FDA: Pfizer COVID-19 Vaccine Receives Final Approval
The U.S. Food and Drug Administration has given a full stamp approval for the Pfizer-BioNTech COVID-19 Vaccine.
The two-step vaccine has been authorized for emergency use since December 2020 and is the only COVID-19 vaccine available for young people ages 12 to 17. The fully-approved vaccine applies to anyone who is at least 16 years of age.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock, M.D. in a news release. "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.
"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 continued. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
According to the FDA website, all vaccines must go through the "standard process for reviewing the quality, safety and effectiveness of medical products" before earning approval. Emergency-Use Authorization vaccines and medications still undergo rigorous trials and tests but won't receive full FDA approval until the standard processes are completed.
The Kaiser Family Foundation ran a survey in June asking why unvaccinated adults are still reticent to get the shot. Just over 50% of respondents indicated that the vaccine being "too new" was a major reason why they haven't gotten it.
The Foundation also reported that in parents, about 40% want to "wait and see" what happens before allowing their children to get vaccinated. About 10% of adults indicated that they wanted to "wait and see" what happens before getting the jab themselves.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine," said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, in a news release. "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," Marks continued. "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."
For more information about the Pfizer COVID-19 vaccine and its full approval under the FDA, click here.