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在conditional marketing authorisation這個產品中，有3篇Facebook貼文，粉絲數超過30萬的網紅MedPartner 美的好朋友，也在其Facebook貼文中提到， #陳文茜 又在鬼扯，說什麼歐盟2020/12/27全歐疫苗開打，堅持市場核准程序未動用EUA，整個鬼扯到爆！他的目標就是要讓國產疫苗沒辦法EUA，或者取得台灣EUA後民眾不敢打。 如果他還會google 的話，去搜尋歐盟緊急授權使用，就會發現，在去年12/1，歐盟就已收到美國輝瑞藥廠與德國BioN...

conditional marketing authorisation 在 MedPartner 美的好朋友 Facebook 的最讚貼文

MedPartner 美的好朋友 By MedPartner 美的好朋友

2021-07-06 20:48:19 有 3,660 人按讚
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#陳文茜 又在鬼扯，說什麼歐盟2020/12/27全歐疫苗開打，堅持市場核准程序未動用EUA，整個鬼扯到爆！他的目標就是要讓國產疫苗沒辦法EUA，或者取得台灣EUA後民眾不敢打。

如果他還會google 的話，去搜尋歐盟緊急授權使用，就會發現，在去年12/1，歐盟就已收到美國輝瑞藥廠與德國BioNTech合作及美國莫德納公司共2款2019冠狀病毒疾病疫苗申請的緊急使用授權，評估結果將在數週內公布。

補充趙醫師的說法：歐盟沒有動用EUA⋯⋯歐盟動用的是CMA （Conditional Marketing Authorisation，大概就是限期一年的正常販售許可）。至於要不要EUA（不限期的販售免責權）是單一國家的事，歐盟不管。

https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/questions-and-answers-covid-19-vaccination-eu_en

也就是說，歐盟也是使用有限制性的授權方式，但名稱不是EUA

目前世界各國，連美國的疫苗都是EUA啦，有些跑得比較快的，都還在申請正式藥證的階段而已。

連你最愛的科興跟國藥都是EUA的啦！台灣的國產疫苗到底能不能取得我國的EUA，這是我們的主權，還有衛生主管機關的權責，到底能不能拿到，就看有沒有符合標準。你不要繼續鬼扯了。

造謠造成這樣，真的會有報應喔…

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Med，是Medicine，醫學的縮寫。Med 唸起來也是「美的」。我們希望用醫學專業，分享更多美的知識。Partner則是我們對彼此關係的想像。我們認為醫師和求診者不只是醫病關係，更應該是夥伴關係。 如果您也認同我們的理想，歡迎和我們一起傳播更多正確的醫美知識。 我們的內容製作，完全由MedPartner專業醫療團隊負責，拒絕任何業配。 contact us: [email protected]
MedPartner 美的好朋友 www.medpartner.club 一群專業醫師、藥師、營養師、化妝品配方師，希望透過實證科學精神，努力分享最正確的健康、美容、保養相關資訊。歡迎加入Line@好友，可享跟醫師線上
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conditional marketing authorisation 在 Facebook 的最讚貼文

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2021-06-02 09:52:31 有 732 人按讚
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關於疫苗的二三事

最近網路消息太多了，相信大家都非常的混亂。現在市面上的疫苗當初申請核准的時候，到底有沒有做第三期臨床試驗? 這應該是很多人不太清楚的事情。

我是醫生，我覺得要根據事實做陳述，我在這邊提供大家一些資料可以去自己查詢。我沒有政治立場，所以請不要戰我。資料是英文的，幫大家節省時間，我這邊簡單跟大家解釋一下：

1️⃣MODERNA 疫苗：

✅美國FDA在2021.02.25針對MODERNA的「緊急使用授權」（EUA)的正式核准函裡面指出：重點在第二頁的第一段到第三段：簡單的結論就是，根據MODERNA疫苗收案三萬人的「第三期」臨床實驗結果，證實此疫苗的安全性跟有效性。因此FDA決定核准MODERNA疫苗的EUA。

🉑USFDA正式核准函連結如下：

https://www.fda.gov/media/144636/download

⭕️第三期臨床試驗正式論文

https://www.nejm.org/doi/10.1056/NEJMoa2035389?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

2️⃣AZ疫苗
2021.01.29 AZ疫苗拿到歐洲EMA的「有條件市場授權」（conditional marketing authorisation)，該公司向歐洲EMA提交了一份收案23848人的第1/2/3期綜合臨床試驗。核准函第四頁內文指出，雖然有少數血栓風險，EMA經過評估認為該疫苗的好處還是比較多，因此有條件的核准通過，並要求AZ公司必須持續提供更多的資料供EMA查驗。

✅歐洲EMA核准頁：

https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-covid-19-vaccine-astrazeneca_en.pdf

⭕️第1/2/3期臨床試驗連結：
https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2932661-1

⭕️另一篇分析報告指出，AZ疫苗對英國變異株應該有約7成保護力：

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00628-0/fulltext

❌目前美國FDA尚未核准AZ疫苗在美國上市。

3️⃣輝瑞/BNT疫苗：
USFDA核准函第二頁第三段指出，該公司一樣有提交第一期到第三期的臨床人體試驗結果給美國FDA，收案人數將近44000人。BNT疫苗隨後在2021.05.10進一步得到美國FDA核准，疫苗施打年齡降至12歲以上即可接種。

✅USFDA核准函連結：

https://www.fda.gov/media/144412/download

⭕️輝瑞BNT疫苗的第1/2/3期臨床試驗正式論文：

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2034577?articleTools=true

⭕️以色列全國接種輝瑞BNT疫苗，接種覆蓋率達72%（接種人數471萬人）的全國報告顯示：輝瑞BNT162b2疫苗對COVID-19的有症狀感染、重症、住院及死亡的保護力均達97%；對無症狀感染的保護力也有91%。本報告指出：以色列國內的英國變異株估計盛行率是94.5%，因此該報告認為BNT疫苗對英國變異株證實有效。
連結如下：

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00947-8/fulltext

結論：目前市面上的疫苗都有經過「大型」上萬人的1/2/3期臨床人體試驗的驗證，確定對人體安全並且能有效預防新冠肺炎。

#任何疫苗都該有第三期臨床試驗結果
#能打到安全又有效的疫苗就是好疫苗
#發展國產疫苗是正確的
#但是要照規矩來
#整理資料完畢
#來企睏

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conditional marketing authorisation 在 Facebook 的精選貼文

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2021-05-31 19:42:04 有 115 人按讚
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疫苗的品牌可能會影響以後的國際差旅嗎？
那些疫苗目前獲得歐盟疫苗認可？
#歐盟7月1號啟用數位認證 🛂
😶 希望逐漸認可更多品牌
歐盟委員會剛剛在 Twitter 宣布七月一號之前要努力推動「疫苗護照」概念的 Digital green certificates 當中該認證會發給給而歐盟目前核可的疫苗施打者，詳細文字請看以下，以及本篇文章留言截圖。

白話文：目前施打完成輝瑞，莫德納，AZ以及嬌生的旅客，可以依照規則申請認證，可依屆時規定，作為入境所需文件之一入境歐洲。

#打的疫苗品牌會影響認證嗎
基本上就是歐盟市場認可的疫苗可以申請，當然特別成員國可以開放除了歐盟市場任何以外的疫苗。
Vaccination certificates will be issued to a vaccinated person for any COVID-19 vaccine.
When it comes to waiving free movement restrictions, Member States will have to accept vaccination certificates for vaccines which received EU marketing authorisation.
Member States may decide to extend this also to EU travellers that received another vaccine.

#哪歐盟認可的疫苗有哪些
在EMA對安全性和有效性進行積極評估之後，歐盟委員會迄今已授予BioNTech和Pfizer，Moderna，AstraZeneca和Janssen Pharmaceutica NV所開發疫苗的4個有條件銷售許可。歐洲藥品管理局（EMA）正在評估其他幾種疫苗。
The Commission has so far given 4 conditional marketing authorisations for the vaccines developed by BioNTech and Pfizer, Moderna, AstraZeneca and Janssen Pharmaceutica NV following EMA positive assessment of their safety and efficacy. Several other vaccines are at different stages of assessment by the European Medicines Agency (EMA).

#大多數疫苗在上市前均有經過嚴謹測試
#大多數疫苗的不良反映甚微
#疫苗 #是全球數十億人口對付疫情最好的武器

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CF Europe requests that EMA consider a conditional marketing authorisation for the triple combination. In February, we appealed to the EMA ...

#77. First Ebola Vaccine Gains Conditional Marketing Authorization ...

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing ...

#78. EMA recommends conditional marketing authorisation for ...

According to EMA, conditional approval allows the agency to recommend a medicine for marketing authorization before all data from clinical ...

#79. EU Regulatory Pathways for ATMPs: Standard, Accelerated ...

Marketing Authorisation. advanced therapy medicinal product. cell therapy. gene therapy. regulation. conditional approval.

#80. EC grants conditional marketing authorisation for Crysvita

The European Commission (EC) has revealed its decision to grant conditional marketing authorisation to Kyowa Kirin for Crysvita (burosumab) ...

#81. Achieving accelerated patient access to life-saving medicines

The conditional marketing authorisation, coupled with an accelerated assessment process, were designed to speed access to innovative medicines ...

#82. Remdesivir awaiting conditional marketing authorisation in the ...

The European Medicines Agency is, at short notice, planning the conditional marketing authorisation for the antiviral medicine Remdesivir in ...

#83. EC regulation on conditional approval of medicinal products

In a situation of conditional approval, the manufacturer, or "marketing authorisation holder" is committed to fulfil post-marketing obligations to obtain a ...

#84. Conditional Marketing Authorization Has Positive Impact in ...

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

#85. 歐洲藥品管理局有條件授權COVID-19疫苗販售(The European ...

歐洲藥品管理局有條件授權COVID-19疫苗販售(The European Medicines Agency's EU conditional marketing authorizations for COVID-19 vaccines).

#86. Sinovac receives conditional marketing authorisation for ...

Sinovac Biotech Ltd has announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing ...

#87. Questions and Answers: COVID-19 vaccination in the EU

When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into ...

#88. Update on application for conditional marketing authorisation ...

Update on application for conditional marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Agency.

#89. Oncopeptides submits application for conditional marketing ...

Oncopeptides submits application for conditional marketing authorization of melflufen in the EU. STOCKHOLM — April 16, 2021 — Oncopeptides ...

#90. Selinexor + dexamethasone receives conditional marketing ...

... the European Commission now grants conditional marketing authorization for selinexor in combination with dexamethasone for the treatment ...

#91. bluebird bio Announces EU Conditional Marketing ...

ZYNTEGLO is the first gene therapy approved for transfusion-dependent β-thalassemia (TDT). European marketing authorization for ZYNTEGLO ...

#92. EMA receives application for conditional marketing ... - In-Cyprus

EMA has started evaluating an application for conditional marketing authorisation for Novavax's COVID-19 vaccine, Nuvaxovid (also known as ...

#93. Novavax Confirms European Medicines Agency Review of ...

... for conditional marketing authorization (CMA) for Novavax' COVID-19 ... COVID-19 Vaccine Filing for Conditional Marketing Authorization.

#94. European Commission Grants Conditional Marketing ... - AbbVie

Conditional marketing authorization is granted to medicines that address an unmet medical need, where the benefit of its immediate ...

#95. Moderna gets EC conditional marketing authorisation for ...

Moderna has secured conditional marketing authorisation (CMA) from the European Commission (EC) for mRNA vaccine called Covid-19 Vaccine ...

#96. AstraZeneca says it has provided full data for European ...

AstraZeneca said it has submitted full data to pursue conditional marketing authorisation from the European Medicines Agency for its ...