I-WHO Ngoku iBonelela ngokuSebenzisa oluNgxamisekileyo lwe-NVX-CoV2373 COVID-19 isitofu

I-EUL iqinisekisa ukuba isitofu sokugonya i-Novavax 'COVID-19 sihlangabezana nemigangatho esekiweyo ye-WHO yomgangatho, ukhuseleko kunye nokusebenza kakuhle. I-EUL yimfuneko yokuthunyelwa kumazwe angaphandle kumazwe amaninzi, kubandakanywa nalawo athatha inxaxheba kwiZiko leCOVAX, elasekwa ukuze libonelele kwaye lisasaze amayeza okugonya ngokulinganayo kumazwe athatha inxaxheba kunye noqoqosho.

"Isigqibo sanamhlanje esivela kuMbutho wezeMpilo weHlabathi sibalulekile ekuqinisekiseni ukufikelela kwihlabathi jikelele kwisitofu sokugonya esisekwe kwiprotheyini ye-COVID-19 kumakhulu ezigidi zabantu kwihlabathi liphela," utshilo uStanley C. Erck, uMongameli kunye neGosa eliyiNtloko lesiGqeba, uNovavax. “Sibulela uMbutho wezeMpilo weHlabathi ngovavanyo lwawo olucokisekileyo. Sikholelwa ukuba esi sitofu sokugonya siza kunceda ukoyisa imiqobo ekufikeleleni kugonyo kwiindawo ezininzi zehlabathi ngokusebenzisa ifriji yesiqhelo esetyenziswa kumajelo okubonelela ngogonyo, ngelixa ikwabonelela nokukhetha okusekwe kubuchwephesha obuqhelekileyo nobuqondwa kakuhle. ”

“I-EUL yoMbutho wezeMpilo weHlabathi lukhuthazo olukhulu ekwenzeni amayeza okugonya i-COVID-19 afikeleleke ngakumbi. Ubudlelwane bethu noNovavax bube yimpumelelo ekuboneleleni ngobunkokeli bezempilo kuluntu jikelele kunye nokuqinisekisa ukuba onke amazwe anofikelelo olubanzi kugonyo olusebenzayo, utshilo u-Adar Poonawalla, iGosa eliLawulayo eliyiNtloko, iSerum Institute of India. "I-COVOVAX lukhetho lokuqala lokugonya olusekwe kwiprotheyini ye-COVID-19, kunye nokusebenza okubonakalisiweyo kunye neprofayili enyamezelekileyo yokhuseleko, ukuba yenziwe ifumaneke kwi-COVAX Facility. Siyayibulela i-WHO kwaye sifuna ukunceda ihlabathi lilawule ukusasazeka kobhubhane. ”

“Ziindaba ezamkelwa kakhulu ukuba umhlaba ngoku unesixhobo esitsha kuluhlu lwawo lwezixhobo zokulwa i-COVID-19,” utshilo uGqr Richard Hatchett, iGosa eliLawulayo eliyiNtloko, iCoalition for Epidemic Preparedness Innovations (CEPI). "Utyalo-mali lwe-CEPI ukukhawulezisa uphuhliso lweklinikhi kunye nokuveliswa kwesitofu sokugonya i-Novavax 'belubalulekile ekwenzeni ukuba kufikeleleke ngokulinganayo kugonyo nge-COVAX."

"Siyazamkela iindaba zokuba isitofu sokugonya se-COVOVAX sifumene uLuhlu lwe-WHO oluNgxamisekileyo lokuSebenzisa, ukubonelela ngehlabathi- kunye nabathathi-nxaxheba be-COVAX - nolunye udidi oluthembisayo lwesitofu sokugonya kunye nesinye isixhobo kumlo ochasene ne-COVID-19," utshilo uGqr Seth Berkley, I-CEO ye-Gavi, i-Vaccine Alliance. "Ngedatha yokhuseleko kunye nokusebenza ngokuchasene neentlobo ezininzi, amandla anamandla kumxube kunye nerejimeni ye-booster, kunye namaqondo obushushu aqhelekileyo okugcina, olu gonyo luya kubonelela amazwe ngolunye ukhetho olubalulekileyo kumzamo wokunceda ukukhusela abantu bawo."

Uncedo lwe-EUL lwalusekwe kwitotali yedatha yaphambi kweklinikhi, yokwenziwa kunye nolingo lwezonyango olungeniselwe ukujongwa. Oku kubandakanya izilingo ezimbini ezibalulekileyo zeSigaba se-3 zekliniki: I-PREVENT-19, eyabhalisa malunga nabathathi-nxaxheba be-30,000 e-US naseMexico, iziphumo ezapapashwa ngoDisemba 15, 2021 kwiNew England Journal of Medicine (NEJM); kunye nolingo oluvavanye isitofu sokugonya ngaphezulu kwe-14,000 yabathathi-nxaxheba e-UK, iziphumo zalo zapapashwa nge-30 kaJuni ngo-2021 kwi-NEJM. Kuzo zombini izilingo, i-NVX-CoV2373 ibonise ukusebenza okuphezulu kunye nokhuseleko oluqinisekisayo kunye neprofayili yokunyamezela. I-Novavax iya kuqhubeka nokuqokelela kunye nokuhlalutya idatha yehlabathi lokwenyani, kubandakanywa ukubeka esweni ukhuseleko kunye novavanyo lwezinto ezahlukeneyo, njengoko isitofu sokugonya sisasazwa.

I-Novavax kunye ne-SII mva nje bafumana ugunyaziso lokusetyenziswa olungxamisekileyo (EUA) kwi-COVOVAX e-Indonesia nasePhilippines. Isitofu sokugonya sikwaphantsi kovavanyo ngoku zii-arhente ezininzi ezilawulayo kwihlabathi jikelele. Inkampani ilindele ukuhambisa iphakheji yedatha epheleleyo ye-chemistry, imveliso kunye nolawulo (CMC) kwi-FDA yase-US ekupheleni konyaka.