EUL yanhasi ine chekuita nekudzivirira kutengeswa neNovavax seNuvaxovid ™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) muEurope nemimwe misika. NVX-CoV2373 iri kugadzirwawo uye kutengeswa muIndia nenzvimbo dzine marezenisi neSerum Institute of India Pvt. Ltd. (SII), seCovovax™, iyo yakapihwa EUL musi waZvita 17. Nuvaxovid neCovovax zvakabva pane imwecheteyo Novavax recombinant protein tekinoroji uye maEULs akavakirwa pane yakajairwa pre-kiriniki, kiriniki uye chemistry, kugadzira uye kutonga. CMC) package.
EUL yanhasi inotevera kutambirwa kwemvumo yekushambadzira kubva kuEuropean Commission uye inofanidza Nuvaxovid sekusangana neWHO zviyero zvemhando, chengetedzo uye kushanda. EUL inodiwa kuti itumire kunze kwenyika kune dzakawanda nyika, kusanganisira idzo dziri kutora chikamu muCOVAX Facility, iyo yakavambwa kuti igone kugovanisa vaccine uye kugovera. EUL inobvumirawo nyika kuti dzikurumidze kubvumidzwa kwadzo kupinza uye kupa vaccine yeCOVID-19. Novavax neSII vakaita bhiriyoni imwe chete yemadhora ekudzivirira kweNovavax kuCOVAX.
Kupihwa kweEUL kwakavakirwa pahuwandu hwepreclinical, kugadzira uye kliniki yedata data rakaunzwa kuti riongororwe. Izvi zvinosanganisira maviri akakosha Phase 3 miedzo yekiriniki: PREVENT-19, iyo yakanyoresa vangangoita zviuru makumi matatu vatori vechikamu muUS neMexico, mhedzisiro yacho yakabudiswa muNew England Journal of Medicine (NEJM); uye kuyedza kwakaongorora vaccine mune vanopfuura zviuru gumi nezvina vakapinda muUK, mhedzisiro yacho yakatsikiswa zvakare muNEJM. Mune ese ari maviri miedzo, NVX-CoV30,000 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 'COVID-19 vaccine ichangobva kupihwa mvumo yekushandisa emergency (EUA) muIndonesia nePhilippines, uko ichatengeswa seCovovax neSII. NVX-CoV2373 zvakare iri pasi pekuongororwa neakawanda masangano anodzora pasi rese. Iyo kambani inotarisira kuendesa yakazara CMC data package kuUS FDA mukupera kwegore. Zita remhando yeNuvaxovid™ harisati rapihwa mvumo yekushandiswa muUS neFDA.
