Ngo-Oktobha 22, ixesha laseMpuma,i-US FDAyamkelwe ngokusesikweni iVeklury (remdesivir) yaseGiliyadi ukuba isetyenziswe kubantu abadala abaneminyaka eli-12 nangaphezulu kwaye abanobunzima obungama-40 kg abafuna ukulaliswa esibhedlele kunye nonyango lwe-COVID-19. Ngokutsho kwe-FDA, iVeklury ngoku kuphela kwe-FDA-evunyiweyo yonyango lwe-COVID-19 eUnited States.

Ukuchaphazeleka kwezi ndaba, izabelo zaseGiliyadi zinyuke nge-4.2% emva kwemarike. Kuyafaneleka ukuqaphela ukuba uTrump wayekhe wathetha esidlangalaleni ukuba i-Remdesivir "lunyango olubalulekileyo kwizigulana ezisesibhedlele ezinenyumoniya entsha ye-coronary" kwaye wabongoza i-FDA ukuba ivume ichiza ngokukhawuleza. Emva kokuba kufunyaniswe ukuba unenyumoniya entsha, wamkela i-Remdesivir.

Ngokutsho kwe “Amaxesha eMali” ingxelo, izazinzulu zavakalisa ukuxhalaba ngolu kwamkelwa. Inkxalabo enjalo ibangelwa kukuba unyulo lukamongameli waseMelika luza kubanjwa kwiiveki ezimbini ezizayo. Imvume ye-FDA isenokuba ngenxa yoxinzelelo lwezopolitiko, kwaye kuyafuneka ukubonisa ukuba urhulumente usabela ngokukhutheleyo kulo bhubhani. NgoMeyi walo nyaka, owayesakuba nguMongameli wase-US u-Barack Obama wayigxeka impendulo yolawulo lukaTrump kwisibetho esitsha senyumoniya, esithi“Intlekele enkulu ngokupheleleyo.“

Ukongeza kwizinto zezopolitiko, kwinkomfa ye-WHO yesiqhelo yabezindaba ye-coronary pneumonia entsha ngo-Okthobha we-16, uMlawuli-Jikelele we-WHO uTedros wathi iziphumo zaphakathi kwexesha "lovavanyo lwe-solidarity" zibonise ukuba i-remdesivir kunye ne-hydroxychloroquine, i-Lopinavir / ritonavir kunye nonyango lwe-interferon. zibonakala zinefuthe elincinane kwizinga lokufa leentsuku ezingama-28 okanye ubude besibhedlele esihlala kwizigulana ezisezibhedlele. Ulingo lwe-WHO lubonise ukuba i-Redecivir ayisebenzikwiimeko ezinzima.I-301 ye-2743 izigulane ezigula kakhulu kwiqela le-Redecive zafa, kwaye i-303 ye-2708 izigulane ezigula kakhulu kwiqela lolawulo lafa; izinga lokusweleka laliyi-11, ngokulandelelanayo. I-% kunye ne-11.2%, kunye ne-28-day curve ye-Remdesivir kunye neqela lolawulo zidibene kakhulu, kwaye akukho mahluko ubalulekileyo.

Kodwa ngaphambi kokuba iziphumo zolu manyano kunye novavanyo lokuncedana luphume,IGiliyadi yasingenisa ukuba samkelwe ngoAgasti.

Ukwamkelwa kwe-Remdesivir kusekwe kwiziphumo zolingo lweklinikhi olulawulwa ngokungacwangciswanga oluthathu olubandakanya abaguli ababelaliswe esibhedlele ngenxa yobuzaza be-COVID-19. Ulingo lweklinikhi olungakhethiyo, olungaboniyo kabini, olulawulwa yi-placebo oluqhutywa liZiko leSizwe leZigulo zoKwalisa kunye neZifo ezosulelayo luvavanye ixesha elithathayo ukuba izigulana ziphile kwi-COVID-19 kwiintsuku ezingama-29 zokufumana unyango. Ulingo luqwalasele abaguli abayi-1062 abanobungqongqo, obuphakathi, kunye nobungqongqo be-COVID-19 abangeniswe esibhedlele kwaye bafumana i-remdesivir (abantu abangama-541) okanye i-placebo (abantu abangama-521), kunye nonyango oluqhelekileyo. Ixesha eliphakathi lokuchacha kwi-COVID-19 yayiziintsuku ezili-10 kwiqela le-remdesivir kunye neentsuku ezili-15 kwiqela le-placebo, kwaye umahluko wawubalulekile ngokwezibalo. Ngokubanzi, xa kuthelekiswa neqela le-placebo, ithuba lokuphuculwa kwezonyango ngosuku lwe-15 kwiqela le-Remdesivir laliphezulu kakhulu ngokwezibalo.

Intloko ye-FDA, uStephen Hahn, uthe le mvume ixhaswa yidatha evela kwizilingo ezininzi zeklinikhi ezithe i-arhente ivavanye ngokungqongqo kwaye imele inyathelo elibalulekileyo lezenzululwazi.r ubhubhani wesithsaba esitsha.