{"id":10728,"date":"2021-08-26T15:20:04","date_gmt":"2021-08-26T05:20:04","guid":{"rendered":"https:\/\/mvec.mcri.edu.au\/?p=10728"},"modified":"2021-10-27T13:41:16","modified_gmt":"2021-10-27T02:41:16","slug":"fda-news-release-fda-approves-first-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/mvec.mcri.edu.au\/vi\/fda-news-release-fda-approves-first-covid-19-vaccine\/","title":{"rendered":"Th\u00f4ng c\u00e1o b\u00e1o ch\u00ed c\u1ee7a FDA: FDA ch\u1ea5p thu\u1eadn v\u1eafc-xin COVID-19 \u0111\u1ea7u ti\u00ean"},"content":{"rendered":"<p>C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u00e3 ph\u00ea duy\u1ec7t ho\u00e0n to\u00e0n v\u1eafc xin COVID-19 c\u1ee7a Pfizer-BioNTech cho nh\u1eefng ng\u01b0\u1eddi t\u1eeb 16 tu\u1ed5i tr\u1edf l\u00ean. V\u1eafc xin mRNA l\u1ea7n \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t theo \u1ee7y quy\u1ec1n s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p v\u00e0o th\u00e1ng 12 n\u0103m 2020 v\u00e0 hi\u1ec7n l\u00e0 v\u1eafc xin COVID-19 \u0111\u1ea7u ti\u00ean v\u00e0 duy nh\u1ea5t \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n s\u1eed d\u1ee5ng \u0111\u1ea7y \u0111\u1ee7.<\/p>\n<p>Pfizer CEO Albert Bourla said in a statement the FDA&#8217;s approval &#8220;affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.&#8221;<\/p>\n<p>T\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i v\u1eafc-xin \u0111\u01b0\u1ee3c FDA ch\u1ea5p thu\u1eadn \u0111\u1ec1u tr\u1ea3i qua m\u1ed9t quy tr\u00ecnh ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t \u0111\u1ec3 xem x\u00e9t ch\u1ea5t l\u01b0\u1ee3ng, \u0111\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3. \u0110\u1ed1i v\u1edbi Comirnaty, d\u1eef li\u1ec7u l\u00e2m s\u00e0ng m\u1edbi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng c\u00f9ng v\u1edbi th\u00f4ng tin hi\u1ec7n c\u00f3 \u0111\u01b0\u1ee3c g\u1eedi trong giai \u0111o\u1ea1n EUA ban \u0111\u1ea7u. Qu\u00e1 tr\u00ecnh ph\u00ea duy\u1ec7t c\u1ee7a FDA \u0111\u00e3 k\u1ebft lu\u1eadn r\u1eb1ng v\u1eafc xin 91% c\u00f3 hi\u1ec7u qu\u1ea3 trong vi\u1ec7c ng\u0103n ng\u1eeba b\u1ec7nh COVID-19 d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 c\u1ee7a kho\u1ea3ng 20.000 ng\u01b0\u1eddi nh\u1eadn v\u1eafc xin c\u0169ng nh\u01b0 20.000 ng\u01b0\u1eddi nh\u1eadn gi\u1ea3 d\u01b0\u1ee3c t\u1eeb 16 tu\u1ed5i tr\u1edf l\u00ean. H\u01a1n n\u1eefa, \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u1ed1t h\u01a1n c\u00e1c k\u1ebft qu\u1ea3 an to\u00e0n l\u00e2u d\u00e0i, kho\u1ea3ng 12.000 ng\u01b0\u1eddi nh\u1eadn \u0111\u00e3 \u0111\u01b0\u1ee3c theo d\u00f5i th\u00eam 6 th\u00e1ng sau li\u1ec1u v\u1eafc xin th\u1ee9 hai c\u1ee7a h\u1ecd. K\u1ebft qu\u1ea3 cu\u1ed1i c\u00f9ng cho th\u1ea5y v\u1eafc-xin l\u00e0m t\u0103ng nguy c\u01a1 vi\u00eam c\u01a1 tim v\u00e0 vi\u00eam m\u00e0ng ngo\u00e0i tim, \u0111\u1eb7c bi\u1ec7t l\u00e0 \u1edf nam gi\u1edbi d\u01b0\u1edbi 40 tu\u1ed5i, sau l\u1ea7n ti\u00eam th\u1ee9 hai. FDA v\u00e0 Trung t\u00e2m Ki\u1ec3m so\u00e1t v\u00e0 Ph\u00f2ng ng\u1eeba D\u1ecbch b\u1ec7nh c\u00f9ng v\u1edbi c\u00f4ng ty s\u1ebd ti\u1ebfp t\u1ee5c gi\u00e1m s\u00e1t t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a v\u1eafc xin Comirnaty, \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o m\u1ecdi m\u1ed1i lo ng\u1ea1i ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u00e0 \u0111\u00e1nh gi\u00e1 k\u1ecbp th\u1eddi.<\/p>\n<p>\u0110\u1ec3 \u0111\u1ecdc to\u00e0n b\u1ed9 b\u00e0i vi\u1ebft, b\u1ea5m v\u00e0o li\u00ean k\u1ebft d\u01b0\u1edbi \u0111\u00e2y:<br \/>\n<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-covid-19-vaccine\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-covid-19-vaccine<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration (FDA) has granted full approval of Pfizer-BioNTech COVID-19 vaccine for people aged 16 and above.<\/p>","protected":false},"author":493,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_lmt_disableupdate":"no","_lmt_disable":"","footnotes":"","_wp_rev_ctl_limit":""},"categories":[1],"tags":[],"class_list":["post-10728","post","type-post","status-publish","format-standard","hentry","category-default"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - 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