Ente ea Novavax 'COVID-19 e fane ka tumello ea nakoana New Zealand

Novavax, Inc. (Nasdaq: NVAX), k'hamphani ea biotechnology e ikemiselitseng ho nts'etsapele le ho rekisa liente tsa meloko e tlang bakeng sa mafu a tšoaetsanoang, kajeno e phatlalalitse hore Medsafe ea New Zealand e fane ka tumello ea nakoana ea NVX-CoV2373, Novavax 'COVID-19 ente (adjuvated). ), bakeng sa ente e sebetsang ea ho thibela lefu la coronavirus 2019 (COVID-19) le bakoang ke SARS-CoV-2 ho batho ba lilemo tse 18 le ho feta. Ente e tla fuoa New Zealand tlas'a lebitso la Nuvaxovid™.

"Kamohelo ea nakoana ea Nuvaxovid ke Medsafe e tla thusa Novavax ho fana ka ente ea pele e thehiloeng ho protheine ea COVID-19 New Zealand," ho boletse Stanley C. Erck, Mopresidente le Ofisiri e Moholo, Novavax. "Re leboha Medsafe ka tlhahlobo ea eona e phethahetseng, 'me, ha seoa sena se ntse se tsoela pele, re ntse re ikemiselitse ho tšehetsa New Zealand le lefats'e ntoeng khahlanong le COVID-19."

Tumello ea nakoana ke Medsafe e ipapisitse le tlhahlobo ea boleng, polokeho, le lintlha tsa ts'ebetso tse romelloang hore li hlahlojoe. Sena se kenyelletsa liteko tse peli tsa bohlokoa tsa Phase 3: PREVENT-19 e ngolisitse barupeluoa ba ka bang 30,000 US le Mexico, liphetho tsa tsona li phatlalalitsoe ho The New England Journal of Medicine (NEJM); le teko e nang le barupeluoa ba ka bang 15,000 UK, tseo liphello tsa tsona li ileng tsa hatisoa hape ho NEJM. Litekong tsena ka bobeli, NVX-CoV2373 e bonts'itse ts'ebetso le ts'ireletso e khothatsang le boemo ba mamello. Liketsahalo tse mpe tse tebileng le tse matla li ne li le tlase ka palo 'me li leka-lekane pakeng tsa ente le lihlopha tsa placebo. Litlamorao tse atileng haholo tse ileng tsa bonoa nakong ea lithuto tsa bongaka (sekhahla sa khafetsa sa ≥1/10) e ne e le hlooho, ho nyekeloa ke pelo kapa ho hlatsa, myalgia, arthralgia, bonolo/bohloko sebakeng sa ente, mokhathala le malaise. Novavax e tla tsoelapele ho bokella le ho sekaseka datha ea lefats'e la 'nete, ho kenyelletsa le ho lekola polokeho le tlhahlobo ea mefuta e fapaneng, ha ente e ntse e ajoa.

Novavax le Mmuso oa New Zealand pejana ba phatlalalitse tumellano ea theko ea pele (APA) bakeng sa litekanyetso tse limilione tse 10.7 tsa ente ea Novavax 'COVID-19. Tumello ena ea nakoana e matlafatsa tšebelisano ea tlhahiso ea Novavax le Serum Institute of India (SII), e leng moetsi e moholo ka ho fetisisa lefatšeng oa ente, e tla fana ka litekanyetso tsa pele New Zealand. Tumello ea nakoana hamorao e tla tlatselletsoa ka lintlha tse tsoang litsing tse ling tsa tlhahiso ea thepa ea lefats'e ea Novavax.

Novavax o fumane tumello ea ho bapatsa e nang le maemo bakeng sa NVX-CoV2373 ho European Union, lenane la ts'ebeliso ea tšohanyetso (EUL) ho tsoa ho World Health Organisation (WHO) mme a fuoa ngoliso ea nakoana ke Therapeutic Goods Administration e Australia, hara ba bang. Ente e boetse e ntse e hlahlojoa ke mekhatlo e mengata ea taolo lefatšeng ka bophara, ho kenyeletsoa US Food and Drug Administration (FDA).

Bakeng sa tlhahisoleseding e eketsehileng ka Nuvaxovid, ho kenyelletsa le Datasheet e amohelehang ea New Zealand le Boitsebiso bo amohelehang ba Meriana ea Bareki le Boitsebiso ba Bohlokoa ba Tšireletseho, kapa ho kopa tlhahisoleseding e eketsehileng, ka kopo etela liwebsaete tse latelang:

• Webosaete ea tumello ea lefats'e ea Novavax
• Boemo ba Likopo tsa Ente ea COVID-19
• Tlhahisoleseding bakeng sa Batlotlehi/Bareki Batla  

Lebitso la lebitso la Nuvaxovid™ ha le so lumelloe ho sebelisoa US ke FDA. Motšehetsi oa Novavax oa Australia le New Zealand ke Biocelect Pty. Ltd. 

Tumello ea Nakoana ea Nuvaxovid^™ New Zealand

Medsafe e fane ka tumello ea nakoana ea Nuvaxovid ™ COVID-19 Vaccine (adjuvanted) bakeng sa ente e sebetsang ho thibela COVID-19 e bakoang ke SARS-CoV-2 ho batho ba lilemo tse 18 ho ea holimo. 

Tlhahisoleseling ea Bohlokoa ea Tšireletso

• Nuvaxovid e thibetsoe ho batho ba nang le hypersensitivity ho ntho e sebetsang, kapa ho efe kapa efe ea li-excipients.
• Liketsahalo tsa anaphylaxis li tlalehiloe ka tsamaiso ea liente tsa COVID-19. Kalafo le tlhokomelo e nepahetseng li lokela ho ba teng haeba ho ka ba le karabelo ea anaphylactic ka mor'a ho tsamaisoa ha ente. Tekanyetso ea bobeli ea ente ha ea lokela ho fuoa ba nang le phihlelo ea anaphylaxis ho tekanyo ea pele ea Nuvaxovid.
• Boitšoaro bo amanang le ho tšoenyeha, ho akarelletsa le vasovagal reactions (syncope), hyperventilation, kapa khatello ea maikutlo e amanang le khatello ea kelello e ka 'na ea etsahala hammoho le ente e le karabo ea psychogenic ho ente ea nale. Ke habohlokoa hore ho be le mehato ea ho itšireletsa ho qoba kotsi ea ho akheha.
• Ho entoa ho lokela ho chechisoa ho batho ba nang le lefu le matla la febrile kapa tšoaetso e matla.
• Nuvaxovid e lokela ho fanoa ka tlhokomeliso ho batho ba fumanang kalafo ea anticoagulant kapa ba nang le thrombocytopenia kapa lefu lefe kapa lefe la coagulation (joalo ka haemophilia) hobane ho tsoa mali kapa matetetso a ka hlaha kamora ts'ebetso ea intramuscular ho batho bana.
• Ho sebetsa ha Nuvaxovid ho ka ba tlase ho batho ba nang le immunosuppressed.
• Tsamaiso ea Nuvaxovid nakong ea kemolo e lokela ho nahanoa feela ha melemo e ka bang teng e feta likotsi tse ka bang teng ho 'm'a le lesea.
• Litlamorao tse nang le Nuvaxovid li ka ama ka nakoana bokhoni ba ho khanna kapa ho sebelisa mechini.
• Batho ba kanna ba se sireletsehe ka botlalo ho fihlela matsatsi a 7 kamora tekanyetso ea bona ea bobeli. Joalo ka liente tsohle, ente ea Nuvaxovid e kanna ea se sireletse bohle ba amohelang ente.
• Litlamorao tse atileng haholo tse ileng tsa bonoa nakong ea lithuto tsa tleliniki (sekhahla sa khafetsa sa ≥1/10) e ne e le hlooho, ho nyekeloa ke pelo kapa ho hlatsa, myalgia, arthralgia, bonolo/bohloko sebakeng sa ente, mokhathala le malaise.