番茄社区

In this video interview, Paul Offit, MD, of Children's Hospital of Philadelphia and a member of FDA's Vaccines and Related Biological Products Advisory Committee, reflects on the FDA's communication around the COVID-19 vaccine and how it could have led some people to mistrust "the greatest medical accomplishment" in his lifetime.

The following is a transcript of his remarks:

In December 2020, we had available to us mRNA vaccines. The process by which that was done so quickly was something called Operation Warp Speed.

We isolated and sequenced SARS CoV-2 virus by January of 2020. By sequencing it, we now could make a vaccine. Eleven months later, we had two large clinical trials: one 40,000 persons big for Pfizer's trial and about 30,000 for Moderna's trial. Those are the sizes of any typical adult or pediatric vaccine [trial].

That's amazing. That was amazing. I mean, you have this virus, SARS CoV-2, which had unusual biological characteristics, had unusual clinical characteristics, which we met with the technology of messenger RNA that we had never used to make vaccines before. I think it was the single greatest scientific or medical accomplishment in my lifetime, and I'm old enough to have lived through the polio vaccine. So, I think this was remarkable.

Unfortunately, we chose to call it Operation Warp Speed, which I think scared people because of the fact that it was made so quickly and then was given a name that implied speed. Warp speed, for those of you who watched Star Trek, meant speed faster than the speed of light. The person at the FDA who was associated with this program gave it that name because he was a Star Trek fan. But I think when people hear that, they're concerned that there may have been critical phases of development that were truncated, or worse, that there were vaccine safety guidelines that were ignored -- none of which was true.

So, I think it was an unfortunate name. I wish we'd called it something like "Operation Defeat COVID." But in any case, it's too bad that we had chosen that name because I think it sort of took away from how amazing this event was.

The second thing was -- actually we, the FDA Vaccine Advisory Committee, discussed this in December of 2020 -- the use of the term "emergency use authorization." The term "emergency" also suggested that things were being done drastically differently than they would if it was a licensed product. So much so that you had people like Ron Johnson, who's a Republican senator from Wisconsin, or Tucker Carlson when he was on Fox News, or Robert F. Kennedy Jr. saying, "I'm not getting this vaccine. I'm not getting the emergency authorization vaccine. I'm going to wait until it's licensed."

It was the same product. It was the exact same product. The way that the FDA usually licenses a vaccine is a three-part process. The first is that you license the product. The second is that you license the process by which the product is made, which is to say you go through all of these protocols from beginning to end about how the vaccine is constructed. And then thirdly, you license the building.

Well, that was all done in real time. That was all done during that 11-month period, so nothing was skipped. It was the same product. And there were many of us actually on the FDA vaccine advisory committee that wanted to drop the word "emergency" and just call it "authorization," but that didn't happen.

In any case, we should be reassured by how remarkable these mRNA vaccines were, given how quickly we had to make them. I mean, you had a thousand people dying a day, 2,000 people dying a day, 3,000 people dying a day. And when you have that kind of pressure, mistakes can be made. But mistakes weren't made. I would argue that some of the labeling in retrospect could have been less frightening, but it's always easy in retrospect.

Comment