Ua hāʻawi ʻia ka lāʻau lapaʻau Novavax 'COVID-19 i ka ʻae manawaleʻa ma New Zealand

Novavax, Inc. (Nasdaq: NVAX), he hui biotechnology i hoʻolaʻa ʻia no ka hoʻomohala ʻana a me ka kūʻai ʻana i nā lāʻau lapaʻau o ka hanauna e hiki mai ana no nā maʻi maʻi maʻi koʻikoʻi, i kēia lā ua hoʻolaha ʻo Medsafe o New Zealand i ka ʻae ʻana o ka NVX-CoV2373, Novavax 'COVID-19 vaccine (adjuvanted). ), no ka lāʻau lapaʻau ikaika e pale aku i ka maʻi coronavirus 2019 (COVID-19) i hoʻokumu ʻia e SARS-CoV-2 i nā poʻe 18 makahiki a ʻoi aku. E hoʻolako ʻia ke kano i New Zealand ma lalo o ka inoa inoa Nuvaxovid™.

"ʻO ka ʻae kūpono o Nuvaxovid e Medsafe e hiki ai iā Novavax ke hoʻopuka i ka huakaʻi mua o ka protein-19 i New Zealand," wahi a Stanley C. Erck, Pelekikena a me Luna Nui, Novavax. "Ke hoʻomaikaʻi nei mākou iā Medsafe no kāna loiloi piha ʻana a, ke hoʻomau nei ka maʻi maʻi, hoʻomau mākou i ke kākoʻo ʻana iā New Zealand a me ka honua i ka hakakā ʻana me COVID-19."

Hoʻokumu ʻia ka ʻae kūpono ʻana e Medsafe ma luna o ka loiloi o ka ʻikepili maikaʻi, palekana, a me ka pono i waiho ʻia no ka loiloi. Loaʻa kēia i ʻelua mau hoʻokolohua lapaʻau pivotal Phase 3: PREVENT-19 i hoʻopaʻa inoa ma kahi o 30,000 i komo i ka US a me Mexico, a ua paʻi ʻia nā hopena ma The New England Journal of Medicine (NEJM); a me kahi hoʻokolokolo me kahi kokoke i 15,000 mau mea komo ma UK, a ua paʻi pū ʻia nā hopena ma NEJM. Ma nā hoʻokolohua ʻelua, ua hōʻike ʻo NVX-CoV2373 i ka pono a me ka hōʻoia ʻana i ka palekana a me ka ʻae ʻana. He haʻahaʻa ka nui o nā hanana koʻikoʻi koʻikoʻi a kaulike ma waena o nā hui kano a me kahi placebo. ʻO nā hopena ʻino maʻamau i ʻike ʻia i ka wā o nā noiʻi lapaʻau (ka māhele pinepine o ka maʻamau ≥1/10) ʻo ia ke poʻo, nausea a me ka luaʻi ʻana, myalgia, arthralgia, ʻoluʻolu/ʻeha o ka wahi i hoʻopaʻa ʻia, luhi, a me ka malaise. E hoʻomau ʻo Novavax i ka hōʻiliʻili ʻana a me ka nānā ʻana i ka ʻikepili o ka honua maoli, me ka nānā ʻana i ka palekana a me ka loiloi o nā ʻano like ʻole, ʻoiai ua puʻunaue ʻia ke kano.

Ua hoʻolaha mua ʻo Novavax a me ke Aupuni New Zealand i kahi kuʻikahi kūʻai mua (APA) no 10.7 miliona mau ʻāpana o ka lāʻau Novavax 'COVID-19. Hoʻohana kēia ʻae manawaleʻa i ka hui ʻana o Novavax me Serum Institute of India (SII), ka mea hana kano nui loa o ka honua ma ka nui, e hāʻawi ana i nā kumu mua i New Zealand. Ma hope e hoʻohui ʻia ka ʻae manawaleʻa me ka ʻikepili mai nā kahua hana hou i loko o ke kaulahao lako honua o Novavax.

Ua loaʻa iā Novavax ka mana kūʻai kūʻai kūlana no NVX-CoV2373 i ka European Union, ka papa inoa hoʻohana pilikia (EUL) mai ka World Health Organization (WHO) a ua hāʻawi ʻia i ka hoʻopaʻa inoa manawa e ka Therapeutic Goods Administration ma Australia, a me nā mea ʻē aʻe. Ke nānā ʻia nei ka lāʻau lapaʻau e nā hui hoʻoponopono he nui i ka honua holoʻokoʻa, me ka US Food and Drug Administration (FDA).

No ka ʻike hou aku e pili ana iā Nuvaxovid, e komo pū ana me ka New Zealand Datasheet i ʻae ʻia a i ʻae ʻia i ka ʻike lāʻau lapaʻau a me ka ʻike palekana koʻikoʻi, a i ʻole e noi i ka ʻike hou aku, e ʻoluʻolu e kipa i kēia mau pūnaewele:

• Novavax pūnaewele mana honua
• ʻO ke kūlana o ka maʻi maʻi COVID-19 o nā noi
• ʻIke no ka ʻimi ʻōlelo a nā mea kūʻai aku  

ʻAʻole i ʻae ʻia ka inoa inoa Nuvaxovid™ no ka hoʻohana ʻana ma US e ka FDA. ʻO ke kākoʻo ʻo Novavax ma Australia a me New Zealand ʻo Biocelect Pty. Ltd. 

Apono Kuikawa o Nuvaxovid^™ ma Aotearoa

Ua hāʻawi ʻo Medsafe i ka ʻae manawaleʻa o Nuvaxovid™ COVID-19 Vaccine (adjuvanted) no ka pale ʻana i ka COVID-19 i hoʻokumu ʻia e SARS-CoV-2 i nā poʻe he 18 mau makahiki a ʻoi aku. 

Kaʻikepili kūlana koʻikoʻi

• Hoʻopaʻa ʻia ʻo Nuvaxovid i nā poʻe i loaʻa ka hypersensitivity i ka mea hana, a i ʻole kekahi o nā mea kōkua.
• Ua hōʻike ʻia nā hanana anaphylaxis me ka hoʻohana ʻana i nā kano COVID-19. Pono e loaʻa ka lāʻau lapaʻau kūpono a me ka nānā ʻana inā loaʻa kahi hopena anaphylactic ma hope o ka lawelawe ʻana o ke kano. ʻAʻole pono e hāʻawi ʻia ka lua o ka lāʻau lapaʻau i ka poʻe i loaʻa i ka anaphylaxis i ka nui mua o Nuvaxovid.
• ʻO nā hopena pili i ka hopohopo, e like me nā hopena vasovagal (syncope), hyperventilation, a i ʻole nā ​​hopena pili i ke koʻikoʻi hiki ke loaʻa i ka hui pū ʻana me ka hoʻopaʻa ʻana ma ke ʻano he pane psychogenic i ka ʻiʻo o ka nila. He mea nui ka mālama ʻana i mea e pale aku ai i ka ʻeha mai ka maule.
• Pono e hoʻopaneʻe ʻia ka hoʻopaneʻe ʻana i ka poʻe i loaʻa i ka maʻi febrile koʻikoʻi a i ʻole ka maʻi ʻeha.
• Pono e hāʻawi ʻia ʻo Nuvaxovid me ka akahele i nā poʻe e loaʻa ana i ka anticoagulant therapy a i ʻole ka poʻe me ka thrombocytopenia a i ʻole kekahi maʻi coagulation (e like me ka hemophilia) no ka mea hiki ke kahe a i ʻole ka ʻeha ʻana ma hope o ka hoʻokele intramuscular i kēia mau kānaka.
• Hiki ke emi ka maikaʻi o Nuvaxovid i nā poʻe immunosuppressed.
• Pono e noʻonoʻo ʻia ka lawelawe ʻana o Nuvaxovid i ka wā hāpai inā ʻoi aku ka maikaʻi o nā pōmaikaʻi ma mua o nā pilikia kūpono no ka makuahine a me ka pēpē.
• Hiki i nā hopena me Nuvaxovid ke hoʻopilikia i ka hiki ke hoʻokele a hoʻohana paha i nā mīkini.
• ʻAʻole hiki ke pale piha ʻia nā kānaka a hiki i 7 mau lā ma hope o kā lākou ʻano lua. E like me nā lāʻau lapaʻau āpau, ʻaʻole hiki i ka lāʻau lapaʻau me Nuvaxovid ke pale i ka poʻe i loaʻa i ka maʻi āpau.
• ʻO nā hopena ʻino maʻamau i ʻike ʻia i ka wā o nā noiʻi lapaʻau (ka māhele pinepine o ka maʻamau ≥1/10) ʻo ia ke poʻo, nausea a me ka luaʻi ʻana, myalgia, arthralgia, ʻoluʻolu/ʻeha o ka wahi i hoʻopaʻa ʻia, luhi, a me ka malaise.