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FDA Meets on Pfizer Vaccine as U.S. Reports Deadliest Day; Trump Joins Long Shot Lawsuit Aiming to Overturn Election. Aired 1- 1:30p ET

Aired December 10, 2020 - 13:00   ET

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

[13:00:00]

BROOKE BALDWIN, CNN RIGHT NOW: Hi there. You're watching CNN. I'm Brooke Baldwin. Thank you for being with me.

This is a huge day. A potentially historic meeting is under way, as I speak, to determine if Pfizer will be granted emergency use authorization for its COVID-19 vaccine. If green lit, it will pave the way for tens of millions of vaccine doses to get into the arms of Americans in just days from now.

And this morning, the head of the FDA struck an optimistic tone.

(BEGIN VIDEO CLIP)

DR. STEPHEN HAHN, COMMISSIONER, FOOD AND DRUG ADMINISTRATION: We think that our initial assessment is that 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)

BALDWIN: This vote could not come soon enough. The United States just reported its deadliest day so far with 3,124 Americans losing their battles with coronavirus on Wednesday alone. Hospitalizations, they're at all-time highs nationwide. And as doctors and nurses are being stretched and the issue of space is reaching crisis levels, the virus is showing no signs of slowing down.

Each and every day in this country, more than 209,000 Americans are getting sick. That is up 27 percent from just a week ago.

Well, let's begin with a crucial FDA meeting and our Elizabeth Cohen, she's our CNN Senior Medical Correspondent, following this huge moment for us. And so what do we know at this hour and how will all this play out if the Pfizer vaccine is green lit?

ELIZABETH COHEN, CNN SENIOR MEDICAL CORRESPONDENT: Brooke, hopefully, today is the beginning of a new chapter, the beginning of the end of this pandemic. So the FDA, of course, has to give permission for any vaccine to go on the market, the one they're considering now, the very first one, is from Pfizer.

But the FDA does something interesting. It doesn't just say, hey, we're giving a green light to this, or red light, we're going to bring in external experts. These are folks who are mostly doctors in universities and they asked their advice. These doctors don't work for the FDA, they don't work for the government, they are independent. And they are to look at several issues, the two most important, does the vaccine work and is it safe.

So let's take a look at that. This vaccine has been shown to be 95 percent effective. That is more effective than, really, beyond anyone or almost anyone's wildest dreams. There have been frequent side effects. Many people who took the vaccine in clinical trials felt fatigue, achiness, fevers, symptoms like that, but they lasted only about a day. There were no serious side effects of concern in this clinical trial.

Now, it's interesting, in the clinical trial, more than 40,000 people involved, however, it was not tested on purpose in certain groups. And so no one knows if the vaccine is safe for those groups. So the FDA or the CDC might say, you know what, let's not give this vaccine to these groups, let's take a look at a list of who the groups are.

So the vaccine was not tested in children under 16, in pregnant women or women that are breastfeeding, was not tested in people that are immunocompromised or people who have had allergic or severe reactions to vaccines in the past. So it is possible that the vaccines will not be made available to those groups.

But, really, that is a relatively small group. If most of the rest of the country gets vaccinated, that produces what's called herd immunity and it could protect people who aren't able to get vaccinated. Brooke?

BALDWIN: If and when this vaccine today gets the thumbs up, how quickly can people get the shot?

COHEN: So, to be clear, we don't know but we do expect that it's going to get the green light. So, let's talk about what happens next.

Within days, maybe a week, or we think it will be days, the first shots could go into arms. And those first shots are going to go to health care workers and they're going to go to residents of nursing homes. That has already been decided. The next group will be essential workers, firefighters, police officers, et cetera, other elderly people, and also those with underlying medical conditions, such as heart disease or obesity or other kinds of medical conditions. And then later, it would be available to everyone else.

Now, if you're in the everyone else category, and wondering when can I get it, it likely wouldn't be until in the spring. So this will take several months to roll out. We will still have to wear masks. We'll still have to do social distancing, but as I said, Brooke, hopefully the beginning of the end. Brooke?

BALDWIN: Yes. There's the injection of hope, as those nurses in the U.K. were referring to it earlier this week. Elizabeth, we'll take it. Thank you.

Now, the second that this Pfizer vaccine is authorized, all systems are go when it comes to distribution. And for that, we go to Pete Muntean. He's at Pfizer facility in Michigan where workers are standing by for the go-ahead.

Pete, what is the plan once they get the okay?

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PETE MUNTEAN, CNN AVIATION CORRESPONDENT: Well, this is the start of a massive effort here, Brooke. Pfizer says that within 24 hours of FDA emergency use authorization, trucks carrying the vaccine could begin leaving here. What's so is interesting is this is a key spot in the distribution of the vaccine, Pfizer's largest manufacturing facility here in Kalamazoo, 1,300 acres.

We know vaccine arrived here late last month. Operation Warp Speed tells us vaccine leaving here will go to 600 individual locations, places like hospitals, CVS, Walgreens, things that Pfizer refers to as the point of use. We know that it will be UPS and FedEx carrying those packages, carrying doses. They will be packed with dry ice keeping the Pfizer vaccine at its required negative 100 degree temperature. Also, those packages will be equipped with thermal sensor to alert UPS and FedEx if the temperature is off by only a few degrees.

We know that 2.9 million doses are going out as soon as the FDA gives Pfizer the green light. And while that does not sound like very much, Operation Warp Speed says this is a rollout. More vaccine is on the way starting next week.

We know it is getting in place now, on the move now are that things physically needed to administer the vaccine, things like syringes, alcohol swabs, they're in kits from the federal government. 100 million of them, Operation Warp Speed says, will be in place by tomorrow.

So, a massive effort here , Brooke, and it all starts right here in Michigan.

BALDWIN: Great. I'm glad they'll be ready to roll. Pete Muntean, thank you so much.

Let's get some medical expertise on all of this. With me, Dr. Michelle McMurry-Heath, she is an immunologist and former director of Science at the FDA, and she is currently president and CEO of Biotechnology Innovation Organization. It's the world's largest trade organization representing the biotechnology industry.

So, Doc, welcome back, good to have you back on the show this week. And let me just be clear as we go through this conversation. You are a medical doctor, but you're representing the pharmaceutical industry. This FDA meeting, put it in perspective for all of us. How huge is this?

DR. MICHELLE MCMURRY-HEATH, FORMER SENIOR FDA OFFICIAL INVOLVED IN CLINICAL TRIALS PROCESS: Well, it is historic, Brooke. And what's so wonderful about it is that the FDA has embraced full transparency in their reviews of COVID vaccines.

So, not only are they considering this in record time but they're doing it in full light of day. We have sources watching the proceedings all day, giving us reports back and forth as to how it is going. And there's robust discussion inside of that room, that virtual room. And there are a lot of tough questions being asked.

BALDWIN: What will you specifically be listening for coming out of this virtual meeting?

MCMURRY-HEATH: Well, a lot of it we heard already. We heard very detailed conversation about the side effect profile. It is looking very, very promising. We know that the Pfizer vaccine is showing 95 percent efficacy, which is fantastic, but it is also important to know that they haven't seen a lot of serious side effects. They have things like muscle ache, fatigue, sometimes fever, in substantial portion of patients, but it seems to resolve in 24 to 48 hours.

So, everyone should expect this. It is not a simple vaccine to have but as we are facing a day with two Americans dying every hour from COVID, it is a good alternative.

BALDWIN: And we're educating everyone too just when it comes to your point on the side effects, like this is totally normal. And as you point out, they go away in about a day.

There were some complications out of the U.K. with their rollout a couple of days ago with people with allergic reactions. Do you think the FDA will recommend that certain groups of people here in the U.S. should not get the vaccine and who might that pertain to?

MCMURRY-HEATH: Well, it is not uncommon to have contraindications with any drug or biologic approval. So that is completely customary. And often it comes because that group was not tested. And as you saw in your opening remarks, people with a history of severe allergic reactions to vaccines were not included in that original trial. So that would be customary that they wouldn't necessarily be included in the indication or that is the instructions for who should receive the vaccine.

This is just common sense. We want to test it in those most likely to respond well first. And then once we know a little bit more about the vaccine, we'll extend to other populations. And, for example, that's why they're rolling in children as kind of the next wave of COVID vaccine trials.

So we've launched a website covidvaccinefacts.org. And you and I had a chance to speak about it, which really has a lot of good straight talk about what goes into a vaccine and what to expect. So please check it out.

BALDWIN: Dispelling all of the misinformation, as we are all in the education process together.

In terms of this vaccine, how concerned are you about availability?

[13:10:01]

We're hearing bits and pieces about shortages in certain states. And also since this has to be kept so, so cold, what concerns do you have in terms of distribution?

MCMURRY-HEATH: Well, I think they mounted a good response to a lot of logistical limitations. Let's face it, storing the vaccine at these super cold liquid nitrogen level freezing is not common for any of the vaccines we typically use. But Pfizer has had awhile to work on this problem and they have very good controls in place to try to make sure the vaccine gets to the points of care where people can actually receive it in good shape.

But it is going to be -- there's a lot more to do still. And we are expecting if both the Pfizer vaccine and the Moderna vaccine, which is coming to FDA's advisory panel next week are approved or authorized, I should say, for emergency use, then we should have 20 million doses available for individuals by the end of the year. So that is a good first step.

BALDWIN: Good. And when we talk about the doses, are we just to assume when folks go in for the first dose that the second dose is guaranteed? Like, will it absolutely be supplied?

MCMURRY-HEATH: Yes, most definitely. They are supplying them in kind of in duets, and it is very, very important that once you get your first dose of the vaccine that you get the second dose of the exact same one. There are 191 COVID vaccines in development. These are just the first two that we're hearing a lot about today. Hopefully, by the time we get to the springtime, we'll have quite an armament of different vaccines that we can use. But no matter which one you start with, that's the one you should end with.

BALDWIN: Right. I got a question on Instagram this week, and I start with the Moderna and with Pfizer, I hear you, the answer is no. You get Pfizer, you stick with Pfizer, you get Moderna, you stick with Moderna.

There is still a large number of Americans, Dr. McMurry-Heath, who still say they will not get the vaccine. We'll show the poll here. It's a new poll from Axios/Ipsos. And it shows 53 percent are willing to take a first generation vaccine as soon as it is available, and that is better than the 38 percent you saw in a poll from October, but 53 percent. Will that be enough to keep Americans safe, to create that herd immunity from vaccinations? And, if not, what should the messaging be?

MCMURRY-HEATH: So, we have been talking with, for example, governors across the country, as well as health professionals across the country, and we understand that people are waiting to see how well it works in this initial population center.

Our health care providers are such a perfect place to start because they know how vaccines work. They're at incredible risk of exposure and they're so critical to make sure that our health care system continues to function to be able to take care of those who do come down with COVID.

So they will be to teach us a lot, and through their own personal experiences, I think, communicate and educate others. So, I expect that number to move. We are doing everything we can to get good information out there that's clear and that's understandable and that sound. But I think it will move as people see how amazingly efficacious this vaccine appears to be at stopping the surge.

BALDWIN: Let's hope so. Dr. McMurry-Heath, always a wealth of information. I appreciate your expertise so, so much. We'll talk again. Thank you.

MCMURRY-HEATH: Thank you.

BALDWIN: Hospitals are now taking extreme measures to handle the flood of coronavirus cases, even treating patients at a parking garage. We'll take you there.

And President Trump still hasn't said 3,124 Americans who died from the virus just yesterday. But what he is doing is spending plenty of time pushing a new lawsuit to overturn the election. Those details are ahead.

And if it seems like the president's good friends, inner circle, is enjoying better treatment for coronavirus, it is because they are. Why? Is this fair?

You're watching CNN. I'm Brooke Baldwin.

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BALDWIN: We're back. You're watching CNN. I'm Brooke Baldwin. Thank you for being here.

As Americans suffered the deadliest day of the coronavirus pandemic just yesterday, more than 3,000 people, President Trump said nothing, absolutely -- pandemic. Instead of supporting of Americans who are struggling -- he is fighting so hard to hang onto, the president of the United States threw his support behind a long shot lawsuit from an indicted Texas attorney general. This lawsuit is trying to overturn the will of the American people in four different battleground states, four states that President-elect Joe Biden won. All 50 states have certified election results, by the way.

17 Republican attorneys general, in addition to President Trump, have now signed on to this one lawsuit. They are all appealing to the U.S. Supreme Court to hear a case which, by the way, is very unlikely. But if they do, President Trump called on a lawyer to argue the case and he went with this guy.

(BEGIN VIDEOTAPE) SEN. TED CRUZ (R-TX): I tell you what I really think of Donald Trump. This man is a pathological liar. He doesn't know between truth and lies. He lies practically every word that comes out of his mouth. He had a pattern that I think is straight out of a psychology textbook.

His response is to accuse everybody else of lying. He accuses everybody on that debate stage of lying and it is simply a mindless yell. Whatever he does, he accuses everyone else of doing. The man cannot tell the truth, but he combines it with being a narcissist, a narcissist at a level I don't think this country has ever seen.

[13:20:08]

Donald Trump is such a narcissist that Barack Obama looks at him and goes, dude, what's your problem? Everything in Donald's world is about Donald. And he combines being a pathological liar. And I say pathological because I think Donald, if you hooked him up to a lie detector test, he could say one thing in the morning, one thing at noon and one thing in the evening, all contradictory and he pass the lie detector test each time, whatever lie he is telling at that minute, he believes it.

But the man is utterly amoral.

(END VIDEOTAPE)

BALDWIN: Senator Ted Cruz of 2016 clearly in a different place than the Ted Cruz we know now in 2020.

Let's go straight to our White House Correspondent Kaitlan Collins. And, Kaitlan, it's just amazing thinking back to four years ago, anyhow --

KAITLAN COLLINS, CNN WHITE HOUSE CORRESPONDENT: It is.

BALDWIN: -- there is so much happening with this lawsuit but this indicted Texas A.G., Ken Paxton, he is at the White House today. Tell me more.

COLLINS: Yes, he is. And the White House says this was a previously scheduled lunch with Republican attorneys general that President Trump is having here today close to reporters. But, of course, Ken Paxton who filed this lawsuit that the president has been touting that now Ted Cruz has apparently personally been asked by the president to argue if it does go before the Supreme Court, he is the one who has filed that.

So, he is having lunch with the president. Obviously, that is likely to get brought up since the president has been cheering Republican A.G.s who have signed on to -- they're throwing their support, essentially, behind this lawsuit, and now the Atlanta Journal Constitution is reporting that the president has told and warned the Georgia attorney general not to convince others now to also sign onto this.

But, of course, when you've got to actually look at this lawsuit and you're listening to what legal experts are saying, where even some Republicans, Brooke, they say it's long shot case, that it is not likely that Ted Cruz is ever going to have to do it because they don't think the Supreme Court is going to take it up.

And look at what other lawmakers in Texas are saying. John Cornyn, the other senator from Texas, dismissed the lawsuit, said he doesn't think it has merit behind it. Kay Granger, another Texas lawmaker, said similar, she said she did not believe that it was going to really have legal muster behind it.

And you're hearing other Republicans criticize it as well and tying that in with who Ken Paxton is and the fact that he is under investigation currently by saying it's basically a P.R. stunt, because Ben Sasse, from Nebraska, said he believes Ken Paxton is looking for a pardon from President Trump.

So the president and his legal team are framing this as the kind of the big case, their actual case, what they have been waiting for, essentially, to try to challenge these election results. But if you talk to people internally, they don't believe it has any merit behind it. So, despite what they are saying publicly, that's not what you are hearing behind the scenes despite what the president is tweeting.

BALDWIN: Thank you for all of the perspective. Kaitlan Collins, good to see you.

Let's continue the conversation. My next guest, Election Law Expert Trevor Potter, he is the founder and president of the Campaign Legal Center. It's a non-profit group focused on campaign finance and elections. And he is also former chairman of the FEC, the Federal Election Commission.

So, Trevor, welcome back.

TREVOR POTTER, FOUNDER AND PRESIDENT, CAMPAIGN LEGAL CENTER: Thanks, Brooke. Good to be with you.

BALDWIN: This Texas lawsuit, can you just help us understand what the lawsuit is even claiming, that they are saying there are these voter irregularities? Where is the evidence?

POTTER: Well, to start with, they're not even claiming voter irregularity. So it is a very bizarre lawsuit. What they're saying, first of all, in order to file a suit in federal court, you have to show some sort of injury. And what they're saying is that Texas is injured if a Democrat is sworn in as vice president and, therefore, presides over the Senate and could vote in the case of tie votes and that somehow the possibility of Vice President Harris could injure Texas. That's an enormous stretch.

Then what they are saying they object to the way that other states chose to conduct their elections and, specifically, they complain about Wisconsin and Pennsylvania and Georgia and Michigan. And in each case, they don't allege there was fraud, there's no proof that there was anything wrong about the election. What they're saying is the way those states chose to vote and the way voters were told to do it somehow was wrong under those states' laws, or followed those state's laws and the laws were wrong.

So, you put all of this together and you say, wait a minute, not only is this a crazy theory but this is a theory that is asking for judicial activism from the U.S. Supreme Court, something that Texan Republicans have long opposed, and it is anti-federalist.

[13:25:18]

Because it's saying, we want the U.S. Supreme Court to tell the states and specifically these four states how they should run their elections.

BALDWIN: Well, that same U.S. Supreme Court did hear the election challenge out of Pennsylvania, again, the same Supreme Court with three justices that this president appointed himself, and we have been reporting out how the decision was in one sentence. There were no noted dissents.

Do you think the Supreme Court hears the Texas lawsuit? I am hearing no from you.

POTTER: It depends what hear means, because they have used a section of the Constitution called original jurisdiction, which means a state has a right to bring a lawsuit against other states. Now, they could simply say, we decline this case, this challenge. I think it is more likely they'll have briefing and then turn it down.

I would be shocked if they add formal oral argument, which is not required. And for a case that's this farfetched, I think, would dignify it in a way that's not warranted.

BALDWIN: And to hear as Kaitlan was just talking about, how Ken Paxton, the Texas A.G., is over at the White House today having lunch, and, again, just reminding everyone, this guy is currently under indictment for securities fraud, and I think it was Ben Sasse who had that floated, well, he is probably there because he wants a pardon. What do you make of his involvement in particular?

POTTER: Well, it is peculiar because some of his top people have already resigned, the solicitor general of Texas is not on the brief, a Washington lawyer apparently drafted the Texas brief based on the metadata in it, and that's a lawyer who has been drafting briefs for President Trump. So, it's a peculiar long shot theory.

And what's amazing to me is that 17 Republican attorney generals were willing to support it, yes. That tells you a lot about President Trump's cloud at the moment and the fact that he is opposing Republican attorney generals in some of the states like Georgia.

BALDWIN: His cloud at the moment, I hear you. It's interesting, because this president keeps losing in all these various legal battles so far, but I had conversations with just really smart people in the world of politics saying when it comes to being a kingmaker, at least at the moment, politically, though, to your point about the 17, he does seem to be doing pretty well.

Trevor Potter, we'll speak again. Thank you, sir.

POTTER: Thank you, Brooke.

BALDWIN: Breaking news, we are following headlines from this FDA meeting today where this critical vote will soon take place on whether to move forward on the first COVID-19 vaccine for Americans.

Also breaking, Ellen DeGeneres announced she has tested positive for COVID. Of course, we wish her well. What she's revealing about her diagnosis, next.

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