BACKGROUND PRESS CALL BY
SENIOR ADMINISTRATION OFFICIALS
ON AN EXECUTIVE ORDER MODERNIZING INFLUENZA VACCINES
Via Teleconference
3:05 P.M. EDT
SENIOR ADMINISTRATION OFFICIAL: Hi, good afternoon everybody, and apologies for the delay in getting started here. We had some delays in the signing and some technical challenges. But anyway, we are ready to get started.
This call is on the new executive order on modernizing influenza vaccines in the United States to promote national security and public health.
This call is on background, attributed to a senior administration official. And I’m going to ask you to embargo it until the EO is officially released and announced by the White House. You’ll receive an e-mail on that when that happens. I expect it will be about 4:30 p.m. or earlier.
So we have a variety of U.S. government officials who will brief us, plus a few others on the call to answer technical questions that you might have. So we’ll have a Q&A at the very end of the call, but we are strictly limited to end at 3:30 p.m. So we’ll try to keep this as brief as we can. So with that, I’ll turn it over to [senior administration official].
SENIOR ADMINISTRATION OFFICIAL: Thank you. Good afternoon. Today, the President signed the executive order to modernize influenza vaccines in the United States. This executive order builds on the National Biodefense Strategy and the Global Health Security Strategy, and is the most recent example of the actions taken by the President and his administration to protect the national security and the health of the American people.
This administration has and will continue to lead the way on innovative public health solutions for all Americans to strengthen the national security of the United States.
As we all know, getting the seasonal flu vaccine is the most effective defense against influenza. This EO directs actions to reduce our reliance on older, egg-based production, expand domestic capacity, promote uptake of influenza vaccines, and advance the development of new, broadly protective vaccine candidates.
In addition to ensuring seasonal vaccines are well matched to circulating strains, more agile production will also aid rapid response to pandemic influenza, which has the potential to kill millions and cost the economy trillions of dollars.
With his action today, President Trump has reaffirmed his administration’s commitment to protect the American people as he promotes American innovation and American production.
SENIOR ADMINISTRATION OFFICIAL: Great. Thank you.
Now, with that, I’m going to ask -- I’m not positive we have DOD on the line.
SENIOR ADMINISTRATION OFFICIAL: Do we have the Council of Economic Advisers on the line?
Okay, so with that we’re going to turn it over to Health and Human Services. We have [senior administration official]. We do also have [senior administration official].
SENIOR ADMINISTRATION OFFICIAL: So thank you and good afternoon. I’m just going to make a couple of brief comments. I think we all know seasonal flu is a real threat to America’s health. Every year, millions of Americans become ill with the flu. Hundreds of thousands are hospitalized and tens of thousands of Americans die.
In the 2018-2019 flu season, 36,400 Americans died. And in 2017-2018 it was more than double.
While most people who get the flu have a mild illness, for some, it can cause serious illness and even death. Complications from the flu are more likely in babies and young children, like the ones I cared for in my pediatric intensive care unit, but also pregnant women, older adults, and people with certain long-term health conditions.
Early estimates from last year’s flu season -- which lasted a record-breaking 21 weeks -- indicated that upwards of 37 million Americans becomes ill from flu, with more than half a million being hospitalized.
In addition to seasonal flu, pandemic influenza is a real threat to our health and national security. There have been four pandemics in the last 100 years. The most severe one was in 1918, which killed upwards of 50 million people worldwide, as well as 675,000 Americans.
Our current seasonal flu vaccines are safe and effective. CDC estimates that just in 2017-2018, over 7 million illness were prevented by the simple flu shot. But we recognize that our flu vaccines must get better and it is essential we make them more quickly, with modern technology, to be more effective, and on U.S. soil.
Through today’s actions, President Trump’s executive order established a task force chaired by HHS and the Department of Defense to cooperate on modernizing our flu vaccine production, identifying objectives, and monitoring progress so that we will have a more modern, reliable, and rapid method to vaccine production, more broadly protective and long lasting flu vaccines, and, again, more domestic manufacturing capability.
Now I’d like to have [senior administration official] make a few comments.
SENIOR ADMINISTRATION OFFICIAL: Thank you, and good afternoon. As my colleague mentioned, I’m [senior administration official]. And we have the benefit as well, on the phone, today, [senior administration official].
I think -- to take from my colleague’s comments, to just point out that any benefits we get with seasonal flu with this executive order signed by the President today will be magnified during a pandemic.
As my colleague mentioned, there were four in the last century. And clearly, each year, there’s about a 4 percent risk of having a pandemic. And notably, we're watching with great concern and vigilance events in Asia that relate to the H7N9 virus that is circulating in parts of China at this moment.
The point being is, if there were to be a pandemic, we would expect that it (inaudible) the events in 1918, there could be 100 million or more Americans that would be affected by a highly virulent flu that could result in over 4 million hospitalizations, and up to 500,000 American deaths. This is not only a great concern to us because of its direct impact on livelihood and the benefit of American people, but also on our national security.
So what the executive order does very clearly -- it states that we not only need to make better vaccines for each year for seasonal flu, but also faster. And that requires new technologies, like recombinant vaccines or cell culture-derived vaccines. And it's a way that basically we can respond rapidly to mitigate the loss of lives and also sickness that would result from a pandemic.
To put it in monetary terms, each year, the seasonal flu costs about $50 billion in direct possible costs as well as lost productivity. In the case of a pandemic, particularly of a moderate to severe purpose or nature, it would be $1.8 trillion to $3.8 trillion of lost revenue as a result of direct costs, lives lost, and loss of productivity.
So this would touch every sector of our society: food production, energy generation, and even the defense of our country by our military. So it's a matter of grave concern, and the President's steps today will ensure that we are in a better position to respond to whatever may happen during our tenure or any future President's tenue to make America not only safe, but more economically strong and certainly healthy.
With that, I'll turn my comments back to our moderator.
SENIOR ADMINISTRATION OFFICIAL: Great, thank you. I'll check again. Do we have anybody from DOD on the line? And from the Council of Economic Advisers? I know they've been trying to get in and having some technical challenges. Are the Council of Economic Advisers on the line?
Okay. With that, why don’t we turn it over. We'll do some Q&A.
Q Good afternoon. This is Toby Capion calling from EWTN. My question has to do with the composition of the flu vaccine. I know you guys recognize that it's always changing which strains you think will be impacted each year, but is there any progress on making a better-educated guess on which strain it is? And do you still promote the flu vaccine even if the viruses it protects from are not the viruses that are most spreading that particular season?
SENIOR ADMINISTRATION OFFICIAL: This is [senior administration official]. Yes. I mean, obviously it is an intelligent guess, but it is based on a number of factors that actually, historically, over the years, gives us a pretty good batting average.
With regard to perfecting that, I mean, obviously, we want to do better each year. That leads to one of the points of one of our long-range strategies of developing a universal-like vaccine that actually covers a wide range and broader coverage of the flu to make it less important to get exactly the right pick.
But the second part of your question was very important. Even though the virus might drift a bit from what the vaccine selection was, it is still unquestionably beneficial to get vaccinated. Because even though vaccines are not perfect, they clearly can not only prevent infection, but they can prevent the serious consequences, including hospitalization and death. So we will still recommend very strongly that one gets a vaccine every year -- anyone 6 months of age or older.
SENIOR ADMINISTRATION OFFICIAL: And this is [senior administration official] here. Just one more comment on that. Of course I agree with [senior administration official], but part of the executive order is to create technologies that are faster so that we don’t need to start six months ago using 900,000 eggs per day. This rapid responsive technology would allow us to better match, in a much shorter period of time, any changes in the circulating strain to what we give individuals when the vaccine comes out.
Q Hello, this Donna Young from S&P Global News. I did have -- first of all, I wanted to clarify: Is [senior administration official] and [senior administration official] and [senior administration official] all on the record? So that’s my first question.
Second, I wanted to find out: Again, what will this executive order actually do that NIH isn’t already doing right now? Like, what action will this put into motion that they’re not already doing? And how can they do it better without the funding? Or is the President going to actually call for more funding? Thank you.
SENIOR ADMINISTRATION OFFICIAL: As for your first question -- this is [senior administration official] from NSC Press -- this entire briefing is on background, attributed to a “senior administration official.” And I will repeat that at the end as well. So with that, I’ll let my colleagues answer the technical question.
SENIOR ADMINISTRATION OFFICIAL: Well, there are a number of things -- this is [senior administration official] -- there are a number of things in the EO that actually fortifies some of the things that we are doing, but also calls for additional things.
Just a couple, for example: It calls for a task force within 120 days to develop a five-year plan. And that plan needs to have an update and reporting on that no later than June 1st of each of the five years following it. It also talks about the NIH making sure that we, as an organization, continue to pursue the strategic plan that we’ve already developed for a broad of coverage. There are a lot of things in this plan, but those are some of the things that not only fortify what’s being done, but also talks about things in the future.
SENIOR ADMINISTRATION OFFICIAL: Donna, this [senior administration official]. If I might add to my colleague’s great comment as well: One of the additional things, as you know very well, BARDA and the U.S. government has invested in the development and licensure of these new modern technologies to produce influenza vaccines, including the cell-based and the recombinant-based influenza vaccine.
One of the challenges we have with these newer, faster technologies is they have limited capacity right now in the United States. And we want to be able to utilize those fast technologies when we need them for seasonal production, as well as for pandemic production. So one of the important parts of this executive order is to have us put together a feasibility and a budget plan to be able to expand and solidify that domestic production capabilities of these faster influenza vaccine-production technologies, such as cell-based and recombinant-based.
SENIOR ADMINISTRATION OFFICIAL: And now, Moderator, if we can pause for a minute. I believe we might have somebody from the Council of Economic Advisers on.
SENIOR ADMINISTRATION OFFICIAL: Hello?
SENIOR ADMINISTRATION OFFICIAL: Hi, this it -- is this [senior administration official]?
SENIOR ADMINISTRATION OFFICIAL: It is. Can you hear me now?
SENIOR ADMINISTRATION OFFICIAL: We can. Great. So I would just like to introduce the [senior administration official]. He was going to talk very briefly about the economic ramifications of this.
And apologies for the out of order discussion, but we’ll return to questions in a moment.
SENIOR ADMINISTRATION OFFICIAL: Thank you. Good morning -- afternoon. My name is [senior administration official] from the Council of Economic Advisers.
Today, CEA released a paper available on our website that estimates the large health and economic losses associated with an influenza pandemic and the benefits of moving to newer vaccine technologies that would speed production and make these vaccines more effective.
We estimate that the average pandemic would cost $1.8 trillion and that deaths in that -- a pandemic in the most serious case -- could be 538,000. Moving to faster vaccine manufacturing technologies that would make a vaccine available near the outset of a pandemic would save over $730 billion, over an average pandemic. And if that new technology also includes vaccine effectiveness by 30 percent over the effectiveness seen in the most recent pandemic in 2009, it would save $953 billion, or roughly half the cost of an average pandemic.
We found that there is a lack of appropriate innovation incentives, due in part to a misalignment between social and private returns, which partly explains why private markets have failed to provide the innovation needed to reduce pandemic risk and improve pandemic influenza preparedness.
Today through the EO, the administration is proposing studies and public-private partnerships and other incentives that will produce innovations needed to accelerate vaccine production timelines needed for pandemic influenza, and could also potentially improve the vaccine effectiveness for both seasonal and pandemic influenza.
SENIOR ADMINISTRATION OFFICIAL: Great. Thank you, [senior administration official].
We’ll now return to the question-and-answer period.
Q You’re not calling people by name, so I hope you can hear me. This is Arthur Allen from Politico. I had a couple of questions. One, is there -- are you asking for more money? Because pretty much -- I mean, most of what you discussed here has already, in some form or another, been begun over the last 10 or 15 years. Building another -- you built a flu factory for -- in North Carolina last time. So, is this basically -- you’re going to build a new factory for somebody or put up the money for a new factory?
And, I guess, yeah, the question, again, is: Is Congress being asked to put up more -- to put up more money for any of the particulars of this plan?
SENIOR ADMINISTRATION OFFICIAL: Hi, this is [senior administration official] and I will ask [senior administration official] to add to my response. But I think the critical thing is, is the executive order asks us in the next 120 days to evaluate what we have on hand and what we need to really meet the needs as go forward.
You’re correct to say that we built capacity down in North Carolina, as well as in a couple other places. But the question is, is whether -- even with the investment that was made during the Bush administration in 2005 and 2006, whether that was sufficient to address what is a continuing need, in terms of optimizing existing vaccines, as well as building capacity to meet what could be the real challenges of a pandemic, knowing that it’s the speed and effectiveness of the vaccine, as you just heard from my colleague at the Council of Economic Advisers, that prevents a lot of -- (inaudible) a lot of loss of money, which equates to the loss of lives and illnesses that that really represents. And so that’s really the initial phase of this effort.
And then, also, I think, the point here is to evaluate what kind of incentives, so we can work in a private-public partnership with the industry to basically see how we can optimize the use of these newer technologies that are a little bit more expensive, but probably more effective, and certainly leverage what we could do in pandemic.
[Senior administration official], would you like to add anything further?
SENIOR ADMINISTRATION OFFICIAL: No, [senior administration official], I think that covers it nicely. Unless there is additional questions.
SENIOR ADMINISTRATION OFFICIAL: Great. Moderator, I believe we now have DOD on the line. I’m sorry. [Senior administration official], are you on the line?
SENIOR ADMINISTRATION OFFICIAL: Yeah. Hi. Yeah, I am. Good afternoon. This is [senior administration official]. The Department of Defense is committed to modernizing influenza vaccines in the United States in close collaboration and partnership with the U.S. interagency. It’s a matter of national security and public health.
As co-chair of the newly established National Influenza Vaccine Task Force, the department is going to work closely with Health and Human Services and interagency partners to accelerate vaccine manufacturing technology and innovation. And because of the morbidity and mortality associated with the influenza virus, this is a readiness threat to U.S. forces. And as a result, the department requires vaccination for virtually 100 percent of the force every year.
Through enhanced research and development collaborations made possible by this executive order, we will modernize the influenza vaccine enterprise to ensure access to the vaccine, advanced agility, and rapid response to emerging influenza viruses, increasing manufacturing and effectiveness of influenza vaccines, and developing new vaccine candidates with longer-lasting immunity.
These efforts support the National Defense Strategy’s priority to advance readiness of the force, providing the best possible support to our warfighters in the battlefield and back at home. So I wanted to make that statement. We are -- we really looking forward to working on this unique opportunity created by the current administration.
SENIOR ADMINISTRATION OFFICIAL: Great. Thank you very much [senior administration official]. I think we can go back to a couple more questions before we’re going to run out of time.
Q Thanks so much. This is Jacquie Lee with Bloomberg Law. I’m curious -- and this question is for the gentlemen who works at BARDA -- what the administration is going to do, if anything, to ensure that there’s a market for the pandemic flu vaccine? Obviously, you can’t sell it until there is a pandemic. And I know that with antibiotics, that’s sometimes the problem -- that there isn’t really the market for those. But you need to have them just in case something happens. What is your guys’ solution to do to ensure that no one goes bankrupt?
SENIOR ADMINISTRATION OFFICIAL: Well, thanks for that question. And I’ll open it and then [senior administration official] can finish it. I think the key thing here is the availabilities of these new-technology vaccines have been fairly limited. 90 percent of our seasonal flu vaccines come from eggs. So our intent is to expand the market for these newer technologies.
And again, part of the opportunity and direction under the executive order is actually working with CMS and HHS to basically see what we can do in terms of (inaudible) schedules that would allow for greater utility -- use of these new products that would, again, enhance the market over time.
The fact is, is that these newer technologies will likely result in more effective vaccines. And [senior administration official], you may want to talk about, specifically, some of the work that you’ve been leading as well.
SENIOR ADMINISTRATION OFFICIAL: Thank you, [senior administration official]. And, Jacquie, thanks for your question.
Yes, I mean, as we’ve shown, as we developed and gotten and received FDA licensure for the cell-based and the recombinant-based influenza vaccines. In a head-to-head efficacy trial with the recombinant-based influenza vaccine with the traditional egg-based influenza vaccine, in older populations -- people 50 years and above -- where we saw a 30 percent improvement in efficacy of recombinant-based vaccines.
So there is a mounting level of evidence that’s showing that when we have a better-matched influenza vaccine, something that is afforded by using recombinant-based technologies, that that does often translate into a more effective influenza vaccine.
And as [senior administration official] mentioned, one of the -- and to your question about the marketplace for pandemic vaccines -- of course we hope that we never have to use pandemic vaccines, but we do know the threat of a pandemic is there and looming. And as history has shown us, it will happen again.
But the beautiful thing about these influenza vaccines is that we use them in the seasonal marketplace every single year. And the technologies -- the platform-based technologies -- that we’re investing in, with the cell-based and recombinant-based and the next generation synthetic-based vaccines, serve as platforms that we can utilize to make more of the influenza vaccines as well. So those multi-purpose facilities can be using -- be used to make influenza vaccines during seasonal influenza vaccine production cycle, but those technologies and platforms might also be used to make other vaccines in that same platform or same facility as well.
SENIOR ADMINISTRATION OFFICIAL: I think we have time for one more question, then we’re going to have call it a brief.
Q Hi, thank you for taking the call. It’s Josh Wingrove with Bloomberg. Can I just ask, quickly, for clarification: Is there any funding associated with this EO?
SENIOR ADMINISTRATION OFFICIAL: No -- not as of yet. And again, it’s dependent on the evaluation of what is the current status of our seasonal and pandemic influenza abilities. And then it established what the plans are to address the opportunities to improve existing platform that exist, as well as look at what would be necessary to support universal flu vaccine research and development.
SENIOR ADMINISTRATION OFFICIAL: Okay. I think we can probably squeeze one more in if it’s a short question.
Q Hi, just a follow-up on the funding question. So I think in 120 days it sounds like there is going to be a plan. Is that plan going to include a budget for how to distribute funds, say, to improve facilities for recombinant vaccines, and then also to put into universal vaccines R&D. Is that budget just coming out in 120 days -- the proposed budget?
SENIOR ADMINISTRATION OFFICIAL: The executive order basically requires to cost out what would be required to basically do exactly what you’re describing. So the answer is simply, yes.
Q Thanks.
SENIOR ADMINISTRATION OFFICIAL: Great. Great. Thank you everybody for joining us. And apologies again for the delay.
Just to repeat, this is all on background, attributable to a senior administration official. And we ask that you embargo this briefing until -- you’ll see a public announcement from the White House that will go out through the White House Press DL. You can also check the White House website. It will be posted there as well. It should be in the next hour anyway. It may -- it’s possible it’s already out. But please, just hold for that release.
And thank you again for calling in. Bye bye.
END 3:32 P.M. EDT
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