Transcript for 'I feel very confident about the decision we made' on vaccine: FDA commissioner
vaccine Friday night, fda [ commissioner Dr. Stephen Hahn. Dr. Hahn, great to have you with us as always. We have heard again and again those first shots of the vaccine 48 hours. So paint us a 0r we'll see in the coming days. So fda does not have a e1 primsponsibility in the allocation of distribution, and we know that "Operation warp speed" and health and human services and the CDC have been working very closely with the states. One thing we did when it wxde1 clear that we were going to authorize the vaccine is to -- to communicate with those xd partners, with those folks in government and outside of government, obviously pfizer, e1 about our decision so they could begin the process of distribution, and I think we've seen in the press that the vaccines are rolling out as we speak to get to loca ejp)ound the country, and then the statesw3 will operationalize that, and vaccines will be administered. Martha, one key part about this is the letter of authorization and conditions of use the fda put out, really does need to be detailed as much as possible and driven by the data, which is why we took the time to look at thatok application and make sure we e1 could answer questions from t(e1e1 providers and people who receive the vaccine. The development and manufacturer of the pfizer vaccine has really been tru extraordinary, but this initial batch doesn't come close to ok covering even the estimated 21 million heale workers, 3 million in long-term facilities, who are at the top of the list to receive it. So how soon will they be covered?e1e1 So I am aware that many in U.S. Government are working very closely with pfizer and other developers to try to get as much out there as possible.e1 we at fda, what we're doing is we're working in terms o9hp &H% sure the supply chain for the precursors, and everything we can do to expedite, we will do that. It's an all hands on deck approach to get to the numbers.r[ [ we're going to need to get to herd immunity. So at what point can the general population receive a vaccine?t( how does that work?i do people call up Walgreens? Do you call up cvs?5a do you call your doctor?e1 So we're going to see that play out over the next couple of weeks. Obviously with the supply that we have right now, it's going to likely be a targeted approach based upon the recommendations from the acip, that committee that helps with those recommendations, and what the states prioritize. So -- I think I'd be onl3f speculating on how that would happen in individual states, bute1t( you can imagine through hospitals and et cetera, there would be the identification of those, who had been prioritized based upon the recommend days as well as the state's prioritization.e1 Let's talk about this. The uk is advising people with severe allergies not to get the pfizer vaccine. What do you advise, and is there anything that gives you pause at all?e1 So Martha, again, this is why we do a line by line assessment of the data, .r on't know if you saw any of the advisory committee public discussion of this, but we did not see within the clinical trial, significant allergic reactions among the subjects of the trial. However, that was seen in the uk rollout and distribution. So what we said, first of all, we're taking this very xd seriously. The safety is very important.lp we put in our label that those who have any evidence of severe allergy to any component of this pfizer vaccine should not receive it, however, we also outxd of an abundance of caution have asked the distribution sites, belpe1 available those medicines that might be available to address it.e because of the clinical trial data, the riski appears to be f low, but we have to be very careful about this, and make sure wec=#ujj appropriately. And I want to talk a little bit about the skepticism about the vaccine. No matter how many times you talk about it being safe, dy -- despite the assurances, many in the u.s.7oo continue with a recent poll shows between one quarter and one-third of Americans do not want to receive a shot. What kinds of problems do those numbers present? Martha, that is a significant problem. If you think about how we get out of thysm95% continue our mitigation effort right now. That is so important, mask wearing, et cetera, but the way we see light at the end of the tunnel, the way we get through e1 this is to achieve herd to vaccinate a significant number of people in this country, including those who are their fears and concerns. Eed to roll this out in a way that provides confidence to people, but we also need to be transparent.jf what do we know? What do we not know? And our process, they S our contribution of the w3 transparency. We want the data to be known. We wanted that advisory committee to b(8%u we wanted everyone in America, around the world frankly to se what information was available, w3e1 and why we made the judgment we made about the safety and efficacy of the vaccine, and as xu can see, the experts on the panel also gave with their vote a thumbs up to that authorization process as well. So I think that level of transparency and information helps us. Dr. Hahn, I want to go back to the approval that you talked en president trump tweeted at you last Friday, get the damn vaccines out now, I know you have said that you were V threatened with being fired, but did chief of staff mark meadows call you and say, hurry up? So we have, from E beginning, Martha, said that the only thing that's going to matter in this is the science T( and data, and of course -- of course, we have been asked to speed this process as much as possible. So this did happen Friday? The president has now said he did push you and it could have been out a week earlier. Is that true? We do not feel his could have been week V earlier.@ we promise, Martha, the American people that we would do a thorough review of the application, and that's what we we followed our process.e1i Thursday evening after the vaccine advisory committee meeting made our decision to go forward, but we had to continue our discussions with the sponsor and we put out a statement early Friday saying we were moving lpe1 forward with this authorization with the sponsor. That was early Friday morning, and then we probtq"ed to do that thuou $u$e day. That is the urgency of situation that we felt, and we did this on behalf of the American people. Just qu1e9 mark meadows said what ,o]e=uk&%m have to resign? So again, I'm not going to e1xde1 uss individual conversations. We were encouraged to move quickly, and we were already moving quickly, and I feel very confident about the decision we Okay. Thanks so much for joining us this morning, Dr. Hahn.w3 always great to see you.
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