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HomePosts Tagged "authorization"

Stories tagged with: authorization

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Panel recommends Moderna vaccine, paving way for FDA authorization

Thursday, December 17 by ABC News
By ANNE FLAHERTY, STEPHANIE EBBS, SOPHIE TATUM, and ARIELLE MITROPOULOS(WASHINGTON) -- Federal advisers voted overwhelmingly Thursday to recommend the Moderna vaccine for people over the age of 18, clearing a path for government authorization on what would become the nation's... Read More.

More vaccines need authorization to inoculate all Americans

Thursday, December 17 by ABC News
By VICTOR ORDONEZ, ABC News (NEW YORK) -- Millions of the Pfizer and Moderna COVID-19 vaccines are likely to be distributed before year’s end, but experts say more vaccines will need authorization if most Americans wish to be vaccinated in the months to... Read More.

FDA ‘working day and night’ on COVID-19 vaccine emergency use authorization, commissioner tells ABC News

Tuesday, December 1 by ABC News
BY: CATERINA ANDREANO, ABC NEWS (WASHINGTON) — Food and Drug Administration Commissioner Dr. Stephen Hahn told Dr. Jennifer Ashton, ABC News' chief health and medical correspondent, that the agency has "all hands on deck" and is "working day and night, and on the... Read More.

Moderna to seek FDA emergency authorization after COVID-19 vaccine shows 94% efficacy

Monday, November 30 by ABC News
By SONY SALZMAN, ABC News(NEW YORK) -- Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19... Read More.

General: COVID-19 vaccines will be ready for delivery 24 hours after FDA authorization

Tuesday, November 24 by ABC News
By LUIS MARTINEZ, ABC News(WASHINGTON) -- Gen. Gustave Perna, who is leading Operation Warp Speed's effort to distribute coronavirus vaccines nationwide, told ABC News he is confident that vaccines will be "on the street" and headed to communities just 24... Read More.

Pfizer, BioNTech to seek FDA authorization Friday for COVID-19 vaccine

Friday, November 20 by ABC News
By MORGAN WINSOR, ABC News(NEW YORK) -- Pfizer and partner BioNTech announced they will submit a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.The submission, which is... Read More.

Pfizer vaccine 95% effective in final analysis, plans to seek emergency authorization ‘within days’

Wednesday, November 18 by ABC News
By SONY SALZMAN, ABC News(NEW YORK) -- Pfizer and partner BioNTech announced their coronavirus vaccine is more than 95% effective in the final analysis of its massive Phase 3 trial on Wednesday, and has reached a key safety milestone that... Read More.

White House OKs FDA asking for 2 months monitoring, likely delaying vaccine authorization past Election Day

Tuesday, October 6 by ABC News
By STEPHANIE EBBS, ABC News(WASHINGTON) -- The FDA has told companies working on COVID-19 vaccines it expects at least two months of follow up on clinical trial participants after they complete a full regimen of a vaccine, which likely means... Read More.

Emergency plasma authorization sparks concern for those leading charge on treatment

Monday, August 24 by ABC News
By SASHA PEZENIK, ABC News(WASHINGTON) -- In the high-pressure push to combat COVID-19, two things have become abundantly clear: we need effective treatment and we need further data to inform our findings.Sunday evening, the FDA issued what was... Read More.

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