Those hundreds of millions of doses of COVID-19 vaccines that already have been administered to Americans all have been classified “experimental.”
Now, the Food and Drug Administration announced that has given full approval for the use of Pfizer’s vaccinations to people 16 years old and older.
The federal agency said, “Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older.”
— U.S. FDA (@US_FDA) August 23, 2021
Fox Business reported acting FDA Commissioner Janet Wood claimed, “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.”
The move likely will make possible the development of more vaccination mandates, since the law technically does not allow those requirements to be imposed by government when the vaccines are experimental.
The vaccines from Pfizer, Moderna and Johnson & Johnson all were given emergency use authorization earlier.
But the announcement Monday stems from a biologics license application that added to the previously assembled pre-clinical and clinical data from the company.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” the FDA’s Dr. Peter Marks 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.”
Specifically, the paperwork completed now paves the way for the Pentagon to require the 1.3 million active-duty service members to take the vaccine.
Surgeon General Vivek Murthy just a day earlier expressed his hope that the approval would convince more people to take the shots, a campaign that the Biden administration has been vigorously pursuing.
CNBC reported Pfizer’s product was developed with BioNTech, and is an mRNA vaccine that will be known commercially as Comirnaty.
Pfizer’s product still remains under emergency use authorization for children 12 to 15.
While the multiple vaccines are credited with diminishing significantly the number of COVID-19 cases across America, they have proven less effective against variants of the virus that apparently came out of a research lab in Wuhan, China.
There also have been documented thousands of adverse effects, including many fatal, from the vaccines themselves.
Pfizer recently raised the price of each dose from $18.40 to $23 and said it expects to generate billions in income.
It also wants the FDA to authorize a third dose as a “booster” shot.
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