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August 23, 2021

Pfizer-BioNTech becomes the First COVID-19 Vaccine to receive Full FDA Approval; It would now be called 'Comirnaty.'

Approval Signifies Key Achievement for Public Health.

FDA, Pfizer, Vaccine

SILVER SPRING, Md., Aug. 23, 2021 — Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine was earlier called Pfizer-BioNTech COVID-19 Vaccine. It will now be marketed as Comirnaty (Koe-mir’-na-tee) to prevent COVID-19 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 administering a third dose in specific immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. This one and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization. The public can be very confident that, as the first FDA-approved COVID-19 vaccine, 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.”

“Our scientific and medical experts conducted an in-depth and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages. In addition, we conducted our analyses of Comirnaty’s safety and effectiveness and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. Therefore, the public and the medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

• Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems to ensure that any safety concerns continue to be identified and evaluated on time. In addition, Pfizer has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to assess pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

• Important Safety Information

What should you mention to your Vaccination Provider before you get the COVID-19 vaccine?

Tell the vaccination provider about all of your medical conditions, including if you:

Source: U.S. Food and Drug Administration

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Edited & Posted by the Editor | 1:25 PM | Link to this Post

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