Forwarded from 疫時代🌊Pandemic ᴛʀᴜᴛʜs
📩 注意:據此,FDA 並未批准輝瑞疫苗,而是延長 #緊急使用授權 (EUA)。📄📄📄
Accordingly, FDA DID NOT approve Pfizer's vaccine, but instead extended the Emergency Use Authorization (EUA).
https://www.fda.gov/media/150386/download
在2021年8月23日,FDA得出結論,根據該法案第564(g)(2)條,修訂該EUA是適當的,以便保護公眾健康或安全。
8月12日,FDA重新發布了2021授權證書與修訂整合並澄清EUA事先批準的適應癥和使用在Pfizer-BioNTech COVID-19疫苗中繼續有效。
COMIRNATY 疫苗的授權使用(COVID-19,mRNA)在這個EUA之下的某些用途,不包括BLA批準。
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.
Resource:
https://publielectoral.lat/nocovidvaccines/520643
#FDA #Approval #EUA
轉發分享 🌟 @PandemicTruths
Accordingly, FDA DID NOT approve Pfizer's vaccine, but instead extended the Emergency Use Authorization (EUA).
https://www.fda.gov/media/150386/download
在2021年8月23日,FDA得出結論,根據該法案第564(g)(2)條,修訂該EUA是適當的,以便保護公眾健康或安全。
8月12日,FDA重新發布了2021授權證書與修訂整合並澄清EUA事先批準的適應癥和使用在Pfizer-BioNTech COVID-19疫苗中繼續有效。
COMIRNATY 疫苗的授權使用(COVID-19,mRNA)在這個EUA之下的某些用途,不包括BLA批準。
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.
Resource:
https://publielectoral.lat/nocovidvaccines/520643
#FDA #Approval #EUA
轉發分享 🌟 @PandemicTruths
Forwarded from 疫時代🌊Pandemic ᴛʀᴜᴛʜs
『緊急使用授權和完全核准差異在哪?』
——輝瑞、莫得納力拼C-19疫苗的最後一哩路!
秒數閱讀:
疫苗的開發往往需要花費數年的時間,然而在 #FDA 頒布的緊急使用授權 (EUA) 下,使得許多疫苗開發商公司能從研究開發、臨床試驗快速推進至製造與分發階段。
點擊進入
http://www.genetinfo.com/international-news/item/49015.html
#Approval #EUA #緊急使用授權
轉發出去
ᴾᵃⁿᵈᵉᵐⁱᶜᵀᴿᵁᵀᴴˢ·疫時代資訊
——輝瑞、莫得納力拼C-19疫苗的最後一哩路!
秒數閱讀:
疫苗的開發往往需要花費數年的時間,然而在 #FDA 頒布的緊急使用授權 (EUA) 下,使得許多疫苗開發商公司能從研究開發、臨床試驗快速推進至製造與分發階段。
點擊進入
http://www.genetinfo.com/international-news/item/49015.html
#Approval #EUA #緊急使用授權
轉發出去
ᴾᵃⁿᵈᵉᵐⁱᶜᵀᴿᵁᵀᴴˢ·疫時代資訊