Sunday, March 1, 2020

ON-THE-RECORD PEN AND PAD ROUNDTABLE BY HEALTH AND HUMAN SERVICES SECRETARY ALEX AZAR, OFFICE OF MANAGEMENT AND BUDGET ACTING DIRECTOR RUSS VOUGHT, AND WHITE HOUSE DIRECTOR OF LEGISLATIVE AFFAIRS ERIC UELAND ON RESOURCES AVAILABLE TO COMBAT CORONAVIRUS

Office of the Press Secretary
ON-THE-RECORD PEN AND PAD ROUNDTABLE
BY HEALTH AND HUMAN SERVICES SECRETARY ALEX AZAR,
OFFICE OF MANAGEMENT AND BUDGET ACTING DIRECTOR RUSS VOUGHT,
AND WHITE HOUSE DIRECTOR OF LEGISLATIVE AFFAIRS ERIC UELAND
ON RESOURCES AVAILABLE TO COMBAT CORONAVIRUS

South Court Auditorium

 
2:01 P.M. EST

SECRETARY AZAR:  Well, thanks for coming, everybody.  In case you didn’t hear from us enough the other night, wanted to give you an update on the budget issues, in particular.

As the President has repeatedly emphasized, there is no higher priority for us than protecting the health and safety of Americans.  Thanks to the President’s aggressive containment efforts, at this time, the risk from COVID-19 to the American public is low.  But as we have all repeatedly emphasized, that has the potential to change.

The President’s bold, decisive decisions have brought us extremely -- have bought us extremely valuable time to prepare for the possibility that the situation may worsen and we may need to mitigate its spread in the United States.  That time is valuable for all sorts of things, including state and local preparation, and the development of diagnostics, therapeutics, and vaccines.

It’s also helped us determine our funding and resource needs, allowing the White House to make its supplemental funding request of Congress earlier this week.  We want to work with Congress to determine the funds we need for FY2020 first, because our priorities here are speed and flexibility.

HHS is already using up the $105 million in the Infectious Disease Rapid Response Reserve Fund, which has been vital, but it’s not enough -- which is why we are moving forward with a transfer of $136 million to continue our public health response, which I notified Congress about on February the 2nd.

Thanks to investments supported by this administration, we have highly valuable and flexible relationships and contracting methods for developing and purchasing diagnostics, therapeutics, and vaccines through entities like BARDA.  But we’ll need more money for the focused drive toward countermeasures that we need to keep America safe.

Working on a supplemental needs to be a top priority for Congress.  As the President has said, this is not a time for politics.  We cannot undertake all the preparation that it’s widely acknowledged we need without more funding.

As chairman of the Coronavirus Task Force, I have already begun working alongside Vice President Pence, Acting Director Vought, Director Euland, and others to begin productive discussions with Congress about what funding should look like.

We laid out five key elements of our supplemental request.  First, surveillance.  Second, state and local support.  Third, therapeutics.  Fourth, vaccines.  And fifth, personal protective equipment, or PPE.

I want to mention some particular activities we plan with the funding.  With surveillance funds, we’ll build on existing influenza surveillance systems, covering all states and adding coronavirus testing and reporting to the current flu systems.  We request funding for grants to state and local jurisdictions for epidemiology, lab capacity, infection control, and other activities, complementing CDC investments over the years.  And we’ve requested new funding for the 62 recipients of our hospital preparedness program.

We request $1 billion in support for the development of up to five candidate coronavirus vaccines, including support for one or more through phase-three clinical trials.

On therapeutics and diagnostics, we request support for investigation of broad-spectrum antivirals, research on existing monoclonal antibodies that work on other coronaviruses, development of new targeted monoclonal antibodies, and screening of small molecule compounds that have existing clinical data.  We request support for these activities through early clinical trials.

We also request support for development of assays to ensure ready availability of diagnostics, plus funding to help the FDA support these development priorities -- pipelines.

On personal protective equipment, we propose almost half a billion dollars in investments for the Strategic National Stockpile to increase production, capacity, and purchase of respirators, ventilators, and antimicrobials for secondary infections.

These kinds of activities will build on activities that we have prioritized and generously funded over the years.  Since FY2017, under President Trump, the CDC’s budget has increased by $668 million, while NIH’s budget has increased by more than $7 billion.

The FY2020 appropriations signed by President Trump include $2.7 billion for preparedness programs in HHS’s Office of the Assistant Secretary for Preparedness and Response, up about $600 million from FY2017.  That included a 130-million-dollar increase in annual spending for the Strategic National Stockpile, and a 203-million-dollar increase in our Pandemic Preparedness Program.

The President's 2021 budget for CDC, developed before we knew the coronavirus would present such an emergency, reflects similar priorities.  It maintains the $675 million in state and local preparedness investments, the FEP funding.  It prioritizes infectious disease funding and proposes a $50 million increase for CDC’s Global Health Security Agenda efforts.

That reflects this administration's longtime focus on effective preparedness programs, the CDC’s core mission of infectious disease response, and support for tackling infectious disease threats, especially ones that can cross borders.

I've been a strong advocate for this work and so have leaders across the Trump administration.  Tragically, we are now reminded why we've made the case for these priorities over the years.  And this situation demands more support from Congress, just as earlier potential pandemic situations have.

We look forward to working with Congress on this issue.  And I'm going to now turn it over to Russ Vought and Eric Euland, and then we'll get -- open for your questions.

DIRECTOR VOUGHT:  Sure.  With my time, I want to do a little bit of what I think is addressing some of the main inaccuracies or nuances that are out there in the public debate.

So the first one I want to tackle is the total amount for CDC of fighting infectious diseases and preparedness in the President's budget versus last year.  So, last year, fiscal year 2020, there was $4.182 billion for fighting infectious diseases and preparedness within CDC.  We then increased that in the President's budget by 3 percent -- $135 million -- to $4.317 billion.

So from the standpoint of everything that -- all of the activities that are going on at CDC in this area, there's an increase of 3 percent.

There is a topline reduction in the President's budget for CDC in areas that are not infectious disease fighting and preparedness -- things like climate change research; things like occupational health research that is not going to go away, but is merely something that we no longer feel like we need to jumpstart research that universities are doing, and they have been doing it since 1970, when these programs were first created because it wasn't happening at universities.

We also think there's waste, fraud, and abuse in this area, where you have studies on how taxi drivers are taking too few bathroom breaks, and whether that's an important occupational health issue.

Those are the kinds of things that we still think, even in a time of making sure that all the resources are there for CDC, we can find inefficiencies and waste, and deal with mission creep at the same time.

So it is not true that we cut CDC infectious disease fighting -- which gets me to the second one, which I think this is the main inaccuracy out there, which is this notion that you see in some of the New York Post and CNN reporting that we cut CDC by 80 percent.  It's flat-out inaccurate.

Let me explain how the numbers are concocted, comparing apples and oranges, to get that 80 percent.  When the Ebola supplemental was passed, there was $597 million provided over five years.  It was not an annual spend; it was a five-year lump sum supplemental.  Per year, that was $119 million for global health activities that would apply to any infectious disease.  But that was passed by Congress as part of the Ebola supplemental.     

The last two years of that five-year supplemental, we began to make sure that it would be funded within the base amount of resources.  So we put forward $50 million in Fiscal Year ’18, $50 million in Fiscal Year ’19, $125 million in Fiscal Year ’20, and in this budget we propose $175 million in Fiscal Year ‘21.

So, in -- while it was still available, we were taking steps to make sure it was funded within base resources.  So when the supplemental emergency funding expired, there would still be there, and then when that expired we then pulsed it up to $125 [million].  And this year we propose it at $175 [million].  So significant resources there.

You hear, in the same kind of stories, about leaked memos regarding contingency plans.  Those were -- we never got to the point where the funds were expired.  And so the contingency plans were what they're meant to be: contingency plans if the funds go away.  So, kind of -- we keep seeing this story out there.  It's flat-out inaccurate.

I want to talk a little bit about the run rate.  So when we talk about: Is there money in the account right now?  There's money in the account.  We have spent $77 million of the $105 million that Secretary Azar mentioned.

We will be able to get through into April.  We can't tell you with a specific degree of certainty, but we're in a good place right now, temporarily.  The difference between what we have actually spent, and the -- and the amounts that are provided, we have committed to other activities.  We need a supplemental; we need it soon.  There's no doubt about that.  But we haven't run out of money.  And we've got some time and we think that Congress is taking this very seriously.

Eric will speak to how quickly they will move a supplemental.  But we're moving forward and we are making sure we have all the accurate data.

I've heard the argument from the Hill: “Well, you haven't given us all of the obligation rates.”  Well, that's because we're trying to get all of the obligation rates ourselves: collect them, make sure we have all of them from the various different accounts across the federal government, compile them, and get them to the Hill.  And we will be as transparent as we always have.

And then the last thing I would just say from a comparison of -- this is our sup request versus their sup request.  Remember that ours was based on the notion of what's needed for the seven months remaining in Fiscal Year ‘20.  We put forward a two-and-a-half-billion-dollar request.  The President has been very -- made it very clear.  Secretary Azar, as head of our task force, has made it very clear.  We are willing to go to a higher level if Congress feels the need to do that.  But we put forward a two-and-a-half-billion-dollar request based on what was required in seven months, knowing that we're going to go right into Fiscal Year ‘21 appropriations, and build in additional resources for this area.

So when you see a big number from Senator Schumer -- again, not much detail there, but the assumption is that that is a five-year number.  “No-year money” was what we call it.  And so, to some extent, you're dealing, again, with apples and oranges.  The Ebola supplemental was, again, no-year money, so it wasn't intended to be for what was needed in this particular fiscal year.

So those are the main things that I've seen that I wanted to make sure we definitely unpack.  And I'm sure we'll do more of that in the Q&A.

MR. UELAND:  Russ, Alex, thank you very much.  I want to spend a couple minutes talking about our connectivity with Congress and then update on the supplemental, at least from our perspective.

So, once this began to be very serious in early January -- on the surveillance and warning and conversation with Alex and our international team -- we began conversations and discussions with folks on the Hill.

This actually was going on during impeachment.  I spent a lot of time, while working impeachment every day and half the night out on the Senate floor, also talking to members of both the House and Senate during breaks back behind the Senate floor about specific questions they had, interests they had, and information we had in relation to the outbreak and what was going on internationally.

The President was very clear to us from the beginning of this challenge.  He directed his team to be robustly engaged in sharing everything we do with Congress as quickly as we knew it.  So, even though there was this partisan distraction on the impeachment challenge facing us, this public health crisis internationally also faced us.

And so we followed through on the President's direction, fitting in with the Secretary's direction for radical transparency, ensuring that, as quickly as we could, we would be able to provide full panels of administration scientists, experts, and leaders to brief senators and congressmen in all-member conversations, held in the Senate and House every week Congress has been in session.

We've used those opportunities to provide answers, follow up on questions, and work to solve problems or challenges identified in real time that members have laid out to us.  In addition, we've leaned in with all-staff conference calls, again, for the Senate and the House.  These conference calls have happened twice a week with the latest one occurring today, right now.

On average, we have about 250 lines open every time we spend a significant amount of time with staff up on the Hill.  Today's conference call, going on right now, has 430 lines open, demonstrating the interest, and the ability of us to be able to provide information quickly and directly to Hill offices.

A wide variety of experts and scientists are on those calls to provide updates, answer questions, and serve as resources for offices as they deal with constituents, groups in their districts or states, and members of the press.  Specifically, at their invitation, we briefed over 144 member offices and 88 senator offices, in many instances, multiple times over the past few weeks.  We’ve briefed the staff and membership of at least 25 committees and subcommittees in the same period of time.

For the most recent four weeks that members have been in session, we've held one all-Senate and one all-House briefing every week at the member level.  We've also held briefings here at the White House for House and Senate members of both parties.  On the Hill, there's been over 12 committee or subcommittee hearings at which COVID-19 was discussed in the past few weeks.  Alex has had the special privilege of enjoying (inaudible) the tender mercies of members of Congress at those appearances.

There are also about 10 more -- at least 10 more committee or subcommittee hearings scheduled in the very near future.  Again, Alex and the experts do attend.

Agencies involved in the congressional response and briefing process have included the Department of Health and Human Services, the Department of Homeland Security, the Department of State, the U.S. Agency for International Development, the Department of Defense, the Office of Management and Budget, and the Department of Transportation.  Many of these conversations have been led by principals at those departments and agencies, demonstrating the seriousness with which we take the need for these conversations and the identified obligation we have and the interest we have in sharing information in real time as quickly as possible with members of Congress.

To give you some sense or perspective on some of the other things that we've been doing or the volume of interest and work we've been doing on this issue, the CDC has responded to approximately 450 phone calls, letters, and briefing requests from Congress in just the past few weeks.  HHS itself has responded to hundreds of phone calls, letters, and briefing requests from Congress, and that will only continue to accelerate, I'm sure, in the weeks to come.

We'll continue to keep up a steady and full engagement with Congress, in addition to all the communications that we do publicly on a regular basis across the entire administration.

With respect to the supplemental, very briefly: Our understanding is since the submission of the supplemental, Monday evening, by the President, good progress has been made this week between the majority and minorities -- the leadership of both the House and Senate appropriation committees, as well as the House and Senate leaderships.

We know that the pace of conversations is accelerating into this weekend.  We're very appreciative that the discussion has stayed focused on COVID-19 and has not brought up unrelated issues.

It's important that we deal with the first problems first -- COIVD-19 -- here for this fiscal year.  And I'm looking forward for what's coming up in FY2021, but not get distracted on unrelated and unattached issues.

If everything stays on track up there, we would expect Congress to provide us a package as early as the top of next week, in just a few days.  We want the President to be able to sign a supplemental spending bill by the end -- no later than the end of this work period, which is the week after next, but as quickly as possible.  As fast as Congress can act, we’ll be ready to act as well.

I think with that, we’ll stop and are happy to take questions.

Q    Mr. Secretary, if I could, are you -- have you had any plans to use the Defense Procurement [sic] Act to step up production of PPE and other items?  And then I have a question for --

SECRETARY AZAR:  We will use the Defense Production Act as necessary to enable that our contracts go to the front of the line on contracting.  So that is an authority that we have, and we intend to use it to acquire anything that we need to acquire.  We won't use it unnecessarily, of course.  We don't want to be disruptive if that's not needed.  But if we need to, we will use it.  We won't hesitate.

Q    Do you have a top-five list at this point of what you need?

SECRETARY AZAR:  I'm not going to say what we would use DPA for -- the Defense Production Act for.  But, of course, we've been very clear in the supplemental of the core items that we've got to do, which is personal protective equipment.  So that includes N95 masks.  We've spoken of procuring at least 300 million N95 masks.  We need additional gowns -- the Tyvek gowns, as well as gloves.  So that kind of personal protective equipment most immediately.

Q    And, Russ, if I could to you, you’ve said that comparing your supplemental request with what Schumer is talking about is “apples to oranges”: yours is for seven months, his is for five years.  Do you have a five-year estimate of what you're looking at so that we can compare apples to apples?

DIRECTOR VOUGHT:  We don't at this point.  That's one of the reasons why we've been open to working with Congress on building out the request over a period of time.  We wanted to, at every step of the way, provide the most accurate reflection of what's necessary.  And we're learning about the resource needs with each day as we assess what's the spend rate in these programs and what's going to be needed.

And so we put forward seven months.  We're going to have -- we're going to continue to have a good conversation over the weekend with the Hill, and hopefully we get a supplemental that is acceptable to all sides.

Q    The World Health Organization today said that the risk is “very high” for COVID to spread.  I've also read reports that say 50 to 70 percent worldwide -- population -- could be infected with a 2 percent mortality rate.  So that could be hundreds of millions of people in this country infected and millions dead.

How do you assess the -- how do you look at the -- and how do you assess the accuracy of those reports?  And if they’re anywhere near accurate, of what we've heard today, what are we preparing to do in hospitals and clinics to prepare for such an inundation of sickness?

SECRETARY AZAR:  So, I have seen those reports about the 70 percent projection.  That’s just not something that we've experienced so far.  For instance, I think the highest attack rate that we've seen so far is on the Diamond Princess, the cruise ship in Japan, and I believe the attack rate there has been approximately 30 percent.  And that's been -- and that, of course, was under the unique circumstance of that ship, which was really an incubator right there.  I think that was higher even than what's been reported out of Wuhan itself, the original epicenter.

In terms of fatalities, what the -- the most recent data we have there is from the WHO (inaudible) team that deployed in China and was able to look at raw data and speak with officials there.  And what's been reported is, within Wuhan, over a 2 to 2.5 fatality rate -- percent fatality rate.  But outside of Hubei Province -- I think it was defined by Hubei Province -- outside of Hubei Province, I believe it was closer to a 0.7 percent, is what they were reporting.

What we don't know is what kind of fatality rate we’ll see in a much more advanced public health and healthcare system that also has the early, early containment and mitigation efforts, unlike what we saw in China where they had to play a bit of catch -up there.

So the cases -- we've, of course, had the benefit of massive active containment measures, as well as mitigation preparations.

And so it's not clear you see the same fatality rates in, say, our healthcare system, and it's not clear you see the same attack rates or penetration rates of infection with the type of early, advanced world's best public health system that identifies cases early on, contains and mitigates off of that.

We're doing modeling on that now.  We’re doing meta-analyses.  You see, for instance, some of the more extreme reports -- I think it was the London School of Economic Report, and that might've been where that 70 percent number came from.  And that was based off of -- I think that was based off of the first 4,000 cases in Wuhan.  So, very early on.

So, right now, one of things we will do is a meta-analysis across all peer-reviewed articles and studies that have come out, as well as our own modeling work on that.  So there's it's still -- there's still a lot of unknowns here.  A lot of unknowns.

Q    Just a follow-up.  I mean, in hospitals and clinics, are we going to be putting any of this money into state and local hospitals and clinics?

SECRETARY AZAR:  So that's something that we would discuss.  That’s not a direct funding in the President's request on the emergency supplemental, but that has been raised by members of Congress as something that they would like to see as we work together on that.

And I think Dr. Schuchat, I think she spoke about this with you all.  She might've done this one just over at HHS.  One of the things that is really important as you think about this disease -- and we need your help on this, actually, as members of the media: We are engaged in very active and aggressive containment measures now.  We have brought back over 800 Americans and relatives on repatriation flights.

As a result of bringing them back from the hot zones, either the Diamond Princess or Wuhan, we have people who are either infected or very susceptible of being infected and carrying the disease.

And so when we had cases, we used -- we had first federal quarantines in 50 years to accommodate that.  When they come back, they're on military bases because we don’t sit around having quarantine space for federal quarantines here in the United States.

My colleague, Secretary Esper, was extremely accommodating to get us space to house people.  But we also, under DOD rules, we can’t have actively infected people on a DOD base just from a force protection perspective.  And so we then need a place to put them.

Because we're in this aggressive act of containment, we are putting them actually in very high containment facilities usually.  Negative air flow.  The kinds of facilities you might be familiar from the Ebola response with West Africa.  Even if there is zero medical indication for that level of treatment --people with mild symptoms, for instance -- that is not how one will treat people who are infected with the novel coronavirus once we're in a -- if we end up being in a mitigation phase, as opposed to this very aggressive act of containment.

So what Dr. Schuchat has said is, if you have mild to moderate symptoms -- which is the vast, vast, vast majority of people being experienced in any country that has had larger outbreaks -- the advice is going to be: Stay home, manage your symptoms, and we'll provide guidance of at what point would you seek higher-level medical attention.

So, like having a severe cold, like having the flu: Manage at home, treat the symptoms.  There will be circumstances where it will be indicated to come to the hospital.  Because we don't want a situa- -- China has two big problems: One of them is it's a hospital-based healthcare system.  They don't have doctors' offices in China.  You go to the hospital is where your doctor is.  That's how you get treated.  So you go there.  That clogs up the system.

The second is, there was a real sense of panic. Okay?  Because of just, obviously, the massive quarantine measures, over 700 million Chinese under travel restrictions, over 70 million in a quarantine cordon sanitaire system.  Panic.  People go to the hospital; that's their normal place.  And then panic on top of that really chokes that hospital system.

So a lot of dealing with hospital infrastructure for us is appropriate, balanced public health messaging and clinical guidance so that we don't have people excessively going to the hospital, which also runs the risk of nosocomial infection, which of course is a critical priority.

So that's how we -- that's how we try to think about it.  That's why, as we go forward, messaging, educating the public, educating healthcare providers is so absolutely important to our work.

Is that John Gizzi back there?

Q    Yes.  Hi.

SECRETARY AZAR:  Hey.  (Laughs.)  It's been a long time.  How are you doing?

Q    It's been a long -- how is Jennifer?

SECRETARY AZAR:  She's doing great.  Thank you.  Yeah, John.

Q    Thank you.  Mr. Secretary, since you called on me, sort of -- (laughter) a question: Japan -- as you know, Prime Minister Abe has closed the schools because of the epidemic and the possibility of worse things.  Is there any plan -- in the works, on the table, anywhere -- for the closing of U.S. schools under similar circumstances, or could there be?

SECRETARY AZAR:  So there is a whole continuum of mitigation steps that one can do in the event of an epidemic, an outbreak, or eventually if there were ever a pandemic situation, a range.  Social -- we call these different forms of social distancing.  Okay?  It can be indicated under certain circumstances that it might make sense to close a school or schools, or take other measures like that.  I think Chief of Staff Mulvaney made reference this morning in some remarks to those.

Those are all items on a broad continuum from least intrusive to more intrusive, in terms of movement and the economy.

Of course, every option needs to be on the table as we assess the situation.  But it depends really on what circumstances we end up facing, if we end up seeing community transmission, if we end up seeing larger-scale community transmission.

And I think what we're all trying to do is just be very transparent with you all and with the public to get our mental frame around that there are things that you might see.  That doesn't mean you will see.  Many contingencies happen before you get there, but it's underst- -- it's just being realistic and understanding you might see various things in the armamentarium.

Most of those measures actually are state and local.  Like I said, for 50 years, no secretary has exercised the federal quarantine authority until I did, in January.  I think the last case was a smallpox at the Mexico border, if I remember correctly.  There's a reason for that.  It doesn't mean that in 50 years nobody has been quarantined in America.  We quarantine all of the time, especially tuberculosis cases.  We do voluntary home isolation all the time.  It's done at the state and local level, in partnership with the CDC or independently, as they take these measures.  These public health measures are used quite frequently, all the time.  It’s just not always seen quite as much.

Q    Mr. Secretary --

SECRETARY AZAR:  Yes.  Yep, in the back.  Yep.

Q    Yeah, thank you very much, Secretary Azar.  So you mentioned the military bases.  I have a question about that.  In California, there is a confirmed case of someone with coronavirus.  Do you know what the origin of that is?  And could it be related to the quarantine at the military base?

SECRETARY AZAR:  So this question is in reference to the 15th case which was disclosed on Wednesday.  So this individual is a suspect community transmission case at this point, meaning we do not have a definitive link showing how she contracted the illness.  Okay?  This is what we've been talking about.  Nancy Messonier made a reference on Monday that we might see community transmission.  This is a possible.  We are now aggressively working with state and local.  CDC is deployed to do the contact tracing to -- she has, of course, been contained and is under treatment -- to now do the contact tracing to discern the etiology of her disease; can we find the origins of her disease.

We do not -- our current thinking is we do not believe it could be connected to the Travis Air Base repatriation efforts, just in terms of the timing of when she presented symptoms.  We did not have any -- so we had the Wuhan flight initially -- Wuhan repatriation initially, and no individuals from that Wuhan repatriation contracted the virus.

Then she presented -- she was symptomatic.  Then the Diamond Princess passengers.  So, not definitive.  Still very much under investigation.  But it does not appear that way at this point. And that's why we are, at the moment, calling it a suspect community transmission case until we can define it better the basis.

Q    And a quick follow-up on that.  Are there are more CDC resources on their way to Northern California?

SECRETARY AZAR:  I don't know about more.  We have deployed there.  I don't know the -- I don't know if there are people literally in transit right now.  We'll send whatever we need to to assist the state and local public health authorities with the contact tracing and getting to the bottom of her case.

Q    Well, they're asking.  So that’s why they're asking for faster testing.

SECRETARY AZAR:  Oh.  In terms of testing, we've already worked -- so we -- so, in terms of testing, let me give -- because I assume maybe one or two questions about diagnostics out there.

In terms of testing, we've already worked with the state of California to get them additional shipments of the CDC kits.  So those are already out -- getting out there.  We also are -- let me explain what's going on, on the diagnostic, as background. Within a week, CDC developed a diagnostic here based on, I think, it's three elements of genetic sequencing.  It's a three-part test.  That then rushed through FDA approval with emergency use authorization and was approved for use, or authorized for use.

CDC has consistently been able to do the testing and do so with valid quality control with no backlog, added staff.  So no issue on throughput there.  We sent that diagnostic out as kits and a recipe out to our public health labs in the United States.

There was an issue on the third part of that test in terms of its ability to be quality controlled in certain labs. Essentially, once they set up the test, they have to run their own quality control and validate that they are able to exercise that test functionally.  What happened on the third stage is that many were unable to actually do the quality control on the third stage of that.

As a result, we reexamined the test and determined that actually -- and the FDA has determined that the first two elements of the test are sufficient for accurate testing.  And so we on, I believe -- what day was that? -- Wednesday -- Wednesday evening, we alerted the labs that have these tests that they could proceed with the first two elements of the test, and that was actually accurate testing per FDA guidance.

We also are in the process right now, through the FDA, of increasing flexibility to allow private sector labs to develop coronavirus testing on an accelerated basis, and a combined CDC-FDA guidance will be out soon with specifics on that.

So what does that mean?  That means we have kits we're sending out.  We have some labs, like I think Nebraska, that have developed -- that have basically recreated and validated that test on their own.  So we have 12 that are doing this.  But we now -- with the recipe of the test, the instruction of how to do that, the FDA and CDC are putting out guidance about a streamlined, expedited process to proceed with that testing in labs across America.   So we hope within a fairly short period of time to have a vast increase in the capacity of testing here in the United States.

Q    Thank you.  Let me just follow up on two of those questions -- one on the testing and one on what Francesca was asking about.

I think the reason people are about any link between that 15th patient you mentioned and Travis might be in part because of that whistleblower complaint that, as you know, has been reported on regarding potentially your staffers not having proper training, proper protective gear.  I'm hoping you can speak to that and whether you've implemented separate measures now given the response that you, the CDC, your agency is implementing here.  And I want to follow up on your testing question.

SECRETARY AZAR:  Soin terms of the whistleblower complaint -- and I said this to the Ways and Means Committee when I was asked.  I didn't know about the complaint, but I was asked basically surreptitiously by someone who must have seen it before I had the benefit of seeing it.  But I was asked questions about the elements.

First, protecting our employees is of vital importance. Second, we insist on compliance with isolation and quarantine procedures and personal protection.  We will -- we are fully investigating the allegations in the complaint, interviewing, gathering data to get to the bottom to see if there is any validity to the allegations.  And we will take remedial measures if needed.

The entity that was involved in that complaint is not involved anymore in the efforts.  That is what's called the Office of Refugee Resettlement in the Administration for Children and Families.  Part of their job is, when Americans are repatriated by the State Department, there is a function that we have that's rarely seen where this part of ACF deploys and provides Human Services assistance to individuals who may have -- they may be American citizens but have never lived in America before; they may be low income -- transition money, transportation, transition housing, support, et cetera.  So they're there to assess and provide that type of assistance.

We don't have any new repatriations.  We do not plan any more repatriations.  And so that has been long -- that group hasn’t been long and not part of this.  But we will very transparently investigate.  And if there's any problem, there will be appropriate remedial action on that.

Q    On the diagnostic that -- excuse me, the diagnostic point you mentioned, you said you hope in a fairly short period of time to ramp up.  Can you quantify some of those numbers?  I think a big concern that some officials we've talked to had is that, you know, what's the timeline?  What's the number of -- put some numbers behind that if you can.

SECRETARY AZAR:  Yeah.  So as of that Wednesday night guidance about the first two-stage -- using the first two stages, there were 40 labs that could then -- that validated and could be able to start executing on the test.  So there should have been 40 as of Wednesday night, Thursday morning.  I know there's a fellow from the one of the lab associations, but he's -- I think, his info was a bit dated when he commented on Thursday morning, because it should be 40.  There should have been 40 as of Wednesday night.

We are continuing to -- first, we have complete throughput at CDC, no backlog for the tests that come to CDC.  We're shipping out more cases.  I think we're getting 1,000 more kits out to California or have already arrived in California.  So we're working very closely.  We've got an incredibly collaborative relationship with Governor Newsom and the California government.  Getting that out there on their request.

And then on this new guidance, we'll get that out very soon, about how basically private CLIA labs could implement their own -- basically get their own approved test so they don't rely on CDC for any materials, rely on CDC for any shipments.  Nothing.  It would be totally a lab-based -- a lab-developed diagnostic test that would be authorized by FDA within a very quick time.  It would be at their initiative; we can't force them.  But these labs could develop that very quickly within the period of weeks.

MS. MILLER:  All right.  Last question, guys.

Q    Mr. Secretary, I have a follow-up on the schools.

Q    Mr. Secretary, I have two quick questions.  The first, you talked about 1,000 kits going to California.  Do you have any timeline or the goal that every doctor in the United States would be able to test someone for coronavirus?  And if that would be the goal if that -- how far are we from that being  able to be the case?

SECRETARY AZAR:  So, with diagnostic testing, it's important to think about the different types that we have.  So, this kind of PCR diagnostic that we're using now at CDC, that can be done in public health labs, that can also be done in these CLIA -- the clinical lab -- I forget, the Integrity Act -- labs that are certified labs.  That can be done there.  That should rapidly expand in the next several weeks for the reasons I've said -- that type of lab-based testing.

What you're talking about at the doctor's office would be a bedside-type diagnostic, which we have, for instance, for strep, for flu.  We need to get to that, but that is a longer development process with -- private sector entities who are working on that.  When we get the supplemental through, we will --

Q    Longer, being like months?

SECRETARY AZAR:  Months.  We will put money -- we will -- I’ve told the team we will spend whatever amount of money Congress gives us to rapidly speed along the development of the bedside diagnostic.  But once we get this fully out to public health labs, as well as CLIA labs, that's going to give us tremendous, tremendous capacity out there in the United States, and also large, large reach.

These are labs that are common household names to you that will be able to develop a lab-based -- lab-developed test authorized by FDA and do massive amounts of testing as soon as those get up and running.

MS. MILLER:  All right.  Thanks, guys.

SECRETARY AZAR:  Thank you all very much.

Q    And a quick follow-up, please.  A quick follow-up: Could you just say how many cases there are in the United States, and whether or not you feel comfortable that that’s an accurate number given that there isn’t widespread testing kits right now?

SECRETARY AZAR:  So, yes, I want to get my -- I don't want to give you anything -- any information that is not completely accurate.  Let me make sure I reference.

So, as of this morning, there were 15 disclosed cases in the U.S. that are the individuals in the U.S. that had not been repatriated.  Okay?  That is -- there were, of those -- 12 of those were individuals who had traveled in Wuhan.  Two of those were spouses of infected travelers from Wuhan.  And our 15th is the woman we were speaking about before, who is the potential community transmission case in northern California.

There are -- as of this morning, my last data point was 47 cases from individuals who were repatriated to the United States -- that would be American citizens, or family members, or permanent residents -- from Wuhan.  Three of those infected.  Or from the Diamond Princess, 44 of those who have been infected.  Okay.

MS. MILLER:  All right.  Thank you, guys.

SECRETARY AZAR:  Thank you.

Q    Where are you on the vaccine?

SECRETARY AZAR:  So what Dr. Fauci has told all of us is we are about six weeks away from entering phase one clinical trials on that.  That is the initial human testing on the vaccine.  So that’s the Moderna vaccine.  So in approximately in about six weeks that would be.  So that’s basically in the three-month timeframe from developing the vaccine, which I think is historic in its dimension.

But then, as he said, that's a fairly small -- those are your basic safety, small efficacy.  And then you'd have to move into your phase two studies, your larger-scale efficacy, (inaudible) ranging studies just to make that you've got something there.

Q    Can you just clarify -- on DPA -- you've not made a final decision on DPA, sir, is that what you said?  No final DPA decision?

SECRETARY AZAR:  We'll use it if we need it.  I don’t have any procurements I need it for right yet, but if we need it, we'll use it.

Q    Okay.  Thank you.
 
                         END                 2:46 P.M. EST

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