Hāʻawi ʻo WHO i ka papa inoa o ka hoʻohana ʻana i ka pilikia no ka Novavax COVID-19 Vaccine

ʻO ka EUL o kēia lā e pili ana i ka lāʻau lapaʻau e kūʻai ʻia e Novavax e like me Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) ma ʻEulopa a me nā mākeke ʻē aʻe. Ke hana ʻia nei a kūʻai ʻia ʻo NVX-CoV2373 ma India a me nā wahi laikini e Serum Institute of India Pvt. Ltd. (SII), e like me Covovax ™, i hāʻawi ʻia iā EUL i ka lā 17 Dekemaba. Ua hoʻokumu ʻia ʻo Nuvaxovid a me Covovax i ka ʻenehana protein recombinant Novavax like a ua hoʻokumu ʻia nā EUL ma kahi pre-clinical, clinical and chemistry, manufacturing and controls ( CMC) pūʻolo.

ʻO ka EUL o kēia lā e hahai ana i ka loaʻa ʻana o ka ʻae kūʻai kūʻai kūlana mai ke Komisina ʻEulopa a hoʻopaʻa mua iā Nuvaxovid e hālāwai me nā kūlana WHO no ka maikaʻi, palekana a me ka pono. He koi mua ʻo EUL no ka lawe ʻana aku i nā ʻāina he nui, me ka poʻe e komo ana i ka COVAX Facility, i hoʻokumu ʻia e hiki ai i ka hoʻokaʻawale ʻana a me ka hāʻawi ʻana i ke kano. ʻAe ʻo EUL i nā ʻāina e hoʻolalelale i kā lākou ʻae kānāwai e hoʻokomo a lawelawe i nā kano COVID-19. Ua hana ʻo Novavax a me SII i ka huila 1.1 biliona o ka lāʻau lapaʻau Novavax iā COVAX.

Hoʻokumu ʻia ka hāʻawi ʻana o EUL ma ka huina o nā ʻikepili preclinical, hana hana a me ka hoʻokolohua lapaʻau i waiho ʻia no ka loiloi. Loaʻa kēia i ʻelua mau hoʻokolohua lapaʻau pivotal Phase 3: PREVENT-19, i kākau inoa ma kahi o 30,000 mau mea komo i ka US a me Mexico, a ua paʻi ʻia nā hopena ma ka New England Journal of Medicine (NEJM); a me kahi hoʻāʻo i loiloi i ke kano ma mua o 14,000 mau mea komo ma UK, a ua paʻi ʻia nā hopena ma NEJM. I nā hoʻokolohua ʻelua, ua hōʻike ʻo NVX-CoV2373 i ka hana kiʻekiʻe a me ka hōʻoia ʻana i ka palekana a me ka ʻae ʻana. 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 ʻana o nā ʻano like ʻole, no ka mea i puʻunaue ʻia ke kano.

Ua hāʻawi ʻia ka lāʻau lapaʻau Novavax 'COVID-19 i ka mana hoʻohana pilikia (EUA) ma Indonesia a me Philippines, kahi e kūʻai ʻia ai ʻo Covovax e SII. Ke nānā ʻia nei ʻo NVX-CoV2373 e nā hui hoʻoponopono he nui i ka honua. Manaʻo ka hui e hoʻouna i kāna pūʻulu data CMC piha i ka US FDA ma ka hopena o ka makahiki. ʻAʻole i ʻae ʻia ka inoa inoa Nuvaxovid™ no ka hoʻohana ʻana ma US e ka FDA.