WHO Yanzu Ta Bada Amfani da Gaggawa na NVX-CoV2373 rigakafin COVID-19

EUL yana ƙaddamar da rigakafin Novavax' COVID-19 kamar yadda ya dace 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, wacce aka kafa don rarrabawa da rarraba alluran rigakafi daidai gwargwado ga ƙasashe da tattalin arziƙin da ke shiga.

"Shawarar yau daga Hukumar Lafiya ta Duniya tana da mahimmanci don tabbatar da samun damar yin amfani da allurar rigakafin COVID-19 mai gina jiki ga miliyoyin mutane a duniya," in ji Stanley C. Erck, Shugaba da Babban Jami'in Gudanarwa, Novavax. “Muna godiya ga Hukumar Lafiya ta Duniya saboda cikakken tantancewar da ta yi. Mun yi imanin wannan maganin zai taimaka wajen shawo kan matsalolin samun allurar rigakafi a yankuna da yawa na duniya ta hanyar yin amfani da na'urar sanyi ta gargajiya da ake amfani da su a tashoshin samar da alluran rigakafin da ake da su, tare da bayar da zabin da ya danganci fasaha da aka saba da su."

“EUL ta Hukumar Lafiya ta Duniya babban kwarin gwiwa ne ga samar da allurar COVID-19 mafi sauki. Haɗin gwiwarmu da Novavax ya yi nasara wajen samar da jagorancin lafiyar jama'a a duniya da kuma tabbatar da cewa dukkan ƙasashe suna da fa'ida don samun ingantaccen rigakafin, "in ji Adar Poonawalla, Babban Jami'in Gudanarwa, Cibiyar Serum ta Indiya. "COVOVAX shine zaɓi na farko na tushen furotin na COVID-19, tare da ingantaccen inganci da ingantaccen bayanin martabar aminci, wanda za'a samar dashi ta wurin COVAX Facility. Muna gode wa WHO tare da neman taimakawa duniya wajen shawo kan yaduwar cutar."

"Abin farin ciki ne labari cewa yanzu duniya tana da sabon makami a cikin tarin kayan aikinta don yakar COVID-19," in ji Dokta Richard Hatchett, Babban Jami'in Gudanarwa, Coalition for Epidemic Prevention Innovations (CEPI). "Zuba hannun jari na CEPI don haɓaka haɓakar asibiti da kera rigakafin Novavax sun kasance masu mahimmanci don ba da damar samun daidaiton rigakafin ta hanyar COVAX."

Dr Seth Berkley ya ce "Muna maraba da labarin cewa maganin na COVOVAX ya karbi Jerin Amfani da Gaggawa na WHO, yana samar da duniya - da mahalarta COVAX - tare da wani nau'in rigakafin rigakafi da kuma wani kayan aiki a yakin COVID-19," in ji Dr Seth Berkley. Shugaba na Gavi, the Vaccine Alliance. "Tare da bayanai kan aminci da inganci a kan bambance-bambancen da yawa, da ƙarfi mai ƙarfi a cikin haɗe-haɗe da daidaitawa da tsarin haɓakawa, da daidaitaccen yanayin yanayin ajiya, wannan rigakafin zai ba wa ƙasashe wani zaɓi mai mahimmanci a cikin ƙoƙarin don taimakawa kare al'ummarsu."

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-gwajen asibiti masu mahimmanci guda biyu: PREVENT-3, waɗanda suka yi rajista kusan mahalarta 19 a cikin Amurka da Mexico, sakamakon waɗanda aka buga Disamba 30,000, 15 a cikin New England Journal of Medicine (NEJM); da gwajin da ya tantance maganin a cikin mahalarta sama da 2021 a Burtaniya, wanda aka buga sakamakonsa ranar 14,000 ga Yuni, 30 a NEJM. A cikin duka gwaje-gwajen guda biyu, NVX-CoV2021 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.

Novavax da SII kwanan nan sun sami izinin amfani da gaggawa (EUA) don COVOVAX a Indonesia da Philippines. Har ila yau, a halin yanzu ana duba maganin alurar riga kafi daga hukumomi da yawa na duniya. Kamfanin yana tsammanin ƙaddamar da cikakken kunshin bayanan sinadarai, masana'anta da sarrafawa (CMC) ga FDA ta Amurka a ƙarshen shekara.