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    --- image: https://images.api.hahow.in/images/5b5745e45738e6001e2b8830?width=1000 --- # COVID 疫苗購買、臨床試驗與 EUA 時程 [^vaccine-wiki]: https://en.wikipedia.org/wiki/COVID-19_vaccine) [^vaccine-history-wiki]: https://en.wikipedia.org/wiki/History_of_COVID-19_vaccine_development <style> code { border: 1px solid currentColor; } </style> ## 輝瑞(Pfizer–BioNTech) > [Vaccine Tracker](https://covid19.trackvaccines.org/vaccines/6/) [^bnt-wiki]: https://en.wikipedia.org/wiki/Pfizer%E2%80%93BioNTech_COVID-19_vaccine [^bnt-dev-pdf]: https://investors.biontech.de/static-files/53f0968a-279b-4f82-a2fc-d67dcb6e4e91 - 2020-04-23 Phase I-II 臨床試驗開始 [^bnt-wiki] - 2020-07-22 💰 `🇺🇸 開買` [美國購買 1 億劑,可加購 5 億劑](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600) - $19.5 億美元 / 1 億劑,每劑 19.5 美元 - 2020-07-27 Phase II-III 臨床試驗開始,44,000 受試者 [^bnt-dev-pdf] - 2020-09-16 💰 德國政府提供 [4.45 億美元資金](https://www.reuters.com/article/health-coronavirus-germany-vaccine-idUSKBN2661KP) - 2020-10 開始向各國做 rolling submission [^bnt-dev-pdf] - 2020-10-14 `發表` 於期刊發表(預印本)Phase I-II 研究成果 [^bnt-wiki] - 2020-11-18 - `發表` [新聞稿](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine)發佈 Phase III efficacy 95% - 第三期試驗將持續 2 年,監測 efficacy 與安全性 [^bnt-dev-pdf] - `送件→🇺🇸` 送美國 FDA [^bnt-dev-pdf] - 2020-12-02 `🇬🇧 通過` 英國 MHRA 通過 temporary regulatory approval [^vaccine-wiki] - 2020-12-10 `發表` 於[期刊發表 Phase III 安全性與有效性報告](https://www.nejm.org/doi/full/10.1056/nejmoa2034577) - 2020-12-11 `🇺🇸 通過` 美國 FDA 通過 EUA [^vaccine-wiki] ---- - 2021-06-10 台灣[有條件通過 BNT 之 EUA](https://health.udn.com/health/story/121833/5524307) - [仍缺製造廠資料待補](https://health.udn.com/health/story/121833/5524307),故為有條件通過 - [由疾管署向食藥署提出](https://www.rti.org.tw/news/view/id/2102306) - 用於[向原廠要求出貨證明](https://udn.com/news/story/122190/5528427) - 2021-07-12 💰 `🇹🇼 開買` 鴻海、台積電[發表重訊表示完成簽約](https://www.moneydj.com/kmdj/news/newsviewer.aspx?a=2a0e740a-7639-468d-96d8-44a43e5bdb9c) - 2021-07-21 [慈濟完成簽署捐贈契約](https://www.bcc.com.tw/newsView.6724940) - 將統一由疾管署併案向食藥署[申請 EUA 專案輸入許可](https://www.cna.com.tw/news/firstnews/202107215004.aspx) - 2021-08-03 `🇹🇼 通過` [台灣核准使用](https://www.rti.org.tw/news/view/id/2107361) - 2021-08-04 台灣[更新 BNT 適用對象為 12 歲以上](https://www.ettoday.net/news/20210804/2048108.htm) ## 莫德納(Moderna) > [Vaccine tracker](https://covid19.trackvaccines.org/vaccines/22/) [^moderna-wiki]: https://en.wikipedia.org/wiki/Moderna_COVID-19_vaccine - 2020-04 Phase I 臨床試驗開始 [^moderna-wiki] - 2020-04-16 💰 美國政府提供 [4.83 億美元](https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million/) - 2020-05-25 Phase IIa 臨床試驗開始,預計收 600 成人 [^moderna-wiki] - 2020-07-14 `發表` 發表 Phase I 前期成果 [^moderna-wiki] - 2020-07-26 💰 美國政府再提供 [4.72 億美元](https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-expansion-barda-agreement-support-larger-phase/) - 2020-07-27 Phase III 開始,預計收 30,000 志願者 [^moderna-wiki] - 2020-08-11 💰 `🇺🇸 開買` [美國購買一億劑](https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-supply-agreement-us-government-initial-100/) - 15.25 億美元 / 1 億劑,每劑 15.25 美元 - 2020-10 完成 30,000 受測者收案 [^moderna-wiki] - 2020-11-15 `發表` 發表 phase 3 中間報告,[美國 NIH 表示結果大有可為](https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine)。 [^moderna-wiki] - 2020-12 `送件→🇬🇧 🇺🇸 🇪🇺 🇨🇦` EUA 申請已送件多國 [^moderna-wiki] - 2020-12-18 `🇺🇸 通過` 美國 FDA 通過 EUA [^vaccine-wiki] - 2020-12-30 `發表` 於期刊發表 Phase III [安全性與有效性報告](https://www.nejm.org/doi/10.1056/NEJMoa2035389),包含 30,420 名受試者。整個試驗會在 2022 年尾結束。 [^moderna-wiki] ## 牛津-AZ(Oxford–AstraZeneca) > [Vaccine Tracker](https://covid19.trackvaccines.org/vaccines/4/) [^az-wiki]: https://en.wikipedia.org/wiki/Oxford%E2%80%93AstraZeneca_COVID-19_vaccine - 2020-04-01 [Phase I 臨床試驗開始](https://clinicaltrials.gov/ct2/show/NCT04816019) - 2020-04-23 [Phase I-II 臨床試驗開始](https://clinicaltrials.gov/ct2/show/NCT04324606) - 2020-05-18 💰英國政府提供[6.55 千萬英鎊](https://www.ox.ac.uk/news/2020-05-18-funding-and-manufacturing-boost-uk-vaccine-programme)(約 0.9 億美金) - 2020-05-21 💰 美國政府[提供 10 億美金](https://www.forbes.com/sites/isabeltogoh/2020/05/21/astrazeneca-receives-1-billion-from-us-government-to-produce-oxford-coronavirus-vaccine/) - 2020-05-28 [Phase II-III 臨床試驗開始](https://clinicaltrials.gov/ct2/show/NCT04400838) - 2020-08-27 💰 `🇪🇺 開買` [歐盟簽約購買 3 億劑](https://ec.europa.eu/commission/presscorner/detail/en/IP_20_1524) - [價格未公開,有保密協定](https://udn.com/news/story/120944/5108717) - 2020-08-31 美國 [NIH 宣布招募 30,000 受試者進行 Phase 3](https://www.nih.gov/news-events/news-releases/phase-3-clinical-testing-us-astrazeneca-covid-19-vaccine-candidate-begins) [^az-wiki] - 2020-10 💰 `🇹🇼 開買` [台灣簽約購買 1000 萬劑](https://www.ftvnews.com.tw/news/detail/2021209L12M1) - 2020-11-23 `發表` [Phase III 第一次中期報告資料釋出](https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html)[^az-wiki],發表有效性 efficacy 70% - 2020-12-08 `發表` 於期刊發表 [Phase III 安全性與有效性的中期分析報告](https://doi.org/10.1016%2FS0140-6736%2820%2932661-1) [^az-wiki] - 2020-12-30 `🇬🇧 通過` 英國核准使用 [^az-wiki] - 2021-01-12 `送件→🇪🇺`向歐盟 EMA [申請 EUA](https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-astrazeneca) [^az-wiki] - 2021-01-29 `🇪🇺 通過` 歐盟 EMA 建議疫苗用於 18 歲以上成人,歐洲議會通過 [^az-wiki] - 2021-02-19 `發表` 於期刊發表 [Phase III 後續分析](https://doi.org/10.1016%2FS0140-6736%2821%2900432-3) [^az-wiki] --- ## 高端疫苗 Medigen > [Vaccine Tracker](https://covid19.trackvaccines.org/vaccines/24/) - 2020-10-07 開始 [Phase I 臨床試驗](https://clinicaltrials.gov/ct2/show/NCT04487210?term=04487210&draw=2&rank=1),45 人 - 2020-10-14 💰 台灣政府補助 [4.7 億新台幣](https://www.chinatimes.com/newspapers/20201014000255-260204?chdtv) - 2020-12-30 開始 [Phase II 臨床試驗](https://clinicaltrials.gov/ct2/show/NCT04695652?term=MVC-COV1901&draw=2&rank=1),3700 成人 - 2021-03-21 於期刊發表 [Phase I 期中分析數據](https://www.medrxiv.org/content/10.1101/2021.03.31.21254668v1) - 2021-05-30 💰 `🇹🇼 開買` [台灣疾管署與高端簽約 500 萬劑](https://www.cna.com.tw/news/firstnews/202105300199.aspx) - 單價「[比 750 (新台幣)高一點](https://udn.com/news/story/122190/5522720)」 - 2021-06-10 公布 Phase II 期中成果 - [二期臨床主試驗解盲](https://www.medigenvac.com/public/news/detail/78?from_sort=1) - 2021-06-15 `送件→🇹🇼` [申請 EUA](https://ctee.com.tw/news/biotech/474985.html) - 2021-07-19 `🇹🇼 通過` 台灣有條件核准使用 - 08-02 公佈[EUA 的會議記錄](https://www.commonhealth.com.tw/article/84822) ## 聯亞疫苗 > [Vaccine Tracker](https://covid19.trackvaccines.org/vaccines/43/) - 2020-09-25 開始 [Phase I 臨床試驗](https://clinicaltrials.gov/ct2/show/NCT04545749),60 人 - 2020-10-16 💰 台灣政府補助 [4.3 億新台幣](https://money.udn.com/money/story/10161/4939115) - 2021-01-30 開始 [Phase II 臨床試驗](https://clinicaltrials.gov/ct2/show/NCT04773067),3,850 人 - 2021-05-30 💰 `🇹🇼 開買` [台灣疾管署與聯亞簽約 500 萬劑](https://www.cna.com.tw/news/firstnews/202105300199.aspx) - 2021Q2 [預計](http://www.unitedbiopharma.com/tw/news_detail.php?id=334):[Phase II/III 臨床試驗](https://clinicaltrials.gov/ct2/show/NCT04683224),7320 人

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