Ikhomishini YaseYurophu Manje Inikeza Izibonelelo Zokumaketha Okunemibandela Komgomo we-Novavax COVID-19

Umbono we-EMA kanye nesinqumo se-EC esihlobene sisekelwe ekupheleleni kwedatha yokuhlolwa kwangaphambi komtholampilo, ukukhiqizwa kanye nesivivinyo somtholampilo esithunyelwe ukuze sibuyekezwe. Lokhu kuhlanganisa izinhlolo ezimbili ezibalulekile zeSigaba sesi-3 zomtholampilo: I-PREVENT-19 ehlanganisa ababambiqhaza abangu-30,000 e-US nase-Mexico, imiphumela yako eyashicilelwa ku-New England Journal of Medicine (NEJM); kanye necala elinabahlanganyeli abangu-15,000 e-UK, imiphumela yalo yaphinde yanyatheliswa ku-NEJM. Kuzo zombili izivivinyo, i-NVX-CoV2373 ibonise ukusebenza kahle okuphezulu kanye nephrofayili eyamukelekayo yokuphepha nokubekezeleleka. I-Novavax izoqhubeka nokuqoqa nokuhlaziya idatha yomhlaba wangempela, okuhlanganisa nokuqapha ukuphepha nokuhlolwa kwezinhlobonhlobo, njengoba umgomo usatshalaliswa.

I-Novavax kanye ne-EC bamemezele isivumelwano sokuthenga kusengaphambili (i-APA) imithamo efinyelela ezigidini ezingama-200 yomgomo we-Novavax' COVID-19 ngo-Agasti 2021. Imithamo yokuqala kulindeleke ukuthi ifike eYurophu ngoJanuwari. I-Novavax isebenza ne-EMA kanye nozakwethu ukusheshisa ukuhlolwa kokukhishwa kwendawo.

Lokhu kugunyazwa kuthuthukisa ubudlelwano bokukhiqiza be-Novavax ne-Serum Institute of India (SII), umkhiqizi wokugoma omkhulu kunawo wonke emhlabeni ngevolumu, ezohlinzeka imithamo yokuqala ye-EU Kamuva izongezwa ngedatha evela kumasayithi okukhiqiza engeziwe e-Novavax' global supply chain.

I-Novavax kanye ne-SII basanda kuthola ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo (i-EUA) e-Indonesia nase-Philippines, lapho izothengiswa khona yi-SII ngaphansi kwegama lokuhweba elithi Covovax™. Izinkampani ziphinde zithole uhlu lokusetshenziswa okuphuthumayo kwe-Covovax oluvela kwi-World Health Organization. Umuthi wokugoma nawo njengamanje usabuyekezwa yizikhungo eziningi ezilawulayo emhlabeni jikelele, futhi inkampani ilindele ukuthi ithumele iphakethe layo ledatha eliphelele lamakhemikhali, ukukhiqiza nokulawula (CMC) ku-US Food and Drug Administration (FDA) ekupheleni konyaka.

Ukusetshenziswa Okugunyaziwe kwe-Nuvaxovid™ e-European Union

I-European Commission inikeze ukugunyazwa kokuthengisa okunemibandela kwe-Nuvaxovid™ COVID-19 Vaccine (i-recombinant, adjuvated) yokugonywa okusebenzayo ukuvimbela i-COVID-19 ebangelwa i-SARS-CoV-2 kubantu abaneminyaka engu-18 nangaphezulu.

Ulwazi Olubalulekile Lwezokuphepha

• I-Nuvaxovid™ ayivunyelwe kubantu abanokuzwela ngokweqile kwento esebenzayo noma kunoma yiziphi izithasiselo.

• Izehlakalo ze-anaphylaxis zibikiwe ngokuphathwa kwemithi yokugomela i-COVID-19. Ukwelashwa okufanele kanye nokuqondisa kufanele kutholakale uma kwenzeka ukusabela kwe-anaphylactic

• Ukusabela okuhlobene nokukhathazeka, okuhlanganisa ukusabela kwe-vasovagal (syncope), i-hyperventilation, noma ukusabela okuhlobene nokucindezeleka kungase kwenzeke ngokuhambisana nokugoma njengempendulo yokujova inaliti. Kubalulekile ukuthi kube nezinyathelo zokuvikela ukugwema ukulimala ngenxa yokuquleka

• Ukugoma kufanele kuhlehliswe kubantu abanesifo esibi kakhulu se-febrile noma isifo esiyingozi

• Nikeza i-Nuvaxovid ngokuqapha kubantu abathola ukwelashwa kwe-anticoagulant noma labo abane-thrombocytopenia noma noma isiphi isifo sokuqina kwemithambo (njenge-haemophilia) ngoba ukopha noma imihuzuko kungase kwenzeke ngemva kokuphathwa kwe-intramuscular kulaba bantu.

• Ukusebenza kwe-Nuvaxovid kungase kube phansi kubantu abakhubazekile

• Ubude besikhathi sokuvikela okunikezwa umgomo akwaziwa njengoba kusanqunywa izinhlolo zokwelashwa eziqhubekayo

• Abantu bangase bangavikeleki ngokugcwele kuze kube yizinsuku ezingu-7 ngemva komthamo wabo wesibili. Njengayo yonke imigomo, ukugoma nge-Nuvaxovid kungase kungabavikeli bonke abamukeli bomgomo

• Ukusabela okubi 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 kanye nokungezwani komzimba.