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Now: FDA Panel Meeting to Consider Authorization of Pfizer Vaccine; States Prepare to Receive First Vaccine Doses; Trump Asks U.S. Supreme Court to Invalidate Millions of Votes. Aired 11-11:30a ET

Aired December 10, 2020 - 11:00   ET

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

[11:00:00]

POPPY HARLOW, CNN ANCHOR: That's what's we call Minnesota nice and so and so until the chain reaction lasted nearly two days and over 900 cars.

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TINA JENSEN, DAIRY QUEEN STORE MANAGER: No matter what hard times everybody is going through, just take care of each other.

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HARLOW: The store manager right there. Pretty good to see good people in this world, Jim. Thanks to everyone.

JIM SCIUTTO, CNN ANCHOR: When are you buying me some?

HARLOW: When I get to see you in person and not these stupid split screens. I will buy you as many Dilly Bars as you want.

SCIUTTO: I'll take a tip.

HARLOW: Thanks for joining us. I'm Poppy Harlow.

SCIUTTO: And I'm Jim Sciutto. NEWSROOM with Kate Bolduan starts right now.

KATE BOLDUAN, CNN ANCHOR: Hello, everyone. I'm Kate Bolduan. Thank you so much for joining us this hour.

We start with breaking news on the authorization of Pfizer's COVID vaccine in the U.S. today on Pfizer's COVID vaccine. This meeting on Pfizer's COVID vaccine being considered today. An FDA advisory panel is holding an all-day meeting right now. A vote will be held later today on whether to authorize the vaccine for emergency use in the United States. If it gets the OK, which is expected, the first Americans could be vaccinated within days. This morning, a member of the advisory board laid out the significance of this meeting.

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DR. DORAN FINK, DEPUTY DIRECTOR, FDA DIVISION OF VACCINES: Today, we will be considering whether to make available to millions of Americans and as yet investigational vaccine that has been developed, tested and reviewed in record time. We will have a single question for the committee to vote on. The question is, based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?

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BOLDUAN: Contrast this hope with the sad reality that the country just had the worse day in the history of the pandemic. The numbers really are staggering, more than 3,100 deaths were reported yesterday. The first time the nation has topped more than 3,000 deaths in a single day. Since the start of this month more than 21,000 Americans have been killed by the virus. Hospitalizations are once again at an all- time high. Nearly 107,000 Americans currently receiving treatment in the hospital for COVID. All of this makes today's meeting and the expected decision all the more urgent and meaningful.

Let's get to all of this. First, this meeting of the independent experts on the Pfizer vaccine. The meeting is ongoing.

CNN's Elizabeth Cohen has been following this. Elizabeth, what has happened so far? Where are they focused and what's expected to happen?

ELIZABETH COHEN, CNN SENIOR MEDICAL CORRESPONDENT: Kate, they're focused on two areas. One, does this vaccine work? Does it actually keep people from getting COVID-19? And number two, is it safe? So, let's go over what we know about that so far.

The FDA was basically hoping for a vaccine that would be 50 percent effective. That would have made them happy. Instead, thank goodness they got a vaccine that's 95 percent effective. That is really astounding. And there were frequent side effects, people did tend to get sleepy, they were achy, they had fever, but those things only lasted about a day, there were no serious adverse events because of this vaccine.

Now one thing we should note is the vaccine was tested in more than 40,000 people but this committee is going to talk about the people that it wasn't tested in because if it wasn't tested in a certain type of person, well then maybe those people should not be getting the vaccine because we don't know if it's safe for them because it wasn't tested in them.

So, let's take look at that group. We do not know if the vaccine is safe for children under 16 because it wasn't tested in them, same for pregnant women, same for women who are breastfeeding, same for people who have - who are immunocompromised. We don't know if it's safe for them. Also, people who have had severe reactions like allergic reactions to vaccines in the past, we haven't tested this vaccine out on them yet. So, we don't know if it's safe or not. So, are the questions that the FDA is going to be looking at.

Now, the timeline of course is what everyone wants to know. What we know, Kate, as you mentioned, is that first, if it gets authorization, which is we think it will, the first shots could be going into arms within a matter of days maybe a week. The first group to get the vaccine, we already know, will be healthcare workers and residents of nursing homes. They'll be the first.

It will then go to the next group, which is essential workers, firefighters, police officers, et cetera. Other elderly, not those living in nursing homes and also those with underlying medical conditions, everything from heart disease to obesity. Later is when everyone else will get it. And Kate, that later could be this spring. If you don't fall into one of those high-risk groups, you may not be getting the vaccine until the spring. Kate?

[11:05:04]

BOLDUAN: Elizabeth, thank you.

Joining me right now is Dr. Richard Besser, former acting director of the CDC. He's also the president and CEO of the Robert Wood Johnson Foundation.

Thank you for being here again, Doctor. If in this meeting so far, we have been hearing from the - they're talking about many things, but we heard from an FDA official about their assessment of Pfizer's manufacturing quality. I want to play for you what this FDA official said.

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FINK: In information submitted prior to the EUA, FDA has been conducting an ongoing review of manufacturing quality, consistency, and control. And we have found this information to be adequate to support emergency use authorization of the vaccine.

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BOLDUAN: Adequate to support emergency use. Why is this element an important one in getting the green light here?

DR. RICHARD BESSER, FORMER ACTING DIRECTOR, CDC: Yes. So, you know, as Elizabeth Cohen was saying, safety and effectiveness are critical pieces. The third piece, though, is the company has to demonstrate that they're going to be able to manufacture the vaccine with all of the safety controls that you want to have in place in a manufacturing process. And making a vaccine, making a drug, making any product that's going to be put into a body, requires having very good controls on that process. So, what they're saying is, from what the company submitted they're able to determine that the company has the adequate production capabilities to be able to manufacture the vaccine.

BOLDUAN: And the FDA commissioner has said that no matter what happens with this independent panel, the FDA of course is the agency that makes the final call. And he said today when he was asked about this, the FDA's plan, the panel's recommendation -- the FDA's plan to take the panel's recommendation into account for our decision making, is how he put it, do you see a scenario, Dr. Besser, where the FDA would act against the recommendation of this panel? BESSER: You know there have been rare occasions where an FDA panel has made a recommendation and the FDA or at times the department has gone against that recommendation. It's rare. I don't think that's going to happen here. I think if that were to happen, it would be a big mistake because one of the wonderful things about this process is the transparency.

You know, I really enjoyed being able to dive into the materials that FDA had posted on their website to see what their analysis had showed to see what their company analysis had showed. It's great that the meeting today, the questions, the deliberations are open to the public.

And the reason that's so important is during this pandemic there's been a lot of political interference. Interference in terms of drugs being pushed, the FDA being pushed to approve things that some felt were not of the quality that should be approved. And so, for this process to go forward it has to be seen as one where science is ruling the day. Without that, we're not going to see the increase in people's desire to get this vaccine.

And as you know, the polling data show that there are quite a lot of people in this country who have concerns about safety, concerns about the speed by which these vaccines have been developed and tested. And much higher rates of concern among communities of color. Communities that have been, historically, mistreated by the public health system, by the medical community. Communities that are being hit really hard by this pandemic.

BOLDUAN: And that's exactly what I was going to ask you because the latest polling has it at 61 percent of Americans say that they're willing to get the vaccine. How do you get that number to 70, 75 percent? Kind of the level that we've been told they need people across the country the level -- the percentage of Americans to get the vaccine for it to be really effective. How do you get there?

BESSER: Well, you know, a number of things are going to have to take place. One is the transparency of this approval process. That's really key that people believe that it was done fairly. That the same standards that are normally in place are in place here. That's what I'm going to be looking for, as I think about whether to recommend this to my 90-year-old parents, whether I recommend it to the families of my pediatric patients, whether I personally want to get in line, that's really important to me.

But beyond that, it's critical for health departments to be working with communities, community leaders, identifying trusted voices so the concerns people have can be addressed. You're not going to get to 70 percent by haranguing people. By not respecting people's concerns. You have to address those. You have to do a lot of listening.

[11:10:00]

And recognize that some people are going to wait. They're going to wait until the first few million have been out there. They're going to wait to see, as this is given to people who did meet the criteria for a trial, whether it's still safe and effective in the same way. So, what this committee says in terms of how you monitor and look for that, the information out of the UK in terms of two people having a severe allergic reaction, that's really important information because that could change how you look to administer the vaccine to people who have had a history of allergic reactions. But more data like that is going to be really, really important to increase the levels of trust to the levels we really want to see.

BOLDUAN: Doctor Besser, thank you.

BESSER: Thanks, Kate.

BOLDUAN: Coming up, once a green light -- once a vaccine gets the green light it's up to each state to get millions of shots where they need to be. But what will they to do if they're not getting enough? The head of Maine's CDC is our guest.

Plus, President Trump and 18 Republican attorneys general asked the highest court in the land to throw out millions of votes. What this case is really about. We'll get to that.

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[11:15:18]

BOLDUAN: We are continuing to follow this critical meeting of the FDA advisory panel set to decide on emergency use authorization of Pfizer's coronavirus vaccine. So immediately after it gets the green light, which is expected, Pfizer is expected to kick into high gear to get the vaccine shipped out. And then it's all up to the governors and top health officials in all 50 states to get these shots into people's arms. It's a massive challenge in the race to beat the pandemic.

Joining me right now is Dr. Nirav Shah. He's one of the top officials in charge of vaccine distribution in the state of Maine. He's the director of Maine's CDC. Thank you for being here, Doctor. Do you have a clear sense of how many doses you'll be receiving in the first shipment?

DR. NIRAV SHAH, DIRECTOR, MAINE CENTER FOR DISEASE CONTROL AND PREVENTION: We do. And thank you for having me on, on such a momentous day.

We have been working with colleagues at Operation Warp Speed and the U.S. CDC. And we have good clarity on what the number of doses we will receive in the first week will be. And then going on, at least into weeks two and weeks three. We understand from our colleagues at Warp Speed that they're working with manufacturers to project what we may receive in weeks four, five and six, which better enables us to make our planning decisions.

BOLDUAN: In the first shipment, is it going to be enough? How far is it going to get you?

SHAH: Well, what we've been briefed on for months now, is that on day one, whenever the first shipment arrives of course it won't be enough for every single person in Maine who may want or need the vaccine. We're anticipating in our first week shipment enough vaccine for the first dose for about 12,600 people. Of course, that is not what any of us would have wanted it to be, that's a challenge and it's one that our department has been facing for many months.

Unfortunately, that has prompted us to have to make some difficult, unsavory choices. In our case and in many states, we follow the U.S. CDC's recommendations and we are going to be working with healthcare providers as well as the vulnerable patients they care for to make sure that they get vaccinated first.

BOLDUAN: You've laid out some pretty detailed -- some details on the plans for how the state is going to store and distribute the vaccine. For example, I was really struck, you wrote about this, you wrote about this last week. You wrote the phase that we're at right now is figuring out how many cubic feet of space hospitals have this minute in their freezers. Just the level of detail that you are into at this point I find fascinating. Why this level of detail?

SHAH: You know, for early on we started running the race and now we were -- a couple weeks ago we were in the last mile. Right now, we are in the last few feet. I think of it like a relay race. And just like in any relay race. Before the baton is handed to you, you've already got to start running. We've been running now for weeks.

Where we are right now is in recognition that those little small, seemingly granular details can make the difference of whether, for example, a hospital can actually accommodate 975 doses of vaccine or alternatively whether they need to have a vaccine that's diverted elsewhere and have it be piecemealed to them.

If we don't think through those details, not just the last mile but the last few feet, if we don't think those through now, we won't be able to achieve what our might to win goals in Maine, which is to vaccinate with velocity as well as equity. That's why this planning is so critical.

BOLDUAN: And Doctor, what does the lobster industry have to do with all of this?

SHAH: Well, owing to our robust seafood industry dry ice is a thing. And there are distributors of dry ice that are well-known to all of us. And as a result of that, the throughput, the supply chain of dry ice is something that helps us make sure that vaccine can be shipped outside the ultra-cold freezer environment for a number of days without the risk of spoilage.

So, we owe a debt of gratitude to our colleagues in the seafood industry here for paving the way to make dry ice, a commodity that is well-known to many of us here in Maine. That all of course helps get vaccines to the most remote parts of the state.

Again, our goal is to vaccinate with velocity but also with equity. And in a state like Maine, with rural and urban elements, keeping in mind that geographic equity is a top consideration for us. BOLDUAN: The lobster industry to the rescue. What are you most concerned about or maybe just nervous about and focused on as this massive effort is getting underway?

SHAH: Well, you're right. It's a massive effort. And this is what public health does every single day. My team and I at the Maine CDC, we come into work every day and we tackle what is seemingly impossible on a daily basis. But even for us this will be a significant challenge.

[11:20:06]

There are a few things that we are focused on right now in our problem-solving mode. The first is making sure we've thought the process through to the last few inches, making sure our IT System knows where vaccines are at any one moment and can spot instances of vaccines not being administered in a timely fashion.

So, the IT architecture is a top consideration. The other consideration that we're focused on is communication. It's one thing to have the vaccine, but unless folks use and take it up and are willing to receive it in high numbers, it doesn't get us anywhere.

So, a big focus of ours right now is communicating with folks to answer their questions. Too often, when we encounter folks that are hesitant with respect to vaccines, we treat it like a high school debate match. And we just try to score points off the other person. And that has never changed anyone's mind, let alone their behavior. What we want right now is to get folks who are on the fence to come to our side to get vaccinated. That's a big focus of mine right now.

BOLDUAN: Doctor, thank you.

SHAH: Thank you very much.

BOLDUAN: Still ahead for us, President Trump's latest long shot dead end attempt to overturn the results of the election. The Texas attorney general now suing four battleground states that President Trump lost.

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[11:26:14]

BOLDUAN: We could hear, as early as this afternoon, what the Supreme Court plans to do with a new legal challenge from President Trump to the already decided presidential election. To call it a long shot is beyond charitable. What's so startling about this one isn't that the president is involved, it's that he has 18 states attorneys general now in on it too.

This is a bit - this case originates with the Texas attorney general asking the highest court in the land to throw out the results in four states none of them Texas all of them battleground states, Michigan, Wisconsin, Pennsylvania and Georgia, all states Donald Trump lost. The request from this group of Republicans attorneys general amount to asking the Supreme Court of the United States to disenfranchise some 20 million voters. That's what they're asking.

Let me bring in CNN's Jessica Schneider. She's been looking for this very closely. Jessica, can you take us through this lawsuit?

JESSICA SCHNEIDER, CNN JUSTICE CORRESPONDENT: Yes, Kate. So, first the Supreme Court actually has to agree to let Texas file this case and that is a major procedural hurdle in itself. So, the Supreme Court it does have this what's called original jurisdiction over state versus state dispute but that's typically meant for border disagreements or lawsuits over water rights. And this is a case where Texas is suing to stop millions of votes in four battleground states from being counted and it's a case where Texas is calling into question the election procedures in those states. Mind you, election procedure is typically left for states to decide for themselves, that's all spelled out in the Constitution.

So, in this case, the Texas attorney general is asking the court to stop the certification process and in turn let the Republican led legislatures of these four battleground states decide the winner of the presidential race. This is all because the Texas AG is arguing that the changes made to broaden out mail-in voting in the states because of COVID were unconstitutional.

Specifically, he says because the decisions in many cases were made of secretaries of state and governors and not the state legislatures. So, really Kate, on its face, this is a dispute that probably should be brought in the lower court first but if the Supreme Court does decide it will allow it, it's quite possible it will shut it down just as fast as we saw earlier this week when the Supreme Court quickly denied a request from Republicans in Pennsylvania to invalidate 2.5 million absentee ballots.

And what's also important to point out here is that this case is being brought by the Texas AG, Ken Paxton, he's under federal investigation in a separate criminal indictment, Kate. So really, this could all be part of a pardon play, possibly, from the president because Ken Paxton is putting this forward. But regardless the Supreme Court has to agree in the first place to take this case up. And then it goes from there. So, we will see probably in the next day or two. Kate?

BOLDUAN: Jessica, thank you very much. The details of it really do matter.

Joining me now is a former Republican governor of Ohio, John Kasich who is a CNN senior political commentator. Governor, if we could set aside that according to all the smart people, I've heard from that this lawsuit isn't going anywhere. What is going on here? 18 attorneys general are now in on this.

JOHN KASICH, CNN SENIOR POLITICAL COMMENTATOR: Kate, what I wonder about is what happens in their offices when somebody comes in and suggests that they ought to file a brief, friend of the court brief. I was talking to my legal council last night and I said what would you have done if somebody had asked you to come in when I was governor and to pursue this. He said, I would never have come in your office because you would have told me to leave and maybe go home and soak my head in a bucket of water.

It's unbelievable. And I think, over time, this has the possibility of damaging their political careers. If I were a candidate against him, I would absolutely bring this up.