I-EUL yanamuhla iphathelene nomgomo ozokhangiswa yi-Novavax njenge-Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) eYurophu nakwezinye izimakethe. I-NVX-CoV2373 nayo iyakhiqizwa futhi imakethwe eNdiya nasezindaweni ezinelayisensi yiSerum Institute of India Pvt. Ltd. (SII), njenge-Covovax™, eyanikezwa i-EUL ngo-December 17. I-Nuvaxovid ne-Covovax zisekelwe kubuchwepheshe obufanayo be-Novavax recombinant protein futhi ama-EUL asekelwe ekuhlolweni okujwayelekile komtholampilo, umtholampilo kanye namakhemikhali, ukukhiqiza nokulawula ( CMC) iphakheji.
I-EUL yanamuhla ilandela ukwamukela ukugunyazwa kokumaketha okunemibandela okuvela kuKhomishini YaseYurophu futhi ifanelekela i-Nuvaxovid njengokuhlangabezana nezindinganiso ze-WHO zekhwalithi, ukuphepha nokusebenza ngempumelelo. I-EUL iyimfuneko yokuthunyelwa kwamanye amazwe emazweni amaningi, okuhlanganisa nalawo abamba iqhaza ku-COVAX Facility, eyasungulwa ukuze kunikwe amandla ukwabiwa kokugoma okulinganayo nokusabalalisa. I-EUL iphinde ivumele amazwe ukuthi asheshise ukugunyazwa kwawo ngokomthetho ukuze angenise futhi alawule imigomo ye-COVID-19. I-Novavax kanye ne-SII benze imithamo ehlanganisiwe ye-1.1 billion yomuthi wokugomela i-Novavax ku-COVAX.
Uxhaso lwe-EUL lwalusekelwe enanini ledatha yokuhlolwa kwangaphambi komtholampilo, ukukhiqizwa kanye nesivivinyo somtholampilo esithunyelwe ukuze sibuyekezwe. Lokhu kufaka phakathi izinhlolo zokwelapha zeSigaba sesi-3 ezibalulekile ezimbili: I-PREVENT-19, ebhalise ababambiqhaza abangaba ngu-30,000 e-US nase-Mexico, imiphumela yako eyashicilelwa ku-New England Journal of Medicine (NEJM); kanye nocwaningo olwahlola umgomo kubahlanganyeli abangaphezu kuka-14,000 e-UK, imiphumela yalo yaphinde yashicilelwa ku-NEJM. Kuzo zombili izivivinyo, i-NVX-CoV2373 ikhombise ukusebenza kahle okuphezulu kanye nephrofayili yokuphepha eqinisekisayo nokubekezeleleka. I-Novavax izoqhubeka nokuqoqa nokuhlaziya idatha yomhlaba wangempela, okuhlanganisa nokuqapha ukuphepha nokuhlolwa kwezinhlobonhlobo, njengoba umgomo usatshalaliswa.
Umuthi wokugomela i-Novavax 'COVID-19 usanda kugunyazwa ukusetshenziswa kwezimo eziphuthumayo (EUA) e-Indonesia nasePhilippines, lapho uzomakethwa khona njenge-Covovax yi-SII. I-NVX-CoV2373 nayo njengamanje ingaphansi kokubuyekezwa yizinhlangano eziningi ezilawulayo emhlabeni jikelele. Inkampani ilindele ukuthi ithumele iphakheji yayo ephelele yedatha ye-CMC ku-US FDA ekupheleni konyaka. Igama lomkhiqizo i-Nuvaxovid™ alikakagunyazwa ukuthi lisetshenziswe e-US yi-FDA.
