Moderna thov FDA tso cai tshuaj tiv thaiv Covid rau cov menyuam yaus hnub nyoog qis dua 6 xyoos

Moderna rau hnub Thursday tau hais kom Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj tso cai rau nws cov tshuaj tiv thaiv Covid rau cov menyuam yaus hnub nyoog 6 hli txog 5 xyoos.

Cov tshuaj tiv thaiv yog kwv yees li 51% zoo tiv thaiv kab mob los ntawm omicron variant rau cov menyuam yaus hnub nyoog qis dua 2 xyoos thiab kwv yees li 37% siv tau ntawm cov menyuam yaus hnub nyoog 2 txog 5 xyoos, raws li lub tuam txhab xov xwm tshaj tawm. Dr. Paul Burton, Moderna tus thawj saib xyuas kev kho mob, tau hais tias cov qib no zoo ib yam li kev tiv thaiv ob koob tshuaj rau cov neeg laus.

Kev tiv thaiv Moderna cov tshuaj tiv thaiv tiv thaiv kab mob tau poob qis heev los ntawm cov cim dej siab ntawm 90% kev ua tau zoo thaum txhaj tshuaj thawj zaug. Cov omicron variant, uas muaj ntau dua 30 qhov kev hloov pauv, yog qhov ua tau zoo ntawm kev khiav tawm cov tshuaj tiv thaiv kab mob uas thaiv tus kab mob los ntawm kev cuam tshuam tib neeg lub hlwb.

Txawm li cas los xij, Burton tau hais tias cov menyuam yaus hnub nyoog qis dua 6 xyoo uas tau txais ob koob tshuaj yuav tsum muaj kev tiv thaiv kev mob hnyav. Cov neeg laus muaj txog 1,000 units ntawm cov tshuaj tiv thaiv tom qab ob koob tshuaj tiv thaiv tsawg kawg yog 70% tiv thaiv kab mob hnyav, thaum cov menyuam yaus hauv txoj kev tshawb no muaj 1,400 txog 1,800 units ntawm cov tshuaj tiv thaiv tom qab ob koob tshuaj, nws hais.

Burton tau hais tias "Qhov peb paub yog tias cov tshuaj tiv thaiv kab mob no yuav txhais ua kev tiv thaiv siab heev tiv thaiv kab mob hnyav thiab mus pw hauv tsev kho mob," Burton tau hais. Tsis muaj ib tus menyuam hauv txoj kev kawm no tau pw hauv tsev kho mob nrog Covid, nws hais ntxiv.

Moderna npaj los kawm txog koob tshuaj ntxiv rau cov menyuam yaus hnub nyoog qis dua 6 xyoos nrog kev kho dua tshiab uas tsom rau omicron nrog rau tus kabmob thawj tus kabmob uas tau tshwm sim hauv Wuhan, Suav. Ib qho ntawm cov laj thawj kev txhaj tshuaj tiv thaiv kab mob tau poob qis heev vim tias qhov kev txhaj tshuaj tam sim no tseem tsom rau Wuhan hom, txawm tias tus kab mob no tau hloov zuj zus mus txij li nws tau pom thawj zaug thaum xyoo 2019.

Yog tias tau tso cai los ntawm FDA, cov menyuam yaus hnub nyoog qis dua 6 xyoos yuav tau txais ob koob tshuaj 25-microgram, ib koob me me dua li 100 microgram txhaj tam sim no tau pom zoo los ntawm FDA ua thawj koob tshuaj tiv thaiv rau cov neeg laus. Burton tau hais tias cov ntaub ntawv kev nyab xeeb rau cov menyuam yaus muaj kev nyab xeeb, nrog 0.2% ntawm cov menyuam yaus ua npaws ntawm 103 degrees Fahrenheit, lossis 40 degrees Celsius. Kwv yees li 17% ntawm cov menyuam yaus hnub nyoog qis dua 2 xyoos tau ua npaws ntawm 100 degrees Fahrenheit thaum me ntsis ntau dua 14% ntawm cov menyuam yaus hnub nyoog 2 txog 6 xyoos tau ua npaws, raws li xov xwm tshaj tawm Moderna tau tshaj tawm rau lub Peb Hlis ntawm nws cov txiaj ntsig kev tshawb fawb.

Cov menyuam yaus hnub nyoog qis dua 6 xyoos yog nyob rau hauv ib pawg hnub nyoog hauv Asmeskas uas tseem tsis tau txais kev txhaj tshuaj. FDA tau cog lus tias yuav txav mus sai sai rau kev tso cai txhaj tshuaj rau cov menyuam mos, menyuam yaus thiab cov menyuam kawm ntawv preschool thaum cov neeg tsim tshuaj tiv thaiv xa cov ntawv thov tiav.

Dr. Peter Marks, uas yog tus thawj coj ntawm FDA lub luag haujlwm rau cov tshuaj tiv thaiv, hais rau Senate pawg saib xyuas kev noj qab haus huv lub lim tiam no tias pawg tswj hwm tshuaj ntawm pawg kws pab tswv yim ywj pheej yuav ntsib los tshuaj xyuas cov ntaub ntawv tag nrho.

Marks tau hais tias "Peb yuav ua txhua qhov nrawm thaum peb tau ua tiav daim ntawv thov," Marks hais. Nws tau hais rau pawg neeg saib xyuas tias FDA yuav tshaj tawm lub sijhawm teem sijhawm nyob rau lub lim tiam tom ntej rau pawg neeg tawm tswv yim cov rooj sib tham ntawm ntau daim ntawv thov siv xwm txheej ceev. FDA tab tom ua kom tshem tawm ntau lub sijhawm muaj peev xwm rau pawg neeg sib ntsib hauv Lub Rau Hli, raws li tus neeg paub txog qhov teeb meem.

Cov niam txiv tau tos ntau hli rau txoj hauv kev los tiv thaiv lawv cov menyuam tiv thaiv tus kabmob. Thaum lub caij ntuj no omicron nthwv dej, cov menyuam yaus hnub nyoog qis dua 5 xyoos tau mus pw hauv tsev kho mob nrog Covid ntawm tsib zaug tus nqi ntawm tus kabmob kis mus rau qhov kawg, thaum delta tseem ceeb, raws Lub Chaw Tiv Thaiv thiab Tswj Xyuas Kab Mob. Kwv yees li 75% ntawm cov menyuam yaus hnub nyoog qis dua 11 xyoos tau kis tus kabmob Covid thaum Lub Ob Hlis, raws li cov ntaub ntawv tshaj tawm los ntawm CDC lub lim tiam no.

FDA tau pib nrhiav kev tso cai sai sai ntawm Pfizer's Covid tshuaj tiv thaiv rau cov menyuam yaus hnub nyoog qis dua 5 xyoos thaum Lub Ob Hlis los ntawm kev tshem tawm thawj ob koob tshuaj tiv thaiv peb zaug. Txawm li cas los xij, Pfizer txiav txim siab ncua nws daim ntawv thov thiab tos cov ntaub ntawv ntawm kev txhaj tshuaj thib peb, vim tias cov txiaj ntsig ntawm thawj ob koob tshuaj tsis zoo txaus.

Pfizer CEO Albert Bourla, hauv kev xam phaj podcast, hais tias thawj ob qhov kev txhaj tshuaj tsuas muaj 30% mus rau 40% kev ua tau zoo, tab sis nws cia siab tias qhov koob thib peb yuav txhim kho kev tiv thaiv zoo. Cov tshuaj tiv thaiv muaj qib peb-microgram dosing, ntau me dua li 30-micrograms siv rau cov neeg laus.

Bourla tau hais tias nws cia siab tias Pfizer cov tshuaj tiv thaiv yuav tau txais FDA tso cai rau lub Rau Hli.

Tau qhov twg los: https://www.cnbc.com/2022/04/28/moderna-asks-fda-to-authorize-covid-vaccine-for-kids-under-6-years-old.html