CDC Media Telebriefing Transcript on Operation Warp Speed

[Dr. Robert Redfield]

Are you mine? Ok great.

Good afternoon and thank you Secretary Azar for joining us today at CDC headquarters. It’s a privilege to have you with us and we appreciate your leadership throughout this unprecedented response.

COVID-19 is the most significant public health challenge our country’s faced in more than a century and the pandemic is not over. Earlier this week COVID virus cases reached over 40 million globally. Here in the United States, we’re approaching a critical phase. In a few moments Dr. Jay Butler, CDC’s Deputy Director for Infectious Diseases and the former incident manager of the CDC’s COVID-19 response, will provide you a brief update on our current domestic situation.

I know it’s been a difficult year for Americans, but we are going to come through this on the other side. I’m also optimistic that we’ll have a limited supply of one or more COVID vaccines available for distribution before the end of this year but we’re not quite there yet. That is why it’s so important that all of us remain diligent in our efforts to defeat this virus and to protect ourselves, our families, and our communities. At CDC, science, data, and service have driven our unprecedented response to the COVID-19 pandemic and our mission is to protect the health of every American and save lives. Personally, I’m incredibly proud of the men and women at CDC and it’s truly been an honor for me to lead them during these extraordinary times and to lead these extraordinary people.

I would like now to introduce Dr. Jay Butler who will make remarks and then followed by Secretary of Health and Human Services Alex Azar and then we’ll be happy to take your questions. Jay.

 

[Dr. Jay Butler]

Good afternoon everybody. Thank you for being here it’s fabulous to be able to speak to you today and thank you for that introduction Dr. Redfield. We’re here to give you the latest on what’s going on with the COVID-19 pandemic.

Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75 percent of the country. To date, we’ve confirmed over 8.1 million cases and sadly over 220 thousand deaths since January. I know these are numbers, but these are also people and we mourn these losses. The past week we’ve seen nearly sixty thousand cases a day on average as well as 700 deaths. Here in Georgia, we’ve also seen an increase in the number of cases despite the decline that we had experienced beginning in August.

And we’re also seeing cases increase in really all parts of the country in the Midwest particularly likely in part because people are moving indoors with the arrival of cooler temperatures. Another factor is that smaller more intimate gatherings of family, friends and neighbors may be driving infection as well especially as these gatherings move indoors and adherence to face coverings and social distancing may not be optimal. I recognize that we are all getting tired of the impact that COVID-19 has had on our lives. We get tired of wearing masks but it continues to be as important as it’s ever been and I would say it’s more important than ever as we move into the fall season.

It’s incredibly important to continue these steps also as we look towards the upcoming holidays. We know that every activity that involves interacting with others has some degree of risk right now. There are four general rules of thumb for assessing risk and deciding how to best protect yourself and those you love.

First, the more closely you interact with others.

Second, the longer the interaction asks.

Third, if the interaction is indoors rather than outdoors.

And fourth, interactions with the greatest number of people translate into the higher risks of COVID19 spread.

Understanding these risks and how to adapt different prevention measures can help you protect yourselves and your families and your communities. We all want to live as safely as we can and minimize the risk of COVID-19 while it is circulating. Secretary Azar will highlight what people can do to protect themselves, but I want to spend a few minutes talking about an additional tool we’ll likely have very soon. The COVID-19 vaccines that Dr. Redfield mentioned. We’re cautiously optimistic that vaccine will be available although likely in limited quantities before the end of 2020. Preparing for implementing a successful COVID-19 vaccine program is a crucial next step as part of our overall effort to protect Americans, reduce the impact of the COVID-19 pandemic, and continue to restore more normalcy to our lives and our country.

CDC is a proud part of Operation Warp Speed, the partnership between parts of HHS and the Department of Defense, to develop, make, and distribute millions of COVID-19 vaccine doses as quickly as possible while ensuring that they are safe and effective. In other words we want to make sure they work. I’m pleased to announce that all jurisdictions including Georgia have submitted their initial vaccine program plans. These plans are an important milestone in our efforts to ensure successful delivery and administration of safe and effective COVID-19 vaccines to the ultimate goal that everyone who wants to be immunized can be. Over the past month CDC has provided technical assistance to each jurisdiction including nearly daily check-ins with jurisdictional staff, weekly conference calls with immunization and preparedness managers, and in some cases on-site assistance.

My colleagues are currently conducting a thorough review of the draft plans we’ll be providing feedback to the jurisdiction during the next two weeks it’s important to recognize that these plans are flexible because things may change as we learn more about which vaccines become available and what amounts and when. Additionally each plan will include an executive summary that we plan to post online later this month allowing for maximal transparency and a general understanding of each jurisdiction’s approach.

I want to highlight also the pharmacy partnership we announced last week with CVS and Walgreens. Again we anticipate that initially the vaccine will be available in a limited supply and when the limited when the supply of vaccine is limited our efforts to vaccinate may need to focus on those who are at highest risk of severe disease as well as those critical to the response including those who provide care to people in the health care system. People at risk include those in long-term care facilities like nursing homes and assisting living facilities as well as independent living facilities. The Pharmacy Partnership for Long-Term Care Program provides end-to-end management of the COVID-19 vaccination process including getting vaccines to facilities. It provides for on-site vaccinations and fulfillment of all reporting requirements. Long-term care facilities will have the option of partnering with CVS in Walgreens whose combined national footprint will allow most facilities nationwide to opt into this program.

Before I close, I want to remind you that tomorrow the vaccine and related biological products advisory committee is meeting to discuss the latest COVID-19 vaccine development and next week the Advisory Committee on Immunization Practices will be meeting. Both of these meetings independent committees will be broadcast live for the public to see the data that is being discussed as well as the process that’s being used to ensure that Americans have a safe and effective variety of COVID-19 vaccines.

We know that stopping this pandemic is going to take all of our tools: hand washing, masks, social distancing, and hopefully quite soon vaccines. Taken together these tools are our best chance of getting our communities, schools, and health systems back into normal operations.

I’d like to turn the podium over at this point to Alex Azar. Secretary Azar, thank you for being here.

 

[Secretary Alex Azar]

Well thank you so much Dr. Butler and Dr. Redfield and thanks to everybody at CDC for hosting us here today. It’s an honor to be here to express my gratitude to the incredibly hard-working team here at CDC for their efforts throughout this pandemic. While in Atlanta I’ve also had the chance to learn about the heroic efforts of the health care providers, the janitorial staff, everybody, at Grady Memorial Hospital as well as Emory University’s hospital’s work on clinical trials for Regeneron’s antibody cocktail and Moderna’s candidate vaccine. Thanks to how we designed Operation Warp Speed, if and when the FDA gives the go-ahead for these therapeutic and vaccine products we will have supplies already manufactured and ready for distribution. In conjunction with Operation Warp Speed, the CDC as Dr. Butler mentioned is leading the effort to coordinate vaccine distribution and administration working with the 64 public health jurisdictions they partner with on vaccines each year. I want to offer a special thank you to every American who has volunteered for COVID-19 clinical trials or helped raise awareness especially among diverse communities where we need representation in our clinical trials. Anyone interested in signing up for a vaccine trial can visit Coronavirus.gov and for therapeutic trials go to RiseAboveCovid.org. While we make this exciting progress on vaccines and therapeutics we see concerning trends in many parts of the country as Dr. Butler explained.

I’m briefed with the latest data from across the country by CDC’s career experts each and every morning. There is hope on the way in the form of safe and effective vaccines in a matter of weeks or months. But in the meantime, to bridge to that next phase we have to take steps that can keep ourselves our families and our communities safe. Those are the three W’s:

Wash your hands,

Watch your distance,

Wear your face covering when you can’t watch your distance.

And avoid settings where you can’t do those things. Thank you all for joining us here today, thank you to the American people for the incredible sacrifices that you have made throughout this pandemic, and thank you to again to the dedicated team here at CDC for their incredibly hard work.

We’re not happy to take some questions. Yeah.

 

[Questioner]

Thank you, Mr. Secretary. Last week, Emory University’s Dean of Public Health called your agency’s undermining of the CDC under president trump unforgivable, called the president’s leadership anti-science. Dr. Butler, I believe, was quoted in ProPublica as saying he was deeply concerned that actions the agency was forced to take would cost lives. Have you discussed any of that in your conversations today since all this was in the last week and do you have any concerns about the allegations?

 

[Secretary Azar]

Well I’m not going to talk about my discussions internal here within CDC what did I come down here to do I came down here to thank the incredible people of the CDC for their work. We talked about the most recent data around the efficacy and importance of wearing face coverings. We talked about the vaccine planning work around distribution of vaccines and I got an update about the incredible progress CDC is making on increasing the data submissions from nursing homes into the national health safety network. In terms of the question that you asked let me be really clear the CDC is the premier epidemiological organization on the face of the planet. When we go to other countries as I often did before the COVID pandemic they literally are named the blank centers for disease control and prevention named after this very institution. So this is a crown jewel of American and global public health. We revere it. But CDC plays a role in what is a very unique, unprecedented pandemic. It has been 100 years, as Dr. Redfield noted, since we have had a public health crisis of this type. This is bigger than H1N1. This is not SARS this is not MERS. This is something that impacts the entire government and the entire economy. CDC plays a very important role in that. But it plays a role of public health and epidemiology. There are other key players even within my department substance abuse mental health services agency with important equities around mental health, opioid abuse during the pandemic, NIH and FDA around research and countermeasures, veterans department around care for our veterans, the defense department around force protection, transportation, DHS around transportation issues, international commerce, the state department, international relations, spread of disease globally. So the CDC plays a very important and vital role but in a pandemic of this scope, size, and magnitude, it plays a role, not just the role and I think some of the people who comment are not having actually lived in or led in this organization during this type of a crisis failing to appreciate that. But make no mistake the CDC is a science and evidence-led organization we respect CDC’s science and evidence conclusions what comes out of CDC at the end of the day is Dr. Redfield’s conclusions around science and evidence with the support of his team. And that’s how we operate and that’s how we’re going to keep operating. Yes

[Questioner]

The CDC guideline that talks about what a contact is it now says that it is being within six feet of someone for a total of 15 minutes or more and also there’s reporting that there’s an effort to CDC to shorten the isolation of quarantine time for school children, can you talk about that?

 

[Director Redfield]

Sure, thank you very much for the question. I think just to take the big picture as we said before CDC is science-based and data-driven and as a consequence as we get more data and understand the science of COVID we’re going to continue to incorporate that in our recommendations. Originally contact as you know that was considered to be high risk for potential exposure to COVID was someone within six feet that was for more than 15 minutes. There is some recent data that has been determined an individual who had a series of shorter contacts but over time added up to more than 15 minutes became infected, in clarifying that new science that new data into our contact recommendation is what you’re alluding to and again it’s based on data that one didn’t have four months ago but it is data now that we have based on situations recorded. The second part of your question, could you say it again for a second. (OVERTALK) For the effort in quarantine. So again as you know the data that we have right now, that’s in play, is that individuals who have had a high-risk exposure have a period of time after that when they actually become detectable for virus. Originally the average was a little more than five days and then then new data showed it was a little more than seven days. When you looked at the data collectively if you did the cut off at 14 days you actually identified almost everyone that was positive. If you tried to shorten it to 10 days we found that we missed around maybe 12 percent of people and so therefore we stayed at the 14 days. Now all of those decisions were made without testing so now there’s a series of studies gathering data that are trying to determine can you use testing during the quarantine to determine if you could shorten the quarantine from 14 days, to 10 days, or seven days. So again it’s data driven, it’s under evaluation, obviously we don’t want to have people be quarantined for you know 14 days unnecessarily. So we are working hard to see if there’s data now that we have testing that may allow us to be more confident that if we do testing at day five or day seven that we can use that information then more effectively understand that we could shorten the quarantine period. So it’s not a policy it’s basically an it’s an area of research where we’re gathering that data now.

 

[Unintelligible question]

Yeah if again I try to say this many times I get the opportunity. Science is a science-based data-driven service organization, CDC is. We’re not an opinion organization. So if we get data that supports the change in our recommendations then those recommendations will be changed.

 

[Secretary Azar]

Yes in the middle.

 

[Questioner]

(Unintelligible) 19 deaths could be much higher compared to I guess it would be a question for Dr. Redfield compared to or Butler in previous years I think we’re off nearly 300,000 deaths and I believe the CDC said two out of every three deaths is COVID related. Could you just talk about that?

 

[Deputy Director Butler]

Sure, so the concept of excess deaths is one that may sound a little cold but basically life is a sexually transmitted condition which is 100% fatal. So we know that all of us are going to die eventually. There is an expected periodicity to that. There is the average life expectancies. We know that at any time there’s a certain amount of seasonal variation also and this is something that we’ve looked at for years in terms of the number of excess deaths that are caused during an influenza season. Using that same type of methodology to look at what’s happened during the time of the COVID pandemic is how we’re able to come up with the fact that we know more people have died this year, we know that some people are going to die no matter what. But comparing the total number to that expected number leads to a difference that ultimately leads to the 300,000 excess deaths that you just mentioned. About two-thirds of those we can link directly to COVID-19. What about the other third – that’s as you know an important question to address as well. Some of those may be unrelated perhaps because of limitations on access to medical care. Some of them also may be unrecognized impacts of COVID-19. So when we look at factors like cardiovascular death that aren’t directly linked to COVID-19, there’s not a really great explanation for why we would see that increase in cardiovascular death and we know that it’s possible that COVID-19 could be playing a role in those deaths as well. And overall I think it emphasizes the importance of the prevention measures that we’ve been talking about.

 

[Questioner]

Dr. Butler you said that the vaccine could be available for distribution towards the end of the year I’m sorry um does that mean how widely and um how long do you think it could be before a vaccine is available for widespread distribution to anyone who needs it could that be march summer of 2021?

 

[Deputy Director Butler]

Sure I mean these are these are the questions that we are asking every day as we move forward with vaccine planning because as you’re aware there’s a number of different products that are currently in clinical trial. There’s a process to make sure that those vaccines are safe and effective that we have to go through as well and a number of the clinical trials are ongoing and still in a fairly early phase. So I wish we had a crystal ball so that we could look at it I wish I could say everything is going to go 100% according to plan but we also know that we have to be ready for if it doesn’t. I think looking at the current trends in the studies and the production of vaccines it’s reasonable to expect that we will have at least one possibly two products available before the end of the calendar year. The next question is okay that’s when and again no guarantees how much and that’s also part of the iterative process as we continue to learn what the production capacity will be going forward. One of the beauties of operation warp speed is we’re not waiting until we have all of the the studies completed and the reviews done before we start the production process. It may be that we find for instance that a vaccine is not effective and that’s a vaccine that ultimately is not going to be administered to Americans.

 

[Secretary Azar]

And if I could just in terms of your question around the timelines on quantities so as Dr. Butler mentioned we’ve got the Pfizer and Moderna vaccines which are very close to if not fully enrolled in their clinical trials when we get data out of those we’ll really be dependent on events in the trial. It’s outside of anyone’s control. We are as Dr. Butler mentioned concurrently manufacturing commercial scale production of all six of the vaccines that we have investments or contracts with including of course Pfizer and Moderna and we expect that we would have by the end of this year enough vaccine to be that is FDA authorized to be able to vaccinate all of our vulnerable into the most vulnerable individuals. Then by the end of January we expect we’d have enough to vaccinate all seniors as well as our health care workers and first responders and by the end of March to early April enough vaccine for all Americans who would want to take a vaccine. Let me we’ve got we have an overflow room because of abiding by CDC’s restrictions on number of people in the room could I ask you do we have anyone on the phone a question from the phone that has been asked we’ll turn over to the phone now if somebody has a question do we have Bloomberg on the phone please go ahead.

 

[Questioner]

Hi uh this is I’m a quote with Bloomberg um we were told by uh the leader of operation Warp speed today that Astra Zeneca and Johnson & Johnson trials are going to resume this week can you share any more about this as well as the nature of these safety concerns?

 

[Secretary Azar]

You broke up a great deal there I’ll try to I believe your question was regarding the status of the AstraZeneca vaccine clinical trials. So as of now within the United States, unless something has changed in the time since I’ve been standing here the AstraZeneca trial remains on clinical trial hold here in the United States because of uh the review by the FDA and the company uh as to a possible serious adverse event and what we do is the company as well as the FDA examined the data to determine when there’s a serious event is there a connection to the vaccine. Do we believe that’s a valid connection, a causative connection, and if so uh should the trial be restarted and continued or are there other precautions that one should take for instance modifying the informed consent forms, uh anything about the protocol that’s part of that. So the FDA has been working to gather uh data and information from uh AstraZeneca uh to make to assist it in that evaluation uh and as far as I know that process is continuing as we speak that will be a determination made by made by the FDA. One more, okay. yep can we see if the on the phone. Who do we have on the phone? Did we have fox on the phone?

 

[Questioner]

Secretary Azar thank you for taking our questions today? The president of the united states has held numerous rallies around the country many in the hottest of hot spots and most with no social distancing and little mask wearing. The president also says we are rounding the corner. In simple English sir are we rounding the corner and are these rallies a good idea? And the second part of my question sir is the president has also been critical of Dr. Fauci lately, what impact do you believe this will have as your department tries to distribute and convince Americans to take a vaccine that many surveys are now showing some Americans are skeptical about or concerned about taking?

 

[Secretary Azar]

So in terms of in terms of your first question uh listen our guidance is the same regardless of setting; wash your hands, watch your distance, wear your face covering when you can’t watch your distance, and avoid settings where you can’t do those things. For anybody reconnected to school, reconnected to work, going back to worship, or reconnecting to health care or engaging in the political and civic life of our country, our advice remains the same; which is wash your hands, watch your distance, wear face coverings when you can’t watch your distance, and avoid settings where you don’t where you aren’t going to be able to do those things. That that advice is the same regardless of any type of gathering. With regard to your second question the uh the president has assembled and has direct access to many different advisors including the people on this stage as well as others. I try to make sure from the beginning of this of this outbreak that the president is getting the best medical scientific advice from a diverse range of the top doctors uh within this department. And the president hears divergent viewpoints, the president’s made clear that he has great respect for Dr. Fauci and has a close relationship with Dr. Fauci he said that in follow-up from those other comments uh that should have no impact on the vaccine work that we do. The vaccine work that we’re doing the American people should feel very reassured by the process that is established here. There are five independent checks around vaccine regulation. First a vaccine clinical trial has pre-specified end points they’re statistical and actually these drug companies have been transparent for the first time in history laying out exactly what those statistical endpoints are. There is a totally independent data and safety monitoring board that will look at the data as it comes in determine if those endpoints have been met. If and only if those endpoints are met that data gets revealed to the company and the FDA. Then the company will have its own second independent process it will have to meet their ethical standards for submission of an application for either an emergency use authorization or a biologic license. Third it’ll come to the FDA where the FDA will evaluate that vaccine according to two sets of guidances it put out. Its general vaccine guidance for COVID and its second EUA guidance for what it would require and expect in terms of approval. Then you’ve got the fourth check which is as Dr. Butler mentioned the advisory committee at the FDA. An external advisory committee that will be webcast. A public external advisory process will advise the FDA. And then fifth the decision about whether to approve or authorize a vaccine at FDA will be made by FDA’s career scientists. So that’s five independent checks that combined with how this is working so far. Look at look at the fact that we have three clinical trials that have been put on hold because of any type of safety concern. The system’s working. This is being played by the book. So one antibody trial has been put on hold, two vaccine trials put on hold to ensure that FDA and we are putting patient safety at the center following all regulatory ethical standards for development of both therapeutics and vaccines. All of those elements of process should reassure the American people that when a vaccine or therapeutic comes out with the authorization or approval of FDA it represents FDA’s career scientists best judgment, that it meets their scientific evidence legal and regulatory standards. So, thank you all very much for coming today we Dr. Redfield and I’ve got to get to the airport but we really appreciate your being here today and Dr. Butler very much appreciate that. As I said Dr. Butler is the senior career official at CDC leading the coronavirus effort and we’re very grateful to him for his leadership uh and I’d like to as we move into the future want to make sure as you have had access we’re going to make sure that there are continued interactions and opportunities uh for you all to be continuing to engage with CDC as well as our career leaders here. Thank you very much bye-bye.

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