{"id":1340,"date":"2021-12-10T14:21:47","date_gmt":"2021-12-10T07:21:47","guid":{"rendered":"https:\/\/news.eloqasia.com\/?p=1340"},"modified":"2022-01-10T14:25:12","modified_gmt":"2022-01-10T07:25:12","slug":"lieu-phap-bo-doi-khang-the-don-dong-tac-dung-keo-dai-azd7442-con-co-ten-la-evusheld-duoc-cap-phep-su-dung-khan-cap-o-hoa-ky-cho-du-phong-truoc-phoi-nhiem-phong-ngua-covid-19","status":"publish","type":"post","link":"https:\/\/news.eloqasia.com\/?p=1340","title":{"rendered":"Li\u1ec7u ph\u00e1p b\u1ed9 \u0111\u00f4i kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i AZD7442 (c\u00f2n c\u00f3 t\u00ean l\u00e0 Evusheld) \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p \u1edf Hoa K\u1ef3 cho d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m (ph\u00f2ng ng\u1eeba) COVID-19"},"content":{"rendered":"

Li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i Hoa K\u1ef3 cho<\/em> d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m<\/em>\u00a0 <\/em><\/p>\n

D\u1eef li\u1ec7u quan tr\u1ecdng t\u1eeb th\u1eed nghi\u1ec7m pha III cho th\u1ea5y th\u1eddi gian b\u1ea3o v\u1ec7\u00a0 l\u00e2u d\u00e0i \u1edf nh\u00f3m \u0111\u1ed1i t\u01b0\u1ee3ng c\u00f3 nguy c\u01a1 cao ch\u1ec9 v\u1edbi 1 li\u1ec1u ti\u00eam<\/em><\/p>\n

Li\u1ec7u ph\u00e1p b\u1ed9 \u0111\u00f4i kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i (LAAB) AZD7442 c\u1ee7a AstraZeneca (tixagevimab k\u1ebft h\u1ee3p c\u00f9ng cilgavimab), \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p (EUA) \u1edf Hoa K\u1ef3 cho d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m COVID-19. Nh\u1eefng li\u1ec1u \u0111\u1ea7u ti\u00ean d\u1ef1 ki\u1ebfn s\u1ebd s\u1edbm \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng.<\/p>\n

C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u00e3 c\u1ea5p EUA cho AZD7442 cho vi\u1ec7c d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m COVID-19 \u1edf ng\u01b0\u1eddi l\u1edbn v\u00e0 thanh thi\u1ebfu ni\u00ean (t\u1eeb 12 tu\u1ed5i tr\u1edf l\u00ean, v\u1edbi c\u00e2n n\u1eb7ng t\u1eeb 40kg tr\u1edf l\u00ean) b\u1ecb suy gi\u1ea3m mi\u1ec5n d\u1ecbch t\u1eeb trung b\u00ecnh \u0111\u1ebfn n\u1eb7ng do t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00fd ho\u1eb7c s\u1eed d\u1ee5ng thu\u1ed1c \u1ee9c ch\u1ebf mi\u1ec5n d\u1ecbch \u2013 nh\u1eefng ng\u01b0\u1eddi c\u00f3 th\u1ec3 kh\u00f4ng t\u1ef1 sinh \u0111\u01b0\u1ee3c mi\u1ec5n d\u1ecbch \u0111\u1ea7y \u0111\u1ee7 v\u1edbi v\u1eafc xin COVID-19, c\u0169ng nh\u01b0 nh\u1eefng c\u00e1 nh\u00e2n kh\u00f4ng \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o ti\u00eam v\u1eafc xin COVID-19. Ng\u01b0\u1eddi s\u1eed d\u1ee5ng li\u1ec7u ph\u00e1p n\u00e0y c\u1ea7n ph\u1ea3i \u0111ang kh\u00f4ng b\u1ecb nhi\u1ec5m ho\u1eb7c g\u1ea7n \u0111\u00e2y ch\u01b0a ti\u1ebfp x\u00fac v\u1edbi ng\u01b0\u1eddi b\u1ecb nhi\u1ec5m SARS-CoV-2.<\/p>\n

Myron J. Levin, B\u00e1c s\u0129, Gi\u00e1o s\u01b0 Nhi khoa v\u00e0 Y khoa, Tr\u01b0\u1eddng Y c\u1ee7a \u0110\u1ea1i h\u1ecdc Colorado, Hoa K\u1ef3, v\u00e0 l\u00e0 m\u1ed9t trong nh\u1eefng ch\u1ee7 nhi\u1ec7m ch\u00ednh c\u1ee7a th\u1eed nghi\u1ec7m PROVENT, cho bi\u1ebft: \u201cH\u00e0ng tri\u1ec7u ng\u01b0\u1eddi \u1edf Hoa K\u1ef3 v\u00e0 tr\u00ean to\u00e0n th\u1ebf gi\u1edbi v\u1eabn \u0111\u1ee9ng tr\u01b0\u1edbc nguy c\u01a1 nghi\u00eam tr\u1ecdng t\u1eeb b\u1ec7nh COVID-19 b\u1edfi v\u00ec h\u1ec7 mi\u1ec5n d\u1ecbch c\u1ee7a h\u1ecd kh\u00f4ng t\u1ea1o ra \u0111\u1ee7 \u0111\u00e1p \u1ee9ng mi\u1ec5n d\u1ecbch, ngay c\u1ea3 sau khi \u0111\u01b0\u1ee3c ti\u00eam t\u1ea5t c\u1ea3 c\u00e1c li\u1ec1u v\u1eafc xin \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o. T\u00f4i r\u1ea5t vui v\u00ec c\u00f3 th\u1ec3 cung c\u1ea5p AZD7442 cho c\u00e1c b\u1ec7nh nh\u00e2n c\u1ee7a m\u00ecnh \u2013 m\u1ed9t l\u1ef1a ch\u1ecdn m\u1edbi, d\u1ec5 d\u00e0ng s\u1eed d\u1ee5ng v\u00e0 cung c\u1ea5p s\u1ef1 b\u1ea3o v\u1ec7 l\u00e2u d\u00e0i c\u1ea7n thi\u1ebft, gi\u00fap h\u1ecd \u0111\u01b0\u1ee3c tr\u1edf l\u1ea1i cu\u1ed9c s\u1ed1ng h\u00e0ng ng\u00e0y.\u201d<\/p>\n

Mene Pangalos, Ph\u00f3 Ch\u1ee7 t\u1ecbch \u0110i\u1ec1u h\u00e0nh BioPharmaceuticals R&D thu\u1ed9c AstraZeneca, cho bi\u1ebft: \u201cCh\u00fang t\u00f4i t\u1ef1 h\u00e0o \u0111\u01b0\u1ee3c \u0111\u00f3ng g\u00f3p \u0111\u00e1ng k\u1ec3 trong cu\u1ed9c chi\u1ebfn ch\u1ed1ng l\u1ea1i \u0111\u1ea1i d\u1ecbch COVID-19. V\u1edbi s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a AZD7442,<\/em> hi\u1ec7n ch\u00fang t\u00f4i \u0111\u00e3 c\u00f3 li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p t\u1ea1i M\u1ef9 \u0111\u1ec3 ng\u0103n ch\u1eb7n c\u00e1c tri\u1ec7u ch\u1ee9ng c\u1ee7a COVID-19 tr\u01b0\u1edbc khi ph\u01a1i nhi\u1ec5m v\u1edbi virus, \u0111\u1ed3ng th\u1eddi mang l\u1ea1i s\u1ef1 b\u1ea3o v\u1ec7 l\u00e2u d\u00e0i v\u1edbi m\u1ed9t li\u1ec1u duy nh\u1ea5t. AZD7442 trung h\u00f2a t\u1ea5t c\u1ea3 c\u00e1c bi\u1ebfn th\u1ec3 SARS-CoV-2 cho \u0111\u1ebfn nay, v\u00e0 ch\u00fang t\u00f4i \u0111ang nhanh ch\u00f3ng ti\u1ebfn h\u00e0nh nghi\u00ean c\u1ee9u \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 c\u1ee7a li\u1ec7u ph\u00e1p n\u00e0y \u0111\u1ed1i v\u1edbi bi\u1ebfn th\u1ec3 Omicron. Ch\u00fang t\u00f4i mu\u1ed1n g\u1eedi l\u1eddi c\u1ea3m \u01a1n \u0111\u1ebfn nh\u1eefng ng\u01b0\u1eddi tham gia th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, c\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u, c\u00e1c nh\u00e0 khoa h\u1ecdc, c\u00e1c c\u01a1 quan ch\u00ednh ph\u1ee7 v\u00e0 c\u00e1c \u0111\u1ed3ng nghi\u1ec7p t\u1ea1i AstraZeneca, nh\u1eefng ng\u01b0\u1eddi \u0111\u00e3 \u0111\u00f3ng g\u00f3p cho s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a AZD7442.\u201d<\/p>\n

Brian Koffman, \u0110\u1ed3ng s\u00e1ng l\u1eadp, Ph\u00f3 Ch\u1ee7 t\u1ecbch \u0110i\u1ec1u h\u00e0nh ki\u00eam Gi\u00e1m \u0111\u1ed1c Y khoa c\u1ee7a H\u1ed9i b\u1ec7nh b\u1ea1ch c\u1ea7u m\u1ea1n t\u00ednh (CLL), Hoa K\u1ef3, cho bi\u1ebft: \u201cM\u1ed9t trong nh\u1eefng c\u00e2u h\u1ecfi ch\u00ednh m\u00e0 b\u1ec7nh nh\u00e2n li\u00ean t\u1ee5c h\u1ecfi t\u00f4i l\u00e0 ‘Khi n\u00e0o t\u00f4i m\u1edbi c\u00f3 th\u1ec3 \u00f4m c\u00e1c ch\u00e1u c\u1ee7a m\u00ecnh?’ L\u00e0 m\u1ed9t b\u00e1c s\u0129 v\u00e0 b\u1ea3n th\u00e2n l\u00e0 m\u1ed9t ng\u01b0\u1eddi c\u00f3 h\u1ec7 mi\u1ec5n d\u1ecbch suy y\u1ebfu, gi\u1edd \u0111\u00e2y t\u00f4i tr\u00e0n \u0111\u1ea7y hy v\u1ecdng r\u1eb1ng AZD7442 s\u1ebd s\u1edbm \u0111\u1ebfn \u0111\u01b0\u1ee3c v\u1edbi nh\u1eefng ng\u01b0\u1eddi kh\u00f4ng th\u1ec3 ch\u1ec9 d\u1ef1a v\u00e0o v\u1eafc xin \u0111\u1ec3 c\u00f3 \u0111\u01b0\u1ee3c s\u1ef1 b\u1ea3o v\u1ec7 m\u00e0 h\u1ecd c\u1ea7n.”<\/p>\n

AZD7442 l\u00e0 s\u1ef1 k\u1ebft h\u1ee3p c\u1ee7a hai kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i v\u00e0 l\u00e0 li\u1ec7u ph\u00e1p kh\u00e1ng th\u1ec3 duy nh\u1ea5t \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p \u1edf Hoa K\u1ef3 \u0111\u1ec3 d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m COVID-19 v\u1edbi m\u1ed9t li\u1ec1u ti\u00eam b\u1eafp (150mg tixagevimab v\u00e0 150mg cilgavimab).<\/p>\n

Kho\u1ea3ng 2% d\u00e2n s\u1ed1 to\u00e0n c\u1ea7u \u0111\u01b0\u1ee3c cho l\u00e0 c\u00f3 t\u0103ng nguy c\u01a1 kh\u00f4ng \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 v\u1edbi v\u1eafc xin ph\u00f2ng COVID-19.1,2<\/sup> \u0110\u1ed1i t\u01b0\u1ee3ng n\u00e0y bao g\u1ed3m nh\u1eefng ng\u01b0\u1eddi b\u1ecb ung th\u01b0 m\u00e1u ho\u1eb7c c\u00e1c b\u1ec7nh ung th\u01b0 kh\u00e1c \u0111ang \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng h\u00f3a tr\u1ecb, b\u1ec7nh nh\u00e2n l\u1ecdc m\u00e1u v\u00e0 nh\u1eefng ng\u01b0\u1eddi \u0111ang d\u00f9ng thu\u1ed1c sau khi gh\u00e9p t\u1ea1ng, ho\u1eb7c nh\u1eefng ng\u01b0\u1eddi \u0111ang d\u00f9ng thu\u1ed1c \u1ee9c ch\u1ebf mi\u1ec5n d\u1ecbch cho c\u00e1c t\u00ecnh tr\u1ea1ng bao g\u1ed3m \u0111a x\u01a1 c\u1ee9ng v\u00e0 vi\u00eam kh\u1edbp d\u1ea1ng th\u1ea5p.5-9<\/sup><\/p>\n

D\u1eef li\u1ec7u ch\u00ednh h\u1ed7 tr\u1ee3 cho vi\u1ec7c c\u1ea5p EUA c\u1ee7a AZD7442 l\u00e0 t\u1eeb th\u1eed nghi\u1ec7m PROVENT giai \u0111o\u1ea1n III v\u1ec1 d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc ph\u01a1i nhi\u1ec5m, hi\u1ec7n v\u1eabn \u0111ang ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c tri\u1ec3n khai, cho th\u1ea5y li\u1ec7u ph\u00e1p n\u00e0y gi\u00fap gi\u1ea3m \u0111\u00e1ng k\u1ec3 v\u00e0 c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea (77% \u1edf ph\u00e2n t\u00edch ch\u00ednh, 83% \u1edf ph\u00e2n t\u00edch sau theo d\u00f5i s\u00e1u th\u00e1ng) \u0111\u1ed1i v\u1edbi nguy c\u01a1 m\u1eafc b\u1ec7nh COVID-19 c\u00f3 tri\u1ec7u ch\u1ee9ng so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, v\u00e0 kh\u1ea3 n\u0103ng b\u1ea3o v\u1ec7 kh\u1ecfi virus \u0111\u01b0\u1ee3c duy tr\u00ec li\u00ean t\u1ee5c trong \u00edt nh\u1ea5t s\u00e1u th\u00e1ng. C\u1ea7n theo d\u00f5i th\u00eam \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c th\u1eddi gian b\u1ea3o v\u1ec7 \u0111\u1ea7y \u0111\u1ee7 m\u00e0 AZD7442 c\u00f3 th\u1ec3 cung c\u1ea5p. D\u1eef li\u1ec7u t\u1eeb th\u1eed nghi\u1ec7m sau ph\u01a1i nhi\u1ec5m STORM CHASER giai \u0111o\u1ea1n III v\u00e0 th\u1eed nghi\u1ec7m AZD7442 giai \u0111o\u1ea1n I c\u0169ng h\u1ed7 tr\u1ee3 cho vi\u1ec7c c\u1ea5p EUA n\u00e0y. AZD7442 \u0111\u01b0\u1ee3c dung n\u1ea1p t\u1ed1t trong c\u00e1c th\u1eed nghi\u1ec7m.<\/p>\n

AZD7442<\/strong> v\u00e0 c\u00e1c bi\u1ebfn th\u1ec3 SARS-CoV-2<\/strong><\/p>\n

C\u00e1c nghi\u00ean c\u1ee9u hi\u1ec7n \u0111ang \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u0111\u1ec3 cung c\u1ea5p th\u00eam th\u00f4ng tin v\u1ec1 t\u00e1c \u0111\u1ed9ng c\u1ee7a bi\u1ebfn th\u1ec3 Omicron (B.1.1.529) \u0111\u1ed1i v\u1edbi AZD7442.<\/em>10,11<\/sup> Trong s\u1ed1 c\u00e1c \u0111\u1ed9t bi\u1ebfn thay th\u1ebf t\u1ea1i v\u1ecb tr\u00ed li\u00ean k\u1ebft t\u01b0\u01a1ng \u1ee9ng c\u1ee7a Omicron v\u1edbi AZD7442 \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1eed nghi\u1ec7m cho \u0111\u1ebfn nay trong c\u00e1c x\u00e9t nghi\u1ec7m ti\u1ec1n l\u00e2m s\u00e0ng, kh\u00f4ng c\u00f3 thay th\u1ebf n\u00e0o cho th\u1ea5y virus c\u00f3 th\u1ec3 tho\u00e1t kh\u1ecfi qu\u00e1 tr\u00ecnh trung h\u00f2a c\u1ee7a AZD7442.10,11<\/sup> C\u00e1c ph\u00e1t hi\u1ec7n t\u1eeb th\u00ed nghi\u1ec7m (in vitro)<\/em> ch\u1ee9ng minh AZD7442 trung h\u00f2a c\u00e1c bi\u1ebfn th\u1ec3 virus SARS-CoV-2 \u0111ang n\u1ed5i tr\u1ed9i g\u1ea7n \u0111\u00e2y, bao g\u1ed3m c\u00e1c bi\u1ebfn th\u1ec3 Delta v\u00e0 Mu.10<\/sup><\/p>\n

AZD7442 \u0111ang \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n v\u1edbi s\u1ef1 h\u1ed7 tr\u1ee3 t\u1eeb ch\u00ednh ph\u1ee7 Hoa K\u1ef3, bao g\u1ed3m qu\u1ef9 li\u00ean bang t\u1eeb B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh; V\u0103n ph\u00f2ng Tr\u1ee3 l\u00fd B\u1ed9 tr\u01b0\u1edfng Chu\u1ea9n b\u1ecb v\u00e0 \u1ee8ng ph\u00f3; C\u01a1 quan Nghi\u00ean c\u1ee9u v\u00e0 Ph\u00e1t tri\u1ec3n N\u00e2ng cao v\u1ec1 Y sinh h\u1ecdc h\u1ee3p t\u00e1c v\u1edbi B\u1ed9 Qu\u1ed1c ph\u00f2ng; V\u0103n ph\u00f2ng \u0110i\u1ec1u h\u00e0nh Ch\u01b0\u01a1ng tr\u00ecnh Li\u00ean h\u1ee3p v\u1ec1 Ph\u00f2ng th\u1ee7 H\u00f3a h\u1ecdc, Sinh h\u1ecdc, Ph\u00f3ng x\u1ea1 v\u00e0 H\u1ea1t nh\u00e2n, theo H\u1ee3p \u0111\u1ed3ng s\u1ed1 W911QY-21-9-0001.<\/p>\n

Nitin Kapoor, Ch\u1ee7 t\u1ecbch ki\u00eam T\u1ed5ng Gi\u00e1m \u0111\u1ed1c AstraZeneca Vi\u1ec7t Nam v\u00e0 c\u00e1c Th\u1ecb tr\u01b0\u1eddng M\u1edbi n\u1ed5i Khu v\u1ef1c Ch\u00e2u \u00c1, cho bi\u1ebft: \u201cC\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p c\u1ee7a FDA Hoa K\u1ef3 cho AZD7442 v\u1ec1 vi\u1ec7c ph\u00f2ng ng\u1eeba COVID-19 l\u00e0 m\u1ed9t d\u1ea5u m\u1ed1c quan tr\u1ecdng tr\u00ean to\u00e0n c\u1ea7u. Ch\u00fang t\u00f4i \u0111ang l\u00e0m vi\u1ec7c ch\u1eb7t ch\u1ebd v\u1edbi B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam \u0111\u1ec3 cung c\u1ea5p nh\u1eefng d\u1eef li\u1ec7u m\u1edbi nh\u1ea5t v\u00e0 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u v\u1ec1 h\u1ed3 s\u01a1 c\u1ea5p ph\u00e9p. Ch\u00fang t\u00f4i hy v\u1ecdng r\u1eb1ng 20.000 li\u1ec1u AZD7442 m\u00e0 C\u00f4ng ty C\u1ed5 ph\u1ea7n Vacxin Vi\u1ec7t Nam VNVC \u0111\u1eb7t mua c\u00f3 th\u1ec3 s\u1edbm \u0111\u00e1p \u1ee9ng nhu c\u1ea7u \u0111\u01b0\u1ee3c b\u1ea3o v\u1ec7 c\u1ee7a c\u00e1c nh\u00f3m d\u00e2n s\u1ed1 d\u1ec5 b\u1ecb t\u1ed5n th\u01b0\u01a1ng \u1edf Vi\u1ec7t Nam.\u201d<\/p>\n

AstraZeneca \u0111\u00e3 \u0111\u1ed3ng \u00fd cung \u1ee9ng cho ch\u00ednh ph\u1ee7 Hoa K\u1ef3 700.000 li\u1ec1u AZD7442. Ch\u00ednh ph\u1ee7 Hoa K\u1ef3 cho bi\u1ebft, h\u1ecd c\u00f3 k\u1ebf ho\u1ea1ch ph\u00e2n ph\u1ed1i nh\u1eefng li\u1ec1u n\u00e0y \u0111\u1ebfn c\u00e1c ti\u1ec3u bang v\u00e0 v\u00f9ng l\u00e3nh th\u1ed5 c\u1ee7a m\u00ecnh mi\u1ec5n ph\u00ed v\u00e0 theo t\u1ef7 l\u1ec7.<\/p>\n

AstraZeneca \u0111ang ti\u1ebfn h\u00e0nh \u0111\u1ec7 tr\u00ecnh h\u1ed3 s\u01a1 tr\u00ean to\u00e0n c\u1ea7u cho vi\u1ec7c c\u1ea5p ph\u00e9p s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p ho\u1eb7c ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n AZD7442 trong c\u1ea3 ph\u00f2ng ng\u1eeba v\u00e0 \u0111i\u1ec1u tr\u1ecb COVID-19.<\/p>\n

Ghi ch\u00fa<\/u><\/strong><\/p>\n

AZD7442<\/strong><\/p>\n

AZD7442,<\/em> c\u00f2n c\u00f3 t\u00ean l\u00e0 Evusheld<\/em>, l\u00e0 s\u1ef1 k\u1ebft h\u1ee3p c\u1ee7a hai LAAB – tixagevimab (AZD8895) v\u00e0 cilgavimab (AZD1061) \u2013 c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb t\u1ebf b\u00e0o B do b\u1ec7nh nh\u00e2n ph\u1ee5c h\u1ed3i sau khi nhi\u1ec5m virus SARS-CoV-2 hi\u1ebfn t\u1eb7ng. \u0110\u01b0\u1ee3c ph\u00e1t hi\u1ec7n b\u1edfi Trung t\u00e2m Y t\u1ebf \u0110\u1ea1i h\u1ecdc Vanderbilt v\u00e0 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho AstraZeneca v\u00e0o th\u00e1ng 6 n\u0103m 2020, c\u00e1c kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng c\u1ee7a ng\u01b0\u1eddi li\u00ean k\u1ebft v\u1edbi c\u00e1c v\u1ecb tr\u00ed ri\u00eang bi\u1ec7t tr\u00ean protein gai13<\/sup> c\u1ee7a SARS-CoV-2 v\u00e0 \u0111\u01b0\u1ee3c AstraZeneca t\u1ed1i \u01b0u h\u00f3a v\u1edbi th\u1eddi gian b\u00e1n h\u1ee7y k\u00e9o d\u00e0i v\u00e0 gi\u1ea3m vi\u1ec7c li\u00ean k\u1ebft gi\u1eefa th\u1ee5 th\u1ec3 Fc v\u00e0 b\u1ed5 th\u1ec3 C1q. Th\u1eddi gian b\u00e1n h\u1ee7y n\u00e0y gi\u00fap k\u00e9o d\u00e0i h\u01a1n g\u1ea5p ba l\u1ea7n \u0111\u1ed9 b\u1ec1n ho\u1ea1t \u0111\u1ed9ng c\u1ee7a kh\u00e1ng th\u1ec3 so v\u1edbi c\u00e1c kh\u00e1ng th\u1ec3 truy\u1ec1n th\u1ed1ng v\u00e0 c\u00f3 th\u1ec3 cung c\u1ea5p kh\u1ea3 n\u0103ng b\u1ea3o v\u1ec7 ch\u1ed1ng l\u1ea1i COVID-19 l\u00ean \u0111\u1ebfn 12 th\u00e1ng sau m\u1ed9t l\u1ea7n ti\u00eam;14-16<\/sup> D\u1eef li\u1ec7u t\u1eeb th\u1eed nghi\u1ec7m PROVENT Giai \u0111o\u1ea1n III cho th\u1ea5y kh\u1ea3 n\u0103ng b\u1ea3o v\u1ec7 k\u00e9o d\u00e0i \u00edt nh\u1ea5t s\u00e1u th\u00e1ng.17<\/sup> Vi\u1ec7c gi\u1ea3m li\u00ean k\u1ebft th\u1ee5 th\u1ec3 Fc nh\u1eb1m m\u1ee5c \u0111\u00edch gi\u1ea3m thi\u1ec3u nguy c\u01a1 t\u0103ng c\u01b0\u1eddng b\u1ec7nh t\u1eadt ph\u1ee5 thu\u1ed9c v\u00e0o kh\u00e1ng th\u1ec3 – m\u1ed9t hi\u1ec7n t\u01b0\u1ee3ng trong \u0111\u00f3 c\u00e1c kh\u00e1ng th\u1ec3 \u0111\u1eb7c hi\u1ec7u v\u1edbi virus th\u00fac \u0111\u1ea9y, thay v\u00ec \u1ee9c ch\u1ebf, vi\u1ec7c l\u00e2y nhi\u1ec5m v\u00e0\/ho\u1eb7c ti\u1ebfn tri\u1ec3n b\u1ec7nh.18 <\/sup>AZD7442 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ed9t li\u1ec1u ti\u00eam b\u1eafp (150mg tixagevimab v\u00e0 150mg cilgavimab) \u0111\u01b0\u1ee3c ti\u00eam v\u1edbi hai m\u0169i ti\u00eam ri\u00eang bi\u1ec7t, tu\u1ea7n t\u1ef1 nhau.<\/p>\n

V\u00e0o th\u00e1ng 8 n\u0103m 2021, AstraZeneca th\u00f4ng b\u00e1o r\u1eb1ng AZD7442<\/em> \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh gi\u1ea3m \u0111\u00e1ng k\u1ec3, c\u00f3 \u00fd nh\u0129a th\u1ed1ng k\u00ea \u0111\u1ed1i v\u1edbi nguy c\u01a1 ph\u00e1t tri\u1ec3n COVID-19 c\u00f3 tri\u1ec7u ch\u1ee9ng trong th\u1eed nghi\u1ec7m PROVENT; hi\u1ec7u l\u1ef1c l\u00e0 83% so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c trong ph\u00e2n t\u00edch s\u00e1u th\u00e1ng \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 v\u00e0o ng\u00e0y 18 th\u00e1ng 11 n\u0103m 2021. V\u00e0o th\u00e1ng 10 n\u0103m 2021, AstraZeneca \u0111\u00e3 c\u00f4ng b\u1ed1 k\u1ebft qu\u1ea3 t\u1ed5ng qu\u00e1t t\u00edch c\u1ef1c t\u1eeb th\u1eed nghi\u1ec7m \u0111i\u1ec1u tr\u1ecb ngo\u1ea1i tr\u00fa AZD7442<\/em> TACKLE giai \u0111o\u1ea1n III. AZD7442<\/em> c\u0169ng \u0111ang \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u nh\u01b0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ti\u1ec1m n\u0103ng cho b\u1ec7nh nh\u00e2n COVID-19 \u0111\u00e3 nh\u1eadp vi\u1ec7n, thu\u1ed9c th\u1eed nghi\u1ec7m ACTIV-3 c\u1ee7a Vi\u1ec7n Y t\u1ebf Qu\u1ed1c gia v\u00e0 trong m\u1ed9t th\u1eed nghi\u1ec7m h\u1ee3p t\u00e1c v\u1ec1 \u0111i\u1ec1u tr\u1ecb khi \u0111\u00e3 nh\u1eadp vi\u1ec7n.<\/p>\n

Theo c\u00e1c \u0111i\u1ec1u kho\u1ea3n c\u1ee7a th\u1ecfa thu\u1eadn c\u1ea5p ph\u00e9p v\u1edbi Vanderbilt, AstraZeneca s\u1ebd tr\u1ea3 ti\u1ec1n b\u1ea3n quy\u1ec1n m\u1ed9t ch\u1eef s\u1ed1 cho doanh thu thu\u1ea7n trong t\u01b0\u01a1ng lai.<\/p>\n

AstraZeneca<\/strong><\/p>\n

AstraZeneca (LSE \/ STO \/ Nasdaq: AZN) l\u00e0 m\u1ed9t c\u00f4ng ty d\u01b0\u1ee3c sinh h\u1ecdc to\u00e0n c\u1ea7u t\u1eadp trung v\u00e0o vi\u1ec7c kh\u00e1m ph\u00e1, ph\u00e1t tri\u1ec3n v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a c\u00e1c lo\u1ea1i thu\u1ed1c k\u00ea \u0111\u01a1n trong Ung th\u01b0, C\u00e1c b\u1ec7nh hi\u1ebfm g\u1eb7p v\u00e0 D\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc, bao g\u1ed3m Tim m\u1ea1ch, Th\u1eadn & Chuy\u1ec3n h\u00f3a v\u00e0 H\u00f4 h\u1ea5p & Mi\u1ec5n d\u1ecbch h\u1ecdc. C\u00f3 tr\u1ee5 s\u1edf t\u1ea1i Cambridge, V\u01b0\u01a1ng qu\u1ed1c Anh, AstraZeneca ho\u1ea1t \u0111\u1ed9ng t\u1ea1i h\u01a1n 100 qu\u1ed1c gia v\u00e0 c\u00e1c lo\u1ea1i thu\u1ed1c c\u1ea3i ti\u1ebfn c\u1ee7a c\u00f4ng ty \u0111\u00e3 \u0111\u01b0\u1ee3c h\u00e0ng tri\u1ec7u b\u1ec7nh nh\u00e2n tr\u00ean to\u00e0n th\u1ebf gi\u1edbi s\u1eed d\u1ee5ng. Vui l\u00f2ng truy c\u1eadp astrazeneca.com v\u00e0 theo d\u00f5i C\u00f4ng ty tr\u00ean Twitter @AstraZeneca.<\/p>\n

Li\u00ean h\u1ec7 <\/strong><\/p>\n

Li\u00ean h\u1ec7 b\u1ed9 ph\u1eadn Truy\u1ec1n th\u00f4ng c\u1ee7a AstraZeneca Vi\u1ec7t Nam t\u1ea1i: communication-vietnam@astrazeneca.com.<\/p>\n

T\u00e0i li\u1ec7u tham kh\u1ea3o <\/strong><\/p>\n

    \n
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  2. AstraZeneca data on file.<\/li>\n
  3. Taken as percentage of U.S Population: 328.2m (2019).<\/li>\n
  4. CDC: Lower range: adult pneumococcal vaccine (~25% ), mid range: flu (~48%), upper range: COVID vaccine (~70%).<\/li>\n
  5. Centers for Disease Control and Prevention. Altered Immunocompetence. General Best Practice Guideline for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. [Online]. Available at: https:\/\/www.cdc.gov\/vaccines\/hcp\/acip-recs\/general-recs\/immunocompetence.html. [Last accessed: December 2021].<\/li>\n
  6. Boyarsky BJ, et al. Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. 2021; 325 (17):1784-1786.<\/li>\n
  7. Rabinowich L, et al. Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients, Journal of Hepatology<\/em> (2021). doi: https:\/\/doi.org\/10.1016\/ j.jhep.2021.04.020.<\/li>\n
  8. Deepak P, et al. Glucocorticoids and B Cell Depleting Agents Substantially Impair Immunogenicity of mRNA Vaccines to SARS-CoV-2. medRxiv [Preprint]. 2021 Apr 9:2021.04.05.21254656. doi: 10.1101\/2021.04.05.21254656. PMID: 33851176; PMCID: PMC8043473.<\/li>\n
  9. Simon D, et al. SARS-CoV-2 vaccination responses in untreated, conventionally treated and anticytokine-treated patients with immune-mediated inflammatory diseases. Ann Rheum Dis<\/em>. 2021 May 6: annrheumdis-2021-220461. doi: 10.1136\/annrheumdis-2021-220461. Epub ahead of print. PMID: 33958324.<\/li>\n
  10. National Center for Advancing Translational Sciences Open Data Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https:\/\/opendata.ncats.nih.gov\/variant\/activity. [Last accessed: December 2021].<\/li>\n
  11. Bloom Labs. Available from:<\/li>\n<\/ol>\n

    https:\/\/twitter.com\/jbloom_lab\/status\/1464005705891868702\/photo\/1 [Last accessed December 2021].<\/p>\n

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    1. AstraZeneca data on file.<\/li>\n
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    3. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother<\/em>. 2013; 57 (12): 6147-53.<\/li>\n
    4. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Antimicrob Agents Chemother<\/em>. 2017; 61(3): e01714-16.<\/li>\n
    5. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants. Pediatr Infect Dis J<\/em>. 2018; 37(9): 886-892.<\/li>\n
    6. AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention. Available at: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html. [Last accessed: December 2021]<\/li>\n<\/ol>\n

      van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol<\/em>. 2019; 10: 548.<\/p>\n

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      Th\u00f4ng c\u00e1o b\u00e1o ch\u00ed ph\u00e1t h\u00e0nh b\u1edfi agency\u00a0Truy\u1ec1n th\u00f4ng EloQ<\/a>.<\/em><\/p>\n<\/div>\n<\/div>\n