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Trump: Operation Warp Speed

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President Trump delivered an update on Operation Warp Speed in the Rose Garden.

Trump was Monday’s KVML “Newsmaker of the Day”. KVML airs the President’s weekly address on Mondays and the Democratic response on Tuesdays. Here are his words:

“In the past nine months, my administration has initiated the single greatest mobilization in U.S. history — pioneering, developing, and manufacturing therapies and vaccines in record time. Numbers like nobody has seen before.

No medical breakthrough of this scope and magnitude has ever been achieved this rapidly, this quickly. And we’re very proud of it, and I had tremendous help from the military — generals, admirals — and many of the great people at the White House.

Operation Warp Speed is unequaled and unrivaled anywhere in the world, and leaders of other countries have called me to congratulate us on what we’ve been able to do, and we’ve helped many countries with their ventilators and all of the problems they were having.

And I’d like to congratulate everyone involved in this effort. It’s been an incredible effort. As a result of Operation Warp Speed, Pfizer announced on Monday that its China virus vaccine is more than 90 percent effective. This far exceeds any and all expectations. Nobody thought they’d get to that level. And we have others coming which we think will be at equal level — maybe more, if that’s possible.

In July, my administration reached an agreement with Pfizer to provide $1.95 billion to support the mass manufacturing and distribution of 100 million doses, with the option to purchase a total of 600 million doses shortly thereafter. Our investment will make it possible for the vaccine to be provided by Pfizer free of charge.

Pfizer said it wasn’t part of Warp Speed, but that turned out to be a unfortunate misrepresentation. They are part. That’s why we gave them the $1.95 million — billion dollars. And it was an unfortunate mistake that they made when they said that.

We will work to secure an emergency use authorization, which should be coming down extremely soon. And my administration will then coordinate the distribution of the vaccine, and it will be approved, I think — again, it will be approved very, very quickly, we hope.

The average development timeline for the vaccine, including clinical tests and manufacturing, can take 8 to 12 years. Through Operation Warp Speed, we’re doing it in less than one year. If you had a different administration with different people, what we’ve done would have taken, in my opinion, three, four, five years, and it would have been in the FDA forever.

This is five times faster than the fastest prior vaccine development in history. Five times faster. Say it again: five times faster. Nobody can believe it, actually.

Three other vaccines are also in the final stages of trial. They’ll arrive within a few weeks, and they will also be mass produced, and the delivery will be very rapid. We’re ready to go.

The vaccine will be distributed to frontline workers, the elderly, and high-risk Americans immediately. It will be very — a matter of weeks. Get out very, very much ahead of schedule. Any schedule that I said, we’re going to be far ahead of that.

We know that this virus primarily targets older populations and those with underlying health conditions. Well, over 99.98 percent of those under the age of 50 make a full and quick recovery. By giving the vaccine to high-risk individuals right away, we will dramatically reduce hospitalizations and deaths.

Case levels are high, but a lot of the case levels are high because of the fact that we have the best testing program anywhere in the world. We’ve developed the most and the best tests. And we test far more than any other country, so it shows, obviously, more cases.

By vaccinating the elderly and the high-risk, we will effectively end this phase of the pandemic and allow seniors to reclaim their golden years — the golden years of their lives, which is so incredible. And it’s about time that they can have those golden years.

Again, this process is starting right away. Millions of doses will soon be going out the door. They’re all ready, waiting for that final approval. As soon as April, the vaccine will be available to the entire general population, with the exception of places like New York state, where, for political reasons, the governor decided, they say — and, you know, I don’t think it’s good, politically; I think it’s very bad from a health standpoint — but he wants to take his time with the vaccine. He doesn’t trust where the vaccine is coming from.

These are coming from the greatest companies anywhere in the world, greatest labs in the world. But he doesn’t trust the fact that it’s this White House, this administration. So we won’t be delivering it to New York until we have authorization to do so, and that pains me to say that.

This is a very successful, amazing vaccine at 90 percent and more. But — so, the governor, Governor Cuomo, will have to let us know when he’s ready for it. Otherwise, we — we can’t — we can’t be delivering it to a state that won’t be giving it to its people immediately. And I know many — I know the people of New York very well. I know they want it.

So the governor will let us know when he’s ready. He’s had some very bad editorials recently about this — this statement and what’s happened with respect to nursing homes and his handling of nursing homes, and I hope he doesn’t handle this as badly as he’s handled the nursing homes.

But we’re ready to provide it as soon as they let us know that they’ll actually use it. And again, it’s a very safe and a great vaccine.

Already, we have among the lowest case-fatality rates — our country — anywhere in the world, the entire world. And we performed significantly better than our peer countries.

As far as therapeutics are concerned, my administration has also made critical investments in therapies that have helped reduce the mortality rate by 85 percent. That’s, to me, one of the most exciting things. It’s incredible, some of the antibody vaccines and others that have come out and have really helped people — 85 percent.

Last month, the FDA approved remdesivir, and we’ve secured enough remdesivir to treat 850,000 patients.

My administration finalized an agreement with Eli Lilly to purchase the first doses of their antibody therapy, which shows amazing results. This treatment will be available completely free of cost to patients. Five thousand units have already been shipped, and many more are going out the door as we speak.

We also reached an agreement with AstraZeneca for the largescale manufacturing of their antibody treatment, which is excellent. We expect to issue emergency use authorizations for a number of additional treatments in the near future. Tremendous promise. But remember the 85 percent number. That’s an incredible, incredible number. But we have some tremendously promising drugs on line and ready to come out.

We have ensured that our frontline workers have all the tools they need. My administration has invoked the Defense Production Act and related authorities over 100 times, and have made a historic investment into our industrial base. All states that requested PPE from the federal government have received the PPE almost immediately upon request.

Every American who needed a ventilator has had access to a ventilator. Think of that. A very complicated piece of equipment. Very expensive. And we haven’t had one person in this whole country that has requested or needed a ventilator that hasn’t had it. Every single request has been immediately filled. So that was something. That was a great job.

And now we’re helping the rest of the world with ventilators, because it’s a very hard thing. We’re producing them, thousands of — thousands of ventilators a month.

The federal government has 22,000 beds immediately available for states and jurisdictions that need additional capacity, but we think that it’s going to start going down, possibly very quickly. We’ll see what happens. But with the vaccine, it’ll — you’ll see numbers going down within a matter of months, and they’ll go down very rapidly.

As we continue to combat the virus, our economy is rebounding far beyond any expectations. I see the stock market is up almost 400 points today again, and it’s ready to break the all-time record.

Our jobs records are incredible. The job numbers are incredible. In the last six months, we’ve created over 13 million jobs and slashed the unemployment rate by more than half.

Last quarter, we witnessed the fastest economic growth ever recorded in the history of our country: 33.1 percent. It’s a number that is more than double our highest — that was in 1952, and we’ve more than doubled it.

The United States experienced the smallest economic contraction and the most rapid economic recovery of any major Western nation. We went down less and we went up more, which is quite a combination of facts.

While healthy Americans have gone back to work and to school, we continue to spare no expense to protect the elderly and the vulnerable. According to some estimates, a national lockdown costs $50 billion a day and hundreds of thousands of jobs every single day.

Ideally, we won’t go to a lockdown. I will not go — this administration will not be going to a lockdown. Hopefully, the — the — whatever happens in the future — who knows which administration it will be? I guess time will tell. But I can tell you, this administration will not go to a lockdown. There won’t be necessity. Lockdowns cost lives, and they cost a lot of problems.

The cure cannot be — you got to remember — cannot be worse than the problem itself, and I’ve said it many times. And when you look at what happens during a lockdown — I just say it very loudly — it’s horrible what happens with drugs, alcohol, depression, loss of jobs, business closures. It’s a terrible thing.

So this administration will not go, under any circumstances — will not go to a lockdown, but we’ll be very vigilant, very careful. We understand the disease. It’s a — it’s a complicated disease, but we understand it very well.

We ask all Americans to remain vigilant, especially as the weather gets colder and it becomes more difficult to go outside and to have outside gatherings.

And with that, I just want to ask some very talented people to come up and say a few words. General Perna and Dr. Slaoui have been incredible. The General is really getting started right now, but he’s really — what we don’t know and what people don’t know, he started putting this all together six months ago, and you’re going to see some real action.

So, General, maybe you’ll start it off? And then, Doctor, you’ll go right after that. Thank you very much.

And then we’re going to finish it off with Mike Pence. Okay? Thank you, please. Thank you. Sure.

DR. SLAOUI: Thank you, Mr. President. Hi, everybody. So Operation Warp Speed’s mission is to enable and accelerate the development of vaccines and therapeutics to help control the COVID-19 pandemic and save lives.

On May 15th, almost six months ago to the day, we stated the goal of the operation, which was to have vaccines and therapeutics available and approved for use in the U.S. population by the end of the year 2020. We said then that, while very challenging, the goal was credible and therefore was worth trying with the best — our best to achieve it.

Today, we’re almost six months later, and I think we can say that significant progress has been made. And while we are not there yet, we are close to the objective.

Let me share with you some facts. If I look at the vaccine side, we’ve selected a portfolio of six vaccines, using three different platform technologies, and we elected to have two vaccines from each platform technology. The first platform is what’s called “messenger RNA,” and two vaccines using that platform were in the portfolio: one by Pfizer and one by Moderna.

The second platform is using what is called “live viral vectors,” and we had one vaccine from J&J and one vaccine from AstraZeneca, in partnership with Oxford University.

And the third platform was the recombinant protein platform, with one vaccine from a biotech company here in the U.S. called Novavax and another one from a partnership between Sanofi and GlaxoSmithKline.

These vaccines are now — six vaccines are all in the clinical development stages, and four of them are in phase three trials. And of the four that are in phase three trials, two have effectively completed enrollment in the phase three trial. And one of the two has announced on Monday — to, I think, thrilling information — that they had 90 percent efficacy — that was the Pfizer vaccine — demonstrating that vaccination is possible against COVID-19, that the kind of choices we have made in terms of the antigen selected was effective, and made us optimistic that other vaccines may also be effective.

On Wednesday, the same week — just this Wednesday — Moderna, the other company with the vaccine using similar platform technology — messenger RNA — announced that they have achieved the number of cases in their trial to allow for a first interim analysis, and I would expect that shortly — probably next week — we may hear what I hope to be another very good information regarding an efficacious vaccine.

The two other vaccines that are in phase three trial that are using the live vector platform — the J&J vaccine and the AstraZeneca vaccine — have recruited already a few thousand subjects in their trials. I would like to take this opportunity to invite as many Americans as possible who would like to volunteer to participate in these clinical trials, as that’s the only way we are able to achieve a demonstration of the safety and the efficacy of these vaccines.

The last two vaccines — the protein recombinant protein vaccines — are planned to start their phase three trials within the next few weeks. And while we are developing these vaccines, we haven’t only looked at the clinical development, of course, in partnership with the companies that are the sponsors for the vaccine; we also invested very significantly in the manufacturing of this vaccine, in such a way as to when we have the clinical efficacy demonstration with these vaccines, we would also have vaccine doses to be able to immunize the U.S. population.

So the two vaccines that are completing their phase three trial are likely to be filing their files with the FDA for a potential emergency use authorization within the next few weeks. And hopefully, if approved, they could be used for immunization in the U.S. population in the month of December. And we have — we plan to have enough vaccine doses available for use in the U.S. population to immunize about 20 million individuals in the month of December, and another 25 to 30 million per month on an ongoing basis from there on. And as of the month of February or March, if we have more vaccines approved, such as the live vector vaccine, we may be able to immunize a larger number of Americans, on an ongoing basis, per month.

Operation Warp Speed didn’t only focus on vaccines; we also looked at therapeutics. And we have worked with a number of companies developing monoclonal antibodies, in particular, that are able to neutralize the virus.

As Mr. President said, we have announced partnerships with Eli Lilly, with Regeneron, and with AstraZeneca. And, on Monday, Eli Lilly’s monoclonal antibody was granted an emergency use authorization to treat the patients that are infected and at risk of hospitalization. The Regeneron monoclonal antibodies have been also filed for emergency use authorization, which is currently under review and is potentially reaching approval within the next few weeks.

And finally, AstraZeneca, just in the last few days, has received a green light to start two large phase three trials with their monoclonal antibodies, supported by Operation Warp Speed, to prevent the acquisition of COVID-19 disease in very frail subjects or in very high-risk subjects, as a protective alternative to a vaccine.

So, potentially two vaccines and two therapeutics may be granted an emergency use authorization before the end of this year. I think it’s a remarkable achievement within a period of six to seven months.

It is important to know that this progress has been achieved without any political interference. I said it many times. And at every step has been and is being judged by independent expert bodies, whether it’s when the FDA grants the green light to go into clinical trials, or whether when the Data Safety Monitoring Boards review the safety of the studies on an ongoing basis and sometimes put them on hold, as I’m sure you have witnessed with the AstraZeneca vaccine, for instance.

And these same Data Safety Monitoring Boards are the independent boards of experts that analyze the efficacy of the vaccines and the safety of the vaccines and tell the companies whether they should progress with the filing of an emergency use authorization or not.

So it’s not the companies. It’s not Operation Warp Speed. It’s not the U.S. government. It is independent experts that assess the safety and the efficacy of the vaccines that are being tested.

And when the FDA will review these vaccines and therapeutics, they will also have the advice — public advice from boards; one of them is called the “VRBPAC,” that is the advisory board to the FDA for vaccine reviews — after review of the data transparently and available to everybody to look into before the FDA then makes its decision to either authorize the vaccine or not authorize it.

On that basis, I personally feel very comfortable to say that the vaccines and the therapeutics that we have helped develop and accelerate will be judged independently, and, if approved, should be used by all in the population. Because I believe vaccination is likely to be the cornerstone among all the other measures that we have to take to help us really control this pandemic.

I will now pass to my co-leader, General Perna, who will tell you more about the support that the operation has provided to manufacturing of the vaccine and also to their distribution.

Thank you very much.

GENERAL PERNA: Mr. President, thank you for allowing me to continue service of our great nation as the co-leader with Dr. Moncef Slaoui on this mission.

Let me start by emphasizing, for me, what is Operation Warp Speed about: It is about saving lives, and it is a herculean task that the President put us on many months ago. And as Dr. Slaoui just laid out, we are making steady progress and we are ready to execute.

Through the whole-of-America approach, we have leveraged the best of nation in federal government, local, states, industry, and academia to expand the capacity and capability to achieve our mission. It has been powerful.

We have capitalized on the best contracting, logistics, and planning experts available to synchronize and integrate all phases of the operation, from development of the vaccine, manufacturing of the vaccine, and finally distribution of the vaccine.

Six months ago, the capacity did not exist in our nation’s pharmaceutical production base. We went to work building brick and mortar manufacturing facilities, bringing in the right specialized machinery, and prioritizing supply-chain materials through the Defense Production Act.

Today, we expect to have tens of millions of doses immediately following EUA, and we will distribute them as soon as the FDA applies the EUA. We will do that within 24 hours of the EUA. We are harnessing the strength of commercial industry and the existing vaccine delivery capabilities and infrastructure. Our nation deserves this. Vaccines will be allocated pro rata by population so that we ensure fair and equitable across.

We need the states who are part of the planning to accept the vaccine. We are working closely along with the CDC, the 64 jurisdictions, and states to ensure a vaccine can safely and quickly get to those who need it first. And then we have plans to ensure that it spreads exponentially across our country and that no place is left without a vaccine. At the end of the day, our success is going to be judged by the availability of the vaccine as shots go in arms.

It is the partnerships we have formed with the pharmaceutical companies like Pfizer and Moderna; distribution companies like McKesson, FedEx, and UPS; and pharmacies like CVS and Walgreens that have agreed to do things differently, to think, “How can we get this to the American people in the most rapid and expedition- — expeditious way?” We will be successful because of this all-of-America approach, this collaboration, this effort that everybody is leading towards.

I will end where I started: This is about saving lives, the lives of the great American people. And we will not rest until we are successful and that we have irreversible momentum to returning our nation back to normal. Thank you, Mr. President.

THE PRESIDENT: Thank you very much. Thank you, General, very much. Great job.

Alex, please.

SECRETARY AZAR: Thank you, Mr. President, for providing the leadership that’s gotten us where we are today. The success that Operation Warp Speed has realized so far has been made possible only because of the bold vision you announced not even six months ago, right here in the Rose Garden.

To highlight three of the remarkable accomplishments we see just this week: First, Pfizer announced very promising data on its vaccine candidate.

Second, Eli — second, the FDA authorized and we have begun to distribute and administer Eli Lilly’s monoclonal antibody to help Americans at risk for serious disease stay out of the hospital.

Third, another vaccine company, Moderna, announced that it’s reached a critical clinical trial milestone, meaning we may see data from them within days.

Back in the spring, we were told by all of the experts that a vaccine was a year or a year and a half away, and the announcements I just highlighted would have been unthinkable. The President said, “That’s not acceptable.” And thanks to the support he’s provided, we’re now on track to deliver a safe and effective vaccine to our most vulnerable this year.

As I worked with the President to assemble this team and organize this effort, his support was indispensable at each step of the way. We went out and found the very best people on the planet to do the job, who you just talked with: Dr. Slaoui, the world’s most successful vaccine developer; General Perna, one of the world’s most qualified logistics leaders.

When I first talked to Dr. Slaoui and General Perna about our goals and recruited them to this effort, we dreamed of being at the point we’re at today: on track to achieve the incredibly ambitious goal we set together.

The President gave us the full financial support we needed, enabling us to invest more than $10 billion to de-risk vaccine companies’ development efforts and manufacture product in advance.

Our completely unprecedented partnership with the Defense Department has given us a comprehensive public-private plan for distribution and help each Operation Warp Speed vaccine maker secure what they needed for manufacturing, including Pfizer’s ongoing production this week.

Operation Warp Speed has always had one goal: saving lives. The President has given OWS the independence it needs to achieve that goal and ensure that we’re following the procedures that Americans expect for any medical product they take. At every step, ensuring patient safety has been our top priority.

This process has been driven solely by science and data. So it’s a shame that some — one example being the Governor of New York — have actually injected politics into the process and suggested the possibility of intentionally delaying access to an FDA-authorized vaccine, which is simply unconscionable.

Because the President has delivered the full funding we need, the best people on the planet, and real independence for this project, Operation Warp Speed is doing something that has never been done before in history. This success means there is light at the end of the tunnel.

Right now is not the time to let our guard down. We continue to encourage Americans to follow the three “W’s”: Wash your hands; watch your distance; wear a mask when you can’t watch your distance; and avoid settings where you can’t do those things.

Because of the incredible American spirit, because of what great scientists and public servants and innovators have done through Operation Warp Speed, we have such a bright future ahead of us. If we continue to protect ourselves, our families, and our communities, then I firmly believe that future will be here very soon.

Thank you, Mr. President, for making that very bright future possible for the American people.

THE PRESIDENT: Appreciate it. Thank you.

Mike Pence, please.

THE VICE PRESIDENT: Thank you, Mr. President. And on behalf of the White House Coronavirus Task Force, I was grateful to just have a few minutes today to commend the team of Operation Warp Speed.

It was your vision that we could harness the ingenuity and the creativity of America’s greatest pharmaceutical and research companies to speed, in record time, a vaccine that would save American lives.

You told the American people that we would have a vaccine before the end of the year, and some scoffed at that timetable. But I can tell you, the team on Operation Warp Speed didn’t; these great research companies didn’t.

And as you’ve articulated here, Mr. President, the American people can be comforted with all the news this week that help is on the way. That literally, pending FDA approval of the Pfizer vaccine and perhaps very soon another vaccine that will be submitted by Moderna and even other companies — that before the year is out, we’ll be able to administer a vaccine to tens of millions of Americans, as you’ve said Mr. President, beginning with those most vulnerable, beginning with our seniors all across this country, beginning with our healthcare workers and first responders at the point of the need.

It is an unprecedented medical mobilization, the greatest in the history of our country. And I join you in commending this team.

Let me also say, Mr. President, that the White House Coronavirus Task Force will be meeting with our nation’s governors in our regular conference call this Monday. We’ll be reviewing with them the progress on the development of a vaccine, our plans for distribution. But we’ll also be reviewing each and every state’s specific plans for distributing the vaccine, continue to urge governors to have those plans developed and prepared and ready for immediate implementation.

And finally, Mr. President, as we see cases rising around the country, as we see hospitalizations rising around the country, I want to encourage the American people with the news that, as we have done from the very beginning, we’re going to continue to move Heaven and Earth to make sure that your family has access to the level of healthcare that we’d want any one of our members of our family to have.

I spoke to FEMA today, and as we heard reported at our last taskforce meeting, Mr. President, we’re receiving requests from states for PPE, for personnel, but we’re meeting all of those requests. And according to our team on the ground, we continue to believe that we’ll be able to meet the requests for PPE and equipment — both from the Strategic National Stockpile, also from the commercial market — to make sure that those needs are all met.

And the American people can also be confident, because of the system that you established, that since this past July, we’re actually able to track PPE — gowns and gloves and N95 masks — on a hospital-by-hospital basis, so we can continue to deliver, as you said, Mr. President, on that extraordinary record in America, where no American who has ever required a ventilator has ever been denied a ventilator, no American who has ever been required an ICU bed has ever been denied an ICU bed.

So the good news today, through Operation Warp Speed, Mr. President, is help is on the way. It’s on the way right around the corner. As one of the members of our task force said recently, the cavalry is coming. But we want to encourage every American that we’re going to continue to make sure that our healthcare system has the resources, the support, the equipment and supplies that they need.

And we also, Mr. President, as — as we see cases rising, particularly in — in the Heartland of this country, but in communities all across America, we encourage every American, as the Secretary did and as you have, to continue to practice good hygiene, wash your hands, practice social distancing, wear a mask when that’s not possible.

We all have a role to play. We all know what to do to protect the vulnerable and to look after our families and our neighbors and friends. And we encourage every American, with all the good news this week, to continue to be persistent in putting the health of yourself, your family, your neighbors, coworkers, and friends first.

And — and we’ll get through this, and we’ll get through this together. Thank you, Mr. President.

THE PRESIDENT: Thank you very much, Mike. And thank you, everybody. Thank you very much.”

The “Newsmaker of the Day” is heard every weekday morning at 6:45, 7:45 and 8:45 on AM 1450 and FM 102.7 KVML.

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