WHO ta Bada Lissafin Amfani na Gaggawa na Biyu don rigakafin Novavax COVID-19

EUL na yau ya shafi maganin alurar riga kafi da Novavax zai tallata azaman Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) a Turai da sauran kasuwanni. Hakanan ana kera NVX-CoV2373 da siyarwa a Indiya da yankuna masu lasisi ta Cibiyar Serum ta Indiya Pvt. Ltd. (SII), kamar yadda Covovax ™, wanda aka ba EUL a kan Disamba 17. Nuvaxovid da Covovax sun dogara ne akan fasahar gina jiki guda ɗaya Novavax recombinant kuma EULs sun dogara ne akan wani pre-clinical, asibiti da sunadarai, masana'antu da sarrafawa ( CMC) kunshin.

EUL na yau ya biyo bayan karɓar izinin tallace-tallace na sharadi daga Hukumar Turai kuma ya ƙaddamar da Nuvaxovid a matsayin saduwa da ƙa'idodin WHO don inganci, aminci da inganci. EUL wani sharadi ne don fitarwa zuwa ƙasashe da yawa, gami da waɗanda ke shiga cikin Cibiyar COVAX, wanda aka kafa don ba da damar rarraba alluran rigakafi da rarraba. EUL kuma yana bawa ƙasashe damar hanzarta amincewar nasu tsarin don shigo da gudanar da allurar COVID-19. Novavax da SII sun yi allurai biliyan 1.1 na rigakafin Novavax zuwa COVAX.

Taimakon EUL ya dogara ne akan jimillar bayanan ƙididdiga, masana'anta da bayanan gwaji na asibiti da aka ƙaddamar don bita. Wannan ya haɗa da gwaje-gwaje na asibiti guda biyu masu mahimmanci na Phase 3: PREVENT-19, wanda ya shiga kusan mahalarta 30,000 a Amurka da Mexico, sakamakon da aka buga a cikin New England Journal of Medicine (NEJM); da gwajin da ya tantance maganin a cikin mahalarta sama da 14,000 a Burtaniya, wanda kuma an buga sakamakonsa a NEJM. A cikin duka gwaje-gwajen guda biyu, NVX-CoV2373 ya nuna ingantaccen inganci da ingantaccen bayanin martaba da haƙuri. Novavax zai ci gaba da tattarawa da kuma nazarin bayanan duniya na ainihi, gami da sa ido kan aminci da kimanta bambance-bambancen, kamar yadda ake rarraba rigakafin.

An ba da kwanan nan rigakafin cutar COVID-19 na Novavax'a izinin amfani da gaggawa (EUA) a Indonesia da Philippines, inda za a sayar da shi azaman Covovax ta SII. NVX-CoV2373 kuma a halin yanzu ana duba shi ta hukumomin gudanarwa da yawa a duk duniya. Kamfanin yana tsammanin ƙaddamar da cikakken kunshin bayanan CMC ga FDA ta Amurka a ƙarshen shekara. Har yanzu FDA ba ta ba da izinin amfani da sunan Nuvaxovid™ don amfani a cikin Amurka ba.