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FDA Reportedly Considering Requiring Two-Month Waiting Period from when Vaccine Trial Participants Receive Second Dose before Granting Emergency Approval for Coronavirus Vaccine; Justice Ruth Bader Ginsburg to Lie in Repose at U.S. Capitol; Sen. Sheldon Whitehouse (D-RI) is Interviewed About GOP Senators' Push to Confirm SCOTUS Pick Before Election Day. Aired 8-8:30a ET

Aired September 23, 2020 - 08:00   ET

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

[08:00:00]

ALISYN CAMEROTA, CNN ANCHOR: Now calls it a shame. You'll remember, he had said it is what it is.

JOHN BERMAN, CNN ANCHOR: New this morning, CNN has learned that the FDA is considering tough now authorization rules that could push emergency approval for a coronavirus vaccine past Election Day. That is if the president and the administration doesn't get involved some time in next few days.

Also, this morning, a new warning from the FBI with the election now just 41 days away. It is warning about foreign actors getting involved, but it might as well be warning about President Trump, because listen to what the Bureau says. It is warning against the false information in an attempt to discredit the electoral process and undermine confidence in U.S. democratic institutions. Again, it's warning about foreign actors. The president is doing that every day on the campaign trail right now.

BERMAN: Let's talk, though, about the pandemic and where we are heading into the fall and then winter. Joining us, CNN chief medical correspondent Dr. Sanjay Gupta. Also with us, CNN medical analyst Dr. Rochelle Walensky. She is the chief of the Division of Infectious Diseases at Massachusetts General Hospital.

And Sanjay, we know, and you've spoken to Dr. Fauci about this, Dr. Fauci wanted us to be at 10,000 cases per day by now. We're at about 40,000 cases a day right now. That is a huge gap. Why is that gap so important as we head into the winter?

SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Yes, and we're already starting to see I think what are objective signs of increasing numbers of cases now as well. So it plateaued for a long time, and we're already starting to see that tick upward.

The concern is that if you have so much virus that's already starting -- that's already spreading within the country, and then you layer in all these other factors, the weather is getting colder, people are starting to cluster more indoors, there's a lot of corona fatigue, as people know, so they may be less diligent about abiding by these basic public health practices, that's when you can run into a real problem.

Obviously, everyone hopes that that doesn't happen, and I always hesitate a little bit to show this graphic of 1918, but if we can show this for a second, we know that that sort of -- that pandemic occurred in three waves. It's the second wave that was the most frightening and tragic. And you had close to 200,000 deaths, 195,000 deaths occur in one month, the month of October. That's what you want to try and avoid here. And again, basic public health measures work. We've seen them work around the world. They can still work here in the United States as well.

CAMEROTA: Dr. Walensky, what are you seeing as fall hits and we head into winter?

DR. ROCHELLE WALENSKY, CNN MEDICAL ANALYST: Good morning, Alisyn. I echo what's been said. We squandered our summer. We should have been from 20,000 cases going into the summer, we should be at 5,000 or 10,000 cases a day. We are now at 40,000 cases a day. People are gathering. It's cold outside, people want to be inside. The air is drier, which means that the virus can be sustained in the air for a little bit longer because it's not as heavy, it doesn't fall. And I think we are at real risk unless we do more for prevention in terms of masks, in terms of distancing, in terms of really being careful, we saw summer footage of people gathering, of rallies, motorcycle rallies, political rallies, and I would say that did harm going into the fall that we were worried about.

BERMAN: It's a sobering place to be as we just begin to enter this season. Dr. Walensky, if I could stick with you on information that CNN has confirmed, "The Washington Post" was first to report it, that the FDA is considering new guidelines, a new structure for emergency approval of a vaccine. It would require a two-month waiting period from when the participants in one of the vaccine studies received the second dose. What would that do to the calendar, first of all, of when you would first be able to give emergency approval for a vaccine? And why, why have that waiting period?

WALENSKY: Great, thanks. I think that there is a lot of discussion and a lot of mistrust happening right now, both at the FDA as well as at the CDC. And maybe this is an attempt to try and regain some of that trust. Whether it will hold, whether that will be something that we actually see I think remains to be determined.

What this would do, as you say, is pose more stringent timelines, more stringent benchmarks such that we would have to wait beyond just seeing a first signal, but get some safety and some efficacy data two months after that second dose. So what does that mean in terms of time line? Well, the earliest of the three vaccine candidates that are currently enrolling in phase three trials started enrolling on July 27th. One of them has not even completed their 30,000 person enrollment. The Moderna vaccine is almost there. The Pfizer vaccine is not quite there, and the AstraZeneca vaccine, as we know, has been paused. But if you look at that timeline, by the time they have received their second dose two months after that, we're talking about probably late November at the very earliest, early December.

[08:05:06]

And then I really want to sort of just remind people that the rollout of this vaccine is going to be an enormous effort when and if it is approved.

CAMEROTA: Sanjay, do you have new information on this FDA announcement?

GUPTA: No, the same sort of thing in terms of the timeline. One thing that Dr. Walensky was pointing out is the efficacy data as well is going to be important. We have gotten a look at the protocols with regarding to these vaccine manufacturers, the protocols that they're going to be looking for. And one of the things that jumped out a little bit was you have the placebo group, you have vaccinated group. What degree of infection do you need to see in the placebo group in order to say the vaccine is definitely working? In part it's the number of infections, but another part of it is the severity of infections as well.

And there's been some concern that the protocols allow for too mild of an infection to count. If the infections are too mild in the placebo group, then all you can really say is the vaccine is sort of providing protection against mild disease. So in a strange way, you want to see more serious infections in the placebo group in order to say that the vaccine is really working. And that's something that's starting to come out in these protocols, and hopefully they'll be modified in order to actually show the effectiveness of this vaccine in a significant way.

BERMAN: So the head of the public health agencies will be testifying on Capitol Hill, and they will face a lot of questions. I'm sure the FDA timeline will be one area where they will face questions. It will be interesting to see if they stick to their guns on this new protracted timeline. They also might be asked, Sanjay, about the CDC guidelines, a little bit of an alphabet soup here, but the CDC guidelines that were taken down suggesting that the virus is aerosolized. You had a chance to talk to Dr. Fauci about this. What did he have to say?

GUPTA: This has been a point of debate back and forth, I've got to tell you, for some time, and I'm not sure what Dr. Walensky thinks about this, but I went back and looked at some of the data going back to early summer, and I think there's been pretty significant evidence that this tiny virus, about less than a micron in size, could aerosolize, could actually get into the air, suspend itself, and perhaps travel more than six feet.

And there's implications to that. It means especially if you're in an indoor setting, poorly ventilated, it's not just being six feet away from somebody, you need to wear a mask regardless because that virus could be spreading through the air. They had that on the CDC's website on Friday. People said finally. And then they took it down a few days later. I asked Dr. Fauci, what is the truth, can the virus spread this way?

(BEGIN VIDEO CLIP) DR. ANTHONY FAUCI, NATIONAL INSTITUTES OF ALLERGY AND INFECTIOUS DISEASES: You can make a reasonable assumption, Sanjay, that some aspect of transmission can be and is by aerosol. The interesting thing about that, it doesn't change anything that we have been saying. It means wear your mask. It means avoid close contact.

(END VIDEO CLIP)

GUPTA: So as he points out, it doesn't necessarily change what we should be doing, should have been doing at least in places. But I think visually, you think of the respiratory droplets in close quarters, that makes a lot of sense. But if you start to think or imagine the virus more like in these clouds of smoke that can waft around rooms, it does change your perception a little bit and maybe makes you more diligent about wearing the mask.

CAMEROTA: And on that front, Dr. Walensky, since so many of us are wearing masks and still social distancing is there some hope -- maybe you're seeing some evidence that the flu season won't be as bad as predicted?

WALENSKY: Yes, it's a great question. So I do think that if those of us who are wearing masks, distancing, getting their flu shots, doing everything that we should be doing to prevent coronavirus, we have every hope that we'll have a more mild flu season here. The problem is, as you can see, there's plenty of coronavirus out there, which leads us to believe that many people are not taking those measures, and those people are therefore not only at risk of coronavirus but also at risk of influenza.

And I want to echo what Dr. Gupta is saying and say, yes, we have known for a long time that aerosolization of this virus is possible, that you can get it from aerosols. And the science, when it's posted on the CDC website and then removed just has fingerprints of the government on it.

CAMEROTA: Dr. Walensky, Dr. Sanjay Gupta, thank you both very much for all of the information.

WALENSKY: Thank you.

CAMEROTA: All right, well, thousands are expected to pay their respects to Justice Ruth Bader Ginsburg today and tomorrow as she lies in repose at the Supreme Court. Dozens of her former law clerks will play a key role today. And CNN's Jessica Schneider is live at the court with a preview. So what do we expect, Jessica?

JESSICA SCHNEIDER, CNN JUSTICE CORRESPONDENT: Well, Alisyn, those law clerks will be waiting here at the Supreme Court when Justice Ginsburg's casket arrives around 9:30 this morning.

[08:10:01]

All of those law clerks will be serving as honorary pallbearers. They also will be standing watch, standing guard over Justice Ginsburg's casket over the next two days of public viewing. So the rundown will look like this. At 9:30 this morning, Justice Ginsburg's casket arrives here at the Supreme Court. That's when it will be brought into the great hall for a private ceremony. That will be for close friends and family, and the justices speaking at that will be Chief Justice John Roberts as well as a rabbi.

After that, the casket will be brought out to the portico here at the top of the Supreme Court steps, and that's when the public viewing will begin around 11:00 this morning. There will be two days of public viewing until 10:00 p.m. each night. We are expecting thousands and thousands of people here. All of the roads around the Supreme Court have been blocked off for people to gather and then file in to line to come here for the viewing where Justice Ginsburg will lie in repose.

After that public viewing, Justice Ginsburg's casket will go across the street for Friday where she will lie in state at the U.S. Capitol, making history as the first woman to lie in state. And then next week we're expecting that private burial service, that will be at Arlington National Cemetery. And Alisyn, that is exactly where Ruth Bader Ginsburg's beloved husband Marty is also buried. So they will be buried together at Arlington. Alisyn?

CAMEROTA: That is really touching. Jessica, thank you very much.

Well, President Trump says he'll announce his Supreme Court nominee this weekend. Senate Republicans are speeding towards a confirmation hearing and a vote before Election Day. We're going to get reaction from a Senate Democrat, what are they going to do, next.

(COMMERCIAL BREAK)

[08:15:14]

JOHN BERMAN, CNN ANCHOR: President Trump says he will announce his Supreme Court nominee on Saturday afternoon. Senate Republicans are now laying the groundwork for confirmation hearings next month and a vote possibly before Election Day.

Joining me now is Democratic Senator Sheldon Whitehouse. He is on the Judiciary Committee.

Senator Whitehouse, thank you very much for being with us.

And we should also say that the leading contender all reporting says is Judge Amy Coney Barrett, who's an appellate judge.

So, my question to you is, to what extent will you as a Democrat on this committee participate in these hearings that will be scheduled for next month?

SEN. SHELDON WHITEHOUSE (D-RI): I expect to participate. I don't know of any decision that we have taken not to. And I think participating gives us a chance to make some important points about what's going on around here with these judicial nominations. As you know, there's a lot of very weird behavior happening and we haven't focused enough on the why of all that weird behavior.

BERMAN: What do you mean?

WHITEHOUSE: Well, the elimination of legislation in the Senate for basically an entire Congress. That's pretty weird. The smashing through of all sorts of norms and traditions and rules of the Senate, that's pretty weird.

The hypocritical -- hypocritical reversal of the -- a full 180 really on whether you should be filling Supreme Court seats immediately prior to an election, that's a little weird. And all my Republican colleagues coming out to support a nominee before the nominee has been named, that's all a little bit of weird, and the press has covered the who and the what and the where and the when pretty well, but there's been precious little look at the why.

And if you look at the why, you've got a whole second section of who, what, when, where questions about how the money flows, and what these groups are doing, and who gives $17 million donations to the scheme and all of those questions that we have a chance to drill in to.

BERMAN: And you said we'll talk about that in whatever hearing in a couple of weeks.

WHITEHOUSE: That's my plan.

BERMAN: Judge Amy Coney Barrett, you voted against her when she was up for confirmation for the appellate court. What do you plan to ask if she is the nominee?

WHITEHOUSE: I don't know. I don't give away my questions in advance.

But I think it is important to continue to focus on this question of whether these people are being brought on to be judges to provide fair and impartial justice, or whether all the filtering that they've gone through by the big donors behind the Federalist Society and the big donors behind the Judicial Crisis Network, and all of that will be part of a plan that so far has teed up 80, 80 partisan 5-4 decisions under Chief Roberts that gave wins to big Republican donor interests.

And if we've got a court that is going to be serving big Republican donor interests rather than justice, we have a real problem on our hands and I think we need to drill into that.

BERMAN: The Biden campaign is trying to focus on the health care decision and the case that the Supreme Court will hear on November 10th.

How important do you think that issue is and how important it will be in the confirmation hearings?

WHITEHOUSE: Yeah. I think it's very salient for a lot of Americans. We just went through 200,000 deaths. We have millions of people who have been infected. We have an economy that is in upheaval, all because of a pandemic. And in the middle of a pandemic people like to be able to know that they have got real health insurance.

So, the persistent Republican effort having failed in the Congress to throw out Obamacare in the courts and take away people's pre-existing conditions I think is a real focus for people. It's one of those gut 2:00 in the morning worries that people wake up and think, oh, my God, what happens if they do this, and they're out to do this.

So, it's -- it couldn't be more pertinent.

BERMAN: To what extent is the nominee's faith a factor for you?

WHITEHOUSE: We have gone over this in the Judiciary Committee over and over again and I abide by what I call the robing room rule. I honestly don't care about a nominee's faith. I don't think it's really our business, as long as they can leave their beliefs in the robing room, and when they step up on the bench, they're then judges for the law and not representatives of a particular faith or sect or cult or anything else. That's the test.

And if they're so infatuated with some extremist views that they may have, who knows what religion we might see judges come before us with some day. But if they don't pass the robing room test, I don't think they believe they should be on the bench. Every American should be treated fairly before the law and not run through some judge's personal religious screening.

BERMAN: I want to ask you a couple of questions about news of the day here. One, the FBI has put out new warnings about the efforts of the Russia to undermine the election. We learned yesterday that the CIA put on assessment that Vladimir Putin is probably directing the efforts to undermine Joe Biden.

[08:20:04]

Now, the FBI is saying that the foreign actors are trying to spread false information about the integrity of the elections. They say, quote, they may spread false information in an attempt to discredit the electoral process and undermine confidence in U.S. democratic institutions.

The FBI is warning the Russians are doing that.

WHITEHOUSE: Yes.

BERMAN: But all you have to do is listen to what's being said on the campaign trail. It's not just the Russians.

WHITEHOUSE: No, there's a lot of false information out there and it's one of the reasons that our major platforms need to step up and clean up their act. I mean, I sat next to Al Franken the day that he asked the telling question of Mark Zuckerberg about not realizing that something was up when they were running political ads that were paid for in rubles.

So, the Facebook and the other platforms have a huge clean-up job to do to protect us from deliberate, false disinformation, much of it prompted by or spun out of Putin's shops. And at the moment, unfortunately, we have so much creepy political American dark money and disinformation that we're a little bit pinioned in our ability to combat foreign disinformation, because if you clean up the foreign disinformation channels, now, the fossil fuel industry can't do their climate change disinformation, for instance, at least not in the same way.

BERMAN: I want to ask you --

WHITEHOUSE: So, we've left ourselves exposed to this in ways that are wrong.

BERMAN: I want to ask you about something the president, and let me preface this by saying that first generation Americans, new immigrants to America, this is their country. Our country is for anyone who is an American, no matter where they were born.

Now, that said, the president continued persistent attacks on Congresswoman Ilhan Omar who is born in Somali but is an American citizen. I want you to hear it.

(BEGIN VIDEO CLIP)

DONALD TRUMP, PRESIDENT OF THE UNITED STATES: How about Omar of Minnesota?

(BOOS)

We're going to win the state of Minnesota because of her, they say. She's telling us how to run our country.

How did you do where you came from? How is your country doing? They're going to tell -- she's going tell us -- she's telling us how to run our country.

(END VIDEO CLIP)

BERMAN: What do you make of that?

WHITEHOUSE: Donald Trump has a taste for cruelty and he enjoys picking on people. And the only thing that's worrisome and distasteful is this president's comments in that circumstance was that roar of approval and anger and hatred from that crowd. Not a great American moment.

BERMAN: Senator Sheldon Whitehouse of Rhode Island, we appreciate you being with us this morning.

I want to give you a give you a quick programming note. Cindy McCain will join Jake Tapper to talk about why she is endorsing Joe Biden. That will be on "THE LEAD" at 4:00 p.m. Eastern, here on CNN.

So, each of the Americans who died from coronavirus, they're all people with families, friends, colleagues mourning their loss. We're going to speak to the friends of a young doctor whose promising future was cut short by the virus, next.

(COMMERCIAL BREAK)

[08:27:17]

(BEGIN VIDEO CLIP)

BRANT FAGAN, DAUGHTER, DR. ADELINE FAGAN, DIED OF COVID-19 COMPLICATIONS: She just loved to help people. She really, really did. That's what she saw was her goal in life was to help women especially, but to help people, underprivileged people.

MARY JANE FAGAN, DAUGHTER, DR. ADELINE FAGAN, DIED OF COVID-19 COMPLICATIONS: I basically held her until the very end. And that was pretty much it. You know?

So we are very thankful that we had that opportunity. So many parents have not been able to and that breaks my heart.

(END VIDEO CLIP)

ALISYN CAMEROTA, CNN ANCHOR: That's Dr. Adeline Fagan's mother and father talking to Anderson Cooper about her life and her final moments.

Dr. Fagan was a medical resident working at a Houston hospital before coronavirus took her life at just 28 years old. She was also a sister, a daughter and a friend to so many people.

Joining us now, three of Dr. Fagan's close friends from medical school, Dr. Catherine De Guzman, Timothy Shub, and Tiffany Lin.

Thank you all for being here. I really -- I'm so sorry for your loss.

Catherine, this isn't supposed to happen to a healthy 28-year-old. I mean, you as a doctor, do you have any medical explanation for why she died from this?

DR. CATHERINE DE GUZMAN, RESIDENT PHYSICIAN, MAIMONIDES MEDICAL CENTER: There wasn't and there really is no medical explanation that I can personally fathom. It's not something that you think of at 27, 28 that your friend dies. And that's kind of what's happening during this pandemic. We're seeing all these young adults getting infected by this virus and it breaks my heart to see people outdoors with no masks on, knowing that there's like loved ones suffering because of it.

CAMEROTA: Catherine, I know you yourself were very sick with coronavirus back in April, but you recovered as we expect people your age to.

DE GUZMAN: And I think that's why it's really hard for me to accept that this actually happened. I have like nightmares and I wake up thinking that maybe this isn't real. But then I remind myself that it is.

CAMEROTA: Tim, or Timothy, do you know if she knew -- if she knew how sick she was or did she think she was getting better?

DR. TIMOTHY SHUB, RESIDENT PHYSICIAN, STONY BROOK UNIVERSITY HOSPITAL: In the beginning when she initially got sick at the hospital, you know, she had asthma. So being a little short of breath wasn't the end of the world for her. She had her inhalers and she went home and she was taking steroids.

And, you know, just like, you know, Catherine is a little ill in April, I was also sick myself, and we both got better. So, we thought, Adeline will get better too.

Unfortunately, that wasn't really the case for her, she kind of just kept getting worse and worse, and had too go.