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FDA Says Johnson & Johnson Vaccine Meets Requirements for Emergency Use Authorization; White House COVID Response Team Holds Briefing. Aired 11-11:30a ET

Aired February 24, 2021 - 11:00   ET

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

[11:00:33]

KATE BOLDUAN, CNN ANCHOR: Hello, everyone. I'm Kate Bolduan. Thanks for joining us for the hour.

Moments from now, President Biden's COVID response team will be updating all of us on the fight against the virus. The briefing comes at really a critical moment as America is now looking at its third vaccine with Johnson & Johnson's version of the COVID vaccine taking a big step toward getting the green light.

This morning, the FDA released its data on the company's single-dose vaccine, saying it does meet the requirements for emergency use authorization. Put another way, FDA sees it as safe and effective.

This Friday, an independent group of advisers to the FDA will be meeting to make their recommendation on the vaccine. So hearing from the president's top COVID advisers and how they will describe this coming step will be very interesting. We're going to bring you that briefing from the COVID response team once it gets under way any minute now.

Before then, let me bring in CNN's Sanjay Gupta -- it's good to see you, Sanjay -- on this J&J news.

This analysis that was put out this morning you've been going through, it says that J&J, it protects well against severe disease and death.

Can you put numbers to that for us? What does this mean? What is the FDA releasing with this?

DR. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Yeah. So, this is -- this is the FDA's analysis of this data. And let's put the numbers up and I'll talk you through this a little bit because I think this is important. First of all, when we look at these numbers in terms of how protective this vaccine is against moderate and severe disease, I can tell you these numbers are a little different from what we first heard from Johnson & Johnson and they're a little better.

The South African, you know, variant, the one that's circulating predominantly in South Africa, previously it was thought to be 57 percent protective against moderate and severe disease. A little better now. But, Kate, you can see there's the difference, the U.S., 72 percent, that's the coronavirus strain circulating here. In Latin America, that's most likely, more of the strain that's been circulating in Brazil and then the variant in South Africa.

There is a difference, and that's just something to make note of in terms of just how much of a difference these strains, how protective the vaccine will be. But it was the bottom number to your question, 85 percent across the board globally where they said it's 85 percent protective against severe and critical disease. No hospitalizations at one month, no deaths in people who received the vaccine.

And that's going to be the data point I think the FDA is going to be largely focused on. What is the goal of the vaccine? To prevent you from getting really sick, needing hospitalizations, and death. And this vaccine seems to work well in that regard.

BOLDUAN: It's such good news to hear that coming out and see the FDA's analysis on this. It does appear that, as everyone is focusing on the efficacy levels of vaccines, like we have never done before -- oh, Sanjay, we're going to have run over to the briefing right now. The White House COVID response team giving their update, getting under way right now.

(WHITE HOUSE COVID BRIEFING)

JEFF ZIENTS, WHITE HOUSE COVID-19 RESPONSE COORDINATOR: Too many businesses and schools have been closed for way too long. President Biden is clear, we are at war with there virus, and we're using every resource at our disposal to defeat it.

We're keeping equity at the front and center of our response, partnering with states, tribes and territories to increase vaccinations in the hardest-hit and hardest-to-reach communities. Increasing supply to convenient and trusted locations like community health centers. Deploying mobile units to meet people where they are and improving data collection so that we have a better understanding of the inequities currently experienced.

Today, we're announcing another action we're taking to ensure an equitable response. In the month of March, we will begin to deliver millions of masks to food banks and community health centers around the country. These are nationwide networks that serve populations hit hard by the pandemic. While masks are widely available in many different shapes and sizes, many low-income Americans still lack affordable access to this basic protection.

That's why we're taking this important action to keep Americans safe.

[11:05:04]

We will deliver more than 25 million masks across the country. These masks will be available at more than 1,300 community health centers and at 60,000 food pantries nationwide. Any American who needs a mask will be able to walk into these health centers or food pantries and pick up high-quality, American-made masks.

These masks will be available at no cost. They will be well fitting cloth masks available in children's and adult sizes and they can be washed for reuse, all consistent with CDC guidance and all made in the USA.

Once again, our decisions here have been made with equity at the center. Not all Americans are wearing masks regularly. Not all Americans have access and not all masks are equal. With this action, we're helping to level the playing field, giving vulnerable populations quality, well-fitting masks.

When President Biden delivered his inaugural address, he made a very clear request to the country. Mask up. And he's taken action to require masks in federal buildings, on federal lands and on public transportation like planes, trains and buses.

The action we're announcing today is a targeted step to help Americans respond to the president's challenge to mask up, to protect themselves and their fellow Americans. As we encourage people to continue to mask up, we're focused on vaccinating people quickly and equitably.

Today, I will give you the latest update on our execution on vaccinations in the three key areas that we're focused on -- more vaccine supply, more vaccinators and more places to get vaccinated.

First, on vaccine supply, yesterday, we announced the fifth consecutive week of supply increases to states, tribes and territories. From 8.6 million doses when we took office to 14.5 million doses this week. That's an increase in vaccine allocations to states of nearly 70 percent during the Biden-Harris administration.

The retail pharmacy program we launched a few weeks ago has performed well so far, and this week, we'll increase the allocation to pharmacies to 2.1 million doses. So with 14.5 million doses allocated to states, tribes and territories, and 2.1 million through the federal retail pharmacy program, we've nearly doubled weekly supply of doses in just five weeks.

Second, we're mobilizing teams to get shots in arms. We've deployed over 800 federal personnel as vaccinators, and the federal government is now funding 1,200 National Guard members to serve as vaccinators.

We've also deployed 1,000 federal personnel to support community vaccination sites in operational and support roles. Third, we continue creating more places where Americans can get vaccinated. We've now expanded financial support to bolster community vaccination centers nationwide with over 3.6 billion in FEMA funding to 44 states, tribes and territories for vaccination efforts.

We're bringing vaccinations to places communities know and trust. Community centers, high school gyms, churches and stadiums nationwide. We continue to work with states to set up innovative high-volume, federally run sites that can each give over 30,000 shots a week. These sites are up and running in California and are ramping up in Texas, Florida and Pennsylvania.

We've also launched federal programs to get vaccines to pharmacies and local community health centers. As we've always said, we're committed to providing clarity on our

progress, and that includes when we hit bumps in the road. Last week, we got hit with the very severe weather which impacted the vaccination supply chain from manufacturing to shipping, to the ability to get shots in arms. The manufacturers, the shipping firms, the states, the tribes, the territories and pharmacies work to overcome these challenges.

And despite all the temporary weather-related delays, our seven-day average daily doses administered is at 1.4 million, and we've already caught up on the weather-related shipping backlogs.

[11:10:11]

Teams worked through out last weekend to pack and ship doses. On Monday, yesterday, 7 million doses -- two days ago. 7 million doses were delivered. That coupled with the 14.5 million doses allocated this week, results in record supply going to the states. We've encouraged states to get needles into arms by extending vaccine clinic hours, offering services 24 hours a day where possible, adding weekend appointments, and having more staff on hand.

On this point, I want to stress that if states do not have the staff to work around the clock and on the weekends, the federal government stands ready to help.

I also want to spend a couple of minutes on our plans for the Johnson & Johnson vaccine, which is currently pending approval for emergency use authorization by the FDA. Yesterday, I again updated and renewed with our nation's governors our plans to distribute the Johnson & Johnson vaccine if the EUA is granted. The governors are carefully planning their efforts and getting ready for the possible new vaccine.

If authorized, we're ready to roll out this vaccine without delay. Our distribution approach will mirror the current allocation process against jurisdictions, pharmacies and community health centers. If an EUA is issued, we anticipate allocating 3 to 4 million doses of Johnson & Johnson vaccine next week. Johnson & Johnson has announced it aims to deliver a total of 20 million doses by the end of March. We're working with the company to accelerate the pace and time frame by which they deliver the full 100 million doses which is required by contract by the end of June.

While we await the FDA's decision, we want the American people to know that we're doing the work. That if the EAU is granted, we will waste no time getting this life-saving vaccination into arms of Americans.

With that, I'll turn it over to Dr. Walensky.

DR. ROCHELLE WALENSKY, CDC DIRECTOR: Thank you, Jeff. I'm delighted again to be with you today.

We continue to see trends heading in the right direction. In the past week, average daily cases declined 25 percent to approximately 64,000 cases per day. This is slightly less than the summer peak of 60,000 daily cases reported last July. While this is good news, cases remain high and we continue to watch

the data closely. We also see declines in hospital admissions for the most recent week. An average of 6,500 patients with COVID-19 were admitted per day, a decrease of 16 percent from the week prior. The number of reported deaths is also dropping with a seven-day average of slightly less than 2,000 per day.

This represents a 35 percent decline compared to the prior week. On Monday, I announced we're kicking off our three-day national COVID-19 vaccine forum. And since that time we've had an extraordinary few days. Our final tally, we virtually assembled over 12,000 participants from across the United States representing state, tribe, local and territorial governments, private sector partners, medical and public health institution, community-based organization, faith-based groups and educators, among others.

The discussions and presentations from over 100 speakers showcased promising practices and critical scientific information for those involved in vaccination efforts in communities across the nation.

I'd like to share a few examples of what we learned over the last three days. First, trust and community confidence are cornerstones of our national vaccine efforts. Trusted voices are critical to building confidence in vaccines and addressing misinformation. Our community leaders are often those trusted voices.

We heard from national, state and local health leaders about communication and public education campaigns they are deploying to combat myths and disinformation and instill confidence and interest in COVID-19 vaccines, as well as tools and strategies health care providers can use when talking with their patients about COVID-19 vaccination. For example, we learned about a new communications campaign in New Orleans that is grounded in the local flavor and culture as a way to resonate with the city's residents.

Second, one of the most powerful benefits of the forum was learning about on-the-ground experiences and new innovations to expand vaccination efforts. We heard about creative ways providers and volunteers have been getting vaccinations into communities using boats, ferries and snowmobiles in Alaska, leveraging emergency medical services to provide vaccinations to homebound individuals in Indiana, and using awareness campaigns featuring trusted elders and health care workers in the Cherokee Nation of Oklahoma.

[11:15:22]

Finally, forum sessions taught us every person, community, faith-based organization, governmental and non-governmental partner and business has a role to play in supporting our nation's COVID-19 vaccination strategy. We learned about faith-based efforts like the outreach to people of color being led by the Metropolitan International Church in Nashville, Tennessee, where faith ambassadors engage with local clergy to help spread accurate information on COVID-19 vaccines to these high-risk communities. We also heard about successful public-private partnerships like in San Diego where vaccination supper sites like Petco Park Stadium are vaccinating thousands of people a day, and in Colorado, where there's a government-private partnership, the champions for vaccine equity task force where the health department and ten medical champions of color are working with and through community-based organizations to create opportunities for listening and sharing information about COVID-19 vaccines.

These are just a few of many practical innovations and solutions shared during the forum. And I want to let you know that all these sessions as well as resources and materials will be posted on the CDC website following the forum. I encourage you to check it out when you're able.

Next, I would like to take a moment to highlight the progress made so far in our efforts to rapidly expand genome sequencing nationally including through our $200 million investment announced last week. This work is more important than ever given the continue spread of COVID-19 variants in the United States. As of February 23rd, we now have identified nearly 1,900 cases of B.1.1.7 variant in 45 states, 46 case of the B.1.351 in 14 states and five cases of the P1 variant in four states.

The pace of our genomic sequencing has scaled up from about 400 samples a week when I started as CDC director, to now more than 9,000 samples as of the week of February 20th. We are continuing to increase this pace with our state public health and private lab partners with a goal of 2,700 samples per week in the coming weeks.

The increased volume is helping us to better understand the diversity of variants circulating in the United States, where they're located and how they're spread. With the samples in hand, we can scientifically examine how variants impact vaccines and therapeutics moving forward.

Finally, I want to say we are proud to be partners in the announcement made today about providing masks to underserved and vulnerable populations. One of the most impactful things we can do is wear a mask. And this is so important in this critical period where variants are increasing throughout our country.

CDC continues to recommend everyone two years of age or older wear a mask when out in public. The mask should have two or more layers, completely cover your nose and mouth and fit snugly against your nose and sides of your face. It's essentially you wear your mask correctly and it fits well to get the most protection.

By wearing masks in combination with social distancing, washing your hands, avoiding crowds and travel and getting vaccinated when it's available, we can bring an end to this pandemic.

Thank you. I, of course, look forward to your questions. I'll first turn things over to Dr. Fauci -- Dr. Fauci.

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: Thank you very much, Dr. Walensky.

What I'd like to do over the next couple minutes is just update you on an important component of the spectrum of COVID-19 disease. If I could have the first slide.

Many of you are now aware of what had long been called long COVID, but actually what that really is post-acute sequelae of SARS-CoV-2 infection which we're now referring to as PASC, or P-A-S-C.

The reason I'm bringing it up with you today will become apparent in just a minute or two.

Just to refresh your memory, the symptoms of this include fatigue, shortness of breath, sleep disorders, sleep disorders, fevers, GI symptoms, anxiety and depression and what some have referred to as brain fog or an inability or difficulty in concentrating or focusing. Remember, these are post-acute sequelae after the virus essentially has been cleared from the body.

And actually, new symptoms sometimes arise well after the time of infection or they evolve over time and they may persist, as I'll get to in a moment, for months, and can range from mild, annoying, to actually quite incapacitating.

[11:20:16]

The magnitude of the problem is not yet fully known.

Next. There have been a number of papers that have described in some detail large cohorts. Here is one from China which was published online on January 8th in more than 1,700 patients who actually had been hospitalized. I point out that you can get this post-acute syndrome even in individuals who did not require hospitalization.

The six-month follow-up showed a variety of signs and symptoms shown here with many having fatigue and weakness, as I mentioned on the prior slide, sleep difficulties, anxiety or depression, and the greater proportion of patients with more severe illness had impaired lung diffusing capacity.

Next, most recently in a study from the University of Washington that appeared just a few days ago, it was found really something alarming, that approximately 30 percent of the patients who were enrolled at the university of Washington reported persistent symptoms from as long as nine months after illness. Fatigue was the most common reported symptom and persistent symptoms were reported by one-third of outpatients with mild disease.

Next slide. What we did, we being an interagency group, the NIH, the CDC and others, put together a workshop in Rockville just a little north of Washington, D.C. on December 3rd and 4th of last year in which we looked at various organ symptoms and brought in experts in all these areas -- cardiovascular, pulmonary, renal, neurologic, immunologic and pediatric, to scope out the kind of things we would be looking at with this puzzling syndrome.

Now, the reason I'm bringing it up at this press conference -- next slide -- is just yesterday, February 23rd, the NIH launched a new initiative to study this PASC or post-acute sequelae. Now, looking back a bit in December of last year, the Congress

provided $1.5 billion funding over four years for the NIH to support research looking into this. I'm happy to say yesterday was the first in what will be a series of research opportunity announcements released for NIH initiative on this puzzling syndrome.

The research studies will look at SARS-CoV-2 recovery cohorts, some that are already established and some that will be established. They'll be looking at large data banks from resources such as electronic health records and health symptoms. And they'll be studying a number of biological specimens.

And, finally, on the last slide, there are selective questions that this initiative hopes to answer, and they are important. What does the spectrum of recovery from this infection look like across all the entire population? Young individuals, middle aged, elderly? How many people continue to have symptoms of COVID-19 or even, as we've seen, develop new symptoms that they did not have even as part of their acute infection.

Importantly, what is the underlying biological cause of these prolonged symptoms? We refer to that as pathogenesis. What makes certain people vulnerable while others recover fully and quickly and have no sequelae?

And, finally, does SARS-CoV-2 infection trigger changes in the body that actually increase the risk later on of such abnormalities such as chronic heart or brain disorders.

A lot of important questions that are now unanswered that we hope with this series of initiatives we will ultimately answer.

So, I'll stop there and hand it back to Jeff.

ZIENTS: Well, thank you, Doctors Fauci and --

(END OF WHITE HOUSE COVID BRIEFING)

BOLDUAN: All right. We've been listening in to the White House coronavirus response team with interesting updates this week.

Let me bring in Dr. Megan Ranney. She's emergency room physician at Brown University.

It's good to see you again, Doctor.

Just your -- what do you think was most important -- what was your most important takeaway from today's briefing?

[11:25:03]

DR. MEGAN RANNEY, EMERGENCY PHYSICIAN, BROWN UNIVERSITY: So, as you know, I co-founded an organization, get us PPE almost a year ago because of the lack of personal protective equipment for health care workers across the country. So, to me, the most exciting and important thing out of this press

announcement was their declaration that they're going to be delivering millions of masks to community health centers and food pantries across the United States. That's huge in terms of our ability to prevent the transmission of this disease while we wait for vaccines to get in arms.

The other thing, Kate, is how refreshing it is to hear a press conference that's driven by science and by data. It's such a stark contrast to what we heard in so much of 2020.

BOLDUAN: Yeah, I mean, it was really interesting. I was struck by that mask announcement, 25 million masks they'll be delivering for free in March, that there is this -- maybe not renewed focus, but continued focus, as they have said, on masks. I guess you could say they're putting their money where their mouth is on this.

On the J&J announcement that we heard this morning, the FDA analysis coming out, and Jeff Zients announcing because there had been some question about if J&J -- when J&J gets emergency authorization, how much is going to be available, and Jeff Zients saying between 3 million and 4 million doses are going to be allocated next week.

What does that mean for the country's vaccination effort as you add that on to the Pfizer and Moderna? What's your reaction to that?

RANNEY: So the biggest thing about the J&J vaccine is how much easier it is to distribute and administer. So, those 3 million to 4 million doses are going to be able to get to places that can't maintain the cold storage requirements for the mRNA vaccines. It's going to allow to get to rural areas or to underserved areas and people who will be tough to get back for a second dose.

This is going to be tremendous in terms of our ability to get more people vaccinated more quickly. I'm so enthused about that 3 to 4 million number. Now, of course, the proof is in the pudding to see how many comes in the weeks after that. There's been some concern about how much J&J will continue to produce.

I'm quite happy to hear what they think they'll be able to get out next week.

BOLDUAN: Yeah, they definitely seem to be focused on helping J&J ramp that up, because that was contract is for I believe they 100 million doses.

But now with the J&J news, Dr. Ranney, one question I know people are asking more and more and it's coming to Dr. Fauci and other doctors and experts more and more is can you -- can we and should we be able to choose what vaccine we get? What do you think about that?

RANNEY: So my takeaway and I've been discussing this with other medical and public experts all morning. We've been combing through this new FDA release and trying to make sense of it, my takeaway really is to get the vaccine that you're offered. Waiting an extra month or two for vaccine with an extra 10 or 20 percent efficacy against mild or moderate disease, you have the chance of getting COVID in the next month or two.

So, I would say take what you can get now. That said, we're going to be waiting to see ACIP's recommendations about how to prioritize this vaccine. My suspicion is it's going to start with those people who are lower risk for severe disease to being with.

So, people without comorbidities, people who are younger, the general population. That said, if you're offered a vaccine, take it. If my own parents were offered the J&J instead of the mRNA vaccine, I'd tell them to get it.

BOLDUAN: Yeah. Well, it comes to getting a single dose out to populations that are more rural, harder to get to, there are a lot of positives that comes with what J&J's offers as well.

It's good to see you, Doctor. Thanks for coming in.

RANNEY: Thank you.

BOLDUAN: Still ahead for us, the latest on golf legend Tiger Wood's condition and we have an update from the crash site for you. I'm going to bring that to you, coming up.

And, later, the House of Representatives is set to vote Friday on President Biden's massive COVID relief package. Right now, the bill includes an increase in the minimum wage to $15. But will that make it into the final version? We've got an update.

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