Pawg neeg saib xyuas FDA pom zoo Moderna ob koob tshuaj tiv thaiv Covid rau cov menyuam hnub nyoog 6 txog 17 xyoo

Moderna ob koob tshuaj tiv thaiv Covid-19 rau cov menyuam yaus hnub nyoog 6 txog 17 xyoo tau txais kev pom zoo los ntawm Food and Drug Administration pawg thawj coj ntawm cov kws paub txog kev txhaj tshuaj ywj pheej rau hnub Tuesday, ib kauj ruam tseem ceeb ntawm txoj hauv kev los faib rau cov menyuam yaus.

Pawg neeg ua haujlwm tau pom zoo pom zoo rau kev txhaj tshuaj rau hauv cov menyuam yaus hauv tsev kawm ntawv qib siab tom qab kev sib tham rau pej xeem txhua hnub uas ntsuas qhov kev txhaj tshuaj muaj txiaj ntsig zoo thiab muaj txiaj ntsig.

Cov kev mob tshwm sim feem ntau ntawm cov tshuaj tiv thaiv yog mob ntawm qhov chaw txhaj tshuaj, qaug zog, mob taub hau, ua daus no, mob nqaij thiab xeev siab. Tsis muaj tus mob myocarditis, ib hom mob plawv, tau pom nyob rau hauv Moderna qhov kev sim tshuaj rau cov menyuam yaus hauv cov hnub nyoog no, raws li FDA.

Cov kev sim tshuaj tau ua ua ntej omicron variant tau dhau los ua qhov tseem ceeb. Raws li qhov tshwm sim, nws tsis paub meej npaum li cas kev tiv thaiv ob qhov kev txhaj tshuaj yuav muab rau hauv pawg hnub nyoog tam sim no. Kev txhaj tshuaj thib peb hauv lwm pab pawg hnub nyoog tau pom tias muaj kev tiv thaiv omicron ntau ntxiv. Dr. Doran Fink, tus thawj coj loj hauv FDA lub chaw ua haujlwm tshuaj tiv thaiv, hais tias Moderna npaj siab muab cov ntaub ntawv sai sai ntawm koob thib peb rau cov hnub nyoog no.

Kev kwv yees ntawm cov tshuaj tiv thaiv kev ua tau zoo yog tawm tsam lwm yam Covid variants uas tsis muaj qhov tseem ceeb. Kev txhaj tshuaj rau cov tub ntxhais hluas muaj hnub nyoog 12 txog 17 xyoo tau kwv yees qhov ua tau zoo ntawm 90% tiv thaiv kab mob los ntawm alpha variant thiab thawj Covid hom uas tau kuaj pom thawj zaug hauv Wuhan, Tuam Tshoj, raws li FDA nthuav qhia. Kev txhaj tshuaj rau cov menyuam muaj hnub nyoog 6 txog 11 xyoos tau kwv yees kwv yees li ntawm 76% kev tiv thaiv kab mob los ntawm qhov sib txawv ntawm delta.

Cov menyuam yaus hnub nyoog 6 txog 11 xyoos yuav tau txais kev txhaj tshuaj me me 50 micrograms, thaum cov hluas hnub nyoog 12 txog 17 xyoo yuav tau txais cov koob tshuaj tib yam li cov neeg laus ntawm 100 micrograms.

Dr. Paul Offit, tus tswvcuab hauv pawg, tau hais tias ob koob tshuaj tsis zoo li yuav muab kev tiv thaiv mob me me los ntawm omicron's subvariants, tab sis lawv yuav muaj peev xwm tiv thaiv tus mob hnyav nrog koob thib peb. 

"Kuv xav tias cov txiaj ntsig tau pom meej dua qhov kev pheej hmoo, tab sis kuv hais tias nrog kev nplij siab uas tau muab los yuav muaj koob thib peb," said Offit, tus kws kho mob menyuam yaus thiab kws tshaj lij kis mob ntawm Children's Hospital of Philadelphia. “Yog tias qhov ntawd tsis muaj tseeb, kuv yuav tsis xav li ntawd. Peb tsis nyob hauv ib feem ntawm tus kabmob kis no ntxiv lawm. Nws yog lub sijhawm sib txawv. "

Txawm li cas los xij, Dr. Eric Rubin tau hais tias FDA yuav ib txwm tshuaj xyuas cov tshuaj tiv thaiv kev ua tau zoo raws li Covid yav dhau los hloov pauv tau muab tus kab mob hloov zuj zus sai npaum li cas thiab lub sijhawm nws siv los sau cov ntaub ntawv.

"Peb yuav tsum tau txiav txim siab raws li cov ntaub ntawv zoo tshaj plaws uas peb muaj, uas ib txwm yuav yog cov ntaub ntawv qub thaum muaj kev sib kis tas li," said Rubin, tus tswv cuab ntawm FDA thiab tus kws tshaj lij kis mob ntawm Harvard.

FDA xav tias yuav tso cai rau cov tshuaj tiv thaiv lub lim tiam no. Lub Chaw Saib Xyuas Kab Mob thiab Tiv Thaiv ces yuav tsum tau kos npe tawm ntawm kev txhaj tshuaj ua ntej cov khw muag tshuaj thiab cov kws kho mob tuaj yeem pib tswj hwm lawv. Kev txhaj tshuaj Moderna hauv pawg hnub nyoog no tuaj yeem pib sai li sai tau rau lub lim tiam tom ntej.

Cov menyuam yaus hnub nyoog 5 xyoos thiab siab dua twb tau txais kev txhaj tshuaj tiv thaiv Pfizer thiab BioNTech's tshuaj tiv thaiv, txawm tias ntau tus niam txiv tsis tau txhaj lawv cov menyuam. Kwv yees li 30% ntawm cov menyuam hnub nyoog 5 txog 11 xyoos thiab 60% ntawm cov tub ntxhais hluas hnub nyoog 12 txog 17 xyoos tau txhaj tshuaj tiv thaiv tag nrho thaum lub Rau Hli.

Kev tso cai ntawm Moderna tshuaj tiv thaiv rau menyuam yaus hnub nyoog 6 txog 17 xyoo yuav ua rau muaj kev tsim nyog raws li Pfizer txhaj tshuaj. Qhov no tseem yuav tso cai rau FDA tso cai rau Moderna thiab Pfizer cov tshuaj tiv thaiv rau cov menyuam yaus hnub nyoog qis dua 5 xyoos tib lub sijhawm. Pawg neeg saib xyuas FDA yuav ntsib hnub Wednesday los tham txog cov tshuaj tiv thaiv rau cov menyuam mos los ntawm cov menyuam kawm ntawv preschool, tsuas yog pab pawg hnub nyoog sab laug tsis tsim nyog tau txhaj tshuaj.

Moderna tau thov FDA tso cai rau nws cov tshuaj tiv thaiv rau cov hluas 12 txog 17 ntau tshaj ib xyoos dhau los thaum Lub Rau Hli 2021. Txawm li cas los xij, FDA tau txwv tsis pub tso cai txhaj tshuaj raws li cov ntaub ntawv thoob ntiaj teb qhia tias Moderna cov tshuaj tiv thaiv muaj kev pheej hmoo siab mob plawv, hu ua myocarditis. , dua li Pfizer txhaj. Moderna tau thov kev tso cai rau pawg hnub nyoog 6 txog 11 xyoo nyob rau lub Peb Hlis xyoo no.

Txawm li cas los xij, Asmeskas kev soj ntsuam tshuaj tiv thaiv mus txog lub Tsib Hlis tsis pom muaj kev pheej hmoo siab ntawm myocarditis nrog Moderna cov tshuaj tiv thaiv piv rau Pfizer txhaj tshuaj rau cov txiv neej hnub nyoog 18 txog 25 xyoos, hais tias FDA tus thawj coj Hui-Lee Wong thaum nthuav tawm rau pawg thawj coj hnub Tuesday.

Pfizer thiab Moderna txhaj tshuaj siv tib lub tshuab xa xov RNA. Lawv ob leeg muaj kev pheej hmoo ntawm myocarditis, feem ntau tom qab koob thib ob thiab feem ntau hauv cov txiv neej hluas thiab cov tub hluas. Txawm li cas los xij, CDC tau pom tias cov Kev pheej hmoo ntawm myocarditis yog siab dua los ntawm Covid kis tshaj qhov txhaj tshuaj tiv thaiv. Myocarditis feem ntau tshwm sim los ntawm kev kis kab mob.

CDC tau pom 635 tus neeg mob myocarditis hauv cov menyuam yaus thiab cov hluas hnub nyoog 5 txog 17 ntawm ntau dua 54 lab Pfizer koob tshuaj. Qhov kev pheej hmoo siab tshaj plaws ntawm cov tub hluas hnub nyoog 12 txog 17 xyoo tom qab koob thib ob, raws li CDC. Tsis pom muaj qhov pheej hmoo siab rau cov menyuam hnub nyoog 5 txog 11 xyoos, raws li CDC.

Muaj kwv yees li 46 tsab ntawv ceeb toom ntawm myocarditis ib lab thib ob koob tshuaj Pfizer ntawm cov tub hluas hnub nyoog 12 txog 15 xya hnub tom qab tau txais kev txhaj tshuaj, thiab 75 tshaj tawm ib lab thib ob koob tshuaj ntawm cov tub hluas hnub nyoog 16 txog 17 xyoo, raws li CDC cov ntaub ntawv.

Dr. Mark Sawyer, tus xibfwb ntawm kws kho menyuam yaus ntawm University of California San Diego thiab tus tswvcuab pov npav ib ntus hais tias "Kuv tau mob siab me ntsis los ntawm cov ntaub ntawv myocarditis thiab qhov zaus uas tau tshwm sim." "Yog li qhov ntawd yuav tsum tau saib xyuas kom zoo mus tom ntej thaum peb nthuav dav siv tshuaj tiv thaiv."

Cov neeg uas mob myocarditis tom qab txhaj tshuaj tiv thaiv feem ntau tau pw hauv tsev kho mob ob peb hnub raws li kev ceev faj. Txawm li cas los xij, cov neeg mob feem ntau zoo li zoo li zoo li peb lub hlis tom qab lawv kuaj mob, raws li CDC kev soj ntsuam ntawm cov kws kho plawv thiab lwm tus kws kho mob.

Txawm hais tias Covid feem ntau tsis tshua muaj mob hnyav rau cov menyuam yaus dua li cov neeg laus, ntau tus menyuam yaus tau pw hauv tsev kho mob nrog tus kabmob thaum lub sijhawm omicron nthwv dej ntau dua li lwm qhov ntawm tus kabmob kis, raws li CDC. Kwv yees li ob feem peb ntawm cov menyuam hnub nyoog 5 txog 17 xyoo tau pw hauv tsev kho mob nrog Covid muaj tsawg kawg yog ib qho mob hauv qab no, xws li ntshav qab zib lossis rog rog.

Dr. Katherine Fleming-Dutra, tus thawj coj ntawm CDC, hais rau pawg neeg saib xyuas FDA tias feem coob ntawm cov menyuam yaus tau mus pw hauv tsev kho mob vim lawv muaj Covid. Hauv lwm lo lus, feem ntau ntawm lawv tsis tau kuaj pom tus kab mob zoo tom qab nkag rau lwm qhov laj thawj kev noj qab haus huv.

Covid tau tua 202 tus menyuam hnub nyoog rau lub hlis txog rau 4 xyoos, 189 tus menyuam hnub nyoog 5 txog 11, thiab 443 tus menyuam yaus thiab cov hluas hnub nyoog 12 txog 17 xyoo txij li lub Ib Hlis 2020. Covid yog ib qho ntawm tsib qhov ua rau tuag rau cov menyuam yaus hnub nyoog qis dua 19 xyoo. -xyoo-laus, raws li CDC.

Nyob rau hauv tag nrho, ntau dua 13 lab tus menyuam yaus hnub nyoog qis dua 18 xyoo tau kis tus kabmob Covid thaum muaj kev sib kis, raws li CDC. Nws tsis paub meej tias pes tsawg tus menyuam yaus hauv Asmeskas tau ntev Covid. Txawm li cas los xij, kev tshawb fawb hauv tebchaws United Kingdom pom tias muaj txog li 8% ntawm cov menyuam yaus muaj Covid cov tsos mob rau ntau tshaj 12 lub lis piam. Ntev Covid tuaj yeem tshwm sim txawm tias tom qab kis mob me.

Ruth Link-Gelles, tus thawj coj ntawm CDC, tau hais tias nws yog "zoo heev" tias lwm qhov kev kis kab mob yuav tshwm sim raws li omicron subvariants tshiab, BA.4 thiab BA.5, pib nthuav dav ntxiv.

"Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias peb txhaj tshuaj tiv thaiv menyuam yaus, lossis muaj peev xwm txhaj tshuaj tiv thaiv menyuam yaus, tam sim no nrog kev cia siab tias kev txhaj tshuaj tiv thaiv yuav tiv thaiv lawv nyob rau lub hlis tom ntej, thaum peb xav tias yuav muaj kev nce ntxiv," Link-Gelles tau hais.