WHO Tsopano Yapereka Katemera wa NVX-CoV2373 COVID-19 Mwadzidzidzi

EUL imakonzekeretsa katemera wa Novavax 'COVID-19 kuti akwaniritse miyezo yokhazikitsidwa ya WHO pazabwino, chitetezo ndi mphamvu. EUL ndiyofunikira pakutumiza kunja kumayiko ambiri, kuphatikiza omwe akutenga nawo gawo mu COVAX Facility, yomwe idakhazikitsidwa kuti igawa ndi kugawa katemera moyenera kumayiko omwe akutenga nawo gawo pazachuma.

"Lingaliro lamasiku ano kuchokera ku World Health Organisation ndilofunika kuti dziko lonse lapansi lipeze katemera wa COVID-19 wopangidwa ndi mapuloteni kwa anthu mamiliyoni mazana ambiri padziko lonse lapansi," atero a Stanley C. Erck, Purezidenti ndi Chief Executive Officer, Novavax. "Tikuthokoza World Health Organisation chifukwa chowunika bwino. Tikukhulupirira kuti katemerayu athandiza kuthana ndi zolepheretsa kupeza katemera m'madera ambiri padziko lapansi pogwiritsa ntchito firiji yomwe imagwiritsidwa ntchito m'njira zoperekera katemera, komanso kupereka njira yotengera ukadaulo wodziwika bwino komanso womveka bwino. ”

"EUL yopangidwa ndi World Health Organisation ndiyolimbikitsa kwambiri kuti katemera wa COVID-19 apezeke mosavuta. Mgwirizano wathu ndi Novavax wachita bwino popereka utsogoleri wa zaumoyo padziko lonse lapansi ndikuwonetsetsa kuti mayiko onse ali ndi mwayi wopeza katemera wothandiza, "atero a Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "COVOVAX ndiye njira yoyamba yopezera katemera wa COVID-19 wopangidwa ndi puloteni, yemwe ali ndi mphamvu komanso mbiri yotetezedwa bwino, yopezeka kudzera mu COVAX Facility. Tikuthokoza WHO ndipo tikufuna kuthandiza dziko lonse lapansi kuthana ndi mliriwu. ”

"Ndi nkhani zolandirika kwambiri kuti dziko lapansi tsopano lili ndi chida chatsopano mu zida zake zomenyera COVID-19," atero Dr Richard Hatchett, Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI). "Ndalama za CEPI zopititsa patsogolo chitukuko chachipatala ndi kupanga katemera wa Novavax kwakhala kofunikira kuti athe kupeza katemerayu kudzera mu COVAX."

"Tikulandira uthenga woti katemera wa COVOVAX walandira WHO Emergency Use Listing, kupatsa dziko lonse lapansi - ndi omwe atenga nawo gawo la COVAX - ndi gulu lina lodalirika la katemera komanso chida china cholimbana ndi COVID-19," atero Dr Seth Berkley, CEO wa Gavi, Vaccine Alliance. "Pokhala ndi chidziwitso chokhudzana ndi chitetezo ndi mphamvu zolimbana ndi mitundu ingapo, kuthekera kwamphamvu pakuphatikiza ndi machesi ndi zida zolimbikitsira, komanso kutentha kosungirako, katemerayu apatsa mayiko njira ina yofunika kwambiri pofuna kuteteza anthu awo."

Kupereka kwa EUL kudachokera pazambiri zonse zachipatala, zopanga ndi zoyesa zamankhwala zomwe zidatumizidwa kuti ziwunikenso. Izi zikuphatikiza mayeso awiri ofunikira a Phase 3: PREVENT-19, omwe adalembetsa nawo pafupifupi 30,000 ku US ndi Mexico, zotsatira zake zidasindikizidwa Disembala 15, 2021 mu New England Journal of Medicine (NEJM); ndi kuyesa komwe kudayesa katemerayu mwa anthu opitilira 14,000 ku UK, zomwe zotsatira zake zidasindikizidwa June 30, 2021 ku NEJM. M'mayesero onsewa, NVX-CoV2373 idawonetsa kuchita bwino kwambiri komanso mbiri yolimbikitsa yachitetezo komanso yolekerera. Novavax ipitiliza kusonkhanitsa ndi kusanthula zenizeni zenizeni padziko lapansi, kuphatikiza kuwunika kwachitetezo ndikuwunika kwamitundu yosiyanasiyana, pomwe katemera akugawidwa.

Novavax ndi SII alandila chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) kwa COVOVAX ku Indonesia ndi Philippines. Katemerayu akuwunikiridwanso ndi mabungwe angapo owongolera padziko lonse lapansi. Kampaniyo ikuyembekeza kutumiza phukusi lathunthu la chemistry, Production and Control (CMC) ku US FDA kumapeto kwa chaka.