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FDA Panel Meeting to Consider Authorization for Pfizer Vaccine; Poll Shows 63 Percent of Americans say They're Willing to Get a COVID- 19 Vaccine; Stimulus Talks Stall as Millions Desperate for Relief. Aired 10-10:30a ET

Aired December 10, 2020 - 10:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


[10:00:00]

JIM SCIUTTO, CNN ANCHOR: Well, a very good Thursday morning to you. I'm Jim Sciutto.

POPPY HARLOW, CNN ANCHOR: And I'm Poppy Harlow.

This is happening right now. An FDA panel is meeting to decide whether they'd give emergency use authorization for Pfizer's COVID-19 vaccine. It is a huge step in this pandemic. And listen to this from just a few moments ago.

(BEGIN VIDEO CLIP)

DR. DORAN FINK, DEPUTY DIRECTOR, FDA DIVISION OF VACCINE: The American public demand and deserve a rigorous, comprehensive and independent review of the data. And that's what FDA physicians and scientists, all of us career public health servants, have been doing over days, nights, weekends, and, yes, over the Thanksgiving holiday.

(END VIDEO CLIP)

SCIUTTO: That meeting, of course, taking place remotely, like so many meetings now due to the pandemic and it's happening one day after this nation saw its deadliest day so far in the entire pandemic, including the spring.

Let's get right to CNN Senior Medical Correspondent Elizabeth Cohen. So, Elizabeth, what data do they look at and what markers does a vaccine need to meet to get approval?

ELIZABETH COHEN, CNN SENIOR MEDICAL CORRESPONDENT: Jim, what they look at simply is, does this vaccine work and is it safe. And we've talked about that data before on this show and, really, the FDA is going to be looking at that data. So in simple, boiled down terms, let's talk about what that data looks like.

That data, so far, looks like the vaccine is 95 percent effective, based on a clinical trial of more than 40,000 people. There were frequent side effects, fatigue, achiness, fever, et cetera, but they lasted about a day and went away, there were no serious side effects. That is really much more than anyone had ever asked for. They were looking for 70 percent, maybe 80 percent effective, if we were lucky, and instead they got 95 percent effective.

Now, having said that, there may be some people who should not get this vaccine. So let's take look at who it was not studied in, because if it wasn't studied in them, maybe they shouldn't be getting it. So, children under the age of 16 perhaps should not get this vaccine because, well, it hasn't been studied in them.

Also unclear if the vaccine is safe for pregnant women, breast-feeding mothers, people who have diseases that leave them immunocompromised and people who, in the past, have had severe reactions or allergies to vaccines. So there are going to be some questions about whether or not those folks should get this vaccine. But all in all, it is expected this group will green light this vaccine.

Now, this is an important note. The FDA has already looked at this data. This group, this is a group of experts from outside the FDA. These are university professors, these are medical doctors who work in academic research centers, and the FDA called them in to say, hey, we want you to look at the data as well to basically back us up. Jim, Poppy?

HARLOW: If it gets that authorization today, Elizabeth, when do you think people will actually start getting the shots in their arms?

COHEN: It actually, Poppy, likely will not get the authorization today. They may get the green light from this committee saying, yes, we think this is good, we think you're good here, but there will still be some more work to be done. So when you put all that work together that the FDA has to do, that the CDC has to do, we could see shots going into arms in just a matter of days or maybe a week. It could happy quite quickly.

SCIUTTO: Yes. Well, anticipation understates it. The country awaits. Elizabeth Cohen, thanks so much.

HARLOW: Well, this is all coming, and this is good news it's coming, but it's coming amid horrible news that the U.S. has recorded a record number of COVID deaths again and hospitalizations hit an all-time high again. All eyes are on this FDA meeting today hoping for some light at the end of this tunnel.

SCIUTTO: But if the authorization goes through, there is another hurdle, that is simply a logistic one, getting this vaccine to hospitals to millions, tens of millions of people across the country. CNN's Alexandra Field goes to a New Jersey hospital to see their rollout plan.

(BEGIN VIDEOTAPE)

ALEXANDRA FIELD, CNN CORRESPONDENT (voice over): Intensive care units in some hospitals running out of space this morning, the result of an alarming surge in new coronavirus cases in many states. For the first time, the United States reported over 3,100 coronavirus related deaths in one day.

DR. JONATHAN REINER, CNN MEDICAL ANALYST: It's going to get worse. Our case counts are continuing to rise.

FIELD: More than 106,000 people are hospitalized with the disease, a record. In California, there are only around 1,500 ICU beds available within the nation's most populous state. The Los Angeles County Health Department says there are around 500 new hospitalizations daily and that will only increase.

BARBARA FERRER, LOS ANGELES COUNTY PUBLIC HEALTH DIRECTOR: This is the most dangerous time for L.A. County. And I do ask everyone to please be extremely careful and diligent in protecting yourself and everyone else.

FIELD: This as the U.S. recorded over 221,000 new infections Wednesday. Some state and local leaders tightening stay-at-home restrictions.

[10:05:00]

GOV. KAY IVEY (R-AL): The facts are indisputable. Our cases continue to rise.

MAYOR BRANDONG SCOTT (D-BALTIMORE, MD): COVID doesn't care how you want to go back to normal. It is actively looking to infect us all.

FIELD: In just hours, the first vaccine could clear a hurdle for distribution in the United States. An FDA panel is scheduled to meet today to discuss whether to approve Pfizer's candidate for emergency use authorization. They're also investigating why two health care workers in the U.K. had allergic reactions to that vaccine.

DR. JAMES HILDRETH, MEMBER, FDA ADVISORY BOARD: Pfizer and the U.K. health officials are going to pinpoint exactly what it is in the vaccine formulation that caused that allergic reaction. This is not a major concern. They're going to sort out what it is and make sure that folks allergic to it do not get the vaccine.

FIELD: At this point of the crisis, health experts emphasizing it will take many months to make a vaccine available to the general public.

RICK BRIGHT, BIDEN COVID-19 ADVISORY BOARD MEMBER: So, we want to make sure that everyone is doing everything they can to wear their face masks and reduce the spread of the virus.

FIELD: And for those hesitant to take it, Dr. Anthony Fauci is stressing there are no corners being cut in the approval process.

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: If the United States Food and Drug Administration says that a vaccine is safe and effective, I can promise you that I will take that vaccine myself and I will recommend that my family does that.

(END VIDEOTAPE)

FIELD (on camera): And as we all wait for that emergency use authorization, states across the nation are getting ready to get that shot into people's arms. The site we're at in New Jersey is one that will be used to vaccinate the general public. Of course, that won't happen until the vaccine does get authorization and until frontline medical workers get access to those critical first doses first.

But the big lift ahead of us is also for public health officials to convince the public that that vaccine is safe. A recent Quinnipiac survey says just 61 percent of respondents are likely to get the vaccine. Dr. Fauci says we'll need 75 to 80 percent in order to bring us anywhere close to, quote/unquote, normal perhaps by the second quarter of 2021. Jim, Poppy?

SCIUTTO: The good news, I suppose, is that in the public polling, those figures are going up at least but certainly still a lot of work to do. Alexandra Field, thanks very much.

CNN's Frederik Pleitgen, he is outside the Pfizer and BioNTech headquarters in Germany. Frederik, they've done a lot of work here, they're basically first out of the gate. What's the mood there this morning?

FREDERIK PLEITGEN, CNN SENIOR INTERNATIONAL CORRESPONDENT: Well, they're obviously a bit very excited, Jim. And, of course, they're eagerly watching that experts meeting that's going on in the U.S.

And one of the things that the CEO of BioNTech told me a couple of days, he said, look, he's so confident in the trial data. He believes that it's so good that he does thinks that that emergency use authorization could happen fairly quickly. He also said that from some of the conversations that they have been having with the FDA as well, they are also fairly confident that it could happen quite quickly.

And on the whole, I've been speaking to BioNTech over the past couple of months a lot. And they said that the development process of this vaccine was about as smooth as could be. We just heard some of the numbers from Elizabeth Cohen, 95 percent efficacy, much better than they initially would have thought. They were aiming for possibly getting 50 percent, that will serve their lowest benchmark, and yet they achieved 95 percent. That was huge.

Efficacy across all age groups also a major factor for them. They achieved that as well, also people with different ethnicities, also big efficacy there as well. So, so far, they say the process has been working very well.

And one of the other things that BioNTech has also been doing as it seemed to become more clear that they could get this emergency use authorization, also, of course, some approvals in some other countries as well, they have been scaling up their production. They actually, recently bought another production plant here in Germany to achieve what they want to do with Pfizer next year, is making 1.3 billion doses across all of 2021 just to make sure that folks in the U.S. but, of course, in other countries as well get that vaccine as fast as possible to make sure that a lot of people can get their shots. Jim?

HARLOW: Okay. A big day there as well, as you said. Fred, thanks so much for the reporting.

We are on top of all of this news coming out minute by minute from this FDA meeting. Also, the pandemic has devastated businesses across the country. You see it in all the layoffs. But today, a comeback story for a big company, Airbnb making their debut on the stock market. We'll talk to the CEO about how on earth did they turn things around.

SCIUTTO (voice over): And millions of Americans are set to lose their unemployment benefits in just days. So where is the stimulus deal they've been working on for weeks, for months? I'm going to ask a Democratic senator, as talks stall.

(COMMERCIAL BREAK)

[10:10:00]

SCIUTTO: All right. So, progress on the pandemic. Happening right now, this meeting, the FDA's advisory committee meeting to discuss Pfizer and BioNTech's COVID-19 vaccine. They're talking about approval and, of course, Poppy, they're doing it remotely, like so many of us these days because of the pandemic.

HARLOW: Exactly. At the same time we have devastating news, learning that more Americans have died than any other day, that happened yesterday. From the vaccine -- but some encouraging news on the vaccine is that more people sound like they're willing to take it once it is approved. There's a new poll from Gallup and it shows 63 percent of people say they would get the vaccine. That's up from 58 in just October.

With us to talk about all of this is the former FDA commissioner, Dr. Peggy Hamburg. Good morning. We're so glad we have you.

I mean, you know how this stuff works. So, the meeting that is happening today, if the vaccine gets authorization, Doctor, by the end of today, when would you realistically expect Americans to start getting the shots?

[10:15:01]

DR. MARGARET HAMBURG, FORMER FDA COMMISSIONER: Well, it is a really important day, a historic day, as less than a year after this new virus and disease was first being recognized, we actually have a vaccine candidate that looks like it has enormous promise in terms of safety and efficacy.

The meeting today is an advisory board meeting. It means that external, outside, independent scientists will be looking at and discussing the data and analysis with the FDA scientists and the company scientists, and it will all be in an open public forum and critical questions can get asked and hopefully answered.

The FDA will then take back the information from today's discussions and discuss it further within their own ranks. And I imagine that, very quickly, they will make a decision about whether to authorize this emergency use.

But that's not the task for today. The advisory board will make a recommendation to the FDA but it's only a recommendation. The FDA will be making their actual approval decision very shortly thereafter.

SCIUTTO: Dr. Hamburg, I wonder when approval comes, it does appear likely, are we sadly going to continue this tale of two countries that we have right now? Because we have bubbles, right, fairly persistent bubbles where there's a portion of the country that believes the disinformation that this virus is not as serious as the doctors and the experts like you say. Could that lead to consequences in terms of the rollout and acceptance of this vaccine, right?

I mean, we have got the White House holding maskless Christmas parties right now. I mean, you have that fact out there. Will that be a major impediment to the success of a vaccine?

HAMBURG: Well, there's a lot to worry about, and this next period is going to be absolutely essential to our health and the ability to make the opportunity of this vaccine real. You can have the world's most safe and effective vaccine, but if people don't take it, it won't make a difference in controlling this devastating epidemic.

So, first, we have got to get it distributed. There's not going to be enough vaccine. Initially, we're going to have to target priority groups. That's going to be very hard. And states have a lot of responsibility in terms of making determinations about who's going to get it, in what order and making sure that the supply chain works to get the vaccine to the people who need it.

Then you've got the issues of tracking people to make sure they get their second dose of vaccine because at least this vaccine requires two doses to reach the level of efficacy that is reported. And then you do have to have people who have trust and confidence in the vaccine. They have to be willing to take it. They have to understand why it will make a difference for them and their family and their community and their country.

And we've got to make sure that we're talking in clear, understandable ways to all the different communities at risk for this terrible disease. We have to make sure that it's not just government officials and people in white coats, also that it's people meaningful to them that are talking to them about the vaccine.

So we really have to have an organized campaign to engage people about taking the vaccine. We have to make sure that it's available to all communities and accessible. And we have to really make sure that as the administration shifts from the Trump administration to the Biden administration that there is a seamless pass off of both information and activities.

SCIUTTO: Yes. Well, listen, in that vein, right, it's good to see, for instance, former presidents, Clinton, Bush, Obama, saying, hey, they will be first in line for this vaccine to help increase that confidence. Dr. Peggy Hamburg, we appreciate the work you do and the expertise you're sharing with our audience. HAMBURG: Thank you.

SCIUTTO: Well, despite millions being desperate for relief, stimulus negotiations appear to be falling, that's right, falling apart again on Capitol Hill. One Democrat brought in to help with those talks, Senator Bob Menendez, he joins me next. We'll get an update on everything.

(COMMERCIAL BREAK)

[10:20:00]

SCIUTTO: This just in to CNN. New reporting, the Department of Defense is planning to withdraw most support for CIA counterterror missions around the world starting next month. The changes involve returning Department of Defense personnel detailed with the CIA, as well as military equipments, such as Predator drones. Acting Defense Secretary Christopher Miller informed CIA Director Gina Haspel of the decision this week. My colleague, Ryan Browne, and I are told the CIA and Pentagon have not yet responded to CNN's request for comment.

The move has sparked strong opposition from many deployed CIA operatives.

[10:25:02]

It is also the latest major policy change during the transition since the president initiated a major personnel shakeup at the Pentagon following his loss to Joe Biden.

Well, also this morning, another story we're following closely, stimulus talks appear to be stalling at best on Capitol Hill. The focus remains on unemployment benefits, aid for small businesses, as well as other targeted assistance, still some major issues out there.

I'm joined by one of those senators negotiating, New Jersey Senator Bob Menendez. Senator, thanks so much for taking time this morning.

SEN. BOB MENENDEZ (D-NJ): Good to be with you, Jim.

SCIUTTO: My colleague, Lauren Fox, reporting that the talks are falling apart this morning. You've been taking part. Are they dead?

MENENDEZ: Well, no. I think they are at a critical juncture and I've been taking part particularly on the state and local issue with five other Republicans and Democrats. But there are some critical issues.

And the real question here is whether Senator McConnell really wants this bipartisan group to even get past first base. There's many members of his caucus who have said they don't think we need to vote for anything more, and that puts him at a disadvantage in terms of a negotiation. And so this bipartisan group is trying to move forward to create a foundation. There's a lot of commonality.

The questions come down, really, as I see it for two separate issues, state and local and liability questions. And even there, I thought there was some good progress being made.

SCIUTTO: Now, that group has seemed to be willing to do some horse trading there, but Mitch McConnell has proposed a plan that strips that out in effect. Would you, would your colleagues vote for a plan that leaves those issues aside, state and local funding, liability protections and just gets money into the pockets of Americans that need it now?

MENENDEZ: Well, of course, we want to see those things that you have said, those who need it now. But you know what, the states also need it now, not about the states being amorphous. What is this for? This is for the very people who are helping us in the pandemic, public health nurses, police, firefighters, emergency management coordinators, ambulance corps.

At this rate we've lost a million of them. Moody's says we will lose 6 million more in the height of the pandemic, the people we need the most. We need them to be on the frontlines, not on the unemployment line. And that's why that's so important.

SCIUTTO: I want to move on to the administration's latest court challenge to the election. This now, another case, which the president has involved himself personally in, brought by a number of states attorneys general to throw out millions of votes in several other battleground states. Your colleague, Ted Cruz, has even volunteered to argue the case before the Supreme Court. Your reaction to this.

MENENDEZ: Well, I cannot imagine that the Supreme Court would disenfranchise millions of Americans and their votes by such a decision. This is the most fraudulent case I've seen brought before the court.

You know, there's an old adage about lawyers, if you have the law on your side, you argue the law. If you have the facts on your side, you argue the facts. And if you don't have either one of them, you bang on the table and create a diversion. At best, this is a nefarious diversion, totally without merit. To disenfranchise million, I cannot imagine the Supreme Court would even agree to hear it.

SCIUTTO: The vast majority of your colleagues still have not acknowledged President-elect Biden. They won't do it. And many of them, we did a segment on this broadcast a couple of weeks ago, immediately congratulated Trump after his victory in 2016, though it was a tighter one in many of these states. What do you say to those colleagues, and what do you say to a Ted Cruz, for instance, who called Donald Trump a pathological liar in 2016 and now is offering to argue this case before the Supreme Court?

MENENDEZ: Well, Jim, evidently, consistency is not a virtue in the United States Senate. The reality is that, you know, it's not about Joe Biden getting a congratulatory all or being acknowledged, it's about our democracy, it's about our respect for the will of the people.

Joe Biden got nearly 6 million more votes than Donald Trump. It seems to me that that pretty much is determinative along with the Electoral College that he is the president-elect of the United States. And when you are unwilling to acknowledge that, you subvert not Joe Biden but you subvert our democracy

SCIUTTO: I want to move on to another topic. We learned yesterday that Hunter Biden is under an ongoing investigation for his taxes related to his business dealings in China. I wonder, should President- elect Biden, when he takes over, January 20th, should he avoid any attempt to interfere or end this probe?

MENENDEZ: I would expect that he would absolutely not interfere with any probe.

[10:30:04]