Operation Warp Speed COVID-19 Press Conference Transcript by Defense Officials January 12

Secretary Azar: (00:01)
We have achieved several milestones, several triggers that brought us to this point. Nearly 38 million total doses of vaccine to date, including about 25 million first doses have been made available for states to order against with more becoming available this week. The doses allocated exceeds the priority populations in group 1A including frontline health workers and seniors living in longterm care facilities, which means that supply now exceeds demand from those groups.

Only four weeks into our launch, we have gained confidence in the integrity of our distribution system, which has now successfully delivered to over 14,000 locations, essentially without a hitch. Over the last several days, we’ve averaged around 700,000 reported vaccinations each day. And we are on track to hit 1 million per day in a week to 10 days time. In total, we have more than nine million first vaccinations already given far more than any Western country. By the end of next week, 95% of long-term care facilities will have had their first visit with vaccine doses.

All of this means it’s time to move onto the next phase of the vaccination campaign as we had planned to do when the data showed we could. This next phase reflects the urgency of the situation we face. Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied. The next phase has several components. First we’re expanding the groups getting vaccinated because state restrictions on eligibility have obstructed speed and accessibility of administration.

Second, we’re telling states to expand the channels and access points for administering vaccines and we’re helping them to do so. Third, we are really the entire supply we have for order by states rather than holding second doses in physical reserve. Fourth, we are announcing a forthcoming change to how we allocate doses in order to encourage states to support rapid vaccination and to focus on the most vulnerable.

So the first point about expanded eligibility, we’re telling States today that they should open vaccinations to all of their most vulnerable people. That is the most effective way to save lives now. And some states heavy handed micromanagement of this process has stood in way of vaccines reaching a broader swath of the vulnerable population more quickly. Specifically as Dr. Redfield will discuss, we are telling states they should open vaccinations to all people over age 65 and over, and all people under age 65 with a comorbidity, with some form of medical documentation as defined by governors.

Leaders in some States have forged ahead with steps like this in very diverse settings and demonstrated real success. I’ll just mention a couple like governor Lamont in Connecticut and governor Justice in West Virginia. Expanding eligibility to all of the vulnerable is the fastest way to protect the vulnerable. It’s simply much easier to manage allocating vaccines and appointments to everyone 65 and over rather than narrower, more complex categories. And it enables States to use much more diverse administration channels. There was never a reason that states needed to complete vaccinating all healthcare providers before opening vaccinations to older Americans and other vulnerable populations. States should not be waiting to complete 1A priorities before proceeding to broader categories of eligibility. Think of it like boarding an airplane. You might have a sequential order in which you board people, but you don’t wait until literally every person from a group has boarded before moving on to the next, you have to keep the process moving. Imagine if you find gate agents for boarding people out of order, you’d be standing at the gate for hours. Of course, moving on from initial phase of say healthcare workers before everyone is vaccinated is not declaring victory for that category. State should continue working to support vaccinations of those populations.

But moving on to broader populations when supply meets demand was always part of the recommendations that CDC had provided to states. Second, we are states to open up more channels for administration and we’re helping them do so. Hospitals made sense as the early distribution sites when the focus was on healthcare workers, but they are not where most Americans go to get vaccines. States should move on to pharmacies, community health centers and mass vaccination sites as desired or needed.

To support that work, last week we announced that states could start using pharmacies enrolled through our federal partnership with 19 pharmacy chains and associations. General Perna, Dr. Redfield, and some pharmacy leaders held a briefing for governors on this topic last Thursday. This federal partnership allows states to allocate vaccines directly to these partners. And these partners can then administer vaccines to particular groups and eventually to the general public. These pharmacy partners handle the administrative tasks such as scheduling appointments and reporting vaccinations. States can and should choose the most strategically placed pharmacy partners to send vaccines to now.

We’re also activating our federally qualified community health centers for vaccination. Some of these community health centers are already being utilized by state plans, but every state should be using them. Community health centers have more than 13,000 delivery sites across America. And they have both particularly convenient locations and strong connections in low-income and minority communities. Further, if States wish to set up mass vaccination sites, we stand and ready to help both through CDC guidance and other support, including deploying personnel to assist with technical expertise and setup. We’re here to work with them. States have ample funding, including $3 billion, more on the way to support such efforts.

Third, we’re now making the full reserve of doses we have available for order. We are 100% committed to ensuring a second dose is available for every American who receives a first dose, let me repeat that, our approach continues to ensure that there will be a second dose available for someone who gets a first dose of vaccine, based on the science and evidence we have, it is imperative that people receive their second doses on time. That’s what the science says, that ignoring that would be reckless, but we had always planned to move to a more advanced phase of how we manage this. Once we had confidence in our supply chains, that is the key trigger we needed to see.

Because we now have a consistent pace of production, we can now ship all of the doses that had been held in physical reserve with second doses being supplied by doses coming off of manufacturing lines with quality control. Going forward, each week, doses available would be released to first cover the needed second doses and then cover additional first vaccinations. Finally effective two weeks from now, we are changing how we allocate first doses among the states, in order to ensure doses are being put to use and put to use for the most vulnerable. We will be allocating them based on the pace of administration as reported by states and by the size of the 65 and over population in each state. We’re giving States two weeks notice of this shift to give them the time necessary to plan and to improve their reporting if they think their data is faulty.

This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they’re currently not. And it gives states a strong incentive, ensure doses are going to work, protecting people rather than sitting on shelves or in freezers. With the case counts we face now, there is absolutely no time to waste. We need doses going to where they’ll be administered quickly and where they’ll protect the most vulnerable. Finally, as we face rising case counts in a number of parts of the country, we need all Americans to keep up the same public health measures we’ve been recommending throughout this crisis. Hope is here in the form of vaccines, we just have to keep up our guard for a bit longer.

I want to add one more key message to our recommendations of washing our hands, watching your distance and wearing your face coverings when you can’t watch your distance. If you test positive and are at risk for severe disease, meaning you are over 65 or have a comorbidity, you should be asking your doctor or healthcare provider, why you are not being given one of the FDA authorized antibody therapies that are in ready supply. We have products sitting on the shelves that can help keep people out of the hospital. That is just as unacceptable as vaccines sitting on shelves, unused. People in the appropriate categories should be asking their doctors or healthcare providers, why they aren’t being offered these antibody therapies. With that, I’ll hand things over to Dr. Redfield, our CDC director, Dr. Redfield.

Dr. Redfield: (10:34)
Thank you, Mr. Secretary. I want to echo some of the important comments that the secretary made. Clearly, as we began vaccination with our frontline healthcare workers and individuals in long-term nursing care and assisted living, that was the initial phase to begin to roll out this vaccine distribution. As the secretary said that as we sit here in the fourth week of this vaccination program, we now are at a time where actually there’s more vaccine available than it’s being requested for vaccination within the 1A group.

The ACIP and CDC guidelines that came out on vaccination to the states were never meant to be somehow finished the first phase. Then you move to the second phase, then you move to the third. So I’m here as the CDC director to ask our governors to echo what the secretary said and strongly recommend the vaccination now be expanded to those individuals 65 or over, and those individuals between 16 or 18, depending on the vaccine being used to 64 that have a co-morbidity with a medical documentation of such. We clearly have enough vaccine at this point to begin to expand and get more and more of the vulnerable individuals in our country vaccinated.

… the vulnerable individuals in our country vaccinated. This is particularly important right now, as we’re seeing the post holiday surge surge. We have many jurisdictions now that are on the verge of going from a linear growth to basically exponential growth. We believe it’s critically important at this time to get those most vulnerable people, as quickly as we can, into vaccination programs as a key strategy to maintain hospital resilience.

I also want to echo what the secretary said about the importance of using the approved, EUA-approved monoclonal antibodies for individuals at highest risk that develop symptoms prior to hospitalization. That’s a second really important intervention that we have at this moment to maintain hospital resilience.

Finally, I just have to echo also the closing comments of the secretary. This is a time that we call on all Americans to be vigilant in the mitigation steps that was asked, particularly in their own households. Most of the transmission that is occurring in our nation right now is not occurring in the public square. It’s occurring one household to one household to one household.

Again, wear a mask, they work. Social distance, it works. Staying away and being smart about crowds, washing your hands, they work. We need to work all together now. It’s going to be a difficult, difficult January and probably February. But with a vaccine and the new therapeutics we have, there’s really strong light at that end of that tunnel as we enter March. But we need to really commit right now and get as many Americans vaccinated as we can that are particularly the most vulnerable and at risk for hospitalization. Thank you.

General Pernett next. Moncef is going to be-

Yeah. General Pernett will talk next.

Right?

General Pernett: (14:02)
Good morning, everybody. We are in the beginning of … or continuing our execution. I’m very excited and I’m very proud about it. A month ago is when we started delivering vaccines around the world, around the country. They went to the hospitals as we focused on the categories for first-line medical responders.

Four weeks later, we’ve made significant progress, as the secretary has highlighted. There is nobody working harder to ensure that vaccines are being distributed than the OWS team in execution, to get it to where it needs to be. Distribution of the vaccines is getting them to the States so that they can ensure that it gets to the arms. We are enabling that every day. We, as the secretary said, have sent over 25 million doses of vaccines over to 16,000 different locations, really, really great effort.

The cadence of allocations, the cadence of orders, the cadence of picking and packing, the cadence of what’s being shipped, has really become a remarkable feat for all of us, the whole of America to be proud of. We are executing this every day, every week and the months will go by and the result, the effects will be safe and effective vaccines to the American people.

I do want to, as I always do, thank the men and women of Pfizer, Moderna, McKesson, FedEx, and UPS, who are working 24 hours a day, 7 days a week to deliver the vaccine in a timely manner.

As the secretary talked about, our responsibility is to make sure all vaccine that is releasable, available for distribution, gets out to the American people. That is what we are doing. As early as 24 November, standing right here, talking to you, I talked about our ability to plan, our ability to collaborate, our ability to see ourselves, and then to make sure we continue to execute to the maximum extent possible, delivering the most vaccines to the American people. That is what we’re doing now. That is what the secretary laid out in execution of how we are managing the second doses to ensure, first and foremost, it’s always available. But second, we ensure that the max available doses of vaccine are available to the American people every day.

My personal confidence in both the distribution capability, as demonstrated over the last four weeks, and the addition of manufacturing confidence has increased significantly, which allows me to approach and execute distribution and allocation of the vaccines differently. It ensures maximum execution and allows us to pass maximum doses of vaccine to the American people in a timely manner.

Today, I want to give you a quick update of where we are with the facilities that we’ve made significant progress in working to get long-term health care facilities up and running in collaboration with CVS and Walgreens. We know we have 70,000 facilities that are enrolled, which includes skilled nursing facilities and assisted living facilities.

We started, in week one, three weeks ago, with 900 facilities. In three weeks since, we’ve completed over 11,000 facilities, just under a million first doses have been given. 12,000 more clinics are scheduled this week and every week following, as we go forward. Today, we know that we are making a difference in these facilities. It is because of the great work by the CDC, CVS, and Walgreens that are making the difference. As the secretary said, we are quickly coming on to administer a first dose to everybody in this category.

We are expanding our distribution to the retail pharmacies, as the secretary talked about. We have opened it up for States to utilize the over 40,000 provider, pharmacy providers that are enrolled. We want to expand it up to 70,000 providers that are enrolled. We think that we can open up the aperture and give access, greater access, to the American people through the pharmacies.

What does it do? It allows us to have competence in the executors. It allows us to distribute it throughout the country. It allows us to give a place where the American people are comfortable of going and receiving the shot.

I want to give you four slides that I asked the team to put together. The first slide is the vaccinations that we executed on day one of distribution of the Pfizer product. We went to over 636 sites on day one, across our country. Why did we do this specifically? It was the Pfizer vaccine. We knew there was cold chain requirements. We wanted to ensure capability and capacity match the distribution. We worked with states, we collaborated with them, and we put it exactly where they wanted it, when they wanted it.

On the second week, when we brought the Moderna vaccine in, we were able to expand distribution, primarily because of the availability of doses at lower amounts, where the Moderna vaccine is at 100 minimum, ordering at 100 doses.

What could we do? We could expand out through the country because of the dose requirement, minimum dose requirement, and also less refrigeration requirement. We were able to send doses to long-term health care facilities. We were able to extend it into doctor’s offices and into pharmacies as the states asked us to do. The expansion was quick and rapid in just a week.

Now, today, as of yesterday, we have gone to over 16,000 locations across the country, as depicted on this slide. We go there on a routine basis, delivering vaccines as directed by the states, in distribution to the quantities and locations that they want, really covering the mass population of the country.

Now, what is in the realm of possible? This last slide. As we open up the 70,000 pharmacy chain and individual capabilities, we are covering the entire United States and vaccine can be distributed, as of this week, to where the States would like it to go, across the country.

We know that these pharmacies, because we’ve been working with them at the CDC level, are ready to execute this mission. As the states allocate vaccine to them and direct it, we are ready to deliver to all these locations, every day, every week, every month, as required. This alone will open up the capability and capacity to ensure that the American people have direct access to the vaccine as we go forward.

In closing, challenging times, as I’ve told you many times and the secretary said, we are not fighting the plan. We are fighting the situation. We are making adjustments and moving forward in that light, just like we had always planned to do. We are just able to change in a more rapid and steady pace.

I want to say thank you for all the support from the states. I want to say thank you for, again, to the industry partners that are helping us execute this flawless distribution, because every day they do their job, more vaccine gets out to the American people. Then in closing, as I like to remind us all, there is a group of people that are on the front lines every single day, helping us take care of those who have reached a certain point of their illness, and these medical professionals and their supported staff are really just doing a tremendous job. I just wanted to say thanks to all of you. That concludes my comments, Mr. secretary.

Thank you very much. I did want to note, as you saw, Dr. Slaoui is with us on stage and will be available for questions. He just didn’t feel the need to have an opening statement. But Michael Pratt?

Michael Pratt: (23:39)
Thank you all. We will now open up for questions, operator. A friendly reminder that when asking a question, please state your name and publication. Please keep your questions as short as possible so we can get to as many as we can in the time that we have. I’ll turn it over to the operator.

Operator: (23:54)
Thank you so very much. If you would like to ask a question, please press star then one on your phone. Be sure to provide your name and media outlet. Our first-

Operator: (24:03)
And be sure to provide your name and media outlet. Our first now is from Drew Armstrong with Bloomberg news. Sir, your line is open.

Drew Armstrong: (24:10)
Hi, it’s drew. I run our vaccine tracker here and had a question for you all about, what has actually been the problem in administering shots in some of these states that are showing low numbers of percentage of the distributions to them used? Because clearly, there’s a number of States that are working through between 70 and 80% of their distributions on a rolling basis. But others, Mississippi, Alabama, Georgia, North Carolina, perpetually kind of stuck in a very low percentage of what’s been shipped to them. Is it that it got distributed to the wrong places? Are there holdups in shipping? What is actually going on here? Because I don’t think we’ve really gotten a good answer from anybody about where these bottlenecks are that are preventing some states from reaching some of the numbers that you all had cited as being successes elsewhere.

Drew, and I’ll ask General Perna or Dr. Redfield to add to what I’ve got to say, but first, we need to recognize that we’re now four weeks into this program. And this is a major operational and logistics issue. It’s a scale-up. As with any enterprise, you’re going to have a scale up that is predictable and known that that would happen. But we have seen variable performance among the states and among providers. What’s going on there? And now each state may be slightly different, but for the most part, what we have seen, is the states that are lagging. It certainly could be a data issue. The health commissioner here in the District of Columbia, for instance, revealed that 40% of pharmacies aren’t reporting. We had data reporting issues with one chain pharmacy in terms of its ability to connect into the system on vaccinations. We had one state that has had some significant challenge with interconnectivity of data reporting systems. \.

And as Dr. Redfield can let you know, what we’re asking for is very novel in the history of vaccination programs in the United States. Usually, with public health vaccinations, providers have to report within 30 days, right, Bob?

Bob: (26:16)
Yes, sir.

Within 30 days. Now, they’ve signed as part of their agreement to be providers in [inaudible 00:26:22] with operation warp speed agreements to provide their data within 72 hours. But that’s a major workflow change for them. And there are going to be kinks in the system on that data improving consistently over time. And I think with the new incentives that we are announcing today, that states will receive their allocations, in part based on the data that we have on what percent of vaccines that they’ve received have they actually gotten administered, we’ll see that data improve.

The other major barrier, and I talked about this last week, has been states that are being overly prescriptive and trying to micromanage every single dose of vaccine, down who gets it, to ensure that only group 1A people get vaccinated before they’re willing to open up, and look at group 1B people, even if that’s the approach that they’re taking. So that might be states that are insisting that all healthcare providers have to be vaccinated before you start vaccinating the most vulnerable. And that’s why from the get go, I’ve talked about the need to not be cabined in by the different groups from the ACIP or from the CDC. They’re not meant to be prescriptive. Some governors have overreacted, have taken them in an overly prescriptive manner. And this is a logistical issue. This is an operational issue. If you try to be too micromanaged, too tailored, too focused, you let the perfect be the enemy of the good and a massive vaccine campaign like this.

I said last week, we would rather have some lower priority individuals get vaccinated along with the high priority individuals if it makes us go fast and if it avoids vaccines sitting on the shelves, and for the love of God, not having vaccine actually wasted or thrown away because of a failure to administer. So those have been the major issues. Really, at the state level, it’s first reporting, overly prescriptive approaches to vaccination, and then finally, an unwillingness to move to alternative channels of distribution over Alliance. I call it the hospitalization of vaccine distribution. And that was natural, as I said, at the outset. But it’s time to move beyond that. We have too much vaccine sitting in freezers at hospitals with hospitals not using it.

Now, sometimes hospital systems can be very effective partners in these vaccine programs, as they have networks, they have primary care practices. They are themselves health systems, not just hospitals. And so if they can get to their patients, get to their customers and clients that are vulnerable, those 65 and above, and those under age 64 and below who have comorbidities, well that’s ideal also. But use every channel, get the vaccine out there. I would rather have people working to get appointments to get vaccinated than having vaccine going to waste sitting in freezers. General Perna or Dr. Redfield, anything you’d like to add?

Thank you, Mr. Secretary. And I agree with your answers. The other thing I would just say is right now, CDC is doing a, I’ll call it a deep dive, on the 64 jurisdictions to try to understand exactly what that issue is. I do think a lot of it is reporting, as the secretary said. The standard the CDC has had in the past for reporting vaccination was the providers to report within 30 days. We’re now asking them to report within three days. So I do think some of that is part of the hiccup. But we’re doing a deep dive in all the jurisdictions, as was mentioned, some of them are less than 15%, and then we have other jurisdictions that are over 80%, to understand exactly what those factors are, and pretty confident we’ll have an understanding of that by the end of the week.

General, different you have anything you wanted to add?

Mr. Secretary, I agree with all that was just said completely. I would just add the separation of distribution from actual administration, we are tracking distribution at a success rate of 99.999%. So in other words, if the state tells us where they want it in one of the 70,000 enrolled providers, we are able to distribute there, in accordance with the order. And we, Pfizer, Moderna, McKesson, UPS, and FedEx are literally going through snow storms and distributing vaccine every day to the location as desired, at a very high success rate.

Next question?

Operator: (30:54)
That is from Dan Vergano with Buzzfeed News. Your line is open.

Dan Vergano: (31:01)
Thank you, Dan Vergano, Buzzfeed News. I’m wondering if this change will necessitate any widening of the time window for the 21 day and 28 day second dose. What is the widening? How close to 21 or 28 days you have to get now? WHO’s advisory committee has said you might go to six weeks. What do you see as the window for that? And what do you recommend?

So, Dan, thank you for asking about that. I want to be very clear. The labeled indication from the FDA on the vaccines for the Pfizer vaccine is 21 days between first dose and second dose and 28 days between first dose and second dose for the Moderna vaccine. That’s what the clinical trials were based on, that is the data submitted to the FDA, and that is what we are executing towards. So that is the goal. Now, if people end up coming in a day or so on each side, the goal is still 21 or 28 days, but we are not comfortable with approaches that are not based in evidence that has been generated to support these incredibly safe and effective vaccines. And I think that’s part of why the American public has shown such surging vaccine confidence, that every aspect of this has been data and science driven, and the FDA will make the determinations what appropriate administrations are.

The general laid out… And this was always part of the plan. You can go back to my statements, I think it was in December at these press conferences, where I said, “What we’re going to do is manage the flow of vaccines.” We must ensure that if you get a first vaccine, there will be a second vaccine at the 21 day or the 28 day mark at the provider for you to get that. We have two sources for vaccine. One would be holding back some of the initial stocks of vaccine that were releasable in December to guarantee that we’d have that second dose.

But I said, over time, as we gain confidence in the manufacturing quality and processes at Moderna and Pfizer, and with our deep, deep, deep operation warp engagement at Moderna and our increasing engagement now with Pfizer and their manufacturing processes and use of the defense production act, we have greater visibility and greater confidence in their production capabilities, we now have been able to move to where we do not need to hold back reserve doses, because we can predict with better certainty the doses that will arrive off the production lines, and quality control at the 21 day and 28 day mark to fulfill our second dose obligations to patients. And that will be our primary. And so if they’re, heaven forbid, were any type of glitches in production, the way this would work is new production off the production lines would be going towards, first and foremost, fulfilling the second dose obligation, and any first doses would be delayed to ensure that patients get, at the 21 or 28 day mark, that second dose. Thank you.

Speaker 1: (33:46)
We have time for two more questions.

Operator: (33:49)
Thank you. Our next from Ricardo Alonso-Zaldivar with Associated Press. Your line is now open.

Ricardo Alonso-Zaldivar: (33:57)
Hi, thank you for taking my question. And Mr. Secretary, can you walk us through the change in allocation to the states that you announced today? Does that mean that some states may end up getting less than they otherwise would have? And is there risk of disruption with that? And finally, do you have buy-in to that approach from the incoming administration?

So Ricardo, thank you for the question on that. So the two changes that we have outlined are, first, that our allocations among the states will not remain purely on a per capita basis, but rather be based on the reported data, showing the percentages of vaccine administered versus their allocations that they’ve received. In other words, if you’re not using vaccine that you had the right to, then we should be rebalancing to states that are using that vaccine. It is common sense. It seems hard to actually defy that. But we want to give notice, especially because of these data issues. We want to give notice. Within two weeks, we’ll be doing that. So get your data in order. Work on that data.

Ricardo, you may remember we followed a very similar approach when we were in shortage situations with Remdesivir, doing allocations to the states, and needing to get reported data on Remdesivir location and utilization. And so we followed that approach and it worked exceptionally well in the context of Remdesivir. And then the other change is to really emphasize, to make it very clear how vitally important it is to prioritize and focus on those who are most vulnerable, for whom the vaccine will have the biggest effect. And those are those aged 65 and over, and those 64 and below with co-morbidities. And so that will be a change. I believe it’s about 10 States most impacted based on the data, there. It’d be fairly common sense where that would be. But again, our States, aren’t using 100% of their allocated vaccine.

… Our states aren’t using a hundred percent of their allocated vaccine. So this ends up being, I think at least in the interim, a redistribution between and among the states that should not necessarily hurt many states, but will enhance the benefit to those that are actually getting vaccines done and performed. Thanks. Next question, please.

Moderator: (36:22)
Time for one last time.

Operator: (36:24)
Our final question is from Tom Howell, with the Washington Times. And your line is now open.

Tom Howell: (36:31)
Hi, thanks for doing the call. Can you address the backend of Ricardo’s question about whether the Biden team has bought into that plan? And also can Dr. Slaoui update us on AstraZeneca and J&J, when will they seek approval and how many doses have you secured of either one? Thanks.

We, at the Operation Warp Speed board, made the determination on the changes and distribution allocation methodologies among the states. While we will certainly brief the Biden team on those changes, we operate as you know, with one government at a time. This is the approach that we believe best fulfills the mission and the current situation that we are facing. Dr. Slaoui.

Moncef Slaoui: (37:20)
Thank you for your question. Regarding the Johnson’s vaccine, as you know, the phase three trial is fully recruited. There are unfortunately, fortunately for the trial, very significant number of cases accruing. We are very clear… We, meaning operation and Johnson’s Pharmaceuticals, that analysis will be completed before the end of the month. And the EUA submission will take place at the end of this month. In terms of vaccine dose availability, if submission is happening at the end of January, one could project that approval of the emergency use authorization may happen somewhere in the middle of the month of February. We project to have single digit million number of doses available in the second half of February. We’re trying to make that number, get as close to a double digit number as possible, and then a larger number in March, and a much larger number in April.

Remember, this is a one-shot vaccine. So those are millions of individuals fully immunized. In terms of the AstraZeneca vaccine. The assumption we are working on is that the emergency use authorization will be submitted on the basis of the ongoing phase three trial in the U.S. The phase three trial is effectively, fully enrolled. There are a few individuals more enrolled on it, primarily to ensure appropriate representation of all diverse population in the country. Cases are accruing. The 60 days upon completion of full immunization schedule follow-up safety, as required by the FDA guidance, happens during the first week of the month of March. And the projection would be to have a submission of the EUA around that time. Assuming of course, that cases have accrued. Again, unfortunately, I think that will be the case. Hopefully the vaccine again is efficacious, as has been shown in the trials conducted in Brazil and in the UK.

Maybe an approval somewhere towards the latter part of the month of March, and a significant number of doses available around that time. And since you asked the question, maybe I’ll also update on the Novavax vaccine. The Novavax vaccine is the fifth program out of the six programs we have that is in phase three trial or completed the phase three trial. The phase three trial has now recruited about 8,000 or so subjects. It is recruiting very fast at a rate of 800 subjects per day, volunteers. Hopefully we can go to a higher number. It’s very important that people continue to participate generously to be volunteers in this clinical trial. The projection is to complete recruitment of this trial somewhere very early in the month of February. Based on timelines of immunization, et cetera, maybe there, we can have an outcome somewhere in the month of very late March or in April.

The Sanofi trial program, which is the last program in our portfolio, will start phase 2B trial in the middle of February. In a comparative trial to a messenger RNA vaccine. Maybe also on a progress part of things. We are working now, experimentally, testing Sierra for identification of immune correlates of protection. That’s really super important, because if and when we have the data, somewhere in the middle of February is the projection currently, that identify an immune correlates of protection that will dramatically accelerate potential approval of other vaccines, including the protein vaccines, particularly that from Sanofi and vaccines from others.

And of course, across the world, provided people use readouts that are validated or cross validated with the readouts that have been used. I do want to say a final point, is we are running a clinical trial, a phase three trial in adolescents, 12-18 years of age, with the Moderna vaccine. It’s a real challenge. It’s been four weeks ongoing. We only recruited about 800 subjects in the trial. Remember I just said earlier, the AstraZeneca… Sorry, Novavax vaccine is recruiting 800 subjects per day. Here, we’re talking about 800 subjects in a month. It’s really very important for all of us, for all the population in America to realize that we can’t have that indication unless adolescents age 12-18 decide to participate. Of course, as a voluntary decision, into the clinical trials. We need to recruit about 3,000 subjects into the trial to complete them. Thank you.

This is very likely the last Operation Warp Speed briefing with this team for you all. I just wanted to express three notes of thanks. First, I want to thank the members of the media who participated in these Operation Warp Speed calls. You have been unfailingly professional and allowed an educational and technical level briefing that I hope your readers, and listeners and viewers have appreciated. We have tried at every step of the way to be factual and transparent with you, and bring you on the journey with us of vaccine approvals, and distribution and now administration. So thank you for making that possible. Second, I want to express my appreciation to former Secretary Esper, Acting Secretary Miller, and Deputy Secretary Norquist of the Defense Department. The collaboration between DOD and HHS has been unprecedented and really in my decades around government, government service, I’ve just never seen this type of collaboration and cooperation.

That comes from the top. That is a credit to the leadership of the Defense Department to make this happen. So thank you for that. Finally, people is policy. And we fortunately at the outset of Operation Warp Speed, we’re able to have some exceptional people leading this. In all of my time, leading in business and in government, I have never been part of a team that has demonstrated teamwork, and professionalism, and integrity, discipline, as this team does. I want to express my personal appreciation to all of the members of the team. But especially General Perna, who was a hero for America before he did this. Now he’s a hero for America’s public health. To Moncef Slaoui, who was a hero of the biopharmaceutical industry before doing this, and is now a hero of America’s public health.

These selfless individuals have dedicated every waking minute since they were tapped back in May to lead these efforts. The results have been remarkable. I hope that the next team with the Biden administration will be able to carry forward these results. We will do everything in our power to ensure a smooth and effective continued transition. The first meeting, I believe of any transition team between this administration, the Biden administration, was before Thanksgiving and it was for Operation Warp Speed. We’ll continue those efforts up through the last day of this administration, and into the Biden administration. Thank you all very much. We appreciate everything.

Moderator: (45:11)
Thank you, Mr. Secretary. Additional follow up questions can be sent to media@hhs.gov. And I’ll turn it over to the operator to finish up the call. Thank you.

Operator: (45:21)
The conference is now concluded. Again, thank you everyone for your participation. Please go ahead and disconnect. Thank you very much.

Operation Warp Speed COVID-19 Press Conference Transcript by Defense Officials January 12

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