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To: bitt

https://www.wsj.com/articles/pfizer-biontech-ask-fda-for-full-approval-of-covid-19-vaccine-11620415712

Top News: Pfizer, BioNTech ask FDA for full approval of COVID-19 vaccine
Manufacturing partners Pfizer and BioNTech are seeking full FDA approval for their COVID-19 vaccine, which received emergency use authorization in December. The designation, based on about 2 months of follow-up data from an estimated 38,000 volunteers, allows the vaccine to be distributed only as directed by CDC and other federal bodies. FDA also has the wherewithal to restrict advertising and communications related to the vaccine, but Pfizer executives say obtaining a Biologics License Application would allow for more outreach aimed at increasing awareness of and instilling confidence in the vaccine. To support their application, Pfizer and BioNTech are providing approximately 6 months of follow-up data from more than 46,000 volunteers. The companies have filed for priority review, which would yield an FDA decision in 6 months instead of the standard 10-month review period. “


1,624 posted on 05/10/2021 8:40:10 AM PDT by smileyface ("The illuminati's whole philosophy demands the use, abuse, sacrifice and consumption of children.")
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To: smileyface

FDA approval paves the way for a mandate by the more pushy communists.

The PSucky WH briefing reporters want forced Vax, badly! Militant Media will love the Leverage an FDA approval would bring.


1,631 posted on 05/10/2021 9:05:14 AM PDT by RitaOK (Viva Christo Rey! Publik Skules/Academia -> The Farm team, for more Marxists coming. Infinitum.)
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To: smileyface; bitt

I take it that the “Biologics License Application” is separate from the full FDA approval?

The priority review that Pfizer and BioNTech are asking for pegs approval occurring around November 2021 instead of March 2022.


1,671 posted on 05/10/2021 10:13:39 AM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000))
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