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O se Tui fou COVID-19 i le faiga: Leai ni aʻafiaga!

Valneva SE os being developed by Dynavax Technologies Corporation It is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through Toll-like Receptor (TLR) stimulation. Dynavax develops, and commercializes novel vaccines.

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  • Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), o se kamupani tuʻufaʻapitoa tui puipuia, aso nei na folafolaina lelei topline iʻuga mai le Phase 3 taua faʻamasinoga Cov-Faʻatusatusa o lona le faʻagaoioia, adjuvanted COVID-19 tui sui tauva, VLA2001.
  • O le taua o le Vaega 3, Cov-Faʻatusatusa faʻataʻitaʻiga suʻeina le aofaʻi o 4,012 tagata auai 18 tausaga le matutua i luga atu 26 faʻataʻitaʻiga nofoaga i le United Kingdom. O le faʻamasinoga na feiloaʻi ma faʻaiʻuga autu: VLA2001 faʻaalia le sili atu i le AZD1222 (ChAdOx1-S), i le tulaga o le geometric uiga titer mo le faʻamamaina o vailaʻau (GMT ratio = 1.39, p <0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48 , 862.59)), (AZD1222 (ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), faʻapea foi ma le le maualalo i tulaga o seroconversion fua faatatau (SCR i luga 95% i vaega togafitiga uma) i le lua vaiaso talu le tui lona lua (ie Aso 43) i tagata matutua e 30 tausaga le matutua pe sili atu.
  • T-cell tali na suʻesuʻeina i se vaega laiti o tagata auai na faʻaalia ai o le VLA2001 na faʻaosofia le lautele antigen-faʻapitoa IFN-gamma gaosia T-sela toe faʻamalosia e faasaga i le S- (74.3%), N- (45.9%) ma le M- (20.3%) porotini.

VLA2001 na masani ona talia lelei. O le faʻapalepale faʻamatalaga o le VLA2001 na sili atu ona alofagia pe a faʻatusatusa i le vailaʻau tui galue malosi. O tagata na auai i le 30 tausaga ma sili atu na lipotia mai e toalaiti lava le aofai o mea leaga na tutupu e oʻo atu i le fitu aso talu ona uma le tui, e faatatau i aafiaga o le tuiina (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) ma lagona faʻaalia (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

Leai se faʻamalosia togafitiga faʻatatau-fesoʻotaʻi mataga leaga (SAE) na lipotia mai. I lalo ifo o le 1% lipotia se faʻalavelave matuia o le fiafia faapitoa i vaega togafitiga e lua. O tagata na auai i vaega laiti na tuiina ile VLA2001 na faʻaalia se tulaga lautele o le saogalemu e faʻatusatusa ile matutua tausaga.

O le tutupu mai o COVID-19 mataupu (exploratory endpoint) na tutusa i le va o vaega togafitiga. O le leai atoa o ni mataupu ogaoga COVID-19 atonu e taʻu mai ai o tui uma e lua na faaaoga i le suʻesuʻega na taofia ai le ogaoga o le COVID-19 e mafua mai i le taamilosaga (s) Delta).

Adam Finn, Polofesa o Paediatrics, Iunivesite o Bristol, Trial Chief Investigator, Fai mai: "O le maualalo o le reactogenicity ma le maualuga o le tali atu o le vailaʻau faʻamalosi tino i autafa o le lautele o le T-cell tali na vaʻaia ma lenei vailaʻau o le siama atoa ua le toe faʻagaoioia e mataʻina ma faʻamalosia foi. O se auala masani lenei i le faiga o tui nai lo tui ua leva ona faaaogaina i Peretania, Europa, ma Amerika i Matu ma o nei iʻuga e taʻu mai ai o lenei tui sui tauva o loo i ai i le ala e taua tele i le foiaina o le faʻamaʻi. "

Thomas Lingelbach, Ofisa Sili o Pulega o Valneva, Fai mai: "O nei iʻuga e faʻamaonia ai le lelei e masani ona fesoʻotaʻi ma tui puipuia o siama atoa. Matou te naunau e aumai le matou sui tauva tui i le laisene i se vave e mafai ai ma faʻaauau pea ona talitonu o le a mafai ona matou faia se sao taua i le taua i le lalolagi faʻasaga i le faʻamaʻi o le COVID-19. Matou te naunau e fai se isi fofo o vailaʻau mo tagata e leʻi tuiina. "

Juan Carlos Jaramillo, MD, Ofisa Sili o Fomaʻi o Valneva, faʻapea: "Ou te fia faʻafetai i tagata suʻesuʻe faʻataʻitaʻi faʻapea foi ma i latou uma na auai faʻataʻitaʻi ma tagata galulue faʻatasi, aemaise le National Institute for Health Research ma vaega faʻafomaʻi i totonu o le NHS Research Centres faʻapea ai ma le Public Health England. Lenei iʻuga faʻaalia ai le taua o le galulue faʻatasi na matou amata ia Setema 2020 ma e le mafai ona tatou ausia lenei mea taua e aunoa ma latou. O le a faʻaauau pea ona matou galulue vavalalata ma le MHRA e faʻamaeʻa la matou folasaga mo le faʻamaonia. "

Valneva amata faʻasolosolo tuʻuina atu mo le uluaʻi faʻamaonia ma le UK's Medicines and Healthcare oloa Regulate Agency (MHRA) ma o loʻo sauni e amata faʻasolosolo tuʻuina atu mo faʻamaonia tuʻutuʻu ma le European Medicines Agency. Ole suʻega mulimuli na manaʻomia e le MHRA e faʻamaonia ai le faʻamaoni o le VLA2001-301 faʻamaumauga o loʻo tumau pea ma o se mea e manaʻomia muamua mo le faʻamaeʻaina mulimuli o le lipoti suʻesuʻe a le falemaʻi.

I le avea ai o se vaega o le atinaʻe o oloa, Valneva ua maeʻa ona faafaigaluegaina le 306 volenitia mai le 56 tausaga le matutua i totonu o Niu Sila i totonu o lana VLA2001-304 faamasinoga ma o loʻo faamoemoe topline faʻamaumauga i le amataga o le 2022. faʻalauteleina o le Cov-Faʻatusatusa faʻamasinoga[2].

O loʻo sauniuni le Kamupani mo faʻataʻitaʻiga i tamaiti (5-12 tausaga le matutua) ma le Valneva na lagolagoina le faʻamalosiʻau faʻamalosiʻau e iloilo le VLA2001's booster performance mo tagata manaʻomia se booster.

E uiga ile Vaega 3 Fa'ata'ita'iga Cov-Fa'atusatusa (VLA2001-301)
Cov-Faʻatusatusa (VLA2001-301) o se faʻasolosolo, mataitu-tauaso, faʻatonutonu, faʻatusatusa faʻamalositino faʻataʻitaʻi i 4,012 tagata matutua ma 660 talavou. Co-Peraimeri manatu faʻaiuga o le sili atu o GMT fuafaatatau o VLA2001 faʻatusatusa i le AZD1222 (ChAdOx1-S) faʻapea foi ma le le maualalo o le seroconversion fua faatatau o le faʻamamaina o vailaʻau faʻataʻitaʻi e faia i le lua-inumua tui puipuia faʻavasega fa vaiaso vavae ese, fuaina i le lua vaiaso mulimuli ane le tui lona lua (ie Aso 43) i tagata matutua e 30 tausaga le matutua pe sili atu. E iloiloina ai foʻi le saogalemu ma le gafataulimaina ole VLA2001 ile lua vaiaso talu le tui lona lua i tagata matutua ma talavou e 12 tausaga le matutua. O le faamasinoga o loo faia i 26 nofoaga i le salafa o le UK 2,972 tagata auai 30 tausaga o le matutua ma sili atu na randomized i le 2: 1 fua faatatau e maua ai lua intramuscular tolo o VLA2001 (n = 1,977) po o AZD1222 (ChAdOx1-S) (n = 995) i le tulaga fautuaina fualaʻau, 28 aso vavaeʻese, i Aso 1 ma le 29. Mo faʻataʻitaʻiga o le faʻamalosiʻau, faʻataʻitaʻiga mai le 990 tagata na auai (492 na tuiina i le VLA2001, 498 na tuiina i le AZD1222 (ChAdOx1-S)) na faʻataʻitaʻia le le lelei mo le SARS- CoV-2 i le suʻega na suʻesuʻeina. 1,040 sui auai e i lalo o le 30 tausaga le matutua na faʻafaigaluegaina i se le faʻasolosolo togafitiga togafitiga ma mauaina VLA2001 28 aso vavae ese. O faʻamaumauga saogalemu mo i latou na auai 18-29 tausaga le matutua o loʻo suʻesuʻeina faʻatusatusa i tagata matutua 30 tausaga o luga atu. Talu ai nei, na amata ai le faʻamasinoga na lesitalaina muamua tamaiti na auai.

E tusa o le VLA2001
O le VLA2001 ua naʻo le pau lea o le siama atoa, ua le toe faʻagaoioia, o le sui o tui puipuia faasaga i le COVID-19 i faʻataʻitaʻi falemaʻi i Europa. E faʻamoemoeina mo le tui puipuia o tagata e ono aʻafia e puipuia ai taʻavale ma faʻamaʻi pipisi ma le COVID-19 i le taimi o le faʻamaʻi pipisi ma ono mulimuli ane mo tui masani e aofia ai le faʻatalanoaina o ni suiga fou. VLA2001 atonu e talafeagai mo le faʻamalosia, ona ua toe faʻamalosia le faʻamalosia o tui ua faʻaalia e galue lelei ma le atoa siama inactivated tui. VLA2001 o loʻo gaosia i luga o le faʻamaumauga Vero-cell faʻavae a Valneva, faʻaaogaina ai o tekonolosi mo le faia o tui laisene Iapani ensefalitis a Iapani, o Valneva, IXIARO®. VLA2001 aofia ai le faʻagaoioia vaega siama atoa o SARS-CoV-2 ma maualuga S-polotini density, faatasi ai ma lua adjuvants, alum ma CpG 1018. se suiga o le tali atu le puipuia agai Th1. CpG 1018 adjuvant, sapalaiina e Dynavax Technologies Corporation (Nasdaq: DVAX), o se vaega o le US FDA- ma le EMA-faamaonia HEPLISAV-B®  tui O le gaosiga o gaioiga mo VLA2001, lea ua maeʻa ona siʻitia i le tulaga tau alamanuia mulimuli, e aofia ai le le toe faʻagaoioia o vailaʻau e faʻasao ai le fausaga o le S-protein. VLA2001 e faʻamoemoe e faʻafetaui ma tulaga masani malulu filifili filifili (2 tikeri i le 8 tikeri Celsius).

E uiga i Valneva SE
Valneva o se faʻapitoa tui kamupani faʻatauaina i luga o le atinaʻe ma faʻapisinisi o tui puipui prophylactic mo faʻamaʻi pipisi ma le taua tele le manaʻomia fomaʻi. O le Kamupani na te faia se faʻapitoa faʻapitoa ma faʻatatauina auala i tui atinaʻe ma faʻapipiʻi lona loloto malamalamaʻaga o tui Saienisi e atiaʻe prophylactic tui faʻafitauli nei faʻamaʻi. Valneva ua faʻaaogaina lona tomai ma agavaʻa uma e faʻatautaia ma le manuia ni vailaʻau se lua ma ia vave alualu i luma le tele o ituaiga o tui sui tauva i totonu ma ala atu i le falemaʻi, e aofia ai sui tauva faasaga i le Lyme faamaʻi, o le chikungunya virus ma le COVID-19.

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Juergen T Steinmetz

O Juergen Thomas Steinmetz sa galue pea i galuega femalagaaʻi ma turisi talu mai lona talavou i Siamani (1977).
Na ia faavaeina eTurboNews i le 1999 o le muamua lugalaina lugalaina mo le lalolagi femalagaaiga turisi pisinisi.

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