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FDA Panel Meets to Consider Authorization for Pfizer Vaccine; FedEx and UPS Awaiting Pfizer Vaccine for Distribution; FDA Panel Meeting to Consider Authorization for Pfizer Vaccine; Trump Asks Supreme Court to Invalidate Millions of Votes; Seventeen Other Attorneys General Rally Behind Texas AG Over Election Results Suit. Aired 9-9:30a ET
Aired December 10, 2020 - 09:00 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
[09:00:23]
POPPY HARLOW, CNN ANCHOR: Good morning, everyone, I'm Poppy Harlow.
JIM SCIUTTO, CNN ANCHOR: And I'm Jim Sciutto.
The breaking news this morning, potentially some very good news. A major meeting now under way on whether to grant Emergency Use Authorization, a first step, for Pfizer's COVID-19 vaccine. An independent panel of health experts and scientists for the FDA are expected to hold a vote just hours from now.
This could potentially pave the way for tens of millions of vaccine doses to be shipped across the country within days. This morning the head of the FDA signaled it could get the green light very quickly.
(BEGIN VIDEO CLIP)
DR. STEPHEN HAHN, FOOD AND DRUG ADMINISTRATION COMMISSIONER: We think that our initial assessment is that this is a vaccine that is -- that does meet our criteria, but we do want to hear from the Vaccine Advisory Committee.
(END VIDEO CLIP)
HARLOW: This is a critical meeting at a critical time in this pandemic. Here is where we sit. Sadly this morning the United States just saw its deadliest say so far, more than 3,100 Americans died from COVID yesterday, hospitalizations at an all-time high across the nation, and we have not even yet seen the full impact of gatherings over the Thanksgiving holiday.
Before we get to all of that let's begin with our Dr. Sanjay Gupta who has a closer look at today's pivotal FDA advisory meeting.
(BEGIN VIDEOTAPE)
DR. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT (voice-over): It was the shot seen around the world. 90-year-old Margaret Keenan, the first woman in the United Kingdom, in the world, to receive an authorized COVID-19 vaccine.
It had been 286 days since the first patient in the United States died and now finally a signal of hope.
BROOKE BALDWIN, CNN ANCHOR: Pfizer and BioNTech have submitted --
GUPTA: Up until now the only real information about how well the vaccines were working was coming from the companies themselves.
ALBERT BOURLA, PFIZER CEO: Ninety percent is a game changer.
GUPTA: But the world is now watching as this vaccine is being rolled out in real time with all the excitement, but also the concerns.
ALEX AZAR, HEALTH AND HUMAN SERVICES SECRETARY: We want to make sure that any vaccine that comes out in America has the full gold standard stamp of approval of the FDA career people.
(On camera): The data was submitted three days earlier to the FDA versus to the U.K. regulatory authorities. Why is it?
HAHN: If we don't do our job to reassure and ensure the safety and efficacy of the vaccine to the American people, then we're going to contribute to vaccine hesitancy.
PETER MARKS, DIRECTOR, FDA'S CENTER FOR BIOLOGICS EVALUATION AND RESEARCH: We look at the actual adverse event reports, the bad spelling errors that are made by physicians.
GUPTA (voice-over): Peter Marks is director of the FDA's Center for Biologics Evaluation and Research, leading the FDA team reviewing the data of about 44,000 Pfizer trial volunteers, half on placebo, half on actual vaccine. Their findings so far similar to what we've heard from Pfizer itself.
MARKS: They had 95 percent effectiveness across a wide range of individuals.
GUPTA: Since November 20th, FDA scientists have pored over tens of thousands of data down to the level of the individual participant's medical records. Now more than 20 scientists and committee members collectively known as the Vaccines and Related Biologicals Product Advisory Committee will review all the data. Yes, for effectiveness, but equally important, how did the vaccine fair among people of different ages, different races and different medical conditions.
HAHN: We're going to look at underrepresented minorities, we're going to look at the elderly, we're going to look at young folks, pregnant women, folks with underlying immunodeficiencies, immune problems. That's part of the entire package that we'll present to the vaccine advisory committees.
GUPTA (on camera): But after the first dose, there was also a fair amount of protection, it was 52.4 percent roughly. Obviously a lot lower but better than the 50 percent that the FDA originally required. Does it make sense to you to take the 40 million projected doses by the end of the year and give all those as first doses to people?
DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: We considered that, Sanjay, and we decided that it would be more prudent not to do that, namely to get the real total degree of protection, not the 52 percent, but the 95 percent after the second dose.
GUPTA (voice-over): These are the kinds of questions the advisory group will ask to help determine who the vaccine will be authorized for and then the group will vote. Their vote doesn't bind the FDA, but the agency usually does follow their lead. The goal, to have 60 percent to 70 percent of the country vaccinated to achieve herd immunity and protect our communities from this virus, which is why this meeting will be repeated again next week as the FDA considers the equally promising vaccine candidate from Moderna, and again to consider other vaccines like that from Johnson & Johnson and Oxford/AstraZeneca.
[09:05:20]
GUPTA: All of it to get to this point for all Americans and eventually all the citizens of the world.
(END VIDEOTAPE)
HARLOW: I can't stop smiling.
(LAUGHTER)
SCIUTTO: Yes.
HARLOW: And as you saw her the first woman to get it, just smiling under her mask.
Sanjay, thank you for that. So assuming this gets approved by the FDA perhaps later today, how quickly are we going to see the impacts of vaccination across this country?
GUPTA: Well, you know, the vaccine itself is likely to be rolled out if it's authorized today within the next few days and I think we could see for the first time people outside of the clinical trial getting this vaccine in the United States, so that is a pretty remarkable timeline.
When does it have an impact overall on society, to your question? Well, that's a more complicated question. You know, when you look at the modeling overall they say that when you get to 30 percent of the country being vaccinated you'll start to see some impact. But it's not really until you get to this 60 percent or 70 percent number which is the herd immunity that everyone talks about that you'll see the most impact.
Think of the vaccine more like a very powerful but slow acting medicine as compared to things like masks which are almost surgical, put masks on stops transmission. You're hoping the vaccine can help people -- keep people from getting sick but masks will work much more quickly.
SCIUTTO: Now that requires time, right, to get to those numbers you're talking about, 30 percent, 60 percent. And you've written that with that in mind science can't save us. Tell us what you mean specifically about that, about what all of us need to do in the meantime.
GUPTA: Yes, I mean, what I wrote was science can't rescue us from ourselves and, you know, it's been an interesting year, Jim, I mean, you know, in this regard. I mean as a surgeon myself you always think about the cutting edge technology and the breakthroughs having such impact and they do, but unless you have good basic public health behavior it's very hard to counteract, you know, those things with science.
What I was really talking about the fact was that over the next few months there is a lot of optimism obviously about the vaccine and it is worth celebrating. I mean, it's a remarkable really eight months between having a genetic code to applying for an Emergency Use Authorization. I don't think anybody thought it was going to be that fast, but unless we can actually bring down the amount of virus transmission in the country overall, which is quite possible, it's within our -- within our power to do so, the vaccine doesn't have as much an impact or as quick an impact.
So the science is really important, but the basic public health behaviors are so critical. You know, I've gone back and looked at 1918 and we've been tracking here in this country now at this time 100 years later what happened in 1918. I mean, it's amazing to me. We have ICUs, we have hospitals, we have therapeutics, we have better overall medical care, and yet basic human behavior still ends up being the most important determinant of exactly how much of an impact this has on us.
HARLOW: Sanjay, before you go, when are we going to know if this is OK for those other groups to take that we've been talking about all week, pregnant women, breast-feeding women, people with -- you know, that are immunocompromised, cancer, et cetera? How long?
GUPTA: I think we'll know within the next few days. I mean, you know --
HARLOW: OK. Great.
GUPTA: The authorization if it comes today may come with some caveats. The groups that you mentioned, Poppy, they may also address this idea of people who've had severe allergic reactions in the past, they may be excluded from this group. They weren't part of the original trial. So we are going to be keeping a close eye out for not only who should be getting it, but to your point, who should not as well, at least initially.
HARLOW: OK. Sanjay, thank you so much. It is a very big and consequential day. We appreciate it.
As we speak FedEx and the UPS are on standby. They are ready to distribute Pfizer's vaccine as soon as it is authorized. SCIUTTO: CNN's Pete Muntean is at a Pfizer facility in Portage,
Michigan, where those trucks will start rolling as soon as they can.
Pete, I've been watching your reports this morning. I mean, as soon as approval, assuming it comes through, I mean, those trucks start rolling within hours?
PETE MUNTEAN, CNN AVIATION CORRESPONDENT: Yes, within 24 hours according to Pfizer, Jim and Poppy. You know, this is where it all starts. Pfizer's largest facility in the country, 1300 acres, a sprawling complex. We know that vaccine arrived here late last month but according to Operation Warp Speed the vaccine will be leaving here on trucks bound for 600 individual locations. Pfizer says in some cases directly to the point of use.
[09:10:02]
You mentioned that FedEx and UPS will be handling those packages. We know they are packed with dry ice. They need to be negative 100 degrees Fahrenheit. Equipped with a thermal sensor and also a GPS tracker as the packages pass through trucks and planes and FedEx and UPS cold storage facilities. I have been inside some of those mega freezers.
The hope is that those will be just a pit stop on the way to getting this 2.9 million dose initial shipment out of the door, but what's so interesting here is that we're hearing from states that that initial shipment will not be enough to cover those who need the vaccine right away. Those living in long-term care facilities and those on the frontlines of the health care field.
Now states will have to prioritize within that top priority group and that will be a tough job at the dawn of what will be a massive distribute effort that all starts right here in Kalamazoo, Michigan.
HARLOW: Pete, it's exciting. We'll wait to see what happens in the meeting today. Thank you for that reporting.
Well, this just in, the Gates Foundation has just pledged a quarter of a billion dollars to the fight against COVID at a pivotal time in this pandemic. How they plan to use it to help get more people vaccinated. We'll have an exclusive interview with Melinda Gates ahead.
SCIUTTO: And the president is focusing his energy, not on the pandemic, but another fight. He is calling on the Supreme Court to invalidate millions of votes in key battleground states. That's right, throw those votes out. And he is rallying many Republicans to get behind him.
Plus, we are on Capitol Hill where stimulus talks are falling apart it seems as millions of Americans wait for relief.
(COMMERCIAL BREAK)
[09:15:00] SCIUTTO: These are live pictures of the FDA's advisory committee
meeting. Of course, it's done remotely in these times on Pfizer's COVID-19 vaccine. The U.S. could have its first authorized vaccine for the coronavirus in just hours. The decision to take place in that meeting you're watching right now.
HARLOW: So, let's get to our colleague Alexandra Field, she joins us today from New Jersey. Alex, you are at a facility that is getting ready to be a vaccine distribution site. What's happening?
ALEXANDRA FIELD, CNN CORRESPONDENT: Exactly, Poppy. Look, this is actually a gym at a nursing school, and it's just like a lot of sites all over the country that are being converted for this huge undertaking, conducting a mass vaccination.
This is a site that would be used for the general public once the vaccine is available for the general public. It's a site that's also being administered by Holy Name Medical Center, but they say when they received the first doses of the vaccine, those of course as we've been reporting will be going to the front line workers.
So, they are waiting along with the rest of us for that emergency-use authorization from the FDA. After that, they should get all important phone call that will kick off the vaccination process. It will go something like this.
(BEGIN VIDEO CLIP)
NANCY PALAMARA, VICE PRESIDENT OF DIAGNOSTICS & THERAPEUTICS, HOLY NAME MEDICAL CENTER: Ideally, sometime next week, we would expect to get that phone call, sometimes it's -- could be the same day and say, hey, we're on our way and we're going to be bringing you product, and we're used to that through this pandemic, and we have our storage location ready and that vaccine would arrive if it's the Pfizer vaccine next week.
(END VIDEO CLIP)
FIELD: The first shipment coming to Holy Name will be a relatively small one, about a 1,000 doses, that's enough for 500 front-line workers. So, the focus will be on getting vaccines to those people who are in the closest contact with COVID patients first, after that, they'll continue to get more guidance about how many vaccines could be coming. That will help them determine how many sites like this one they need, and it will give us a much clearer timeline of how quickly the rest of the public can get vaccinated. Jim, Poppy?
SCIUTTO: Alexandra Field, thanks very much. Joining me now to talk about this, the vaccine rollout, the importance, Dr. Chris Pernell, public health physician at Newark University Hospital volunteer as well in the Moderna vaccine trial. Dr. Pernell, good to have you on -- back on the show.
CHRIS PERNELL, PUBLIC HEALTH PHYSICIAN, NEWARK UNIVERSITY HOSPITAL: Good to be here. SCIUTTO: So, you are -- in addition to your expertise, I mean, you've
had tremendous personal experience of this, you're taking part in a trial, but sadly, you lost your father to this. Big picture. Tell us about the importance of this moment, the likely it appears approval today of the first vaccine for COVID-19.
PERNELL: Personally, I need this light at the end of the tunnel. You described that I lost my father, but today is also the funeral for a beloved cousin --
SCIUTTO: Yes --
PERNELL: Who has died because of coronavirus complications. And so, I am poised to see the results that come out of the process today, I am hopeful, and I remain vigilant. And for the nation, we're beleaguered, we are fatigued. We've been fighting this demon for quite some time, and we need a tool, we need a tool in addition to the basic public health measures that we've been preaching and emphasizing to the public to get us out of this very dark and grim spot. But I do want to manage expectations.
SCIUTTO: Yes --
PERNELL: It's not going to be a silver bullet, it's not going to be a flip of a light switch, it's going to be a process, but it is the beginning of a hopeful and vigilant process.
SCIUTTO: So, it will be months, not a whole bunch of months, but months at least until the Spring time when most Americans will have access to this. What do most folks watching this program right now need to do in the interim? Stick to the basics, right?
PERNELL: Look, continue to wear your mask. I can't emphasize that enough. That is bedrock. Wear your mask, continue to wash your hands frequently, continue to avoid crowds and to stay home as much as possible.
And again, we have the holiday season upon us, do not mix households. Be safe during this Winter. This Winter is going to be very difficult. Just today -- yesterday, we crossed a very grim mark, Jim, we lost more Americans in a day than we had previously to this pandemic. And so, we can't lose sight of that, we can't let up. And I can't emphasize that enough.
[09:20:00]
SCIUTTO: Yes, no question. I mean, I watched that number continue every day on our screen, up to nearly 290,000 Americans lost. A big need for the vaccine to be successful, right, is for people to take it and with confidence. And we saw confidence in the vaccine drop somewhat according to public polling, down to around 50 percent, it's now up to 63 percent in a new Gallup Poll. So, coming up, again, why do you see -- why do you believe confidence is growing in this?
PERNELL: Well, I'm not sure confidence is growing across all groups, Jim. I do think we see a spotlight, but the more we see safety and efficacy data roll out for the public, the more we have a national conversation about what that data means, I believe we can reassure people, but we have to walk with people hand-in-hand. I have these conversations every day in community. I just had this conversation by a text last night with a local community leader. A black woman who said to me, you know, I still feel uneasy about publicly supporting the vaccine.
And I reassured her, embrace your fears and your concerns, and then let's talk about the root of what's driving that. And we have to be willing to do that day-in and day-out. This is going to be a hard- fought battle --
SCIUTTO: Yes --
PERNELL: To show people that this is safe, and to show people that this is an important national step that we have to take.
SCIUTTO: There is a lot of disinformation out there, right? I mean, some coming from the president himself, other state, local leaders still denying the seriousness of the pandemic here, but there will be new leadership on January 20th. If you had five minutes with President-elect Biden, what would you tell him to be job number one, as he and his administration take over the management of the pandemic response?
PERNELL: Continue to lead with empathy. We've lacked that. We've lacked that for years as a nation, because as you lead with empathy, you can lead with truth, you can lead with science, you can lead with data. We're in a moral battle, this is a moral fight. This is a moral fight to emphasize that truth matters. This is a moral fight to emphasize that those disenfranchised communities, those historically excluded communities --
SCIUTTO: Yes --
PERNELL: Lives matter, and that's where I would start with the president-elect.
SCIUTTO: It is a logistical battle as well because getting these doses out, tens of millions, right? Hundreds of millions at the end of the day of doses to hundreds of millions of Americans across the country, and with conditions that are difficult, right? The Pfizer vaccine requires, you know, deep freeze, right? In terms of transporting and storing. Based on what you've seen of the plan, are you confident that this country will handle this well?
PERNELL: I'm confident that we have the right people at the table poised to help solidify the distribution process. And when I say poised to help solidify the distribution process, yes, we're getting ready to get out of the gate, but this process will unfold across months. This process will unfold as we go through the transition. I do expect there will be some bumps, but I do expect that we'll be able to recover because we have people poised and ready in hospitals across United States. There are discussions, there are discussions around logistics, there are discussions --
SCIUTTO: Yes --
PERNELL: Around distribution, and people are taking this seriously, and we have to take this seriously. So, I expect that by and by, through and through, we will get it right. But it will take constant attention and vigilance and being not asleep at the wheel.
SCIUTTO: Yes, well, Dr. Pernell, we appreciate your work on this, but also sorry to hear about your own personal loss as a result of the pandemic and we wish you and your family the best.
PERNELL: Thank you.
SCIUTTO: Poppy?
HARLOW: Well, President Trump wants to block millions of votes, and he's trying to do it again, asking the Supreme Court to intervene here. Will the high court even take up this case or will they put an end to this baseless fight next?
(COMMERCIAL BREAK)
[09:25:00]
HARLOW: President Trump is right now asking the Supreme Court to intervene and essentially invalidate millions of American votes. This is according to a filing from the president, a motion from the president to intervene in a lawsuit that has already been filed by the Texas Attorney General, Ken Paxton. Paxton is expected to be at the White House today.
SCIUTTO: Seventeen other Republican attorneys general declared support for the lawsuit. This as the Atlanta Journal Constitution reports that the president called Georgia's attorney general, also a Republican, yesterday, and warned him not to rally other Republicans against the lawsuit.
Another example of the president's personal intervention in this. CNN White House correspondent John Harwood is in Washington. So, John, the president reportedly looking to Texas Senator Ted Cruz to lead this fight, should it reach the Supreme Court, but I mean, the Supreme Court very quickly dismissed Pennsylvania case with similar arguments behind it. I mean, is this a charade or is this a genuine legal attempt right now?
JOHN HARWOOD, CNN WHITE HOUSE CORRESPONDENT: This case, Jim, is a gigantic clownish lie that has no merit whatsoever, it's not going anywhere. And there is an incredible irony in the fact that Ted Cruz, the senator from Texas --
SCIUTTO: Yes --
HARWOOD: Is going to advance this lie for President Trump. Let's remember, go back a few years ago, Ted Cruz came to the Senate, immediately became loathed by his colleagues because he was the one who would shamelessly pretend that you could do things that you couldn't do.
