FDA Fully Approves First COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted the first full approval of a COVID-19 vaccine for the Pfizer-BioNTech vaccine for use in individuals aged 16 years or older.1

The vaccine continues to be available to individuals aged 12 through 15 years under an emergency use authorization. A third dose of the vaccine has recently been authorized in certain immunocompromised populations, such as those who have undergone an organ transplant.2

Now marketed as Comirnaty, the vaccine will still be administered in 2 doses given 3 weeks apart. No changes to the vaccine’s formulation have been made from the emergency use authorization vaccine.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” concluded Peter Marks, MD, PhD, who is the director of the FDA’s Center for Biologics Evaluation and Research.1 “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 US and that the public is counting on safe and effective vaccines,” he 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 US.”


—Leigh Precopio



  1. FDA approves first COVID-19 vaccine. News release. US Food and Drug Administration; August 23, 2021.
  2. Precopio L. COVID-19 roundup: additional vaccine dose, breakthrough cases, death toll. Consultant360. Published online August 17, 2021.