FDA expected to give full approval to Pfizer vaccine by next month

Pfizer Vaccine
Posted at 10:20 PM, Aug 04, 2021
and last updated 2021-08-04 23:19:03-04

TAMPA, Fla. — The FDA is now aiming to give full approval of the Pfizer COVID-19 vaccine by early September. It’s a move that could spark vaccination mandates across the country.

Pfizer received the FDA Emergency Use Authorization (EUA) for their shot last December. As part of the full approval process, the company continues to follow their trial participants to continue evaluating the vaccine’s safety and the antibody response.

The EUA came after the company went through phased trials of their mRNA-based vaccine, trials that any other vaccine or medication would have to go through.

“Almost any approval process would entail 3 phases,” said Dr. Kevin Sneed, Dean of the Taneja College of Pharmacy at USF Health.

The Pfizer vaccine has already undergone those three phases, so have Moderna and Johnson and Johnson. And while the process was sped up a little, Dr. Sneed reminds people that no steps were skipped.

“We still have phases 1, 2, and 3, but now, instead of taking a long pause in between 1 and 2, they have shortened that pause and they’re evaluating the data along the way,” said Dr. Sneed.

The number of trial participants was also much larger than typical, at more than 43,000.

“Typically, you probably would have nowhere close to the number of people who have been in any [COVID-19] clinical trial, for a normal approval process,” said Dr. Sneed.

Now the FDA is going through the process of granting full approval for Pfizer's vaccine. They already know it’s safe and effective, now they’re evaluating everything on the back end, too.

“How is it going to be manufactured, what will be the distribution, do you have enough supply chain and materials to continue to manufacture things, have you done things to prevent infection and other contaminants,” said Dr. Sneed.

It’s a process that goes beyond how the vaccine impacts the person who receives it, but many people are still awaiting that full approval to feel comfortable getting it.

“I think sometimes when I describe exactly what they’re waiting for, it’s a little surprising that it’s not like additional people in the study or things like that, they’re just following the same people and making sure that everything’s okay,” said Dr. Allison Messina, Chief of the Division of Pediatric Infectious Diseases at All Children’s Hospital.

And it’s going to take a lot more people getting it in order to achieve herd immunity.

“The science has been saying the same thing all along. You’re safest, if you can be vaccinated, to be vaccinated,” said Dr. Messina.

Dr. Sneed emphasized the mRNA technology has been studied for decades.

“A lot of people don’t know, but Moderna had a very effective Zika vaccine. It was 97 percent effective, but it never got beyond phase 3 because Zika went away,” said Dr. Sneed.

He says getting the vaccine will prevent long-hauler COVID-19 symptoms like brain fog, cardiac damage, and organ damage, among others.

“For me, it’s not just whether you live or you die, it really is about maintaining your quality of life,” said Dr. Sneed.

Full FDA approval of the vaccine will likely pave the way for vaccine mandates coming from places like the Department of Defense, health care systems, colleges and universities, among a list of others.

Moderna has also applied for full approval of their vaccine, but theirs is likely to come later as Pfizer submitted their application first.