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FDA Warns Against 'Off-Label' Use of Pfizer COVID-19 Vaccine in Younger Children drugs
August 25, 2021
"Off-label" use of the Pfizer COVID-19 vaccine in children younger than 12 years is "not appropriate," the U.S. Food and Drug Administration warned Monday. The American Academy of Pediatrics (AAP) also "strongly discourages" such use.
Pfizer CEO says COVID-19 vaccine-resistant variant likely to emerge firstwordpharma
August 25, 2021
Pfizer CEO Albert Bourla said the company believes a COVID-19 vaccine-resistant variant will likely one day emerge, but it has a system in place to turn around a variant-specific vaccine within some three months, Fox News reported.
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older drugs
August 24, 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for Comirnaty (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years.
Israeli Study Shows Pfizer Booster Gives Seniors Big Rise in Immunity drugs
August 24, 2021
A third dose of the Pfizer COVID-19 vaccine gives four times greater protection against COVID-19 infection and is five to six times more effective in preventing serious illness and hospitalization in seniors than just two doses.
Pfizer-BioNTech shot becomes first COVID-19 vaccine to gain full FDA approval cphi-online
August 24, 2021
Pfizer and BioNTech’s shot on Monday became the first COVID-19 vaccine to be granted full approval by the US Food and Drug Administration.
Pfizer, BioNTech's COVID-19 vaccine on brink of full FDA approval firstwordpharma
August 23, 2021
According to people familiar with the matter, the FDA is expected to grant full approval to Pfizer and BioNTech's COVID-19 vaccine BNT162b2 as soon as Monday, The New York Times reported.
Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine drugs
August 20, 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine.
COVID-19 Booster Shots for All Americans, Starting Sept. 20 drugs
August 19, 2021
After concluding that a third dose of a COVID-19 vaccine is needed to fight off waning immunity in the fully vaccinated, the Biden administration said Wednesday it will begin offering booster shots to all Americans starting Sept. 20.
Gov't to focus on buying Pfizer, Moderna over Sinovac shots – Galvez firstwordpharma
August 19, 2021
The Philippine government will focus on procuring US-made COVID-19 vaccines such as Pfizer and Moderna as the deal for China’s Sinovac vaccine is set to be completed, secretary Carlito Galvez Jr., the national vaccine manager, said Wednesday, reported INQ
A million Israelis get third dose, with early data showing heightened protection firstwordpharma
August 17, 2021
Officials said Monday that more than one million Israelis have received the third-dose COVID-19 booster shot, The Times of Israel reported.

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