O le oloa e na'o le fa'atagaina mo i latou e le'o a'afia i le taimi nei i le SARS-CoV-2 virus ma e le'i leva ona fa'aalia i se tagata ua a'afia i le SARS-CoV-2. E manaʻomia foʻi e le faʻatagaga ia tagata taʻitoʻatasi pe iai:

• fa'aletonu i le ogaoga fa'aletonu o le puipuiga ona o se ma'i po'o ona o le inuina o vaila'au fa'ama'i po'o togafitiga ma e le mafai ona fa'apipi'iina se tali fa'asa'o lelei ile tui COVID-19 (o fa'ata'ita'iga o ia tulaga fa'afoma'i po'o togafitiga e mafai ona maua ile pepa fa'amatalaga mo le soifua maloloina. tausi ma'i) po'o;

• ose tala'aga o ni fa'alavelave matuia i se tui COVID-19 ma/po'o ni vaega (s) o na tui, o lea e le fautuaina ai le tui i se tui COVID-19 avanoa, e tusa ai ma le fa'atonuga po'o le fa'atonuga fa'atulagaina.

“O tui ua faʻamaonia o le puipuiga sili lea e maua mai le COVID-19. Ae ui i lea, o loʻo i ai nisi tagata faʻafefeteina puipuia e ono le mafai ona faʻapipiʻiina le tali atu i le tui puipuia o le COVID-19, poʻo i latou o loʻo i ai se talaʻaga o ni faʻalavelave matuia i se tui COVID-19 ma o lea e le mafai ai ona maua se tui ma manaʻomia se isi puipuiga, ” o le tala lea a Patrizia Cavazzoni, MD, le faatonu o le FDA's Center for Drug Evaluation and Research. "O le gaioiga o aso nei e faʻatagaina ai le faʻaogaina o le tuʻufaʻatasiga o lua monoclonal antibodies e faʻaitiitia ai le lamatiaga o le atiaʻe o le COVID-19 i nei tagata."

E tasi le fua o le Evusheld, fa'atonuina e lua tui fa'asolosolo fa'atasi (tasi tui i le monoclonal antibody, tu'uina fa'asolosolo vave), e ono aoga mo le puipuia a'o le'i fa'aalia mo le ono masina. E le fa'atagaina Evusheld mo tagata ta'ito'atasi mo togafitiga ole COVID-19 po'o le puipuia ole COVID-19 pe a uma ona fa'aalia. E tatau i tagata ma'i ona talanoa ma latou tausi soifua maloloina e iloa ai pe o le Evusheld o se filifiliga talafeagai e puipuia ai a'o le'i fa'aalia mo i latou.

O le puipuiga a'o le'i fa'aalia ma Evusheld e le o se suitulaga mo le tui i tagata ta'ito'atasi o lo'o fautuaina ai le tui COVID-19. Ua fa'atagaina e le FDA se tui e tasi ma fa'atagaina isi e puipuia le COVID-19 ma i'uga ogaoga fa'afoma'i e feso'ota'i ma fa'ama'i COVID-19, e aofia ai le falema'i ma le oti. O lo'o una'ia e le FDA tagata lautele ina ia fai se tui pe a agava'a. A'oa'o atili e uiga i tui COVID-19 ua fa'atagaina e le FDA pe fa'atagaina.

Monoclonal antibodies o polotini na faia ile falesuesue e fa'atusaina le malosi ole tino puipuia e tetee atu ai fa'ama'i fa'ama'i e pei ole virus. O le Tixagevimab ma le cilgavimab o faʻamaʻi faʻamaʻi umi o loʻo galue e faʻatatau i le polotini spike o le SARS-CoV-2, ua fuafuaina e poloka ai le pipii o le siama ma ulufale i totonu o sela o tagata. O le Tixagevimab ma le cilgavimab e fusifusia i nofoaga eseese, e le o fa'atasi i luga ole polotini spike ole siama.

O le tuʻuina atu o se EUA e ese mai le faʻatagaina a le FDA. I le fuafuaina pe tu'uina atu se EUA, e iloilo e le FDA le aofa'iga o fa'amaoniga fa'asaienisi o lo'o avanoa ma fa'apaleni ma le fa'aeteete so'o se fa'afitauli e iloa po'o fa'alavelave fa'atasi ma so'o se fa'amanuiaga iloa po'o fa'amanuiaga o le oloa. E tusa ai ma le iloiloga a le FDA i le aofaʻi o faʻamaoniga faʻasaienisi o loʻo maua, ua fuafuaina e le lala sooupu e talafeagai le talitonu e ono aoga Evusheld mo le faʻaaogaina e fai ma puipuiga aʻo leʻi faʻaalia i nisi tagata matutua ma tamaiti tamaiti (12 tausaga ma matutua atu le mamafa. a itiiti ifo i le 40 kilokalama). Ua fa'amautu fo'i e le lala sooupu o fa'amanuiaga e iloa ma ono mafai a Evusheld, pe a fa'aogaina e ogatasi ma aiaiga ma aiaiga o le fa'atagaga, e sili atu nai lo le iloa ma le ono a'afia o le oloa. E leai ni auala talafeagai, fa'amaonia ma avanoa mo Evusheld mo le puipuia o le COVID-19 i le faitau aofa'i fa'atagaina.

O faʻamaumauga muamua e lagolagoina ai lenei EUA mo Evusheld e mai i le PROVENT, o se faʻataʻitaʻiga faʻapitoa, lua-tauaso, faʻataʻitaʻiga faʻapitoa i tagata matutua e sili atu i le 59 tausaga poʻo faʻatasi ma se maʻi faʻamaʻi faʻamaʻi faʻamaʻi poʻo le faʻateleina o le lamatiaga o le SARS-CoV-2 faʻamaʻi mo isi. mafua'aga e le'i maua se tui COVID-19 ma e leai se tala'aga o le SARS-CoV-2 fa'ama'i po'o se su'ega lelei mo le SARS-CoV-2 i le amataga o le fa'amasinoga. O le taunuuga autu na fuaina i le faamasinoga pe o se tagata na auai i le faamasinoga na i ai se mataupu muamua o le COVID-19 ina ua uma ona maua Evusheld poʻo placebo ma aʻo leʻi oʻo i le aso 183 o le faamasinoga. I lenei faamasinoga, e 3,441 tagata na mauaina Evusheld ma 1,731 na mauaina se placebo. I le suʻesuʻega muamua, na vaʻaia e le au Evusheld le 77% faʻaititia le lamatiaga o le atiaʻe o le COVID-19 pe a faʻatusatusa ia i latou na mauaina se placebo, o se eseesega taua tele. I faʻamatalaga faʻaopoopo, o le faʻaititia o le lamatiaga o le atiaʻe o le COVID-19 na faʻatumauina mo Evusheld na mauaina i le ono masina. O le saogalemu ma le aoga o Evusheld mo le faʻaaogaina i le puipuia o le COVID-19 o loʻo faʻaauau pea ona iloiloina.

I lalo o le EUA, o pepa faʻamatalaga e tuʻuina atu ai faʻamatalaga taua e uiga i le faʻaaogaina o le Evusheld i le puipuia o le COVID-19 aʻo leʻi faʻaalia e pei ona faʻatagaina e tatau ona faʻaavanoaina i tagata tausi soifua maloloina ma tagata mamaʻi ma tagata tausi. O nei pepa o fa'amatalaga e aofia ai fa'atonuga o tui, a'afiaga e ono tutupu ma fegalegaleai o vaila'au.

O a'afiaga e ono a'afia ole Evusheld e aofia ai: fa'aoso fa'ama'i (e aofia ai anaphylaxis), tafetotoi ile nofoaga o tui, ulu, vaivai ma tale.

E seasea ona tupu ni fa'alavelave matuia ile fatu ile PROVENT. Ae ui i lea, o le tele o tagata suʻesuʻe na i ai ni faʻalavelave matuia o le fatu (pei o le myocardial infarction ma le faʻaletonu o le fatu) ina ua uma ona maua Evusheld pe a faʻatusatusa i le placebo. O nei tagata auai uma na i ai tulaga lamatia mo maʻi fatu poʻo se talaʻaga o le maʻi cardiovascular aʻo leʻi auai i le faʻataʻitaʻiga falemaʻi. E le o manino pe na mafua e Evusheld nei faʻalavelave faʻalavelave fatu.

Ole FDA o loʻo galulue faʻatasi ma sponsors o togafitiga uma ua faʻatagaina nei e suʻesuʻe le gaioiga e faasaga i soʻo se faʻaogaina o le SARS-CoV-2 i le lalolagi atoa ma e naunau e fesoʻotaʻi ma tagata lautele a o tatou aʻoaʻoina atili.

O le EUA na tuʻuina atu i AstraZeneca.

OA MEA E AVEA MAI LENEI TUSI:

The primary data supporting this EUA for Evusheld are from PROVENT, a randomized, double-blind, placebo-controlled clinical trial in adults greater than age 59 or with a prespecified chronic medical condition or at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine and did not have a history of SARS-CoV-2 infection or test positive for SARS-CoV-2 infection at the start of the trial.
Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Evusheld may be effective for use as pre-exposure prevention in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms).
However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,”.