FDA Fully Approves Pfizer-BioNTech’s COVID-19 Vaccine For Use In Adults

On Monday afternoon, the Food and Drug Administration (FDA) officially granted full approval of the Pfizer-BioNTech COVID-19 vaccine for use in adults. This is a major milestone that could convince unvaccinated people across the nation to get the jab.

FDA’s decision, which applies to vaccine recipients 16 and older, comes as the United States struggles with surging COVID-19 cases due to the Delta variant. New cases have increased since July, packing ICUs in some of the hardest-hit states like Florida.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, in a statement.

“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The statement also added that the FDA would continue to maintain the emergency use authorization (EUA) to Pfizer vaccine “for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

Following the FDA’s announcement, President Joe Biden urged unvaccinated people to get their vaccine against COVID-19, especially now that the agency has officially confirmed its safety and effectiveness.

“Those who have been waiting for full approval should go get your shot now,” Biden said during a White House press conference.

Biden also stressed that most of the current hospitalizations due to the virus are from unvaccinated individuals.

“The overwhelming majority of people in the hospital with COVID-19 or almost all those dying from COVID-19 are not vaccinated, not vaccinated,” he told reporters. “If you’re fully vaccinated – both shots, plus two weeks – your risk of severe illness with COVID-19 is very, very low.”

Article by Dongyoon Shin