Background Press Call on the Operation Warp Speed Vaccine Summit

The White House

Office of the Press Secretary

December 7, 2020 BACKGROUND PRESS CALL BY SENIOR ADMINISTRATION OFFICIALS ON THE OPERATION WARP SPEED VACCINE SUMMIT

Via Teleconference

4:54 P.M. EST

SENIOR ADMINISTRATION OFFICIAL: Well, thank you, Operator, and thank you everyone for joining the call. This afternoon's call will be on background, attributable to senior administration officials, and we will embargo it until the conclusion of the call.

With that, I'm going to walk you through what to expect with tomorrow's Operation Warp Speed Vaccine Summit. And I will be joined for some additional remarks by [senior administration official] of the Department of Health and Human Services, as well as my colleague [senior administration official] from the National Security Council.

At the conclusion of our remarks, we will be happy to open it up for some questions.

So, first, I'll start by just noting the key purposes of this summit. Number one is educating the American public about the vaccine development process and how extensive it is, as well as the vaccine distribution process and how we will reach every zip code in America very quickly, as soon as a vaccine is approved by the FDA.

Second, it's to instill confidence in both of those processes so that Americans know that the vaccine is safe and so that they know that every community is being considered very thoroughly in how we get this out.

And third, it's really to congratulate the members of Operation Warp Speed, the members of the administration, the members of the scientific community, the members of the public sector, the U.S. military all coming together in, really, the most spectacular mobilization since World War Two to get a vaccine to market much, much faster than has ever been done before.

So those are sort of the key purposes. I'll walk you through the agenda quickly.

The President, President Trump, will lead off the event and deliver remarks, and he will discuss this great achievement. He will offer his congratulations to all those involved. He'll also be signing an executive order, which we'll get into a little later on this call.

Then, following the President's remarks will be the first session titled "Operation Warp Speed." There will be remarks by Dr. Moncef Slaoui. He is the chief scientific adviser for Operation Warp Speed, and he'll discuss the vaccine development process. That'll be followed by remarks by General Gus Perna, the chief operating officer for Operation Warp Speed. He'll discuss the logistics and distribution process.

The second session will be called "How the FDA Is Evaluating Vaccines." That will be a fireside chat between Adam Bowler, the chief executive officer of the U.S. Development Finance Corporation, and Dr. Peter Marks, and he is the director of the Center for Biologics Evaluation and Research at the FDA. That panel will be very important because Dr. Marks will explain to the audience how the FDA goes about reviewing vaccines and how thorough they are, and just why the FDA's review process is the gold standard for the world.

The third session will be called "How Vaccines Will Be Distributed." That will be moderated by Admiral Brett Giroir, Assistant Secretary for HHS, and he will be having a discussion with representatives from UPS, FedEx, McKesson, and Thermo Fisher. And these companies are going to explain to the American public exactly how we're getting the vaccine from the producers to the end users -- the packaging, the shipping operation, the state-of-the-art logistics that go into this process.

Following that, there'll be a break. And then after the break will be the fourth session titled "How Vaccines Will Be Administered." The moderator will be Brad Smith, Deputy Assistant to President Trump. He works on healthcare policy, and he will have a discussion with representatives from CVS and Walgreens. These pharmacies are critical partners in this effort to get the vaccines to the end users.

And then the fifth session will be titled "The Critical Role of Jurisdiction in Vaccine Administration." That panel will be moderated by Secretary Alex Azar, and he will have panelists; it will be governors from around the country: Governor John Bel Edwards from Louisiana, Governor Bill Lee from Tennessee, Governor Greg Abbott from Texas, and Governor Ron DeSantis from Florida. And they'll discuss how the federal government has issued a vaccine distribution playbook for all jurisdictions, and then each jurisdiction has submitted their plans -- we'll call them "micro plans" -- to reach all of their constituents with the vaccine.

It will conclude with remarks by Vice President Pence.

There is one question that we've gotten incoming as we were getting ready to start this call, so I may as well just address it before I hand it over to my to my colleagues here. But there was a question about the vaccine companies -- Pfizer and Moderna -- and their participation. We were in discussions with them in the planning process for participation. Ultimately, the determination was, when we had Dr. Peter Marks of the FDA participating, there was a change of direction. In light of the fact that we would have their regulator participating in the event, it was more appropriate not to have one or more vaccine companies with pending applications before the FDA also participating in that event.

So with that, for more information, I will pass the baton to actually the emcee of tomorrow's event, and that is [senior administration official] at the Department of Health and Human Services.

SENIOR ADMINISTRATION OFFICIAL: I think implicit in the agenda that my colleague just read to you are three very important vital partnerships that have made Operation Warp Speed a success, and I think it's just important to review those, and you'll be seeing that tomorrow for those of you who are attending.

One is the Department of Defense and the Department of Health and Human Services. It's a wonderful kind of marriage of their logistics expertise from the Defense Logistics Command under General Perna and, of course, all of the public health expertise that resides within HHS and particularly CDC. Nothing like this has ever been done before. The attempt to distribute and vaccinate 300 million Americans, two doses each for the most part, in six months or so, is unprecedented. So we thought that was very important.

The second partnership has to do with the federal, state, and we're going to adhere very much, and when we deal with distribution to our principle of federally supported, state-managed, and locally executed. And Secretary Azar is going to be talking about that in depth to the governors. But also note that we have a large number, actually, of county commissioners and mayors who will be in the audience, who will be also vital to the success of this.

And then the third one, which is featured and I think very much celebrated tomorrow, is the public-private partnership. We are enabling the success of the private sector, but as you heard the name McKesson, UPS, FedEx, Thermo Fisher, these -- CVS, Walgreens -- these are all iconic brands, either in the healthcare field or more largely consumer brands within the United States. And they're the ones who are actually going to be most involved with getting specimens from point A to point -- I'm sorry; I say "specimens" -- doses from point A to point B.

If we talk just for a moment about the distribution process, there's been a lot of confusion about this, and I started -- we were on a call earlier this morning, and I think the statement stands, which is: It's highly unlikely that any U.S. government official will touch a dose of vaccine before it gets shot into Americans' arms. And that's consistent with what I just mentioned, which is this great public-private partnership.

But just to put this into perspective: Moderna and Pfizer, in this case, will actually have a slightly different starting point because Pfizer has decided it wants to play a larger role in the physical distribution of its vaccines. But just follow me for a second. The way this is going to work is as doses come out of the finish-and-fill facility, and they are designated for us, we will keep track of that in an information technology system. As you've already heard, we've made allocations to the 64 jurisdictions which comprise dates and cities and territories and islands and that type of thing; there are 64 actual jurisdictions.

The jurisdictions will have enrolled, and they have already enrolled, thousands of vaccinators who are registered to vaccinate. They had to go through training, they got approved, they had cold storage requirements, and they have to be linked to our information technology system. So they will order -- at the direction of the state, those vaccination sites can order product. We will then direct either Pfizer or Moderna to distribute those. If it's a Moderna vaccine, it will go through McKesson, which is the CDC's distributor. If it's a Pfizer vaccine, they will do it.

Both of those, McKesson and Pfizer, will use some combination of UPS and FedEx; that's why they're going to be there. And the doses will be delivered directly to the point of vaccination, if specified by the jurisdiction.

So that's all just to say that the states and the jurisdictions play a vital role here, but it's mainly an air traffic control role. Every dose is already paid for. The syringes and needles and swabs necessary to vaccinate will be merged with the vaccines going out, and those are already paid for. We're providing the dry ice with the vaccines for the cold storage. And the distribution itself, whether that's through FedEx, UPS, Pfizer, McKesson, is already paid for by the federal government.

Now, when the vaccines get to the vaccination site, and they're administered, whoever is administering those will actually bill the third party who is responsible for covering that individual. That could be Medicare, it could be Medicaid, it could be commercial. If it's uninsured -- if it's an uninsured person, then the Provider Relief Fund, through the CARES Act, will be covering the cost of that at Medicare reimbursement rates.

And it's all to say just two things: One is, no American will have to pay a penny out of his or her pocket to get vaccinated. There will be absolutely no copays, deductibles, or coinsurance associated with this. And number two, that vaccinator will bill at approximately $20 to $25 an injection. Think about that as $40 to $50 per person vaccinated if it's two doses. And you can do the math on 300 million vaccinations. If we get to that point, it's 12 to 15 billion dollars. So, in addition to providing everything for free, we are actually going to be reimbursing the vaccination site up to 12 billion -- 12 to 15 billion dollars over the next six to seven months.

So that's just a little bit more about distribution and the partnerships. And I'll hand it back to my colleague.

SENIOR ADMINISTRATION OFFICIAL: Thank you, [senior administration official]. And now I'm going to introduce my colleague [senior administration official] with the National Security Council, and he will talk to you about the President's executive order.

SENIOR ADMINISTRATION OFFICIAL: Thank you. And thank you, [senior administration official].

I think it's really important to note that, tomorrow, the President's going to be signing an executive order on ensuring access to U.S. government COVID-19 vaccines. This is a reaffirmation of the President's commitment to America First to ensure the health and safety of our citizens, the viability of our economy, the security of our nation, and ensure that Americans are able to resume normal life. That's the first and most directive thing the executive order does.

The next thing it does is it asks State Department, USAID -- that's the U.S. Agency for International Development -- the U.S. International Development Finance Corporation, and the Export-Import Bank to work collaboratively with HHS to find ways to help our strategic partners, allies, and other countries that are in need of vaccine with that task.

So we will go through that in three different methods. There is the partners, allies, and strategic countries that can afford to procure directly. We'll help ensure that they have access to the private market to procure that vaccine.

There will be your middle-income countries that are not well off and are able to work with DFC and Ex-Im to use different levers and tools that they have to achieve the procurement of a vaccine, ancillary kits, and distribution. And then, third, work through organizations like Gavi, on the donation side, in coordination with USAID.

So, in all, the executive order reaffirms to the American people that we're going to put America first and work to ensure they have access to vaccines, and secondly, it helps coordinate an interagency on an unprecedented level of international, global health security here.

SENIOR ADMINISTRATION OFFICIAL: Okay. Thank you, [senior administration official]. There was one other question we received as we were getting started. It related to a story that just came out regarding doses that we could procure from Pfizer. [Senior administration official], do you want to just address that before we open up the line?

SENIOR ADMINISTRATION OFFICIAL: Yeah, sure. So I think the story commented on something about us denying the opportunity to procure 400 million doses from Pfizer months ago. I'll tell you that's false. I'll also tell you we're in the middle of a negotiation right now and can't talk publicly about it.

But we feel absolutely confident we will get the vaccine doses for which we've contracted, and we'll have sufficient number of doses to vaccinate all Americans who desire one before the end of the second quarter of 2021.

SENIOR ADMINISTRATION OFFICIAL: With that, why don't we open it up to questions?

Q Hi. Thanks for having the call. Two questions. The first is: Is there any sort of thought to getting the vaccines to teachers so that public schools can open up" And, second, how did you choose which governors would be on the panel tomorrow?

SENIOR ADMINISTRATION OFFICIAL: I'll let [senior administration official] answer that one -- those two, actually.

SENIOR ADMINISTRATION OFFICIAL: Yeah. So just to be clear, the Advisory Committee on Immunization Practices is asserting recommendations as to who should be prioritized to get vaccines. However, the jurisdiction leaders -- again, states and certain cities and territories -- those jurisdiction leaders will actually set the priorities. It's up to them. And, in fact, we've heard, at least anecdotally, a number of them are considering having teachers in the highest priority category so they can make sure the children stay in school. That is completely up to those jurisdiction leaders, in this case the governors or, you know, mayors in some cases. So we may indeed see that.

I think, second, what we did was all 64 jurisdictions submitted their vaccination plan -- their detailed vaccination plans in October, around the middle of October. Some of those were outstanding. Some of them needed some work. We deployed a lot of folks to work with those that weren't up to snuff. But we chose -- there were five or six jurisdictions that were absolutely outstanding. And that is the basis for the invitations that we made. And these four governors accepted the invitation. So it was based on the strength of the plans that they had submitted.

SENIOR ADMINISTRATION OFFICIAL: It's an important part of sharing best practices. As you may know, the Vice President and the coronavirus task force have frequent contact with these jurisdictions and governors' calls. And one of the very important parts of the federal government's response is ensuring that best practices are shared on a variety of issues. But vaccine distribution, of course, is a very important one.

With that, why don't we move on to the next question" Q Yes. Thank you for taking this question. Eric Poders of the North Shore Voice. I was the gentleman that was working directly with the press at the White House and asking Vice President Pence, once the 50 states and all the territories were basically under a state of emergency, what exactly, if you can -- I know there's the confusion, what have you -- is going to be the plan now that the President has, I guess, extended the, I guess, the responsibility to these governors?

And, you know, can you get into, you know, the numbers, what each state -- and how you're going to roll this out with UPS and FedEx and all these distribution channels" Because obviously there's a lot of surging going on after the holidays. And we have another holiday coming up, so we might see a resurge, and you're talking second quarter of, you know, next year, in 2021.

SENIOR ADMINISTRATION OFFICIAL: Can you start -- restate the question" Sorry. I mean, we -- we can walk through the number of doses that we anticipate having, sort of, on average each week and then each month.

I believe that the latest I've heard is we can expect about 6 million doses available in the first week of authorization. We're still expecting about 20 million people and 40 million doses available in the month of December. And then I believe it should be approximately 30 million people, 60 million doses, in the month of February. And then we're looking at 100 million doses in the month to follow. So I think those are the latest numbers I'm aware of, in terms of the vaccine and doses being available.

Can you maybe restate your question or the other part of it so we understand" I just want to make sure we address it.

Q Yeah, if you'd like me to extrapolate on the question. The question basically is, you know, taking these numbers and then breaking them down from the 300 million -- let's say, in December, the 20 million -- how is that going to be distributed on the state basis?

And then, what's the demographic that you're going to tap into, because obviously there's outbreaks, you know, with seniors and nursing homes and, you know, obviously, people in hospitals that are on their deathbeds, you know, with respirators?

SENIOR ADMINISTRATION OFFICIAL: Yeah. So, real quick then, a couple things: So we are using a modified per capita distribution system -- modified per capita. So, for instance, children are not eligible to be vaccinated because the clinical trials have not included them thus far, and that is very common with almost all vaccine development. So it's not uncommon at all, and the trials are going on with kids now.

So we took a modified per capita distribution because when you looked at the highest categories -- of those in nursing homes, frontline healthcare workers, those with underlying conditions at any age, by the way, not just those over 70 -- we ran a whole bunch of different numbers, and it came out surprisingly close, in terms of when you considered all those factors -- EMF, you know, firefighters, and those types of things -- first responders.

So that's the way the allocation is taking place. And as my colleague just said, we already have somewhere between 6- and 8 million doses of vaccine ready to ship today, as soon as the EU is approved. We will not be shipping all of those; we'll be shipping half of what we have. And the reason is: This is a two-dose vaccine, and we don't want to get into a situation where we ship enough for one dose -- I'm sorry, both -- you know, we ship, let's say, 8 million doses out there, everyone gets their first vaccine -- first shot, and then there's a manufacturing problem, and we can't give them their second shot within 21 days, which is the interval.

So we're being a little bit conservative, but that's because we think we have an ethical commitment to making sure those who get the first dose actually get the second dose. And we're still in a situation, very early in the manufacturing process, where those types of things could happen. As we get later into the season, so to speak, it'll be a lot easier for us to distribute every dose we get.

As my colleague said, there are going to be continuous deliveries into our warehouses. We will continue to send out those. And we anticipate, between Moderna and Pfizer, that 20 million Americans will get their first dose before the end of the year, and that we will have an additional 20 million doses in reserve so that we can ensure they get their second dose as well.

And then when we get into January, (inaudible) another 25 to 30 million persons should be able to be vaccinated with two doses. And then February and then into March, we're going to get closer to 100 million. So that's the way it ramps up, and that's the way we're distributing and allocating.

Q It's a great strategy. Can I ask just one quick more follow-up, sir?

SENIOR ADMINISTRATION OFFICIAL: Sure.

Q Then what is going to be the transition now that President Biden has named Xavier Becerra -- the former top dog in California, Attorney General -- taking over the HHS" Is there strategy then, you know, bringing him in maybe before, with the transition" Or are you going to start talking with him, you know, let's say -- you know, at the Inauguration" Like, what's the transition going to be to make it --

SENIOR ADMINISTRATION OFFICIAL: There are public comments on those meetings taking place -- on the transition meetings taking place. But we're here to discuss the vaccine summit tomorrow and the distribution strategy currently being carried out.

So, with that, why don't we move on to the next question. Thank you.

Q Thank you.

Q Hi, thanks so much for taking my call. I have a question about -- I know you can call the New York Times report false, but could you talk a little bit more about whether or not -- or talk a little bit more about whether any of that (inaudible) happened, in terms of U.S. turning down more doses" And can you talk a little -- also a little bit more about the EO that's going to be signed tomorrow. But first, if you could address the New York Times report.

SENIOR ADMINISTRATION OFFICIAL: Yeah, let me tell you, first of all, the Pfizer contract -- the initial one -- was signed on July 22nd, before they even entered phase three clinical trials. That was in advance of the purchase agreement -- this is all public -- in advance of a purchase agreement for 100 million doses.

We have six vaccine candidates. Between our contracts for doses, guaranteed purchase, and options, we have the opportunity to purchase 3 billion doses of vaccines, okay" Anyone who wanted to sell us a guarantee without an EUA approval, hundreds of millions of doses back in July and August, was just not going to get the government's money. No one offered us 400 million doses, I can guarantee you that, from the start.

So that's a -- that's a -- I don't know where that source came from, but we can guarantee you that's not true. We have continued to negotiate with all of the vaccine manufacturers, particularly the ones who now have good data -- those who are in the window for an EUA authorization. We're not going to talk about those because those negotiations are underway.

I will restate: We are absolutely confident we'll have enough doses to vaccinate the American people by the end of second quarter, 2021.

SENIOR ADMINISTRATION OFFICIAL: Thanks. And then, for the executive order, it's really important just to highlight the fact that the priority of this administration, this President, since day one, has been to put America first.

This executive order reemphasizes that, stating that we are going to ensure access to free, safe, and effective COVID vaccines to the American people. Once we've ensured the ability to meet the needs of the American people, it would be, then, in the interests of the United States to facilitate international access to COVID vaccines. So that's what we're doing.

The executive order also comes with an accompanying framework which provides the guidelines for the interagency to execute that -- that directive.

SENIOR ADMINISTRATION OFFICIAL: Okay, why don't we move on to the next question.

Q Hi, thank you so much for taking my question. So I had a question, first of all, about Dr. Peter Marks. Was he ordered to be at this event tomorrow?

And then, as far as the companies, did they actually already decline the invitation before your discussion not to have the companies there" And will there be any vaccine makers there at all -- not just, you know, that Pfizer and Moderna won't be there because they have applications before the -- the FDA" Are there any vaccine makers that will be there at all" Thank you.

SENIOR ADMINISTRATION OFFICIAL: Hey, I'll answer. So Peter Marks is coming completely voluntarily. The only concern we had was keeping him focused on moving the EUA process along, but we weighed that against the imperative to ensure that Americans have great confidence in these vaccines. And there's probably no one in the world more rigorous in terms of evaluating the data, looking at it closely, and making a determination than Peter Marks. So we thought it was quite important. He's going to come for his session. He's going to leave shortly after that to get back to work. Completely voluntary. I was involved in that myself. That's number one.

Number two is, we spoke with several vaccine manufacturers -- in fact, some contacted us unsolicited and asked if they could come -- and we had early discussions with several of them. I don't want to reveal the specifics of those discussions, but we wound up going in a different direction, which was we thought Peter Marks, if we're trying to instill greater confidence, would be an independent voice for quality and effectiveness, and that would be more effective than the companies who are producing the vaccines themselves.

Then there was one other complication, which is the following. We couldn't -- and [senior administration official] said this at the beginning: We cannot -- just from a regulatory perspective, we cannot have the person in the room who's going to adjudicate that emergency use authorization with those who have submitted it during that evaluation period. So we made the decision to deny, if you will, any participation by the pharmaceutical companies, in favor of having the chief regulator in the room describing the process.

Q Well, why do you need Peter Marks there" Isn't there, you know, somebody else that you could have there instead of him?

SENIOR ADMINISTRATION OFFICIAL: There's no one who knows the process better than Peter Marks.

I'm sorry, he is the head -- just so you know, he is the head -- the director of the Center for Biologics Evaluation and Research. He is the guy in charge.

Q Hi, thanks for taking the question. First, former President Barack Obama and former Vice President Joe Biden have repeatedly cited Dr. Anthony Fauci as the authoritative source on whether the vaccine is safe or not. Will Dr. Fauci participate in this summit, and what is the thinking on that" And then, secondly, does the President expect that he will ever receive the vaccine himself on live TV to promote the safety of the vaccine?

SENIOR ADMINISTRATION OFFICIAL: So, thanks for the question. This is [senior administration official].

Number one, we had invited and discussed having Dr. Fauci participate. He wanted to, but he had a scheduling conflict. As you know, he is a leading voice on this issue and a trusted voice on vaccine confidence. So he would have liked to participate, and we would have welcomed his participation, but due to an important scheduling issue, he just -- he couldn't make it, unfortunately. But, you know, he's been on the air this week, in fact, talking about it.

Number two, with respect to the President and taking the vaccine, that's certainly something that is under consideration. The President has previously expressed his willingness to do whatever the experts thought was the best path, in terms of instilling vaccine confidence.

As you know, the President recovered from COVID. And so I think there is something that's up for discussion as to whether someone who's recovered from COVID and has antibodies would necessarily be a high priority for receiving the vaccine and for the purposes of vaccine confidence. But he's expressed his willingness. I think there is an open question as to whether, ultimately, he will be one of the ones to take it on air. And that's simply a function of whether that would actually serve the desired purpose, given the fact that he's a recovered patient.

But there are other sort of famous, shall we say, vaccine influencers and experts who I think have come forward and volunteered to participate in an effort to help instill public confidence, and we're certainly considering such offers.

And we want the American people to know that this vaccine is safe and effective. It's one of the key purposes of having Dr. Marks participate in the summit. And then, you know, we'll proceed from there.

I think we have just about run out of time, so we'll have to leave it there. But I'd like to thank all of you for joining.

And again, on background, attributable to senior administration officials. And now that the call is concluding, the embargo is lifted.

Thank you very much and have a good day.

END 5:27 P.M. EST