Isitofu esitsha se-Spikevax COVID-19 Sifumana iMvume kwi-US FDA

“Ukwamkelwa kwe-FDA kwe-Spikevax linyathelo elibalulekileyo kumlo ochasene nobhubhani we-COVID-19, iphawula isitofu sokugonya sesibini esivunyiweyo ukunqanda i-COVID-19. Uluntu lunokuqinisekiswa ukuba iSpikevax iyahlangabezana nemigangatho ephezulu ye-FDA yokhuseleko, ukusebenza kunye nomgangatho wokuvelisa ofunekayo kulo naliphi na iyeza elivunyiweyo ukuba lisetyenziswe eUnited States, utshilo uMkomishinala we-FDA obambeleyo uJanet Woodcock, MD "Ngelixa amakhulu ezigidi zeedosi zeModerna COVID. -19 Isitofu sokugonya sinikezelwe kubantu abaphantsi kogunyaziso losetyenziso olungxamisekileyo, siyaqonda ukuba kwabanye abantu, imvume ye-FDA yolu gonyo inokufaka ukuzithemba okongeziweyo ekwenzeni isigqibo sokugonywa.

I-Spikevax inokwakheka okufanayo kunye ne-EUA Moderna COVID-19 Vaccine kwaye ilawulwa njengoluhlu oluphambili lweedosi ezimbini, ngaphandle kwenyanga enye. I-Spikevax inokusetyenziswa ngokutshintshanayo kunye ne-EUA Moderna COVID-19 Vaccine ukubonelela ngothotho logonyo lwe-COVID-19. Ugonyo lweModerna COVID-19 luhlala lufumaneka phantsi kwe-EUA njengoluhlu lweedosi ezimbini eziphambili kubantu abaneminyaka eli-18 ubudala nangaphezulu, njengedosi yesithathu yoluhlu oluphambili lwabantu abaneminyaka eli-18 ubudala nangaphezulu abazimisele ukuba neentlobo ezithile zokugonywa komzimba, kunye nedosi enye ye-booster kubantu abaneminyaka eli-18 ubudala nangaphezulu ubuncinci iinyanga ezintlanu emva kokugqiba uthotho olungundoqo lwesitofu sokugonya. Ikwagunyaziswe ukuba isetyenziswe njenge-heterologous (okanye "xuba kwaye utshatise") idosi enye ye-booster kubantu abaneminyaka eli-18 ubudala nangaphezulu emva kokugqitywa kogonyo olusisiseko ngogonyo olwahlukileyo lwe-COVID-19.

“Iingcali zonyango nezenzululwazi ze-FDA zenze uphononongo olucokisekileyo lwedatha yesayensi kunye nolwazi olubandakanyiweyo kwisicelo esiphathelele kukhuseleko, ukusebenza, kunye nomgangatho wokwenziwa kweSpikevax. Oku kubandakanya uqinisekiso oluzimeleyo lohlalutyo olungeniswe yinkampani, uhlahlelo lwethu lwedatha, kunye novavanyo oluneenkcukacha lweenkqubo zokwenziwa kwemveliso, iindlela zovavanyo kunye nezixhobo zokuvelisa, ”utshilo uPeter Marks, MD, Ph.D. Iziko le-FDA loVavanyo lweBiologics kunye noPhando. “Ugonyo olukhuselekileyo nolusebenzayo lolona khuselo lwethu luchasene nobhubhani we-COVID-19, kubandakanya nokwahluka okujikelezayo ngoku. Uluntu lungaqinisekiswa ukuba olu gonyo luye lwamkelwa ngokuhambelana nemigangatho engqongqo yesayensi ye-FDA. ”

UVavanyo lwe-FDA lweDatha esebenzayo yokuVunywa kwabantu abaneminyaka eyi-18 nangaphezulu

Isicelo selayisensi yebhayoloji yeSpikevax (i-BLA) yakhela phezu kwedatha kunye nolwazi oluxhasa i-EUA, njengedatha yangaphambili kunye nekliniki, kunye neenkcukacha zenkqubo yokwenziwa kunye neendawo apho ugonyo lwenziwa khona. I-FDA ivavanya kwaye iqhube olwayo uhlalutyo lwedatha ukufumanisa ukuba ingaba ukhuseleko kunye nokusebenza kwesitofu sokugonya kubonisiwe kwaye kuyahambelana nomgangatho wokuvunywa, kwaye ingaba ulwazi lokwenziwa kunye noncedo luqinisekisa umgangatho wesitofu sokugonya kunye nokungaguquguquki. 

Ukwamkelwa kwe-Spikevax kusekwe kuvavanyo lwe-FDA kunye nohlalutyo lokhuseleko olulandelelweyo kunye nedatha esebenzayo evela kulingo oluqhubekayo olungahleliwe, olulawulwa yi-placebo, olumfamekileyo lwezonyango oluxhasa uDisemba ka-2020 i-EUA yeModerna COVID-19 Vaccine kunye nolwazi oluvela kwi-EUA. amava okwazisa ngakumbi ukhuseleko nokusebenza kakuhle. 

Uhlahlelo oluhlaziyiweyo lokumisela ukusebenza kwe-Spikevax lubandakanya i-14,287 yabafumana ugonyo kunye ne-14,164 yabamkeli be-placebo abaneminyaka eli-18 ubudala nangaphezulu ababengenabo ubungqina bosulelo lwe-SARS-CoV-2 phambi kokufumana idosi yokuqala. Idatha esetyenzisiweyo kuhlalutyo yafunyanwa ngaphambi kokuba kuvele ukwahluka kwe-Omicron. Ezi datha zibonise ukuba iSpikevax yayisebenza ngama-93% ekuthinteleni i-COVID-19, ngamatyala angama-55 e-COVID-19 ayenzeka kwiqela lokugonya kunye neemeko ezingama-744 ze-COVID-19 kwiqela le-placebo. Isitofu sokugonya besisebenza ngama-98% ekuthinteleni izifo ezimandundu.

UVavanyo lwe-FDA lweDatha yoKhuseleko ekuVunyweni kwabantu abaneminyaka eyi-18 nangaphezulu

Uhlalutyo lokhuseleko lwe-FDA lwe-Spikevax lubandakanya malunga ne-15,184 yabafumana isitofu kunye nabamkeli be-placebo abali-15,162 abaneminyaka eli-18 ubudala nangaphezulu, ngaphezu kwesiqingatha saba bathathi-nxaxheba baye balandelwa kwiziphumo zokhuseleko ubuncinane kwiinyanga ezine emva kwedosi yesibini. Phantse abathathi-nxaxheba be-7,500 ekuqaleni ababelwe ukuba bafumane i-Spikevax kwisigaba esingaboniyo solingo lweklinikhi olugqityiweyo ukulandelela ukhuseleko ubuncinane kwiinyanga ze-6 emva kwedosi yesibini.

Ezona ziphumo bezingalindelekanga zixhaphakile zixelwa ngabathathi-nxaxheba bolingo lwezonyango ibizintlungu, ububomvu nokudumba kwindawo ebekutofa kuyo, ukudinwa, intloko ebuhlungu, izihlunu okanye iintlungu zamalungu, ukubanda, isicaphucaphu/ukuhlanza, ukudumba i-lymph nodes phantsi kwengalo kunye nomkhuhlane.

Ukongeza, i-FDA yenze uphononongo olungqongqo lwedatha yovavanyo lokhuseleko lwasemva kogunyaziso olubhekiselele kwi-myocarditis (ukudumba kwemisipha yentliziyo) kunye ne-pericarditis (ukudumba kwezicubu ezijikeleze intliziyo) kulandela ugonyo lweModerna COVID-19 Vaccine kwaye yagqiba ukuba Idatha ibonisa imingcipheko eyongeziweyo ingakumbi phakathi kweentsuku ezisixhenxe emva kwedosi yesibini, kunye nomngcipheko ophezulu obonwayo kumadoda aneminyaka eli-18 ukuya kuma-24 ubudala. Idatha efumanekayo evela kulandelelo lwexeshana elifutshane icebisa ukuba abantu abaninzi baye bafumana isisombululo seempawu. Nangona kunjalo, abanye abantu bafuna uncedo lonyango olunzulu. Ulwazi alukabikho malunga neziphumo zempilo ezinokubakho zexesha elide. I-Spikevax Prescribing Information ibandakanya isilumkiso malunga nale mingcipheko.

I-FDA iqhube olwayo uvavanyo lomngcipheko wenzuzo isebenzisa imodeli ukuqikelela ukuba zingaphi na iimeko ezineempawu ze-COVID-19, ukulaliswa esibhedlele, indawo yokhathalelo olunzulu (ICU) kunye nokufa kwabantu abavela kwi-COVID-19 isitofu sokugonya kubantu abaneminyaka eli-18 nangaphezulu siyakuthintela ngokuchaseneyo. inani leemeko ezinokubakhona ze-myocarditis/pericarditis, ukulaliswa esibhedlele, ukulaliswa e-ICU kunye nokufa okunokunxulunyaniswa nesitofu sokugonya. I-FDA imisele ukuba uncedo lwesitofu sokugonya luyodlula umngcipheko we-myocarditis kunye ne-pericarditis kubantu abaneminyaka eyi-18 nangaphezulu.

I-FDA ifuna inkampani ukuba iqhube izifundo ze-postmarketing ukuze ihlole ngakumbi ingozi ye-myocarditis kunye ne-pericarditis emva kokugonywa nge-Spikevax. Olu phononongo luya kubandakanya uvavanyo lweziphumo zexesha elide phakathi kwabantu abaphuhla i-myocarditis emva kokugonywa nge-Spikevax. Ukongeza, nangona ingezizo iimfuno ze-FDA, inkampani izibophelele ekuqhubeni izifundo ezongezelelweyo zokhuseleko emva kokuthengisa, kubandakanya ukuqhuba isifundo sobhaliso lokukhulelwa ukuvavanya ukukhulelwa kunye neziphumo zosana emva kokufumana i-Spikevax ngexesha lokukhulelwa.

I-FDA inike esi sicelo uPhononongo oluPhambili. Imvume inikwe iModernaTX, Inc.