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FDA Head Stephen Hahn On What's Next For Pfizer Vaccine In Fast-Moving Process

Dec 8, 2020
Originally published on December 9, 2020 1:23 pm

The Food and Drug Administration has found that there are "no specific safety concerns" that would stop the agency from approving the COVID-19 vaccine made by Pfizer and BioNTech for emergency use.

Career scientists at the FDA analyzed the data from the ongoing Pfizer trial to form their own conclusions about its safety and efficacy.

Stephen Hahn, who heads the FDA, says the public analysis is a "very, very important part of our promise to the American people that we won't cut corners in how we assess the safety and effectiveness of a vaccine."

Polling from November shows about 40% of Americans are hesitant to take one.

The FDA's findings come in documents posted Tuesday. Independent experts are meeting Thursday to advise the FDA on whether to approve the vaccine, which the FDA's analysis says is 95% effective — affirming Pfizer's findings.

Hahn talked with NPR's All Things Considered about where the vaccine approval process goes from here. Here are excerpts:

How much time do you think it would take to make an assessment about emergency use authorization?

So this will then go to the vaccine advisory committee. And we're expecting a good discussion there of the data that we're presenting to them. And then we believe shortly after that meeting we'll be able to make a decision.

A lot of what this depends upon is what the discussion is like [with] these outside experts from the vaccine advisory committee. If they have substantial questions or additional analyses that they think are relevant to our decision-making, we will judge whether that's important to do. That may need to be done and that may contribute to some additional time needed. But again, I can't prejudge what that conversation is going to be like.

You have made adjustments to the review process to try to guarantee safety, but ultimately you only have a few months of data. Does that shortened timeline concern you in any way?

So two months' follow-up data was required from a safety perspective. Remember also that we have data from the phase 1 and phase 2 clinical trials that were performed in the spring and the summer that gives us additional information about the vaccine, particularly with respect to safety. But one of the reasons that we chose the two-month period was because our data and others' data in the literature suggests that that time period captures the overwhelming a number of side effects that might be seen.

But really important for the American public to know, regardless of the medical product, whether it's this vaccine or any other medical product, we will always have a monitoring that occurs after an authorization so that if there are additional data that come in that we need to know about, particularly around side effects but also efficacy, we can incorporate that into our decision-making.

How can you be sure that there are no long-term side effects from this vaccine with only several months of data?

So even if you look at other vaccine approvals, the normal approval process, we can, as with any medical product, never 100% predict long-term side effects. That's why we have a vigorous post-authorization process for assessing both safety and effectiveness.

So I want to be really clear with the American people. This is expedited. We're not cutting corners in terms of our assessment. But we know that the work isn't done. If there's an authorization that's upcoming, we have to continue to monitor and to have surveillance.

We also need to balance. This is an important balance. We know that people are dying of COVID-19 and that prevention of COVID-19, if the data support it, is likewise a very important measure that needs to be instituted and the vaccine can help us with that potentially if it's authorized.

Sam Gringlas and Courtney Dorning produced and edited the audio interview. James Doubek produced for the Web.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

AILSA CHANG, HOST:

There are, quote, "no specific safety concerns identified that would preclude issuance of an EUA." That's the finding of the Food and Drug Administration on Pfizer's COVID-19 vaccine. The announcement comes a little more than two days before an FDA advisory panel will meet to determine whether or not the vaccine can be authorized for emergency use. Dr. Stephen Hahn is the head of the FDA. He joins us now. Welcome back to ALL THINGS CONSIDERED.

STEPHEN HAHN: Well, thank you, Ailsa. It's - I'm happy to be here and happy to answer questions today about this really important topic.

CHANG: Very glad to hear that. So this analysis that you released this morning also confirms what Pfizer has been reporting, which is that this vaccine is 95% effective after two doses. Let me ask you, how quickly do you think the FDA can make a decision about emergency use authorization?

HAHN: So we've been really clear about our process. We, of course, have done the scientific review since the application's been in our hands on November 20. And the conclusions that you just read are formed by our career scientists who look very detailed - in a detailed way as to safety but also the efficacy of the vaccine. They do their own analysis, look at subgroups of patients, look at immunity levels, if you will, after one versus two doses of this two-dose regimen, and then they come to their conclusions. And so that is a very, very important part of our promise to the American people that we won't cut corners in how we assess the safety and effectiveness of a vaccine.

CHANG: So how much time do you think it would take to make an assessment about emergency use authorization?

HAHN: So this will then go to the Vaccine Advisory Committee. And we're expecting a good discussion there of the data that we're presenting to them. And then we believe shortly after that meeting, we'll be able to make a decision. Also, a lot of what this depends upon is what the discussion is like at these outside experts from the Vaccine Advisory Committee. If they have substantial questions or additional analyses that they think are relevant to our decision-making, we will judge whether that's important to do. That may need to be done, and that may contribute to some additional time needed. But, again, can't prejudge what that conversation is going to be like or...

CHANG: Right.

HAHN: ...What is going to be raised.

CHANG: OK. Well, tell me; as more than 40% of Americans right now are expressing reluctance to get vaccinated, at least according to polling, how important is this to get this right?

HAHN: It is critically important, Ailsa, that we get this right. That was the reason that we've been transparent about the criteria we would use. It's why we have stringent criteria that are very similar to what we would use for a regular approval called a biological license application. And so following our processing process, giving our scientists the time to review the data, having the outside experts give us recommendations to the vaccine advisory committee, in our opinion, not only is this the right thing to do to get the decision right; it's the right thing to do in terms of transparency and confidence.

CHANG: That said, the approval process for this vaccine is moving faster than any other in memory. You have made adjustments to the review process to try to guarantee safety, but ultimately you only have a few months of data. So does that shortened timeline concern you in any way?

HAHN: So two months follow-up data was required from a safety perspective. Remember also that we had data from the phase 1 and phase 2 clinical trials that were performed in the spring and the summer that gives us additional information about the vaccine, particularly with respect to safety. But one of the reasons that we chose the two-month period was because our data and others' data and the literature suggest that the overwhelming amount of side effects - that that time period captures the overwhelming number of side effects that might be seen.

But, Ailsa, really important for the American public to know - regardless of the medical product, whether it's this vaccine or any other medical product, we will always have a monitoring that occurs after an authorization so that if there are additional data that come in that we need to know about, particularly around side effects but also efficacy, we can incorporate that into our decision-making.

CHANG: What about long-term side effects? How can you be sure that there are no long-term side effects from this vaccine with only a few months or several months of data?

HAHN: So even if you look at other vaccine approvals, the normal approval process, we can, as with any medical product, never 100% predict long-term side effects. That's why we have a vigorous post-authorization process for assessing both safety and effectiveness. So I want to be really clear with the American people. This is expedited. We're not cutting corners in terms of our assessment. But we know that the work isn't done if there's an authorization that's upcoming.

We have to continue to monitor and to have surveillance. We also need to balance. This is an important balance. We know that people are dying of COVID-19 and that prevention of COVID-19, if the data support it, is likewise a very important thing. It's a very important measure that needs to be instituted. And the vaccine can help us with that potentially if it's authorized.

CHANG: Finally, I just want to touch upon this. President Trump has made all of this very political, not least of which by saying that positive data about the vaccines was withheld until after Election Day. I'm curious. How do comments like that, this politicized atmosphere that you're all working under - how does that affect your ability to do your job?

HAHN: Well, Ailsa, I'm just so proud of our agency - 17,000-plus employees, great scientists, doctors, nurses, pharmacists. We have been and will continue to remain primarily focused on getting the job done for the American people. We represent the gold standard around the world from regulatory agencies using science and data. That was our promise. We're going to keep that promise, and we're doing that. So I told the agency lots of times, whatever else is going externally, we need to focus on doing our job and looking at the science and data. And, again, I'm really proud of our agency and our scientists because we have done that.

CHANG: FDA commissioner Dr. Stephen Hahn, thank you very much for joining us today.

HAHN: Thanks, Ailsa. Transcript provided by NPR, Copyright NPR.