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Khomishene ea Europe Joale e Fana ka Lithuso tsa Mebaraka ea Maemo bakeng sa Novavax COVID-19 Vaccine

ngotsoeng ke mohlophisi

Novavax, Inc., 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 Khomishene ea Europe (EC) e fane ka tumello ea ho bapatsa ka maemo a Novavax (CMA) bakeng sa Vaccine ea Nuvaxovid ™ COVID-19 (recombinant, adjuvanted) bakeng sa ente e sebetsang ea ho thibela COVID-19 e bakoang ke SARS-CoV-2 ho batho ba lilemo tse 18 ho ea holimo. Tumello e latela khothaletso ea Komiti ea European Medicines Agency (EMA) bakeng sa Lihlahisoa tsa Meriana bakeng sa Tšebeliso ea Batho (CHMP) kajeno ea ho fana ka tumello ea ente (eo hape e tsejoang ka hore ke NVX-CoV2373) mme e sebetsa linaheng tsohle tse 27 tsa litho tsa European Union (EU).

Maikutlo a EMA le qeto e amanang le EC e ipapisitse le kakaretso ea tlhaiso-leseling ea pele, tlhahiso le tlhaiso-leseling e kentsoeng bakeng sa tlhahlobo. Sena se kenyelletsa liteko tse peli tsa bohlokoa tsa Phase 3: PREVENT-19 e neng e kenyelletsa barupeluoa ba 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 15,000 UK, eo liphello tsa eona li ileng tsa boela tsa hatisoa ho NEJM. Litekong tsena ka bobeli, NVX-CoV2373 e bontšitse ts'ebetso e phahameng le boemo bo amohelehang ba polokeho le mamello. 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 EC ba phatlalalitse tumellano ea theko ea pele (APA) bakeng sa litekanyetso tse ka bang limilione tse 200 tsa ente ea Novavax 'COVID-19 ka Phato 2021. Litekanyetso tsa pele li lebelletsoe ho fihla Europe ka Pherekhong. Novavax e sebetsa le EMA le balekane ba eona ho potlakisa tlhahlobo ea tokollo ea lehae.

Tumello ena e eketsa tšebelisano 'moho ea tlhahiso ea Novavax le Serum Institute of India (SII), e leng moetsi e moholo ka ho fetisisa lefatšeng oa ente ka bongata, e tla fana ka litekanyetso tsa pele tsa EU.

Novavax le SII haufinyane ba fumane tumello ea tšebeliso ea tšohanyetso (EUA) naheng ea Indonesia le Philippines, moo e tla rekisoa ke SII tlasa lebitso la khoebo Covovax™. Likhamphani le tsona li fumane lethathamo la ts'ebeliso ea tšohanyetso bakeng sa Covovax ho tsoa ho Mokhatlo oa Lefatše oa Bophelo. Ente e boetse e ntse e hlahlojoa ke mekhatlo e mengata ea taolo lefatšeng ka bophara, 'me k'hamphani e lebelletse ho fana ka sephutheloana sa eona sa data sa chemistry, Production and Controls (CMC) ho US Food and Drug Administration (FDA) mafelong a selemo.

Tšebeliso e lumelletsoeng ea Nuvaxovid™ ho European Union

Khomishene ea Europe e fane ka tumello ea ho bapatsa e nang le maemo bakeng sa Vaccine ea Nuvaxovid ™ COVID-19 (recombinant, 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 hanetsoe ho batho ba nang le hypersensitivity ho ntho e sebetsang kapa ho efe kapa efe ea lisebelisoa.

• Liketsahalo tsa anaphylaxis li tlalehiloe mabapi le tsamaiso ea liente tsa COVID-19. Kalafo le tlhokomelo e nepahetseng e lokela ho ba teng haeba ho na le karabelo ea anaphylactic

• Maikutlo a 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 karabelo ea 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 tšoeroeng ke lefu le matla la febrile kapa tšoaetso e matla

• Fana ka Nuvaxovid ka hloko ho batho ba fumanang kalafo ea anticoagulant kapa ba nang le thrombocytopenia kapa lefu leha e le lefe la ho putlama ha mali (joaloka haemophilia) hobane ho tsoa mali kapa matetetso a ka hlaha ka mor'a tsamaiso ea mesifa ho batho bana.

• Ho sebetsa ha Nuvaxovid ho ka ba tlase ho batho ba nang le immunosuppressed

• Nako ea ts'ireletso e fanoang ke ente ha e tsejoe kaha e ntse e khethoa ke liteko tse tsoelang pele tsa bongaka

• Batho ba ka 'na ba se sireletsehe ka ho feletseng ho fihlela matsatsi a 7 ka mor'a tekanyo ea bona ea bobeli. Joalo ka liente tsohle, ente e nang le Nuvaxovid e kanna ea se sireletse bohle ba amohelang ente

• Litlamorao tse mpe ka ho fetesisa tse ileng tsa bonoa nakong ea lithuto tsa kliniki (mokhahlelo oa khafetsa oa ≥ 1/10), e ne e le hlooho, ho nyekeloa ke pelo kapa ho hlatsa, myalgia, arthralgia, bonolo/bohloko sebakeng sa ente, mokhathala le malaise.

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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