MEMPHIS, Tenn. — Pfizer’s coronavirus vaccine received full FDA approval on Monday following speculation that it would be upgraded from emergency use authorization. The vaccine has been under emergency use authorization since release.
“No shortcuts have been taken here, so we hope it will get a lot more people to take the vaccine. I think at the very least it will certainly make a lot more companies more likely to require the vaccine,” said Dr. Stephen Threlkeld, an infectious disease expert at Baptist Hospital.
Pfizer’s was the first coronavirus vaccine to receive this kind of approval.
“I distinctly remember the feeling we had when the first data came back from the vaccine trial that got emergency use authorization. It literally was like a sun rising in absolute darkness,” Threlkeld said.
On yet another dark time for healthcare workers as the Delta variant surges, Monday’s news was like a ray of hope as the FDA granted full approval to Pfizer’s COVID-19 vaccine for people 16 and older.
In a statement the FDA said in part, “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.”
Dr. Threlkeld hopes that will help reassure those who were hesitant.
“You hope it will give those folks that have been sitting on the sideline waiting finally the confidence to say it’s approved every bit as much as any other vaccine out there,” Dr. Threlkeld said.
This approval required six months of data, several trial phases, and inspections to prove safety, effectiveness, and manufacturing quality.
“Those all-important phase three studies, no corners were cut at all,” Dr. Threlkeld said about the approval process. “There were tens of thousands of people studied. They did it rigorously. No vaccine has been looked at nearly as rigorously as this one has.”
This news comes as Shelby County reports a rolling seven-day average of new covid cases up to 785. That’s compares to a daily average of 182 a month ago.
Doctors hope today’s news encouraged unvaccinated people to get their shots before it’s too late.
“We said if we could just bottle this pain and this regret and let people taste a drop of it for a minute just to realize this is a choice now. It’s an avoidable problem. You can spare your own illness and the pain of your family,” Dr. Threlkeld said.
The FDA said the Pfizer Vaccine will now be marketed as Comirnaty.
The vaccine still remains under emergency use authorization for children ages 12 through 15 years old.