FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020

Aug 5, 2020
Originally published on August 5, 2020 6:10 pm

In June, the Trump administration introduced Operation Warp Speed, an initiative to deliver 300 million doses of an effective COVID-19 vaccine by January 2021.

On Fox & Friends Wednesday morning, President Trump said the effort to accelerate the development, manufacturing and distribution of a vaccine for COVID-19 is making good progress.

"I've streamlined the process," the president said. "This would have taken three, four years to be where we are right now. And we're going to have one, I believe, long before the end of the year."

This comes with elections just months away and as the virus continues to spread across the United States. More than 4.7 million people in the U.S. have tested positive for the virus, more than in any other nation, and more than 157,000 people have died.

Dr. Paul Offit, a professor at the University of Pennsylvania who serves on a panel advising the Food and Drug Administration, tells All Things Considered that he's cautiously optimistic for the future of an effective COVID-19 vaccine but that he doesn't think one will be ready before the end of the year.

Here are excerpts of the conversation.

Does it seem realistic to have a vaccine before the end of the year?

No, it doesn't. As it stands right now, the vaccines that we've been talking about, which are two-dose vaccines, those phase 3 trials — meaning large, prospective, placebo-controlled trials — just started.

You wrote an op-ed for The New York Times in June and expressed some concern that the president could announce a vaccine prematurely. Do you think the administration has been racing ahead too quickly?

The way this process has worked so far is fine. As long as you do a phase 3 trial, then you have proven that the vaccine is safe, at least in, say, 15,000 or 20,000 people, and that it's effective at least for a certain length of time, which is reasonable. That's as big as many vaccines trials are.

What you don't want to have happen is you don't want the administration to reach their hand into the "warp speed" bucket, where there are tens of millions of doses, pull out one or more vaccines and say, look, it's been tested in a few thousand people, we know it induces an immune response without knowing whether or not it's effective, and then putting it out into the American public. That would be a mistake.

What could happen?

Well, what could happen is that the vaccine is far less effective than you think it is, in which case you've shaken what is a fragile vaccine confidence in this country, or that it has a safety problem that would have been picked up in 15,000 or 20,000 people but wasn't picked up in only a few thousand people.

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STACEY VANEK SMITH, HOST:

The Trump administration has dubbed it Operation Warp Speed. That is the initiative to develop a coronavirus vaccine. With more than 156,000 Americans dead and a presidential election months away, the president is eager to highlight progress. On "Fox & Friends" this morning, President Trump said the development of a vaccine for COVID-19 is making good progress.

(SOUNDBITE OF TV SHOW, "FOX & FRIENDS")

PRESIDENT DONALD TRUMP: I've streamlined the process. This would have taken three, four years to be where we are right now. And we're going to have one, I believe, long before the end of the year.

VANEK SMITH: Our next guest has insight into both the science and the politics behind the race to find a COVID vaccine. He is Dr. Paul Offit, a professor at the University of Pennsylvania who serves on a panel advising the Food and Drug Administration on whether to recommend if a vaccine is licensed. Dr. Offit, welcome to the program.

PAUL OFFIT: Thank you.

VANEK SMITH: So first off, let me just ask you to comment on the president's assessment on "Fox & Friends." What did you think of it?

OFFIT: Well, in part, he's right. I mean, the administration basically sped up this process by taking the risk out of making a vaccine for pharmaceutical companies. Typically, pharmaceutical companies go slowly from preclinical trials to Phase 1 dose-ranging trials to Phase 2 trials, which involve hundreds of people, to Phase 3 trials, which involve tens of thousands of people. And at each step, it costs logarithmically more money when you go from millions to tens of millions to hundreds of millions of dollars. What the government did was basically by saying, look; we'll pay for the Phase 3 trials, we'll pay for manufacturing, they took the risk out of it for pharmaceutical companies, which made this a much faster process.

VANEK SMITH: Having a vaccine before the end of the year, does that seem realistic?

OFFIT: No, it doesn't. I mean, as it stands right now, the vaccines that we've been talking about, which are two-dose vaccines, those Phase 3 retrials, meaning large, prospective, placebo-controlled trials, just started.

VANEK SMITH: A two-dose vaccine just meaning, like, you'd have to get two shots or two doses of the vaccine.

OFFIT: That's right, two separate doses separated by a month apart. So if you start these trials now, let's assume that people will get their first dose in August because they're not going to all get it on day one, either vaccine or placebo. And then they get their second dose a month later, which is September. It takes a couple weeks after that second dose to sort of get the - ramp up the immune response to where you want it to be. So now you're already talking about the middle of October, and then you have to have in your placebo group a representative number of people, either around 150 to 200, who are sick, meaning who have moderate to severe disease. I just don't see that all happening by the end of October, which is what the president occasionally says.

VANEK SMITH: Now, you wrote an op-ed for The New York Times in June, and you expressed some concern that the president could announce a vaccine prematurely, kind of in light of that campaign coming up. Do you think the administration has been racing ahead too quickly still?

OFFIT: Well, so the way this process has worked so far is fine. I mean, as long as you do a Phase 3 trial. Then you have proven that the vaccine is safe at least in, say, 15 or 20,000 people, and that it's effective, you know, at least for a certain length of time, which is reasonable. I mean, that's as big as many vaccine trials are. What you don't want to have happen is you don't want the administration to reach their hand into the Warp Speed bucket where there are tens of millions of doses, pull out one or more vaccines and say, look; it's been tested a in few thousand people. We know it induces an immune response without knowing whether or not it's effective and then putting it out into the American public. That would be a mistake.

VANEK SMITH: What could happen?

OFFIT: Well, what could happen is that the vaccine is far less effective than you think it is, in which case you've sort of shaken what is a fragile vaccine confidence in this country, or that it has a safety problem that would have been picked up in 15,000 or 20,000 people but wasn't picked up in only a few thousand people.

VANEK SMITH: COVID-19 has taken a disproportionate toll on people of color. I know that at least one potential vaccine is in a Phase 3 clinical trial now. Have the trials been sufficiently diverse?

OFFIT: Don't know. I mean, that's certainly the recommendation. I mean, the public, nor, frankly, people who are even on the inside in this are not going to know that. The only people who really are going to know as this rolls out are the people that are constructing the trials, and then the data safety monitoring board. But that is the recommendation, so I am - I fully believe that we will have those subgroups adequately represented.

VANEK SMITH: Dr. Paul Offit is a member of the Food and Drug Administration's vaccine advisory panel.

Thank you, Dr. Offit.

OFFIT: Thank you very much. Transcript provided by NPR, Copyright NPR.