Kusintha Kwatsopano kwa COVID-19: FDA Ivomereza Ma Antibodies Atsopano Okhalitsa Otalikirapo

Zogulitsazo zimaloledwa kokha kwa anthu omwe sanatenge kachilombo ka SARS-CoV-2 komanso omwe sanakumanepo ndi munthu yemwe ali ndi kachilombo ka SARS-CoV-2. Chilolezocho chimafunanso kuti anthu akhale ndi:

• chitetezo chamthupi chocheperako kapena chofooka kwambiri chifukwa cha matenda kapena kumwa mankhwala ochepetsa chitetezo chamthupi kapena machiritso ndipo mwina sangakhudze chitetezo chokwanira pa katemera wa COVID-19 (zitsanzo za matenda otere kapena machiritso atha kupezeka mu pepala lazaumoyo osamalira) kapena;

• mbiri ya kukhudzidwa kwakukulu kwa katemera wa COVID-19 ndi/kapena zigawo zake za katemerayu, chifukwa chake katemera wa katemera wa COVID-19 yemwe alipo, malinga ndi dongosolo lovomerezeka kapena lovomerezeka, sikovomerezeka.

"Matemera atsimikizira kuti ndiye chitetezo chabwino kwambiri chopezeka ku COVID-19. Komabe, pali anthu ena omwe ali pachiwopsezo cha chitetezo chamthupi omwe sangakhale ndi chitetezo chokwanira pa katemera wa COVID-19, kapena omwe ali ndi mbiri yokhudzana ndi katemera wa COVID-19 ndipo chifukwa chake sangalandire ndipo amafunikira njira ina yopewera, "Anatero Patrizia Cavazzoni, MD, mkulu wa FDA's Center for Drug Evaluation and Research. "Zochita lero zikuloleza kugwiritsa ntchito kuphatikiza kwa ma antibodies awiri a monoclonal kuti achepetse chiopsezo chokhala ndi COVID-19 mwa anthu awa."

Mlingo umodzi wa Evusheld, woperekedwa ngati majekeseni awiri otsatizana otsatizana (jekeseni imodzi pa anti-monoclonal antibody, woperekedwa motsatizana nthawi yomweyo), atha kukhala othandiza popewera matenda asanachitike kwa miyezi isanu ndi umodzi. Evusheld siyololedwa kwa anthu payekhapayekha pochiza COVID-19 kapena popewa kukhudzana ndi COVID-19. Odwala akuyenera kukambirana ndi azaumoyo kuti awone ngati Evusheld ndi njira yoyenera yopewera kuti asadzadziwike.

Kupewa kutetezedwa ndi Evusheld sikulowa m'malo mwa katemera wa anthu omwe akulimbikitsidwa kulandira katemera wa COVID-19. A FDA avomereza katemera m'modzi ndikuloleza ena kuti aletse COVID-19 komanso zotsatira zoyipa zachipatala zomwe zimakhudzana ndi matenda a COVID-19, kuphatikiza kugona m'chipatala ndi imfa. A FDA amalimbikitsa anthu kuti alandire katemera ngati akuyenera. Dziwani zambiri za katemera wovomerezeka ndi FDA kapena wovomerezeka wa COVID-19. 

Ma antibodies a monoclonal ndi mapuloteni opangidwa ndi labotale omwe amatsanzira mphamvu ya chitetezo cha mthupi kulimbana ndi tizilombo toyambitsa matenda monga ma virus. Tixagevimab ndi cilgavimab ndi ma antibodies a monoclonal omwe amakhala kwanthawi yayitali omwe amawongoleredwa ndi puloteni ya spike ya SARS-CoV-2, yopangidwira kuletsa kulumikizidwa kwa kachilomboka ndikulowa m'maselo amunthu. Tixagevimab ndi cilgavimab zimamangiriza kumasamba osiyanasiyana, osaphatikizika pa protein ya spike ya kachilomboka.

Kutulutsidwa kwa EUA ndi kosiyana ndi kuvomereza kwa FDA. Pozindikira ngati angatulutse EUA, a FDA amawunika kuchuluka kwa umboni wasayansi womwe ulipo ndikuwunika mosamala zoopsa zilizonse zodziwika kapena zomwe zingachitike ndi zabwino zilizonse zomwe zimadziwika kapena zomwe zingachitike. Kutengera ndi kuwunika kwa FDA pazambiri zaumboni wasayansi womwe ulipo, bungweli latsimikiza kuti ndizomveka kukhulupirira kuti Evusheld ikhoza kukhala yothandiza kuti igwiritsidwe ntchito ngati kupewa kuwonetseredwa kwa anthu ena akuluakulu ndi ana (azaka 12 zakubadwa ndi kukulirapo zolemera). pafupifupi 40 kilogalamu). Bungweli latsimikizanso kuti phindu lomwe limadziwika komanso lomwe lingakhalepo la Evusheld, likagwiritsidwa ntchito molingana ndi zomwe wavomerezedwa, zimaposa zoopsa zomwe zimadziwika komanso zomwe zingachitike. Palibe njira zina zokwanira, zovomerezeka komanso zopezeka kwa Evusheld zopewera kukhudzana ndi COVID-19 mwa anthu ovomerezeka.

Zomwe zimachirikiza EUA iyi ya Evusheld zikuchokera ku PROVENT, kuyesa kosasinthika, kwakhungu kawiri, koyendetsedwa ndi placebo mwa achikulire opitilira zaka 59 kapena omwe ali ndi vuto lodziwikiratu lachipatala kapena pachiwopsezo chowonjezeka cha matenda a SARS-CoV-2 kwa ena. zifukwa omwe sanalandire katemera wa COVID-19 ndipo analibe mbiri ya matenda a SARS-CoV-2 kapena kuyezetsa kuti ali ndi kachilombo ka SARS-CoV-2 kumayambiriro kwa mlandu. Chotsatira chachikulu chomwe adayezetsa mumlanduwo chinali ngati woyeserera anali ndi mlandu woyamba wa COVID-19 atalandira Evusheld kapena placebo komanso tsiku la 183 la mlandu lisanafike. Muyeso uwu, anthu 3,441 adalandira Evusheld ndipo 1,731 adalandira placebo. Pakuwunika koyambirira, omwe adalandira Evusheld adawona kuti 77% yachepetsa chiopsezo chokhala ndi COVID-19 poyerekeza ndi omwe adalandira placebo, kusiyana kwakukulu. Mukuwunika kwina, kuchepetsa chiopsezo chokhala ndi COVID-19 kudasungidwa kwa omwe adalandira Evusheld m'miyezi isanu ndi umodzi. Chitetezo ndi mphamvu ya Evusheld kuti igwiritsidwe ntchito popewa kukhudzana ndi COVID-19 ikupitiliza kuunikiridwa.

Pansi pa EUA, zolemba zowona zomwe zimapereka chidziwitso chofunikira chokhudza kugwiritsa ntchito Evusheld popewa kukhudzana ndi COVID-19 monga momwe zavomerezedwera ziyenera kupezeka kwa othandizira azaumoyo komanso kwa odwala ndi osamalira. Zowonadi izi zikuphatikiza malangizo amomwe mungasinthire, zotsatira zoyipa zomwe zingachitike komanso kuyanjana kwamankhwala.

Zotsatira za Evusheld zomwe zingachitike ndi monga: hypersensitivity reaction (kuphatikiza anaphylaxis), kutuluka magazi pamalo obaya jekeseni, mutu, kutopa komanso chifuwa. 

Zowopsa zazikulu zamtima sizinachitike kawirikawiri mu PROVENT. Komabe, otenga nawo gawo ambiri adakumana ndi zovuta zoyipa zamtima (monga infarction ya myocardial ndi kulephera kwa mtima) atalandira Evusheld poyerekeza ndi placebo. Otsatirawa onse anali ndi zifukwa zowopsa za matenda a mtima kapena mbiri ya matenda a mtima asanayambe kutenga nawo mbali pa mayesero a zachipatala. Sizikudziwika ngati Evusheld adayambitsa zovuta zamtima izi.

A FDA akugwira ntchito ndi othandizira azachipatala omwe ali ndi chilolezo kuti awone zomwe zikuchitika motsutsana ndi mitundu ina iliyonse yapadziko lonse ya SARS-CoV-2 yomwe ili ndi chidwi ndipo yadzipereka kulankhulana ndi anthu pamene tikuphunzira zambiri.

EUA idaperekedwa ku AstraZeneca.