Novavax, Inc. (Nasdaq: NVAX), o se kamupani biotechnology e tuuto atu i le atinaʻeina ma le faʻatauina o tui puipui mo faʻamaʻi pipisi ogaoga, i aso nei na faʻasalalau ai le faʻatagaina e le Medsafe a Niu Sila le faʻatagaina le tumau o le tui NVX-CoV2373, Novavax' COVID-19 (faʻaopoopoina). ), mo tui puipui malosi e puipuia ai le faama'i coronavirus 2019 (COVID-19) e mafua mai i le SARS-CoV-2 i tagata ta'ito'atasi e 18 tausaga ma matutua atu. Ole tui ole a avatu ile Niu Sila ile igoa ole Nuvaxovid™.
"O le faʻatagaina le tumau o Nuvaxovid e Medsafe o le a mafai ai e Novavax ona tuʻuina atu le tui muamua COVID-19 i Niu Sila," o le tala lea a Stanley C. Erck, Peresetene ma le Ofisa Sili o Pulega, Novavax. "Matou te faʻafetai ia Medsafe mo lana iloiloga maeʻaeʻa ma, a o faʻaauau pea le faʻafitauli o le faʻamaʻi, matou te tumau pea i le lagolagoina o Niu Sila ma le lalolagi i le taua faasaga i le COVID-19."
O le fa'atagaga le tumau a Medsafe e fa'avae ile iloiloga ole tulaga lelei, saogalemu, ma le aoga fa'amaumauga na tu'uina atu mo le iloiloga. E aofia ai fa'ata'ita'iga fa'apitoa e lua Phase 3: PREVENT-19 e tusa ma le 30,000 tagata auai i le US ma Mekisiko, o taunu'uga na lomia i le New England Journal of Medicine (NEJM); ma se faʻataʻitaʻiga ma toetoe lava 15,000 tagata auai i Peretania, o faʻaiʻuga na faʻasalalau foi i le NEJM. I faʻataʻitaʻiga uma e lua, NVX-CoV2373 faʻaalia le aoga ma le faʻamautinoaina o le saogalemu ma le faʻamalieina. O mea matuia ma ogaoga na tutupu na maualalo le numera ma paleni i le va o tui ma vaega placebo. O a'afiaga sili ona taatele na matauina i taimi o su'esu'ega fa'afoma'i (vaega masani o le ≥1/10) o le ulu, faufau po'o le pua'i, myalgia, arthralgia, tiga/tiga i le nofoaga o tui, vaivai, ma le vaivai. 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 faalauiloa muamua e Novavax ma le Malo o Niu Sila se maliega faatau muamua (APA) mo le 10.7 miliona tui ole tui ole Novavax' COVID-19. O lenei fa'atagaga le tumau e fa'aogaina ai le faiga fa'apa'aga a le Novavax ma le Serum Institute of India (SII), o le gaosiga o tui puipui aupito tele i le lalolagi, lea o le a tu'uina atu muamua tui i Niu Sila. O le fa'atagaga le tumau o le a fa'aopoopoina mulimuli ane i fa'amaumauga mai nofoaga fa'aopoopo falegaosimea i Novavax 'fa'atosina sapalai o le lalolagi.
Na maua e Novavax le fa'atagaga tau maketi mo le NVX-CoV2373 i le Iuni a Europa, lisi fa'aoga fa'afuase'i (EUL) mai le Faalapotopotoga o le Soifua Maloloina a le Lalolagi (WHO) ma fa'atagaina le resitalaina le tumau e le Therapeutic Goods Administration i Ausetalia, ma isi. O le tui o loʻo i ai foi i lalo o le iloiloga e le tele o lala sooupu i le lalolagi atoa, e aofia ai le US Food and Drug Administration (FDA).
Mo nisi fa'amatalaga i Nuvaxovid, e aofia ai le Pepa Fa'amaumauga a Niu Sila ma fa'amaonia Fa'amatalaga Fa'afoma'i Fa'atau ma Fa'amatalaga Taua Taua, po'o le talosagaina o fa'amatalaga fa'aopoopo, fa'amolemole asiasi i upegatafa'ilagi nei:
- Novavax lalolagi faʻatagaina upega tafaʻilagi
- Tulaga Tu'i COVID-19 o Talosaga
- Fa'amatalaga mo Fa'atonu/Su'esu'ega a Tagata Fa'atau
Ole igoa ole Nuvaxovid™ e le'i fa'atagaina mo le fa'aoga ile US e le FDA. O le lagolago a Novavax i Ausetalia ma Niu Sila o le Biocelect Pty. Ltd.
Fa'atagaina le tumau a Nuvaxovid™ i Niu Sila
Ua tuuina atu e Medsafe le faatagaga le tumau o le Nuvaxovid™ COVID-19 Vaccine (adjuvanted) mo tui puipui malosi e puipuia ai le COVID-19 e mafua mai i le SARS-CoV-2 i tagata taitoatasi e 18 tausaga ma matutua atu.
Faamatalaga Taua o le Saogalemu
- Nuvaxovid e fa'asaina i tagata o lo'o maua i le hypersensitivity i le vaila'au malosi, po'o so'o se mea fa'aoga.
- O mea na tutupu o anaphylaxis ua lipotia mai ile faʻaaogaina ole tui ole COVID-19. O togafitiga faafoma'i talafeagai ma le vaavaaiga e tatau ona avanoa pe a iai se fa'afitauli anaphylactic pe a uma le tu'uina atu o le tui. Ole tui lona lua ole tui e le tatau ona tu'uina atu ia i latou ua maua ile anaphylaxis ile tui muamua ole Nuvaxovid.
- O fa'alavelave fa'apopoleina, e aofia ai fa'alavelave vasovagal (syncope), hyperventilation, po'o fa'alavelave fa'apopoleina e ono tupu fa'atasi ma le tui o se tali fa'afoma'i i le tui o le nila. E taua le faia o puipuiga e aloese ai mai manu'a mai le matapogia.
- E tatau ona tolopo le tui i tagata ta'ito'atasi o lo'o maua i se ma'i fiva tu'i tuga po'o fa'ama'i pipisi.
- O le Nuvaxovid e tatau ona tu'uina atu ma le fa'aeteete i tagata ta'ito'atasi o lo'o maua togafitiga fa'aanticoagulant po'o i latou e maua i le thrombocytopenia po'o so'o se ma'i fa'atupu toto (e pei o le haemophilia) ona e mafai ona tupu le toto po'o le manu'a pe a mae'a le fa'aulu i totonu o nei tagata.
- Ole aoga ole Nuvaxovid atonu e maualalo ile immunosuppressed tagata.
- Ole fa'atonuga ole Nuvaxovid ile ma'itaga e tatau ona fa'atatau pe a sili atu fa'amanuiaga e mafai ona maua nai lo so'o se a'afiaga mo le tina ma le pepe.
- O a'afiaga o le Nuvaxovid e ono a'afia ai mo sina taimi le mafai ona ave ta'avale pe fa'aaoga masini.
- E le mafai ona puipuia atoatoa tagata ta'ito'atasi se'ia o'o i le 7 aso talu ona mae'a a latou tui lona lua. E pei o tui uma, o le tui ile Nuvaxovid atonu e le puipuia uma tagata e mauaina tui.
- O a'afiaga sili ona taatele o lo'o matauina i taimi o su'esu'ega fa'afoma'i (vaega masani o le ≥1/10) o le ulu, faufau po'o le pua'i, myalgia, arthralgia, tiga/tiga i le nofoaga o tui, vaivai, ma le vaivai.
OA MEA E AVEA MAI LENEI TUSI:
- Nuvaxovid e fa'asaina i tagata o lo'o maua i le hypersensitivity i le vaila'au malosi, po'o so'o se mea fa'aoga.
- Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
- A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.