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Umuthi wokugomela i-Novavax 'COVID-19 unikeze imvume yesikhashana eNew Zealand

Ibhalwe ngu UHarry Johnson

INovavax, Inc. (Nasdaq: NVAX), okuyinkampani ye-biotechnology ezinikele ekuthuthukiseni nasekuthengiseni imigomo yesizukulwane esilandelayo yezifo ezithathelwanayo ezinzima, namuhla imemezele ukuthi iMedsafe yaseNew Zealand inikeze imvume yesikhashana ye-NVX-CoV2373, Novavax 'COVID-19 vaccine (adjuvated). ), yokugoma okusebenzayo ukuze kuvinjelwe isifo se-coronavirus 2019 (COVID-19) esibangelwa i-SARS-CoV-2 kubantu abaneminyaka engu-18 nangaphezulu. Umuthi wokugoma uzohlinzekwa eNew Zealand ngaphansi kwegama lomkhiqizo i-Nuvaxovid™.

"Ukugunyazwa kwesikhashana kwe-Nuvaxovid yi-Medsafe kuzokwenza i-Novavax ikwazi ukuletha umuthi wokugomela i-COVID-19 wokuqala osuselwa kumaprotheni eNew Zealand," kusho uStanley C. Erck, uMongameli kanye neSikhulu Esiphezulu, uNovavax. "Sibonga i-Medsafe ngokubuyekeza kwayo kahle futhi, njengoba lolu bhubhane luqhubeka nokuvela, sizibophezele ekusekeleni iNew Zealand kanye nomhlaba wonke ekulweni ne-COVID-19."

Ukugunyazwa kwesikhashana kwe-Medsafe kusekelwe ekuhlolweni kwekhwalithi, ukuphepha, kanye nedatha esebenzayo ethunyelwe ukuze ibuyekezwe. Lokhu kuhlanganisa izinhlolo ezimbili zomtholampilo zeSigaba sesi-3 ezibalulekile: I-PREVENT-19 ibhalise ababambiqhaza abangaba ngu-30,000 e-US nase-Mexico, imiphumela yako eyashicilelwa ku-The New England Journal of Medicine (NEJM); kanye nesivivinyo esinabahlanganyeli abacishe babe yi-15,000 e-UK, imiphumela yalo yaphinde yanyatheliswa ku-NEJM. Kuzo zombili izivivinyo, i-NVX-CoV2373 ikhombise ukusebenza kahle kanye nephrofayili yokuphepha eqinisekisayo nokubekezeleleka. Izehlakalo ezimbi kakhulu nezinzima beziphansi ngenani futhi zilinganiswe phakathi komgomo namaqembu e-placebo. Ukusabela okungekuhle okuvame kakhulu okubonwe ngesikhathi socwaningo lwemitholampilo (isigaba semvamisa esivame kakhulu ≥1/10) kwakuyikhanda elibuhlungu, isicanucanu noma ukuhlanza, i-myalgia, i-arthralgia, ubumnene/ubuhlungu bendawo yomjovo, ukukhathala, nokungezwani komzimba. I-Novavax izoqhubeka nokuqoqa nokuhlaziya idatha yomhlaba wangempela, okuhlanganisa nokuqapha ukuphepha nokuhlolwa kwezinhlobonhlobo, njengoba umgomo usatshalaliswa.

UNovavax kanye noHulumeni waseNew Zealand phambilini bamemezele isivumelwano sokuthenga kusengaphambili (APA) imithamo eyizigidi eziyi-10.7 yomgomo weNovavax 'COVID-19. Lokhu kugunyazwa kwesikhashana kukhulisa ubudlelwano bokukhiqiza kukaNovavax neSerum Institute of India (SII), umkhiqizi wokugoma omkhulu kunawo wonke emhlabeni ngomthamo, ozohlinzeka imithamo yokuqala eNew Zealand. Ukugunyazwa kwesikhashana kuzokwengezwa kamuva ngedatha evela kumasayithi okukhiqiza engeziwe e-Novavax' global supply chain.

UNovavax uthole ukugunyazwa kokuthengisa okunemibandela kwe-NVX-CoV2373 e-European Union, ukufakwa kuhlu kokusetshenziswa kwezimo eziphuthumayo (EUL) okuvela ku-World Health Organization (WHO) futhi wanikwa ukubhaliswa kwesikhashana yi-Therapeutic Goods Administration e-Australia, phakathi kwabanye. Umuthi wokugoma okwamanje usabuyekezwa yizikhungo eziningi ezilawulayo emhlabeni wonke, okuhlanganisa ne-US Food and Drug Administration (FDA).

Ukuze uthole ulwazi olwengeziwe nge-Nuvaxovid, okuhlanganisa ne-New Zealand Datasheet egunyaziwe kanye nolwazi olugunyaziwe lwe-Consumer Medicine kanye nolwazi olubalulekile lokuphepha, noma ukucela ulwazi olwengeziwe, sicela uvakashele amawebhusayithi alandelayo:

  • Iwebhusayithi yeNovavax yokugunyazwa komhlaba wonke
  • Isimo Sezicelo Zomgomo we-COVID-19
  • Ulwazi Lwababhalisi/Usesho lwabathengi  

Igama lomkhiqizo i-Nuvaxovid™ alikakagunyazwa ukuthi lisetshenziswe e-US yi-FDA. Umxhasi kaNovavax e-Australia naseNew Zealand yiBiocelect Pty. Ltd. 

Ukugunyazwa Kwesikhashana kwe-Nuvaxovid eNew Zealand

I-Medsafe inikeze imvume yesikhashana ye-Nuvaxovid™ COVID-19 Vaccine (adjuvant) yokugoma okusebenzayo ukuze kuvinjelwe i-COVID-19 ebangelwa i-SARS-CoV-2 kubantu abaneminyaka engu-18 nangaphezulu. 

Ulwazi Olubalulekile Lwezokuphepha

  • I-Nuvaxovid iphikisiwe kubantu abane-hypersensitivity entweni esebenzayo, noma kunoma yiziphi izinto ezisizayo.
  • Izehlakalo ze-anaphylaxis zibikiwe ngokuphathwa kwemithi yokugomela i-COVID-19. Ukwelashwa okufanele kanye nokuqondisa kufanele kutholakale uma kwenzeka kuba nokusabela kwe-anaphylactic ngemva kokuphathwa komgomo. Umthamo wesibili womgomo akufanele unikezwe labo abaye babhekana ne-anaphylaxis kumthamo wokuqala we-Nuvaxovid.
  • Ukusabela okuhlobene nokukhathazeka, okuhlanganisa ukusabela kwe-vasovagal (syncope), i-hyperventilation, noma ukusabela okuhlobene nokucindezeleka kungase kwenzeke ngokuhambisana nokugoma njengempendulo ye-psychogenic kumjovo yenaliti. Kubalulekile ukuthi kube nezinyathelo zokuvikela ukugwema ukulimala ngenxa yokuquleka.
  • Ukugoma kufanele kuhlehliswe kubantu abanesifo esibi kakhulu se-febrile noma ukutheleleka okunamandla.
  • I-Nuvaxovid kufanele inikezwe ngokuqapha kubantu abathola ukwelashwa kwe-anticoagulant noma labo abane-thrombocytopenia noma noma yikuphi ukuphazamiseka kwe-coagulation (okufana ne-haemophilia) ngoba ukopha noma imihuzuko kungase kwenzeke ngemva kokuphathwa kwe-intramuscular kulaba bantu.
  • Ukusebenza kwe-Nuvaxovid kungase kube phansi kubantu abangenawo amandla omzimba.
  • Ukuphathwa kwe-Nuvaxovid ekukhulelweni kufanele kucatshangelwe kuphela lapho izinzuzo ezingaba khona zedlula noma yiziphi izingozi ezingaba khona kumama ne-fetus.
  • Imiphumela nge-Nuvaxovid ingase ithinte ikhono lokushayela noma ukusebenzisa imishini okwesikhashana.
  • Abantu ngabanye bangase bangavikelwa ngokugcwele kuze kube yizinsuku ezingu-7 ngemva komthamo wabo wesibili. Njengayo yonke imigomo, ukugoma nge-Nuvaxovid kungase kungabavikeli bonke abamukeli bomgomo.
  • Ukusabela okungekuhle okuvame kakhulu okubonwe ngesikhathi socwaningo lwemitholampilo (isigaba semvamisa esivame kakhulu ≥1/10) kwakuyikhanda elibuhlungu, isicanucanu noma ukuhlanza, i-myalgia, i-arthralgia, ubumnene/ubuhlungu bendawo yomjovo, ukukhathala, nokungezwani komzimba.

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Mayelana umbhali

UHarry Johnson

UHarry Johnson ube ngumhleli wesabelo se- eTurboNews iminyaka engaphezu kwengu-20. Uhlala e-Honolulu, eHawaii, futhi udabuka eYurophu. Uyakujabulela ukubhala nokubika izindaba.

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