The U.S. Food and Drug Administration (FDA) has approved the first vaccine to fight COVID-19, now called Comirnaty.
Up until now, the Pfizer vaccine was available through emergency use authorization.
"This is another key milestone in our nation’s fight against COVID-19," Gov. David Ige wrote in an Aug. 23 Facebook post. "FDA approval is the gold standard, and now that it’s been fully granted, it may give people the needed encouragement to sign up to get vaccinated. Those interested can register here: https://hawaiicovid19.com/vaccine-info/."
The Pfizer vaccine has been available in the U.S. since December 2020 for those 16 years and older.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.
"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, according to FDA.gov. "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."
The vaccine is still available for those 12 through 15 years old the under emergency use authorization and for the administration of a third dose in certain immunocompromised individuals. The vaccine has not yet been approved for children under the age of 12.