WHO Zvino Inopa Kushandiswa Kwechimbichimbi kweNVX-CoV2373 COVID-19 Vaccine

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rakanyorwa Linda Hohnholz

Novavax, Inc., kambani yebiotechnology yakatsaurirwa kugadzira nekutengesa chizvarwa chinotevera chekudzivirira zvirwere zvinotapukira, uye Serum Institute of India Pvt. Ltd. (SII), mugadziri mukuru wepasi rose wejekiseni nehuwandu, nhasi azivisa kuti World Health Organisation (WHO) yapa Emergency Use Listing (EUL) yeNVX-CoV2373, Novavax 'recombinant nanoparticle protein-based COVID-19 vaccine ine Matrix. -M™ adjuvant, yekushanda kwekudzivirira kwevanhu vane makore gumi nemasere ekuberekwa zvichikwira kudzivirira chirwere chekoronavirus 18 chinokonzerwa neSARS-CoV-2019. EUL yanhasi ine chekuita nejekiseni rinogadzirwa uye kutengeswa neSII seCOVOVAX™, riini recombinant, adjuvated SARS-CoV-2 rS Vaccine, muIndia nenzvimbo dzine rezinesi. Imwezve EUL faira iri kuongororwa neWHO kuti vaccine itengeswe neNovavax pasi pezita remhando Nuvaxovid™.

Iyo EUL inofanidza Novavax 'COVID-19 yekudzivirira sekusangana neyakagadzika WHO zviyero zvemhando, chengetedzo uye kushanda. EUL inodiwa kuti itumire kunze kwenyika kune dzakawanda nyika, kusanganisira idzo dziri kutora chikamu muCOVAX Facility, iyo yakavambwa kuti igove nekugovera majekiseni zvakaenzana kune nyika dziri kutora chikamu uye hupfumi.

"Sarudzo yanhasi kubva kuWorld Health Organisation yakakosha kuti ive nechokwadi chekuwaniswa kwepasi rose kwekudzivirira kweprotein-based COVID-19 kumazana emamiriyoni evanhu pasi rese," akadaro Stanley C. Erck, Mutungamiriri uye Chief Executive Officer, Novavax. “Tinotenda World Health Organisation neongororo yayakaita. Tinotenda kuti vaccine iyi ichabatsira kukunda zvipingamupinyi zvekuwana majekiseni munzvimbo dzakawanda dzepasirese nekushandisa firiji yechinyakare inoshandiswa mumatanho ekugovera majekiseni aripo, ukuwo ichipa sarudzo zvichienderana nehunyanzvi hwakajairika uye hunonzwisiswa.

"EUL neWorld Health Organisation ikurudziro huru mukuita kuti mishonga yekudzivirira COVID-19 iwanikwe. Kudyidzana kwedu neNovavax kwakabudirira mukupa hutungamiriri hwehutano hweveruzhinji pasi rose uye nekuona kuti nyika dzese dzawana mukana wakawanda wemushonga unoshanda, "akadaro Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "COVOVAX ndiyo yekutanga yekudzivirira-protein-based COVID-19 vaccine sarudzo, ine yakaratidza kushanda uye yakatenderwa kuchengetedza mbiri, kuti iwanikwe kuburikidza neCOVAX Facility. Tinotenda WHO uye tinotsvaga kubatsira nyika kudzora kupararira kwedenda. "

"Inhau dzinogamuchirwa kuti pasi rose rave nechombo chitsva mudura rayo rematurusi ekurwisa COVID-19," akadaro Dr Richard Hatchett, Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI). "Kudyara kweCEPI kusimudzira budiriro yekiriniki nekugadzirwa kweNovavax's vaccine kwakakosha kugonesa kuwana mukana wekudzivirira kuburikidza neCOVAX."

"Tinogamuchira nhau yekuti mushonga weCOVOVAX watambira WHO Emergency Use Listing, ichipa pasirese - uye vatori vechikamu veCOVAX - neimwe kirasi inovimbisa yekudzivirira uye chimwezve chishandiso muhondo yekurwisa COVID-19," akadaro Dr Seth Berkley, Mukuru weGavi, iyo Vaccine Alliance. "Nedata rekuchengetedza uye kugona kunopesana neakasiyana akati wandei, simba rakasimba mukusanganisa uye match uye booster regimens, uye tembiricha yekuchengetera, jekiseni iri rinopa nyika imwe sarudzo yakakosha mukuda kubatsira kuchengetedza vanhu vadzo."

Kupihwa kweEUL kwakavakirwa pahuwandu hwepreclinical, kugadzira uye kliniki yedata data yakaunzwa kuti iongororwe. Izvi zvinosanganisira maviri akakosha Phase 3 kiriniki miedzo: PREVENT-19, iyo yakanyoresa vangangosvika zviuru makumi matatu vatori vechikamu muUS neMexico, mhedzisiro yacho yakaburitswa Zvita 30,000, 15 muNew England Journal of Medicine (NEJM); uye kuyedza kwakaongorora vaccine mune vanopfuura zviuru gumi nezvina vakapinda muUK, mhedzisiro yacho yakaburitswa June 2021, 14,000 muNEJM. Mune ese ari maviri miedzo, NVX-CoV30 yakaratidza kushanda kwakanyanya uye inosimbisa kuchengetedza uye kushivirira chimiro. Novavax icharamba ichiunganidza uye kuongorora data renyika chaiyo, kusanganisira kutarisa kwekuchengetedza uye kuongororwa kwezvakasiyana, sezvo vaccine ichigoverwa.

Novavax neSII nguva pfupi yadarika vakawana mvumo yekushandisa emergency (EUA) yeCOVOVAX muIndonesia nePhilippine. Mushonga uyu zvakare uri kuongororwa nemasangano akawanda anodzora pasi rese. Iyo kambani inotarisira kuendesa yakazara chemistry, kugadzira uye zvidzoreso (CMC) data package kuUS FDA mukupera kwegore.

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Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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