One of the reasons that people who are reluctant to be vaccinated for Covid 19 often mention is that the vaccines aren’t FDA approved. That is correct. Why? The short answer is PAPERWORK. This is an article in a prestigious medical journal, USA Today, which explains the Herculean process of getting a drug or a vaccine approved by the FDA.
USA TODAY spoke with Dr. Peter Marks of the U.S. Food and Drug Administration, who has played a key role in nearly every major vaccine-related decision since the country’s coronavirus outbreak began.
He discussed the differences between emergency authorization and licensing, why the process takes time, and what he hopes to do once this is all over. Marks’ answers were edited for length and clarity.
What’s the difference between EUA and a license granted using a Biological License Application?
Emergency use was developed to be a relatively flexible process that would allow us to adapt to a variety of different types of natural emergencies, be they biologic, chemical or radio-nuclear, so it’s pretty flexible. The known potential benefits have to outweigh the known potential risks.
What came in (with the emergency authorization vaccine application) was the data from patients who had been randomized to receive the vaccine with about two months of median follow-up data. Once you have a biological license application, what comes in are the longer-term follow up data, so six months or so. Suddenly, what was a more limited data package becomes a much larger data package.
How much bigger is a BLA application?
It’s hundreds of thousands of electronic pages of data. I was actually around when we used to send off the applications on paper. You would fill a whole UPS truck with paper.
Why does it take so long for full approval using the BLA?
We are somewhat unique in the United States in that we review every last page of what comes into us, every patient, every table is reviewed, accuracy is reviewed. It takes time to do the high-quality review that people have come to depend on FDA for.
Is manufacturing also part of the approval process?
Yes. We require three conformance lots. That means the manufacturer shows that they can make something exactly the same way three times over.
When can we expect the first COVID-19 vaccine license?
It’s very hard to say exactly when. FDA has said the Prescription Drug User Fee Act goal date (to complete the process) is January of 2022. That’s basically a commitment letter that says we will get it done by then. I’m happy to offer that we intend to be long since done with this by then.
Why does a license rather than an EUA matter to physicians?
Once a product is approved, it can be used according to practice of medicine. That means that it can be used on-label and potentially off-label. Not that we’re recommending off-label uses, but there is a broader potential use of that product. So when we give something a biologics license, we are really saying that we have a lot of confidence in that product, in the safety, efficacy and manufacturing information. Not just when it’s used exactly according to how it’s labeled, but potentially if it were used somewhat differently by physicians.
Why does a license matter to the public?
Many people feel more comfortable getting a licensed product because an emergency use authorization is making available a product that’s approved in an emergency situation. A licensed product is saying that we have put our imprimatur on something that FDA approved. We want to allow people to have the opportunity to choose to get a licensed vaccine, for those who feel that that’s what they need to be able to make the decision to get vaccinated. Once we have the approval, hopefully we’ll have that increase in confidence.
If Pfizer’s COVID-19 vaccine receives a license, will that speed up the process for the other vaccines?
Each application stands on its own. But efficiencies that we have developed in a product class or in how we go about the process of doing the review, we will certainly be applying them to each successive application.
The federal government says the vaccines’ emergency status doesn’t prohibit employers or others from requiring inoculations. If that’s the case, why does it matter?
There are certain states as well as certain organizations like universities I’ve heard from that despite (the Department of Justice statement) are hesitant to do so until there is an approved vaccine. Once there’s an approved vaccine, we are aware of entities that will then make vaccine mandatory.
The three vaccines still need to go through the full licensing process. When will you get to take a vacccination?
I’m planning my next summer vacation. I’m thinking about someplace in Maine where there’s not a lot of cellphone coverage.
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I hope this clarifies this issue. Scratch this off the worry list and get vaccinated. In the meantime, wear a mask when you can’t socially distance.