FDA Approves Pfizer Vaccine

FDA+Seal+of+Approval

Last Monday (August 23, 2021) the U.S. Food and Drug Administration, more commonly known as the FDA, announced that they have officially approved the Pfizer COVID-19 Vaccine. In December 2020, the vaccine was given emergency use authorization (EUA). Which allowed it to be administered to those 16 years old or older. Later in May 2021, the EUA was expanded to 12 to 15-year-olds.

In a statement, current FDA Commissioner Janet Woodcock assured the public of the vaccine’s safety and efficacy.

“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.”

This announcement may have a larger impact than previously expected. The Commissioner continued,
“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.”

With this approval, Pfizer is able to market their vaccine. It will now be called Comirnaty, this is a change in name only, chemically it is the same vaccine as what they have been producing thus far.

Multiple polls have suggested that people yet to be vaccinated said they were more likely to get the vaccine if it had full approval from the FDA. Such as the latest poll conducted by the Kaiser Family Foundation in their COVID-19 Vaccine Monitor project; which showed that three in ten unvaccinated adults said they were more likely to receive the vaccine with this news. That same poll found that 65% of U.S. adults have received at least one dose of a COVID-19 vaccine given an EUA.

They have good reason to be reassured by the FDA’s approval. Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said, “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. 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. 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”

It has been reported that the vaccine was evaluated in approximately 44,000 individuals 16 years or older, half of which received the vaccine and half that were given a placebo. Of those evaluated, half were followed for more than four months, and 12,000 were followed for more than six months. The clinical trial found that the vaccine was 91% effective in preventing the COVID-19 disease.
Hopefully, this milestone can move us forward in our journey towards herd immunity across the country.