{"id":6155,"date":"2021-07-01T07:38:46","date_gmt":"2021-07-01T00:38:46","guid":{"rendered":"https:\/\/cdcangiang.vn\/?p=6155"},"modified":"2021-08-07T22:00:48","modified_gmt":"2021-08-07T15:00:48","slug":"bo-y-te-phe-duyet-co-dieu-kien-vac-xin-covid-19-moderna","status":"publish","type":"post","link":"https:\/\/cdcangiang.vn\/index.php\/2021\/07\/01\/bo-y-te-phe-duyet-co-dieu-kien-vac-xin-covid-19-moderna\/","title":{"rendered":"B\u1ed9 Y t\u1ebf ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin COVID-19 Moderna"},"content":{"rendered":"

B\u1ed9 Y t\u1ebf v\u1eeba ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh COVID-19 \u0111\u1ed1i v\u1edbi v\u1eafc xin Spikevax – t\u00ean kh\u00e1c l\u00e0 v\u1eafc xin Moderna<\/h2>\n
\n

B\u1ed9 Y t\u1ebf v\u1eeba c\u00f3 quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh COVID-19 theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 67 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 54\/2017\/N\u0110-CP ng\u00e0y 8\/5\/2017 c\u1ee7a Ch\u00ednh ph\u1ee7 quy \u0111\u1ecbnh chi ti\u1ebft m\u1ed9t s\u1ed1 \u0111i\u1ec1u v\u00e0 bi\u1ec7n ph\u00e1p thi h\u00e0nh Lu\u1eadt d\u01b0\u1ee3c (Ngh\u1ecb \u0111\u1ecbnh 54\/2017\/N\u0110-CP), c\u1ee5 th\u1ec3:<\/p>\n

T\u00ean v\u1eafc xin: Spikevax (T\u00ean kh\u00e1c l\u00e0: COVID-19 Vaccine Moderna).<\/p>\n

Th\u00e0nh ph\u1ea7n ho\u1ea1t ch\u1ea5t, n\u1ed3ng \u0111\u1ed9\/h\u00e0m l\u01b0\u1ee3ng: M\u1ed7i li\u1ec1u 0,5ml ch\u1ee9a 100mcg mRNA (\u0111\u01b0\u1ee3c nh\u00fang trong c\u00e1c lipid nanoparticle SM-102).<\/p>\n

D\u1ea1ng b\u00e0o ch\u1ebf: H\u1ed7n d\u1ecbch ti\u00eam b\u1eafp.<\/p>\n

Quy c\u00e1ch \u0111\u00f3ng g\u00f3i: H\u1ed9p ch\u1ee9a 10 l\u1ecd \u0111a li\u1ec1u; m\u1ed7i l\u1ecd \u0111a li\u1ec1u ch\u1ee9a 10 li\u1ec1u 0,5ml.<\/p>\n

T\u00ean c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t – N\u01b0\u1edbc s\u1ea3n xu\u1ea5t: Rovi Pharma Industrial Services, S.A – T\u00e2y Ban Nha; Recipharm Monts – Ph\u00e1p.<\/p>\n

\"\"<\/p>\n

C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u1eafc xin Spikevax kh\u00e1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c thay \u0111\u1ed5i c\u0103n c\u1ee9 v\u00e0o kh\u1ea3 n\u0103ng cung c\u1ea5p v\u1eafc xin t\u1ea1i th\u1eddi \u0111i\u1ec3m c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u n\u1ed9p H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u v\u1eafc xin theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 67 Ngh\u1ecb \u0111\u1ecbnh 54\/2017\/N\u0110-CP.<\/p>\n

T\u00ean c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t v\u1eafc xin: Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam.<\/p>\n

B\u1ed9 Y t\u1ebf y\u00eau c\u1ea7u C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c c\u00f3 tr\u00e1ch nhi\u1ec7m: C\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u v\u1eafc xin Spikevax theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 67 Ngh\u1ecb \u0111\u1ecbnh 54\/2017\/N\u0110-CP khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 c\u1ee7a c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u; Th\u1ef1c hi\u1ec7n \u0111\u00fang quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd nh\u1eadp kh\u1ea9u, qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u1eafc xin nh\u1eadp kh\u1ea9u.<\/p>\n

C\u1ee5c Khoa h\u1ecdc c\u00f4ng ngh\u1ec7 v\u00e0 \u0110\u00e0o t\u1ea1o c\u00f3 tr\u00e1ch nhi\u1ec7m: L\u1ef1a ch\u1ecdn \u0111\u01a1n v\u1ecb c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 c\u1ee7a v\u1eafc xin tr\u00ean c\u01a1 s\u1edf \u00fd ki\u1ebfn t\u01b0 v\u1ea5n c\u1ee7a H\u1ed9i \u0111\u1ed3ng t\u01b0 v\u1ea5n s\u1eed d\u1ee5ng v\u1eafc xin, sinh ph\u1ea9m y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng; H\u01b0\u1edbng d\u1eabn, ch\u1ec9 \u0111\u1ea1o \u0111\u01a1n v\u1ecb c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec3m a Kho\u1ea3n n\u00e0y t\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 c\u1ee7a v\u1eafc xin Spikevax tr\u00ean c\u01a1 s\u1edf \u00fd ki\u1ebfn t\u01b0 v\u1ea5n c\u1ee7a H\u1ed9i \u0111\u1ed3ng t\u01b0 v\u1ea5n s\u1eed d\u1ee5ng v\u1eafc xin, sinh ph\u1ea9m y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng.<\/p>\n

C\u1ee5c Y t\u1ebf D\u1ef1 ph\u00f2ng th\u1ef1c hi\u1ec7n c\u00e1c tr\u00e1ch nhi\u1ec7m li\u00ean quan \u0111\u1ebfn ti\u00eam ch\u1ee7ng v\u1eafc xin Spikevax \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh t\u1ea1i Quy\u1ebft \u0111\u1ecbnh s\u1ed1 1464\/Q\u0110-BYT ng\u00e0y 05\/03\/2021 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf v\u1ec1 vi\u1ec7c ban h\u00e0nh h\u01b0\u1edbng d\u1eabn ti\u1ebfp nh\u1eadn, b\u1ea3o qu\u1ea3n, ph\u00e2n ph\u1ed1i v\u00e0 s\u1eed d\u1ee5ng v\u1eafc xin ph\u00f2ng COVID-19 v\u00e0 Quy\u1ebft \u0111\u1ecbnh s\u1ed1 1467\/Q\u0110-BYT ng\u00e0y 05\/03\/2021 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf v\u1ec1 vi\u1ec7c ph\u00ea duy\u1ec7t k\u1ebf ho\u1ea1ch ti\u00eam v\u1eafc xin ph\u00f2ng COVID-19 giai \u0111o\u1ea1n 2021 – 2022.<\/p>\n

Vi\u1ec7n Ki\u1ec3m \u0111\u1ecbnh Qu\u1ed1c gia v\u1eafc xin v\u00e0 sinh ph\u1ea9m y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ti\u1ebfn h\u00e0nh ki\u1ec3m \u0111\u1ecbnh v\u00e0 c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn xu\u1ea5t x\u01b0\u1edfng l\u00f4 v\u1eafc xin Spikevax tr\u01b0\u1edbc khi \u0111\u01b0a ra s\u1eed d\u1ee5ng.<\/p>\n

Nh\u01b0 v\u1eady, \u0111\u1ebfn nay \u0111\u00e3 c\u00f3 5 lo\u1ea1i v\u1eafc xin \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh COVID-19 g\u1ed3m: V\u1eafc xin Astra Zeneca; V\u1eafc xin Sputnick; V\u1eafc xin Pfirez; V\u1eafc xin Vero Cell v\u00e0 V\u1eafc xin Spikevax (T\u00ean kh\u00e1c l\u00e0: COVID-19 Vaccine Moderna)<\/p>\n

Quy\u1ebft \u0111\u1ecbnh c\u1ee7a B\u1ed9 Y t\u1ebf c\u0169ng n\u00eau r\u00f5: C\u00e1c \u0111i\u1ec1u ki\u1ec7n \u0111i k\u00e8m vi\u1ec7c ph\u00ea duy\u1ec7t v\u1eafc xin Spikevax cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong giai \u0111o\u1ea1n ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh COVID-19:<\/strong><\/em><\/p>\n

V\u1eafc xin Spikevax \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t d\u1ef1a tr\u00ean d\u1eef li\u1ec7u an to\u00e0n, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 hi\u1ec7u qu\u1ea3 do Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam cung c\u1ea5p cho B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam t\u00ednh \u0111\u1ebfn ng\u00e0y 23\/6\/2021 v\u00e0 cam k\u1ebft c\u1ee7a Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c c\u1ee7a c\u00e1c t\u00e0i li\u1ec7u \u0111\u00e3 cung c\u1ea5p cho B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam.<\/p>\n

Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam c\u00f3 tr\u00e1ch nhi\u1ec7m ph\u1ed1i h\u1ee3p v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u1eafc xin ph\u1ea3n h\u1ed3i k\u1ecbp th\u1eddi c\u00e1c y\u00eau c\u1ea7u t\u1eeb B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam \u0111\u1ec3 b\u1ed5 sung th\u00eam d\u1eef li\u1ec7u ho\u1eb7c c\u00e1c y\u00eau c\u1ea7u kh\u00e1c c\u00f3 li\u00ean quan \u0111\u1ebfn v\u1eafc xin Spikevax v\u00e0 ch\u1ee7 \u0111\u1ed9ng cung c\u1ea5p, c\u1eadp nh\u1eadt c\u00e1c th\u00f4ng tin m\u1edbi c\u00f3 li\u00ean quan \u0111\u1ebfn v\u1eafc xin Spikevax cho B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam trong su\u1ed1t qu\u00e1 tr\u00ecnh ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m;<\/p>\n

Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam ch\u1ecbu tr\u00e1ch nhi\u1ec7m ph\u1ed1i h\u1ee3p v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u1eafc xin \u0111\u1ea3m b\u1ea3o c\u00e1c \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u1eafc xin Spikevax nh\u1eadp kh\u1ea9u v\u00e0o Vi\u1ec7t Nam v\u00e0 \u0111\u1ea3m b\u1ea3o an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a l\u00f4 v\u1eafc xin Spikevax nh\u1eadp kh\u1ea9u v\u00e0o Vi\u1ec7t Nam; Ph\u1ed1i h\u1ee3p v\u1edbi \u0111\u01a1n v\u1ecb ph\u00e2n ph\u1ed1i, s\u1eed d\u1ee5ng v\u1eafc xin Spikevax tri\u1ec3n khai h\u1ec7 th\u1ed1ng c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c to\u00e0n di\u1ec7n \u0111\u1ed1i v\u1edbi v\u1eafc xin n\u00e0y t\u1ea1i Vi\u1ec7t Nam theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;<\/p>\n

Ph\u1ed1i h\u1ee3p v\u1edbi C\u1ee5c Khoa h\u1ecdc c\u00f4ng ngh\u1ec7 v\u00e0 \u0110\u00e0o t\u1ea1o v\u00e0 \u0111\u01a1n v\u1ecb c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 c\u1ee7a v\u1eafc xin Spikevax tr\u00ean c\u01a1 s\u1edf \u00fd ki\u1ebfn t\u01b0 v\u1ea5n c\u1ee7a H\u1ed9i \u0111\u1ed3ng t\u01b0 v\u1ea5n s\u1eed d\u1ee5ng v\u1eafc xin, sinh ph\u1ea9m y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng;<\/p>\n

Ph\u1ed1i h\u1ee3p v\u1edbi Vi\u1ec7n Ki\u1ec3m \u0111\u1ecbnh Qu\u1ed1c gia v\u1eafc xin v\u00e0 sinh ph\u1ea9m y t\u1ebf trong vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh c\u00e1c l\u00f4 v\u1eafc xin Spikevax tr\u01b0\u1edbc khi \u0111\u01b0a ra s\u1eed d\u1ee5ng; ph\u1ed1i h\u1ee3p v\u1edbi C\u1ee5c Y t\u1ebf d\u1ef1 ph\u00f2ng h\u01b0\u1edbng d\u1eabn vi\u1ec7c b\u1ea3o qu\u1ea3n, ph\u00e2n ph\u1ed1i v\u00e0 s\u1eed d\u1ee5ng v\u1eafc xin Spikevax cho c\u00e1c c\u01a1 s\u1edf ti\u00eam ch\u1ee7ng.<\/p>\n

B\u1ed9 Y t\u1ebf c\u0169ng y\u00eau c\u1ea7u Chi nh\u00e1nh C\u00f4ng ty TNHH Zuellig Pharma Vi\u1ec7t Nam ph\u1ea3i ph\u1ed1i h\u1ee3p v\u1edbi B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam \u0111\u1ec3 tri\u1ec3n khai qu\u1ea3n tr\u1ecb r\u1ee7i ro \u0111\u1ed1i v\u1edbi v\u1eafc xin Spikevax trong su\u1ed1t qu\u00e1 tr\u00ecnh l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam. \u0110\u1ed3ng th\u1eddi, vi\u1ec7c s\u1eed d\u1ee5ng v\u1eafc xin Spikevax ph\u1ea3i theo h\u01b0\u1edbng d\u1eabn c\u1ee7a B\u1ed9 Y t\u1ebf Vi\u1ec7t Nam.<\/p>\n

Ngu\u1ed3n B\u1ed9 Y t\u1ebf<\/strong><\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

B\u1ed9 Y t\u1ebf v\u1eeba ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh COVID-19 \u0111\u1ed1i v\u1edbi v\u1eafc xin Spikevax – t\u00ean kh\u00e1c l\u00e0 v\u1eafc xin Moderna B\u1ed9 Y t\u1ebf v\u1eeba c\u00f3 quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1eafc xin cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng, […]<\/p>\n","protected":false},"author":3,"featured_media":6156,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","footnotes":""},"categories":[235,242],"tags":[],"class_list":["post-6155","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-phong-chong-covid-19","category-vaccine-covid"],"_links":{"self":[{"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/posts\/6155","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/comments?post=6155"}],"version-history":[{"count":1,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/posts\/6155\/revisions"}],"predecessor-version":[{"id":6157,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/posts\/6155\/revisions\/6157"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/media\/6156"}],"wp:attachment":[{"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/media?parent=6155"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/categories?post=6155"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cdcangiang.vn\/index.php\/wp-json\/wp\/v2\/tags?post=6155"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}