MILWAUKEE (CBS 58) — Pfizer and BioNTech have submitted their application for full FDA approval of their two-dose COVID-19 vaccine for people 16 and older.
Area doctors say this is the right move and could help drive up vaccine confidence. The application could also open the door for vaccines to be mandated.
Doctors and vaccinators say sometimes their patients question COVID-19 vaccines because they’re not fully approved by the FDA, but this application just further proves the safety and efficacy of these vaccines.
“You know, I’s are dotted T’s are crossed. Hundreds of millions of doses are given and with that amount of data, which is really robust, I suspect they’ll get a green light,” said Dr. Jeff Pothof, chief quality officer at UW Health.
Vaccinators hope an FDA approval will help combat hesitancy for people reluctant to get the shot because it’s under Emergency Use Authorization.
“Of course you would explain to them that it is a public health emergency but people still question it, so I think definitely getting the full approval will give people more confidence to get the vaccine,” said Dimmy Sokhal, doctor of pharmacy at Hayat Pharmacy.
“Each new additional safety metric that is reached, I think we’ll see more people coming in to get vaccinated,” adds Dr. Ben Weston, an associate professor at Froedtert & Medical College of Wisconsin.
Dr. Ben Weston says there’s no reason to wait until full FDA approval to get a vaccine, so far Pfizer has already delivered more than 170 million doses to the U.S.
“It’s not the stamp of approval to show it’s effective, to show it’s safe. We already know it’s effective, we know it’s safe,” he says.
“We’re not going to find things in the data that’s going to be submitted (to the FDA) that we don’t know about already,” Dr. Pothof said.
Once the FDA grants approval to Pfizer and BioNTech, experts say you may start to see COVID-19 vaccines become mandated.
“A lot of employers or schools can kind of make it mandatory, like now it’s gone through the full approval, it’s not just emergency use,” said Sokhal.
“That certainly will be a transition point that we see in the near future I think,” Dr. Weston says. “Certainly heard of organizations around the country that want to wait for that formal approval before they require it.”
Pfizer and BioNTech has asked for an accelerated review of their COVID-19 vaccine, so the FDA could act within six months versus the 10-month standard review.