Via Teleconference August 11
MR. FENTON: Hi, I'm Bob Fenton, the White House National Response Coordinator for monkeypox. And welcome to the White House National Monkeypox Response Briefing.
Today, the Biden-Harris administration is making key announcements in our fight to combat the monkeypox outbreak and protect communities most at risk.
This has been a top priority of President Biden and the entire administration. And today's announcements reinforce our whole-of-government approach to scaling and accelerating our response.
You'll hear today from HHS Secretary Becerra, FDA Commissioner Califf, CDC Director Walensky, and myself. We also have next to me Dr. Demetre Daskalakis, Deputy Coordinator of the White House Monkeypox Response; and Dr. Peter Marks from FDA; and Dawn O'Connell, HHS Assistant Secretary for Preparedness and Response here to answer some questions.
With that, I'll turn it over to Secretary Becerra.
SECRETARY BECERRA: Well, thanks very much. Let me begin with what I've said before: Every American should take monkeypox seriously, and every American must do their part to help us beat back monkeypox.
On May 18, the first case of monkeypox was reported in the U.S. Today, we have some 8,900 cases that have been reported.
At the time that that first case was reported, within two days, we at HHS began to ship out vaccines to the various states that were asking for help. Today we've made more than 1.1 million vaccine doses available throughout the country, and we've delivered more than 620,000 of those doses. We've also deployed more than 15,000 courses of the TPOXX treatment and have increased the country's capacity to administer tests on a weekly basis to some 80,000.
Last week, I declared a public health emergency to address the monkeypox outbreak. Today, we take another important step. I've exercised my authority under Section 564 of the Food, Drug, and Cosmetic Act to allow the FDA to take further measures to safely increase the availability of vaccines to prevent monkeypox.
Dr. Califf, the FDA Commissioner, will go into greater detail on FDA's issuance of an emergency use authorization for the Jynneos vaccine and what today's FDA action means for patients, providers, and states and jurisdictions.
This is very welcome news in our fight against monkeypox.
Today's action will boost and strengthen our response further. It safely accelerates and multiplies our supply of effective vaccines by up to fivefold.
Today's action also reaffirms HHS and this administration's commitment to using all available resources and capabilities to end the monkeypox outbreak and provide the best possible care to those suffering from the virus.
So, with that, let me now turn it over to Commissioner Califf.
DR. CALIFF: Thank you, Mr. Secretary. Since the early days - earliest days of the outbreak, the FDA has been fully committed to combating the outbreak on multiple fronts, working closely with our federal public health partners to ensure the availability of medical countermeasures.
Today is the latest example of all components of the federal government coming together to address an everchanging and evolving outbreak.
As I noted last week, given the continued spread of the monkeypox virus at a rate outpacing the availability of our current vaccine supply, the agency began exploring viable scientific options that would allow for greater access to the currently available vaccine.
After conversations over the past several days with key federal partners, the infectious disease community, and Bavarian Nordic, today the FDA has issued an emergency use authorization - or EUA - allowing healthcare providers to use an alternative dosing regimen of the Jynneos vaccine. This will increase the total number of doses available for use by up to fivefold.
The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection. In these individuals, Jynneos is administered by subcutaneous injection.
As many of you saw, last week, the FDA and CDC were able to quickly adapt and address the needs of dozens of young children following a monkeypox exposure at a childcare facility in Illinois.
As part of the alternative approach under the EUA, one fifth of the current vaccine doses would be administered intradermally, rather than subcutaneously, as the vaccine was originally approved.
Data from a clinical study of the vaccine published prior to its approval in 2019 evaluated a two-dose series given intradermally compared to subcutaneously.
Individuals who received the vaccine intradermally received a lower volume - one fifth - than individuals who received the vaccine subcutaneously.
The results of this study demonstrate that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way.
While the study, which is published in a peer-reviewed journal, found that intradermal administration resulted in some mild to moderate side effects like redness, firmness, itchiness, and swelling at the injection site, these were all manageable.
Additionally, Jynneos has been tested in individuals who have immunocompromising conditions and has been found to be safe and effective in the trials that were performed to support approval.
In granting a temporary unapproved use of an approved product, the FDA is still ensuring the vaccine meets high standards for safety, effectiveness, and manufacturing quality that the American public has come to expect.
We'll continue to work with the federal public health partners to provide the latest information to impacted communities to make informed decisions to protect themselves.
If you have the opportunity to get the Jynneos vaccine, I urge you to consider getting your first dose immediately.
With that, I will turn it over to Bob.
MR. FENTON: Thank you, Dr. Califf. What Dr. Califf just laid out is a gamechanger when it comes to our response and our ability to get ahead of the virus.
It's safe, it's effective, and it will significantly scale the volume of vaccine doses available for communities across the country.
As Secretary Becerra mentioned, we've distributed over 670,000 vials of vaccine already to jurisdictions across the country.
And we have 400,000 vials in the Strategic National Stockpile that have been allocated to jurisdictions, ready to be ordered when jurisdictions use 90 percent of their current supply.
With today's announcement, those 400,000 vials have the potential to provide up to 2 million doses to Americans.
We encourage jurisdictions to utilize the alternative dosing method as quickly as possible, and we'll be your partner in this step every step of the way.
While intradermal administration of vaccine has been used for tests like the tuberculosis skin test, we know that some healthcare professionals and providers may not be as familiar with intradermal administration.
That's why the CDC is launching a robust outreach, training, and education plan starting today to support a transition to intradermal administration of vaccine.
You'll hear Dr. Walensky speak in more detail about this shortly.
Our goal is to get jurisdictions, healthcare providers, and the public informed about this alternative approach immediately and get it put into practice so we can get more doses out to more individuals faster.
We also will be reviewing the current allocation and distribution timeline for vaccines moving forward in light of today's announcements to make sure that jurisdictions have sufficient vaccine supply to meet demand and also make sure that jurisdictions aren't receiving more vaccine than they can store or use in a given time period.
Across the administration, we will continue our work to accelerate vaccine production and distribution.
Just last week, we announced that 150,000 vials of vaccine - now totaling 750,000 doses - will arrive in the United States in September, two months ahead of schedule. And we will still proceed with the procurement of 5.5 million vials of vaccine, totaling potentially over 25 million doses that we will have in the United States supply on top of what we currently have.
So, as I said in today's announcement, this marks a significant acceleration in our efforts to make more vaccines widely available to at-risk communities. And we look forward to working with jurisdictions, providers, and individuals on the ground to help quickly adopt the intradermal dosing approach.
Now I'll turn it over to Dr. Walensky to provide more detail on the CDC's outreach and training plan for intradermal administration of vaccine.
DR. WALENSKY: Thank you, and good afternoon. We are excited to support FDA and the administration in this strategy to make more monkeypox vaccine doses available to those who need them now.
I'd like to briefly share how CDC will be providing resources and education to healthcare providers, public health workers, and the community on this new vaccine strategy.
As Dr. Califf described, this strategy would change the method of administration for the Jynneos vaccine from subcutaneous to intradermal to allow vaccine providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses. Intradermal injections are often used for TB skin tests and have been used for other types of vaccines before.
Some healthcare providers may not be as familiar with intradermal administration, where you deliver the vaccine into the layer of skin just underneath the top layer, compared to the more traditional subcutaneous administration, which goes into the fat layer underneath the skin.
For this reason, CDC will be providing information and educational materials to vaccine providers to help ensure this new strategy can be implemented quickly and as seamlessly as possible.
Today, FDA [CDC] will post interim clinical considerations, distribute a clinician alert message, present this vaccine administration strategy to the Association of State and Territorial Health Officials, conduct outreach to key clinician partners, and post an educational resource video on this new monkeypox vaccine administration strategy.
CDC's interim clinical considerations provide guidance for the use of the Jynneos vaccine as an intradermal regimen for adults, as well as the standard, or subcutaneous, regimen for children.
CDC's interim clinical considerations will also include an overview of both available vaccines; planning considerations for health departments, including health equity; vaccine administration, schedule and dosing regimens, dosing intervals, contraindications and precautions; as well as pre- and post-vaccination counseling.
CDC will also be conducting a series of webinars and training opportunities to educate clinicians on how to appropriately administer the Jynneos vaccine.
Our outreach and education will build upon the in-depth, close communication with clinicians and public health partners CDC has had throughout this outbreak.
Since the start of the monkeypox outbreak, CDC has hosted three "COCA" calls - or Clinician Outreach and Community Activity calls - with 6,000 to 10,000 participants on each call and which were then shared with over 64,000 COCA subscribers and 100 COCA partners comprised of national medical and public health organizations.
We've distributed four Health Alert Network notices on monkeypox to more than 1 million recipients, including public information officers, federal, state, territorial, tribal, and local public health practitioners, clinicians, public health laboratories and members of the media.
And we've held over 15 webinars and listening sessions with key medical associations and community partners.
We will continue to communicate through these and other outreach channels, and we certainly welcome any thoughts on who and how our outreach could reach more and different communities in need.
Any healthcare provider or public health professional can sign up for our health alerts and clinical updates from CDC, and I encourage all of our health colleagues to visit CDC's monkeypox webpage for the latest.
Thank you, and I will now turn it back to, Mr. Fenton.
MR. FENTON: Well, thanks, Dr. Walensky. With that, let's get to some questions. Kevin, over to you.
MR. MUNOZ: Thanks, Bob. We have time for a few questions this afternoon. Let's keep each question one question. Madison Muller at Bloomberg.
Madison, you're unmuted.
Q Oh, there we go. I was wondering if you could provide some more information about why you're still using the subcutaneous approach in children instead of switching to the dose sparing strategy there. Thank you.
MR. FENTON: Well, let me start with going to FDA commissioner, Dr. Califf, and then CDC director, Dr. Walensky, I think, best to answer those questions.
DR. CALIFF: Yes. You know, in the childhood situation, it's a bit different than the way the vaccine was initially tested. And it was felt this was going to be the most convenient and familiar for that population.
I'll ask Dr. Marks to make a comment on it, because he's just finished doing the paperwork - quite an extensive amount of documentation - needed to make sure that we had everything right here.
MR. MARKS: So, thanks, Dr. Califf. I think, first of all, we want to make sure we get it right. And we don't have the data in children that we have an adults.
But second of all, as a practicing physician - and though I'm not a pediatrician, I've treated pediatric patients at times - we have had to give this vaccine to the youngest of children. And it's just giving an intradermal injection to the - a baby is actually just a little more challenging at times.
And so, this - I think, from an operational perspective, this is just the more familiar and simpler thing to do.
MR. FENTON: Dr. Walensky, at CDC, anything you wanted to add?
DR. WALENSKY: I don't have anything to add. Thanks.
MR. FENTON: Thanks. Next question.
MR. MUNOZ: Thanks. Next question. Let's go to Helen Branswell at Stat News.
Q Thank you very much for taking my question. You know, up until now, it's been critical that the rollout of vaccine be accompanied with a study of how well it's actually working. I think, you know, that has notched up even further today with the news that you're going to be using it in an untraditional form.
What steps are being taken to study the rollout to see whether or not it is actually as efficacious?
MR. FENTON: Do we want to start again with FDA, Dr. Califf and Dr. Marks?
DR. CALIFF: Yes. First of all, I want to point out there is no traditional assessment of this vaccine. As you know, it was approved for emergency purposes based on the immunological response, not on clinical outcomes, because there weren't smallpox cases and the monkeypox outbreaks before this were not large enough to really do a clinical trial. And so, the immunologic response with the intradermal approach is exactly the same as with the subq.
Nevertheless, in either case, we'd want to collect outcome data, as we do with all vaccines. And I'd also point out that the NIH will be mounting a clinical trial, and it's working through the logistics of that now.
I know that both Peter and Rochelle have been involved in that planning.
DR. WALENSKY: If I might add, if it's okay - thank you for that question, Helen - CDC is developing - we knew as soon as these vaccines rolled out with - in the absence of clinical data, as Dr. Califf mentioned, that we - that would of course be the next question is how well they're working.
So we've been developing a portfolio of vaccine effectiveness projects that we will identify data from various locales, populations, and time points.
Of course, these proposed projects are going to include some new studies, as well as leverage some of the existing platforms and relationships, some of which we've used during COVID, of course.
We have some initial estimates of vaccine effectiveness that are - we recognize that some of these initial estimates are going to take some time. We have some initial projects that have been underway. For example, in early August, we had a field team that went to help with an investigation in Washington, D.C., to prospectively evaluate infections among some people who have been seeking vaccination.
We've also been conducting a data call to jurisdictions to help us assess the population level vaccination trends in high-burden jurisdictions. Of course, that very much depends on our ability to receive those data voluntarily from those jurisdictions.
But I do want to reiterate that while additional vaccine effectiveness studies are underway, we at CDC are very much recommending that people who get vaccinated continue to take steps to protect themselves from infection, especially if they have only had a single dose, by avoiding close skin-to-skin contact, including intimate contact with somebody who has monkeypox, because we don't yet know how well these vaccines work.
MR. MUNOZ: Thanks, next question. Let's go to Fenit at the Washington Post.
Q Hi, can you hear me?
MR. MUNOZ: Yes.
Q To follow up on Dr. Walensky's point, you just said that people should continue taking steps to protect themselves after getting vaccinated. The guidance you released on Friday about limiting sexual partners encourages people to limit their sexual partners until their second dose. So isn't that a con- - isn't there a contradiction there?
DR. WALENSKY: You know, we have guidance that sort of decreases your risk, and decreasing your risk occurs both with vaccination as well as decreasing your number of sexual partners. Of course, we want to give people choices and to give them the most information possible as they are making informed decisions about their own sexual health.
MR. FENTON: Also, I'd like to go to Dr. Daskalakis, the Deputy Coordinator, to speak to that too, please.
DR. DASKALAKIS: Great, thank you. And to add, I think - as Dr. Walensky said - really, prevention for monkeypox is multi-domain. And so as people are working to get vaccine and with this really, like, as you said, gamechanger of increased supply of vaccines, we really want to give people options and clear guidance of what to do between the first and second dose, and also to be aware that it does take time after the second dose to also achieve adequate protection.
So that guidance is nice and clear. It really gives people a framework to reduce harm and potentially prevent exposure to monkeypox.
DR. CALIFF: Bob, I wonder if we can get Dr. Marks just to say a word about the immunologic response to the first dose, because there has been a lot of time spent studying the available data on that and I think it's very important for people to hear.
DR. MARKS: Yeah, thanks very much, Dr. Califf. So there's a lot of - that's been said about the response after the first dose of the Jynneos vaccine. And one does get a response after the first dose, but that response is not a complete response that one gets - the kind of higher-level response that one gets once one has had a second dose at 28 days.
And the way the studies were done to actually look at protection was originally by comparing with the earlier - the earlier version of the smallpox vaccine, and you needed those two doses to get up to that level of protection.
And so, we feel pretty strongly that the two doses are necessary, in part because we simply don't have any evidence out six, eight, three months later after a single dose to know that people will be adequately protected. And we don't want to give people a false sense of security if they resume activities that they had put a pause on because they erroneously think that they're protected.
MR. MUNOZ: Thanks. Next question, let's go to Cheyenne Haslett at ABC News.
Q Hi, thank you for taking my question. The first question that I have is just a numbers question. If you can clarify to us, in terms of either people or doses, what we now have available with this new method once you subtract the doses that have already shipped out and gone into arms, how many we expect to now go out this way and how far that will stretch.
And my second question is: A lot of people in the affected community are apprehensive of this new approach. We've already seen some criticism. So how can you assure them that they're being given the same amount of scientific due diligence with this new method?
MR. FENTON: So, let's first start off with going to ASPR - Assistant Secretary for Preparedness and Response - Dawn O'Connell to talk about our current vaccine supply and what this provides.
MS. O'CONNELL: Thanks so much. Really appreciate the question. And we're, you know, just grateful for this announcement today, which sees us expand our supply - available supply.
So, we've made 1.1 million doses available under the current one-vial, one-dose calculation. As Bob mentioned, we now, in moving to the - now, this is going to require a little bit of public math, I think. So, we've made 1.1 million available. We've put out 600 - over 600,000 under the current strategy. So that leaves us about 500 - well, why don't we - let me not try to do public math, and let me get an answer to you to be sure that we've got this exactly right against the basic numbers that have gone out, even as recently as today.
So, we'll be right back. Thanks.
DR. CALIFF: Bob, I might comment on the - on the strength of the data and just make the point - I mean, there's been a lot of midnight oil burned over the last few days. Because one advantage we had is that study that we're using was submitted with the data for the approval. It was - so the data was actually available, and we were able to talk with the investigators.
Dr. Marks really led the charge on doing that, so I'll let him speak to it. But I - it will be publicly available - the basis. And you'll see that the immunologic response is - it's superimposable with the two intradermal doses at that dose versus a subcutaneous dose.
DR. MARKS: Yeah. So, thanks, Dr. Califf.
The only thing I want to add is that just for those who might think that giving this particular vaccine (inaudible) is something new that - by the intradermal root. It's not at all new.
In fact, the reason why - the Bavarian part of this equation comes from the fact that, in Germany, this vaccine was given intradermally originally in an effort to replicate the original version of the smallpox vaccine. And it's been given to thousands of people intradermally.
So, this isn't the first time it's been done. It's obviously a little different here. We have a vaccine that's being used for smallpox and monkeypox. But just so you understand, we look at the totality of the available scientific evidence, and we bring that together to try to do the best by public health.
DR. WALENSKY: And maybe if I can just add: We have heard a calling from numerous jurisdictions now that have been talking about using a dose-sparing regimen by only using one dose. And as Dr. Marks indicated, there are not data to do so. And in fact, if anything, there are data saying that that is not protective enough.
So by using this alternative strategy of intradermal dosing, not only do we have more doses, but we actually allow people to get two doses in a way that shows immunologic response that's superimposable from the subcutaneous dosing.
So, we have more doses. And, in fact, we have the ability to doubly vaccinate people so that they get the protection that they need.
SECRETARY BECERRA: Bob, if I could add one last point here to just sort of put the exclamation point on all of this: This is where our partnership with our state and local health authority partners, the communities will be very important, because as we try to track how many vaccines have gone out and how many have been administered to whom, it will be really important - now that we know we have a greater number of vaccines that will be available, it'll be very important to make sure that our state and local partners are staying in touch with us so we can make the best decisions on the allocation of these vaccines.
MR. FENTON: Thank you, Mr. Secretary. I'd like to turn it over to Dr. Daskalakis to talk about the second question a little bit.
DR. DASKALAKIS: And just - just one additional thing to add is that, historically, the population that is being overrepresented in this outbreak - gay, bisexual, other men who have sex with men - in recent history have demonstrated significant confidence in vaccine with COVID vaccination rates that are well over 90 percent.
I think that the due diligence done by the FDA looking into the data should assure them that the vaccine is immunologically equivalent and safe.
So just given the history, I imagine that just being clear with that and making sure that our local departments of health message this correctly - I think we're going to see that we will likely still run out of vaccines before we run out of arms.
MR. FENTON: And just to end with the vaccine question, the first question you asked: There's a little bit over 400,000 doses remaining. Underneath this new strategy, you would multiply that by five, meaning that now 2 million doses - up to 2 million doses are available to be utilized.
So we will work, as I said, with the jurisdictions as they get to 90 percent usage, go ahead and provide additional vaccine based on the original allocation provided.
And then, in addition to that is, I had talked about - we had continued with the purchase of 5 million doses, which would then give us 25 million. And we have doses that are starting to come in from that starting in September. So as we get those numbers in September, and what that equates to on the on the new dosing strategy, we will provide that information to you.
With that -
MS. O'CONNELL: Hey, Bob, can I track real quick?
MR. FENTON: Yep. Yep.
MS. O'CONNELL: It just - we got the latest numbers in from the SNS.
MR. FENTON: Oh, good.
MS. O'CONNELL: So 441,000, as you said, in the SNS, so over 2.2 million under the new administration route. So just wanted to confirm those numbers with you straight - hot off the presses.
MR. FENTON: Yeah, I appreciate that, Dawn. I know it's dynamic and things are moving each day, so I appreciate you getting the latest.
MR. MUNOZ: Thanks. We have time for a couple more questions.
Q Yeah, hi. So I have a question about the decision to authorize the shots for people ages 18 and older. I was just wondering what was behind that decision. I know, you know, a few pediatric cases have been confirmed. Are we seeing more? How many have been confirmed? And is there any concern about, you know, additional pediatric infections heading into the fall when school is back in session? Thank you.
MR. FENTON: So do we want to start off in FDA with Dr. Califf or Marks and then over to CDC?
DR. MARKS: This is Peter Marks. I can at least say that we - I think the question - the (inaudible) question - we did the authorization for those under age 18 because, over the past week, there has been an uptick in exposures - potential exposures of children to those who might have been in infected with monkeypox.
And because of that, this is a much more facile way of getting those children vaccinated, makes it a lot easier for the providers. And we feel very comfortable with the safety of the approach.
MR. FENTON: Dr. Walensky from CDC, do you want to add to that?
DR. WALENSKY: Yeah, I will just say that still now we - the - having cases or even exposures in children is relatively rare. We investigate those. We do want to - should they be real exposures, we want to make sure that they have vaccine available to them, as Dr. Marks said.
But again, those are generally pretty rare, and those case investigations are ongoing. But oftentimes, we see them having contact or prior contact with somebody from a more infected community.
MR. MUNOZ: Thanks. Last question, let's go to Alex Tin at CBS News.
Q Hi, can hear me?
MR. FENTON: Yep.
Q Hi, thanks for taking my question. Just following up on what Dr. Walensky mentioned about the jurisdictions that are already doing that first dose-sparing strategy. What does this new authorization mean for people who got that first dose subq but has, you know, essentially miss their second?
And then, separately, Mr. Fenton, following up on what you said, can you clarify what is expected to change about eligibility of this vaccine or ACAM2000 now that we have more supply? Thanks so much.
MR. FENTON: Thank you. Do we want to start with FDA on that?
DR. CALIFF: Sure. I think that - I mean, the answer is pretty quick: We - you know, if you got your first dose subq, the second dose can be given intradermally, and that's our recommendation, and just make it simpler and straightforward. As we said, the immunologic response should be the same.
Dr. Walensky, you might want to talk about the logistics of that.
DR. WALENSKY: Yeah, and I would just add that, for those who have delayed their second dose, we would encourage them, with now an increased supply, to go ahead and get it so that they can have, you know, a quicker path to protection.
MR. FENTON: Alright, thanks. Anything, Doctor, that you want to add?
DR. DASKALAKIS: Just sort of commenting on the last question about eligibility. I think that - this is potentially also a question for Dr. Walensky - that current eligibility remains the same as vaccine supply increases. So I think there's not a change there yet.
MR. FENTON: So, with that, want to start - or end where I started, which was, you know, this is a significant priority of not only the President but this administration to make sure that we're working across all of government and with all communities to make a whole-of-government process here to make sure that we work as quick as possible to control, contain smallpox in the United States.
And this team here, you see, will continue to collectively work and use every resource available to do exactly that.
Thank you, and have a good day.
JOSEPH R. BIDEN JR.
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