WHO Ua Fa'ataga nei le Fa'aaogaina Fa'afuase'i ole tui ole NVX-CoV2373 COVID-19

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Novavax, Inc., o se kamupani biotechnology e tuuto atu i le atinaʻeina ma le faʻatauina o tui e sosoo ai mo faʻamaʻi pipisi ogaoga, ma Serum Institute of India Pvt. Ltd. (SII), le kamupani sili ona tele o tui puipui i le lalolagi, i aso nei na faasilasila mai ai ua tuuina atu e le Faalapotopotoga o le Soifua Maloloina a le Lalolagi (WHO) le Lisi o Faalavelave Faafuasei (EUL) mo le NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 tui ma Matrix -M™ fesoasoani, mo tui puipuia o tagata taʻitoʻatasi 18 tausaga ma matutua atu mo le puipuia o faʻamaʻi coronavirus 2019 mafua mai le SARS-CoV-2. O le EUL i aso nei e fa'atatau ile tui na gaosia ma maketiina e le SII e pei o le COVOVAX™, ose tala fou toe tu'ufa'atasia, fa'aopoopoina le Vaccine SARS-CoV-2 rS, i Initia ma teritori laiseneina. O lo'o toe iloiloina e le WHO le fa'aulu fa'aopoopo a le EUL mo tui e fa'atauina e Novavax i lalo o le igoa Nuvaxovid™.

O le EUL e mua'i fa'aagavaaina le tui Novavax' COVID-19 e fa'amalieina tulaga fa'avae WHO mo le lelei, saogalemu ma le aoga. O le EUL ose mea e mana'omia muamua mo le auina atu i fafo i le tele o atunuu, e aofia ai i latou o loʻo auai i le COVAX Facility, lea na faʻavaeina e faʻasoa ma tufatufaina tutusa tui i atunuu ma tamaoaiga o loʻo auai.

"O le faaiuga o aso nei mai le Faalapotopotoga o le Soifua Maloloina a le Lalolagi e taua tele i le faamautinoaina o le avanoa i le lalolagi atoa i se tui puipuia COVID-19 mo le faitau selau miliona o tagata i le lalolagi," o le tala lea a Stanley C. Erck, Peresetene ma le Ofisa Sili o Pulega, Novavax. “Matou te faafetai i le Faalapotopotoga o le Soifua Maloloina a le Lalolagi mo lana iloiloga maeʻaeʻa. Matou te talitonu o lenei tui o le a fesoasoani e foia pa puipui i le mauaina o tui i le tele o itulagi o le lalolagi e ala i le faʻaogaina o le pusaaisa masani o loʻo faʻaaogaina i auala o loʻo iai tui, ae o loʻo ofoina atu foi se filifiliga e faʻavae i luga o se tekinolosi masani ma malamalama lelei.

"O le EUL a le Faalapotopotoga o le Soifua Maloloina a le Lalolagi o se faʻamalosiaga sili lea i le faʻafaigofieina o tui COVID-19. O la matou faigapaʻaga ma Novavax ua manuia i le tuʻuina atu o le taʻitaʻiga o le soifua maloloina lautele i le lalolagi atoa ma faʻamautinoa o loʻo maua e atunuʻu uma se avanoa lautele i se tui talafeagai, "o le tala lea a Adar Poonawalla, Ofisa Sili o Pulega, Serum Institute of India. “O le COVOVAX o le tui muamua ole tui ole COVID-19 e fa'atatau i porotini, fa'atasi ai ma le fa'aalia lelei ma le fa'ataga lelei o le saogalemu, e fa'aavanoaina ile Fale COVAX. Matou te faʻafetai i le WHO ma saili e fesoasoani i le lalolagi e pulea le sosolo o faʻamaʻi. ”

"O se tala fiafia tele ua i ai nei i le lalolagi se auupega fou i ana auupega o meafaigaluega e tau ai le COVID-19," o le tala lea a Dr Richard Hatchett, Ofisa Sili o Pulega, Coalition for Epidemic Preparedness Innovations (CEPI). "O tupe teufaafaigaluega a le CEPI e faʻavavevave ai le atinaʻeina o falemaʻi ma le gaosiga o le tui Novavax 'ua taua tele ina ia mafai ai ona maua tutusa le avanoa i le tui e ala i le COVAX."

"Matou te faʻafeiloaʻi le tala o le tui COVOVAX ua maua WHO Faʻalavelave Faʻaaogaina Lisi, tuʻuina atu i le lalolagi - ma COVAX tagata auai - ma se isi vasega faʻamaonia o tui faʻapea foʻi ma se isi meafaigaluega i le taua faasaga i le COVID-19," o le tala lea a Dr Seth Berkley, Pule Sili o Gavi, le Vaccine Alliance. "Faʻatasi ai ma faʻamatalaga i luga o le saogalemu ma le aoga e faasaga i le tele o fesuiaiga, malosi malosi i le fefiloi ma le fetaui ma le faʻaleleia o faiga, ma tulaga masani e teu ai le vevela, o lenei tui o le a maua ai e atunuu se isi filifiliga taua i le sailiga e fesoasoani e puipuia o latou faitau aofaʻi."

O le foa'i a le EUL na fa'avae i luga ole aofa'iga o fa'amaumauga a le falema'i, gaosiga ma fa'ata'ita'iga na tu'uina atu mo le toe iloiloga. E aofia ai faʻataʻitaʻiga faʻapitoa e lua Phase 3: PREVENT-19, lea na lesitalaina pe tusa ma le 30,000 tagata auai i le US ma Mekisiko, o faʻaiʻuga na lomia ia Tesema 15, 2021 i le New England Journal of Medicine (NEJM); ma se faʻataʻitaʻiga na iloilo ai le tui i le silia ma le 14,000 tagata auai i Peretania, o faʻaiʻuga na lomia ia Iuni 30, 2021 i le NEJM. I faʻataʻitaʻiga uma e lua, na faʻaalia ai e le NVX-CoV2373 le maualuga o le aoga ma le faʻamautinoaina o le saogalemu ma le faʻatagaina. Novavax o le a faʻaauau ona aoina ma auʻiliʻili faʻamatalaga moni o le lalolagi, e aofia ai le mataʻituina o le saogalemu ma le iloiloga o fesuiaiga, aʻo tufatufaina atu le tui.

Na maua talu ai nei e Novavax ma SII le fa'atagaga fa'aoga fa'afuase'i (EUA) mo COVOVAX i Initonesia ma Filipaina. O le tui o loʻo i ai foi i le taimi nei o loʻo iloiloina e le tele o lala sooupu i le lalolagi atoa. O loʻo faʻamoemoe le kamupani e tuʻuina atu lana pusa faʻamaumauga o kemisi, gaosiga ma faʻatonuga (CMC) i le US FDA i le faaiuga o le tausaga.

OA MEA E AVEA MAI LENEI TUSI:

  • We believe this vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology.
  • “We welcome the news that the COVOVAX vaccine has received WHO Emergency Use Listing, providing the world – and COVAX participants – with another promising class of vaccine as well as yet another tool in the battle against COVID-19,”.
  • “With data on safety and efficacy against several variants, strong potential in mix and match and booster regimens, and standard storage temperatures, this vaccine will provide countries with another critical option in the quest to help protect their populations.

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