Damakant Jayshi

Tom qab lub hlis ncua sijhawm, tus kws tsim tshuaj Novavax tau xa nws daim ntawv thov mus rau US Food and Drug Administration kom muab nws cov tshuaj tiv thaiv COVID-19 kev tso cai siv thaum muaj xwm txheej ceev (EUA), lub tuam txhab biotechnical tau hais hauv nqe lus rau hnub Monday.

"Qhov kev thov rau EUA yog raws li tag nrho ntawm cov ntaub ntawv ua ntej, kev kho mob thiab kev tsim khoom (CMC) cov ntaub ntawv muab rau lub koom haum, suav nrog cov txiaj ntsig ntawm ob qhov kev sim loj loj uas pom tau tias muaj txiaj ntsig tag nrho ntawm kwv yees li 90 feem pua ​​​​thiab muaj kev nyab xeeb dua. profile, "lub tuam txhab hais.

Cov tshuaj tiv thaiv yog npaj rau cov hnub nyoog 18 xyoo thiab siab dua.

Lub hli tas los, lub tuam txhab tau hais tias nws cov koob tshuaj ob zaug, cov tshuaj tiv thaiv kab mob raws li COVID-19 yog zoo tiv thaiv Omicron, qhov hloov pauv tshiab kawg ntawm tus kabmob coronavirus uas suav nrog feem ntau ntawm cov neeg mob hauv Tebchaws Meskas thiab thoob plaws ntau qhov chaw hauv ntiaj teb. 

Marathon Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv Hauv Lub Nroog Aaron Ruff tau hais tias qhov kev pom zoo tshuaj tiv thaiv tseem nyob rau theem pib.

"Muaj ntau cov kauj ruam tseem ceeb uas yuav tsum tau tshwm sim ua ntej FDA's EUA rau cov tshuaj tiv thaiv," Ruff hais rau Wausau Pilot & Review. "Peb yuav tsum hwm tus txheej txheem ntawd, tos kev taw qhia los ntawm FDA, (lub) Lub Chaw Tiv Thaiv thiab Tiv Thaiv Kab Mob (CDC), thiab Wisconsin Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv."

Ruff tau hais tias lub tuam tsev tseem tab tom hais ntxiv thiab qhia txog kev tshawb fawb txog tshuaj tiv thaiv "thiab qhov peb paub yog tias cov tshuaj tiv thaiv txuas ntxiv ua haujlwm tau zoo heev." Nws hais ntxiv tias lub nroog tseem muaj ntau cov tshuaj tiv thaiv los ntawm ntau qhov chaw thiab cov chaw muag khoom.

Lub nroog tus nqi txhaj tshuaj tiv thaiv yog qab lub xeev thiab lub teb chaws cov nuj nqis. Tsis tas li ntawd, cov kws saib xyuas kev noj qab haus huv hais tias cov neeg uas yog tsis tau txhaj tshuaj tiv thaiv tag nrho yog nyob deb ua ntej ntawm cov neeg mob, pw hauv tsev kho mob thiab tuag hauv nroog Wausau.

Lub tuam tsev tau liam tias kev nom kev tswv thiab cov ntaub ntawv tsis raug rau qhov kev txhaj tshuaj tiv thaiv tam sim no.

Ruff tau hais tias "Peb kuj tseem paub txog kev nom kev tswv thiab cov ntaub ntawv tsis raug uas tshwm sim los ntawm kev txhaj tshuaj tiv thaiv," Ruff hais. "Qhov ob qho no yeej muaj txiaj ntsig rau peb lub zej zog kev txhaj tshuaj tiv thaiv kab mob thiab lawv yog qhov sib txawv ntawm kev tiv thaiv kom kov yeej."

Txog tam sim no FDA tau tso cai EUA rau ob koob txhaj tshuaj ntawm Pfizer-BioNTech thiab Moderns thiab ib koob tshuaj los ntawm Johnson & Johnson.

Novavax qhov kev thov rau EUA tau los tom qab lub tuam txhab tau ntsib cov teeb meem ntsig txog kev tsim khoom thiab kev txhawj xeeb txog kev ua tau zoo, ncua kev nthuav tawm cov tshuaj tiv thaiv uas lub hom phiaj kom tau raws li cov kev xav tau ntawm cov teb chaws tsim.

Cov tshuaj tiv thaiv twb tau txais kev tso cai los ntawm European Union tus tswj hwm, Is Nrias teb, Indonesia, Philippines thiab Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb.Lub koom haum WHO tau koom tes nrog GAVI cov tshuaj tiv thaiv alliance thiab Coalition for Epidemic Preparedness Innovations (CEPI) los tsim COVAX, tshuaj tiv thaiv thoob ntiaj teb. kev faib ua pawg. 

Tsoomfwv Meskas tau nqis peev $ 1.6 nphom hauv Novavax rau cov tshuaj tiv thaiv.