FDA gives full approval to Pfizer COVID-19 vaccine

The approval was seen as a milestone in the fight against the coronavirus pandemic — in part because it could provide reassurance to those who have delayed getting vaccinated.

Pfizer’s COVID-19 vaccine has full approval from the U.S. Food and Drug Administration, officials said Monday.

The approval was seen as a milestone in the fight against the coronavirus pandemic — in part because it could provide reassurance to those who have delayed getting vaccinated because they were concerned the vaccines were rushed into production. 

“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 acting FDA commissioner, Dr. Janet Woodcock, said in a news release. “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 approval applies to the Pfizer vaccine for people 16 and older. It will remain available under emergency use authorization for people ages 12 to 15 and as a third dose for immunocompromised individuals, the FDA said. So far, it is the only COVID-19 vaccine available to people ages 12 to 17.

In the Hopkinsville area, Walgreens administers the Pfizer vaccine. Availability at Walgreens stores can be checked online. There is also a national vaccine search tool that checks numerous chain and independent pharmacies and medical facilities that administer vaccines. 

The Pentagon said it will require members of the military to get vaccinated now that the FDA has fully approved Pfizer’s vaccine, the Associated Press reported. Two weeks ago, President Biden announced he was backing a Department of Defense plan to soon require the vaccine for members of the military even before the FDA granted full approval. 

At Fort Campbell, soldiers, family members and military retirees are given the Pfizer vaccine. The FDA announcement could speed up the process to get all military members at the Army installation vaccinated. 

The FDA said the Pfizer vaccine will be marketed under the brand name Comirnaty.

There are two other COVID-19 vaccines that have been granted emergency use authorization.

Moderna has applied for full approval of its vaccine, and Johnson & Johnson is expected to apply to the FDA later this year, according to the AP report. 

The Christian County Health Department administers the Moderna and Johnson & Johnson vaccines on Tuesday and Thursdays. 

Jennifer P. Brown is co-founder, publisher and editor of Hoptown Chronicle. You can reach her at editor@hoptownchronicle.org. She spent 30 years as a reporter and editor at the Kentucky New Era. She is a co-chair of the national advisory board to the Institute for Rural Journalism and Community Issues, governing board president for the Kentucky Historical Society, and co-founder of the Kentucky Open Government Coalition.