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Mushonga mutsva we COVID-19 mukugadzira: Hapana mhedzisiro!

Valneva SE os inogadzirwa neDynavax Technologies Corporation Iyo izere-yakasanganiswa biopharmaceutical kambani yakanangana nekushandisa simba remuviri wemuviri uye unogadzirisa mhinduro dzemuviri kuburikidza neToll-senge Receptor (TLR) kukurudzira. Dynavax inokura, uye inoshambadza majekiseni ekudzivirira.

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  • Valneva SE (Nasdaq: VALN; E.)uronext Paris: VLA), inoverengeka kambani yekudzivirira, nhasi yazivisa mhedzisiro yakanaka kubva kuChikamu 3 chakakosha kutongwa Cov-Enzanisa neyakagadziriswa, yakagadziriswa COVID-19 mukwikwidzi wekudzivirira, VLA2001.
  • Chikamu chakakosha cheChikamu 3, Cov-Enzanisa muyedzo wakatora huwandu hwevane chikamu che4,012 vevatori vezera vane makore gumi nemasere zvichikwira munzvimbo dzekuyedza makumi maviri nenomwe muUnited Kingdom. Mhosva yacho yakasangana neyekutanga-ekupedzisira endpoints: VLA18 yakaratidza kukwirira kurwisa AZD26 (ChAdOx2001-S), maererano nemajometri anoreva titer yetiutralization antibodies (GMT ratio = 1222, p <1), (VLA1.39 GMT 0.0001 (2001% CI: 803.5 , 95)), (AZD748.48 (ChAdOx862.59-S) GMT 1222 (1% CI 576.6, 95)), pamwe nekusazvidzika maererano nematanho eseroconversion (SCR pamusoro pe543.6% mumapoka ese ekurapa) mumasvondo maviri mushure me kubaiwa kwechipiri (kureva Zuva 611.7) muvanhu vakuru vane makore makumi matatu zvichikwira.
  • T-masero mhinduro dzinoongororwa mune sub-seti yevatori vechikamu yakaratidza kuti VLA2001 yakakurudzira yakafara antigen-yakatarwa IFN-gamma inogadzira T-maseru inoshanda kurwisa S- (74.3%), N- (45.9%) uye M- (20.3%) protein.

VLA2001 yaiwanzoshivirirwa zvakanaka. Huremekedzero hweVLA2001 hwaive hwakanakisa zvakanyanya kana ichienzaniswa nemushonga unoshanda wekuenzanisa. Vatori vechikamu makore makumi matatu zvichikwira vakataura zvakashomeka kukumbira zviitiko zvakashata kusvika mazuva manomwe mushure mekubaiwa, zvese zvine chekuita nejekiseni saiti (30% VLA73.2 vs. 2001% AZD91.1 (ChAdOx1222-S), p <1) uye maitiro ehurongwa (0.0001% VLA70.2 vs. 2001% AZD91.1 (ChAdOx1222-S), p <1).

Hapana zvisina kukumbirwa kurapwa-zvine hukama zvakakomba zviitiko zvakashata (SAE) zvakataurwa. Asingasviki 1% akarondedzera chiitiko chakashata chekufarira kwakakosha mumapoka ese ekurapa. Vatori vechikamu muboka rezera rechidiki vakabaiwa VLA2001 vakaratidza huwandu hwese hwekuchengetedza hwakaenzana neboka rezera revakuru.

Izvo zvinoitika zve COVID-19 kesi (yekuongorora yekupedzisira) yaive yakafanana pakati pemapoka ekurapa. Kushaikwa kwakakwana kwechero zviitiko zvakakomba zveCOVID-19 zvinogona kuratidza kuti majekiseni maviri akashandiswa muchidzidzo akadzivirira zvakanyanya COVID-19 inokonzerwa nekusiyana-siyana (zvikuru) kweDelta).

Adam Finn, Purofesa wePaediatrics, Yunivhesiti yeBristol, Mutongi Mukuru Wekuongorora, yakati: “Kuderera kwemaitiro e-reactogenicity nemhinduro dzakakwirira dzeanorwisa masoja pamwe chete nemhinduro dzakapamhama dzeT-cell dzinoonekwa pamwe nemushonga wekudzivirira hutachiwana wakagadziriswa uyu unoshamisa uye unokurudzira zvikuru. "Iyi inzira yakasarudzika yekugadzira majekiseni kupfuura majekiseni akaendeswa kuUK, Europe, uye North America uye mhedzisiro iyi inoratidza kuti mukwikwidzi uyu arikuda kutora chinzvimbo chakakosha mukukunda denda iri."

Thomas Lingelbach, Chief Executive Officer weValneva, yakati: “Mhedzisiro iyi inosimbisa zvakwakanakira zvinowanzobatanidzwa nemishonga yekudzivirira hutachiwana isingashandi. Takazvipira kuunza mukwikwidzi wedu wekusiyanisa majekiseni ekupa marezinesi nekukurumidza sezvinobvira uye kuramba tichidavira kuti tichakwanisa kuita mupiro wakakosha kuhondo yepasirese kurwisa denda re COVID-19. Tine shungu dzekutaura imwe nzira yekudzivirira vanhu vasati vabaiwa jekiseni. ”

Juan Carlos Jaramillo, MD, Chief Medical Officer weValneva, akataura kuti: “Ndinoda kutenda vanoongorora nyaya iyi pamwe nevose vanenge vachitora chikamu pamwe nevanoshanda navo, kunyanya veNational Institute for Health Research nemapoka emakiriniki ari muNHS Research Centres pamwe nePublic Health England. Mhedzisiro iyi inoratidza kukosha kwekushandira pamwe kwatakatanga munaGunyana 2020 uye isu tingadai tisingakwanise kuwana danho iri pasina ivo. "Ticharamba tichishanda pamwe chete neMHRA kupedzisa kutumira kwedu kubvumidzwa."

Valneva akatanga kuburitsa kuendesa kwekutanga kupihwa mvumo neUK's Medicines uye Healthcare zvigadzirwa Regulatory Agency (MHRA) uye ari kugadzirira kutanga kudzikisira kutumira kwekubvumirwa kune mamiriro neEuropean Medicines Agency. Yekupedzisira assay yekusimbiswa inodiwa neMHRA kuti ione kutendeka kweiyo VLA2001-301 dhata inoramba ichienderera uye ndicho chinhu chinodiwa pakuendesa kwekupedzisira kwemakiriniki ekudzidza mushumo.

Sechikamu chehurongwa hwekuvandudza zvigadzirwa, Valneva apedza kutora makumi matatu nevatanhatu vane makore makumi mashanu nematanhatu zvichikwira muNew Zealand mukutongwa kwavo kweVLA306-56 uye anotarisira data repamusoro kutanga kwa2001. Valneva akazivisawo kutanga kwekutorwa kwevachiri kuyaruka se kuwedzera kweiyo Cov-Enzanisa muyedzo[2].

Iyo Kambani iri kugadzirira kuyedzwa muvana (makore mashanu kusvika pamashanu ezera) uye Valneva yakatsigira booster kutongwa kuti iongorore VLA5's booster performance kune vanhu vanoda booster.

Nezve Phase 3 Trial Cov-Enzanisa (VLA2001-301)
Cov-Enzanisa (VLA2001-301) ndeye yakasarudzika, anoona-bofu, anodzorwa, achienzanisa immunogenicity kutongwa mu4,012 vakuru uye 660 vechidiki. Co-Primary immunogenicity endpoints ari akakwirira e GMT ratio yeVLA2001 zvichienzaniswa neAZD1222 (ChAdOx1-S) pamwe nekusave kushomeka kweseroconversion mwero wekutapudza maantibayosi akaiswa mune maviri-dhijiji yekudzivirira chirongwa masvondo mana akaparadzaniswa, kuyerwa mumasvondo maviri mushure me kubaiwa kwechipiri (kureva Zuva 43) muvanhu vakuru vane makore makumi matatu zvichikwira. Inoongorora zvakare kuchengetedzeka uye kushivirira kweVLA30 mumavhiki maviri mushure mekudzivirira kwechipiri muvakuru nevechiri kuyaruka vane makore gumi nemaviri zvichikwira. Kutongwa uku kuri kuitiswa kunzvimbo makumi maviri nenhanhatu kuyambuka kuUK 2001 vatori vechikamu vane makore makumi matatu zvichikwira vakasarudzika muchiyero che12: 26 yekugamuchira maviri madhiri emuviri weVLA2,972 (n = 30) kana AZD2 (ChAdOx1-S) (n = 2001. CoV-1,977 pakuongorora yakaongororwa. 1222 vatori vechikamu vari pasi pemakore makumi matatu ekuberekwa vakanyoreswa mune isina-kurongwa kurapa boka uye vakagamuchira VLA1 995 mazuva akapatsanurwa. Dziviriro dhata pane avo vatori vechikamu 28-1 yemakore emakore inoongororwa zvakaenzana nevakuru vane makore makumi matatu ekuberekwa uye pamusoro. Munguva pfupi yapfuura, kutongwa kwakatanga kunyoresa vatori vechikamu vekutanga vechidiki.

Nezve VLA2001
VLA2001 parizvino ndiyo chete hutachiona hwese, husina kugadzirwa, hwakagadziriswa mushonga wekudzivirira anopesana neCOVID-19 mumakiriniki ekuedzwa muEurope. Inoitirwa kudzivirira hutachiona hwevanhu vari panjodzi yekudzivirira kutakura uye kuratidzira hutachiona neCOVID-19 panguva yedenda riri kuenderera mberi uye zvingangodaro gare gare kubayiwa nhomba kusanganisa kugadzirisa misiyano mitsva. VLA2001 inogona zvakare kuve yakakodzerwa mukuwedzera, sekudzokorora majoji majekiseni akaratidzirwa kuti anoshanda nemushonga wese hutachiona husina kuvharwa. VLA2001 inogadzirwa paValneva yakagadzwa Vero-cell chikuva, ichisimbisa iyo yekugadzira tekinoroji yeValneva's ine rezinesi yeJapan encephalitis jekiseni, IXIARO®. VLA2001 ine inactivated yakazara hutachiona hweSARS-CoV-2 ine yakakwira S-protein density, pamwe chete nemaviri adjuvants, alum uye CpG 1018. Iyi yekubatanidza adjuvant yakagara ichikonzera yakakwira antibody mazinga muzvipenga zvekuyedza kupfuura alum-chete mafomati uye akaratidzirwa shanduko yemhinduro yemumuviri yakanangana neT1. CpG 1018 inowedzera, inopihwa neDynavax Technologies Corporation (Nasdaq: DVAX), inhengo yeUS FDA- uye EMA-inogamuchirwa HEPLISAV-B®  mushonga. Maitiro ekugadzira eVLA2001, ayo akatokwidziridzwa kusvika pekupedzisira maindasitiri, anosanganisira kusagadziriswa kwemakemikari kuchengetedza chimiro cheS-protein. VLA2001 inotarisirwa kuenderana neyakajairwa kutonhora keteni zvinodiwa (2 madhigirii kusvika 8 madigiri Celsius).

Nezve Valneva SE
Valneva ikambani inodzivirira zvekudzivirira mishonga yakanangana nekusimudzira nekutengesa mishonga yekudzivirira yezvirwere zvinotapukira ine kukosha kukuru kwekurapa. Kambani inotora nzira yakasarudzika uye yakanangana nekusimudzira mishonga uye yozoshandisa nzwisiso yayo yakadzama yesainzi yekudzivirira kugadzira mishonga yekudzivirira inorwisa zvirwere izvi. Valneva yakawedzera hunyanzvi hwayo uye kugona kwayo kuti ibudirire kushambadza majekiseni maviri uye kukurumidza kusimudzira huwandu hwakawanda hwevachapinda kupinda uye kuburikidza nekiriniki, kusanganisira vanokwikwidza kurwisa chirwere cheLyme, chikungunya hutachiona uye COVID-19.

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Nezvomunyori

Juergen T Steinmetz

Juergen Thomas Steinmetz akaramba achishanda muindasitiri yekufambisa uye yekushanya kubva achiri mudiki kuGerman (1977).
Iye akatanga eTurboNews muna 1999 sebhuku rekutanga repamhepo pamhepo yepasirese yekushanya indasitiri yekushanya.

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