Press Briefing by White House Monkeypox Response Team and Public Health Officials 8/09/22 Transcript

Bob Fenton: (00:00) 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. Speaker 1: (01:03) 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 18th, the first case of monkeypox was reported in the US. 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. To date, 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. Speaker 1: (02:14) I've exercised my authority under the 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: (03:18) Thank you, Mr. Secretary. Since the 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 ever-changing 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. Dr Califf: (04:20) 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 does 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 demonstrated that intradermal administration produced a similar immune response to subcutaneous administration. Dr Califf: (05:28) Many 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 with 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. Dr Califf: (06:16) 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'll turn it over to Bob. Bob Fenton: (06:35) Thank you, Dr. Califf. What Dr. Califf just laid out is a game changer 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 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% 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. Bob Fenton: (07:32) While intradermal administration of vaccine has been used for tests like the tuberculosis skin tests, we know that some healthcare professionals and providers may not be as familiar with intradermal administration. That's why 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. Bob Fenton: (08:16) 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 a procurement of 5.5 million vials of vaccine, totaling potentially over 25 million doses that we will have in the United States... Bob Fenton: (09:03) Actually 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 CDCs outreach and training plan for intradermal administration and vaccine. Dr. Walensky: (09:38) Thank you. And good afternoon, we are excited to support FDA in the administration and 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. Dr. Walensky: (10:16) 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 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. Dr. Walensky: (11:14) CDCs 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. CDCs interim clinical considerations will also include an overview of both available vaccines, planning considerations for health departments including health equity, vaccine administrations 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. Dr. Walensky: (11:59) 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 in which were then shared to over 64,000 COCA subscribers. And 100 COCA partners comprised of national medical and public health organizations. Dr. Walensky: (12:34) 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 CDCs monkey pox webpage for the latest. Thank you. And I'll now turn things back to you, Mr. Fenton. Bob Fenton: (13:26) Well, thanks Dr. Walensky. With that, let's get to some questions. Kevin, over to you. Kevin: (13:33) Thanks Bob. We have time for a few questions this afternoon. Let's keep each question to one question. Madison Muller at Bloomberg. Madison you're unmuted. Madison Muller: (13:56) Oh, there we go. I was wondering if you could provide some more information about why you are still using the subcutaneous approach in children instead of switching to the dose sparing strategy there. Thank you. Bob Fenton: (14:10) Well, let me start with going to FDA commissioner, Dr. Califf and then CDC director, Dr. Wolinsky I think best to answer those questions. Dr Califf: (14:24) 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. Dr Peter Marks: (14:48) Yeah. 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 in adults, but second of all, as a practicing physician, and though I'm not a pediatrician, I've treated pediatric patients at time. We have had to give this vaccine to the youngest of children and just giving an intradermal injection to 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. Bob Fenton: (15:25) Dr. Walensky CDC, anything you want to add? Dr. Walensky: (15:28) I don't have anything to add. Thanks. Bob Fenton: (15:29) Thank you. Next question. Thanks. Kevin: (15:32) Next question. Let's go to Helen [inaudible 00:15:36] Helen: (15:37) Thank you very much for taking my question. Up until now, it's been critical that the rollout of vaccine be accompanied with study of how well it's actually working. I think 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? Bob Fenton: (16:06) Do we want to start again with FDA Dr. Califf and Dr. Marks? Dr Califf: (16:10) Yes, I, first of all, I want to point out there is no traditional assessment of this vaccine. As you know, as 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 immunological response with the intradermal approach is exactly the same as with the subcu. 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: (17:00) 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 would of course be the next question as how well they're working. So we've been developing a portfolio of vaccine effectiveness projects that we will identify data from various locals, 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 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, DC, 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- Dr. Walensky: (18:02) Altered 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. Thank you. Speaker 2: (18:43) Thanks. Next question. Let's go to Fennett at the Washington Post. Fennett: (18:50) Hi, can you hear me? Dr. Doskalakas: (18:51) Yes. Dr. Caleb: (18:51) Yep. Fennett: (18:53) 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 there a contradiction there? Dr. Walensky: (19:16) We have guidance that 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. Dr. Caleb: (19:34) Also, I'd like to go over Dr. Doskalakas, the deputy coordinator, to speak to that too, please. Dr. Doskalakas: (19:41) Great. Thank you. And to add, I think as Dr. Walensky said, really prevention from monkeypox is multi domain. And so as people are working to get vaccine, and with this really, as you said, game changer of increased supply of vaccine, 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. Caleb: (20:14) 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 Peter Marks: (20:26) Yeah, thanks very much Dr. Caleb. So there's a lot 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 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. Dr. Doskalakas: (21:41) Thanks. Dr. Caleb: (21:41) Thanks. Speaker 2: (21:42) Next question. Let's go to Cheyenne Haslet at ABC News. Cheyenne Haslet: (21:47) 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. Cheyenne Haslet: (22:11) 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? Fennett: (22:25) So let's first start off with going to Asper, assistant secretary for preparedness and response Donald O'Connell to talk about our current vaccine supply and what this provides. Dawn O'Connell: (22:38) Thanks so much, really appreciate the question. And we're just grateful for this announcement today, which sees us expand our available supply. Dawn O'Connell: (22:46) 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 over 600,000 under the current strategy. So that leaves us about 500 ... Well, 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: (23:29) Bob. I might comment on the strength of the data, and just make the point, there has 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. So the data was actually available, and we were able to talk with the investigators. Dr. Marks really led to charge on doing that. So I'll let him speak to it, but it will be publicly available, the basis. And you'll see that the immunologic response, it's super imposable with the two intradermal doses at that dose versus the subcutaneous dose. Dr Peter Marks: (24:13) Yeah. Thanks, Dr. [inaudible 00:24:15]. The only thing I want to add is that just for those who might think that giving this particular vaccine, modified vaccinia ankara is something new that by the intradermal root. It's not at all new. In fact, the reason why the Bavaria 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: (25:06) 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 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 super imposable 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 Becemba: (25:46) 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, 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. Over. Dr. Caleb: (26:19) Thank you, Mr. Secretary. I'd like to turn it over to Dr. Doskalakas to talk about the second question a little bit. Dr. Doskalakas: (26:26) And 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 of demonstrated significant confidence in vaccine, with COVID vaccination rates that are well over 90%. 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 messaged this correctly, I think we're going to see that we will likely still run out of vaccines before we run out- Dr. Doskalakas: (27:03) I think we're going to see that we will likely still run out of vaccines before we run out of arms. Bob Fenton: (27:06) 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, would multiply that by five, meaning that now 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% 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 new dosing strategy, we will provide that information to you. With that- Dawn O'Connell: (28:08) And, Bob, can I track real quick? Bob Fenton: (28:10) Yeah. Dawn O'Connell: (28:10) You just say we got the latest numbers in from the SNS. So 441,000, as you said in the SNS. So over 2.2 million under the new administration round. So just wanted to confirm those numbers with you, straight hot off the presses. Bob Fenton: (28:22) Yeah, appreciate that, Dawn. I know it's dynamic and things are moving each day, so I appreciate getting the latest. Next question. Speaker 3: (28:29) Thanks. We have time for a couple more questions. Let's go to Don Kapecki at NBC News. Speaker 4: (28:41) 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 a few pediatric cases have been confirmed. Are we seeing more? How many have been confirmed, and is there any concern about additional pediatric infections heading into the fall when school's back in session? Thank you. Bob Fenton: (29:09) So do we want to start off an FDA with Dr. [inaudible 00:29:15] Marks and then over to CDC? Dr Peter Marks: (29:19) This is Peter Marks. I can at least say that we, I think the question ... The [inaudible 00:29:25] 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. Bob Fenton: (30:04) Dr. Walensky from CDC. Do you want to add to that? Dr. Walensky: (30:07) Yeah, I will just say that still now, 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. Mark 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 affected community. Speaker 3: (30:41) Thanks. Last question. Let's go to Alex [inaudible 00:30:44] at CBS news. Speaker 5: (30:54) Hi, can you hear me? Bob Fenton: (30:56) Yeah. Speaker 5: (30:56) 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 sub q, but has essentially missed 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 [inaudible 00:31:21] now that we have more supply? Thanks so much. Bob Fenton: (31:26) Thank you. Do we want to start with FDA on that? Dr Califf: (31:32) Sure. I think that main answers pretty quick. If you got your first dose sub q, the second dose can be given intradermally and that's our recommendation. And just make it simpler and straightforward. As we said, the immunological response should be the same. Dr. Walensky may want to talk about the logistics of that. Dr. Walensky: (31:53) 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 could have a quicker path to protection. Bob Fenton: (32:09) All right. Thanks. Anything, Doctor, that you want to add, Dr. Doskalakas: (32:13) Just commenting on the last question about eligibility. I think that, and 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. Bob Fenton: (32:32) So with that, want to end where I started, which was 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 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.