Ugonyo lwe-Novavax 'COVID-19 lunikwe imvume yethutyana eNew Zealand

INovavax, Inc. (Nasdaq: NVAX), inkampani yebhayoloji ezinikele ekuphuhliseni nasekuthengiseni izitofu zokugonya kwisizukulwana esilandelayo kwizifo ezosulelayo, namhlanje ibhengeze ukuba iMedsafe yaseNew Zealand inike imvume yethutyana yeNVX-CoV2373, Novavax 'COVID-19 iyeza (adjuvated). ), kugonyo olusebenzayo lokuthintela isifo se-coronavirus ka-2019 (COVID-19) esibangelwa yi-SARS-CoV-2 kubantu abaneminyaka eli-18 nangaphezulu. Ugonyo luya kunikezelwa eNew Zealand phantsi kwegama lebrendi i-Nuvaxovid™.

"Ukwamkelwa okwethutyana kweNuvaxovid yiMedsafe kuya kwenza ukuba iNovavax ikwazi ukuhambisa isitofu sokuqala esisekwe kwiprotheyini ye-COVID-19 eNew Zealand," utshilo uStanley C. Erck, uMongameli kunye neGosa eliyiNtloko lesiGqeba, uNovavax. "Siyayibulela iMedsafe ngophononongo lwayo olucokisekileyo kwaye, njengoko ubhubhane uqhubeka nokuvela, sisazibophelele ekuxhaseni iNew Zealand kunye nehlabathi kumlo ochasene ne-COVID-19."

Ukuvunywa okwethutyana yi-Medsafe kusekelwe kuvavanyo lomgangatho, ukhuseleko, kunye nedatha esebenzayo ethunyelwe ukuba iphononongwe. Oku kubandakanya izilingo ezimbini ezibalulekileyo zeSigaba se-3: I-PREVENT-19 ibhalise malunga nabathathi-nxaxheba be-30,000 e-US naseMexico, iziphumo ezipapashwe kwi-New England Journal of Medicine (NEJM); kunye nolingo kunye nabathathi-nxaxheba abaphantse babe yi-15,000 e-UK, iziphumo eziye zapapashwa kwi-NEJM. Kuzo zombini izilingo, i-NVX-CoV2373 ibonise ukusebenza kunye nokhuseleko oluqinisekisayo kunye neprofayili yokunyamezela. Iziganeko ezimbi kakhulu nezimandundu bezisezantsi ngenani kwaye zilinganiswe phakathi kwesitofu sokugonya kunye namaqela e-placebo. Ezona mpendulo zixhaphakileyo zixhaphakileyo eziye zabonwa ngexesha lezifundo zeklinikhi (udidi oluxhaphake kakhulu ≥1/10) yayiyintloko, isicaphucaphu okanye ukugabha, i-myalgia, i-arthralgia, ukuthamba/intlungu kwindawo yokutofa, ukudinwa, kunye nokungabi nangxaki. I-Novavax iya kuqhubeka nokuqokelela kunye nokuhlalutya idatha yehlabathi lokwenyani, kubandakanywa ukubeka esweni ukhuseleko kunye novavanyo lwezinto ezahlukeneyo, njengoko isitofu sokugonya sisasazwa.

UNovavax kunye noRhulumente waseNew Zealand ngaphambili babhengeze isivumelwano sokuthenga kwangaphambili (i-APA) kwiidosi zezigidi ezili-10.7 zesitofu sokugonya seNovavax 'COVID-19. Le mvume yethutyana ikhulisa ubambiswano lokwenziwa kweNovavax kunye neSerum Institute of India (SII), elona shishini likhulu kwihlabathi ngomthamo, eliya kubonelela ngeedosi zokuqala eNew Zealand. Ulwamkelo lwethutyana luza kuthi kamva longezelelwe ngedatha evela kwiziza zokwenziwa ezongezelelweyo kwikhonkco lonikezelo lwehlabathi leNovavax.

UNovavax ufumene ugunyaziso olunemiqathango lwentengiso ye-NVX-CoV2373 kwi-European Union, uluhlu losetyenziso olungxamisekileyo (EUL) oluvela kuMbutho wezeMpilo weHlabathi (i-WHO) kwaye wanikwa ukubhaliswa okwethutyana nguLawulo lweeMpahla zoNyango e-Australia, phakathi kwabanye. Isitofu sokugonya okwangoku siphantsi koqwalaselo zii-arhente ezininzi ezilawulayo kwihlabathi liphela, kubandakanya ne-US Food and Drug Administration (FDA).

Ukufumana ulwazi oluthe kratya malunga neNuvaxovid, kubandakanywa iDatha yeDatha yeNew Zealand evunyiweyo kunye neNgcaciso yeMithi yoMthengi evunyiweyo kunye nolwazi olubalulekileyo loKhuseleko, okanye ukucela ulwazi olongezelelweyo, nceda u tyelele ezi webhusayithi zilandelayo:

• Iwebhusayithi yeNovavax yogunyaziso yehlabathi
• Ubume bosetyenziso lwesitofu se-COVID-19
• Ulwazi lwaBagunyazisi/Ukukhangela abathengi  

Igama lebrendi i-Nuvaxovid™ alikagunyaziswa ukuba lisetyenziswe e-US yi-FDA. Umxhasi kaNovavax eOstreliya naseNew Zealand yiBiocelect Pty. Ltd. 

Ukuvunywa okwethutyana kweNuvaxovid^™ eNew Zealand

I-Medsafe inike imvume yethutyana yeNuvaxovid ™ COVID-19 Vaccine (adjuvated) yogonyo olusebenzayo ukuthintela i-COVID-19 ebangelwa yi-SARS-CoV-2 kubantu abaneminyaka eli-18 ubudala nangaphezulu. 

Ulwazi olubalulekileyo loKhuseleko

• I-Nuvaxovid inqatshelwe kubantu abane-hypersensitivity kwinto esebenzayo, okanye kuyo nayiphi na into encedisayo.
• Iziganeko ze-anaphylaxis zixelwe ngolawulo lwezitofu zokugonya i-COVID-19. Unyango olufanelekileyo kunye nokubekwa kweliso kufuneka kufumaneke kwimeko yokusabela kwe-anaphylactic emva kokulawulwa kwesitofu sokugonya. I-dose yesibini yesitofu sokugonya akufanele inikwe abo baye bafumana i-anaphylaxis kwi-dose yokuqala ye-Nuvaxovid.
• Iimpendulo ezinxulumene nokuxhalaba, kuquka i-vasovagal reactions (syncope), i-hyperventilation, okanye i-stress-related reactions inokwenzeka ngokubambisana nokugonywa njengempendulo ye-psychogenic kwinaliti yenaliti. Kubalulekile ukuba kubekho amanyathelo okuthintela ukwenzakala ngenxa yokufa isiqaqa.
• Ugonyo kufuneka luhlehliswe kubantu abaphethwe sisifo esiqatha kakhulu okanye usulelo oluqatha.
• I-Nuvaxovid kufuneka inikwe ngononophelo kubantu abafumana unyango lwe-anticoagulant okanye abo bane-thrombocytopenia okanye nakuphi na ukuphazamiseka kwe-coagulation (okufana ne-haemophilia) ngenxa yokuba ukopha okanye ukugruzuka kunokuthi kwenzeke emva kokulawulwa kwe-intramuscular kwaba bantu.
• Ukusebenza kweNuvaxovid kunokuba sezantsi kubantu abakhubazekileyo.
• Ulawulo lwe-Nuvaxovid ekukhulelweni kufuneka luthathelwe ingqalelo kuphela xa iinzuzo ezinokuthi zigqithise nayiphi na imingcipheko enokubakho kumama kunye nosana.
• Iziphumo ngeNuvaxovid zinokuchaphazela okwethutyana ukukwazi ukuqhuba okanye ukusebenzisa oomatshini.
• Abantu abanakukhuselwa ngokupheleleyo de kube ziintsuku ezisi-7 emva kwedosi yabo yesibini. Njengazo zonke izitofu zokugonya, ukugonywa nge-Nuvaxovid akunakukhusela bonke abafumana isitofu sokugonya.
• Ezona mpendulo zixhaphakileyo zixhaphakileyo eziye zabonwa ngexesha lezifundo zeklinikhi (udidi oluxhaphake kakhulu ≥1/10) yayiyintloko, isicaphucaphu okanye ukugabha, i-myalgia, i-arthralgia, ukuthamba/intlungu kwindawo yokutofa, ukudinwa, kunye nokungabi nangxaki.