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FDA Releases New Data on Pfizer's Vaccine Ahead of Critical Meeting; Operation Warp Speed Picked Six Vaccine for Portfolio; U.K. Gives First Doses of Pfizer COVID-19 Vaccine; Pennsylvania Governor Warns Hospitalizations are Reaching Critical Levels; Futures Lower Amid Concerns Over Stimulus Plan and Rising COVID Cases. Aired 9-9:30a ET

Aired December 08, 2020 - 09:00   ET

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

[09:00:01]

JIM SCIUTTO, CNN ANCHOR: A very good Tuesday morning to you. I'm Jim Sciutto.

POPPY HARLOW, CNN ANCHOR: And I'm Poppy Harlow.

Today a major milestone in the fight against the coronavirus. Britain is giving out its first doses of the Pfizer vaccine this morning. 90- year-old Margaret Keenan became the first recipient less than one week after the U.K. approved it. And it's something perfectly British, the second person to receive the vaccine, an 81-year-old man, aptly named William Shakespeare.

As people received their vaccines in the U.K., the president, President Trump, says he's going today to sign an executive order aimed at prioritizing the shipment of vaccines to Americans before any other nations. That's according to senior administration officials, but he can't really do that.

SCIUTTO: Well, the chief scientific adviser for Operation Warp Speed was asked about this this morning. Listen to his answer.

(BEGIN VIDEO CLIP)

GEORGE STEPHANOPOULOS, ABC NEWS ANCHOR: Can you explain this executive order the president is going to be putting out? I don't quite understand it. He's saying that foreign countries aren't going to be able to get the vaccine until everybody here in the United States gets it. It sounds like the problem is the opposite right now. Pfizer has made deals with other countries that are going to limit the supply here.

DR. MONCEF SLAOUI, CHIEF SCIENTIFIC ADVISER, OPERATION WARP SPEED: Frankly I don't know, and frankly I'm staying out of this. I can't comment.

STEPHANOPOULOS: You don't know?

(END VIDEO CLIP)

SCIUTTO: He is in charge of the vaccine rollout, by the way, as appointed by the administration and he is saying he doesn't want to get involved in it. Right now the U.S. is seeing the deadliest week since April, more than 15,000 Americans died and the U.S. reported more than one million new infections. That is people infected with this virus.

And breaking just moments ago the FDA released new information specifically on the Pfizer vaccine before the FDA's critical meeting on Thursday. Sanjay Gupta has more.

So, Sanjay, if we could begin first with this new guidance, what are we learning?

DR. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Well, so this is a 53-page sort of briefing document that this advisory committee is going to be looking at and making the determination about Emergency Use Authorization. Obviously we've heard some of this data already, some of this came from the company, but this is the first time we're now seeing the data sort of laid out in terms of who the trial participants were, in terms of their ages, their backgrounds, their ethnicity, their preexisting conditions, and also giving an idea of just how effective it was in these various age groups.

So a couple of things that sort of jump out. First of all, the numbers seem to hold up. We heard that was 90 percent plus effective across the board, 95 percent in some of these certain demographics, but also that it seemed to have some benefit after a single dose. Now, again, it depends a little bit on who specifically we are talking about in terms of their age and their background, but that's going to be a really important point that we're going to keep an eye on.

Overall over 50 percent, 52 percent roughly it seemed effective after a single dose. It's hard to know for sure because it was obviously just three weeks until the next dose. So it was three weeks long enough to say that it has benefit? That's something the FDA is really going to probably weigh in on because there is not enough doses. So if you could get by with one dose, and wait for the manufacturing to catch up on the second dose, that is something that's going to be sort of a point of consideration.

Also, again, 53 pages, one other thing I just want to point out, a question that comes up all the time. If you've already had the infection and you believe you have antibodies, should you still get the vaccine? And the answer, at least according to what we're reading in this document, seems to be yes, you should. It's the idea that the vaccine should provide longer and stronger immunity, but, again, this advisory committee will look at this data and make some of these determinations. This is for people 16 years and older as well in terms of the overall age groups.

SCIUTTO: That's notable for people who had it already because that was an open question.

GUPTA: Yes. HARLOW: Sanjay, just to follow up on that, and thank you for laying

all that out, it's really, really helpful and good to know that there is some protection after the first dose but not full protection. You mentioned this is about people 16 and older. The other thing that stands out to me in this document is that they say there's insufficient data to make conclusions about this vaccine and the efficacy for anyone under 16, but also for pregnant women, breast- feeding women and immunocompromised individuals, so someone with cancer, for example.

Does that mean that all of those folks -- that's a lot of people -- shouldn't be taking it?

GUPTA: Yes, I mean, again, the FDA advisory committee is going to look at that, but if the company themselves as part of their document is saying that they don't have the data on that, that is a lot of people and, you know, one thing to keep in mind especially with people who have weakened immune systems, what you're sort of counting on the vaccine to do is you're counting on their own immune system to sort of make this component of the virus over and over again, the spike protein, and then to generate antibodies to it.

[09:05:07]

So let's say you're somebody who is undergoing chemotherapy, for example, it's not to say that you couldn't get the vaccine, but it's to say that at a time when your immune system is weakened or compromised you just may not generate the immune response. That's what it seems to indicate. I have just sort of started to look at this data, but that seems to be what they're talking about here.

So there may be periods of time, for example, when someone may not be able to use the vaccine. Mostly because it just won't generate the same sort of effective immune response in somebody whose immune system is compromised for some reason. So we'll see. We'll see exactly what they say about those groups.

HARLOW: OK.

SCIUTTO: Sanjay, we've gotten a lot of new information about the vaccine in the last 24 hours. This document, but also questions about what capacity is going to be available by the end of the year. Tens of millions of doses fewer than expected. You know how this news this morning that the administration was offered the possibility of more, but big picture for folks watching at home. Have we learned something in the last 24 hours that means this will be available less soon to a large portions of the population than we hoped? Or are we still on track for springtime for most of us being able to get this?

GUPTA: There's a few assumptions here, Jim, in all of this. First of all, I think the initial projections for the rest of this year still hold true. I spoke to Albert Bourla, who's the CEO of Pfizer, and they sort of talked about this idea that there would be 50 million doses overall from Pfizer alone, 25 million of those staying in the United States and 25 million in Europe. So it was always part of the plan that not all the doses were going to be in the United States. You add in Moderna, which, again, we don't know if the authorization

is happening, it looks likely, that would take the number up to 40 million doses roughly by the end of the year. What I think is important and what we've sort of been investigating for some time is Operation Warp Speed, we know that they were making bets essentially on what they thought was likely to work. The Pfizer and Moderna vaccines, these MRNA vaccines are brand-new. They bought 100 million doses of each of those.

But they also bought some 300 million doses of AstraZeneca's vaccine. Another 100 million of Johnson & Johnson's vaccine. Now those obviously have not been authorized. They are still in phase three trials, but when you speak to the folks at Operation Warp Speed, I spoke to Moncef Slaoui last week, he thinks, you know, maybe by the end of January you could have two more, J&J and AstraZeneca come online with Emergency Use Authorizations.

So to answer your question, when you start to do the math and assume that some of these other vaccines will become available within the next couple of months, then you can start to hit those numbers that we've been talking about where people, you know, by mid-summer roughly should be able to get a vaccine if they want one.

SCIUTTO: Good to hear.

HARLOW: Looking forward to the day for everyone. Sanjay, thank you very, very much.

GUPTA: Me too. Me too.

HARLOW: Let's go to the White House now for more on the president's executive order that is supposed to come a little bit later today and if it really has any teeth.

SCIUTTO: Joe Johns, we know that this is a president who often does executive orders for performance art as opposed to actual policy effect here. Tell us what this is.

JOE JOHNS, CNN SENIOR WASHINGTON CORRESPONDENT: Well, it's basically an order prioritizing Americans for vaccines and then saying after Americans get the vaccines then the rest of the world, but there's really no teeth to all of this and the question, of course, is why is the president doing it? Even Moncef Slaoui asked some questions about that.

But there's also this larger question of the "New York Times" story that is out today indicating that the United States government apparently passed on hundreds of millions of doses of vaccine from Pfizer back about July or August, in that time frame. Kayleigh McEnany, the White House press secretary, was just out here on the driveway and I asked her about that. She flatly denied it. She said the United States government didn't pass on anything.

But we are told that there are negotiations continuing with Pfizer and the other companies. Yesterday there was a conference call with senior administration officials and they gave a little bit of the backstory, again, denying "The New York Times" report, and they said essentially that anybody who wanted to sell a guarantee of hundreds of millions of doses of vaccine without an Emergency Use Authorization was just not going to get the government's money.

Dr. Slaoui talked about that, too, if we have that sound bite. Do we?

(BEGIN VIDEO CLIP)

SLAOUI: Let me remind everybody what our strategy is and has always been. We selected six different vaccines to build a portfolio to manage the risk that some may work and some may not work, but also to ensure that as more than one would work that we would accumulate vaccine doses from this portfolio vaccines.

[09:10:11]

Now in the summer if somebody came to us and said let's buy more of this vaccine or that vaccine, no one reasonably would buy more from any one of those vaccines because we didn't we didn't know which one would work and which one may be better than the other.

(END VIDEO CLIP)

JOHNS: So really underscoring what Sanjay was saying just a few minutes ago. The real question here is about demand and supply. There's going to be a lot of demand for vaccine and the question of course is where that supply is going to go and how much of it Americans are going to get.

Jim and Poppy, back to you.

SCIUTTO: Joe Johns, thanks very much.

Well, let's go for some good news this morning, the U.K. vaccines -- vaccinations are under way there. CNN's Max Foster and Phil Black covering this for us.

Max, to you first. I mean, it's quite a moment in this pandemic to see this, the first people, members of the regular population, getting this vaccine. What are you hearing from folks who are getting this for the first time?

MAX FOSTER, CNN CORRESPONDENT: Well, a huge amount of excitement. You see the British minister was very emotional on British television today. And early in the morning we got news that the first man to be vaccinated was someone called William Shakespeare in Coventry, would you believe, just 20 miles away from William Shakespeare's birthplace in Stratford-upon-Avon.

The first woman was a lady called Maggie, she's 90 years old, she is a grandmother and she had a really strong message actually for the wider world. We're told she was picked at random but she is very on message with the government really on how people should be looking at this vaccination program in the U.K.

(BEGIN VIDEO CLIP) MARGARET KEENAN, FIRST PFIZER VACCINE RECIPIENT OUTSIDE TRIALS: I'd say go for it. Go for it because it's free and it's the best thing that's ever happened at the moment, so do, please, go for it. That's what I say, you know? If I can do it, so can you.

(END VIDEO CLIP)

FOSTER: She's very much the star of the day. I'm across the border in Wales, here they are prioritizing health workers. I was allowed into a vaccination center just this morning. I'm not allowed to tell you where it is because they're keeping these locations secret in Wales. They don't want people cueing up outside to try to get their vaccine ad hoc. I don't think you have the skepticism about vaccination in this country that you do in other countries like perhaps the U.S.

What is clear, though, is that this first phase is going very well. They are taking the vaccine into hub hospitals where people are going in and getting the vaccine, but the next stage is going to be much tougher. You've obviously got to transport the vaccine, these low temperatures, it comes in packs of nearly 1,000 which can't be broken up which presents a challenge, for example, for a care home with just 10 residents.

You can't take the whole pack there, it's a bit of a waste, but also we discovered that you have to mix the vaccine on site and where I was today that required a team of pharmacists. So they're going to have them in place everywhere.

HARLOW: OK. It's great to see people wanting it so much that they're, you know, trying to find it so they can line up, Max. It's very different than some of the skepticism as you know we're seeing here in the U.S.

Phil, what about you? What is the situation in Scotland?

PHIL BLACK, CNN CORRESPONDENT: Well, there is tremendous excitement. I was just talking to a doctor on the way into the hospital who said she was coming here to get her vaccination today and she was tremendously grateful and excited. There is hope, there is optimism. It is a hugely emotional and significant day here, but what we are also hearing from officials both in Scotland, across the U.K., this is this very serious message that for all the significance of this, the history, the hope and the optimism that goes with it, we are not in the end game just yet.

This does not bring us to the point where people can immediately go about to living -- go about living their normal lives or something close to it. So the message is by all means feel this emotion today, feel the optimism, celebrate this achievement for medical science, but crucially do not become complacent. Use those emotions to continue to inspire vigilance and discipline in this final stretch of dealing with the virus.

So the goal here is to prevent deaths initially, that's why the most vulnerable, the people most at risk, front line medical staff, people aged over 80, care home residents, these are the people that will get it first and then as it's rolled out more broadly, well, that's when they hope over time that people can begin to resume their lives.

But as I said for all the hope and emotion of today there is this very somber warning and that is that normalcy is still -- still many months away.

SCIUTTO: Well, it's progress and I think the U.S. now will have to find a George Washington to vaccinate first to catch up with you guys since you got Shakespeare.

(LAUGHTER)

SCIUTTO: Max Foster, Phil black, thanks very much.

HARLOW: All right. Still to come, Pennsylvania's governor says the state will run out of hospital beds if hospitalizations continue to rise. The Health secretary of Pennsylvania is here.

[09:15:00]

SCIUTTO: And we're learning that President Trump made several calls to the Pennsylvania house speaker over the past week, why? To push those officials to overturn the elections in that state, millions of votes in that state, it's remarkable. We'll have more.

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SCIUTTO: Welcome back. New infections in the U.S., that is, people, being newly infected with this virus, coming in at the fastest rate of this pandemic, even faster than in the Spring. The country is now set to top 15 million total infections at some point today.

HARLOW: It's hard to believe they were at this place even though we talk about it every single day. Let's go to our colleague, Alexandra Field, she's live for us in Massachusetts this morning. That is one of the states feeling the effects of this surge, and you did have a chance to look inside a field hospital that they have put up there.

SCIUTTO: Yes --

HARLOW: Describe it for us.

[09:20:00]

ALEXANDRA FIELD, CNN CORRESPONDENT: Hey there, Jim and Poppy. Massachusetts is experiencing what states across the nation are experiencing, this rise in hospitalizations, and it means they've got to move to their backup plans in cases like here in Massachusetts, that means going back to some of the tactics that they employed back in April when the death toll was at its highest, a rate we are now seeing again just nearly.

So, they've opened up a field hospital at the convention center here in Worcester. This is a place where COVID patients will be transferred to from other hospitals, they've already started to bring those patients in, this is a way of taking pressure off of other hospitals around the state. The governor is saying that they're battling a couple of problems at the same time, it is not just the rise in COVID cases that hospitals have to do deal with, but they're also dealing with staff shortages in those hospitals.

So, they've got to turn to these kinds of resources. They also have plans to stand up additional field hospitals if necessary. Again, what's happening in Massachusetts, not different from what is happening across the country where we continue to hit these record high hospitalizations, another 102,000 Americans reported to be in the hospital as of the latest numbers yesterday. Poppy, Jim?

HARLOW: Alexandra Field, thank you for that reporting.

SCIUTTO: Well, the governor of Pennsylvania, Tom Wolf is warning that hospitalizations in that state are reaching critical levels and the hospitals could soon run out of beds.

(BEGIN VIDEO CLIP)

GOV. TOM WOLF (D-PA): If the worst happens, hospitals will not be able to treat all sick Pennsylvanians, they will be forced to turn away people who need treatment, and that means more Pennsylvanians will die.

(END VIDEO CLIP)

SCIUTTO: Well, joining me now is the Pennsylvania Secretary of Health, Dr. Rachel Levine. Doctor, thanks so much for taking the time this morning, we know you have a lot on your plate. Tell us first about where hospitals stand right now. I mean, we heard deep concern in the Spring about hospitals being overwhelmed. Didn't happen then, are you more concerned now?

RACHEL LEVINE, PENNSYLVANIA SECRETARY OF HEALTH: Yes, we are concerned. We are seeing far more new cases now than we saw in the Spring, and on Saturday, we reported 12,700 new cases of COVID-19, and we are seeing record rates of hospitalizations for the coronavirus as well.

SCIUTTO: And tell us where in the state in particular. Is it concentrated in urban areas because Pennsylvania's data seems to indicate a lot of this is happening in more rural areas.

LEVINE: So, that is correct. We're seeing significant rates of community transmission throughout Pennsylvania in our urban areas, such as Philadelphia and Pittsburgh, but also suburban and rural areas. All of those hospitals are being strained and we get, of course, daily reports.

SCIUTTO: Are people still just not believing the risk? I mean, is that your experience here? Are there bubbles, right, where inside those bubbles, people imagine this is not for real?

LEVINE: Well, I think we're seeing a combination of different factors. Of course, this is happening as you reported. Throughout the United States, it has started particularly in the Fall in the Midwest and Mountain West, they have decreasing rates. We're seeing increasing rates now, of course, also the impact of Thanksgiving.

SCIUTTO: Yes, OK. So, this is always a lagging indicator, right? Because we're what? About a week and a half out of Thanksgiving. When do you expect to see the kind of peak aftermath, if that's the right word of Thanksgiving?

LEVINE: Towards the end of this week and next week, I think that we'll see the impact of Thanksgiving, both traveling as well as the small gatherings that people had --

SCIUTTO: Yes --

LEVINE: Despite our recommendations.

SCIUTTO: And then Christmas, of course, is coming. Dr. Fauci has said that Christmas might even be worse. Listen, I understand it, everybody -- you know, Christmas is -- I mean, these holidays are important, right? And if you want to get together at Thanksgiving, God knows you're going to really want to get together at Christmas. What plans do you have to head that off?

LEVINE: Well, so we have a stay-at-home advisory that the governor issued a week or so ago, and we're really recommending that people stay within their home and within their household during Christmas and Hanukkah, Kwanzaa and new year's. Is that they not have the small gatherings that would be typical.

SCIUTTO: Yes --

LEVINE: And we know that's a sacrifice, but that's what we need to do to stop the spread.

SCIUTTO: Yes, a lot of data points to those. OK, let's talk about vaccines. We are getting to the point where these are going to be coming out in numbers. What is Pennsylvania's plan? How quickly do you expect to at least begin vaccinating high-risk populations and healthcare workers?

LEVINE: Sure. So, we are anticipating the release of the Pfizer vaccine next week after the FDA and the CDC meets, and as soon as we obtain the vaccine, then we will be starting the immunizations. The first doses of the Pfizer will go to hospitals, we'll be immunizing healthcare workers, and that eventually to pharmacies that will be working to immunize long-term care facility members.

[09:25:00]

SCIUTTO: Do you anticipate any supply issues, because there's been some news in the last 24 hours, one from Pfizer, they're not going to have as many millions of doses as they expected, at least by the end of the year, and then questions as to whether the administration ordered up enough of these early on. Do you anticipate supply issues in Pennsylvania?

LEVINE: Well, this is going to be a rollout that's going to continue for months and months. So, we're not going to have enough Pfizer vaccine and then hopefully the Moderna vaccine to immunize everyone in those groups right away. This rollout will occur over the next several months in phase one, and then of course, we'll be going on to phase two and phase three. Really, we anticipate the rollout of the vaccine to take six, nine, could even be 12 months before everyone --

SCIUTTO: Wow --

LEVINE: Is immunized.

SCIUTTO: Wow. OK, well, patience is a virtue here. Dr. Rachel Levine, thanks so much for what we are doing, we know you got a lot of hard work ahead of you.

LEVINE: Thank you.

SCIUTTO: Overnight, CNN learned that the president made multiple calls to Pennsylvania's speaker of the house on the state's election results to overturn votes. This is important. We will have more.

HARLOW: We are also moments away from the opening bell on Wall Street this morning. Futures pointing lower, investors worried about rising COVID cases and potential issues in maybe finally reaching a new stimulus package. We'll keep a close eye on the markets. Stay with us.

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