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FDA Authorizes First COVID Antiviral Pill; UK Shortens Isolation Period for Those Vaccinated. Aired 3-3:30p ET

Aired December 22, 2021 - 15:00   ET

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

[15:00:00]

POPPY HARLOW, CNN HOST: It's the top of the hour. So glad you're with me. I'm Poppy Harlow, in today for Victor and Alisyn. Thank you for joining me on NEWSROOM.

At any moment, we're going to hear from the White House. The White House COVID Task Force is going to give us a live update on the surge that we're seeing in the United States right now. This comes just hours after the approval of a potential game-changing first in the pandemic, a pill to treat COVID, the FDA just today giving emergency authorization to Pfizer's antiviral Paxlovid.

This comes as the United States is averaging more than 148,000 COVID cases a day, seeing a 4 percent rise in hospitalizations from just a week ago, and now detecting Omicron in all 50 states just 22 days after the first reported case of it in the country. However, listen to this. A top researcher in South Africa says that the country is beyond its peak of Omicron, saying South Africa is seeing a serious decline in cases in the area where it was first detected.

So that is potentially some good news for the rest of the world.

As we wait for the White House, let's turn to our Elizabeth Cohen, who has many more details on this first ever approved pill to treat COVID.

How well does it work?

ELIZABETH COHEN, CNN SENIOR MEDICAL CORRESPONDENT: It works quite well. And what's really nice is, it's something you can just take it home. Your doctor calls into prescription. It's not like a monoclonal antibody where you have to go in and get shots or an infusion.

So this is the first time there's really a home way to do that. But there is a caveat, which I will get to in a minute. So let's look at the results from Pfizer's clinical trial. They had about 2000 patients, and about 1,000 of them, half of them, they took a placebo. They took a pill that did nothing. And at the end of the month, 66 of them were hospitalized with COVID and 12 of them had died of COVID.

And about half of them took Paxlovid. Of that group, only eight were hospitalized, and none of them died. So that's a pretty dramatic difference. But there's one thing. In the clinical trials, people took it within five days of feeling symptoms of COVID. This pill needs to be taken quickly. You need to notice you have the

symptoms, you need to act on it, you need to get tested, you need to call the doctor, the doctor needs to call it in. That is a lot to have happen within five days, especially given the testing situation in the United States.

So that is one concern about this pill. We will see how it works when it comes out in real life, rather than just in clinical trials.

HARLOW: Yes, that's exactly right.

I mean, Elizabeth, you also have two new studies making some early conclusions on Omicron and on hospitalizations. What did they tell us?

COHEN: Right, so these are studies out of South Africa and Scotland, because they sort of got Omicron before we did and have been doing a good job of measuring it.

So let's take a look at what they found. In the South Africa study, they looked at cases in October and November. They found that folks who had Omicron, 2.5 percent of them ended up getting admitted to the hospital. But folks with Delta, 12.8 percent of them ended up being admitted to the hospital. That really shows you how much milder the disease is with Omicron.

As far as Scotland goes, what they found was a two-thirds reduction in hospitalization risk. And this is important. The booster was linked to a 57 percent reduction in the risk of symptomatic infection, so that booster making a difference. Of course, the most important thing is get vaccinated.

HARLOW: Right.

COHEN: And if you're more than six months past that second shot, get yourself a booster -- Poppy.

HARLOW: For sure.

This is also really interesting, what the United Kingdom has decided to do. And that is to reduce the number of days that people who are fully vaccinated need to isolate if they get infected.

What is the change?

COHEN: Here's the issue.

In the United States, In the U.K. everywhere, we need our doctors and nurses. We need other essential workers. And if Omicron is giving milder disease, if you're asymptomatic or just mildly sick, do you really need to be out for the full 10 days that's now recommended?

[15:05:07]

Let's take a look at what they have done in the U.K. They have shortened that isolation period, if you're vaccinated and you get COVID, shortened that isolation period from 10 to seven days. If you're unvaccinated, you still must isolate for 10 days, because you are going to be sicker and you're going to likely be contagious for longer.

Now, in the United States, it's interesting, the CEO of Delta Air Lines writing a letter to the head of the CDC saying, hey, we'd like you to shorten this time, because, of course, Delta Air Lines an essential service. All the airlines are, all transportation.

So what Delta was asking for is, we want the isolation, again, for fully vaccinated people with COVID to be shortened from 10 to five days and also, of course, have a test before you get out of isolation. Make sure you're negative.

And Ed Bastian, the CEO of Delta, noted that over 90 percent of the Delta work force is vaccinated -- Poppy.

HARLOW: Yes, it would make a huge difference for these businesses that rely on so many of those front-line workers.

COHEN: Right.

HARLOW: Elizabeth, thanks very much for the reporting.

COHEN: Thanks.

HARLOW: And once again, we're seeing incredibly long lines in cities around the country, people waiting and waiting to be tested, and the federal government has vowed to help.

Let's go to our colleagues Shimon Prokupecz. He joins us in New York.

Shimon, across from our home every day, the line is around the block. The line is like around the full block. And it gets longer by the day.

SHIMON PROKUPECZ, CNN CRIME AND JUSTICE CORRESPONDENT: It does.

And what's going on really across the city now, Poppy, as you have been going out, you see these independent kind of privately owned labs setting up shop, just tents that they have set up. And they're really the ones that are doing, at least it would seem, a lot of the testing across the city, certainly in parts of Manhattan, which are seeing a surge, surge, surge in cases.

And so people are lining up at sites like this, where they're testing, they're walking up. These were originally set up for tourists, really, people who were coming in to this country from overseas to get their testing to get back on a flight.

And what's happened now is that a lot of locals are using them for their tests, because other places are just inundated and can't take the capacity. A stunning number. I just want to share something with you from the governor a short time ago here in New York state, close to 30,000 new cases, about 28,900 across the state, a majority of them here in New York City.

Manhattan seeing one of the largest surges that it has seen. So certainly a lot of concern and the testing -- this is why the mayor says they need to increase the testing. The mayor also trying to sound upbeat today, of course, talking about how people need to live their lives as they continue going through day to day. Take a listen to what he said.

(BEGIN VIDEO CLIP)

BILL DE BLASIO (D), MAYOR OF NEW YORK: It's important to say this clearly. We are not telling people to hide or hunker down or surrender to this situation. We're telling people, be smart.

If you're not feeling well, stay home for sure. If you might have been exposed, get a test and act accordingly, depending on the result. Of course, if you're vulnerable person, older, or with serious preexisting conditions, limit the kinds of things you go to.

But we're not telling vaccinated people to stop living their lives.

(END VIDEO CLIP)

PROKUPECZ: And so one of the things that the mayor said that they're going to be doing is, they're going to be increasing testing all across the city.

The other thing is to try and improve some of the safety measures. They are going to be limiting visits to hospitals, obviously, still a huge concern here. The spread is continuing. The mayor, the governor, city officials all saying that they expect the surge and the spread to continue.

But a key in all of this Poppy, of course, is hospitalizations. They are not seeing that steady increase in hospitalizations that would certainly concern them that obviously led to many of the shutdowns and concerns the last time at really the start of this pandemic.

But right now, when you look at these numbers and the way this is going across this state and this city, certainly, Omicron, certainly the epicenter here in New York City.

HARLOW: Yes, I know. For us, it's like work, home, work, home, work, home. And that's sort of it for a lot of us here in New York.

Shimon, thank you very, very much.

Joining me now is CNN medical analysts and E.R. doctor Dr. Leana Wen, former health commissioner for Baltimore as well, and internal medicine Dr. Jorge Rodriguez, a viral specialist .

Doctors, great to have you both on this. I wish it were not on the reality that we're experiencing, but it is.

Let me begin with you, Dr. Wen, and that is what Bill Gates just came out and said this morning, that we could, in his estimation, be -- quote -- "entering the worst part of the pandemic."

That is stunning, especially given that not enough, but a number of people are fully vaccinated and boosted.

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DR. LEANA WEN, CNN MEDICAL ANALYST: I think what we will see with Omicron is a very large number of infections due to COVID-19.

The question, though, is, are we going to see a decoupling of infections with hospitalizations and death? That would be ideal. The entire point of vaccination, the main point of vaccination, I should say, is to reduce severe illness.

And so if we're able to avoid overwhelming our health care systems, that would be the goal. Are there going to be a lot of people who get Omicron? Absolutely. But the hope is that enough people have been vaccinated, certainly in some parts of the country and many parts of the world, that we're going to prevent the worst of it.

Now, I do have a lot of concern about what happens to parts of this country, for example, that have very low vaccination rates? And this is another reason why I think President Biden's message yesterday was the right one in some way in saying vaccinated people should move on with their lives with precautions.

But I wish that he would go further to restrict the activities of the unvaccinated, because they are the ones who are still spreading COVID and prolonging the pandemic for all of us.

HARLOW: Right. We're seeing the vaccine mandates, et cetera, certainly charged all the way up through -- challenged, I should say, all the way up through the courts. We will see where that lands.

Dr. Rodriguez, to you. Just to build on the question that Dr. Wen raises, which is what is Omicron going to show us, will there be a decoupling between infections and hospitalizations, the data out of South Africa just highlighted in "The Washington Post" today is really interesting, right, that they're saying the surge that they saw in Omicron cases is now completely dwindling.

Like, they might be going down the other side of the mountain. But the qualifier is, they note 70 percent of people in South Africa have had some sort -- some variant of COVID, so may be protected and their immune systems built up from that.

So does that mean we cannot exactly read good news out of South Africa as good news for us here?

DR. JORGE RODRIGUEZ, CNN MEDICAL ANALYST: Well, I think we can be hopeful about that news. But I think you brought up one point, is the fact that a lot of the people there have already come into contact with some form of COVID and may have a natural immunity to it.

So I want to caution people not to take too much heed and sort of solace from that, because, first of all, South Africa is not the United States. They're a little bit more homogeneous, both in their population and in their politics, if you will, which makes a difference here in this country. Also, their population tend to skew a little bit younger than in the U.S., which may be why they're not seeing as many people hospitalized.

However, if you're looking at it as a whole, the data for the vaccinated, whether it's Omicron or Delta, is the fact -- and let's keep hammering this home -- is that people that are vaccinated will get less sick, will be hospitalized less often, and there will be less deaths.

HARLOW: Dr. Wen, the U.K. has just said that they will shorten the isolation period for people who have had COVID, but are fully vaccinated.

I think it's to seven days, not 10, and testing twice. Should the United States do that?

WEN: Yes. In a sense, this is a test-to-return policy, just like you have test to stay in schools. This is test to return to work.

There are two major reasons why this is so important. One is to preserve the work force. We're facing a crisis of health care workers all being infected, and not being able to come to work. And so the shorter the duration they have to be out, the better. And the entire point is you get regular testing, and if you're able to show that somebody is no longer shedding virus, especially because, if you're vaccinated, you probably are shedding virus for a shorter period of time, then you should be able to come back to work.

The second major reason is, a lot of people right now are forgoing tests, especially if they're traveling somewhere. They don't want to end up testing positive, for fear that they're stuck somewhere for 10 days.

HARLOW: Right.

WEN: And so we're actually adding a disincentive to testing.

And we could stop that if we if we have a shorter period.

HARLOW: Just because you don't know doesn't mean you don't have it. I mean, that -- yes, you make a such a good point.

Dr. Rodriguez, to you, before we go. The fourth shot for the elderly and immunocompromised that Israel is doing, is that going to come to the United States, do you think?

RODRIGUEZ: Well, it might, but I even said this last night. I think Israel may be jumping the gun a little bit. And even they said that they don't have any data to support this, but they are trying to be ahead of what they think has been a pattern.

So it may come to the United States. I think right now people should definitely not run to their pharmacy or doctor asking for a fourth shot. I think we need more information. But I think repeating vaccinations, whether it's yearly or whatever, is something that is going to happen.

HARLOW: Dr. Wen, Dr. Rodriguez, thank you both. Wishing you a healthy and happy holiday.

RODRIGUEZ: Likewise. Thank you.

[15:15:00]

HARLOW: In the wake of a major setback for Democrats on their campaign to get Build Back Better passed -- actually, let's go here.

This is the White House COVID Task Force briefing. Let's listen in.

(JOINED IN PROGRESS)

JEFF ZIENTS, WHITE HOUSE COVID-19 RESPONSE COORDINATOR: ... underscore the president's message yesterday.

Due to Omicron, we expect a significant rise in cases. Fully vaccinated people, particularly those with a boost, are highly protected. But due to Omicron's highly transmissible nature, we will see fully vaccinated people get COVID. They will likely be asymptomatic or feel under the weather for a few days.

Let's be clear. Unvaccinated people are at a higher risk of getting severely ill from COVID, getting hospitalized and dying. We are prepared for this moment.

Yesterday, the president announced new actions the administration is taking to protect families, communities and hospitals as we face Omicron. These steps include more support for hospitals, including 1,000 military troops deployed, hundreds of ambulances and help for hospitals to ensure adequate supplies, equipment and beds, more testing, including new federal sites, and a half-a-billion tests that will be free to all Americans, and more capacity to get shots and arms, including new mobile clinics, hundreds of additional vaccinators in the field, and tens of thousands of new appointments.

Let me reiterate what the president said yesterday. This is not March 2020. We have more tools than ever before to protect people, vaccinations, boosters, testing and treatments.

Today, I want to give an update on treatments. From day one, our strategy has been to fill the nation's medicine cabinet with a diverse set of options to treat people.

Let me walk through the three types of treatments, starting with monoclonal antibody treatments, which have proven to be highly effective. Since July, we have deployed 2.7 monoclonal antibody treatment courses to help keep people out of the hospital and save lives.

From the moment we learned of Omicron, we began assessing our existing monoclonal antibody treatments and have -- and we learned that two of the three existing treatments are not effective against the new variant. Fortunately, GlaxoSmithKline's monoclonal antibody treatment is effective.

So, we acted quickly to secure more supply of it. We're doubling, more than doubling the supply of GSK's monoclonal to one million treatment courses, with 300,000 treatment courses available in January. And we have already begun making this drug available to every state and territory.

Next, let me touch on a preventative treatment from AstraZeneca, which is especially important for certain immunocompromised individuals at high risk. Many of these immunocompromised people are not able to get the level of protection they need from a vaccine alone. We will have more than half-a-million doses of AstraZeneca's monoclonal antibody treatments on hand in January.

And we're preparing to purchase significantly more across the next three months. And, finally, let me provide an update on antivirals. We got good news today with the authorization of Pfizer's antiviral. Merck's pill, if authorized, along with Pfizer's newly authorized pill, add oral treatment options to our nation's medicine cabinet.

As soon as emerging science showed the promise of these antivirals, we acted quickly and aggressively to pre-purchase 10 million treatment courses of Pfizer and three million of Merck.

For Merck, by end of January, we anticipate about three million treatment courses available to send to states if FDA authorizes. The Pfizer team has a very promising and now authorized treatment, a pill that dramatically reduces the risk of hospitalizations and death for those at risk.

We have purchased 10 million courses, more than anyone else in the world. According to Pfizer, the complex chemistry involved in creating the active ingredient in the pill means production takes about six to eight months. So, supply of this product will ramp up over the next several months.

Knowing that these pills take time to manufacture, Pfizer continues to increase their production plans. And now that the pill is authorized, we will have discussions to explore how we can help them improve their manufacturing capacity even further by providing any resources needed. We will have 265,000 treatment courses of Pfizer available in January, with monthly totals of pills ramping up across the year and all 10 million treatment courses delivered by late summer.

[15:20:30]

As quickly as Pfizer gets the pills manufactured and delivered, we will immediately provide them to states and jurisdictions for distribution. Just as we have done with vaccines and monoclonal antibody treatments, we will ensure equity is at the center of antiviral distribution.

We are not only urging states to ensure equity in their own distribution plans, but we are also distributing antivirals to community health centers across the country. This will help ensure these lifesaving antivirals are available to the most vulnerable communities and hard-hit populations across the country.

In closing, as we face Omicron, the nation's medicine cabinet of treatments gives us more options to protect the American people. It's yet another reason this moment is much different than March 2020. We have tools to keep people safe. And we will continue using them to do so.

With that, over to Dr. Walensky.

DR. ROCHELLE WALENSKY, CDC DIRECTOR: Thank you, Jeff.

Good afternoon.

As usual, I'd like to start by walking you through today's data. The current seven-day daily average of cases is 149,300 cases per day, an increase of about 25 percent over the previous week. The seven-day average of hospital admissions is about 7,800 per day, and the seven- day average of deaths are about 1,200 per day, which is an increase of 3.5 percent over the prior week.

Over the past several weeks, CDC has continued to closely monitor the emergence of the Omicron variant. Currently, over 85 countries have detected Omicron. And, on Monday, we released updated data for the United States, which estimates that the Omicron variant represents approximately 73 percent of COVID-19 cases in the United States.

And in some areas of the country, Omicron has increased even further, accounting for an estimated 90 percent of cases in the Eastern Atlantic states, parts of the Midwest, South, and Northern Pacific states.

This rapid increase in the proportion of Omicron circulating around the country is similar to what we have seen around the world. Although this is a reminder of continued threat of COVID-19 variants, this increase in Omicron proportion is what we anticipated and what we have been preparing for.

I know there are a lot of questions about the Omicron variant, how to protect yourselves, our loved ones, how to safely gather with our family and friends over the holidays. And you have heard me say before we know what works against COVID-19. And it's critically important that we implement our proven multilayer prevention strategies.

Let me reiterate those four prevention measures for you. Get vaccinated. Get boosted. Wear a mask in public indoor settings in areas of substantial and high-risk community transmission, and take a test before you gather.

I know many parents are wondering how they can keep their children safe for the holidays. If your child is 5 or older, get them vaccinated. And if they are younger than 5 years, surround them with adults and siblings who are vaccinated, boosted, if eligible, and masking in public indoor settings.

I also want to be sure people understand the risks around holiday travel. Holiday gatherings and risk of travel really has less to do with the airplane or car ride and much more to do with how people from different households behave in the weeks todays before meeting up. Importantly, consider gathering with family and friends who are also

practicing similar proper prevention measures. And, as we have said before, those who remain unvaccinated are the most vulnerable to COVID-19.

CDC data now updated through November, when Delta was the predominant strain circulating, demonstrated that an unvaccinated person has a 10 times' greater risk of testing positive for COVID-19 and a 20 times' greater risk of dying from COVID-19 when compared to those who are fully vaccinated and received their booster dose.

Although every day we are following more and more studies emerging about the Omicron variant, early data on the vaccine is promising against Omicron, especially when people are boosted.

[15:25:00]

COVID-19 vaccines, especially when accompanied by a booster dose, are likely to protect against severe disease, hospitalization, and death.

Still, we know we will continue to hear more about people who get infected who are vaccinated. These people may get mild or asymptomatic infections and could unknowingly spread those infections to others. Again, this means it is important for everyone, regardless of vaccination status, to wear a mask in public indoor settings in communities of substantial or high transmission.

And I would encourage people to take an at-home COVID-19 test ahead of time to help protect you and your family and friends who may be at greater risk of COVID-19 or severe outcomes. Evidence has repeatedly shown that these prevention measures, when layered together, work.

So, again, if you're wondering how to stay healthy and protect your loved ones this winter, please get vaccinated, get boosted, wear a mask in public indoor settings, and take a COVID-19 test before gathering with others.

We're at a critical point, and how well these measures are implemented by all of us, caring for ourselves and for one another, will largely determine the outlook of the coming weeks and months ahead.

Thank you. Happy holidays.

I will now turn things over to Dr. Fauci.

DR. ANTHONY FAUCI, CHIEF MEDICAL ADVISER TO PRESIDENT BIDEN: Thank you very much, Dr. Walensky.

What I would like to do now is just spend just a few minutes on underscoring and reiterating some of the important principles that Dr. Walensky had mentioned.

I'm going to touch on four areas very quickly, transmissibility, severity, the evasion of immunity by vaccines, and the potential impact on therapeutics. I will point out that there is a relationship between interpreting the

relationship between transmissibility and severity, and I will explain what I mean, in a moment. Next slide.

No doubt, this is a highly transmissible infection. These are the latest data that we get from the CDC about the Omicron variant that is sequenced in the United States isolates. It is now about 73-plus percent.

And speaking to governors from other regions of the country, in some, they're even as high as 80 to 90 percent. So there is no doubt that we are dealing with a highly transmissible virus for the reason, as Jeff mentioned just a moment ago, that we expect that they will be continuing to have a substantial increase in cases.

Next slide.

Now we get to the idea of severity. These are data from our South African colleagues, who have clearly been showing now in conversations we have had and now in this recent publication that, in fact, it appears, that, in the context of South Africa, there is a decrease in the severity compared to Delta, both in the relationship and ratio between hospitalizations and the number of infections, the duration of hospital stay, and the need for supplemental oxygen therapy.

Recently, literally yesterday, there was another paper that came out from Scotland which appears to validate and verify the data that are in South Africa. This is good news. However, we must wait to see what happens in our own population, which has its own demographic considerations.

I would point out that, even if you have a diminution in severity, if you have a much larger number of individual cases, the fact that you have so many more cases might actually obviate the effect of it being less severe. And that's one of the reasons why the president in his remarks yesterday spoke about how we are going to supplement the capability of hospitals to respond to the possibility that there might be a run on the need for hospitalization.

Next slide.

Now let's talk about some of the immune invasion. We have mentioned this in briefings before. But just to reiterate, there's no doubt that there's a marked reduction in neutralizing activity against Omicron when you look at the two-dose mRNA vaccines, when you compare Omicron to earlier variants, such as Delta.

However -- and here, again, why we emphasize the importance of booster shots -- the anti-Omicron activity is about 20-to-40-fold higher vs. the peak in sera from boosted vaccinees vs. the peak in individuals who had the two-dose vaccine.