挺奇特。不得不佩服印度,在辉瑞BioNtech疫苗全球推广顺风顺水的时候,印度未能通过该疫苗的紧急使用许可。
辉瑞告诉Reuters已经撤回对印度紧急使用许可的申请。在印度第一个提出该申请的疫苗就是辉瑞BioNtech,随后是牛津阿斯利康(BTW,可在印度本地产)和印度本土Bharat Biotech的疫苗,结果后2种已经获得紧急使用,辉瑞BioNtech倒是撤回申请了。
辉瑞称:“基于会上的研究和我们对监管机构要求额外信息的理解,本公司决定目前撤回申请。辉瑞还将继续与印度当局接触,在满足额外信息要求后,重新提出申请,以便在近期能让疫苗获得使用。”
Reutesr称,印度药监部门拒绝辉瑞的申请,表示缺少小规模当地人群试验以证明该疫苗对印度人安全有效。印度卫生官员表示,他们一般都会要求该所谓衔接试验来确定疫苗对印度人是否安全和产生免疫反应。他们认为印度人的基因构成可能有别于西方国家的民众(its citizens whose genetic makeup can be different from people in Western nations)。-- 这个我表示莫名其妙,疫苗根本没有这么说的理由。
不过其实据2019年India’s New Drugs and Clinical Trial Rules,在某些特定条件下,可以免除这类试验。辉瑞告诉Reuters,其申请是基于来自全球的数据,疫苗效能95%,没有与疫苗相关的严重安全顾虑。
辉瑞告诉Reuters已经撤回对印度紧急使用许可的申请。在印度第一个提出该申请的疫苗就是辉瑞BioNtech,随后是牛津阿斯利康(BTW,可在印度本地产)和印度本土Bharat Biotech的疫苗,结果后2种已经获得紧急使用,辉瑞BioNtech倒是撤回申请了。
辉瑞称:“基于会上的研究和我们对监管机构要求额外信息的理解,本公司决定目前撤回申请。辉瑞还将继续与印度当局接触,在满足额外信息要求后,重新提出申请,以便在近期能让疫苗获得使用。”
Reutesr称,印度药监部门拒绝辉瑞的申请,表示缺少小规模当地人群试验以证明该疫苗对印度人安全有效。印度卫生官员表示,他们一般都会要求该所谓衔接试验来确定疫苗对印度人是否安全和产生免疫反应。他们认为印度人的基因构成可能有别于西方国家的民众(its citizens whose genetic makeup can be different from people in Western nations)。-- 这个我表示莫名其妙,疫苗根本没有这么说的理由。
不过其实据2019年India’s New Drugs and Clinical Trial Rules,在某些特定条件下,可以免除这类试验。辉瑞告诉Reuters,其申请是基于来自全球的数据,疫苗效能95%,没有与疫苗相关的严重安全顾虑。
#大张伟 我不能挡所有人挣钱的道#
千人唾弃万人锤。
More than 140 constitutional lawyers and scholars wrote in a letter Friday that the First Amendment claims made by former President's lawyers are “legally frivolous” and do “not prevent the Senate” from convicting him during his impeachment trial, set to begin next week, per the New York Times.
千人唾弃万人锤。
More than 140 constitutional lawyers and scholars wrote in a letter Friday that the First Amendment claims made by former President's lawyers are “legally frivolous” and do “not prevent the Senate” from convicting him during his impeachment trial, set to begin next week, per the New York Times.
#美国疫情##全球抗疫# 强生新冠疫苗美国东部时间本周四向FDA提交紧急使用授权申请,预计本月26日FDA将会开会讨论是否给予强生疫苗之“紧急授权”?
强生新冠疫苗的亮点是只需接种一剂(也就是单次注射),但有效率较低(约为72%),且对拉丁和非裔有效率略差(约为66%)。
目前该公司仍在评估接种两剂之有效率哈。
Johnson & Johnson submitted paperwork Thursday requesting that the U.S. Food and Drug Administration authorize its COVID-19 vaccine for use in adults.
The FDA announced later in the evening that its advisory committee will meet Feb. 26 to discuss the application. The agency is expected to authorize the vaccine within a few days of that meeting, making it the third available to the American public.
J&J announced last week that its vaccine was 72% effective in a U.S. trial, though it was less effective among people in Latin America and South Africa, bringing overall effectiveness down to 66%.
强生新冠疫苗的亮点是只需接种一剂(也就是单次注射),但有效率较低(约为72%),且对拉丁和非裔有效率略差(约为66%)。
目前该公司仍在评估接种两剂之有效率哈。
Johnson & Johnson submitted paperwork Thursday requesting that the U.S. Food and Drug Administration authorize its COVID-19 vaccine for use in adults.
The FDA announced later in the evening that its advisory committee will meet Feb. 26 to discuss the application. The agency is expected to authorize the vaccine within a few days of that meeting, making it the third available to the American public.
J&J announced last week that its vaccine was 72% effective in a U.S. trial, though it was less effective among people in Latin America and South Africa, bringing overall effectiveness down to 66%.
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