An ba da izinin rigakafin Novavax' COVID-19 na ɗan lokaci a cikin New Zealand

Novavax, Inc. (Nasdaq: NVAX), wani kamfani na kimiyyar halittu da aka sadaukar don haɓakawa da kuma tallata rigakafin rigakafi na gaba don cututtuka masu haɗari, a yau ya sanar da cewa Medsafe ta New Zealand ta ba da izinin wucin gadi na rigakafin NVX-CoV2373, Novavax' COVID-19 (adjuvanted) ), don yin rigakafi mai aiki don hana cutar coronavirus 2019 (COVID-19) da SARS-CoV-2 ke haifarwa a cikin mutane masu shekaru 18 da haihuwa. Za a ba da maganin alurar riga kafi ga New Zealand a ƙarƙashin alamar sunan Nuvaxovid™.

"Aminci na wucin gadi na Nuvaxovid ta Medsafe zai ba Novavax damar isar da allurar rigakafin COVID-19 na farko na furotin zuwa New Zealand," in ji Stanley C. Erck, Shugaba da Babban Jami'in Gudanarwa, Novavax. "Muna gode wa Medsafe saboda cikakken bitar ta kuma, yayin da cutar ke ci gaba da bunkasa, mun jajirce wajen tallafawa New Zealand da duniya wajen yakar COVID-19."

Yarjejeniyar wucin gadi ta Medsafe ta dogara ne kan kimanta inganci, aminci, da ingantattun bayanan da aka ƙaddamar don dubawa. Wannan ya haɗa da gwaje-gwaje na asibiti guda biyu na Phase 3: PREVENT-19 sun yi rajista kusan mahalarta 30,000 a cikin Amurka da Mexico, sakamakon wanda aka buga a cikin New England Journal of Medicine (NEJM); da gwaji tare da mahalarta kusan 15,000 a Burtaniya, wanda kuma an buga sakamakon a NEJM. A cikin duka gwaje-gwajen guda biyu, NVX-CoV2373 sun nuna inganci da ingantaccen bayanin martaba da haƙuri. Mummunan abubuwan da suka faru masu tsanani sun kasance masu ƙarancin ƙima kuma sun daidaita tsakanin alurar rigakafi da ƙungiyoyin placebo. Mafi yawan halayen halayen da aka gani a lokacin nazarin asibiti (nau'in mitar na yau da kullum ≥1/10) sune ciwon kai, tashin zuciya ko amai, myalgia, arthralgia, wurin allurar taushi / zafi, gajiya, da rashin lafiya. 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 Gwamnatin New Zealand a baya sun ba da sanarwar yarjejeniyar siyan gaba (APA) don allurai miliyan 10.7 na rigakafin COVID-19 na Novavax. Wannan amincewa na wucin gadi yana ba da damar haɗin gwiwar masana'antu Novavax tare da Cibiyar Serum ta Indiya (SII), babbar masana'antar rigakafin rigakafi ta duniya da girma, wanda zai ba da allurai na farko ga New Zealand. Daga baya za a ƙara yarda na wucin gadi tare da bayanai daga ƙarin rukunin masana'antu a cikin sarkar samar da kayayyaki ta duniya Novavax.

Novavax ya karɓi izinin tallace-tallace na sharadi don NVX-CoV2373 a cikin Tarayyar Turai, jeri na amfani da gaggawa (EUL) daga Hukumar Lafiya ta Duniya (WHO) kuma an ba shi rajista na wucin gadi ta Hukumar Kula da Kaya ta Therapeutic a Ostiraliya, da sauransu. Har ila yau, a halin yanzu ana duba maganin alurar riga kafi daga hukumomin da yawa na duniya, gami da Hukumar Abinci da Magunguna ta Amurka (FDA).

Don ƙarin bayani kan Nuvaxovid, gami da amincewa da takaddar bayanan New Zealand da aka yarda da Bayanan Magungunan Mabukaci da Muhimmin Bayanan Tsaro, ko don neman ƙarin bayani, da fatan za a ziyarci gidajen yanar gizo masu zuwa:

• Gidan yanar gizon izini na duniya Novavax
• Halin Aikace-aikacen rigakafin COVID-19
• Bayani don Binciken Masu Rubutu/Masu Amfani  

Har yanzu FDA ba ta ba da izinin amfani da sunan Nuvaxovid™ don amfani a cikin Amurka ba. Novavax' mai tallafawa a Ostiraliya da New Zealand shine Biocelect Pty. Ltd. 

Yarda da Nuvaxovid na ɗan lokaci^™ a New Zealand

Medsafe ta ba da izini na wucin gadi na Nuvaxovid™ COVID-19 Vaccine (adjuvanted) don rigakafin aiki don hana COVID-19 da SARS-CoV-2 ke haifarwa a cikin mutane masu shekaru 18 da haihuwa. 

Mahimmin Bayanin Tsaro

• An hana Nuvaxovid a cikin mutanen da ke da hypersensitivity ga abun da ke aiki, ko ga kowane kayan haɓaka.
• An ba da rahoton abubuwan da suka faru na anaphylaxis tare da gudanar da allurar COVID-19. Ya kamata a sami jiyya da kulawa da ya dace idan an sami maganin anaphylactic bayan gudanar da maganin. Kada a ba da kashi na biyu na maganin ga waɗanda suka fuskanci anaphylaxis zuwa kashi na farko na Nuvaxovid.
• Abubuwan da ke da alaƙa da damuwa, gami da halayen vasovagal (syncope), hyperventilation, ko halayen da ke da alaƙa da damuwa na iya faruwa a cikin haɗin gwiwa tare da allurar rigakafi azaman martanin psychogenic ga allurar allurar. Yana da mahimmanci cewa ana yin matakan kariya don guje wa rauni daga suma.
• Yakamata a jinkirta yin rigakafin a cikin mutanen da ke fama da matsanancin rashin lafiya mai tsanani ko kamuwa da cuta.
• Yakamata a ba da Nuvaxovid tare da taka tsantsan ga mutanen da ke karɓar maganin rigakafin cutar jini ko waɗanda ke da thrombocytopenia ko duk wata cuta ta coagulation (kamar haemophilia) saboda zubar jini ko ɓarna na iya faruwa bayan gudanarwar intramuscularly a cikin waɗannan mutane.
• Tasirin Nuvaxovid na iya zama ƙasa da ƙasa a cikin mutanen da aka hana rigakafi.
• Gudanar da Nuvaxovid a cikin ciki yakamata a yi la'akari da shi kawai lokacin da yuwuwar fa'idodin ya zarce duk wani haɗari mai yuwuwa ga uwa da tayin.
• Tasirin Nuvaxovid na iya yin tasiri na ɗan lokaci ikon tuƙi ko amfani da inji.
• Ba za a iya samun cikakken kariya ga daidaikun mutane ba har sai kwanaki 7 bayan kashi na biyu. Kamar yadda yake tare da duk alluran rigakafi, allurar rigakafi tare da Nuvaxovid maiyuwa ba zai kare duk masu karɓar rigakafin ba.
• Mafi yawan halayen halayen da aka gani a lokacin nazarin asibiti (nau'in mitar na yau da kullum ≥1/10) sune ciwon kai, tashin zuciya ko amai, myalgia, arthralgia, wurin allurar taushi / zafi, gajiya, da rashin lafiya.