Feb 28, 2024 ACIP Meeting - DT Vaccine

good afternoon uh it's 1:30 p.m. and we're uh ready to reconvene the advisory committee on immunization practices meeting um and our next topic up is dip theia and tetanus toxoids um so I will be um uh turning things over to Dr Hughes thank you um so good afternoon I'll be speaking today with Dr santoli and will'll provide an update on cdc's guidance for TD vaccines for young children children next slide next slide okay as part of the routine vaccination schedule CDC recommends a primary series of daap the Pediatric deia tetanus and pressus containing vaccines for children less than seven who developed a contraindication to protestas containing vaccines CDC previously recommended the Pediatric deia and tetanus taxoid vaccine or DT instead of d recently the sole DT vaccine manufacturer in the US discontinued DT production and the last available lot expired in April 2023 there is no longer DT vaccine available in the United States next slide as a reminder the only contraindication specific to the protestas component in Dap is incopy within 7 Days of vaccination which is not attributed to another cause while we don't know the exact number the occurrence of this adverse reaction is extremely rare in light of DT no longer being an available option CDC issued updated vaccination guidance for the use of TD and young children with a contraindication to protestas containing vaccines next slide so here's cdc's current guidance CDC recommends young children receive dap is the first dose in the deia tetanus and pertusus childhood vaccination series CDC recommends continued use of dap unless a contraindication to protestas containing vaccines develops for young children who do develop a contraindication to protestas containing vaccines vaccine providers May administer TD for all recommended remaining doses in place of daap next slide please so TD is a tetanus and deia toxoid only formulation and note that the use of TD in this situation would be an off Lael use as TD is only licensed for ages seven and older TD contains a lower dose of deia toxoid compared to DT and the impact of this lower dose on the protection provided against deia in young children is uncertain there are no available data evaluating the effectiveness of TD against etheria when used as part of the primary Series in young children and there are few available studies that look at its use as a booster dose for young children or in the primary series for older children and adults the limited data are mixed and some suggest that lowd do dither toxoid containing vaccines may not reliably generate a protective deia response in older children and adults thus children may have less protection against diptheria and no additional protection against pressus if they receive TD instead of dap next slide CDC has publicly posted this guidance on its website that may be found here in order to be covered by vfc for children less than S Years A minor update is needed so I will turn it over to Dr santoli to walk through an update on current TD Supply and the proposed vfc updates thank you next slide next slide so as Dr Hughes mentioned I want to give a a supply update prior to walking through the vfc resolution so Mass biologics has recently discontinued their prot production of TD vaccine which is called TD vax and That vaccine is exclusively distributed in the US by Griff who expects to have product available through approximately June of this year santae Pastor who manufactures tenivac which is the other licensed TD vaccine in the US is currently taking steps to augment their available supply of this vaccine but it is anticipated that the supply of TD vaccine in the US market will be constrained during 2024 and as a result temporary ordering controls are being put into place in the public and private sectors in addition it's also important to note that Tdap vaccine is available from both us licensed manufacturers without Supply constraints at this time and finally based on the Rarity of developing a contraindication to pertusus containing vaccine the temporarily contrain constrained supply of TD vaccine is not anticipated to prevent providers from using TD vaccine for the children in the vfc program for whom it's indicated next slide next we're going to walk through some updates to the current resolution for vaccines to prevent diptheria tetanus and pertusus and you'll notice that the red the text that is in red font is what's new all the text in Black font is unchanged from the existing resolution so the purp purpose of the resolution which is shown here is twofold first to add TD vaccine for use in children less than 7 years of age for whom receipt of the pertusus component is contraindicated and second to update the language regarding the Tdap booster in the resolution to align with the acip recommendations next slide so the eligible groups component of the resolution is unchanged next slide in the recommended schedule and intervals component there are two tables this table is for persons aged less than seven years of age and you can see that two rows have been added to the table for the use of TD vaccine for both of the currently available products um for four 6 15 to 18 months and four to 6 years there's also a new table note and we'll get to that in just a minute next slide the first five table notes are unchanged next slide table notes 6 through 8 are unchanged but table note 9 is new and indicates that the use of tetanus toxoid and diptheria toxoid containing vaccine is appropriate if encylopaedia and then there's a link for more information which actually points to the uh web page that Dr Hughes showed in her last slide next Slide the second table in this recommended schedule and intervals component is for persons aged 7 to 18 years of age and there is no change to the body of the table next slide but there is an update to the second table note to more closely align with the language in the current acip guidance persons aged 11 to 18 years should receive a single booster dose of Tdap preferably at preventive care visits at ages 11 to 12 years the booster dose is not necessary if the Tdap dose was given after the 9th birthday the other table notes as you can see are unchanged next slide table notes 4 through six are unchanged changed next slide there's no change to the links for the dosage or the contraindications and precautions next slide and there's no change to the statement at the end of the resolution which just indicates that any acip recommendations which are published regarding dip theot tetanus and pressus vaccination within 6 months would be incorporated by reference into the resolution next slide and that that concludes um the presentation thank you uh thank you Dr Hughes and Dr santoli are there any questions for either of the speakers Dr Lair thank you for that presentation um I looked like the griffle vaccine was still on the schedule when that goes away in June what happens next do you mean with regard to the um the tables the the resolution or or if I understood correctly I thought that the Griff would not be producing something after June right it's available through through sometime in June but it won't be available beyond that yes okay so then if it's on the table now in June what happens to that do it does it come off the table um we could we could sometimes I I think we don't necessarily always remove something right away if it's not available we certainly could plan to do that if we have time to do that at the June meeting okay I'm just I just curious thank you Dr L and with anticip anticipation that Big T Little D is frequently not stocked in places like emergency rooms anymore that um there already is language for sure in the red book which I only know you know the pressus work group of the CDC was disbanded a few years ago so I'm not quite as up to date on the CDC recommendations about this but there is language that t dap can be used if there is no big T Little D and is that language also in your n cdc's lexicon because I think there won't you people are not going to stock Big T Little D and Big T Little D a big p so so for the on the resolution side of things Tdap is absolutely covered um it's it's it's not covered for the persons who are under seven but it's covered for others um in terms of the recommendations I will turn that over to Dr Hughes yes and that acip's previous recommendation that Tdap can be used in Li of TD would remain great thank you Dr lir oh okay uh are there any other questions uh Dr SAS hi uh could you go back to the table that has all the um slide 12 it's not up yet I just had a question about um the TD uh would not be it's only approved after the uh 4month vaccine because the presumably there would have had to be a reaction to the first dap um vaccine that would have led you to go down that pathway and I'm just wondering if there's a way to make that a little bit clearer from in that table um I know that it starts at the 4 months um but just to um I'm sorry no no it's page slide 12 slide 12 yes that one so the TD would only be if um they had already received a Dap dose and they had incopy within seven uh days of that and that's when that scenario would be uh in play I'm just not sure that um looking at this table that that's fully evident so I don't know if there's just a way to make that clearer well I think we could look at table table note 9 which is I think it's two slides up and maybe we could make sure it's clear there I um it it goes sorry yeah here so are you talking about perhaps including that into this footnote 7even I I'm I I think it's probably is it in the link yes that guidance is in that link about young children with a contraindication to protestas containing vaccines includes all of that the full guidance there um I see that u m uh Mr Des Sean did you want to make a comment or ask a question yeah thanks um this is Dana desan from National Association of pediatric nurse practitioners and I don't know if this really fits um into this with my question um but just given the the waning immunity that we have seen with protestas and the the outbreaks in Nigeria my thought is always why don't we give a booster um as the kids get older um so we give it at that 11y old but you know we they leave our office at 18 and then they don't obviously seek That vaccine um quickly into those adult offices is there is there any thought into um a booster when we know some of those are waiting immunities um with that pessis does literature has shown after three or four years with that so T TD or Tdap are recommended for boosters every 10 years and with a most recent acip recommendation Tdap can be used in lie of dap um and the e um the waning immunity from the pressus vaccine I think May uh lead to the decision that we that the priority for boosting pressus every 10 years is not as high as for the tetanus and deia component Dr long and having been on the pressus work grou for years and um when it was just expanded rightfully so um because the longevity of protection from Tdap is short the coste effectiveness did not support more frequent uh administration of Tdap or AP and so we await a better vaccine uh that will be more protective and could could boost immunity um could we get the vote language back up for the vfc vote so because uh we do need to um because TD is not currently included in the vfc program um there's a a proposal to um uh to add it to the vfc resolution and um this is the proposed vote language um are there any questions about this and do we have a motion Dr Daly motion to accept this wording for okay uh Dr long has moved to accept the wording uh Dr cotton I second that uh and Dr cotton has seconded so um we will be voting on this for the vfc program um later on when we do our votes are there any additional questions or comments or discussion on this so we break for five make a couple minutes on the line yeah so um we're going to take a short break just just a a few minutes uh to allow us to get our public comment speakers on the line so those of you who are um intending on getting up out of your chair don't go very far away because we're going to be reconvening in just a few minutes thank you