European Commission Zvino Inopa Mamiriro Ekuita Kushambadzira kweNovavax COVID-19 Vaccine

Maonero eEMA uye yakabatana EC sarudzo yakavakirwa pahupamhi hwe preclinical, kugadzira uye yekiriniki yekuyedza data yakaunzwa kuti iongororwe. Izvi zvinosanganisira maviri akakosha Phase 3 miedzo yekiriniki: PREVENT-19 iyo yaisanganisira vatori vechikamu 30,000 muUS neMexico, mhedzisiro yacho yakabudiswa muThe New England Journal of Medicine (NEJM); uye kutongwa nevatori vechikamu 15,000 muUK, mhedzisiro yacho yakabudiswawo muNEJM. Mune ese ari maviri miedzo, NVX-CoV2373 yakaratidza kushanda kwepamusoro uye inogamuchirwa chengetedzo uye kushivirira chimiro. Novavax icharamba ichiunganidza uye kuongorora data renyika chaiyo, kusanganisira kutarisa kwekuchengetedza uye kuongororwa kwezvakasiyana, sezvo vaccine ichigoverwa.

Novavax neEC vakazivisa chibvumirano chekutenga mberi (APA) kwemadhora mazana maviri emadhora eNovavax 'COVID-200 muna Nyamavhuvhu 19. Madosi ekutanga anotarisirwa kusvika muEurope muna Ndira. Novavax iri kushanda neEMA nevamwe vayo kukurumidza kuyedza kuburitswa kwenzvimbo.

Mvumo iyi inosimudzira mubatanidzwa weNovavax wekugadzira neSerum Institute of India (SII), iyo yakakura pasi rose inogadzira vaccine nehuwandu, iyo ichapa madosi ekutanga eEU Inozowedzerwa nedata kubva kune dzimwe nzvimbo dzekugadzira muNovavax 'global supply chain.

Novavax neSII nguva pfupi yadarika vakawana mvumo yekushandisa emergency (EUA) muIndonesia nePhilippines, uko ichatengeswa neSII pasi pezita rekutengesa Covovax™. Makambani aya akawanawo runyoro rwekushandiswa kwekukurumidzira kweCovovax kubva kuWorld Health Organisation. Mushonga uyu zvakare uri kuongororwa nemasangano akawanda anodzora pasi rese, uye kambani inotarisira kuendesa chemistry, kugadzira uye kutonga (CMC) data package kuUS Food and Drug Administration (FDA) mukupera kwegore.

Kushandiswa Kwemvumo yeNuvaxovid™ muEuropean Union

European Commission yakapa mvumo yekushambadzira yeNuvaxovid ™ COVID-19 Vaccine (recombinant, adjuvanted) yekushanda inoshanda kudzivirira COVID-19 yakakonzerwa neSARS-CoV-2 muvanhu vane makore gumi nemasere zvichikwira.

Yakakosha Yekuchengetedza Ruzivo

• Nuvaxovid™ inopikiswa muvanhu vane hypersensitivity kune chinhu chinoshanda kana kune chimwe chezvinobatsira.

• Zviitiko zveanaphylaxis zvakashumwa nekupihwa kwemishonga yekudzivirira COVID-19. Kurapa kwakakodzera uye kutarisirwa kunofanira kuwanikwa kana pane anaphylactic reaction

• Zvinetso zvine chokuita nekuzvidya mwoyo, kusanganisira vasovagal reactions (syncope), hyperventilation, kana kushungurudzika-kune chokuita nekunetseka kunogona kuitika mukubatana nekudzivirira semhinduro kune jekiseni retsono. Zvakakosha kuti pave nedziviriro kuitira kudzivirira kukuvara kubva pakufenda

• Kubaya majekiseni kunofanirwa kumbomiswa muvanhu vari kurwara nefivha yakanyanya kana utachiona hwakanyanya

• Ipa Nuvaxovid nekuchenjerera kune vanhu vari kuwana anticoagulant therapy kana avo vane thrombocytopenia kana chero coagulation disorder (yakadai sehemophilia) nokuti kubuda ropa kana maronda anogona kuitika mushure mekuita intramuscular muvanhu ava.

• Kushanda kweNuvaxovid kunogona kunge kwakaderera muvanhu vane immunosuppressed

• Nguva yedziviriro inopihwa nejekiseni haazivikanwi sezvo ichiri kuongororwa nemiedzo yekiriniki inoenderera mberi

• Vanhu vanogona kunge vasina kuchengetedzwa zvizere kusvika mazuva manomwe mushure memushonga wavo wechipiri. Sezvakaita nemishonga yese, kubayiwa neNuvaxovid hakugone kuchengetedza vese vanogamuchira vaccine

• Izvo zvinowanzoitika zvakashata zvakaonekwa panguva yezvidzidzo zvekiriniki (frequency category of very common ≥ 1/10), aiva musoro, kuda kurutsa kana kurutsa, myalgia, arthralgia, jekiseni site kupfava/kurwadziwa, kuneta uye malaise.