A President Biden and his entire administration. Tonight todays announcements reinforce our whole approach to government and accelerating our response. You will hear from fda commissioner, the cdc director, and myself. Next to me we have the deputy coordinator of the white house monkeypox response and dr. Peter marx from fda and the hhs assistant secretary for preparedness response here to answer some questions. With that, i will turn it over to secretary becerra. Thanks very much. Let me begin with what up before. Every american should take epoque seriously, and every american must do their part to help us combat monkeypox. On may 18, the first case of monkeypox was reported in the u. S. Today we have some in on hundred cases that have been reported. 8900 cases reported. Within two days, we began to ship out vaccines to the states ever asking for help. Today we have made more than 1. 1 million Vaccine Doses Available throughout the country and we have delivered more than 620 thousand of those doses. We have also deployed more than 15,000 courses and increase the countries capacity to administer tests on a weekly basis. Last week i declared a Public Health emergency to address the monkeypox outbreak. Today take another important step. I have exercise my authority under section 564 of the food drug and cosmetic act to allow the fda to take further measures to safely increase the ability to produce vaccine to prevent monkeypox. We will hear greater detail on the issuance of the emergency use authorization and what the action means for patients, fighters, and states and jurisdictions. This is very welcome news in our fight against monkeypox. Todays action will boost and strengthen our response further. It safely accelerates and multiplies our supplies of effective vaccine by up to five fold. Todays action also reaffirms hhs and this administrations 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 kim. Since the earliest days of the outbreak, the fda has been fully combated to combating the outbreak fully committed to combating the outbreak on multiple fronts. 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 and the availability of our current vaccine supply, the agency began exploring viable scientific options that would allow to greater access to the currently available vaccine. After conversations over the past several days with key federal partners, the Infectious Disease community, today the fda has issued an emergency use authorization allowing Healthcare Providers to use an alternative dosing regimen of the vaccine. This will increase the total number of doses available for use by up to five fold. It also allows for use of the vaccine in individuals younger than 18 years of age. Determined to be at higher risk of monkeypox infection. In these individuals, the vaccine 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, one for that the current vaccine dose 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 receive the vaccine intradermally received a lower volume, 1 5, that individuals who received the vaccine subcutaneously. The results of this study demonstrate that Intradermal Administration produces similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way. While the study which was published in the peerreviewed journal on 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, it has been tested in individuals with immuno compromising conditions and has been found to be safe and effective in the trials that were performed that support approval. In granting a temporary unapproved use of an improved 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 will continue to work with 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 vaccine, consider getting your first dose immediately. With that, i will turn it over to bob. What the doctor just laid out is a game changer when it comes to our response and our ability to get ahead of the virus. It is safe, it is effective, and it will significantly scale the volume of Vaccine Doses Available across the country. As secretary becerra mentioned, we distributed over 670,000 vials of vaccine across the country and we have 400,000 vials that have been allocated to jurisdictions, ready to be ordered when jurisdictions use 90 of the current supply. With this announcement, those 400,000 vials have the potential to provide up to 2 million doses to americans. We encourage jurisdictions to utilize alternative dosing methods as quickly as possible and will be your partner in this step, every step of the way. By Intradermal Administration of vaccine, while it has been used for tests, we know that some Health Care Professionals and providers way not be as familiar with Intradermal Administration. Thats why cdc has launched a robust outreach, training, and education plan. Starting today, to support a transition to Intradermal Administration of vaccine. You will hear the doctor speak in more detail about this shortly. Our goal is to get jurisdictions , Health Care Providers, and the public informed about this alternative approach. And get it put into practice so we can give 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 todays announcements. To make sure that jurisdictions have sufficient vaccine supply to meet demand, and also make sure that jurisdictions are not 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 150,000 bonds of vaccine, now totaling 750 thousand 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 apply on top of what we currently have. As i said in todays announcement, this marks a significant acceleration in our efforts to make more vaccines widely available to at risk immunities. And we look forward to working with jurisdictions, and individuals on the ground to help quickly adopt the intradermal dosing approach. Now i will turn it over to dr. Walensky to provide more detail on the outreach for Intradermal Administration of vaccine. Thank you, and good afternoon. We are excited to support the strategy to make more monkeypox Vaccines Available to those who need them now. I like to briefly share how cdc will provide resources and education to Health Care Providers and the community on this new vaccine strategy. The strategy would change the method of administration for the 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 Health Care Providers may not be as familiar with Intradermal Administration, where you live or 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 provide information and materials to vaccine providers to help ensure the new strategy can be implement it quickly and as seamlessly as possible. Today fda will post clinical considerations, 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. Cdcs interim clinical considerations provide guidance for the use of this 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 Administration schedule and dosing regimen, dosing intervals, contraindications and precautions as well as preand post vaccine counseling. Cbc will also conduct a series of webinars and training seminars to educate on how to properly administer the vaccine. Our outreach and education will build upon the indepth, close communication with clinicians and Public Health partners cdc has had throughout this outbreak. Since the start of the monkeypox outbreak, cdc has posted three clinician outreach and Community Activity calls, with 600010,000 participants on each call which within shared over 64 64,000 subscribers and 100 partners comprised of natural national, medical and Public Health organizations. Weve distributed notices on monkeypox to more than one 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 weve 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 Health Care Provider or Public Health professional can sign up for Health Alerts and clinical updates from cdc, and i encourage all of our Health Colleagues to visit the cdc monkeypox webpage for the latest. With that, lets get to some questions. We have time for a few questions this afternoon. Lets keep each question to one question. I was wondering if you could provide more information about why youre still using the subcutaneous approach in children instead of switching to the other strategy there. Let me start with going to fda commissioner and the cdc director i think our best to answer those questions. In the childhood situation, its 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. Dr. Marx has just finished doing the paperwork an excessive amount of documentation to make sure we had everything right here. First of all, we want to make sure we get it right, we dont have the data and children that we have in adults, and though im not a pediatrician, i have treated pediatric patients at times. We have had to give the vaccine to the youngest of children and is just giving an intradermal injection to a baby is a little more challenging at times. So from an operational perspective, this is just a more familiar and simpler thing to do. I dont have anything to add, thanks. Next question. Thank you very much for taking my question. Up until now, it has been critical that the rollout of vaccine be accompanied with a study of how well it is actually working. I think that has notched up even further today with the news that youre 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 advantageous. First of all, i want to point out there is no traditional assessment of this vaccine. As you know, it is approved for emergency purposes based on the immunologist goal immunological response. There were not smallpox cases and the monkeypox a race before this were not large enough to do a Clinical Trial. So the immunologic response was the intradermal approach, is exactly the same as with the subcutaneous. Nevertheless, in either case, we want to collect outcome data as we do with all vaccines. I would also point out that the nih will be mounting a Clinical Trial and is working through the logistics of that now. I know that both peter and rachelle have been involved in that planning. If i might add, and thank you for that question, helen. We knew as sunnis these vaccines rolled out, in the absence of clinical data, that would we knew as soon as the vaccines rolled out that would be the next question about how effectively they are working. We will identify data from various locales, populations and time points. Of course these proposed projects will include some new studies as well as leverage some of the existing platforms and relationships, some of which we used during covid, of course. We have some initial estimates of vaccine effectiveness and 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 that an investigation in washington dc to prospectively evaluate infections among some people who have been seeking vaccination. We have also been conducting a data call to jurisdictions to help us assess the population level vaccination trends, 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, but avoiding skin to skin contact including intimate contact with someone who has monkeypox because we dont yet know how well the vaccines work. Thank you. Thanks, next question from the washington post. To follow up on one point, you just said that people should continue taking steps to protect themselves after getting vaccinated. They got she released on friday about limiting sexual partners encourages people to limit their sexual partners until their second dose. Isnt there a contradiction there . We have guidance that decreases your risk and decreasing the risk occurs both both with vaccination as well as reducing 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. And to add, as dr. Walensky said, prevention for all the boxes multidomain. As people are working to get vaccine, and as you said, a game changer of increased supply 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 the guidances nice and clear and it gives people a framework to reduce harm and potentially prevent exposure to monkeypox. And if we can get a word about the immunologic response, because there has been a lot of time spence spent studying the available data on that and i think it is important for people to hear. Theres a lot that has been said about the response after the first dose of the jynneos vaccine, and was one does get response after the first dose, but that response is not a complete response that one gets come of the kind of higherlevel response that one gets when one has had a second dose at 28 days. The way the studies were done to actually look at protections 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. So we feel pretty strongly that the two doses are necessary, in part because we simply dont have any evidence out three months later after a single dose to know if people will be adequately protected, and we dont want to give people a false sense of security if the resume activities that they had put a pause on because they erroneously think they are protected. Thanks. Next question from abc news. Thank you for taking my question. The first question i have is just a numbers question, if you can clarify the terms of either people or doses, what we now have available with this new method, once you subtract the doses that are already shipped out and gone into arms, how many we expect to now go out this way and how far that will stretch. Second question is, a lot of people in the infected community are reprehensible of this new approach. How can you assure them they are being given the same amount of scientific Due Diligence with this new method . Lets go to the assistant secretary for preparedness and response to talk about our current vaccine supply and what this provides. I appreciate the question and we are grateful for this announcement today which sees us expand our available supply. We have made 1. 1 million doses available under the current one vial one dose calculation, as bob mentioned. We now in moving to the this requires a little public map. We made 1. 1 million available, we put out over 600,000 under the current strategy. That so that leaves us about let me not try to do public math, and let me get an answer to you to be sure weve got it exactly right against the basic numbers that have gone out, even as recently as today. So we will be right back. Thanks. Ill 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 are 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. Marx really led the charge on doing that, so i will let him speak to it, but it will be publicly available and you will see the immunologic response is super imposable with the two intradermal doses versus the subcutaneous dose. The only thing i want to add is for those who might think that giving a modified vaccine is something new by the intradermal route, it is not at all new. In fact, the reason it is part of this equation comes from the fact that in germany the vaccine was given intradermally originally in an effort to replicate the original version of the smallpox vaccine. It has been given to thousands of people intradermally. So this isnt the first time, it is obviously a little different here. We have a vaccine that is being used for smallpox and monkeypox. Just so you understand, we look at the totality of the available Scientific Evidence and bring that together to try to do the best buy Public Health. And if i can just add, we have heard a calling from numerous jurisdictions that have been talking that using a dose sparing regimen by only using one dose. As dr. Marx indicated, there are not data to do so and if anything there are data saying that is not protective enough. So by using this alternative strategy of intradermal dosing, and idling do we have more doses but we actually allow people to get to doses in a way that shows immunologic response that is 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. One last point to put the exclamation point on all this. With our state and local and as we try to track how many vaccines have gone out and how many have been administered and to whom, it will be really important that we know we have a greater number of Vaccines Available, it will be very important to make sure that our partners are staying in touch with us so we can make the best decisions on the allocation of these vaccines. Thank you, mr. Secretary. Now we will talk about the second question a little bit. Historically, the population that is being overrepresented, gay, bisexual and men who have sex with other men, 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. Just given the history i imagine that being clear with that in making sure that our local department of Health Message this correctly, i think were going to see that we will likely still have more vaccines before we run out of arms. Just to end with the first question you asked, there is a little bit over 400,000 doses remaining. You would multiply that by five, meaning that now 2 million doses are available to be utilized, so we will work with the jurisdictions as we get to 90 usage, go ahead and provide additional vaccines based on the original allocation provided and then in addition to that, i had talked about we would continue with the purchase of 5 million doses, which would then give us 25 million. 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 dosage strategy, we will provide that information to you. We got the latest numbers in, 441,000, so over 2. 2 million under the new administration, i just wanted to confirm those numbers, hot off the presses. I know it is dynamic and things are moving each day, so i appreciate you getting the latest. We have time for a couple more questions. 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, we are seeing more being confirmed, and is there any concern about additional pediatric affects now that school will be back in session. I can say that the question is the authorization for those under age 18, because over the past week there has been an uptick in exposure, potential exposures of children to those who mightve been infected with monkeypox, and because of that, this is a much more facile way of getting those children vaccinated. It makes it a lot easier for the providers, and we feel very comfortable with the safety of the approach. Dr. Walensky from cdc, do you want to add to that . I will just say that still now, having cases or even exposures in children is relatively rare. We investigate those and we want to make sure they have vaccine available to them, 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 in the more affected community. Last question from cbs news. Can you hear me . Thanks for taking my question. Just following up about the jurisdictions that are already doing that first dose strategy, what does this new authorization mean for people who got the first dose but essentially missed their second . And separately, can you clarify what is expected to change about eligibility of this vaccine now that we have more supply . Thank you. New we want to start with fda on that . I will answer this pretty quick. If you got your first dose subcutaneous, the second dose can be given intradermally, and that is our recommendation. Just make it simple and straightforward, the immunologic response should be the same. Dr. Walensky may want to talk about the logistics of that. I would just add that for those who have delayed their second dose, we would encourage them now with the resupply to go ahead and get it so that they can have a quicker path to protection. Just commenting on the last question about eligibility, this is potentially also a question for dr. Walensky. Current eligibility remains the same as vaccine supply increases so there is not a change there yet. With that, i want to start at the end where i started, which is, this is a significant priority of not only the president and this administration to make sure that we are working across all government and with all communities to make the whole government process here to make sure that we work as quick as possible to control, contain smallpox in the United States. This team you see here will continue to collectively work and use every resource ava