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#疫苗研发 #台湾 #Taiwan

【卫福部核准 #高端 MVC-COV1901新冠肺炎疫苗专案制造】
卫生福利部食品药物管理署(以下简称食药署)为积极因应新型冠状病毒疾病(以下简称COVID-19)疫情防疫需求,于110年7月18日邀请台湾化学制造管制、药学、毒理学、临床医学、公卫、法律及医学伦理专家召开会议,讨论高端MVC-COV1901新冠肺炎疫苗(以下简称高端疫苗)专案制造申请案。

经过一天充分的审查与讨论,鉴于高端疫苗的中和抗体数据已证明不劣于国人接种AZ疫苗的中和抗体结果,达成食药署公告之「新冠疫苗专案制造或输入技术性资料审查基准」要求,且安全性数据显示无重大安全疑虑:
1.高端疫苗组与AZ疫苗组之原型株活病毒中和抗体几何平均效价比值(geometric mean titer ratio, GMTR)的95%信赖区间下限为3.4倍,远大于标准要求0.67倍。
2.高端疫苗组的血清反应比率(sero-response rate)的95%信赖区间下限为95.5%,远大于标准要求50%。

基于疾病管制署认定台湾确有疫情及疫苗紧急公共卫生需求之前提,评估整体医疗利益与风险平衡,与会专家出席21人,主席不参与投票,18人同意,1人补件再议,1人不同意。

食药署依「药事法第48条之2规定」,核准高端疫苗专案制造,适用于20岁以上成人之主动免疫接种,接种两剂,间隔28天,以预防COVID-19。另针对专家会议建议,该疫苗于专案核准制造期间,药商须每月提供安全性监测报告,并于核准后一年内检送台湾外执行疫苗保护效益(effectiveness)报告,以保障国人用药安全。(卫生福利部疾病管制署



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#疫苗研发 #台湾 #Taiwan

【卫福部核准 #高端 MVC-COV1901新冠肺炎疫苗专案制造】
卫生福利部食品药物管理署(以下简称食药署)为积极因应新型冠状病毒疾病(以下简称COVID-19)疫情防疫需求,于110年7月18日邀请台湾化学制造管制、药学、毒理学、临床医学、公卫、法律及医学伦理专家召开会议,讨论高端MVC-COV1901新冠肺炎疫苗(以下简称高端疫苗)专案制造申请案。

经过一天充分的审查与讨论,鉴于高端疫苗的中和抗体数据已证明不劣于国人接种AZ疫苗的中和抗体结果,达成食药署公告之「新冠疫苗专案制造或输入技术性资料审查基准」要求,且安全性数据显示无重大安全疑虑:
1.高端疫苗组与AZ疫苗组之原型株活病毒中和抗体几何平均效价比值(geometric mean titer ratio, GMTR)的95%信赖区间下限为3.4倍,远大于标准要求0.67倍。
2.高端疫苗组的血清反应比率(sero-response rate)的95%信赖区间下限为95.5%,远大于标准要求50%。

基于疾病管制署认定台湾确有疫情及疫苗紧急公共卫生需求之前提,评估整体医疗利益与风险平衡,与会专家出席21人,主席不参与投票,18人同意,1人补件再议,1人不同意。

食药署依「药事法第48条之2规定」,核准高端疫苗专案制造,适用于20岁以上成人之主动免疫接种,接种两剂,间隔28天,以预防COVID-19。另针对专家会议建议,该疫苗于专案核准制造期间,药商须每月提供安全性监测报告,并于核准后一年内检送台湾外执行疫苗保护效益(effectiveness)报告,以保障国人用药安全。(卫生福利部疾病管制署

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Traders also expressed uncertainty about the situation with China Evergrande, as the indebted property company has not provided clarification about a key interest payment.In economic news, the Commerce Department reported an unexpected increase in U.S. new home sales in August.Crude oil prices climbed Friday and front-month WTI oil futures contracts saw gains for a fifth straight week amid tighter supplies. West Texas Intermediate Crude oil futures for November rose $0.68 or 0.9 percent at 73.98 a barrel. WTI Crude futures gained 2.8 percent for the week.

Pinterest (PINS) Stock Sinks As Market Gains

Pinterest (PINS) closed at $71.75 in the latest trading session, marking a -0.18% move from the prior day. This change lagged the S&P 500's daily gain of 0.1%. Meanwhile, the Dow gained 0.9%, and the Nasdaq, a tech-heavy index, lost 0.59%. Heading into today, shares of the digital pinboard and shopping tool company had lost 17.41% over the past month, lagging the Computer and Technology sector's loss of 5.38% and the S&P 500's gain of 0.71% in that time. Investors will be hoping for strength from PINS as it approaches its next earnings release. The company is expected to report EPS of $0.07, up 170% from the prior-year quarter. Our most recent consensus estimate is calling for quarterly revenue of $467.87 million, up 72.05% from the year-ago period.

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