{"id":1488256,"date":"2021-09-23T12:34:14","date_gmt":"2021-09-23T19:34:14","guid":{"rendered":"http:\/\/www.sandiegochinesepress.com\/press\/?p=1488256"},"modified":"2021-09-23T12:38:33","modified_gmt":"2021-09-23T19:38:33","slug":"fda%e6%89%b9%e5%87%86%e9%ab%98%e5%8d%b1%e4%ba%ba%e7%be%a4%e4%bd%bf%e7%94%a8%e8%be%89%e7%91%9ebiontech%e7%ac%ac%e4%b8%89%e5%89%82%e5%a2%9e%e5%bc%ba%e7%96%ab%e8%8b%97","status":"publish","type":"post","link":"https:\/\/www.sandiegochinesepress.com\/press\/fda%e6%89%b9%e5%87%86%e9%ab%98%e5%8d%b1%e4%ba%ba%e7%be%a4%e4%bd%bf%e7%94%a8%e8%be%89%e7%91%9ebiontech%e7%ac%ac%e4%b8%89%e5%89%82%e5%a2%9e%e5%bc%ba%e7%96%ab%e8%8b%97\/.html","title":{"rendered":"FDA\u6279\u51c6\u9ad8\u5371\u4eba\u7fa4\u4f7f\u7528\u8f89\u745e\u7b2c\u4e09\u5242\u589e\u5f3a\u75ab\u82d7(\u56fe\uff09"},"content":{"rendered":"

\"\"<\/p>\n

\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08U.S. Department of Health and Human Services, FDA\uff09<\/a><\/strong>9\u670822\u65e5\u5728\u5b98\u7f51\u5ba3\u5e03<\/a><\/strong>\uff0c\u6b63\u5f0f\u6279\u51c6\u7ed9\u9ad8\u5371\u4eba\u7fa4\u4f7f\u7528\u7684\u8f89\u745e-BioNTech\u7b2c\u4e09\u5242\u589e\u5f3a\u75ab\u82d7\uff08single booster dose\uff09 \u3002<\/p>\n

https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations<\/p>\n

FDA\u7684\u7f51\u7ad9\u901a\u7a3f\u8bf4\uff1a<\/p>\n

\u4eca\u5929\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u4fee\u8ba2\u4e86\u8f89\u745e\u751f\u7269\u6280\u672f\u516c\u53f8COVID-19\u75ab\u82d7\u7684\u7d27\u6025\u4f7f\u7528\u6388\u6743\uff08EUA\uff09\uff0c\u4ee5\u5141\u8bb8\u4f7f\u7528\u5355\u6b21\u589e\u5f3a\u5242\u91cf\uff0c\u5728\u4ee5\u4e0b\u4e3b\u8981\u9488\u5bf9\u7684\u4eba\u7fa4\u83b7\u5f97\u5b8c\u5168\u75ab\u82d7\u540e\u81f3\u5c11\u516d\u4e2a\u6708\u5185\u4f7f\u7528\uff1a<\/p>\n

65\u5c81\u53ca\u4ee5\u4e0a\u7684\u4e2a\u4eba\uff1b<\/p>\n

18\u5c81\u81f364\u5c81\u7684\u4eba\u60a3\u4e25\u91cd\u65b0\u51a0\u75c5\u6bd2-19\u7684\u9ad8\u98ce\u9669\uff1b\u53ca<\/p>\n

18\u5c81\u81f364\u5c81\u7684\u4e2a\u4eba\uff0c\u5176\u9891\u7e41\u7684\u673a\u6784\u6216\u804c\u4e1a\u63a5\u89e6SARS-CoV-2\u4f7f\u4ed6\u4eec\u5904\u4e8e\u5305\u62ec\u4e25\u91cd\u7684COVID-19\u5728\u5185\u7684COVID-19\u4e25\u91cd\u5e76\u53d1\u75c7\u7684\u9ad8\u98ce\u9669\u4e2d\u3002<\/p>\n

\u4eca\u5929\u7684\u6388\u6743\u4ec5\u9002\u7528\u4e8e\u8f89\u745e\u751f\u7269\u6280\u672f\u516c\u53f8\u7684\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u3002<\/p>\n

\u201c\u4eca\u5929\u7684\u884c\u52a8\u8868\u660e\uff0c\u79d1\u5b66\u548c\u76ee\u524d\u53ef\u7528\u7684\u6570\u636e\u7ee7\u7eed\u6307\u5bfcFDA\u5728\u8fd9\u6b21\u5927\u6d41\u884c\u671f\u95f4\u5bf9\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u7684\u51b3\u7b56\u3002\u5728\u8003\u8651\u4e86\u6240\u6709\u53ef\u7528\u7684\u79d1\u5b66\u8bc1\u636e\u548c\u6211\u4eec\u7684\u72ec\u7acb\u5916\u90e8\u4e13\u5bb6\u54a8\u8be2\u59d4\u5458\u4f1a\u7684\u5ba1\u8bae\u540e\uff0cFDA\u4fee\u8ba2\u4e86EUA\uff0c\u4ee5e\u8f89\u745e\u751f\u7269\u6280\u672f\u516c\u53f8\uff08Pfizer BioNTech\uff09\u7684\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\uff0c\u4ee5\u5141\u8bb8\u67d0\u4e9b\u4eba\u7fa4\uff08\u5982\u533b\u62a4\u4eba\u5458\u3001\u6559\u5e08\u548c\u65e5\u6258\u4eba\u5458\u3001\u98df\u54c1\u6742\u8d27\u5e97\u5de5\u4f5c\u4eba\u5458\u4ee5\u53ca\u65e0\u5bb6\u53ef\u5f52\u8005\u6536\u5bb9\u6240\u6216\u76d1\u72f1\u4e2d\u7684\u4eba\u7b49\uff09\u589e\u52a0\u5242\u91cf\uff0c\u201dFDA\u4ee3\u7406\u4e13\u5458Janet Woodcock\u533b\u5b66\u535a\u58eb\u8bf4\u3002\u201c\u968f\u7740\u75ab\u82d7\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65b9\u9762\u7684\u65b0\u6570\u636e\u6bcf\u5929\u90fd\u5728\u63d0\u4f9b\uff0c\u8fd9\u79cd\u5927\u6d41\u884c\u662f\u52a8\u6001\u7684\u548c\u4e0d\u65ad\u6f14\u53d8\u7684\u3002\u968f\u7740\u6211\u4eec\u5bf9\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u8fdb\u4e00\u6b65\u4e86\u89e3\uff0c\u5305\u62ec\u5bf9\u589e\u5f3a\u5242\u91cf\u7684\u4f7f\u7528\uff0c\u6211\u4eec\u5c06\u7ee7\u7eed\u8bc4\u4f30\u5feb\u901f\u53d8\u5316\u7684\u79d1\u5b66\uff0c\u5e76\u968f\u65f6\u5411\u516c\u4f17\u901a\u62a5\u60c5\u51b5\u3002\u201d<\/p>\n

\u8bc4\u4f30\u53ef\u7528\u6570\u636e\u7684\u8fc7\u7a0b<\/p>\n

Comirnaty\uff08\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\uff0cmRNA\uff09\uff0c\u4e8e8\u670823\u65e5\u83b7\u5f97FDA\u6279\u51c6\uff0c\u7528\u4e8e\u9884\u963216\u5c81\u53ca16\u5c81\u4ee5\u4e0a\u4eba\u7fa4\u4e2d\u7531SARS-CoV-2\u5f15\u8d77\u7684\u65b0\u51a0\u75c5\u6bd2\u30022021\u5e748\u670825\u65e5\uff0cFDA\u6536\u5230\u8f89\u745e\u516c\u53f8\u5bf9\u5176Comiranty\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u8bc1\u7533\u8bf7\u7684\u8865\u5145\uff0c\u7533\u8bf7\u6279\u51c6\u5728\u5b8c\u6210\u540e\u5927\u7ea66\u4e2a\u6708\u5185\u4f7f\u7528\u5355\u6b21\u589e\u5f3a\u5242\u5bf916\u5c81\u53ca16\u5c81\u4ee5\u4e0a\u7684\u4e2a\u4eba\u8fdb\u884c\u521d\u7ea7\u75ab\u82d7\u7cfb\u5217\u7684\u514d\u75ab\u63a5\u79cd\u3002<\/p>\n

\u4f5c\u4e3aFDA\u5bf9\u900f\u660e\u5ea6\u627f\u8bfa\u7684\u4e00\u90e8\u5206\uff0cFDA\u53ec\u5f00\u4e86\u75ab\u82d7\u548c\u76f8\u5173\u751f\u7269\u4ea7\u54c1\u54a8\u8be2\u59d4\u5458\u4f1a\uff08VRBPAC\uff09\u7684\u516c\u5f00\u4f1a\u8bae9\u670817\u65e5\uff0c\u5c31\u7533\u8bf7\u4e2d\u63d0\u4ea4\u7684\u6570\u636e\u5f81\u6c42\u72ec\u7acb\u79d1\u5b66\u548c\u516c\u5171\u536b\u751f\u4e13\u5bb6\u7684\u610f\u89c1\u3002\u4f1a\u8bae\u671f\u95f4\uff0c\u75ab\u82d7\u5236\u9020\u5546\u63d0\u4ea4\u4e86\u652f\u6301\u5176\u7533\u8bf7\u7684\u4fe1\u606f\u548c\u6570\u636e\u3002FDA\u8fd8\u63d0\u4ea4\u4e86\u5176\u5bf9\u75ab\u82d7\u5236\u9020\u5546\u63d0\u4ea4\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u5206\u6790\u3002\u6b64\u5916\u516c\u4f17\u4e5f\u6709\u673a\u4f1a\u63d0\u4f9b\u8bc4\u8bba\uff1bFDA\u9080\u8bf7\u56fd\u9645\u548c\u7f8e\u56fd\u673a\u6784\u548c\u5916\u90e8\u56e2\u4f53\uff0c\u5305\u62ec\u4ee5\u8272\u5217\u536b\u751f\u90e8\u3001\u5e03\u91cc\u65af\u6258\u5927\u5b66\u3001\u82f1\u56fd\u548c\u75be\u75c5\u9884\u9632\u63a7\u5236\u4e2d\u5fc3\u7684\u4ee3\u8868\uff0c\u4ecb\u7ecd\u6700\u8fd1\u4f7f\u7528\u7684\u75ab\u82d7\u52a9\u63a8\u5668\u3001\u79d1\u5a01\u7279\u6d41\u884c\u75c5\u5b66\u7684\u6570\u636e\u3002-19\uff0c\u4ee5\u53ca\u75ab\u82d7\u6709\u6548\u6027\u7684\u771f\u5b9e\u8bc1\u636e\u3002<\/p>\n

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\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u7684\u8f89\u745e\u751f\u7269\u6280\u672f\u516c\u53f8\uff08Pfizer BioNTech\uff09\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u7684\u914d\u65b9\u4e0e\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u7684Comirnaty\u76f8\u540c\uff0c\u4e14\u75ab\u82d7\u53ef\u4ee5\u4e92\u6362\u4f7f\u7528\u3002<\/p>\n

\u201c\u6211\u4eec\u611f\u8c22\u54a8\u8be2\u59d4\u5458\u4f1a\u7684\u533b\u751f\u3001\u79d1\u5b66\u5bb6\u548c\u4e3b\u8981\u75ab\u82d7\u4e13\u5bb6\u7684\u5efa\u8bae\uff0c\u611f\u8c22\u4ed6\u4eec\u5728\u786e\u4fdd\u6709\u5173\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u7684\u900f\u660e\u8ba8\u8bba\u4e2d\u53d1\u6325\u7684\u91cd\u8981\u4f5c\u7528\u3002\u6211\u4eec\u8d5e\u8d4f\u8fd9\u573a\u70ed\u70c8\u7684\u8ba8\u8bba\uff0c\u5305\u62ec\u5bf965\u5c81\u4ee5\u4e0a\u7684\u4eba\u548c\u611f\u67d3\u65b0\u51a0\u75c5\u6bd2\u7684\u9ad8\u5371\u4eba\u7fa4\u7684\u6295\u7968\u4e25\u91cd\u75be\u75c5\uff0c\u4ee5\u53ca\u59d4\u5458\u4f1a\u5bf9\u673a\u6784\u6216\u804c\u4e1a\u6027\u63a5\u89e6SARS-CoV-2\u60a3\u8005\u4f7f\u7528\u589e\u5f3a\u5242\u91cf\u7684\u610f\u89c1\uff0c\u201dFDA\u751f\u7269\u5236\u54c1\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efbPeter Marks\u533b\u5b66\u535a\u58eb\u8bf4\u3002\u201cFDA\u8003\u8651\u4e86\u59d4\u5458\u4f1a\u7684\u610f\u89c1\uff0c\u5e76\u5bf9\u63d0\u4ea4\u7684\u6570\u636e\u8fdb\u884c\u4e86\u5f7b\u5e95\u7684\u5ba1\u67e5\uff0c\u4ee5\u8fbe\u6210\u4eca\u5929\u7684\u51b3\u5b9a\u3002\u6211\u4eec\u5c06\u7ee7\u7eed\u5206\u6790\u63d0\u4ea4\u7ed9FDA\u7684\u6709\u5173\u4f7f\u7528\u65b0\u51a0\u75c5\u6bd2-19\u75ab\u82d7\u589e\u5f3a\u5242\u7684\u6570\u636e\uff0c\u5e76\u6839\u636e\u8fd9\u4e9b\u6570\u636e\u505a\u51fa\u8fdb\u4e00\u6b65\u7684\u51b3\u5b9a\u3002\u201d<\/p>\n

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