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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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2019 nCoV疫情实时播报🅥 Telegram | DID YOU KNOW?

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Telegram has exploded as a hub for cybercriminals looking to buy, sell and share stolen data and hacking tools, new research shows, as the messaging app emerges as an alternative to the dark web.An investigation by cyber intelligence group Cyberint, together with the Financial Times, found a ballooning network of hackers sharing data leaks on the popular messaging platform, sometimes in channels with tens of thousands of subscribers, lured by its ease of use and light-touch moderation.

Telegram auto-delete message, expiring invites, and more

elegram is updating its messaging app with options for auto-deleting messages, expiring invite links, and new unlimited groups, the company shared in a blog post. Much like Signal, Telegram received a burst of new users in the confusion over WhatsApp’s privacy policy and now the company is adopting features that were already part of its competitors’ apps, features which offer more security and privacy. Auto-deleting messages were already possible in Telegram’s encrypted Secret Chats, but this new update for iOS and Android adds the option to make messages disappear in any kind of chat. Auto-delete can be enabled inside of chats, and set to delete either 24 hours or seven days after messages are sent. Auto-delete won’t remove every message though; if a message was sent before the feature was turned on, it’ll stick around. Telegram’s competitors have had similar features: WhatsApp introduced a feature in 2020 and Signal has had disappearing messages since at least 2016.

2019 nCoV疫情实时播报🅥 from ms


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