Novavax 'COVID-19 yekudzivirira yakapihwa mvumo yenguva pfupi muNew Zealand

Novavax, Inc. (Nasdaq: NVAX), kambani yebiotechnology yakazvipira kugadzira uye kutengesa chizvarwa chinotevera chekudzivirira zvirwere zvinotapukira, nhasi yazivisa kuti Medsafe yeNew Zealand yakapa mvumo yechinguvana yeNVX-CoV2373, Novavax 'COVID-19 vaccine (adjuvanted). ), yekushanda kwekudzivirira kudzivirira chirwere chekoronavirus 2019 (COVID-19) chinokonzerwa neSARS-CoV-2 muvanhu vane makore gumi nemasere zvichikwira. Mushonga uyu uchapihwa kuNew Zealand pasi pezita remhando yeNuvaxovid™.

"Kubvumidzwa kwenguva pfupi kweNuvaxovid neMedsafe kuchagonesa Novavax kuendesa mushonga wekutanga weprotein-based COVID-19 kuNew Zealand," akadaro Stanley C. Erck, Mutungamiriri uye Chief Executive Officer, Novavax. "Tinotenda Medsafe nekuongorora kwayo uye, sezvo denda riri kuramba richiitika, tinoramba takazvipira kutsigira New Zealand nepasirese mukurwisa COVID-19."

Mvumo yenguva pfupi neMedsafe yakavakirwa pakuongororwa kwemhando, chengetedzo, uye dhata rekuita rakaunzwa kuti riongororwe. Izvi zvinosanganisira maviri akakosha Phase 3 miedzo yekiriniki: PREVENT-19 yakanyoresa vangangoita zviuru makumi matatu vatori vechikamu muUS neMexico, mhedzisiro yacho yakabudiswa muThe New England Journal of Medicine (NEJM); uye kuyedza nevanoda kusvika zviuru gumi nezvishanu vatori vechikamu muUK, mhedzisiro yacho yakabudiswawo muNEJM. Mune ese ari maviri miedzo, NVX-CoV30,000 yakaratidza kushanda uye inosimbisa kuchengetedza uye kushivirira chimiro. Zviitiko zvakakomba uye zvakakomba zvakashata zvaive zvakaderera muhuwandu uye zvakaenzana pakati pevaccine nemapoka e placebo. Maitiro akajairika akanyanya kucherechedzwa panguva yezvidzidzo zvekiriniki (frequency chikamu cheakajairika ≥15,000/2373) yaive musoro, kuda kurutsa kana kurutsa, myalgia, arthralgia, jekiseni kunyorova/kurwadziwa, kuneta, uye malaise. Novavax icharamba ichiunganidza uye kuongorora data renyika chaiyo, kusanganisira kutarisa kwekuchengetedza uye kuongororwa kwezvakasiyana, sezvo vaccine ichigoverwa.

Novavax neHurumende yeNew Zealand vakambozivisa chibvumirano chekutenga mberi (APA) chemadhora miriyoni gumi nemazana manomwe ekudzivirira kweNovavax 'COVID-10.7. Mvumo yenguva pfupi iyi inosimudzira kudyidzana kwekugadzira kweNovavax neSerum Institute of India (SII), iyo yakakura pasi rose inogadzira vaccine nehuwandu, iyo ichapa madosi ekutanga kuNew Zealand. Mvumo yenguva ino inozowedzerwa nedata kubva kune dzimwe nzvimbo dzekugadzira muNovavax 'global supply chain.

Novavax yakagamuchira mvumo yekushambadzira yeNVX-CoV2373 muEuropean Union, emergency use listing (EUL) kubva kuWorld Health Organisation (WHO) uye yakapihwa kunyoreswa kwenguva pfupi neTherapeutic Goods Administration muAustralia, pakati pevamwe. Mushonga uyu zvakare uri kuongororwa nemasangano akawanda anodzora pasi rese, kusanganisira iyo US Food and Drug Administration (FDA).

Kuti uwane rumwe ruzivo nezveNuvaxovid, kusanganisira yakatenderwa yeNew Zealand Datasheet uye yakabvumidzwa Consumer Medicine Ruzivo uye Ruzivo Rwakakosha Chekuchengetedza, kana kukumbira rumwe ruzivo, ndapota shanyira mawebhusaiti anotevera:

• Novavax yepasirese mvumo webhusaiti
• COVID-19 Vaccine Status yeMaapplication
• Ruzivo rweVanyoreri/Vatengi Kutsvaga  

Zita remhando yeNuvaxovid™ harisati rapihwa mvumo yekushandiswa muUS neFDA. Novavax' inotsigira kuAustralia neNew Zealand iBiocelect Pty. Ltd. 

Kubvumirwa Kwenguva yeNuvaxovid^™ muNew Zealand

Medsafe yakapa mvumo yenguva pfupi yeNuvaxovid ™ COVID-19 Vaccine (adjuvanted) yekushanda kwekudzivirira kudzivirira COVID-19 yakakonzerwa neSARS-CoV-2 muvanhu vane makore gumi nemasere zvichikwira. 

Yakakosha Yekuchengetedza Ruzivo

• Nuvaxovid inopesana muvanhu vane hypersensitivity kune chinhu chinoshanda, kana kune chero ipi zvayo inobatsira.
• Zviitiko zveanaphylaxis zvakataurwa nekutonga kweCCIDID-19 vaccine. Kurapa kwakakodzera uye kutarisisa kunofanirwa kuwanikwa kana paine anaphylactic reaction zvichitevera kupihwa kwejekiseni. Chirwere chechipiri chekudzivirira hachifaniri kupiwa kune avo vakawana anaphylaxis kusvika kumutambo wekutanga weNuvaxovid.
• Kuzvidya mwoyo-kune chokuita nekuita, kusanganisira vasovagal reactions (syncope), hyperventilation, kana kushungurudzika-kune chokuita nekugadzirisa zvinogona kuitika mukubatana nekudzivirira semhinduro ye psychogenic kune jekiseni retsono. Zvakakosha kuti pave nedziviriro kuitira kudzivirira kukuvara kubva pakufenda.
• Vaccination inofanira kumbomiswa kune vanhu vanorwara nechirwere chakakomba chefivha kana hutachiona hwakanyanya.
• Nuvaxovid inofanira kupiwa nekuchenjerera kune vanhu vanowana anticoagulant therapy kana avo vane thrombocytopenia kana chero coagulation disorder (yakadai sehemophilia) nokuti kubuda ropa kana maronda kunogona kuitika mushure mekuita intramuscular administration muvanhu ava.
• Kushanda kweNuvaxovid kunogona kunge kwakaderera muvanhu vasina immunosuppressed.
• Kudzora kweNuvaxovid pakuzvitakura kunofanirwa kungotariswa kana mabhenefiti angangopfuura chero njodzi dzinogona kuitika kuna amai uye fetus.
• Mhedzisiro neNuvaxovid inogona kukanganisa kugona kutyaira kana kushandisa michina.
• Vanhu vanogona kunge vasina kuchengetedzwa zvizere kusvika mazuva manomwe mushure memushonga wavo wechipiri. Sezvakaita nemishonga yese, kubayiwa neNuvaxovid hakugone kuchengetedza vese vanogamuchira vaccine.
• Maitiro akajairika akanyanya kucherechedzwa panguva yezvidzidzo zvekiriniki (frequency chikamu cheakajairika ≥1/10) yaive musoro, kuda kurutsa kana kurutsa, myalgia, arthralgia, jekiseni kunyorova/kurwadziwa, kuneta, uye malaise.