{"id":20450,"date":"2022-10-28T08:48:25","date_gmt":"2022-10-27T23:48:25","guid":{"rendered":"https:\/\/promea2014.com\/blog\/?p=20450"},"modified":"2022-10-28T08:48:25","modified_gmt":"2022-10-27T23:48:25","slug":"%e3%83%af%e3%82%af%e3%83%81%e3%83%b3%e3%81%ae%e5%89%af%e4%bd%9c%e7%94%a8%e3%81%af%e6%84%8f%e5%9b%b3%e7%9a%84%e3%81%ab%e9%9a%a0%e3%81%95%e3%82%8c%e3%81%a6%e3%81%84%e3%82%8b%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/promea2014.com\/blog\/?p=20450","title":{"rendered":"\u30ef\u30af\u30c1\u30f3\u306e\u526f\u4f5c\u7528\u306f\u610f\u56f3\u7684\u306b\u96a0\u3055\u308c\u3066\u3044\u308b\uff1f"},"content":{"rendered":"

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FDA\u306f\u96a0\u3059\u3088\u3046\u306b\u30012021\u5e747\u6708\u306b\u30d5\u30a1\u30a4\u30b6\u30fc\u306e\u30ef\u30af\u30c1\u30f3\u306e\u526f\u4f5c\u7528\u306b\u3064\u3044\u3066\u958b\u793a\u3057\u3066\u3044\u305f\u3088\u3046\u3067\u3059\u304c\u30011\u5e74\u4ee5\u4e0a\u7d4c\u3063\u305f\u4eca\u3067\u3082\u3001FDA\u306f\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u3092\u51fa\u3057\u305f\u308a\u3001\u533b\u5e2b\u3084\u533b\u7642\u6a5f\u95a2\u306b\u901a\u77e5\u3057\u305f\u308a\u3001\u8ad6\u6587\u306a\u3069\u3067\u8abf\u67fb\u7d50\u679c\u3092\u516c\u958b\u3057\u305f\u308a\u3001\u30ef\u30af\u30c1\u30f3\u306e\u6dfb\u4ed8\u6587\u66f8\u306a\u3069\u3092\u66f4\u65b0\u3057\u305f\u308a\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u5f53\u521d\u306fFDA \u306f\u3001\u300c\u4eca\u5f8c\u306e\u6700\u65b0\u60c5\u5831\u3084\u60c5\u5831\u304c\u5229\u7528\u53ef\u80fd\u306b\u306a\u308a\u6b21\u7b2c\u3001\u4e00\u822c\u306b\u516c\u958b\u3059\u308b\u300d\u3068\u7d04\u675f\u3057\u3066\u3044\u305f\u3088\u3046\u3067\u3059\u3002<\/p>\n

FDA\u306f1\u5e74\u4ee5\u4e0a\u3082\u524d\u306b\u3001\u30d5\u30a1\u30a4\u30b6\u30fc\u306e\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3057\u305f\u9ad8\u9f62\u8005\u30674\u3064\u306e\u6df1\u523b\u306a\u6709\u5bb3\u4e8b\u8c61\u304c\u5897\u52a0\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u3044\u3046\u8abf\u67fb\u7d50\u679c\u3092\u77e5\u3063\u3066\u3044\u307e\u3057\u305f\u3002\u6025\u6027\u5fc3\u7b4b\u6897\u585e\u3001\u64ad\u7a2e\u6027\u8840\u7ba1\u5185\u51dd\u56fa\u75c7\u5019\u7fa4\uff08DIC\uff09\u3001\u514d\u75ab\u6027\u8840\u5c0f\u677f\u6e1b\u5c11\u75c7\uff08ITP\uff09\u3001\u80ba\u585e\u6813\u75c7\u3067\u3059\u3002\u305d\u306e\u5f8c\u3001FDA \u306f\u3001\u3053\u306e\u554f\u984c\u3092\u3088\u308a\u5fb9\u5e95\u7684\u306b\u8abf\u67fb\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u75ab\u5b66\u7814\u7a76\u306e\u6982\u8981\u3092\u793a\u3059\u7814\u7a76\u8a08\u753b\u6587\u66f8 (\u307e\u305f\u306f\u30d7\u30ed\u30c8\u30b3\u30eb) \u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u30011\u5e74\u4ee5\u4e0a\u7d4c\u3063\u305f\u4eca\u3001\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u7814\u7a76\u306e\u72b6\u6cc1\u3068\u7d50\u679c\u306f\u4e0d\u660e\u3067\u3059\u3002<\/p>\n

\u5b89\u5168\u6027\u306e\u30c7\u30fc\u30bf\u306f\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u533b\u5e2b\u3084\u305d\u308c\u3092\u53d7\u3051\u53d6\u308b\u4e00\u822c\u306e\u4eba\u306b\u3082\u77e5\u3089\u3055\u308c\u308b\u3079\u304d\u3067\u3057\u3087\u3046\u3002\u307b\u304b\u306e\u56fd\u304b\u3089\u306e\u30c7\u30fc\u30bf\u3067\u3082\u540c\u69d8\u306a\u30ef\u30af\u30c1\u30f3\u306e\u526f\u4f5c\u7528\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30d5\u30a1\u30a4\u30b6\u30fc\u3068\u30e2\u30c7\u30eb\u30ca\u306e\u4e21\u65b9\u306emRNA\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3057\u305f\u5f8c\u306b\u3001\u8840\u6813\u585e\u6813\u75c7\u3068\u8840\u5c0f\u677f\u6e1b\u5c11\u75c7\u306e\u8ee2\u5e30\u304c\u7d71\u8a08\u7684\u306b\u6709\u610f\u306b\u5897\u52a0\u3059\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3057\u305f\u3002\u3053\u306e\u30ef\u30af\u30c1\u30f3\u304c\u300c\u9069\u5207\u306b\u30c6\u30b9\u30c8\u3055\u308c\u3066\u3044\u306a\u3044\u300d\u3068\u8003\u3048\u308b\u3079\u304d\u3067\u3057\u3087\u3046\u3002<\/p>\n

FDA\u304c\u9069\u5207\u306a\u958b\u793a\u3092\u3057\u306a\u3044\u305f\u3081\u306b\u3001\u4f55\u304b\u3092\u96a0\u3057\u3066\u3044\u308b\u3068\u53d7\u3051\u53d6\u3089\u308c\u3066\u3082\u4ed5\u65b9\u304c\u306a\u3044\u3067\u3057\u3087\u3046\u3002<\/p>\n

\u3069\u306e\u3088\u3046\u306a\u30ef\u30af\u30c1\u30f3\u306b\u3082\u526f\u4f5c\u7528\u304c\u3042\u308a\u3001\u5b8c\u5168\u306b\u5b89\u5168\u306a\u30ef\u30af\u30c1\u30f3\u306f\u5b58\u5728\u3057\u306a\u3044\u3053\u3068\u306f\u660e\u3089\u304b\u3067\u3059\u304c\u3001\u3057\u304b\u3057\u3001\u526f\u4f5c\u7528\u306e\u8cea\u3068\u7a0b\u5ea6\u3001\u983b\u5ea6\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u305d\u308c\u306f\u63a5\u7a2e\u3059\u308b\u304b\u3069\u3046\u304b\u306e\u9078\u629e\u306b\u5927\u304d\u304f\u304b\u304b\u308f\u3063\u3066\u304d\u307e\u3059\u3002<\/p>\n

\u300c\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3057\u306a\u3044\u3068\u6b7b\u306c\u300d\u300c\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3057\u306a\u3044\u3068\u5468\u308a\u306e\u4eba\u3092\u6bba\u3059\u300d\u3068\u3044\u3046\u611f\u899a\u3092\u690d\u3048\u4ed8\u3051\u3066\u3001\u305d\u308c\u304c\u5927\u6210\u529f\u3057\u305f\u3088\u3046\u3067\u3059\u3002\u533b\u5e2b\u307e\u3067\u3082\u540c\u69d8\u306e\u8003\u3048\u3082\u6301\u3063\u3066\u3044\u308b\u4eba\u304c\u3044\u308b\u3067\u3057\u3087\u3046\u3002\u305d\u3046\u3059\u308c\u3070\u30ef\u30af\u30c1\u30f3\u306e\u526f\u4f5c\u7528\u306b\u5bfe\u3057\u3066\u3001\u8a31\u5bb9\u5ea6\u304c\u9ad8\u304f\u306a\u308a\u3001\u3072\u3069\u3044\u9ad8\u71b1\u3082\u3001\u3072\u3069\u3044\u5e2f\u72b6\u75b1\u75b9\u3082\u3001\u81ea\u5df1\u514d\u75ab\u75be\u60a3\u3082\u3001\u305d\u3057\u3066\u5fc3\u7b4b\u708e\u307e\u3067\u3082\u3001\u6b7b\u306c\u3088\u308a\u306f\u30de\u30b7\u306e\u3088\u3046\u306a\u611f\u899a\u306b\u306a\u3063\u3066\u3057\u307e\u3063\u305f\u306e\u3067\u3057\u3087\u3046\u3002\u660e\u3089\u304b\u306b\u9593\u9055\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n

\u3082\u3061\u308d\u3093\u3001\u3044\u307e\u3060\u306b\u30ef\u30af\u30c1\u30f3\u304c\u3053\u308c\u3089\u306e\u526f\u4f5c\u7528\u3092\u8d77\u3053\u3059\u3068\u3044\u3046\u78ba\u56fa\u305f\u308b\u8a3c\u62e0\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u5341\u5206\u306b\u7591\u3046\u3060\u3051\u306e\u30c7\u30fc\u30bf\u306f\u51fa\u3066\u3044\u308b\u3068\u601d\u3044\u307e\u3059\u3002\u305d\u308c\u3060\u3051\u3067\u3082\u5341\u5206\u306b\u4e2d\u6b62\u3059\u308b\u8981\u4ef6\u3067\u3059\u3002\u5c11\u306a\u304f\u3068\u3082\u533b\u5e2b\u304c\u63a8\u5968\u3059\u308b\u30ec\u30d9\u30eb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30b3\u30ed\u30ca\u306e\u6050\u6016\u3067\u60a3\u8005\u3092\u5897\u3084\u3057\u3001\u30ef\u30af\u30c1\u30f3\u3067\u60a3\u8005\u3092\u5897\u3084\u3057\u3001\u305d\u3057\u3066\u56fd\u304b\u3089\u3082\u5927\u5207\u306a\u7a0e\u91d1\u304c\u3063\u307d\u308a\u3068\u5165\u3063\u3066\u304f\u308b\u306e\u3067\u3059\u3002\u717d\u308a\u3001\u63a8\u5968\u3057\u305f\u304f\u306a\u308b\u6c17\u6301\u3061\u306f\u308f\u304b\u3089\u306a\u3044\u3067\u3082\u306a\u3044\u3067\u3059\u3002<\/p>\n

FDA\u306e\u4e88\u7b97\u306e46\uff05\u306f\u30e6\u30fc\u30b6\u30fc\u3064\u307e\u308a\u88fd\u85ac\u4f1a\u793e\u306a\u3069\u306e\u4f01\u696d\u304c\u652f\u6255\u3046\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u306b\u3088\u3063\u3066\u8cc4\u308f\u308c\u3066\u3044\u307e\u3059\uff08\u3053\u3053<\/a>\u53c2\u7167\uff09\u3002\u9006\u306b\u4eca\u56de\u306e\u30ef\u30af\u30c1\u30f3\u958b\u767a\u306b\u306f\u4f01\u696d\u306b\u5de8\u984d\u306a\u8cc7\u91d1\u63f4\u52a9\u304c\u3042\u308a\u307e\u3057\u305f\u3002\u304a\u91d1\u304c\u72ed\u3044\u7bc4\u56f2\u3067\u304f\u308b\u304f\u308b\u56de\u3063\u3066\u3044\u308b\u3060\u3051\u3067\u3059\u306d\u3002\u307e\u305f\u3001\u85ac\u306e\u627f\u8a8d\u306e\u305f\u3081\u306b\u30e6\u30fc\u30b6\u30fc\u306f\u304a\u91d1\u3092\u6255\u3044\u307e\u3059\u304c\u3001\u305d\u308c\u304c\u975e\u5e38\u306b\u91cd\u8981\u306aFDA\u306e\u8cc7\u91d1\u6e90\u3067\u3059\u304b\u3089\u3001\u5229\u76ca\u76f8\u53cd\u304c\u751f\u307e\u308c\u308b\u3053\u3068\u306f\u5341\u5206\u306b\u61f8\u5ff5\u3055\u308c\u308b\u3067\u3057\u3087\u3046\u3002\u3055\u3089\u306b\u3001\u85ac\u306e\u627f\u8a8d\u306e\u5be9\u67fb\u3092\u3059\u308b\u4eba\u306b\u4f01\u696d\u304b\u3089\u304a\u91d1\u304c\u6d41\u308c\u3066\u3044\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002\u3064\u307e\u308a\u3001WHO\u3082CDC\u3082FDA\u3082\u3059\u3079\u3066\u88fd\u85ac\u4f1a\u793e\u306b\u3088\u3063\u3066\u52d5\u304b\u3055\u308c\u3066\u3044\u308b\u3068\u8a00\u3063\u3066\u3082\u904e\u8a00\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u3002<\/p>\n

\u73fe\u5728\u306e\u5730\u70b9\u3067\u307e\u3060\u30ef\u30af\u30c1\u30f3\u3092\u7a4d\u6975\u7684\u306b\u63a8\u5968\u3057\u3066\u3044\u308b\u4eba\u306f\u3001\u4f01\u696d\u304b\u3089\u304a\u91d1\u3092\u3082\u3089\u3063\u3066\u3044\u308b\u304b\u3001\u305d\u308c\u4ee5\u5916\u3067\u3082\u4f55\u3089\u304b\u306e\u5229\u5bb3\u95a2\u4fc2\u304c\u3042\u308b\u304b\u3001\u305f\u3060\u306e\u7121\u77e5\u304b\u3069\u308c\u304b\u3067\u3057\u3087\u3046\u3002\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3059\u308b\u304b\u3069\u3046\u304b\u9078\u629e\u3059\u308b\u4eba\u304c\u7121\u77e5\u3067\u3042\u308c\u3070\u3001\u7c21\u5358\u306b\u9a19\u3055\u308c\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u307e\u305a\u306f\u672c\u5f53\u306b\u3088\u304f\u691c\u8a0e\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u305d\u306e\u30ef\u30af\u30c1\u30f3\u5fc5\u8981\u3067\u3059\u304b\uff1f\u3053\u308c\u304b\u3089\u5c06\u6765\u306e\u3042\u308b\u5b50\u3069\u3082\u306e\u4f53\u306b\u5165\u308c\u3066\u826f\u3044\u3082\u306e\u3067\u3059\u304b\uff1f\u4f53\u306b\u5165\u3063\u3066\u3057\u307e\u3063\u305f\u3089\u623b\u305b\u307e\u305b\u3093\u3002<\/p>\n

\u60aa\u304c\u6210\u6557\u3055\u308c\u308b\u65e5\u306f\u6765\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u304a\u91d1\u306e\u529b\u304c\u52dd\u3064\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/p>\n

 <\/p>\n

\u300cFDA urged to publish follow-up studies on covid-19 vaccine safety signals\u300d<\/span><\/p>\n

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