Experts hopeful full approval of Pfizer shot spurs more Americans to get vaccinated
The U.S. Food and Drug Administration granted full approval to the Pfizer COVID-19 vaccine Monday morning, a decision the agency calls a "milestone" in the fight against the pandemic.
Until now, the vaccine had emergency use authorization from the FDA.
KSTP medical expert Dr. Archelle Georgiou said the vaccine moving from emergency use authorization to full approval required Pfizer to prove more about the safety and effectiveness of the shots.
"Full approval really is a different threshold, and the FDA puts many more stringent standards around that," Georgiou said. "For emergency use authorization, they required three months of data, they required safety data and the manufacturers also had to show the vaccine was most likely effective against COVID-19 and there wasn’t a better alternative. However, to get full approval, they required six months of complete data and they had to show substantial effectiveness."
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency reviewed hundreds of thousands of pages of data over the past three months while evaluating Pfizer’s application for full approval.
"We completed this in about 40% of the normal clock time for a submission of this magnitude," Marks said Monday.
He noted the agency was still "highly rigorous" in its standards for approval.
"We don’t just look at what the summaries of data are, we go down to the level of the individual patients," Marks said.
He said the FDA considered efficacy data and side effects of the vaccine in making its decision while also inspecting facilities where the vaccine is manufactured.
"This is a pivotal moment for our country in the fight against the pandemic," acting FDA Commissioner Janet Woodcock said Monday.
So what changes can Minnesotans expect to see now that a COVID-19 vaccine has full FDA approval?
"For the average individual, this doesn’t change a thing. The formulation is the same and where you can get a shot is the same," Georgiou said. "One thing people will notice is that the Pfizer vaccine is going to change its name so they can brand it."
Pfizer’s vaccine will now be marketed as Comirnaty.
"Pfizer can now sell this vaccine, they can charge for it. And that’s an important change for them. They haven’t been able to do that to date," Georgiou said.
With full FDA approval, Pfizer can also release commercials and other advertising for the vaccine.
Dr. Mark Sannes, an infectious disease doctor at HealthPartners, hopes the approval will decrease vaccine hesitancy.
"As many as 3 out of 10 unvaccinated individuals are saying it was because the vaccine was not fully approved," Sannes said. "If this is what gets even a portion of that group to finally say, ‘OK, I’m ready to get vaccinated,’ I think that will be a huge step forward for us."
Sannes said there were 72 hospitalized COVID-19 patients across the HealthPartners system as of Monday, with a growing percentage of young, healthy people getting sick with the virus.
"Even if we can get that 30% of people that have been on the fence to choose vaccination, we are going to finally start to see hospitalizations come down," Dr. Sannes said. "These aren’t perfect vaccines. They don’t prevent every infection, but they do prevent and protect a person from the most serious consequences."
A nationwide Gallup poll that surveyed 3,475 adults from July 19-26 shows 18% of unvaccinated Americans said they were waiting for FDA approval or to confirm the shot was safe.
Georgiou added, "If people answered the surveys honestly and this is what they were waiting for, then we should see a bump in the number of people who are vaccinated."
She noted people who want to receive a Moderna or Johnson and Johnson vaccine can still do so, as those vaccines remain under emergency use authorization.
The University of Minnesota had been waiting for full FDA approval of a vaccine before requiring it for students and staff. A spokesperson said the university will now add the COVID-19 vaccine to the list of vaccines required for all enrolled students, although a timeline for that is still being determined.
"I think that employers and colleges have been wringing their hands about whether or not they could mandate a vaccine if it didn’t have full FDA approval. For some of them, I think this full approval will take them over the finish line to mandate," Georgiou said.