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Nyowani COVID-19 Yekuvandudza: FDA Inobvumidza Nyowani-Yakareba Inobata Monoclonal Antibodies

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Nhasi, iyo US Food and Drug Administration yakapa mvumo yekushandisa emergency (EUA) yeAstraZeneca's Evusheld (tixagevimab yakarongedzerwa necilgavimab uye inopihwa pamwe chete) yepre-exposure prophylaxis (kudzivirira) yeCCIDID-19 mune vamwe vanhu vakuru nevana ( ane makore 12 zvichikwira anorema anenge makirogiramu 40 [anenge makirogiramu 88]).

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Chigadzirwa chacho chinotenderwa chete kune avo vanhu vasina kutapukirwa nehutachiona hweSARS-CoV-2 uye vanga vasati vafumurwa kumunhu ane hutachiona hweSARS-CoV-2. Mvumo inodawo kuti vanhu vave ne:

• ari pakati nepakati kusvika kune akanyanya kukanganisa masoja ekudzivirira emuviri nekuda kwekurwara kana nekuda kwekutora mishonga yekudzivirira immunosuppressive kana marapirwo uye anogona kusakwanisa kusimudzira mhinduro yakakwana yekudzivirira kweCOVID-19 (mienzaniso yemamiriro ekurapa akadai kana marapirwo anogona kuwanikwa mugwaro rehutano. vanochengeta) kana;

• nhoroondo yekusawirirana kwakanyanya kune yekudzivirira yeCCIDID-19 uye/kana chikamu (s) chemishonga iyoyo, saka kubaiwa nejekiseni rinowanikwa reCOVID-19, zvinoenderana nechirongwa chakabvumidzwa kana chakatenderwa, hazvikurudzirwe.

“Majekiseni aratidza kuti ndiyo yakanakisa kudzivirira iripo kurwisa COVID-19. Nekudaro, kune vamwe vanhu vane immune panjodzi vanogona kusaisa mhinduro yakakwana yekudzivirira kweCCIDID-19, kana avo vane nhoroondo yekusagadzikana kwakanyanya kune yeCCIDID-19 yekudzivirira uye nekudaro havagone kugamuchira imwe uye vanoda imwe nzira yekudzivirira, ” akadaro Patrizia Cavazzoni, MD, director weFDA's Center for Drug Evaluation and Research. "Chiito chanhasi chinobvumidza kushandiswa kwemusanganiswa wemamonoclonal antibodies kudzikisa njodzi yekuva neCCIDID-19 muvanhu ava."

Chipimo chimwe cheEvusheld, chinoitwa semajekiseni maviri akatevedzana anotevedzana (jekiseni rimwe chete pa monoclonal antibody, rinopihwa nekukasira), rinogona kushanda pakudzivirira kusati kwasangana kwemwedzi mitanhatu. Evusheld haina mvumo kune vanhu kurapwa kweCCIDID-19 kana kudzivirira-post-exposure kudzivirira COVID-19. Varwere vanofanira kutaura nemutarisiri wavo wehutano kuti vaone kana Evusheld iri nzira yakakodzera yekudzivirira pre-kufumurwa kwavari.

Pre-exposure kudzivirira neEvusheld haitsivi yekudzivirira muvanhu vanokurudzirwa vaccine yeCOVID-19. Iyo FDA yakabvumidza vaccine imwe uye yakabvumidza vamwe kudzivirira COVID-19 uye zvakakomba mhedzisiro yekiriniki ine chekuita nehutachiona hweCCIDID-19, kusanganisira kuchipatara uye kufa. Iyo FDA inokurudzira veruzhinji kuti vabaiwe kana vachikodzera. Dzidza zvakawanda nezve FDA-yakatenderwa kana -yakatenderwa COVID-19 vaccine. 

Monoclonal antibodies mapuroteni akagadzirwa murabhoritari anotevedzera kugona kwemasoja edziviriro kurwisa zvirwere zvinokuvadza zvakaita semavhairasi. Tixagevimab uye cilgavimab ndeakareba-achibata monoclonal masoja ekudzivirira anonangidzirwa zvakanangana neiyo spike protein yeSARS-CoV-2, yakagadzirirwa kuvharidzira kubatanidzwa kwehutachiona uye kupinda mumaseru evanhu. Tixagevimab uye cilgavimab inosunga kune dzakasiyana, dzisiri-pamusoro masaiti pane spike protein yehutachiona.

Kuburitswa kweEUA kwakasiyana nemvumo yeFDA. Mukuona kuti voburitsa EUA here, iyo FDA inoongorora humbowo hwesainzi huripo uye nekungwarira kuenzanisa chero njodzi dzinozivikanwa kana dzingangoitika nechero inozivikanwa kana mabhenefiti echigadzirwa. Zvichienderana nekuongorora kweFDA kwehumbowo hwesainzi huripo, sangano rakaona kuti zvine musoro kutenda kuti Evusheld inogona kunge ichishanda sekudzivirira kusati kwaonekwa mune vamwe vanhu vakuru nevana (vane makore gumi nemaviri zvichikwira vachirema. anenge 12 makirogiramu). Iyo agency yakateya zvakare kuti iyo inozivikanwa uye inogona mabhenefiti eEvusheld, kana yakashandiswa zvinoenderana nematemu nemamiriro emvumo, inodarika iyo inozivikanwa uye inogona kuitika njodzi yechigadzirwa. Iko hakuna dzakakwana, dzakatenderwa uye dziripo dzimwe nzira dzeEvusheld dzekudzivirira-kuratidzwa kweCCIDID-40 muhuwandu hwakabvumidzwa.

Idzi data rekutanga rinotsigira iyi EUA yeEvusheld rinobva kuPROVENT, yakasarudzika, mapofu maviri, inodzorwa ne placebo muyedzo yekiriniki muvakuru vanopfuura makore makumi mashanu nemapfumbamwe kana neyakatsanangurwa chirwere chisingaperi kana panjodzi yakawedzera yehutachiona hweSARS-CoV-59 kune vamwe. zvikonzero vanga vasina kuwana hutachiona hweCCIDID-2 uye vasina nhoroondo yehutachiona hweSARS-CoV-19 kana kuongororwa kuti vane hutachiona hweSARS-CoV-2 pakutanga kwekuyedzwa. Mhedzisiro huru yakayerwa mukutongwa yaive yekuti mutori wenyaya aive nemhosva yekutanga yeCCIDID-2 mushure mekugamuchira Evusheld kana placebo uye zuva re19 risati rasvika. Mukuedza uku, vanhu 183 vakagamuchira Evusheld uye 3,441 vakagamuchira placebo. Mukuongorora kwekutanga, vanogamuchira Evusheld vakaona 1,731% yakaderedzwa njodzi yekuvandudza COVID-77 zvichienzaniswa nevaya vakagamuchira placebo, mutsauko wakakosha. Mune kumwe kuongorora, kudzikiswa kwenjodzi yekuvandudza COVID-19 kwakachengeterwa vanogamuchira Evusheld kuburikidza nemwedzi mitanhatu. Kuchengetedzeka uye kushanda kweEvusheld yekushandisa mukudzivirira-kuratidzwa kweCCIDID-19 kunoramba kuchiongororwa.

Pasi peEUA, mapepa echokwadi anopa ruzivo rwakakosha nezve kushandisa Evusheld mukudzivirira-kufumurwa kweCCIDID-19 semvumo inofanirwa kuwanikwa kune varapi vehutano uye kuvarwere nevachengeti. Aya mapepa echokwadi anosanganisira mirairo yedosing, zvinogona kuitika uye kusangana kwezvinodhaka.

Zvinogona kuitika neEvusheld zvinosanganisira: hypersensitivity reaction (kusanganisira anaphylaxis), kubuda ropa panzvimbo yejekiseni, kutemwa nemusoro, kuneta uye kukosora. 

Zviitiko zvakakomba zvemoyo zvaisawanzoitika muPROVENT. Zvisinei, vatori vechikamu vakawanda vakave nezviitiko zvakakomba zvemwoyo (zvakadai semyocardial infarction uye moyo kusakundikana) mushure mekugamuchira Evusheld kana ichienzaniswa ne placebo. Ava vatori vechikamu vese vaive nenjodzi dzechirwere chemoyo kana nhoroondo yechirwere chemoyo vasati vatora chikamu muyedzo yekiriniki. Hazvina kujeka kana Evusheld yakakonzera izvi zviitiko zvakaipa zvemoyo.

Iyo FDA iri kushanda nevatsigiri vevese vane mvumo yekurapa parizvino kuti vaongorore chiitiko ichi vachipesana nechero yepasi rose SARS-CoV-2 musiyano (s) wekufarira uye yakazvipira kutaurirana neveruzhinji sezvatinodzidza zvakawanda.

EUA yakapihwa kuAstraZeneca.

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Mupepeti mukuru ndiLinda Hohnholz.

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