EUL yamasiku ano ikukhudzana ndi katemera woti azigulitsidwa ndi Novavax ngati Nuvaxovid ™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) ku Europe ndi misika ina. NVX-CoV2373 ikupangidwanso ndikugulitsidwa ku India komanso madera ovomerezeka ndi Serum Institute of India Pvt. Ltd. (SII), monga Covovax™, yomwe idapatsidwa EUL pa Disembala 17. Nuvaxovid ndi Covovax zimachokera kuukadaulo womwewo wa Novavax recombinant protein ndipo ma EULs amachokera ku pre-clinical, chipatala ndi chemistry, kupanga ndi kuwongolera ( CMC) phukusi.
EUL yamasiku ano ikutsatira kulandila chilolezo chotsatsa kuchokera ku European Commission ndikuwonetsetsa kuti Nuvaxovid akwaniritse miyezo ya WHO pazabwino, chitetezo ndi mphamvu. EUL ndiyofunikira pakutumiza kunja kumayiko ambiri, kuphatikiza omwe akutenga nawo gawo mu COVAX Facility, yomwe idakhazikitsidwa kuti ithandizire kugawa katemera moyenera komanso kugawa. EUL imalolanso mayiko kuti afulumizitse kuvomera kwawo kuti alowe ndi kupereka katemera wa COVID-19. Novavax ndi SII apereka Mlingo wowonjezera wa 1.1 biliyoni wa katemera wa Novavax ku COVAX.
Kupereka kwa EUL kudachokera pazambiri zonse zachipatala, zopanga ndi zoyeserera zamankhwala zomwe zidatumizidwa kuti ziwunikenso. Izi zikuphatikizapo mayesero awiri ofunikira a Phase 3: PREVENT-19, yomwe inalembetsa anthu pafupifupi 30,000 ku US ndi Mexico, zotsatira zake zinasindikizidwa mu New England Journal of Medicine (NEJM); ndi kuyesa komwe kudayesa katemerayu mwa anthu opitilira 14,000 ku UK, zomwe zotsatira zake zidasindikizidwanso ku NEJM. M'mayesero onsewa, NVX-CoV2373 idawonetsa kuchita bwino kwambiri komanso mbiri yolimbikitsa yachitetezo komanso kulekerera. Novavax ipitiliza kusonkhanitsa ndikusanthula zenizeni zenizeni padziko lapansi, kuphatikiza kuwunika kwachitetezo ndikuwunika kwamitundu yosiyanasiyana, pomwe katemera akugawidwa.
Katemera wa Novavax 'COVID-19 waperekedwa posachedwa chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) ku Indonesia ndi Philippines, komwe adzagulitsidwa ngati Covovax ndi SII. NVX-CoV2373 ikuwunikiridwanso ndi mabungwe angapo olamulira padziko lonse lapansi. Kampaniyo ikuyembekeza kutumiza phukusi lathunthu la data la CMC ku US FDA pakutha kwa chaka. Dzina la mtundu Nuvaxovid™ silinaloledwe kugwiritsidwa ntchito ku US ndi FDA.
