It’s officially official — Pfizer’s COVID-19 vaccine has been given the seal of approval from The Food and Drug Administration.
“This is the kind of end-stage for the FDA,” said Dr. Michael Teng, a USF Health Associate Professor of Medicine. “This means it’s safe, it does exactly what it's supposed to do, we’re good with this now, Pfizer can go and market this.”
The approval process usually takes years, but this took a little more than 3 months. The FDA said it was, “an unprecedented timeline given the volume of review and meticulous manner in which it was done.”
But, it also underscored that did not compromise scientific standards or the integrity of the process.
So what is the process? How did we get from emergency use to full approval?
Let’s go back to January 2020 just as the world began to see the scope of the crisis, the sequence of the virus was made public which allowed scientists the ability to work on a potential vaccine.
“It’s basically plug and play,” said Dr. Teng. “You plug in the sequence, you do a couple studies and analyze to make sure it’s still working, and then you tell the FDA you have all this clinical data. In 60 days they got the pre-clinical data necessary to get the FDA to approve a phase 1 trial.”
The FDA requires three clinical trial phases. The 1st includes 20-100 healthy volunteers. It looks at safety, effectiveness, serious side effects, and if the size of the dose is related to the side effects.
As you move into phase two, you’ve got several hundred volunteers and it looks at the most common short-term side effects and how well those volunteer's Immune systems are responding to the vaccine.
The final phase takes hundreds of thousands of volunteers and compares them to people who have not received the vaccine to see the difference. It also looks again at the safety, effectiveness, and most common side effects.
“You wanna do the phase 1 trials, then stop and look then do the phase 2 trials, stop and look, phase 3 trials, get approved start manufacturing. In a global pandemic you don’t have the luxury of time,” said Dr. Teng.
It’s why he says all of that happened at the same time Pfizer manufactured the vaccine, so if and when FDA approved it for emergency use, it could be immediately deployed.
The FDA requires a six-month safety monitoring period that can not be sped up. This began in October 2020.
In May of 2021, Pfizer handed all of its data over to The FDA and the final approval process began.
“We don’t just look at what the summaries of the data are, we go down to the level of the individual patient,” said Dr. Peter Marks, the Director at the FDA Center for Biologics evaluation and research. “What took time is that we actually go and monitor a percentage all of the sites where the clinical trials were conducted in order to make sure the data that was collected was collected accurately and that was what was submitted to the agency.”
Inspectors also go to facilities to make sure the vaccine meets high-quality standards, that it is safe and effective and the benefits outweigh the risks.
On top of a company’s analysis, the FDA does its own on adverse effects, and efficacy data. It also does a benefit-risk assessment based on real-world data. Dr. Marks says their team worked day and night to speed up the process and are confident in the vaccine.
They are urging people to get it now.