No, Pfizer COVID vaccine approval wasn’t rushed — it was prioritized. What that means
First, skepticism regarding COVID-19 vaccines was based on the lack of full approval from federal health officials. Those who have been hesitant from the start didn’t want to take an “experimental” vaccine.
Now that the Pfizer-BioNTech shot is officially approved as of Monday morning, some people are claiming the review process was rushed, suggesting the vaccines are still not considered safe or effective.
The suspicions, in part, are true. The approval process was rushed, but not in the “let’s skim over thousands of documents and call it a day” kind of way.
The vaccine developers requested the review of their data be “fast tracked,” which the U.S. Food and Drug Administration accepted.
In other words, the FDA agreed to prioritize the analysis of Pfizer’s clinical trial and real-world data over existing work, such as meetings with other drug developers. It does not mean the review was rushed in any way — like assigning an intern to answer phone calls and file papers to open time for staff to complete daily tasks.
“We have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” FDA spokesperson Michael Felberbaum said in a statement, STAT reported.
The purpose of giving a certain drug or vaccine a “fast track” designation is to fill unmet medical needs, “defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.”
In turn, this leads to earlier approval and patient access.
The FDA does this by immediately prioritizing “early and frequent communication” with drug developers, in this case Pfizer and BioNTech. Other perks of a fast track designation include “rolling review,” meaning companies can send chunks of data as soon as they’re available, rather than waiting for all of it to be ready before submitting for review.
The standard approval process usually takes about 10 months, but the current situation the world faces is incomparable to traditional timelines, experts say.
Because we’re in a pandemic, there’s naturally more urgency to public health decisions. Second, there’s much more data than usual because millions of people have received the Pfizer vaccine in a short amount of time, meaning doctors and scientists have a much larger data set to study.
Some experts thought the FDA’s approval should’ve come earlier, especially given the spread of the more dangerous delta variant.
“We knew about Delta months ago … and that’s when we should have pulled out all the stops,” Eric Topol, the director and founder of Scripps Research Translational Institute, told STAT.
This story was originally published August 23, 2021 at 2:09 PM with the headline "No, Pfizer COVID vaccine approval wasn’t rushed — it was prioritized. What that means."
