U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health
August 23, 2021 [Text bolding from original]
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

 

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product…

Media Call Recording: https://youtu.be/aHAGnDz9F_w

 

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August 27, 2021 – Coronavirus (COVID-19) Update: August 27, 2021

August 24, 2021 – Coronavirus (COVID-19) Update: August 24, 2021
:: On Aug. 22, the FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months. The extension is also applicable to batches that might have expired prior to the EUA amendment, provided the product was stored at the same temperatures.

 

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Vaccines and Related Biological Products Advisory Committee– FDA
:: Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement – 09/30/2021 – 09/30/2021
No agenda or meeting materials posted as of 28 Aug 2021

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Statement by President Joe Biden on the Investigation into the Origins of COVID-⁠19
August 27, 2021 • Statements and Releases
[See full text of statement above]

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
August 27, 2021 • Press Briefings

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
August 24, 2021 • Press Briefings

Remarks by President Biden on the COVID-⁠19 Response and the Vaccination Program
August 23, 2021 • Speeches and Remarks