/  08.23.2021

On Monday (Aug. 23), Pfizer’s COVID-19 vaccine was formally approved by the Food and Drug Administration, making it the first and only COVID-19 vaccine to be approved by the U.S. federal agency so far.

According to a press statement, the Pfizer-BioNTech COVID-19 vaccine will now be marketed as “Comirnaty” and is fully approved to be used by people who are at least 16 years old. Individuals who are between 12 and 15 years old will still be able to receive the vaccine for emergency use.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “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.”

According to a June poll by the Kaiser Family Foundation, 31 percent of Americans said they would be more likely to get vaccinated once a vaccine was approved by the FDA.

“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,” Woodcock added. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The Pfizer-BioNTech COVID-19 vaccine was first approved by the FDA for emergency use on Dec. 11, 2020 after undergoing a clinical trial. To fully approve the vaccine today, the FDA tested the vaccine again in a larger clinical trial and also monitored individuals after they received the vaccination for a longer duration of time. Based on the results of the trial, the agency says the Pfizer vaccine is 91 percent effective in preventing COVID-19.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “We evaluated scientific data and information included in hundreds of thousands of pages; conducted our own analyses of Comirnaty’s safety and effectiveness; and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,”

“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,” he added. “The public and 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.”


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