2:24 P.M. EDT
MR. FENTON: Good afternoon. I’m Bob Fenton, the White House Monkeypox Response Coordinator.
Today, HHS Assistant Secretary for Preparedness and Response Dawn O’Connell will cover our ongoing work to scale up vaccine supply and distribute vaccine where it is needed. CDC Director Walensky will discuss the initial data we have on vaccinations from a small number of jurisdictions. And Deputy White House Monkeypox Response Coordinator, Dr. Demetre Daskalakis will provide an update on our partnership with impacted communities.
From the start, our vaccination strategy has been centered around reaching approximately 1.6 million Americans, including gay, bisexual, and other men who have sex with men, and others with a known high-risk exposure to monkeypox. To do that, we’ve worked nonstop to scale up access to the JYNNEOS vaccine in the U.S. In fact, we have made more JYNNEOS vaccine available than any other country in the world. And because of the FDA’s authorization of safe and effective intradermal vaccination, we can accelerate the number of shots in arms with the urgency this outbreak warrants.
As of the past — this past Monday, we have made 1.1 million vials of vaccine available to jurisdictions. That is the same total number of vials that jurisdictions were expecting before FDA approval of intradermal administration.
As Administrator O’Connell will discuss shortly, we’re approaching having enough vaccine for everyone in the at-risk community to receive two doses of vaccine.
I’m also glad that we’ve seen significant progress in intradermal administration of vaccine in just the last two weeks.
As of today, 75 percent of jurisdictions are already applying intradermal administration of vaccine, and another 20 percent are working to move in that direction. This is important progress in a short period of time. As a cumulative 1.1 million vials are delivered to jurisdictions and as we get more supply, we are approaching the point where we can offer two doses of vaccine to the entire high-risk population via intradermal administration.
While we continue to deliver as much vaccine to states and jurisdictions as possible, our focus has to be getting those shots into arms.
Over the past couple of weeks, CDC has been working closely with jurisdictions and clinicians directly to operationalize the intradermal approach. They’ve hosted webinars with thousands of providers, provide video trainings, and our team is in touch with health leaders around the clock.
As Dawn will discuss in detail, we have made clear to jurisdictions we stand ready to help in any way we can, including providing additional vaccines once a jurisdiction has attested to using more than 85 percent of their vials.
Currently, there are a handful of jurisdictions, approximately one fifth, that have attested to using 85 percent of their current supply. So our focus right now is working closely with clinicians and local health departments to get shots into arms.
And importantly, we continue to encourage jurisdictions to focus vaccination efforts on getting vaccines out equitably to individuals at highest risk of contracting the virus. That’s why we are working closely with places like Atlanta and New Orleans to prepare for events like Black Friday and Southern Decadence. And last week, we got hundreds of vaccines out to individuals who participated in Pride activities in Charlotte, North Carolina.
The bottom line is this: Over the past three months, we have made significant strides in increasing supply of vaccine, accelerated its delivery, and are strengthening our preparedness for the future. We have a robust supply of vaccine available for jurisdictions out in the field. And we are working hand in hand with jurisdictions to get shots into arms to help adapt the intradermal approach and to answer their questions.
We will also continue to do everything in our power to address needs on the ground and adapt our response as needed so we can get this outbreak under control.
Before I turn it over to Assistant Secretary O’Connell, I want to take a moment to recognize the work of jurisdictions that are leveling up their operations to get more vaccines into arms.
Just this week, our team heard from health leaders here in D.C. who told us they were getting 900 shots out per day using the intradermal method and getting between 4.5 and 5 doses on average per vial. Those aren’t just numbers; that’s real action impacting hundreds of people every day.
So, thank you to all the clinicians, health partners, and members of the community for working together to combat this outbreak.
With that, let me turn it over to Assistant Secretary O’Connell.
MS. O’CONNELL: Bob, thanks so much. At ASPR, we continue to do everything we can to increase the availability and accelerate the distribution of vaccines and treatments nationwide, with a goal of first offering vaccines to Americans at highest risk of contracting monkeypox.
As Bob mentioned, we are soon approaching the point where most people at highest risk will have access to two doses of JYNNEOS. Our work is far from over, but this is a step in the right direction as we continue to fight the spread of the virus.
Now I’m happy to walk through the numbers. To date across all four phases of the national vaccine strategy, we have allocated approximately 1.1 million vials of JYNNEOS vaccine. We shipped about half of that number prior to the FDA issuing their emergency use authorization for JYNNEOS allowing for intradermal administration. So those first 600,000 or so vials were distributed when one vial equaled one dose.
Since the FDA issued the EUA on August 9th, we have shipped approximately 188,000 additional vials of vaccine, which represents up to 940,000 doses using the intradermal vaccination method covered by the EUA. Combined, that comes to about 1.5 million doses already distributed and in the field.
Now, on Monday, we launched the fourth phase of our national vaccine strategy, making the next 360,000 vials of vaccine available to states and jurisdictions for ordering and distribution.
Using the intradermal administration method, jurisdictions can administer up to 1.8 million doses of vaccines from these vials. Taken together, by the end of phase four, we will have provided enough vials to states and jurisdictions to provide more than 3 million doses of vaccines, meaning we have supplied nearly enough vaccine to reach the entire at-risk population.
We’ve got more to do, but this is an important step along the way.
Now, as supply continues to increase steadily and we ship out thousands of doses daily, it’s important that we make sure vaccines are going to the people in places that need the most and that shots, like Bob said, are getting into arms, not sitting on shelves.
As part of phase four, in order for a jurisdiction to order from its allocation, it must attest that it has utilized at least 85 percent of its current supply.
Since Monday, 14 jurisdictions have attested to 85 percent utilization. And as soon as a jurisdiction let us know that they have used 85 percent of their supply, they can order more. The Strategic National Stockpile team immediately fulfills those orders and ships them out.
Of the jurisdictions that have attested to this 85 percent utilization, since Monday, ASPR has shipped nearly 48,000 vials of vaccine, which represents up to 240,000 doses.
Looking ahead, we anticipate another 150,000 vials of vaccine from our supplier, which represents up to 750,000 doses, and all coming in as early as late September.
In addition, last week, we announced that Bavarian Nordic reached an agreement with Grand River Aseptic Manufacturing to establish the first U.S.-based fill-and-finish for JYNNEOS in Grand Rapids, Michigan. Once up and running, this facility will fill and finish 2.5 million vials we ordered this summer. This is an important step in building our domestic capacity and in providing domestic jobs.
In addition to getting vaccines out to those that need it the most, it is also important to us that TPOXX is easily accessible for treatment to those at high risk for severe disease. That is why last week we announced that we would pre-position up to 50,000 patient courses. That’s three times as many treatment courses as there are monkeypox cases.
Jurisdictions were able to start ordering those treatment courses earlier this week. And so far, the SNS has shipped out about 10,000 courses to 19 jurisdictions. That’s in addition to the more than 22,000 courses we have already shipped.
This approach allows us to pre-position these treatment courses for quick and easy access for patients who qualify for them. So, bottom line: Our message to states and jurisdictions is if you need vaccines, if you need treatments, or if you need additional support for your local response, please let us know.
And with that, it’s my pleasure to turn the program over to Dr. Walensky.
DR. WALENSKY: Thank you, Administrator O’Connell. Good afternoon, everyone.
Today I’d like to share with you the latest information and data out of our local health departments and CDC on the current monkeypox outbreak.
As of August 25th, over 46,700 cases have been detected globally in 98 countries. In the United States, there have been nearly 17,000 cases of monkeypox identified across all 50 states, the District of Columbia, and Puerto Rico.
Throughout the current monkeypox outbreak, CDC has worked diligently to make data available as quickly as possible to help raise awareness and guide decision-making. Earlier this week, CDC posted updated data on our website providing an in-depth look at monkeypox case demographics and symptoms, the use TPOXX, an experimental treatment for monkeypox, as well as data from a behavioral survey of gay and bisexual men.
The posting of these data on our website prior to its publication in a scientific journal is an example of the way we are working to modernize CDC and share timely and actionable data with all of you.
Today, CDC is posting additional data that provide a picture of monkeypox vaccine administration in the United States. Our plan is to update these data on a weekly basis on the CDC website. It’s important to note that the data we’re releasing today reflect only 19 jurisdictions where data are flowing to CDC for analysis.
But the data do provide us with an insight and understanding of where we are in our efforts to administer vaccine to those at risk. We’re actively collaborating with the remaining jurisdictions so that they can upload their data in response to our data use agreements.
Now, I’d like to walk you through the vaccine administration data CDC is releasing today. Data as of August 23rd show that over 207,000 doses of vaccine have been administered in these 19 jurisdictions.
The data demonstrate that the vast majority of doses administered — nearly 97 percent — are first doses with consistent week-over-week increases in vaccinations. While we are encouraged by the scale-up, there are many people eligible for second doses, and very few of the doses administered so far are recorded a second doses.
I’d like to take this moment to emphasize that this is a two-dose vaccine and it is important to receive the second dose in the series. I encourage providers to continue to highlight the importance of the second dose so that all vaccinated people optimize their protection from the vaccine.
Now, the administration data also show that among the first doses given, the majority of recipients have been adults age 25-39, with around 53 percent of first doses administered in this age group so far.
The majority of first dose recipients — at 92 percent — have been males, and 6 percent of doses have been administered to women. Regrettably, we at CDC are not receiving data by gender and are unable to report it as such.
Those who are white represent about 47 percent of administered vaccines. Those who are Hispanic represent about 22 percent. And those who are Black represent about 10 percent.
Recently, we’ve seen a demographic shift in new cases, as Black and Hispanic men have increasingly and disproportionately represented new cases, which further highlights the importance of equity in vaccine administration.
Given the early evidence of racial and ethnic disparities in monkeypox vaccine administration, CDC remains committed to reducing the impact of health disparities by collaborating with jurisdictions on provision of educational materials and promotion of equitable access to monkeypox vaccines. We’re also working with communities to provide vaccine and harm reduction education at large events attended by groups at highest risk for monkeypox right now.
States, territories, and large local jurisdictions in the United States have stepped up in the face of this outbreak and agreed to report secure, protected data about monkeypox vaccine administration in their jurisdictions to the CDC. These data are essential to help us understand who the vaccines are going to and, critically, to make sure vaccines are getting to the communities where they are most needed.
The data presented today are from 19 jurisdictions. And as I previously mentioned, we’re actively working with the remaining jurisdictions to get these data flowing.
I want to emphasize that public health data in the United States are unique. They come from a complex, decentralized landscape of state and local health departments with many points of friction that can keep data from getting from local jurisdictions to the CDC.
The effort to secure monkeypox vaccine data represents how we at CDC are working hand in glove with our state and local partners and other federal agencies to continually improve our approaches. Our goal is swift, transparent, publicly available, and actionable data.
And we will share additional jurisdictional data as they become available.
Finally, as students return to college campuses, I want to highlight that earlier this week, CDC made information and resources readily available on our website about monkeypox for administrators, staff, and students at colleges and universities.
We will continue to provide the necessary information and education and conduct outreach to those at risk.
As you have heard me say many times before, we remain open to feedback on how and where we can provide tailored information to those at highest risk.
Thank you and I’ll now thing –- turn things over to Dr. Daskalakis.
DR. DASKALAKIS: Thank you, Dr. Walensky. Today, I wanted to provide an update on a key element of our response: That’s working closely with gay, bisexual, and other men who have sex with men to provide evidence-based behavioral advice to help reduce the risk of monkeypox as we work to get vaccination and testing to scale.
It has been a top priority since the earliest days of the outbreak to communicate in plain and direct language about how monkeypox is transmitted and what actions people, specifically men who have sex with men, can take to avoid exposure to this virus.
It has been core to my and our mission to provide this advice in a way that reaches men who have sex with men in places they know and trust and to speak plainly and directly about behaviors associated with monkeypox transmission so that they and transgender and gender-diverse individuals have the tools to navigate this outbreak.
The queer community has been central in developing, adapting, and amplifying these messages as the outbreak has unfolded and the epidemiology further informed our advice to prevent monkeypox.
Ninety-four percent of cases were associated with sexual activity. And nearly all the cases have been seen in gay, bisexual, and other men who have sex with men.
Today, the CDC’s MMWR reports that a special monkeypox survey of participants of the American Men’s Internet Survey –AMIS — that both reinforce this strategy and highlights the important self-motivated behavioral actions taken by MSM during this outbreak to reduce their personal risk of infection and therefore the spread of monkeypox in the community. Around 50 percent of surveyed men report having reduced their number of sex partners, reduced their one-time sexual encounters, and avoided some virtual and real spaces associated with increased monkeypox exposure risk.
A second MMWR describes a mathematical model that shows that temporary changes in behavior, like the ones reported in the AMIS study, would not only lead to a reduction in the percentage of people who got monkeypox, but it would also slow spread in the population, allowing more time for vaccination efforts to reach people who could benefit most.
What this means is that the LGBTQAI+ people are doing things that are actually reducing their risk and it’s working. And it speaks to the resilience and commitment of this community to addressing the challenge of monkeypox using every tool in their toolkit, as well as the need for clear, frank, and community-responsive advice from the partnership of public health and community.
This is strong progress and shows that the work we’re doing to engage the community is having results and that the community has mobilized to protect itself.
So let me be clear: The advice about how to reduce risk for monkeypox exposure is for now, not forever, and is an important part of our public health and community response as we urgently surge vaccinations to control this outbreak.
I’ll hand the mic back to Kevin for questions.
MR. MUNOZ: We’ll get into a few questions. Please keep your questions to one question.
Let’s go to Carla Johnson at The Associated Press.
Q (Inaudible) about what you’re doing to address the disparities we’re seeing in these new numbers about vaccine administration, particularly to the Black and Hispanic community. Thanks.
MR. MUNOZ: (Inaudible) that one?
DR. WALENSKY: I’m sorry. I’m happy to take that. I – Carla, thank you for that question. And let me just say that we anticipated that these numbers might come; we didn’t wait for these numbers to take action. We are seeing the effects of disparities and we’re taking action right away.
One of the things I do want to say is: Part of the motivation for the pilot projects that Bob mentioned early on in Charlotte, as well as the Black Gay Pride event that will be happening this Labor Day weekend, is exactly to address these health disparities and inequities in vaccine administration. And we’ve seen, as we’re starting to roll these pilot projects out, that they are working.
But not just in vaccination, but also in community and education as Demetre just –- Dr. Daskalakis just noted.
MR. FENTON: Thanks. Let me just see if Dr. Daskalakis wants to add anything to that.
DR. DASKALAKIS: I’ll just add, really, to what Dr. Walensky said. That really — you know, with supply of vaccines increasing, I think we have a new opportunity and strategy which is bringing the vaccine to people as opposed to trying to have people find vaccine.
And so I think that the example of the events that we were talking about are one, but we have others, including allocations of vaccines that are going to Ryan White clinics and Federally Qualified Health Centers.
And then also hearing on the ground — since public health is a local event — strategies that individual jurisdictions are using to actually get vaccines to smaller organizations that reach people better.
MR. FENTON: Thank you. Kevin, next question.
MR. MUNOZ: Let’s go to Pien Huang at NPR.
Q Hi, thanks for taking my question. I had a question about the epidemiology of the outbreak. So in New York and a few other cities, we’re seeing some early signs that monkeypox cases might be starting to fall. So I was wondering, from your perspective, if you think this is a real signal? Could it be a turning point? And what does it mean about how to move forward?
MR. FENTON: Yeah, let me ask —
DR. WALENSKY: Yeah, that’s a -–
MR. FENTON: Oh, go ahead, Dr. Walensky. Perfect.
DR. WALENSKY: That’s a great question. So we have started to see globally that we may be turning a corner. We, in the United States, had our first case about two weeks after some of the European countries that we have also started to see turn around. And as you note — or turn downward. As you note, there are certain jurisdictions — New York, Chicago, San Francisco — that are starting to report that they’re starting to see a downward trend.
I want to be cautiously optimistic about these not only because of the downward trend, but because of the AMIS data that Dr. Daskalakis just noted, that we’re actually seeing vaccines get out, behaviors change, harm reduction messages being heard and implemented. And all of that working together to bend the curve, if you will.
That said, I also want to say that week-over-week, our numbers are still increasing. The rate of rise is lower, but we are still seeing increases. And we are, of course, a very diverse country, and things are not even across the country.
So we’re watching this with cautious optimism, and really hopeful that many of our harm reduction messages and our vaccines are getting out there and working.
MR. FENTON: Thanks. Kevin, can we go to another question?
MR. MUNOZ: Liz Highleyman at POZ.
Q Yes, I’m wondering if you could say more about the cases — I know there’s not many of them yet — among women. But are those largely being — largely related to sexual activity at this point or household transmission or what?
MR. FENTON: Go back to Dr. Walensky?
DR. WALENSKY: Yeah, you know, there are — there are very few of these. But what I will say is: We generally are doing epidemiologic investigations, and for the most part, we are finding that they all have some epidemiologic link to either a known case or a known exposure. So we’re following those very carefully and one by one, really, in terms of epidemiologic links.
MR. FENTON: Kevin.
MR. MUNOZ: Let’s go to Madison Muller of Bloomberg.
Q Hi. Yeah, I was wondering if you could say a bit more about the second shots and people not coming back for second shots. Is that because people are choosing not to come back? Is that because states, you know, until now didn’t have the — have enough supply to administer those second shots? I was just wondering if you could provide more detail there. Thanks.
MR. FENTON: Dr. Walensky, do you want to take that one?
DR. WALENSKY: Yeah, I can start and say we’re just getting our first window into vaccine administration in general and — and these second shots. We have some jurisdictions that have been more vigorous in terms of getting those second shots out. As you probably recall, some of our jurisdictions were using delayed second shots as a dose-sparing mechanism. We’ve encouraged — now that there are plenty of doses out there, as a Administer O’Connell noted, that that is no longer necessary. And so we’re anticipating that people will come back for those second shots. So more to come on that.
But I think one of the benefits now of having ample vaccine out there is that we have ample opportunity to administer not just first shots, but also these second shots.
MR. FENTON: Thank you, Kevin. Next question.
MR. MUNOZ: Let’s go to Jacqueline Howard at CNN.
Q Thanks for taking my question. We understand that in Charlotte, North Carolina, when there were vaccination efforts at the Pride festival there, we understand that about 540 doses of the 2,000 doses were allocated. So, looking forward, are there plans in other locations — like in Atlanta, New Orleans, and others — to make an effort to administer more of the allocated doses during large events? And what are those plans to ensure that more doses are used during these efforts at the large events and during this type of outreach? Thank you.
MR. FENTON: Yeah, we’re definitely looking at events that expand our ability to, through equity, reach not only at-risk populations but focus on certain demographics and — through some of those events. I mentioned the events in Atlanta; Southern Decadence, down in New Orleans.
Let me go ahead and ask Dr. Daskalakis to add some other events that we’re working on, along with CDC, to bring additional vaccine and, more importantly, public education outreach too.
DR. DASKALAKIS: Sure, I’ll start, and then I’ll hand it off to Dr. Walensky as well, just to say that, you know, this is one of the reasons that this is a pilot — to actually, you know, make sure that we’re doing it on the ground in a way that makes great sense.
And I also like to say, as I said before, that, really, public health is a local experience, and we’re really providing — and I think Dr. Walensky can speak more — a lot of technical assistance, and then the local jurisdiction is actually optimizing how they’re delivering, because they actually know their people really well and know their organizations, as well as their events.
So I think, you know, as we go further with more events and we’re getting — hearing more and more events that are coming through jurisdictions, you know, it’s going to get more and more fine-tuned, which is, again, one of the reasons that this is such a great pilot.
DR. WALENSKY: Yeah, maybe I’ll just turn it back and say, you know, we got — because of this pilot, we got 540 people who would otherwise potentially not have been vaccinated, vaccinated; probably reaching a very diverse community. And so, I would consider that a win.
Again, we have more to learn. But also to say that, you know, the vaccine administration is just one marker of the impact that we had at that event and the education and information that we were able to share at that event, I think, should not be overlooked.
So, I think we had a — what I would call a pretty successful first pilot, and looking forward to lessons learned from that pilot and how we can expand and extend in future — future events.
MR. FENTON: Go back to Kevin for next question.
MR. MUNOZ: All right. Let’s go to Julie at Reuters.
Q Hey, can you hear me? Thanks for taking my call.
MR. FENTON: Yeah.
Q So, I have a — the question I have is, you know, basically on the comment that you had some providers reporting that, on the intradermal vaccine, they were getting four and a half to five doses per vial. I’ve actually heard from several sources that they’re getting three to four doses per vial, including the Washington State briefing just yesterday, where they said exactly that — they’re getting three to four doses. And some people are saying one of the issues is that they don’t have the proper syringes that would allow them to get those.
If that — if you’re finding that they’re not actually getting five doses per vial, would — would you consider — first of all, is that happening, and would you considering readjusting your estimates on the number of doses that will be available?
MR. FENTON: Yeah, so let me start with Dr. Walensky, and then we’ll go to Dr. Daskalakis.
DR. WALENSKY: Yeah, great. Thank you for that question. So, we have said that these vials may contain up to five doses. I do want to be clear that we recognize that not all vials will — will — providers be able to get five doses out of — as you know, three may be some possibility.
We also recognize that, in some situations, they may be only able to use a single dose from a vial, either because it’s administered to a child or to somebody who has a keloid reaction from sub-Q dosing. So, we have built in a buffer as we’ve been allocating and distributing to rest assured that people who are getting the doses that they need without anticipating that every single one is going to get five doses of a vial.
DR. DASKALAKIS: And I’ll just add that the feedback is actually always very important. And we’re really trying to shift the thinking away from how many vaccines can you pull out of the vial, but how many arms can you vaccinate. Because that’s going to give us a lot more information. And so, getting the information from jurisdictions, some of the administration data you’re seeing for the first time online today, that data is going to be really helpful for us to understand what’s happening on the ground.
So, with studies having been done that to up to five could be drawn out of the vials, it’s important to know what’s happening in the real world.
And I’ll also add, and I think maybe I’ll send it back to Bob as well or to Dawn, that, in terms of the vials compared to doses, jurisdictions are experiencing a higher number of vaccines that they’re able to give in arms based on the number of vials that they’ve gotten as well.
So, regardless of how many they pulled because of that buffer, it’s still a net increase in doses.
I’m not sure if Bob or Dawn want to comment too.
MS. O’CONNELL: If I can just add one more piece to this — you know, the most important thing to us is getting these vaccines out and into arms, as Demetre just mentioned. If a state comes to us and says they have used 85 percent of their supply, they are able to order the next bit. We are not in the business of holding vaccines back if people need them.
If jurisdictions are using them, if they’re getting out, whether it’s three, four, five per vial, if they’ve used 85 percent of what we’ve given them, they’re — they can come back and get more. And that’s really important to us that we can continue to move these vaccines to those that need them most.
MR. FENTON: Yeah, I think that’s the key part, is the vaccine is available. We want to administer as much vaccine as we can to reach the most at-risk population. While we want to optimize each vial of vaccine — and as I said in my opening, I talk to Washington, D.C., this week, and they were getting 4.5 to 5. I talked to a number of other jurisdictions.
For those that are having difficulty, we’re working with them and providing resources to help them optimize that. But the key is, many more doses are available now than would have been available, and we’re reaching much more of the at-risk population.
Let’s go back to Kevin for another question.
MR. MUNOZ: Let’s do our last question. Let’s go to Arielle Mitropoulos at ABC News.
Q — from some local —
MR. MUNOZ: Arielle, you cut out. If you could restart your question.
Q Could — can you hear me?
MR. FENTON: Yeah, now we hear you. Go ahead.
Q Great. So, with the intradermal approach, we’ve heard from some local officials who say that the technique may be more painful or uncomfortable, and it can scar. Are you guys at all concerned that this may dissuade people from getting the vaccine? And if so, how do you plan to address that with your messaging?
MR. FENTON: Yeah, so let me start off with Dr. Daskalakis, who’s actually administered the intradermal approach, and talk about. Then I’m going to go to Dr. Walensky and see if she wants to add anything.
DR. DASKALAKIS: So, I’ll start by saying, looking at the studies, the intradermal route actually may have more redness and itching but tends to have less pain. In terms of the scarring issue, I think specifically individuals who have a history of keloid, that’s something that’s very specifically concerning, but less concerning among others.
So, I think what we’re doing is making sure that jurisdictions are armed with the right information as well as other trusted messengers to make sure that they get the word out. And I think that the desire for protection here, I think, is going to be important to overwhelm some of the concern for the local reactions, which when compared to the subcutaneous is fairly equivalent.
Dr. Walensky, I’m not sure if you have something to add.
DR. WALENSKY: Nothing to add there. Thanks.
DR. DASKALAKIS: Got it. Okay. Thank you.
MR. FENTON: Well, thank you. This concludes our program today. Have a great weekend.
2:55 P.M. EDT