Via Teleconference

11:47 A.M. EDT

MR. FENTON:  Good afternoon and thank you for joining today’s briefing.

We continue making strong progress in our fight against the current monkeypox outbreak.

As you’ll hear from Dr. Walensky, cases are down and there is promising, real-world data on the effectiveness of vaccines.

And Dr. Daskalakis will discuss a new announcement on how we’re expanding our reach into the highest-risk communities and getting more individuals vaccinated.

As of today, we have administered over 800,000 shots in arms.  That’s tremendous progress from where we were just a few weeks ago.

This progress is a result of our comprehensive effort to get shots into arms, bring vaccines directly to the impacted, and work closely with community groups and health departments to help reduce risk behaviors.

But let me be clear: We are not done with this fight.  There is still a lot of work to do.  We must continue to reach more of the highest-risk communities, especially Black and brown communities.

We continue to provide vaccine allocations at large Pride events, from Las Vegas to San Francisco, which have proven successful at vaccinating people.

And we’re planning for our longer-term needs.  This afternoon, the U.S. Department of Health and Human Services will release a comprehensive compilation of federally funded monkeypox research.  This is an important step forward to further improve federal research transparency during outbreaks and to better understand the full breadth and spectrum of the U.S. government-supported monkeypox research.

Driving research to strengthen the response has been a priority since the first confirmed monkeypox cases in the United States.

I’ll end with this.  We are encouraged by our progress, but we will continue to do our part to ensure we can fully realize equity so that every individual can gain access to the safe, effective, and free Monkeypox vaccines.

So. with that, I will turn it over to Dr. Walensky.

DR. WALENSKY:  Thank you.  Today, I’d like to share with you the latest updates out of CDC on the current monkeypox outbreak and new preliminary data on how the JYNNEOS vaccine is performing.

As of September 27th, over 66,500 cases have been detected globally in 106 countries.  In the United States, there have been over 25,300 cases of monkeypox identified across all 50 states, the District of Columbia, and Puerto Rico.

Nationally, reported daily cases continue to decline week over week.  Even so, we are monitoring trends closely in individual states and regions and remain vigilant and proactive in our robust education and prevention efforts.

In June, we released a national vaccine strategy that worked to get JYNNEOS vaccine to those at highest risk for monkeypox in the current outbreaks.  Since the release of that strategy, we have been working with jurisdictions to match vaccine administration data with case reports.

Today, after tremendous efforts and rapid yet thorough analyses, CDC will post our earliest data online that speak to the protective benefit of JYNNEOS vaccine in preventing monkeypox infections.  We conducted this analysis by intersecting our vaccine and case data.

On this slide, preliminary data from 32 states show that between July 2022 and September 2022, those who were eligible and did not receive the monkeypox vaccine, represented by the black solid line in this chart, were about 14 times more likely to become infected than those who received the monkeypox vaccine, represented by the blue dashed line.  For those vaccinated, protection was seen as early as two weeks after their first vaccine dose.

There have been limited data on how well the JYNNEOS vaccine performs against monkeypox in real-world conditions. These new data provide us with a level of cautious optimism that the vaccine is working as intended.

These early findings and similar results from studies in other countries suggest that even one dose of the monkeypox vaccine offers at least some initial protection against infection.  That said, we know from laboratory studies that immune protection is highest two weeks after the second dose of vaccine.

It is for that reason that we continue, even in light of these promising data, to strongly recommend people receive two doses of JYNNEOS vaccine, spaced out 28 days apart, to ensure durable, lasting immune protection against monkeypox.

CDC will continue to evaluate how these vaccines are working in the current outbreak through a portfolio of vaccine effectiveness projects that will help us understand the level of protection provided and how long that protection lasts.  And we will continue to deliver these data to you as soon as we have them.

Since the early days of this outbreak, CDC has sought to encourage vaccination of those at highest risk for infection.  As more supply became available, we expanded eligibility.  Today, we are now prepared to again expand eligibility, moving to pre-exposure prophylaxis — or “PrEP.”

By expanding eligibility and shifting to a PrEP strategy across the country, we are looking to ensure those who are at the highest risk for monkeypox receive the vaccine before exposure and that vaccines continue to be made available equitably to those who need them.

CDC is also updating our clinical considerations to include expanded vaccine eligibility and to expand intradermal administration sites to locations other than the forearm.

Dr. Daskalakis will share more about this vaccine updated strategy, who should get a monkeypox vaccine, and additional options for vaccine administration sites, which will be included in CDC’s Interim Clinical Considerations that will post today.

People at highest potential for monkeypox exposure, those who are now eligible — are now eligible for monkeypox vaccine should make an appointment to get vaccinated and make sure they receive both doses in this vaccine series.

Remember, protection from your vaccine is highest two weeks after your second dose of vaccine.  And people who are vaccinated should continue to further protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact with someone who has monkeypox, and consider reducing behaviors that could increase risk of exposure.

These prevention measures are key to continuing to drive down monkeypox infections.

Providers should proactively offer the vaccine to newly eligible people, as well as reminding those who have received their first dose when it is time for their second dose.

We still have lots of work to do in our response against monkeypox, and we are committed to delivering resources to those at highest risk.

As you’ve heard me say before, we remain open to feedback and grateful for community mobilization.  Please let us know how and where we continue to closely work with affected communities to provide tailored information to those at highest risk.

Thank you, and I will now turn things over to Dr. Daskalakis.

DR. DASKALAKIS:  Thank you, Dr. Walensky, for sharing important updates and about our progress to control the monkeypox outbreak.

Equity is the cornerstone of our response, and we continue to evolve how we address monkeypox based on what we are hearing from the people overrepresented in the outbreak and the local jurisdictions at the front lines of this fight.

We hear from them that stigma continues to be a barrier to achieving our collective goals to control this outbreak, so intentional actions need to be taken to lessen this barrier.

We are taking several steps today to reduce the barriers identified by the community and implement strategies that are responsive to the experiences of health departments and advocates.

First, with early data that shows that the JYNNEOS vaccine is working against a real-world monkeypox outbreak, we need to make sure people know about this early good news and encourage those who could benefit from vaccine to get both their first and second dose.

We should make sure people know to strive for the best protection, not just partial protection after just one dose.  This knowledge is power and allows people to make more informed decisions about their health and builds confidence in this important two-dose vaccine.

Secondly, as Dr. Walensky said, we are moving to a PrEP strategy — pre-exposure prophylaxis — that increases who is eligible for vaccination and encourages vaccine providers to minimize the risk assessments of people seeking vaccine.  Fear of disclosing sexuality and gender identity must not be a barrier to vaccination.

This new PrEP strategy means that more people who might be at present or future risk for monkeypox now qualify for the vaccine.  That includes gay, bisexual, and other men who have sex with men, transgender or gender-diverse people who have had more than one sex partner in the last six months, had sex in a place associated with higher monkeypox risk, or have had a sexually transmitted infection diagnosed over that same time period.

PrEP also extends vaccines to sexual partners of people with the above risks, and that includes commercial sex workers.

Thirdly, people can choose where on their body they want vaccines.  Many jurisdictions and advocates have told us that some people decline vaccine to monkeypox because of the stigma associated with the visible, but temporary, mark often left on their forearm.

New guidance from CDC allows people who don’t want to risk a visible mark on their forearm to opt for vaccine on the skin by their shoulder or their upper back.  Those are areas more frequently covered by clothes.

Lastly, anxiety and other mental health issues might also be a barrier to accessing vaccination and testing services.  To address this, SAMHSA — the Substance Abuse and Mental Health Services Administration — has released an online resource to help people experience stress — experiencing stress and anxiety related to monkeypox.

SAMHSA has also released a very important Dear Colleague letter that lets their funded organizations know that SAMHSA grantees may use SAMHSA grant resources, including funds or staff, for monkeypox-related activities conducted in conjunction with SAMHSA-supported work.

This important letter signals the importance of mental health and providers of these services to our work to end this outbreak.

In summary, our strategy is working.  We need to keep our momentum going and continue evolving our monkeypox response to make sure that we move closer to achieving equity in our work to serve the LGBTQAI+ community and specifically the Black and brown communities who are overrepresented in this outbreak.

Thank you.

MR. FENTON:  Well, thank you, Dr. Walensky and Dr. Daskalakis.

We’re going to go to Kevin now to coordinate questions.

MR. MUNOZ:  Hey, Bob.  Let’s take a few questions. 

First, Scott Bixby at the Daily Beast.

Q    Good morning.  Thank you all for holding this call.  Dr. Walensky said earlier that people who are vaccinated should still consider reducing behaviors that could increase their risk of exposure to the virus.  At what point will we — or CDC have the data to determine whether those at higher risk of monkeypox can return to their normal level of sexual behavior?

DR. WALENSKY:  Now, that’s a really important question.  You know, what we have right now is data on how well and how our vaccine is working after a single dose.  What we don’t yet have is what happens after a second dose and how durable that protection is. 

And what I can tell you is: We will continue to give you data as soon as we have it.  I think those durability of protection will be really important to address exactly your question.

MR. FENTON:  Thank you.

Kevin, do you want to give us another question? 

MR. MUNOZ:  Let’s go to Alex Tin at CBS.

Q    Hi.  Thanks for taking my question.  First, on the data: Can you clarify how many post-vaccine infections have occurred that make up those rates?  Are you aware of severe cases or deaths in people who had received the vaccine? 

And separately, given that supply increased several weeks ago, why couldn’t PrEP have been rolled out back then?  Thanks so much.

MR. FENTON:  Dr. Walensky, do you want to start?

Dr. WALENSKY:  Maybe — yeah, I’ll get us started and say: You know, I don’t have the exact numbers of the cases in each.  What we’ve done here is we’ve matched the state data in 32 jurisdictions that have the capacity to look at cases among those who have been vaccinated versus cases among those who have been unvaccinated.  Not all jurisdictions have the capacity to do that, and we’re working with jurisdictions closely to be able to scale up that capacity if they don’t.

We then can do a ratio amongst those who have been vaccinated versus those who have not been vaccinated in terms of cases.  And those will be some of the data that are posted online today. 

I am not aware of severe cases that have occurred in vaccinated people.  But that — we should — we will have updated data on severe cases forthcoming as well.  I’m not aware of any of those cases having happened.  Of course, that depends on how one is going to define the word “severe.”  I don’t mean to imply that people who have potentially been infected after vaccination haven’t experienced severe pain, but some of those relating to hospitalization and organ challenges I don’t believe we have yet seen.

And maybe I’ll pass it over now to Dr. Daskalakis. 

DR. DASKALAKIS:  So I’ll answer the question around move to the PrEP strategy.  And I think we’ve been working very closely with our jurisdictions.  And, really, from the perspective of supply and demand and what we’re seeing on the ground, this is the perfect timing to be able to move from that — from the PEP++ to PrEP, given, again, the need to make sure that we are getting second doses in people’s arms as well as what we’re seeing in terms of demand for first doses. 

So I think that the combination of PrEP plus the amazing early news of the effectiveness of the good performance of this vaccine is going to be really critical in us making sure that we keep getting vaccines in arms first and second doses. 

MR. FENTON:  Thank you.

Kevin, we’ll take another question. 

MR. MUNOZ:  Let’s go to Helen Branswell at STAT.

Q    Thank you very much for taking my question.  It’s quite hard to ask decent questions about the data — the efficacy data you’re talking about, because we really haven’t seen very much.

Dr. Walensky, can you tell us: In the analysis that was done, were there separate analyses that looked at people who got one full dose versus one partial dose of — or not partial dose — an intradermal administration dose?  You know, what do you really — what can you really say here? 

DR. WALENSKY:  Right.  Thank you, Helen.  This is a really important question.  So, first to say this is just data that has been limited to those who are two weeks after their first dose.  We have not yet stratified the data by intradermal versus subcutaneous injection.  That is something that we were going to — we have — we’re going to need a little bit more time and a bit more numbers in order to be able to do.  We are going to have more of these data posted online today and more data forthcoming. 

This is really in an effort to give you all the data as soon as we have it.  But we’ll have more data posted online for you to be able to see some of the details of how we’ve conducted this analysis.

MR. FENTON:  Thank you.

Let’s go to Kevin for another question. 

MR. MUNOZ:  Amanda Seitz at the Associated Press.

Q    Yes, thank you for hosting this.  I was hoping you could speak to what kind of recent trends you’re seeing about where cases are coming from and — as far as cities and regions — and when the CDC might make that data more available to the public.

DR. WALENSKY:  Yeah, thank you for that.  You know, we have jurisdictional-level data that are coming more available.  As, of course, the country is not uniform, we are seeing cases come down in certain areas and some cases — although way fewer jurisdictions where cases are rising. 

So, we will have more data available.  We’re just putting that together in an updated technical brief, which will be forthcoming.

MR. FENTON:  All right.  Thank you, Dr. Wal- — Dr. Daskalakis, anything you want to add?

DR. DASKALAKIS:  No, I think we’re all excited for the technical brief, so I thank you for the update, Dr. Walensky.

MR. FENTON:  All right, Kevin.  Another question, please.

MR. MUNOZ:  Let’s go to Brenda Goodman at CNN.

Q    Hi, I wanted to follow up on Helen’s question.  I apologize if I missed this, because I’ve had a few technical difficulties at the beginning of the call.  But did you post efficacy data on how well people are protected two weeks after a second dose?  So, full vaccination, how well people are protected against infection.

And then also, I wanted to ask about sexual — about funding for the response, because sexual health clinics say that they are overwhelmed and underfunded, and I wondered what the administration is doing to get more funding for the response.  Thank you.

MR. FENTON:  Let’s start with Dr. Walensky. 

DR. WALENSKY:  Sure.  So this was an analysis — you know, of course, you know, as we get data, we are updating our analyses, and we have multiple platforms in which we’re looking at vaccine effectiveness.  This was really our first view at how well our vaccines are working.  This was an analysis that looked at those who had a vaccine single dose and had two weeks after that single dose, and then potential exposure to infection.  And of course, after that exposure, that infection could take up to two or three weeks in order to manifest.  So we do need a little bit of time in order to see how that vaccine is working. 

So this analysis that we have done is comparing vaccine protection for those — or a number of cases for those who’ve been vaccinated compared to those who have not been vaccinated after receiving just that first dose, two weeks after that first dose.

We continue to collect data on what happens after a second dose.  And as soon as those data are available, we will, again, present them to you.

MR. FENTON:  And let’s go to Dr. Daskalakis.

DR. DASKALAKIS:  And just to — I’m just going to put an exclamation point behind something that Dr. Walensky said before, which is: When you’re really looking at the laboratory-based data for this vaccine, the second dose is really important.  So we see some response after the first in the laboratory, but the really high responses that we want to really get that, you know, level 10 force field as opposed to a level 5 force field doesn’t happen until the second dose. 

So, the important message is: This just tells us to keep on trucking forward because we need that second dose in arms.  And people who haven’t gotten the first should start their series of two vaccines.

DR. WALENSKY:  Yeah, maybe if I could just, Kev — and thank you, Dr. Daskalakis for highlighting that.  We are demonstrating that, early on, this vaccine looks like it’s working.  That’s terrific news.  What we know from all of our laboratory data is that second dose is really important and that it may be that second dose that provides that durable protection.  So, again, really encouraging that second dose.  Thank you for highlighting that.

MR. FENTON:  And I just wanted to touch a little bit on the funding part of your question — the second part of the question.  There’s — you know, as we had discussed, not only are the vaccines free that we’re providing to state and local jurisdictions, but there’s a number of programs that were — gone ahead and authorized the ability to leverage those to help with the vaccination efforts happening in local and state government.  So, some of those are in CDC and some of those are in SAMHSA.

So, let me start with Dr. Daskalakis to talk about some of them since he has a familiarity with them from his — his day job at CDC.

DR. DASKALAKIS:  And also, I’ll defer to Dr. Walensky, who — who is in her day job there at CDC now. 

So I’ll say that — that three — three agencies, I think, have really released some very important documents.  HRSA — the HRSA HIV/AIDS Bureau was the first, really signaling that Ryan White resources for individuals who are living with HIV and are being supported by Ryan White can be used for both testing and vaccination costs.

Following that, CDC released a letter that signaled that both human resources and fiscal resources — so, cash — could also be used if they’re coming from the HIV or STD grants that are the flagship grants for the nation, not only for health departments but also for community-based organizations that are also funded. 

So, it really signals the idea that monkeypox does not live in isolation.  It is a interacting outbreak with other epidemics — a syndemic — and so it really allows that flexibility.

And just announced today is a really great letter from SAMHSA, along with a SAMHSA online resource, that demonstrates the importance of mental health and mental health providers and those who work with people who use substances — the importance of that community and those grants to help really fuel us closer to the end of the outbreak.

MR. FENTON:  And those are just some of the resources being provided — far more resources when it comes to supporting research and other activities.  I want to see if Dr. Walensky wanted to add anything else about the resources being provided by CDC to help with the monkeypox outbreak.

DR. WALENSKY:  Yeah, thank you.  You know, maybe I’ll just sort of double down on what Dr. Daskalakis has said, and we’re — saying we’re really looking to have people braid these resources together.  It may be that you can’t come up with all the resources you need from a single place, but there are a lot of opportunities to braid these resources together to leverage them together to provide resources for the monkeypox response.

We, too, are welcome, open to calls about how resources might be utilized.  There are opportunities for admini- — administrative requests to mobilize other resources.  We welcome those, although we recognize they can be logistically and administratively cumbersome.

And so we’re looking to have folks braid those resources that Dr. Daskalakis noted and then also say that we’ve mobilized other resources for research opportunities as well. 

Thank you.

MR. FENTON:  Thank you.  Kevin, we’ll ask for another question.

MR. MUNOZ:  We’re going to take a couple more questions.  Let’s going to Christopher Wiggins at The Advocate.

Q    Hi, thank you for taking my question.  Do you have any indication of what percentage of people who got the first dose are getting the second dose?  And with the rates of monkeypox infection declining and the vaccination efforts continuing, is there a point when all Americans will be encouraged to get the monkeypox vaccine to prevent future outbreaks?  Thank you.

DR. WALENSKY:  Maybe to address the first one, I will say that we don’t yet know that.  We certainly, on our CDC website, are providing a number of second doses that have been administered.

Some jurisdictions delayed administering second doses as a mechanism early on to try and mobilize more first doses.  And so we don’t know whether we’re playing catch-up in terms of those as well.

And so we will, probably over the next several weeks, have a better sense.  And we’re really asking providers to do outreach to get people their second doses.  Now we have plenty of vaccine out there for people who want it.  We’re encouraging people to get their first dose and also encouraging providers to do outreach to get those second doses.

Right now, I don’t see a reason.  We — we are — well, what I will say is: Right now, we’re really looking at those who are at the highest risk of infection for pre-exposure prophylaxis strategy.  And we will be looking to where those highest risk of infections are.  Certainly, we also have a post-exposure prophylaxis strategy for those who might have been exposed.

And so, more soon to come on whether there are other populations that will be perceived at highest risk.  But right now, we’re looking at those highest risk from this outbreak.

MR. FENTON:  Thank you.  Kevin, we’ll take another question.

MR. MUNOZ:  The last question, Madison Muller at Bloomberg.

Q    Thanks for taking my question.  Just sort of wondering, with the rates of STDs going up in the U.S. right now — and I know Dr. Daskalakis said that monkeypox is a virus and a disease that isn’t occurring in isolation — you know, what is sort of the strategy — is there a strategy going forward to sort of help address the rising STD rates, STI rates in the U.S. and also monkeypox, and, sort of, kind of tackle these issues together?  And is — you know, sort of, is that going to be a focus going forward?

MR. FENTON:  Yeah, let’s go ahead and start with Dr. Walensky.

DR. WALENSKY:  Well, I was going to ask Dr. Daskalakis to put on his “day job” hat.  (Laughter.)  But, you know, what I might say, just to start, is we are really encouraging folks who are presenting with monkeypox — we had an MMWR several weeks ago that really demonstrated high rates of HIV coinfection, high rates of other STI coinfection.  So if one were to think that a patient is presenting with monkeypox, that should all of a sudden trigger screening for other STIs, including HIV, gonorrhea, chlamydia, syphilis, and others.

So we really are encouraging that screening.  But as you know, we do have a rising challenge with sexually transmitted diseases across this country, not just monkeypox — syphilis, gonorrhea, and chlamydia as well.  And so we really are hoping to capitalize on this moment for awareness, not just about monkeypox but other STIs as well.

Dr. Daskalakis?

DR. DASKALAKIS:  Yeah, so I’ll just add barely anything, given that you’ve sort of covered it so well, but just that the notion that this is an interacting outbreak with these.  And, you know, the people that we’re trying to get vaccine to are the same people that we need screened for HIV and STIs and the same people who could benefit from pre-exposure prophylaxis for HIV, which is different than pre-exposure prophylaxis by vaccine for monkeypox, as well as HIV treatment.

So monkeypox does actually represent an important opportunity for us to bring people closer to the important public health services that are good not only for their monkeypox-related health but their whole person health, looking at HIV, STI, and, as we talked about, also mental health, given the SAMHSA announcement.

Also important to note that STIs have been severely underfunded for decades.  And so, really important to consider that in the future as well, in terms of strategies to be able to address an ongoing health challenge.

MR. FENTON:  Well, thank you.  And I appreciate everyone joining us today on our briefing on the progress to continue to get everyone vaccinated, especially those at risk to monkeypox, especially with an emphasis on equity.

So, with that, thank you, and have a good day.

12:15 P.M. EDT

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