Imiphumela Yokuhlola Umgomo We-COVID-19-Influenza Manje Iyatholakala

I-Novavax, Inc. namuhla imemezele imiphumela yokuqala yokuhlolwa komtholampilo kweSigaba 1/2 somuthi wokugomela i-COVID-Influenza Combination Vaccine (CIC). I-CIC ihlanganisa umuthi wokugomela i-Novavax 'COVID-19, i-NVX-CoV2373, kanye nekhandidethi layo lokugomela umkhuhlane we-quadrivalent. Uhlolo lwe-CIC lubonise ukuthi ukwenza umuthi wokugoma oyinhlanganisela kungenzeka, kubekezelelwe kahle futhi kuvikeleke amasosha omzimba.            

"Siyaqhubeka nokuhlola isimo sezempilo yomphakathi esiguquguqukayo futhi sikholelwa ukuthi kungase kube nesidingo sama-booster aqhubekayo ukulwa nomkhuhlane we-COVID-19 kanye nomkhuhlane wesizini," kusho uGregory M. Glenn, MD, uMongameli Wezocwaningo Nentuthuko, uNovavax. "Sikhuthazwa yile datha kanye nendlela engase iqhubekele phambili yenhlanganisela yomuthi wokugomela umkhuhlane we-COVID-19 kanye nemithi yokugomela yodwa yomkhuhlane kanye ne-COVID-19."

Iphrofayili yokuphepha nokubekezeleleka yomuthi wokugoma oyinhlanganisela ibihambisana ne-NVX-CoV2373 ezimele yodwa kanye nezakhiwe eziyizithenjwa zomuthi wokugomela i-nanoparticle i-quadrivalent ohlolweni. Umuthi wokugoma oyinhlanganisela watholakala ukuthi ubekezelelwa kahle. Okubi kakhulu bekungavamile futhi akukho okwahlolwa ukuthi kuhlobene nomgomo.

Ucwaningo lusebenzise iziphetho ezichazayo, ezihlola ukuphepha kanye nezimpendulo ze-immunological of amakhemikhali ahlukene okugomela i-CIC. Indlela esekelwe kumodeli ye-Design of Experiments (DOE) yasetshenziswa ukuklama ukuhlola, okuvumela ukucutshungulwa okunamandla kakhudlwana kokukhethwa komthamo kokubili kwe-COVID-19 nama-antigen omkhuhlane ukuze kuthuthukiswe okwengeziwe uma kuqhathaniswa nezindlela ezivamile. Imiphumela yocwaningo lokuqala ithole ukuthi ukwakhiwa kwemithi yokugomela i-CIC ehlukahlukene kwenze kwaba nezimpendulo zokuzivikela komzimba kubahlanganyeli ngokuqhathaniswa nereferensi yomkhuhlane ozimele wodwa kanye nokwakhiwa komgomo ozimele we-COVID-19 (owama-H1N1, H3N2, B-Victoria HA kanye nama-antigen e-SARS-CoV-2 rS) . Imiphumela yokumodela iphinde yabonisa ukuthi ukwakheka okuhlanganisiwe kunamandla okunciphisa inani eliphelele le-antigen kufika ku-50% lilonke, kuthuthukisa ukukhiqizwa nokulethwa.

Yomibili imithi yokugoma esekelwe kumaprotheni esetshenziswe ocwaningweni yakhiwe nge-adjuvant ye-saponin-based Matrix-M™ enelungelo lobunikazi ukuze kuthuthukiswe ukusabela komzimba kanye nokugqugquzela amazinga aphezulu amasosha omzimba anciphisa amandla. Le datha isekela ukuthuthukela esivivinyweni sokuqinisekisa seSigaba 2, okulindeleke ukuthi siqale ekupheleni kuka-2022.

Imininingwane evela ocwaningweni yethulwe ku-World Vaccine Congress (WVC) e-Washington, DC.

Ukuvuselelwa Kohlelo Lomkhuhlane 

E-WVC, i-Novavax iphinde yabuyekeza okutholakele okubalulekile ocwaningweni lweSigaba sesi-3 lwekhandidethi elizimele lodwa lomkhuhlane, phambilini elalibizwa nge-NanoFlu, elahlangabezana nesiphetho salo sokuqala sokuzivikela komzimba. Le miphumela ishicilelwe ngaphambilini ku-The Lancet.

Ukugunyazwa e-US

Akekho phakathi kwe-NVX-CoV2373 noma ikhandidethi lokugomela umkhuhlane eligunyaziwe noma eligunyaziwe ukuthi lisetshenziswe e-US yi-US Food and Drug Administration.

Ulwazi Olubalulekile Lokuphepha lwe-NVX-CoV2373

• I-NVX-CoV2373 ivinjiwe kubantu abanokuzwela ngokweqile kwento esebenzayo, noma kunoma yiziphi izisiza.

• Izehlakalo ze-anaphylaxis zibikiwe ngokuphathwa kwemithi yokugomela i-COVID-19. Ukwelashwa okufanele kanye nokuqondisa kufanele kube khona uma kwenzeka kuba nokusabela kwe-anaphylactic ngemva kokuphathwa komgomo. Ukubhekisisa okungenani imizuzu eyi-15 kuyanconywa futhi umthamo wesibili womgomo akufanele unikezwe labo abahlangabezane ne-anaphylaxis kudosi yokuqala ye-NVX-CoV2373.

• 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 isifo esiyingozi. Ukuba khona kokutheleleka okuncane kanye/noma imfiva yezinga eliphansi akufanele kubambezele ukugoma.

• I-NVX-CoV2373 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 kahle kwe-NVX-CoV2373 kungase kube phansi kubantu abangenawo amandla omzimba.

• Ukuphathwa kwe-NVX-CoV2373 ngesikhathi sokukhulelwa kufanele kucatshangelwe kuphela lapho izinzuzo ezingaba khona zedlula noma yiziphi izingozi ezingaba khona kumama nombungu.

• Imiphumela nge-NVX-CoV2373 ingase ithinte okwesikhashana ikhono lokushayela noma lokusebenzisa imishini.

• Abantu bangase bangavikeleki ngokugcwele kuze kube yizinsuku ezingu-7 ngemva komthamo wabo wesibili. Njengayo yonke imigomo, ukugoma nge-NVX-CoV2373 kungase kungabavikeli bonke abamukeli bomgomo.

• Ukusabela okungekuhle okuvame kakhulu okwabonwa phakathi nocwaningo lwemitholampilo kwakuyikhanda elibuhlungu, isicanucanu noma ukuhlanza, i-myalgia, i-arthralgia, ubumnene/ubuhlungu endaweni yomjovo, ukukhathala, nokungezwani komzimba.