Ngo-Okthoba 22, isikhathi saseMpumalanga,i-US FDAigunyazwe ngokusemthethweni i-antiviral Veklury (remdesivir) yaseGileyadi ukuthi isetshenziswe kubantu abadala abaneminyaka eyi-12 nangaphezulu futhi enesisindo okungenani esingu-40 kg abadinga ukulaliswa esibhedlela kanye nokwelashwa kwe-COVID-19. Ngokusho kwe-FDA, i-Veklury njengamanje ukuphela kokwelashwa okugunyazwe yi-FDA kwe-COVID-19 e-United States.

Ethintwe yilezi zindaba, amasheya aseGileyadi akhuphuke ngo-4.2% ngemuva kwemakethe. Kuyaphawuleka ukuthi uTrump uke washo esidlangalaleni ukuthi i-Remdesivir "iyindlela yokwelapha ebalulekile ezigulini ezilaliswe esibhedlela ezinenyumoniya entsha ye-coronary" futhi wanxusa i-FDA ukuthi ivume umuthi ngokushesha. Ngemuva kokuthi kutholwe ukuthi unenyumoniya entsha yenhliziyo, waphinde wayamukela i-Remdesivir.

Ngokusho kwe-“Izikhathi Zezezimali” umbiko, ososayensi bazwakalisa ukukhathazeka ngokugunyazwa. Ukukhathazeka okunjalo kungenxa yokuthi ukhetho lukamongameli weMelika luzakwenziwa kumaviki amabili azayo. Ukugunyazwa kwe-FDA kungenzeka kungenxa yengcindezi yezepolitiki, futhi kuyadingeka ukukhombisa ukuthi uhulumeni uyasabela Ngentshiseko kulolu bhubhane. NgoMeyi walo nyaka, owayenguMongameli waseMelika u-Barack Obama wagxeka impendulo yabaphathi bakaTrump kubhubhane olusha lwe-pneumonia, walibiza ngokuthi“inhlekelele eyisiphithiphithi ngokuphelele.“

Ngaphezu kwezinto zezepolitiki, esithangamini sabezindaba esijwayelekile se-WHO se-coronary pneumonia entsha ngo-Okthoba 16, uMqondisi-Jikelele we-WHO uTedros uthe imiphumela yamaphakathi nethemu "yokuhlolwa kobumbano" ikhombisa ukuthi i-remdesivir ne-hydroxychloroquine, iLopinavir/ritonavir kanye nokwelashwa kwe-interferon. kubonakala kunomthelela omncane ezingeni lokufa kwezinsuku ezingama-28 noma ubude besibhedlela ezigulini ezilaliswe esibhedlela. Uhlolo lwe-WHO lwabonisa ukuthi i-Redecivir ayisebenzi nezeezimweni ezinzima.Iziguli ezingu-301 kwezingu-2743 ezazigula kakhulu eqenjini le-Redecive zashona, futhi iziguli ezingu-303 kwezingu-2708 ezazigula kakhulu eqenjini lokulawula zafa; izinga lokufa laliyi-11, ngokulandelana. % Futhi u-11.2%, kanye nejika lokufa lezinsuku ezingama-28 le-Remdesivir kanye neqembu lokulawula kudlulelene kakhulu, futhi cishe awukho umehluko obalulekile.

Kodwa ngaphambi kokuthi kuphume imiphumela yalokhu kuhlola ubumbano nokusizana okuhlanganyelwe,IGileyadi yasithumela ukuba sigunyazwe ngo-August.

Ukugunyazwa kwe-Remdesivir kusekelwe emiphumeleni yokuhlolwa kwemitholampilo okuthathu okulawulwa ngokungahleliwe okubandakanya iziguli ezilaliswe esibhedlela ngenxa yobucayi be-COVID-19. Ukuhlolwa komtholampilo okungahleliwe, okungaboni kabili, okulawulwa yi-placebo okwenziwa yi-National Institute of Allergy and Infectious Diseases kuhlaziye isikhathi esisithathayo ukuze iziguli zilulame ku-COVID-19 zingakapheli izinsuku ezingama-29 zelashwe. Icala liqaphele iziguli eziyi-1062 ezine-COVID-19 emnene, emaphakathi, futhi eqinile ezingeniswe esibhedlela futhi zathola i-remdesivir (abantu abangama-541) noma i-placebo (abantu abangama-521), kanye nokwelashwa okujwayelekile. Isikhathi esimaphakathi sokululama ku-COVID-19 kwakuyizinsuku eziyi-10 eqenjini le-remdesivir kanye nezinsuku eziyi-15 eqenjini le-placebo, futhi umehluko wawubalulekile ngokwezibalo. Ngokuvamile, uma kuqhathaniswa neqembu le-placebo, ithuba lokuthuthuka komtholampilo ngosuku lwe-15 eqenjini le-Remdesivir laliphezulu kakhulu ngokwezibalo.

Inhloko ye-FDA, uStephen Hahn, ithe lokhu kugunyazwa kusekelwa idatha evela ezivivinyweni eziningi zemitholampilo i-ejensi eye yazihlaziya futhi imele ingqophamlando ebalulekile yesayensi.r ubhubhane olusha lomqhele.