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FDA Panel Reviewing J&J One-Dose Vaccine for Emergency Use; Today: House Votes on Biden's $1.9 Trillion COVID Relief Bill; White House COVID Response Team Holds Briefing. Aired 11-11:30a ET

Aired February 26, 2021 - 11:00   ET

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

[11:00:41]

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

At this hour, we're standing by for a key update from President Biden's COVID response team. They're briefing should start any moment and we'll bring it to you when it begins of course.

It is a critical moment, because America's first single shot vaccine could have emergency authorization as early as tonight. Johnson & Johnson's COVID vaccine is facing a major test right now. An FDA advisory committee is reviewing the safety data on the vaccine this hour as we're speaking right now. A green light from this advisory panel will likely pave the way for a third COVID vaccine to soon be available in the United States.

The timing is also critical. With officials racing to vaccinate as many people as possible, as new coronavirus variants are emerging and spreading across the country.

We're also watching developments on Capitol Hill where the House is expected to pass President Biden's massive COVID relief bill on a party line vote. But now one major hiccup. After the Senate's rule keeper said that the Democrats' desired $15 minimum wage hike violates the rules of Senate.

So, what does this mean for this entire effort? We are going to get to that. But let us first start with the big FDA meeting on the J&J vaccine.

CNN's Kristen Holmes, she's joining me right now on this.

Kristen, what's happening in this meeting and how is this expected to play out?

KRISTEN HOLMES, CNN NATIONAL CORRESPONDENT: Well, this is hopefully the beginning of end for this process for Johnson & Johnson. But there are still a lot of steps. The FDA had a gone through the data and believes that the vaccine is safe and effective.

Now, currently, they are presenting that data to an advisory committee. We also know the CDC as well as Janssen, which is the parent company of Johnson & Johnson, will present to the committee and talk about the vaccine. They'll also talk about where the coronavirus stands right now, the different variants.

And then later the committee will vote on whether to recommend emergency use authorization. Usually the FDA follows their recommendations and we'd see the FDA actually authorize this vaccine.

But it's still not over. On Sunday, another advisory, the CDC Advisory Committee meets to give vaccine recommendations. This is that who, when, how is this all going to work with the vaccine. After that, another signoff from the CDC director and then that is when you're going to start seeing this distribution roll out, Kate.

BOLDUAN: And talk to me about the last bit, next week. Assuming the vaccines are authorized for emergency use, how long before it is reasonable that shots are out and available?

HOLMES: Well, a lot of this is going to depend on the CDC advisory committee. Right now, we've been told by Johnson & Johnson, they've willing to put out that 4 million doses the second they get EUA, but we're still awaiting what the advisory says, are they going to recommend certain communities or younger or older people and figure out how they're going to distribute to the groups following the guidelines of the CDC.

But yet, this is all still expected to happen next week. I've talked to multiple state officials are extremely excited, they've been hearing from the federal government that they're going to get these doses next week and they're thrilled to have the single shot vaccine. I think it is very important to the process, Kate.

BOLDUAN: And as you're laying out, though they have said that they believe it is safe and effective, you're saying as this meeting is happening and we'll bring you updates as we get them, why it is so critical to watch what they are saying in this meeting because it may be safe and effective but how and who it should go to, these are important things being hammered out right now as we speak.

Kristen is going to stick around. Thank you so much, Kristen, I really appreciate it.

Joining me right now is CNN medical analyst, Dr. Leana Wen. She's a former health commissioner for the city of Baltimore.

Doctor, we've talked about this before. You've been a volunteer taking part in the J&J clinical trial.

What are you listening for today? What questions do you have?

DR. LEANA WEN, CNN MEDICAL ANALYST: Well, the most important question is, what is this advisory panel going to do? We fully expect that they're going to be recommending to the FDA for authorization because nothing has really come up in the data thus far that are particularly worrisome.

[11:05:01]

But I will be looking for parameters. For example, there weren't that many individuals enrolled in the study who are age 75 and older. And so, are they going to put an age cap. It was not put on Pfizer and Moderna.

(CROSSTALK)

BOLDUAN: Dr. Wen, I'm only interrupting because we need to jump over to the White House. The White House coronavirus response team is beginning the update today.

Andy Slavitt is speaking.

(BEGIN WHITE HOUSE CORONAVIRUS BRIEFING)

ANDY SLAVITT, SENIOR ADVISER TO WHITE HOUSE COVID-19 RESPONSE TEAM: -- community vaccination centers nationwide to vaccine more people more quickly and more equitably.

Before I get there, let me begin by taking stock of where we are. Even as we have crossed the grimmest of milestones, the loss of over 500,000 American lives, we're pulling together as a country. In the time since the president has taken office, we've now doubled the pace of vaccinations and are rapidly on the way of vaccinating many of the people most at risk of dying or hospitalized from COVID-19.

With nearly one in five adults and nearly half of Americans over 65 have received their first shot. What is important and what I want to cover today is that any progress is a result of the hard work of many. People and entities working together for the greater good, vaccine manufacturers, Pfizer and Moderna, distribution partners at McKesson and FedEx and UPS, governors, mayors county officials and health departments, the thousands of providers, pharmacies and members of the military, FEMA and other state and federal employees that have been part of this vaccination effort.

And, of course, all of the people of science in the NIH, NIAD and CDC and BARDA and FDA. This is all one effort. There is so much more to do but one thing has become clear is that while none of us on our own could defeat COVID-19, all of us working together can. And today, I want to highlight what people across America can contribute to this cause at this critical time.

From day one, President Biden has been pulling the country together to unify against the virus. This begins with Congress. We cannot defeat this virus as rapidly as we need to without action from Congress. Today, the House will start the vote process on the American Rescue Plan.

This legislation will enable Americans across the country to defeat COVID-19 and get back to normal life more quickly. The bill is critical to allowing us to do some things that we all need to do to defeat this virus. Needed funding to make schools safer to open, the ability to stay ahead of the virus as it mutates by funding greater sequencing, testing and tracing to contain outbreaks and stay ahead of new variants and addressing supply shortages and investing in high quality treatments for people with COVID-19, providing paid sick leave and other support to contain the spread of the virus, and providing relief to the communities hardest hit by the disease.

We urge the Senate to quickly follow and pass this legislation. Just as Congress is taking action, so too are the nation's private and civil sectors. And the small and large company that are the heart of our economy and provide jobs to so many. One of the benefits of being and providing honest and clear communication with the public about the challenges that we face are all of the people who raise their hands and offered to help. Since the president's first day on the job 37 days ago, he's called us to come together and defeat this as a nation.

Since January 20th we've been engaging in literally hundreds of conversations with hundreds of companies who are eager to help put an end to COVID-19, get people safely back to work, rehire workers and grow the economy as the president outlined in his national strategy to defeat COVID-19. So, today, the administration is announcing a new partnership with America's leading business organizations to enlist the full force of the private sector to defeat COVID-19 with a call to action.

The Biden administration is joining with the chamber of commerce, leaders of the black, Latino and Asian business community, the National Association of Manufacturers and the business round table to call on businesses big and small to promote three critical efforts across the country. Our call asks three things of America's businesses to increase the safety of employees, customers and the community, and will help us put a more rapid end to this pandemic.

First, require masking and social distancing to protect workers, customers and others on their premises.

[11:10:07]

Second, reduce barriers to vaccinations. Make a plan to get employees vaccinated and make it easier for employees to get vaccinated by providing incentives like paid time off or compensation for employees to get vaccinated when it is their turn.

Third, communicate with customers and educate the public about the benefits of masking and vaccinations. We're asking businesses to amplify CDC messages about masking and vaccinations on their products, properties, and websites. Through these organizations, step by step resources to help businesses operate safely will be available. HHS and CDC are collaborating with them so they could take advantage of our research and approaching to talking about vaccinations most effectively.

Together, we hope to reach hundreds of thousands of businesses representing over 100 million people, to promote efforts to stop the spread of COVID-19, this afternoon at 4:00 p.m., I will be hosting a call with thousands of business owners to lay out this call to action and ask for their help and participation.

But the work has already begun. Since we've arrived, we've had over 250 conversations with business sectors as diverse as technology, retail, social media, medical properties, airlines, health insurance, hospitals and utilities and we're adding more every day. Each of them has something valuable to add.

Ford and The Gap are producing and donating millions of masks. Professional sports leagues and the live events industry have offered their more than 100 stadiums and venues to local communities to be used as vaccination sites. Retailers like Best Buy, Target and Dollar General all are giving more than half a million workers paid time off or compensating employees who get vaccinated. Uber, PayPal and Walgreens are providing $10 million of free rides to vaccination site and Lyft is partnering with CVS and the YMCA to provide $60 million free or discounted rides to vaccination sites.

In both of the efforts, we are encouraging organizations to target the benefits to people who need them the most. So communities hit hardest bounce back. CVS has also agreed to improved access and appointment times for people looking for vaccines and special efforts to reserve vaccine appointments. This is critical to health equity.

The utility company Avangrid has committed to more public health information in more than 3 million paper bills. These are examples. But examples that others could replicate in addition to their own unique efforts.

Our call to action today will ask companies to make similar, unique commitments that bring their unique skills and resources to the problem of keeping Americans safe and ending the pandemic as quickly as possible while also following the lead of these other companies.

Over the coming weeks, the Biden administration will highlight more innovative ways and America's sector is rising to the challenge as we put this crisis to bed by working together.

Let me talk now about the progress we're making to reach the president's goal -- to reach the president's goal of 100 community vaccination centers within the next -- within this first month in office.

Thanks to the incredible work of FEMA, the Department of Defense, and colleagues across the government, since January 20, the Biden/Harris administration has supported the establishment or expansion of 441 community vaccination centers across 37 states, territories and the District of Columbia. Over the past month we've provided 171 sites with federal personnel, we've deployed nearly 3,500 total personnel nationwide to support vaccination operations including expert logistics, vaccinators and greeters and clerks and other support roles.

Personnel are assigned from agencies across the federal government, including FEMA, CDC, DOD, National Guard and the Forest Service Department of Interior, Veterans' Affairs Department and the Army Corp of Engineers. A hundred seventy-seven sites have received federal funding, and at president's discretion, FEMA is reimbursing 100 percent of cost for vaccination operations. This funding covers critical supplies and staffing and training and

transportation that support vaccination distribution and administration. 62 sites have received federal equipment from folding chairs to containers to dry ice. The federal government has provided a range of equipment to meet state, tribal, territory and local needs and help establish and expand sites.

This will get done in the details. Thank you to everyone involved in these efforts.

The president is visiting a federally establishing community vaccination site today in Houston, Texas. This site opened yesterday and has the capacity to vaccinate 6,000 people per day. And today, we're announcing two new federal vaccination sites, one in North Carolina, and the other in Illinois.

Starting in two weeks, the United Center in Chicago will be used to vaccinate up to 6,000 people per day. And in North Carolina, a new site in Greensboro will vaccinate 3,000 people per day. Selection was based on the CDC/FEMA framework to target those most vulnerable. The goal is to launch vaccination sites that use processes and are in locations that promote equity, deploying the CDC social vulnerable index.

In closing I want to come back to the important milestone of where we are this week. With over 50 million shots administers since President Biden took office, 50 million shots in 37 days. That is ahead of our target even with the setbacks during the recent winter storm which devastated millions of people if the Midwest and in the South.

As the president has said, if we do the right things, and we have the right plan, we will get things moving. We've doubled the pace of administering shots in six weeks. We've increased vaccine distribution to nearly -- to states by nearly 70 percent.

And nearly 60 percent of people over 75 now have received at least one shot. That is 14 percent six weeks ago. Close to 50 percent of people over 65 have at least one shot now. That was 8 percent six weeks ago.

Let me repeat that. 8 percent of people over 65 -- six weeks ago had received the first shot, now that is close to 50 percent. That is important because people over 65 account for 80 percent of COVID-19 deaths. And 75 percent of people who live in long-term care facilities have gotten their first dose and those cases are at the lowest level since reporting began in May.

So yes, we're making progress. But we are not there yet and there is lots of hard work to do. But I want to thank everybody, everybody across the country that has been involved in helping us make this progress.

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

DR. ROCHELLE WALENSKY, CDC DIRECTOR: Thank you so much, Andy. I'm glad to be back with you today. Let' get started on an over view of the pandemic. Over the last few

weeks, cases and hospital admissions in the United States have been coming down since early January and deaths have been declined in the past week. But latest data suggest that these declines may be stalling, potentially leveling off at still a very high number.

We at CDC consider this very concerning shift some the trajectory. The most recent seven-day average of cases approximately 66,350 is higher than the average I shared with you on Wednesday. In fact, cases have been increasing for the past three days compared to the prior week. And while deaths fluctuate more than cases and hospital admissions, the most recent seven-day average are approximately 2,000 per day is slightly higher than the average earlier in the week.

We're watching this concerning data very closely to see where they go over the next few days but it is important to remember where we are in the pandemic. Things are tenuous. Now is not the time to relax restrictions.

Although we've been experiencing large declines in cases and admissions over the past six weeks, these declines follow the highest peek we have experienced in the pandemic. So I want to be clear, cases, hospital admissions and deaths all remain very high and the recent shift in the pandemic must be taken extremely seriously. CDC has been sounding the alarm about the continued spread the variants in the United States. Predicting that variants such as the B.1.1.7 variant, which is thought to be about 40 percent -- 50 percent more transmissible than the wild type strain, would become the predominant variant of COVID by mid-March. We may now see the beginning effects of the variants in the most recent data.

Our estimated now indicate that B.1.1.7 accounts for approximately 10 percent of cases in the United States. Up from 1 percent to 4 percent a few weeks ago and prevalence is even higher in certain areas of the country.

And earlier this week, new research came out about additional emerging variants in New York, the B.1.526 variant, and in California, the B.1.427 variant, that also appear to spread more easily and are contributing to a large fraction of current infections in those areas, adding urgency to the situation.

We may be done with the virus but clearly the virus is not done with us. We cannot get comfortable or give in to a false sense of security that the worse of the pandemic is behind us. Not now, not when mass vaccination is to very close, when we need to prevent this is truly imminent.

We must continue to be vigilant and committed to consistently taking the steps that we worked to top the spread of COVID-19.

Where the pandemic goes from here is dependent on our collective behavior and resolve to do our parts to protect ourselves, our families and our communities. Together, we have the capacity to avoid another surge in our nation. I know people are tired, they want to get back to life back to normal, but we're not there yet. Give us time we need to give us more vaccines into our community and to get more people vaccinated. This is our path out.

Here in the United States, over 46 million people or 14 percent of the population have already received at least one dose of the vaccine and so many more of you have ready to roll up your sleeves as soon as vaccine becomes available to you. And indeed, more vaccine is on the way. We are at the precipice of having another vaccine in our tool box, the Johnson & Johnson COVID vaccine.

Like many of you, I'm excited about news that another safe and effective vaccine option could be coming as quickly as next week. We're closely watching the FDA advisory committee today and the actions they may take today and tomorrow on this vaccine.

Following the FDA's actions, CDC's advisory committee on immunization practices or ACIP is prepared to meet over the weekend and continues the same data being discussed at the FDA advisory economy and then the ACIP will make recommendations for the use of the vaccine, and I will stand by to review and ready to sign.

Having an additional safe and effective vaccine will help protect more people faster. I look forward to the ACIP discussion, receiving their recommendations and sharing with you about ACIP's recommendations and our next steps moving forward.

Thank you. I look forward to your questions and with that I'll turn things over to Dr. Fauci.

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

I'm going to give now a brief update on the science particularly focusing on the vaccine, if I go to the first slide.

This is the slide that I've shown to this group before but just building on what Dr. Walensky just said, we're looking forward with very positive anticipation to the final determination of the VRBPAC and the FDA concerning the Johnson & Johnson vaccine. What this means from data that we looked at, that we now have three highly effective vaccines.

Importantly, each of them are very effective against severe disease and virtually all of them say that he look at the data and it is clear that you get essentially no hospitalizations or deaths in any of them.

This is very good news. So, again, we have three candidates now that are in play. We look forward to the results as Dr. Walensky said. This should be forthcoming hopefully within the next day or two, together with the recommendations about how it is to be utilized.

In addition, on this particular slide, there are other candidates that have fulfilled enrollment and we're looking forward with them, too. The bottom line is that the more vaccines that have high efficacy, that we could get into play, the better there is.

Next slide. Now one of the things that was mentioned by Dr. Walensky is the fact

that we have variants that are in play. We have the 117 increasing in its prevalence now in the country with modeling telling us that by the end of March, it might be the overwhelming candidate for -- not candidate but the overwhelming strain that is actually spreading. We also have the others that Dr. Walensky mentioned, the 427 in California, the 526 in New York.

We must address these. There are a couple of ways of doing that. Let's take a look at the 351 that has attracted a lot of attention, which was originally in South Africa and not dominant here in the United States but we need to pay attention to it.

One of the ways to do that is to make a version of the vaccine which actually directly addresses the particular variant in question.

Could I have the next slide?

And what we've seen that just two days ago that the Moderna company began the clinical trials to booster the -- to provide booster shots for the variant from South Africa. What they did, actually, as the first step to beginning these trials, which will begin in mid-March, they sent material to the NIH for a phase one study.

Next slide.

Now, if you take a look at this, what this will be is that a variant specific vaccine candidate which we're referring to as mRNA 1273.351 designated the variant which is as 351 first identified in South Africa.

And as I mentioned, we will conduct a phase one study which we will begin in mid-march in both naive and previously vaccinated adults.

Next slide.

On this last slide, I show you the two cohorts to just give you an example of what the prototype model approach that had as being taken when you want to directly address a specific variant. One of these studies the cohort won was in previous vaccinated volunteers. Namely looking at individuals and again this is a phase one study, not looking at efficacy, but looking at safety and immunogenicity and that is the way things will likely go over the next several months as this company and others approve mainly taking a look at can you induce a level of antibody specifically against the variant in question.

In this case, it is the 351. And you could see, the first cohort is in previously vaccinated volts volunteers and the second cohort is individuals who are either unvaccinated and not previously infected, to determine if you are going to have a vaccine program that would be specifically directed against this particular variant, how would you design it. And this is the way to go.

I want to make one comment that I believe is important. One would ask, are you going to have to do this with every variant? Because we cannot determine now where the 526 or the 427 or other variants will go. So there are two ways to -- actually three ways, one that is common to

both, that you address these variants. First and foremost, is to continue with Dr. Walensky mentioning at the close of her comments, to continue to double down on the public health measures that prevent the transmission, because as I've said often and it is true in virology, that viruses will not mutate if you don't give them the opportunity to spread and replicate. So public health measures are paramount.

Secondly, you could go after the specific mutants, the specific variants as I've shown here. But there is another way to do it. And this has to do somewhat indirectly with what we heard yesterday from Albert Bourla, who is the CEO of Pfizer, when he was talking about the idea of maybe yet again another boost.

Meaning, the higher the tighter of antibody against even the wild type will have spill-over effects in mitigating the problem that is created by the variants. And we know that from experience with the 351 in which the effect of vaccination was diminished by multiple fold, but it wasn't obliterated because of the cushion of a high level of antibody.

So, a couple of things going on. A., you could directly address it specifically or you could get as high of a robust response from the vaccine in question that would have an effect on the variant.

So let me stop there and hand it back to Andy.

SLAVITT: Thank you. Before we turn to the questions, I want to maybe pose a question to you, Dr. Fauci --

(END WHITE HOUSE CORONAVIRUS BRIEFING)

BOLDUAN: All right. We've been listened to the coronavirus response team right there.