On Monday, Aug. 23, the U.S. Food and Drug Administration, or FDA, announced the approval of the Pfizer-BioNTech COVID-19 Vaccine.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA Commissioner Dr. Janet Woodcock said in the 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.” 
This approval comes during a high increase in positive cases across the nation due to the highly transmissible delta variant, and Woodcock said she hopes the FDA approval will help ease vaccine safety fears. 
“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 said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 
In December of 2020, the Pfizer vaccine was approved for emergency use for those over the age of 16 and has since continued to undergo testing leading up to the approval.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” director of FDA’s Center for Biologics Evaluation and Research 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.” 
According to the FDA press release, the vaccine is approved for those as young as 16 years of age but is still in the emergency use authorization period, which began in May, for 12 to 15 year olds.  
Other vaccines, including those manufactured by Moderna and Johnson & Johnson, are still awaiting FDA approval. However, both vaccines are still being offered via emergency usage. The Centers for Disease Control and Prevention’s Committee on Immunization Practices will meet on Aug. 30 to revisit and update recommendations regarding this COVID-19 vaccine. 
“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 said. “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.”