FDA fully approves first COVID-19 vaccine

Pfizer vaccine granted full approval today, Aug. 23

Photo of Angela Mulka
Sherry Stewart, an RN with Walgreens, left, administers the Pfizer COVID-19 vaccine to Erin Aspiranti of Midland, right, during a clinic held in partnership with Walgreens Wednesday, March 24, 2021 at the Midland Center for the Arts.

Sherry Stewart, an RN with Walgreens, left, administers the Pfizer COVID-19 vaccine to Erin Aspiranti of Midland, right, during a clinic held in partnership with Walgreens Wednesday, March 24, 2021 at the Midland Center for the Arts.

(Katy Kildee/kkildee@mdn.net)

Pfizer’s COVID-19 vaccine has been granted full approval by the U.S. Food and Drug Administration today, Aug. 23, 2021. This decision replaces the emergency use authorization given by the agency last December.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds, according to the FDA.

This is the first COVID-19 vaccine to get full approval by the FDA. The decision puts Pfizer’s vaccine equal to any other FDA approved 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. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

What does this mean for our country?

Since the shot now carries the strongest endorsement from the Food and Drug Administration, it will ease the worries of those holding out to get it.

“I think overall, there’s going to be a boom of people ready to get their shots who were waiting for that official approval before getting vaccinated,” said Dr. Mark Hamed, Huron County Health Department medical director. “This will hopefully help relieve fears for people about the vaccine's safety and efficacy. I’m optimistic. I definitely think people, high risk people, who were on the fence before should consider it. And, I’m a big fan of people asking their family physicians and doctors if they have risk factors and are considering it.”

Hamed, is also the medical director of the Huron, Tuscola, and Sanilac county health departments, and District Health Department No. 2 in Northeast Michigan. In addition to his role as medical director of several health departments, Hamed is a practicing physician and has seen first-hand the effect the coronavirus has had on his patients at Henry Ford Hospital in Detroit, and as emergency room and hospital medical director at McKenzie Health in Sandusky.

The FDA’s decision will impact vaccine mandates by companies, universities and local governments. We may see more mandates by these entities in the near future, according to Hamed.

“It might open the door to employers mandating it more now,” Hamed said. “Since it’s fully approved they may have more legal discussion in their favor for enforcing mandates.”

Additionally, the U.S. is the first country to fully approve a COVID-19 vaccine, according to Pfizer.

“The FDA has historically been an organization that other countries watch to see what they do,” Hamed said. “So, I think it’s just a matter of what the usual pattern is: People see what the U.S. does, and they follow suit, because we have pretty high standards of approval for drugs and medical devices, too.”

It is important to note that no other vaccine has had so much evidence to judge its safety by. More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December, according to the Centers for Disease Control and Prevention.

In Michigan specifically, over 5.4 million doses of the Pfizer vaccine have been administered and 65% of Michiganders have gotten at least their first dose of one of the three vaccines. From January to July of 2021, unvaccinated Michiganders accounted for a staggering 98% of COVID cases, 95% of hospitalizations, and 96% of deaths, according to the State of Michigan.

“Today, the FDA granted full approval to Pfizer’s safe, effective COVID-19 vaccine, manufactured right here in Michigan,” said Gov. Gretchen Whitmer in a press release Aug. 23. “The FDA-approved Pfizer vaccine has already saved countless lives in Michigan and around the world, so if you have already gotten your shots, thank you for doing your part to keep yourself, your family, and your community safe. If you still have not, I hope today’s announcement encourages you to get your FDA-approved vaccine. Speak to your doctor or pharmacist if you have more questions and get your free shot soon. The FDA-approved Pfizer vaccine can protect you against COVID-19 and keep you out of the hospital if you get sick. If we all do our part to protect ourselves and the people we love from COVID, we can continue our economic jumpstart and usher in a new era of prosperity for our great state.”

As the delta variant — the most contagious coronavirus mutant yet — causes an upsurge in hospitalizations, shots are on the rise again with a million a day given Thursday, Friday and Saturday, according to the Associated Press.

Still to be decided are booster doses. The FDA’s licensure doesn’t cover those. So, the agency will decide that separately.

You can read the FDA approval letter here