The U.S. Food and Drug Administration (FDA) this morning granted full approval to the Pfizer / BioNTech vaccine against COVID-19 for people 16 years of age and older.
This is the first final approval of coronavirus vaccines by the FDA. The Pfizer / BioNTech vaccine has been authorized for emergency use in the United States since mid-December last year for people over 16 years of age. In May, the permit was extended to those over 12 years of age.
“The public can be very confident that this vaccine meets the high standards of safety, efficacy and quality of manufacture that the FDA requires of an approved product,” said FDA Commissioner Janet Woodcock. “Today’s milestone brings us one step closer to altering the course of this pandemic in the United States,” he added.
This step opens the door to promoting vaccination as a weapon against the pandemic, by dissipating anti-vaccine arguments that were not vaccines with final authorization. “While millions of people have already received COVID-19 vaccines safely, we recognize that for some, the FDA’s approval of a vaccine may now instill additional confidence in getting vaccinated. today brings us one step closer to altering the course of this pandemic in the United States, “Woodcock added.
More than 200 million doses of Pfizer have already been administered in the United States and hundreds of millions of other doses worldwide since the approved emergency use began in December.
An Associated Press review notes that “never before (the FDA) had so much evidence to judge the safety of an injection.”
“I hope this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve collective immunity. Hundreds of millions of doses of vaccine have already been administered. our vaccine in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans, ”said Albert Bourla, president and CEO of Pfizer.