose period and 35.6% during the post booster dose period an estimated 222 cases of s Group C W or Y disease has been averted through vaccination of adolescents from 2006 through 2017 next slide this slide shows the incidence of disease following men ACW vaccine implementation starting with the graph on the left for S groups a c w and y in the prevaccine era noted by by the dark blue line Min awy disease increased around 15 to 16 years of age and following Min ACW vaccine implementation noted by the Light Blue Line disease decreased dramatically although there is still a Peak at 12 years of age which could increase if the 11 through 12y old dose were eliminated moving on to the graph on the right Ser Group B disease became the dominant cause of Menin cockal disease in adolescence although incidence has decreased slightly since the prevaccine era next slide Ser Group B disease is higher among college students college students have a 3.5-fold greater risk of serogroup B disease than non-oled students and the incidence Peaks at 19 years of age and declines after age 20 next slide and that higher risk is associated with students at a fouryear college as opposed to a 2-year College additional risk factors include being a firste student an on-campus resident and participation in Greek life next slide and now to discuss duration a vaccine induced protection protection wanes over time following menitis vaccination for men acwy vaccines protection wains between 3 and 8 years post vaccination within one year of vaccination vaccine Effectiveness is 79% between 1 and 3 years post vaccination vaccine Effectiveness is 69% and between 3 and8 years postvaccination vaccine Effectiveness is 61% for minb vaccines protection wanes one to two years following primary vaccination next slide beero is recommended for the prevention of ser Group B menja cacal disease and deliberations regarding the Adolescent Menin caco vaccine schedule will primarily consider Menino disease prevention beero also appears to provide some protection against ganara neria menius and neria ganaria are genetically closely related sharing about 80 to 90% sequence homology as such it is plausible for outer membrane vesicle menitis B vaccines such as beero to provide cross protection against Gara next slide revisions to the Adolescent menja cocko vaccine schedule should optimize protection against menitis considerations to optimize menitis protection include ages at higher risk for menitis recent epidemiology and duration a vaccine induced protection next slide maintaining harmonization with the existing adolescent platform is an additional consideration as is the use of pentavalent vaccines which provide the opportunity to reduce the number of injections next slide there are several options under consideration when revising the Adolescent schedule for men acwy an option is to eliminate the 11 through 12y old dose or to change the recommended ages for vaccination given the low incidence of disease in young adolescents for Min B an option is to change the recommended age for vaccination to increase protection upon college entry given the limited duration of protection another option for minb is to change the shared clinical decision-making recommendation to either a routine or risk-based recommendation if there is a change to a risk-based recommendation the workg group expressed a preference to include permissive language for vaccinations of persons requesting protection but who may lack risk factors this preference is to address Equity considerations for example such that college attendance would not be a requirement to receive protection from Min be vaccination next slide this slide depicts the four options proposed by the workg group the first row shaded in green represents the current recommendations the next four rows represent four proposed options note that the the numbers 1- 4 do not represent the work group's order of preference but are assigned for ease of referring to the options option one maintains the current Min acwi recommendations and changes minb recommendations to routine recommendations with dose one administered at 16 years and dose two at 177 through 18 years option two is similar to option one except that the recommendations for men B for option two are risk-based as opposed to routine recommendations option three is similar to option two except that option three eliminates the 11 through 12-year-old dose of men acwy option four is for dose one of men acwy at 15 years and dose two of men acwy at 17 through 18 years years and for dose one and two of men be at 17 through 18 years with the routine recommendation next Slide the work group preferred option one or three as noted by the red boxes here next slide in the diagonal shading on this slide depict doses of men ACW recommended at the same age as doses of minb in other words instances in which the pentavalent vaccine may be an option next slide in the next two slides I will summarize the work group's comments there was variability in the desire to keep versus to eliminate the 11 through 12y old dose of men acwy those favoring keeping it noted that it has taken years to ingrain the 11 through 12y old platform and that that dose may have reduced carage and has worked those favor eliminating that dose point to the epidemiology which seems to support starting the series at 16 years of age other comments were to consider minb starting at 15 years of age and to try to achieve acceptable e efficacy for duration of disease incident peak in young adulthood next slide workg group members opposed shared clinical decision-making recommendations citing poor uptake missed vaccination opportunities implementation challenges that a lack of a strong recommendation prevents institutions from implementing policies and that shared clinical decision-making recommendations were not understandable to clinicians as such the work group had interest in changing men recommendations to either risk-based or routine members noted that harmonization of menacwy and MBE schedules could reduce the number of injections if using the pentavalent vaccine but also pointed out that if the use of the pentavalent vaccine resulted in extra antigen Administration that extra antigen administration had not been a concern in the past with other vaccines and members also noted that a change in the schedule May impact School requirements next slide I would now like to open this meeting up for discussion regarding potential changes to the Adolescent schedule and would like to ask acip if they confer if they concur with the four schedule options for further assessment and what additional information will help acip determine the preferred option thank you uh Dr shile maybe it would be helpful to go back to the slide with the preferred options um yes or with the options slide 26 or or yeah that one's fine the next one the next slide yeah that one might be better so it may be hard to provide an immediate response to this but um Dr Lair um one thing the work group was considering was that harmonization with other organizations is very important and so I'd like to call on my Pediatric and Family Practice colleagues on the Leo zones if they have any comments or if their organizations have any opinions on this I'd be interested in what they have to say uh Dr midlan hi good afternoon um I'm Amy midman from the society for Adas and health medicine um I really appreciate this discussion it was very thorough and brought up you know the majority of issues that we've been discussing at the society for adolescent health and Medicine um one thing we did have a talk that um Dr shil so nicely attended as well um and asked for feedback from the attendees who were Adolescent Medicine providers um among the um 25 respondents and it's not a huge group but I think there was um pretty clear concern um about potentially eliminating the 11 to 12 year um vaccination for multiple reasons but I think the health and safety of our adolescent is obviously Paramount but also the integration of that into the um the platform is is important immunization platforms are there to remind people that it's time to think about vaccines and specifically vaccines um I think the reason childhood platforms are so successful is they haven't been changed in a long time and to change the platform would take I think significantly more data than we have that would indicate that it would be of benefit to the health of our teens um I think there was also a very strong sense that the use of the pentavalent vaccine especially if cost savings were associated would be far PR preferable in terms of the ability to decrease the number of products that need to be that are required um for for um vaccination and uh potentially obviously um and I think making the um shared clinical decision Mak recommendation for men be um making that routine would make um administration of all of the these vaccines um more streamlined efficient and easier to follow so I think the qpp um idea was very well received among Adolescent Medicine providers um about 80% of those responding to a brief survey again after the talk also felt that the pentavalent um given at 16 with a second dose either at 16 17 to 18 or or any where between 16 to 18 would be ideal so I know that's a lot of information and one comment but I appreciate you all letting me speak uh thank you uh Dr Rockwell hi uh thank you yes I agree with everything Amy Dr middleman said um I'm speaking as a family physician not on behalf of my Academy at this time but I think I'm representing um same reasons that I also favor what looks like option one from the work group um a not to eliminate the trid and true 11 to 12 year old vaccine recommendation plus I am somewhat swayed by the argument that perhaps giving this vaccine over so many years has lowered the community Carriage of this disease I also favor making this a definitive routine recommendation rather than shared clinical decisionmaking for a lot of the reasons Dr middleman outlined but it is a cleaner approach it is easier speaking for clinicians in practice it's and it's less um uh I I feel like it makes for better discussions with patients who might be hesitant otherwise they just receive their vaccine as recommended and then as far as the pentavalent I don't know personally about the Financial um cost Savings of holding that in our clinics versus um two products but always it's desirable to reduce the number of vaccine vials in our refrigerators thank you thank you uh Dr oi yeah thank you um representing American Academy of Pediatrics um we are not as far along in our deliberations uh as the prior two speakers um but what I would say is is I I think there are a few data points that would be helpful um one you know I don't know that cost Effectiveness analyses are going to be as helpful in these deliberations as in some others given the current epidemiology but I I I would appreciate modeling that looks at uh cases averted deaths averted based on the different scenarios um that you know whether it's you know if if you look at the current epidemiology for example um um you know it seems like these these you know options three or four are the ones that are sort of going where the disease is um but you know I understand the concerns around the potential impact that vaccination at 11 to 12 has had be it disease averted or uh Carriage um the other uh um uh data I think that would be helpful is looking at adolescent visits so you know one of the concerns with or one of the reasons to do it at the younger ages is is the Adolescent tend to come into the office more but those those visits have changed over the years in terms of how often people do seek well child care do do go in for you know sports physicals or whatever so it would be helpful to see the the visits and and how often these adolescents in the older age groups actually come into the office because I think that would would help inform the decision-making as well because if we see for example that visits in those ages are you know a third or half of what they are at the younger ages that may be very helpful in saying well this is really going to present some some Equity issues here in terms of who can get vaccinated because they're not coming in and I'll stop there uh thank you Dr o um before we take any more comments from Liaisons I do want to go back to um the acip members and see if there's additional thoughts or questions that any of them want to make Dr long I think these are very difficult decisions um we're loathed to take away vaccine recommendation Lo when was the last time but the epidemiology of maningo conal disease has done nothing but go down since any of these recommendations were made and I don't think it's as clear as Maybe maybe there are new data that I do not know um that suggest that the vaccine program has had anything to do with the epidemiology the the epidemiology of this disease I think is more Behavior Associated and I may be related to smoking and the epidemiology of decreasing cases to what we've done in this country about cessation of smoking in public places and also it irritates the mucous membranes there was a wonderful article from Atlanta here of bar patronage and a meninga conal disease and in the military getting together smoke and the next one alcohol that your Celia apparently don't just beat in One Direction when you're under the influence of alcohol but they get a little bit wavy so maybe you don't uh you maybe you don't uh protect yourself quite as well I I don't know any of those things for for sure I am concerned however that this idea that college is the deal I think college gets the risk that gets you the problem but that's not limited to college students and I worry about the data of who the non- col students are and if they are inner city overcrowded smoking alcohol using youth I I would be really surprised if they have a lower risk of meninga cockal disease so I'm kind of against the risk based but I also don't think the epidemiology of the disease um suggests that we should continue to give a dose at 11 to 12 years of age we haven't seen the cost Effectiveness models and I don't think it should just be isers over what we currently do I think it should be cost Effectiveness back to the basics because I don't think that would support vaccination from an angal disease at least as many as these and the very short protection from meninga cako B vaccine I think is potentially not worth the uh squeeze so I I don't know maning coal disease we can't really treat it when it occurs these patients it's about the only disease I have to say to a parent someone who comes in with meninga cmia say that the next 12 hours there's probably not going to I can't show tell you that because your child is alive now they'll be alive in 12 hours because all of the cyto kind responses what meningo cmia is and you're only going to make that worse for a few hours so it's one of those few that we do not have treatments that really alter greatly the mortality once the disease is fully expressed so it's very difficult because the disease is so terrible but it doesn't follow the usual rules of vaccination programs and protection of the public because it is so such an uncommon disease now um thank you very much Dr long um do other IP members have comments they wish to make Dr Brooks thank you s one quick comment in terms of looking at the data for um acwy I mean the incidents at 11 age 11 12 is is very very low and instance per 100,000 you know 0.02 which is probably 0.002 per million I mean it's just the incidence is is so well 0.002 point2 per million I mean that's that's so low uh and you know you see maybe 50 deaths a year or something like that I mean it's extremely low so I'm comfortable with removing the 11 to 12y old Al together and changing the schedule it it's just removing a vaccine so instead of three you get two at that particular age as opposed to making it confusing like a different age give it a 14 or you know 10 um and then s Group B you look at the graph and it's basically the same but you do have a higher rate among college students though appreciating what uh Dr Long saying it might be behavioral as opposed to college so for me I would I would have no dose at age 11 12 and I would probably harmonize at 6 age 16 uh number one give it it give it 16 and then give manin B 16 and then 17 18 with no risk based just recommended period yes that should be number five that'd be number five Dr Long says propos a number five okay we're going to take three last comments Dr cotton what oh hi thank you um I think I would favor option one I think it's hard to tell whether the numbers are low in the 11 to 12 years of age whether that's due from um the vaccination program that we've already had in place but do favor moving that second dose of men beat uh towards uh closer since the since it only lasts for about one to two years so moving that closer to when they're going to be in college and uh when they're going to be at highest risk um also I think uh we could leave it as a risk based but I think that's hard and it's also hard for Equity you're asking questions about who's planning on going to college and that can sometimes change and the behavior is also very um high in that uh um in that age group so I think I would favor option one out of those presented okay so Dr cotton Commander Grimes and then Dr lar can have the last word and I apologize to the liaison representatives to have their hands up I think we're not going to have time to take any more comments after that thank you I would also favor option one um especially in the setting of the highest number of cases since 2014 understandably it is in a very young age group but nonetheless I I don't think now is the time to reduce vaccination of a for a severe disease in a population that overall has done well with vaccination um and that's all I'll say for now for time and I agree with many of the comments highlighted by Dr SAS thank you uh I just want to make sure that I'm reading this right because I'm used to looking at the immunization schedule to kind of lay out when when the vaccines are given so regardless on the third recommendation here uh there is going to be a manin cockle vaccine that has a routine uh Administration vaccination recommendation is that correct so number three there's going to be one dose of acwi and that would be routinely or universally recommended at 16 years of age okay um and then and then the minb recommendations would be risk-based at 16 years for the first dose and 17 through 18 for the second dose okay understood I I just asked that question because uh the vaccine injury Compensation Program one of the criteria for coverage is a routine Administration recommendation and so I wanted to make sure that wasn't sort of being pulled away so thank you so uh Commander Grimes in this context would a risk-based recommendation meet that requirement for a routinely recommended vaccine we use the word routine to mean like three different things so would this be considered routine if it's risk-based and be elig ible for inclusion in the program so so at the current time the the excise tax language says any Manja Cole vaccine so the men be vaccines would continue to be covered but if the full category had a routine Administration recommendation pulled off I'm not sure that's ever happened before so I'd have to update you at the next asent meeting so it seems like any of these options would would would be fine from the perspective of the program and coverage yes ma'am so I'm wearing my chair hat I'd like to thank everyone's opinion for giving us your opinions and I appreciate that and we'll take it back to the work group taking off my chair hat and as an acip member I did want to give my personal opinion so very clear this is separate from my chair hat um I will never vote for a routine recommendation for MB the cost Effectiveness is too high and the duration is too short so that's just my personal opinion um and I'm very comfortable removing the 11 to 12 year old vaccination recommendation although I hear many different opinions so again thank you very much for your opinions and I think we can move on to the next presentation can we go to slide 53 please I will now discuss the term of reference for the GSK pentavalent men abcw vaccine next slide there are two new men abcw vaccines one manufactured by fiser and one by GSK the fiser vaccine pin braa is licensed and acip voted on its use at its October 2023 meeting the GSK vaccine is currently in clinical trials each vaccine is a combination of an existing men acwy vaccine and an existing menb vaccine the menja coaco vaccines work group has previously assessed the fiser vaccine and will assess the GSK vaccine separately in the coming months note that there are a lack of data directly comparing these two vaccines next slide for the fiser vaccine the ACW component is nris and the B component is tremend for the GSK vaccine the acwy component is menveo and the B component is beero both vaccines are intended to be administered as two doses separated by six months and are indicated or anticipated to be indicated for 10 through 25 year olds the clinical trial participants included both men acwy primed and naive subjects and Men be naive subjects longer interval studies are planned for both vaccines note that the fiser pentavalent vaccine does not provide protection against ganara while the GSK pentavalent vaccine proi provides some protection against ganara next Slide the policy questions for gsk's pentavalent vaccine mirror those previously used for the fiser vaccine and are depicted here and are should the pentavalent VAC Vine be included as an option for men ACW menb vaccination and people currently recommended to receive both vaccines at the same visit for example 16-year-olds should the pentavalent vaccine be included as an option for people currently recommended to receive men acwi only for example 11 through 12-year-olds should the pentavalent vaccine be included as an option for people currently recommended to receive men B only for example during a s Group B outbreak next slide for the fiser pentavalent vaccine the workg group rated the top six outcomes as listed here menja cockal disease short-term immunity and serious Adverse Events were deemed critical while persistent immunity interference with other vaccines and non-serious Adverse Events were deemed important gonorrhea prevention has been added as an outcome for the GSK pentavalent vaccine and has been ranked as important by the workg group we do not anticipate data on gonorrhea prevention from clinical trials but we will assess this outcome using other available evidence next Slide the next three slides depict the Pico questions which again mirror those previously used for the fiser vaccine I as a result I will not spend much time on these three slides this is the first Pico question next slide and this is the second Pico question next slide and lastly this is the third Pico question next slide that concludes this presentation I would now like to open this presentation up for questions and discussion Dr Lair did Dr coton oh okay um I think I think what Dr SCH presented was quite straightforward but there may be some of you have questions or comments so um we'd welcome those now um so seeing no no request to speak I think we can take this as uh that the committee is fine with the terms of references presented um I it probably didn't hurt that they that this is very similar to what has been done before so thank you very much that was excellent and um so I think um unless uh unless Dr lar or Dr shil have additional comments I I think we can conclude this session um we can so we'll now um now break until um 12:45 so we we'll we'll have just about half an hour and um uh we'll see you back at 12:45 thank you very much