Return to Transcripts main page

CNN Newsroom

FDA Panel Reviews Emergency Authorization for Moderna Vaccine; Two Alaska Health Workers Suffer Allergic Reactions after Vaccination; Lawmakers Looking at Stimulus Deal Close to $900B. Aired 11-11:30a ET

Aired December 17, 2020 - 11:00   ET

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

[11:00:25]

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

Right now, an FDA advisory panel is meeting, debating and will be deciding whether to recommend the agency grant emergency authorization for Moderna's coronavirus vaccine. The vaccine is expected to get the green light, FDA scientists have already found the vaccine to be safe and effective after reviewing data from the company. Listen to this.

(BEGIN VIDEO CLIP)

DR. DORAN FINK, DEPUTY DIRECTOR, FDA DIVISION OF VACCINES: Similar to the case with the Pfizer vaccine last week, FDA has reviewed the manufacturing information provided by Moderna and found it to be adequate to support issuance of an EUA. We expect clear and compelling safety and efficacy data to support a favorable benefit risk of the vaccine when rapidly deployed for administration to millions of individuals, including healthy people.

(END VIDEO CLIP)

BOLDUAN: So, this all could mean the country could be just days away from shipments heading out the doors of a second coronavirus vaccine. This is great news. But it is not all good news today. Actually, there's some very tragic news. The country is in a full-blown crisis. As we've just seen the worst single day in the pandemic by every measure.

More than 3,600 new deaths were reported just yesterday. The deadliest day yet and more people than ever are in the hospital with coronavirus. 113,000 people now hospitalized. ICUs are overflowing. More than 247,000 new cases were reported yesterday. Also, a record high. And just moments ago, the country, as you see on the side of your screen, the country passed 17 million total confirmed cases of COVID.

Let me bring in right now Dr. Sanjay Gupta. Sanjay, the statistics as we're looking at them are just horrible. Which is why this FDA meeting that's happening as we speak today on the Moderna vaccine is so critical. What have you been hearing from the panel? What are the issues that they're focusing on? DR. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Yes. I mean, it is whiplash, first of all, Kate, I mean just to have such awful news and potentially such good news on the same day. What the FDA advisory committee is looking at, the basic question they want answered at the end of the day is do the benefits outweigh the risks to basically validate an Emergency Use Authorization for people 18 and older for this vaccine.

Remember, the Pfizer vaccine was for people 16 and older. This is for people 18 and older. We can show you some of the specifics about these vaccines, but you know when you listen to these advisory committee meetings, the things that we know, is that it's likely to get authorization. We get an idea of who it's likely to be good for. They also want to really drill down on who -- if there's any populations of concern, such as people with allergic reactions.

They're pretty similar vaccines. You can see them on the screen there. Couple differences three weeks apart for the Pfizer vaccine between the two doses, four weeks apart for the Moderna vaccine. Moderna does not need to be kept quite as cold so it can be distributed more widely.

And again, that age thing that ended up being an issue with the Pfizer vaccine, a point of discussion for the Pfizer vaccine. They thought -- some thought maybe it should be 18 and older as well for that. But regardless it looks very promising that we would have both of these vaccines authorized, you know, within the next couple of days and that the government has bought 200 million doses of the Moderna vaccine, which would obviously go a long way towards trying to get to as many people immunized as possible.

BOLDUAN: Absolutely. And you mentioned this, but on the Pfizer vaccine, Pfizer is reporting that they're now studying these two cases of people having an allergic reaction to the vaccine in an Alaska hospital. How concerning is this? Can you kind of give me your thoughts on this?

GUPTA: You know I think this is one of those things that we definitely need to pay attention to. We need to track and not ignore. And this is basically as part of the Emergency Use Authorization. There is an adverse event reporting system that's in place so we will hear about these adverse events.

A couple things to keep in mind. I want to show you what these two people, what they -- actually, the symptoms that they had. And as you look at the symptoms, keep in mind that even with other vaccines, one in a million people do have significant allergic reactions on average. If you start giving it to hundreds of millions of people you are going to see hundreds of these types of allergic reactions.

[11:05:00]

The first person, a woman was a more significant reaction. That sounded like a true anaphylactic reaction. She had flushed feeling first within a few minutes of receiving the vaccine, a shortness of breath, ended up getting epinephrine, needed more epinephrine in the form of a drip. So, a constant infusion of epinephrine, and then eventually recovered. But it was a significant reaction.

The second person does not sound like it was a true anaphylactic reaction. But again, symptoms came on quite quickly. Eye puffiness, scratchy throat, that resolved with epinephrine, some Benadryl and Prilosec. So, you know, they're going to keep an eye on these.

It's curious that they both happened at the same hospital. We'll see if we see more of these types of reactions around the country.

BOLDUAN: Yes. Sanjay is listening in to this meeting as it's going on. Thank you.

Joining me right now -- got a lot of questions. CNN medical analyst Dr. Jorge Rodriguez. He is also a viral specialist. And Dr. Gregory Poland, he is director of the Mayo Clinic's Vaccine Research Group, and editor in chief of the journal, vaccine.

Dr. Rodriguez, what are you picking up so far from this FDA meeting that's taking place as we speak?

DR. JORGE RODRIGUEZ, CNN MEDICAL ANALYST: What I'm picking up is that first of all we have a very effective and safe vaccine. It's very similar to the Pfizer but as much as Sanjay said, it is so much easier to distribute it.

So, I'm picking up what we already know, there's been transparency in the data. It appears as if this is a shoe in to be recommended by this advisory committee. And what I'm picking up is we're going to have a doubling of the amount of vaccines available to the U.S. public and healthcare workers within a matter of days.

BOLDUAN: Which is great news. Dr. Poland, when the same group met on the Pfizer vaccine, the meeting went on for multiple hours. What are you going to be listening closest for as this continues today?

DR. GREGORY POLAND, DIRECTOR, MAYO CLINIC'S VACCINE RESEARCH GROUP: You know I would agree with Jorge that the concerns that come up around allergies and hypersensitivity reactions are probably going to be the focus of the meeting. Earlier this morning it was how do we deal with having two vaccines by EUA and trying to maintain the blinded nature of the studies so that we learn the most and how might we negotiate that. So those are the key things that I think are going to come up and be discussed.

BOLDUAN: And Dr. Rodriguez, can you give me your thoughts on the allergic reaction. Sanjay was giving kind of the reporting on it and that Pfizer was tracking this and they should be looked at. What do you think and hear? What should the public consider and know when you hear about these two allergic reactions in Alaska?

RODRIGUEZ: Well, like already have been mentioned we need to keep this in context. So far there have been four allergic reactions worldwide when tens of thousands of people have already received this vaccine. That is not something that needs to be ignored, but it is something that is expected, almost with any vaccine, any injection. So again, this should not dissuade anybody that is able to get the vaccine to do so, because you have a much greater risk of having COVID and complications from that. However, if you have had allergies before or if you're afraid of that, you may want to wait a little bit and obviously get the vaccine in a place where they can treat you if something happens. But it is something that does happen.

BOLDUAN: For this vaccine and others as well --

RODRIGUEZ: Absolutely.

BOLDUAN: -- as you have well mentioned.

Dr. Poland, one thing that also came up in this meeting of the FDA panel this morning and it's something that a lot of us who don't have medical backgrounds find really fascinating is that pharmacists have been found that they've been able to squeeze extra doses of the Pfizer vaccine from the glass vials that they're in. In the meeting this morning, they said that this is not unexpected. Can you explain this? Does this surprise you?

POLAND: No, not really. Because what you're doing is, you're putting 1.8 ml of fluid into the vial in order to reconstitute it. So logically you're able to get more.

Now what the company is going to say is you know be conservative. You can get five doses out of it. But it turns out you can get six to seven doses out of it, which is a great, fantastic thing, in terms of increasing the supply of vaccine, so not unexpected.

BOLDUAN: Fascinating though, nonetheless. More than I've ever even thought to learn about inoculations and vaccines. It's really a very cool thing.

Dr. Rodriguez, the country back to the sobering fact of where we are right now. The country is in the worst place it's been with this virus yet. It's hard to even imagine that considering the number of conversations you and I have had. The deadliest day yet and the worst day by every other measure as well. What do you attribute this to at this moment?

RODRIGUEZ: Well, I -- first of all, this was something that was expected. All the metrics that were put out there months ago basically predicted this.

[11:10:02]

So, I want the public to realize that when those of us that are familiar with this say this, it is because there is science behind it. In California, first of all, we're the most populous state in the union. There are a lot of areas around Los Angeles that have not been adhering to mask mandates and have equivocated you know their political freedom with protecting others. And we have a very large - I'm not blaming it just on this. but we have a very large population of migrant workers and people that are not documented that are afraid of going to seek help and that's a social issue that must be corrected immediately.

So, we're the most populous state. We have a very diverse population and people move around all over California. That's what's happening here in my state.

BOLDUAN: Thank you both very much. Dr. Jorge Rodriguez, Dr. Gregory Poland, thank you.

Let's turn now to another aspect of this crisis. Capitol Hill, congressional leaders are still trying to work out a deal on a COVID relief package. Both sides keep saying that there is progress, but this relief has been needed for months and that desperation hasn't done anything to move Congress any faster.

CNN's Manu Raju, he is joining us right now. He's on Capitol Hill. He's been tracking all of this as it's going on behind closed doors. Manu, what are you hearing now?

MANU RAJU, CNN SENIOR CONGRESSIONAL CORRESPONDENT: Well, I just had a chance to speak to the number two Senate Republican John Thune. And he told me that he expects the real possibility that they may need to extend the deadlines to essentially allow these talks to continue.

Remember those, as you mentioned, a deadline that would shut the government down by midnight, Friday, 11:59 p.m. Friday. If there's no agreement to fund the government. And that's important for the COVID relief talks because they want to tie the COVID relief proposal unto the government funding package.

But there is no deal yet over the COVID relief proposal between the Republican and Democratic leaders. So, what John Thune just told me is that there is a real possibility they may have to extend the deadline 24 to 48 hours to try to get an agreement potentially in the next couple of days. Sort of get it through Congress very quickly after that.

Now, there are also several key outstanding issues in the talks including how exactly to structure direct payments to individuals. There's part of this agreement, there's $600 they're talking about to give to individuals to -- who are hurting from this pandemic, people who actually are under a certain income threshold.

What John Thune told me is that there's a debate right now by how to, in his words, restrict who essentially gets that money to ensure that people who, in his view, who actually need the money are getting the money. So, there's a debate about how to structure that language that is still outstanding.

But this proposal, as you see on your screen there, includes about $900 billion for COVID relief overall. But in addition to that, part of that, $300 a week for jobless benefits. As we know jobless benefits for millions of Americans are expiring in just a matter of days. That's a critical part of this proposal. In addition to about $330 billion in loans for small businesses. But there are a whole host of other issues that they're still trying to close out. John Thune mentioned also money that would be administered by FEMA. They'll go out to states and cities. He said that debate is ongoing internally as well as other issues such as limiting the Federal Reserve's emergency lending program.

So, we'll see if they're able to reach an agreement. There are signs of optimism that they can still get a deal, even from Nancy Pelosi this morning. So, there's real progress but always those last few issues so hard to close out.

Can they get there? How quickly can they get it done? Big questions here but still we expect they'll get it done but it could extend until next week here. Kate?

BOLDUAN: All right. Manu, thank you.

So, coming up for us, Manu just laid out where things stand with the coronavirus kind of negotiations for relief deal. So, what is holding up a coronavirus relief deal still? Is there really any hope, as Manu was pointing to, the House majority leader joins us next.

Plus, a massive hack into the U.S. government. Russia is suspected. President Trump's former Homeland Security adviser now says the damage could be even worse than expected.

(COMMERCIAL BREAK)

[11:18:23]

BOLDUAN: The latest measure of the country's economic recovery is out and it's not good. 885,000 Americans filing first time unemployment claims last week. That number has risen for four of the last five weeks, pointing to a job crisis that is worsening. Which means help from Congress is more needed than ever.

Joining me right now is the second highest ranking Democrat in the House of Representatives, the majority leader Steny Hoyer. Congressman, thank you very much for coming on. I got an update from Manu kind of where he's heard the negotiations stand. I care about your perspective on this. Can you guarantee to folks out there that you guys are going to get a deal done?

REP. STENY HOYER (D-MD): I can guarantee that we'll get a deal done. I can't guarantee how soon that's going to be. I can guarantee that because hopefully every member of the House and Senate see the economic crisis that confronts our families, our individuals and our small business and the continuing surge of the health crisis in America.

It is a moral imperative, in my opinion, Kate, that we come to an agreement and come to it quickly. If it doesn't happen, we're going to not be doing our job, number one.

Number two, it will increase the crisis for the government shutting down at the very time when government services are absolutely essential to confront both the economic and the health crisis that is plaguing America. This pandemic needs to be fought and needs to be fought with all hands on deck.

[11:20:02]

BOLDUAN: You set the floor schedule. When are you expecting votes?

HOYER: Well, we're going to have votes on some bills that are not controversial that we will pass. But what I'm hoping is that by tomorrow, we are ready to pass a bill that will fund the government and a bill that will provide substantial -- billions of dollars for health, for rent payments, for unemployment insurance extension, and additional payments, family payments, hopefully dealing with the nutritional challenges where people are having trouble having food on their table. We need to deal with all of those issues. We need to deal with them now and hopefully a bill will be ready tomorrow to do that.

Now, when I say, "ready tomorrow to do that," it obviously depends on how quickly that can be put into bill form that we can consider. I will tell you that I think most of the bills are written. Whether it's on the appropriations side, the omnibus as we call it, or on the COVID-19 side, the economic and health bill.

I think much of that is already written. But the last few items that need to be resolved, which are being discussed now, if we can get that done, I'd like to put it on the floor tomorrow. Even if it's late tomorrow into the evening hours.

BOLDUAN: OK. What is a sticking point right now? Can you help me understand that?

HOYER: Well, there are a couple of technical difficulties. In other words, if you reach an agreement on how much money is going to be paid to families, how is the formula to determine that going to be done. If you're talking about rent subsidies, how is that going to be done? So, I think really right now is some of the small technical difficulties.

Unfortunately, I think one of the difficulties as I understand it, is how robust nutritional program will be, Supplemental Nutrition Assistance Program, SNAP, seems to be an item.

For me, it's hard to understand why that's a sticking point when we see lines of people who never expect to be in a food line in their entire lives are there because they want to feed their children and themselves. We ought to be acting. We ought to be acting decisively, robustly and effectively.

BOLDUAN: Well, look, what I'm getting from you is confidence, though you're not going to -- until you see the language, you're not going to say we're over the finish line. I hear confidence from you. If you are looking at a $900 billion deal now, I do wonder if the speaker would have been better served to have accepted what was a bigger deal offered pre-election?

HOYER: Well, when you say it was offered, the president, of course, said something about a bigger number. But the person who controls what goes on the Senate floor never said that. Senator McConnell.

And as you know, we passed four bills in March and April, overwhelmingly in a bipartisan fashion and then for whatever reasons when we passed the last bill, McConnell, when we talked about state and local assistance, he said, let the states go bankrupt and the majority leader or the minority leader in the House of Representatives, Mr. McCarthy, said let's wait and see.

Well, we waited and saw. The Senate didn't act on our bill. It didn't have its own alternative. It didn't amend our bill and send it back. It just did nothing.

BOLDUAN: This hits to kind of what - I mean, you're touching on this, but let me put a finer point on it. This has been going on for months, the need and desperation is clear. There's no question that it's needed. What do you say to the millions of Americans -- you talked about some of them -- who have found themselves in food lines for the very first time, who have lost their jobs, new data shows that it's getting worse in the months just in the months that you all have been at a stalemate over these negotiations.

HOYER: What do I say to them? I say to them, you ought to be upset with us. You ought to be very disturbed that your Congress is not responding.

There was a man on television the other day, a program, his name was John and he looked at the camera and he said, I'm desperate. Please help me. That's why I say it's a moral imperative.

And why we haven't gotten to that deal is I think because, frankly, according to Senator McConnell, said the majority of his caucus doesn't want to take any further action. I don't understand that, Kate. That is not acceptable.

We need to act. We need to act quickly. And we need to act with sufficient resources available to people that we try to help them, try to help heal their pain and make them able to survive and small businesses to survive.

[11:25:03]

So, what I say to them, they ought to be angry. The Congress should have acted. And Republicans, frankly, if they didn't like our proposal in May, if they didn't like our proposal in October, should have come with one of their own.

They came with a $500 billion one, which every economist said was totally insufficient to meet the need. So, we rejected that. Then we offered something that was a lot smaller than -- we had a 3.4 trillion, we went down to 2.2 trillion, a 35 percent decrease.

BOLDUAN: And now you're going to be - and now you're going to be at $900 billion. And so, that's why I'm -- I really do wonder that after all of this, let's just assume you get a deal done. If you're actually going to consider this success, since you're now - you're now far less than where you wanted to be and far less than where negotiations - where you thought an offer was even pre-election. Are you going to consider this a success? HOYER: I think it's the right thing to do, it is not a success. It is the right thing to do. A trillion dollars is -- $908 billion is not chicken feed and it will obviously help millions and millions and millions of people.

Is it enough?

No.

Will we be back at the table?

Yes.

BOLDUAN: How soon? In the first 30 days of the next administration? The first 100 days? When?

HOYER: I don't want to put a date on it, Kate. That's sort of a game. And this is not a game.

(CROSSTALK)

BOLDUAN: I just want to - look, you know what I want to do. I want you to lay down a marker that I can hold you to.

(LAUGHTER)

HOYER: I know you do. And I would hope that we would do whatever we need to do. This is a four-month bill. And certainly, in that time frame we'll be coming back, we've had a tough transition as you well know because Trump and the Republicans wouldn't admit that Biden won the election. So, it's been tough.

But I think he's going to hit the ground running. He's already said, President-elect Biden has said, he wants to deal with this and make sure that we are giving the kind of help that is needed. I think we're going to be doing that. We're going to be considering that in January. I don't want to be held to a magic date, but we need to get it done ASAP.

(CROSSTALK)

BOLDUAN: We're going to have you back on in January and still hold you to it.

HOYER: This is the start.

BOLDUAN: This can be the start.

(LAUGHTER)

HOYER: OK, Kate.

BOLDUAN: First, get this - get it done.

HOYER: All right.

BOLDUAN: Thanks Congressman. Thank you so much.

HOYER: You bet. Thank you.

BOLDUAN: Coming up for us. For the first time, Vladimir Putin is responding to a CNN investigation into the poisoning of one of his most outspoken critics. That's next.

(COMMERCIAL BREAK)