Umuthi omusha we-Spikevax COVID-19 Uthola Ukugunyazwa kwa-US FDA

“Ukugunyazwa kwe-FDA kwe-Spikevax kuyisinyathelo esibalulekile ekulweni nobhubhane lwe-COVID-19, okumaka umuthi wokugoma wesibili ogunyazwe ukuvimbela i-COVID-19. Umphakathi ungaqinisekiswa ukuthi i-Spikevax ihlangabezana nezindinganiso eziphakeme ze-FDA zokuphepha, ukusebenza kahle kanye nekhwalithi yokukhiqiza edingekayo kunoma yimuphi umuthi wokugoma ogunyazwe ukusetshenziswa e-United States," kusho Ibamba likaKhomishana we-FDA uJanet Woodcock, MD "Ngenkathi amakhulu ezigidi zemithamo yeModerna COVID. -19 Umuthi wokugoma unikezwe abantu abangaphansi kokugunyazwa ukusetshenziswa kwezimo eziphuthumayo, siyaqonda ukuthi kwabanye abantu, ukugunyazwa kwe-FDA kwalo mgomo kungase kufake ukuzethemba okwengeziwe ekwenzeni isinqumo sokugoma.”

I-Spikevax inokwakheka okufanayo njenge-EUA Moderna COVID-19 Vaccine futhi isetshenziswa njengochungechunge oluyinhloko lwemithamo emibili, ngokwehlukana kwenyanga eyodwa. I-Spikevax ingasetshenziswa ngokushintshana ne-EUA Moderna COVID-19 Vaccine ukuhlinzeka ngochungechunge lokugomela i-COVID-19. Umuthi wokugomela iModerna COVID-19 usatholakala ngaphansi kwe-EUA njengochungechunge lokuqala lwemithamo emibili kubantu abaneminyaka eyi-18 nangaphezulu, njengomthamo wesithathu oyinhloko wochungechunge lwabantu abaneminyaka eyi-18 nangaphezulu abazimisele ngokuba nezinhlobo ezithile zokuzivikela komzimba, futhi njengedosi elilodwa elikhuthazayo labantu abaneminyaka engu-18 nangaphezulu okungenani izinyanga ezinhlanu ngemva kokuqeda uchungechunge oluyinhloko lomgomo. Igunyazwe futhi ukuthi isetshenziswe njenge-heterologous (noma “hlanganisa uphinde ufanise”) umthamo owodwa we-booster kubantu abaneminyaka engu-18 nangaphezulu ngemva kokuphothulwa kokugoma okuyisisekelo ngomuthi wokugomela ohlukile otholakalayo we-COVID-19.

“Ochwepheshe bezokwelapha nezesayensi be-FDA benze ukuhlola okuphelele kwedatha yesayensi nolwazi olufakwe esicelweni esiphathelene nokuphepha, ukusebenza kahle, kanye nekhwalithi yokukhiqiza ye-Spikevax. Lokhu kufaka phakathi ukuqinisekiswa okuzimele kwe-ejensi kokuhlaziywa okulethwe yinkampani, ukuhlaziya kwethu idatha, kanye nokuhlolwa okuningiliziwe kwezinqubo zokukhiqiza, izindlela zokuhlola nezindawo zokukhiqiza, "kusho uPeter Marks, MD, Ph.D., umqondisi wezokukhiqiza. i-FDA's Center for Biologics Evaluation and Research. “Imithi yokugoma ephephile nesebenzayo iyisivikelo sethu esingcono kakhulu ngokumelene nobhubhane lwe-COVID-19, okuhlanganisa nezinhlobonhlobo ezisatshalaliswa njengamanje. Umphakathi ungaqinisekiswa ukuthi lo mgomo ugunyazwe ngokuhambisana nezindinganiso zesayensi eziqinile ze-FDA.”

Ukuhlolwa Kwedatha Ye-FDA Yempumelelo Yokugunyazwa Kwabantu Abaneminyaka engu-18 nangaphezulu

Isicelo selayisense ye-Spikevax biologics (BLA) yakhela phezu kwedatha nolwazi olusekela i-EUA, njengedatha yomtholampilo kanye nemininingwane yomtholampilo, kanye nemininingwane yenqubo yokukhiqiza kanye nezindawo lapho umgomo wenziwe khona. I-FDA ihlola futhi yenze okwayo ukuhlaziya idatha ukuze inqume ukuthi ingabe ukuphepha nokusebenza komgomo kubonisiwe futhi kuyahlangabezana nezinga lokugunyazwa, kanye nokuthi ulwazi lokukhiqiza nolwazi lwesikhungo luyaqinisekisa yini ikhwalithi nokuvumelana komgomo. 

Ukugunyazwa kwe-Spikevax kusekelwe ekuhlolweni nasekuhlaziyweni kwe-FDA kwedatha elandelwayo yokuphepha nempumelelo evela esivivinyweni somtholampilo esiqhubekayo esingahleliwe, esilawulwa yi-placebo, esiphuphuthekiswe esisekela i-EUA kaDisemba 2020 yoMgonyo weModerna COVID-19 kanye nolwazi oluvela ngemuva kwe-EUA. isipiliyoni sokwazisa okwengeziwe ukuphepha nokusebenza ngempumelelo. 

Ukuhlaziya okubuyekeziwe ukuze kutholwe ukusebenza kahle kwe-Spikevax kufaka phakathi abamukeli bemithi yokugoma abangu-14,287 kanye nabamukeli be-placebo abangu-14,164 abaneminyaka engu-18 nangaphezulu ababengenabo ubufakazi bokutheleleka nge-SARS-CoV-2 ngaphambi kokuthola umthamo wokuqala. Idatha esetshenziselwa ukuhlaziya yaqoqwa ngaphambi kokuvela kwe-Omicron. Le datha ibonise ukuthi i-Spikevax isebenze kahle ngo-93% ekuvimbeleni i-COVID-19, ngamacala angama-55 e-COVID-19 avela eqenjini lokugoma kanye namacala angama-744 e-COVID-19 eqenjini le-placebo. Umuthi wokugoma uphinde wasebenza ngama-98% ekuvimbeleni izifo ezinzima.

Ukuhlolwa kwe-FDA Kwedatha Yokuphepha Yokugunyazwa Kwabantu Abaneminyaka eyi-18 nangaphezulu

Ukuhlaziywa kokuphepha kwe-FDA kwe-Spikevax kufaka cishe abamukeli bemithi yokugoma abayi-15,184 kanye nabamukeli be-placebo abangu-15,162 abaneminyaka engu-18 nangaphezulu, ngaphezu kwesigamu salaba ababambiqhaza balandelwa ngemiphumela yokuphepha okungenani izinyanga ezine ngemva komthamo wesibili. Cishe ababambiqhaza abangu-7,500 ekuqaleni ababelwe ukuthola i-Spikevax esigabeni esiphuphuthekile sokuhlolwa komtholampilo baqede ukulandelela ukuphepha okungenani izinyanga eziyi-6 ngemva komthamo wesibili.

Imiphumela emibi evame ukubikwa ngabahlanganyeli bocwaningo lomtholampilo kwakuwubuhlungu, ububomvu nokuvuvukala endaweni yomjovo, ukukhathala, ikhanda elibuhlungu, ubuhlungu bemisipha noma amalunga, ukugodola, isicanucanu/ukuhlanza, ukuvuvukala kwama-lymph nodes ngaphansi kwengalo kanye nomkhuhlane.

Ukwengeza, i-FDA yenze ukuhlolwa okuqinile kwedatha yokuqapha ukuphepha kwangemva kokugunyazwa ephathelene ne-myocarditis (ukuvuvukala kwezicubu zenhliziyo) kanye ne-pericarditis (ukuvuvukala kwezicubu ezizungeze inhliziyo) kulandela ukugonywa Ngomgomo weModerna COVID-19 futhi inqume ukuthi idatha ibonisa ubungozi obukhulayo ikakhulukazi phakathi kwezinsuku eziyisikhombisa kulandela umthamo wesibili, nobungozi obubonakalayo obuphezulu kwabesilisa abaneminyaka engu-18 kuya kwengama-24 ubudala. Idatha etholakalayo evela ekulandeleni kwesikhathi esifushane iphakamisa ukuthi abantu abaningi baye baba nokuxazululwa kwezimpawu. Kodwa-ke, abanye abantu babedinga ukwesekwa kokunakekelwa okujulile. Ulwazi alukatholakali mayelana nemiphumela yezempilo yesikhathi eside engaba khona. I-Spikevax Prescribing Information ihlanganisa isexwayiso mayelana nalezi zingozi.

I-FDA yenze okwayo ukuhlola ubungozi benzuzo isebenzisa ukumodela ukubikezela ukuthi zingaki izehlakalo ezinezimpawu ze-COVID-19, ukulaliswa esibhedlela, ukungeniswa egunjini labagula kakhulu (ICU) kanye nokufa kwabantu abavela ku-COVID-19 umuthi wokugomela kubantu abaneminyaka engu-18 nangaphezulu ungavimbela uma kuqhathaniswa ne-COVID-18. inani lamacala angaba khona e-myocarditis/pericarditis, ukulaliswa esibhedlela, ukulaliswa e-ICU nokufa okungase kuhlotshaniswe nomgomo. I-FDA inqume ukuthi izinzuzo zomgomo zidlula ingozi ye-myocarditis kanye ne-pericarditis kubantu abaneminyaka engu-XNUMX nangaphezulu.

I-FDA idinga inkampani ukuthi yenze izifundo ze-postmarketing ukuze iqhubeke nokuhlola ubungozi be-myocarditis kanye ne-pericarditis kulandela ukugonywa nge-Spikevax. Lezi zifundo zizobandakanya ukuhlolwa kwemiphumela yesikhathi eside phakathi kwabantu ababa ne-myocarditis ngemva kokugonywa nge-Spikevax. Ngaphezu kwalokho, nakuba kungezona izidingo ze-FDA, inkampani izibophezele ekwenzeni izifundo zokuphepha ezengeziwe ngemva kokumaketha, okuhlanganisa ukwenza ucwaningo lokubhalisa ukukhulelwa ukuze kuhlolwe ukukhulelwa kanye nemiphumela yezinsana ngemva kokuthola i-Spikevax ngesikhathi sokukhulelwa.

I-FDA inikeze lolu hlelo lokusebenza Ukubuyekezwa Okubalulekile. Imvume inikezwe iModernaTX, Inc.