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The Boar’s Head establishment in Jarratt, Va., operates under inspection as part of a cooperative regulatory program, known as the Talmadge-Aiken program, between the Virginia Department of Agriculture and Consumer Services (VDACS) and the US Department of Agriculture Food Safety and Inspection Service (FSIS).
Under the cooperative regulatory program, inspection assignments and records are maintained using the federal Public Health Information System (PHIS). VDACS inspectors conduct inspections every operating day and receive daily inspection tasks through PHIS. Between August 1, 2023, and July 27, 2024, VDACS inspectors conducted 2,127 tasks assigned by PHIS. Published records demonstrate that there were 69 instances of noncompliance out of those tasks.
Noncompliances identified by VDACS inspectors are handled in accordance with federal regulations. When a noncompliance is documented, the food establishment is required to implement corrective actions that meet the standards of FSIS regulations and VDACS inspectors verify the corrective actions were taken before closing the noncompliance in PHIS. Out of the 69 noncompliances at the Boar’s Head facility, 66 were closed following corrective action. The remaining three are noncompliances documented once the traceback investigation had been initiated, and the shutdown of the facility has prevented any further VDACS inspections to record compliance while federal authorities continue their investigation.
Product sampling, including testing for Listeria, is assigned through PHIS. Between Aug. 1, 2023, and the start of the federal traceback investigation in July 2024, VDACS was assigned the collection of 12 samples from the Boar’s Head facility that were sent to a USDA laboratory for testing. All of those routine samples tested negative for Listeria.
Following the recent traceback investigation, FSIS has suspended inspection at the Boar’s Head establishment while working with plant officials to ensure the facility has an effective system in place to reestablish production in a safe manner.
FSIS has suspended inspection at the Boar’s Head establishment in Jarratt, Virginia, which means that it remains closed until the establishment is able to demonstrate it can produce safe product. This facility is inspected by the Virginia Department of Agriculture and Consumer Services (VDACS) as part of the Talmadge-Aiken Cooperative Inspection Program, where some states provide federal inspection services. As the FOIA documents demonstrate, between August 1, 2023, and July 27, 2024, VDACS inspectors found instances of noncompliance, and the establishment implemented corrective actions in keeping with FSIS regulations. FSIS is working closely with VDACS to ensure the establishment has an effective system in place to produce safe food for the public.
The FDA is not able to provide a number because an applicant’s future business plans, and the identity of its contract labs, are considered confidential commercial information that is exempt from disclosure under FOIA and FDA’s regulations.
We deeply regret the impact this recall has had on affected families. No words can fully express our sympathies and the sincere and deep hurt we feel for those who have suffered losses or endured illness.
Food safety is our absolute priority, as is the health and well-being of our consumers. As a USDA-inspected food producer, the agency has inspectors in our Jarratt, Virginia plant every day and if at any time inspectors identify something that needs to be addressed, our team does so immediately, as was the case with each and every issue raised by USDA in this report.
Since our voluntary recall in July 2024 all operations at our Jarratt, Virginia plant have been paused. During this time, we have partnered with the industry’s leading global food safety experts to conduct a rigorous investigation to get to the bottom of the events leading to this recall. We are also taking this time to conduct deep disinfection, enhance policies and procedures where needed, and provide additional training to employees. We want to assure consumers that no product will be released from this facility until it meets the highest quality and safety standards that you deserve and expect.
Due to the recommended shelf-life, recalled products may have remained in people’s homes. Consumers who were unaware of the recall may have eaten recalled products. People may also have a prolonged course of illness. If deaths occur, it takes time for DPH to be made aware of cases and investigate potential causes. DPH shares information as soon as possible when there is a public benefit, such informing people of recalled products they may still have in their refrigerators that should not be eaten. The list of recalled products can be found here.
Mandy Cohen, CDC [00:05:42]
Our work to prepare for the fall and winter started even before last season was over.
– where clinicians needed more support, CDC worked with partners with deep reach into the most at risk populations.
We certainly made it easier as we go into this season for clinicians to pre-order vaccines for the upcoming season, both from the Vaccines for Children program, and from manufacturers.
We created streamlined educational materials with our clinician partners.
And we worked with electronic health record scheduling platform and clinical decision support partners to make it easier for clinicians to get the information into their workflow that they need to vaccinate their patients.
CDC also hosted a series of webinars with clinicians to help clinics prepare for the fall and winter respiratory season, including a recent webinar with the AMA that was viewed over 17,000 times in the first two days alone.
…
Mandy Cohen, CDC [00:06:49]
We, of course at CDC, continue to closely track the changes to the virus that cause COVID and make that information available to the public.
The good news is, so far, that the updated vaccine closely matches the KP.3 family of viruses that continues to grow in dominance.
…
Mandy Cohen, CDC [00:10:37]
Finally, with the end of the bridge program, CDC has identified an additional 62 million dollars for state and local immunization programs to buy COVID vaccines this respiratory season, which will improve access to vaccines for the uninsured and underinsured adults.
We anticipate additional funding coming to community based organizations to continue to help get the word out to populations that public health may not be able to reach.
…
Mandy Cohen, CDC [00:11:06]
In terms of what we expect from the flu, COVID, and RSV season coming up, CDC’s Center for Forecasting and Analytics, otherwise known as CFA, pulled together a fall winter virus outlook, examining historical data and scenario modeling.
And based on all of that information analyzed and consultation with experts, CDC projects that this respiratory season will have a similar or lower number of combined peak hospitalizations across COVID, flu, and RSV compared to last year.
Now that being said, there are a lot of assumptions that go into a projection like this.
– disposal to prevent disease. If those assumptions prove wrong, say for example, the number of people who ultimately get vaccinated against flu COVID and RSV is lower than expected, then that could mean more hospitalizations, not fewer.
So the power is in our hands. Changes to the virus that causes COVID 19 could also drive increased disease severity.
So again, it’s important to stay vigilant and to use the tools we have to keep ourselves safe and healthy.
…
Dawn O’Connell, ASPR [00:12:46]
I’m pleased to announce that ASPR’s free at home COVID 19 test delivery program will reopen in late September as families start to move indoors this fall and begin spending time with their loved ones, both very old and very young.
They will once again have the opportunity to order up to four new COVID 19 tests free of charge and have them sent directly to their homes.
These tests will help keep families and their loved ones safe this fall and winter season.
This is the seventh time over the last three years that the Biden Harris administration has given families the opportunity to order the over-the-counter COVID 19 test for free through COVID tests dot gov.
These tests will detect the currently circulating COVID 19 variants.
Since the program started in 2021, ASPR has provided more than 1.8 billion over the counter COVID 19 tests to Americans.
So far more than 900 million at home tests have been distributed through the COVID tests dot gov program in partnership with our colleagues at the U.S. Postal Service.
In addition, ASPR has distributed 900 million at home tests through community based access points.
These tests have been sent to long-term care centers, food banks, libraries, and many other community based locations.
Mandy Cohen, CDC [00:04:07]
Yes, you absolutely can get COVID, flu vaccines at the same time. It is a best practice.
We want folks to get both the updated COVID vaccine and the updated flu vaccine.
So yes, you can get them at the same time.
…
Mandy Cohen, CDC [00:04:26]
So our Center for Forecasting and Analytics looked at historical data, consulted with experts, and basically their outlook going forward is that this season we can expect a similar or slightly improved, in terms of peak hospitalizations that we saw last year, when you look at combined COVID, flu, and RSV together.
But I do want to reiterate that there are a number of assumptions built into that, including that folks go and get vaccinated. And that’s why you’re hearing so much preparation on our part, both from the operations, the education, to make sure that folks do take the important and best defense that they can get going into this season.
…
Peter Marks, FDA [00:07:53]
Your point is very well taken about a virus that continues to evolve. And we obviously, in conjunction with our CDC colleagues, keep track of its evolution were there to be some tremendous evolution of this virus, such that we thought that the protection provided by the vaccine was no longer present.
We might obviously consider, at something other than an annual update, but the current problem is not that the virus is evolving so much. In, at least in terms of my estimation.
It’s that we don’t have the benefits of the vaccine, which is that, it’s not vaccines that prevent disease, it’s vaccination, it’s getting vaccines in arms.
And so I think the point of this campaign is that, if you have someone in the office and you can get them to get a COVID 19 vaccine while they’re getting their flu vaccine, and we get that immunity into them, that is probably better even than what we have now, which is people who haven’t had a COVID 19 vaccine for one or two years.
So, I think that is the point here, I think of kind of, even though COVID is not the flu, being able to get that shot in the arm is what we really need to have happen. I think that’s the point of this campaign here, and you have our word that we’re gonna continue to monitoring this.
And if something were to, if there were a new mutation in this virus that were really concerning, we would have a conversation with the manufacturers about whether we needed to produce another vaccine or whether we’d have a conversation with CDC about whether an additional dose of the existing vaccine could be beneficial.
…
Mandy Cohen, CDC [00:09:54]
We continue to see the highest amount of hospitalizations and death from COVID happening in the winter months.
And so getting that most updated vaccine, prior to those months, continues and recommending, and second, we already recommend a second dose or a boost up dose with the same version of that vaccine six months after first, if you were at higher risk.
…
Mandy Cohen, CDC [00:11:55]
Unfortunately the Bridge program was sunset because of rescissions, but we were able to identify an additional 62 million that we put into what’s called the 317 program and allows our state and local immunization programs to purchase COVID vaccines for the uninsured and the underinsured.
But so– I would encourage folks to be reaching out to their local public health departments, their state public health departments, but in addition, also their federally qualified health centers as well.
So those are opportunities.
Again, those with insurance, Medicare, Medicaid, private insurance continue to have these vaccines covered. Of course, the Vaccines for Children program covers vaccines for all children. But we do not have that corresponding for adults. So adults should be getting in touch with their local and state public health departments and with federally qualified health centers.
…
David Boucher, ASPR [00:13:21]
Typically in our prior rounds for COVID test dot gov, we range anywhere from about 50 to 75 million tests.
We have quite a bit of supply in the Strategic National Stockpile available to support that. So we won’t have any inventory issues.
We’ll be able to supply those when people log into COVID test dot gov, they’ll be able to order four tests at a time.
…
David Boucher, ASPR [00:17:31]
I think with the resources we have available for COVID, we need to be a little bit strategic.
When we thought about when to launch round seven of COVID tests dot gov, we thought it’s the right time as people start to travel, as they start to get together with friends and family through the holidays, want them to have those four tests available to them at that time.
It’s a great opportunity also for me to mention that we’ve sent out just under 2 billion tests, since we started doing this. Only about half of them go out through COVID tests dot gov.
We have several other distribution channels. The tests that you see in schools, libraries, long term care facilities, food banks, community centers, that type of thing, where they’re close to people’s homes, those distribution channels, don’t pause, they’ve been active since we started, they go year round.
…
Mandy Cohen, CDC [00:18:52]
We are recommending folks September, October, those are a good time to get vaccinated. The important part is getting it done.
So we want folks to do it. If September from a calendar perspective works better for folks, great. October gets you closer to the winter season, but the important part is getting it done.
…
Peter Marks, FDA [00:19:34]
Getting vaccinated now probably gives you the maximum amount of protection that you can get against what’s currently circulating.
And that will last for several months, at least.
I think it is a matter of personal choice, , but at least Dr. Cohen noted, and I can tell you, I already have my appointment.
…
Peter Marks, FDA [00:20:32]
I think there is– the data that we have, is honestly soft.
I think whether it’s a JN.1 or a KP.2 vaccine, getting either one of those in your arm is a good idea.
There are a small amount of that have come out from laboratories, it’s serology data, not clinical trial data, that suggests that perhaps the KP.2 vaccine may provide a modest additional amount of protection, but we’ll have to gather those data as the season goes on.
And I, at this point, I know some of our European colleagues are going to be receiving, in much of Europe, they may be using JN.1.
We will have both JN.1 and KP.2 targeted vaccines here in the United States, ultimately. And I think it just is a matter of getting one of them in your arm.
…
Mandy Cohen, CDC [00:21:42]
So if you look at our wastewater data and our test data, it does look like it is there is a slowing increase or that we are just either at the peak or just past the peak, depending on where you look across the country.
…
Demetre Daskalakis, CDC [00:22:05]
In close collaboration with our Center for Forecasting and Analytics, we also include an RT estimate of what’s happening in the country and sort of syncing to what Dr. Cohen said, about 24 states in the country are showing growth still, while other areas seem to be plateauing or decreasing.
And so that actually compares about 49 states sort of in the weeks before that we’re showing a growth estimate.
So we’re not out of the woods yet. We’re tracking all of the indicators really closely. You heard about wastewater and test positivity.
But I think we are potentially seeing some indication of a plateauing of the summer increase in COVID 19.
…
Mandy Cohen, CDC [00:22:49]
So if you look for the Center for Forecasting and Analytics will put out a more detailed piece on all of what went into their assumptions, but essentially they looked at historical vaccination rates, and you know our vaccination rates are, continued to be lower than I want to see.
So we’re going to be working to get as many people vaccinated as possible, but what went into the forecast was based on historical vaccine uptake that we saw last season.
Mandy Cohen, CDC [00:01:27]
In terms of modes of transmission, we continue to see that there are two different versions of the mpox virus, clade I and clade II, but both versions of those virus continue to look like they are spread through very close contact, sexual contact, being the most likely.
We are seeing some household, very close contact spread, in places like DRC with clade I. But those dynamics are, we’re still investigating those. We still have epidemiologists who are doing that work to understand it.
But we are not seeing transmission in places like churches or markets or others that would make us think that there’s some other transmission dynamics other than very close contact.
So we continue to think that dynamic transmission here is very close contact, even with the more transmissible clade I.
…
David Boucher, CDC [00:02:31]
We’ve had 50,000 doses on the table for donation for a considerable amount of time right now.
I think a lot of the focus for us is taking some of those, and turning them actually into shots in arms, getting regulatory approval to import them into DRC. And then the implementation.
We’re working quite a bit with our international partners. There are quite a few groups who have equities in this space and obviously want to be respectful to the in-country personnel, as this is their outbreak to manage.
We want to make sure we give them assistance. That said, we are constantly looking at resources we might be able to bring to assist them in any way they need.
As of Friday, August 16, 2024, there were 145 cases of illness among individuals ranging in age from 4 to 80 years old.
“Like millions of families across the country, for years, Tim and I tried to start a family through fertility treatments. We followed the journey that is infertility – the anxiety, the agony, and the desperation that can eat away at your soul.
“Knowing that pain, I cannot fathom the cruelty of politicians who want to take away the freedom for couples to access the care they need. After seeing the extreme attacks on reproductive health care across the country – particularly, the efforts in Alabama that jeopardized access to fertility treatments – Tim and I agreed that it was time to formally speak out about our experience. Our experience taught us that there is always hope and we hope other families find solace in our story. Since then, I have been greatly touched by the women who have shared their stories with me.
“Our fertility journey was an incredibly personal and difficult experience. Like so many who have experienced these challenges, we kept it largely to ourselves at the time – not even sharing the details with our wonderful and close family. The only person who knew in detail what we were going through was our next door neighbor. She was a nurse and helped me with the shots I needed as part of the IUI process. I’d rush home from school and she would give me the shots to ensure we stayed on track. Many of our closest family and friends were surprised when we shared these experiences so many years later.”
Beyond that, please see below for statements from the campaign and some additional context for your consideration.
“The Trump campaign’s attacks on Mrs. Walz are just another example of how cruel and out of touch Donald Trump and JD Vance are when it comes to women’s healthcare. Infertility is a deeply personal journey, but the Governor and Mrs. Walz came forward to share their story because they know that MAGA attacks on reproductive rights are putting all fertility treatments at risk.”
…
“Governor Walz talks how normal people talk. He was using commonly understood shorthand for fertility treatments.”
The data we currently have is the most recent available. We do have plans to update it in the future, but at this time, we do not have a specific release date.
Caitlin Huey-Burns [5;43]
As president, would you enforce the Comstock Act, which could prohibit the sale of– or the distribution of medication abortion by mail?
Donald Trump
No. We will be discussing specifics of it, but generally speaking, no, I would not.
Caitlin Huey-Burns
You would not enforce the Comstock Act?
Donald Trump
I– I would not do that.
Caitlin Huey-Burns
Should medication abortion be widely available?
Donald Trump
Well, it’s going to be available, and it is now, and as I know it, the Supreme Court has said, keep it going the way it is.
I will enforce and agree with the Supreme Court. But basically, they’ve said, keep it the way it is now.
Natalie Thornburg, CDC [00:03:36]
So last year we reached a peak of percent positivity in the summer right around August 26 at just around 15%. And we’re a bit higher than that right now. And we’re sitting at about 18% test positivity in the national picture.
There are some indicators that this may be hitting– we may be hitting our peak. There are a couple of regions where we’re starting to see decreases in percent positivity.
So we’re seeing decreases in percent positivity in regions two and region nine. So hopefully we’ll be able to start seeing that in the national picture as well soon.
So what does that mean for our hospitalization rate? So this is hospitalization rate per 100,000 people. This is from COVID-NET, surveillance system. The red line in the bottom is our current year. So 23, 24, starting in August or September last year. And here we are right now.
We’re a little higher than we were this time last year, but we’re a little higher with percent positivity as well. And our– this summer, the summer cases, started a little bit earlier this year than they did last year. But still relatively low in comparison to previous year. So last year, it’s color, green color, this dark green color with circles, 21-22 is this sort of smooth green line. And then 2021 is the blue line here.
So in comparison to 2021, 21-22, 22-23, generally low number of hospitalizations, although not zero hospitalizations.
…
Natalie Thornburg, CDC [00:06:45]
So our modeled Nowcast estimates are estimating the lineage KP.3.1.1 is predicted to be the most prevalent lineage, with somewhere between about 30 and 43% of circulating viruses are this viral lineage, this viral lineage descended from JN.1, which emerged last November-ish and all the viruses that have been circulating since December, January have been JN.1 lineage viruses.
And the updated vaccines that will be released this year are JN.1 formulations. All of these viruses that are circulating currently, even though they have very different names are very, very similar to each other. So it is just a nomenclature issue, why you have these different sounding names like LB.1 and KP.3.
And it’s just because when you get a lot of numbers on the back side of a lineage, it becomes very difficult to say. And so they’re assigned an alias, which is why they have sort of the different numbers.
But in reality, all of these viruses are JN.1 lineage viruses, and they’re very similar to each other with a couple of amino acid differences between them.
…
Gilberto Santiago, CDC [00:29:31]
In the darker color, dark maroon color, you’re going to see, where 2024 is looking, how is it looking so far compared to previous years, even record breaking numbers per week, therefore what this graph is telling us is that we should expect these numbers to continue this upward trends through the rest of the year, maybe next year as well.
…
Question [00:43:54]
How does the prevalence of dengue stereotype change over time and what affects the dominance of a specific stereotype?
Gilberto Santiago, CDC [00:44:02]
That is a very good question.
That is actually something particular to every region that is endemic for dengue, of course, has also to do with epidemiological background of the population that influences and shapes the– the susceptibility of the region.
For example, we have in Puerto Rico, we have had experienced dengue one transmission for many, many years. And then all of a sudden, the population becomes resistant to dengue one and the transmission of dengue one, so it seeds and opens the gateway for the new serotype to come in. And that’s when we see the resurgence of other stereotypes, it’s just of dengue two and dengue three happened recently in the past few years, where the population is more susceptible for this virus and is open for transmission.
00:01:41.180 QUESTION
How many of the 10 drugs now have prices that are lower than both the net price and the foregone discounts in Medicare Part D. So I’m asking if you add up both the net price and the 10 to 20% automatic discounts that they would have paid otherwise, how many of the 10 drugs are below both of those things together?
00:02:01.737 SENIOR ADMINISTRATION OFFICIAL
Yeah, I can start, and then I’ll turn it over to CMS and to ASPE.
So we are releasing the prices today alongside a few different sets of information.
We’re releasing the discounts relative to the list price. And the department is glad to announce that we achieved savings of 38% to 79% on these prescription drugs relative to list price.
We’re announcing the 6 billion dollars in savings. So had the prices been in effect, in 2023, it would have resulted in 6 billion dollars in savings to the Medicare program overall, that is related to net prices as [official] shared.
And then the 1.5 billion dollars in projected savings for beneficiaries in out-of-pocket costs in 2026.
Medicare net prices is not a benchmark that we are able to release. That is based on proprietary information.
And so what we have made available today are the prices themselves. The discounts that we have secured relative to the list price. The savings in Medicare related to the net price as well as the projected out of pocket savings for Medicare beneficiaries.
…
QUESTION 00:03:43.300
I know that that’s proprietary, but I’m wondering how many of the 10 drugs, if not all of them, have prices that are lower than the combination of the net price and the discounts that these drugs would normally have to pay Medicare Part D.
I’m not asking for the savings number, or you know, I’m not asking you to compare the amount of savings to the automatic discounts that they would pay in Part D. I’m just wondering how many of the 10 drugs come in under both of those things.
00:04:22.320 SENIOR ADMINISTRATION OFFICIAL
Yeah, I understand. And I think there is certain there’s certain information– we’ve released everything today that we are able to release, under the constraints of the law and the guidance.
And there’s certain information that we simply cannot share relative to some of that proprietary information. So what we’ve made available are the estimates and the information that we can share.
And we believe, you know very strongly, that this information demonstrates that we really secured a good deal for the Medicare program and tremendous savings for people with Medicare.
They can expect to see lower prices overall, lower out of pocket costs overall. Individual beneficiaries will save in out of pocket costs, in addition, because of these negotiations.
…
00:06:00.021 SENIOR ADMINISTRATION OFFICIAL
So we have released information today about the negotiation process with the drug companies.
What CMS engaged in really was a true, thoughtful, and genuine back and forth with the participating drug companies.
CMS developed initial offers for each of the drugs, collected information from the pharmaceutical companies, collected information from the public and from patients, conducted their own very extensive evidence and literature review, and then held a series of meetings with each of the companies.
We had an initial offer. The companies had a counteroffer. In some cases in the negotiations, we took the offer put on the table by the drug companies. In other cases we made a final offer to the company that they accepted.
So what what we believe we have achieved is a true back and forth with the manufacturers, a constructive and a transparent process, that really lays the foundation for negotiations in the future.
So we have a strong process that we know we can build on in future cycles of the negotiations.
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00:07:30.240 SENIOR ADMINISTRATION OFFICIAL
The negotiations were genuine back and forth with the participating drug companies, and we learned a lot of valuable information in the negotiation meetings.
Some of the topics discussed during those meetings were the information outlined in the law for the selected drug, including clinical benefit, and how a selected drug benefits people with Medicare and the Medicare program, as well as therapeutic alternatives for the selected drug and how they should inform the negotiated price.
Also we discussed the revised offer and counteroffer prices from Cms and the participating companies, and further steps for the negotiations.
And I’ll say that at the forefront of CMS mind always was maintaining access and getting a better price for Medicare.
And so, you know, for 5 of the selected drugs, we reached an agreement on a negotiated price in association with one of those negotiation meetings, and for the remaining 5 selected drugs, we sent a written final offer to those drug companies, and each company accepted that written final offer.
And the last thing I’ll say is that the statute requires that by March 1st of next year, 2025, that we publish explanations of the new negotiated prices.
So we will have more to say about the prices, the data we receive, the exchange of offers, and counteroffers, and the negotiation meetings when we release those explanations by the statutory deadline.
…
00:11:39.310 QUESTION
Can you tell us why you aren’t able to disaggregate that 1.5 billion dollar estimate by drug?
00:11:55.430 SENIOR ADMINISTRATION OFFICIAL
So the 1.5 billion in out of pocket savings is a meaningful difference for people with all Medicare Part D coverage.
And this savings also, we wanted to emphasize, is in addition to savings from other cost saving provisions in the Inflation Reduction Act, such as the first ever cap on out of pocket drug costs for people with Medicare that goes into effect next year in 2025.
So this estimated 1.5 savings further enriches the generosity of the Part D benefit for Medicare Part D beneficiaries.
But it is very hard to predict savings for certain drugs or groups of beneficiaries until Part D plans develop their plan design for 2026. And so that’s why, today, we have a 1.5 billion in out of pocket savings across the program.
00:12:43.210 QUESITON
And then so just to follow up on that, does that mean that it is possible there are some beneficiaries taking these drugs who will not see an out of pocket savings relative to what they’re paying now.
00:12:56.390 SENIOR ADMINISTRATION OFFICIAL
So each enrollee’s specific out-of-pocket costs will vary based on their particular plan design.
But the Inflation Reduction act is saving people costs in so many ways that we expect that people in Medicare are going to experience a real difference.
00:13:12.650 SENIOR ADMINISTRATION OFFICIAL
And just to add to that, you know, I would just underscore the point that Megan made about the importance of understanding the effects for beneficiaries of the law in its entirety.
So we know, as of today, that people with Medicare can say– will– can expect to save an estimated overall 1.5 billion as a result of the negotiation program.
We know that beneficiaries who are paying tens of thousands of dollars on their prescription drugs every year will benefit from the $2,000 out-of-pocket cap, starting next year.
We know that they’re already benefiting from the $35 insulin cap, as well as free recommended vaccines.
I would also point you to some examples that we have shared today of potential lowered coinsurances on some of the highest cost prescription drugs.
So we have in the HHS press release an example for Stelara that demonstrates how, if a beneficiary paying a 25% coinsurance today on that prescription drug, then paid that same coinsurance when the maximum fair prices go into effect, they would see significant savings.
So overall, we believe that this law will tremendously benefit people with Medicare. They will see out of pocket savings as a result of the negotiations, and they will also see out of pocket savings as a result of the many provisions in the law that provide them a guarantee of lower prices.
…
00:16:27.777 SENIOR ADMINISTRATION OFFICIAL
It is important to us that people with Medicare can continue to choose among a variety of health plans that are affordable to them, whether or not that is through their premium or through the cost sharing and out of pocket savings that we’re talking about today as a result of negotiations in the future as well as those that we’ve already discussed, the insulin cap, the $2,000 out of pocket cap, and more.
…
00:16:58.520 SENIOR ADMINISTRATION OFFICIAL
12028176133: Regarding the voluntary demonstration program, this is consistent with past practice, when there have been major changes in the Medicare Part D program.
And so this demonstration program is intended to help with the transition of the redesigned Part D benefit, which is so much more generous for people with Medicare now, and the program will improve premium stability for standalone prescription drug plans.
So what we would say to beneficiaries is that they will have stable, affordable choices of Medicare plans while they are lower– while they are seeing lower drug costs.
And though I would also want to point out that the savings for the negotiation program are only going to scale. This 6 billion is just for one year. But we will be continuing to negotiate, selecting more drugs and accruing savings from the drugs this year as well.
…
00:19:04.359 SENIOR ADMINISTRATION OFFICIAL
The short answer is that CMS has taken action on this issue through guidance, and intends, through its formulary review process, to monitor access to these prescription drugs which must be covered under the law.
…
00:19:20.430 SENIOR ADMINISTRATION OFFICIAL
12028176133: So just emphasize that access to affordable prescription drugs is our primary focus within the drug price negotiation program.
The law requires that plans provide access to the selected drugs that remain in the Medicare program, and we expect that people with Medicare taking the selected drugs will benefit from the lower negotiated prices.
As [official] mentioned, we will ensure meaningful access to the selected drugs, using our formulary review process where we will be monitoring any practices that may undermine access to selected drugs for people with Medicare, and as part of the annual bid review process, we are requiring Part D sponsors provide a reasonable justification to support the submitted plan design that may include any practices that we’ve identified that may undermine access.
Eric Deeble, USDA [00:17:47]
We are seeing a continued high levels of testing. We’re just at about 40,000 individual tests that have been run through the NAHLN system, and understand that there are many more that have gone through the private lab networks.
So we are confident that there is a good level of testing across the nation. Much of this has been associated with pre movement testing.
We’ve also seen an uptick in testing for intrastate activities, often associated with producers who are interested in shipping animals to a state or county fair.
So I will say that the testing remains high.
The detection of new herds, we’ve seen a considerable uptick in Colorado, based in no small part of that state’s excellent efforts to implement a state based bulk milk sampling program.
But across the country, we are seeing a slow number of individual herds added to the total. And we’ve now started to see a small number of herds clear and exit the total of currently affected herds.
So I don’t want to say that we feel like we’re ahead of this.
This is an animal disease of significant concern, and obviously there’s a great deal of concern on the potential and real impacts to human health.
But I do feel like the response is adequate. And I do feel like we are supporting our producers to make it easy for them to test and make it easy for them to get the supports that they need, if in fact they are affected.
…
Eric Deeble, USDA [00:27:01]
So there are challenges associated with closing a dairy premises to the degree that one would close a poultry flock or a swine herd.
They’re much larger animals, the way in which they are kept is quite different, and their degree of movement through the facility, as well as the number of individuals that are necessary to care for them, is significantly different.
We are encouraging producers to adopt additional biosecurity measures, and have supported the updating of several materials that support that, to help producers understand the steps that they can take, things like establishing a clean-dirty line, the use of truck washing and vehicle washing stations, the way in which they can decontaminate potentially equipment that’s moving back and forth, as well as making sure that their staff are using appropriate PPE.
I think that as producers become aware of the way in which this disease is moving within communities, of dairy producers, they can now take better, more focused steps in order to protect their farms, their herds, themselves, and their workers together.
We’re going to be working over the course of the summer very hard to make sure that folks are aware of the steps that they can take to protect themselves.
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Eric Deeble, USDA [00:28:57]
There’s no mandatory measures that farms need to take in biosecurity in any production system.
So it is not that dairy farms are being held to a different standard than other farms.
It is a recognition that enhanced biosecurity is appropriate in light of this new outbreak in dairy cattle.
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Steve Grube, FDA [00:30:55]
We are actively working on it, among all the studies that we’re doing here, to confirm that pasteurization is effective.
That’s our mandate here at FDA to help ensure the safety of our commercial milk supply. And we continue to do that with various studies and the bulk milk work is ongoing.
And as soon as we have information that we can share, we will be pleased to share it with you.
Question [00:31:15]
But can you say, what are the roadblocks to it? Is it expensive? If we want to determine the scope of the spread of this virus, why not just test everything?
Steve Grube, FDA [00:31:27]
So everything is a lot.
And so we’re working with our state co-regulators to understand where in the processing chain does that make the most sense to begin the testing and to continue testing.
Again this is not a sprint, this is a marathon.
We need to understand as a nation how we can address this outbreak and bring it to the swiftest possible end.
And so we’re working with our state partners to understand how best to integrate that into operations.
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Eric Deeble, USDA [00:33:13]
We have a high degree of confidence that the testing that we’re doing is accurately capturing the status of those animals that are moving between states.
I think that, uh, there are additional opportunities for states to explore intra-state testing. And of course, USDA is supportive of those efforts.
I will say that because we have worked so hard to put in place a series of supports for producers, both to help them meet the risk that is associated with this disease coming onto their farm, as well as to deal with any potential income lost, should they have H5N1 affect their herds, we feel quite confident that producers, that we’ve done a good job of destigmatizing this, and de-risking this, for producers, so that we’re hopeful that we have decreased the barriers to testing as much as we can.
And of course, you know, those states that do choose either to implement their own programs within the state, or to create a process by which they can declare herds that have been affected free of the disease or clear that matches our herd status program, we’re of course very supportive of those efforts as well.
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Eric Deeble, USDA [00:35:25]
The answer is, is yes, actually, typically during the warmest summer months, we see a decrease in the number of cattle that are being shipped, and this is due part to avoid the heat, but also because there tends to be a decrease in the amount of demand for fluid milk during the summer months, in part due to consumption patterns in part due to school being out of session.
So there will be a period in the fall in which we anticipate an increase in intrastate cattle movement.
Dr. Gauthier, anything to add here?
Julie Gauthier, USDA [00:36:05]
I’ll just add that we do see a bit of a dip in the summertime, primarily due to the heat and the stress on the cattle being moved at that time.
And there is a steady movement of dairy cattle interstate throughout the year.
Commercial dairies are largely confinement operations. So they’re not being moved from pasture to pasture like you would see with beef cattle. They’re completely separate types of operations.
And so, cattle, dairy cattle, are not being moved for the purposes of pasturing in different locations.
They’re being moved in order to, to add them to milking herds in different parts of the country, and that occurs year round, although there is a slow down in the summertime.
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Eric Deeble, USDA [00:40:28]
I think it’s really important to bear in mind that to the best of our understanding and all of the epidemiological investigation that we have done so far, all of this illness in cattle can be traced back to a single spillover event in the Texas panhandle region, towards the end of last year or the beginning of this year, that we know we have a good understanding of how the disease is spread through cattle movement, and are gaining a better understanding about how it spreads within the communities with the ongoing epidemiological investigation that we’re doing.
So I don’t want folks to conflate the concern with migratory bird movements in the fall as a potential for the spread of this particular strain of B3.13 dairy associated H5N1 in cattle with migratory bird patterns.
I will say that, you know, we continue to work hard to protect poultry operations from H5N1. And we do know that migratory birds pose a risk to the domestic flock.
And so, you know, we are certainly cognizant of and supportive of the efforts of our producers to ensure that there is no additional uptick in the fall, as H5N1 may move through the environment again with those migratory bird patterns.
Although it is important to say that this particular H5N1 event in poultry has lingered for some time.
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Julie Gauthier, USDA [00:42:21]
We do expect the risk to increase for poultry flocks as Dr. Deeble said, because of the movement of migratory birds during the fall.
But we’re finding with this cattle outbreak that we’ve seen just a single spillover event from wild birds into the dairy cattle, and then the dairy cattle have spread it amongst them, the herds amongst themselves.
So we’re not expecting increased risk for the dairy herds.
But we are expecting another upsurge in poultry high-path outbreaks as we have for the last two years.
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Nirav Shah, CDC [00:43:08]
Our bottom line is this: so long as livestock are at risk, workers are at risk, and therefore our work will continue.
Let me zero in on the fall and winter respiratory season. The bottom line there is that the prevalence of things like seasonal influenza, RSV, etc, obscures the picture– I’m sorry, it muddies the picture, but it doesn’t obscure it completely.
First of all, it’s important to note that there has been an overlap of H5 affecting poultry and other livestock with the following winter respiratory virus season before. So this won’t be the first time.
The second, and I’d be remiss if I didn’t note, that this is in part of the reason why two weeks ago, we made the announcement to offer and provide an enhanced channel for influenza vaccination for any and all livestock workers. Partly because of this potential muddying of diagnoses, in addition to the imperative to protect workers.
And then the third thing, Alex, is that from a data perspective, when we look at increases in influenza, be it in waste water, or be it in an emergency department visits, we’re not just looking at it in absolute terms. We’re always looking at it relative to where we were in that particular region, 52 weeks prior.
So we’re trying to do year on year comparisons, which helps us spot something that’s not just increased, but rather increased above the historical norm. And that’s how we separate some of the signal noise there.
So we have been thinking about these issues very carefully in light of the ongoing outbreak. And we feel confident, as we go into the fall winter season, that our antenna will continue to detect any changes.
Question [00:44:49]
And one quick follow up on that. You mentioned wastewater.
Do you think there’s a possibility we’ll have H5 specific wastewater testing by that time, or are you still gonna be relying just on that big bundle altogether?
Nirav Shah, CDC [00:45:02]
It’ll be a mixture of both.
So right now there are a number of jurisdictions that are utilizing wastewater testing, are conducting wastewater testing. What we’re doing right now is to consolidate all of those. So there’s one unified view in all that, into all of that.
But in parallel, we at CDC are also working to roll out more widespread H5 specific wastewater testing, in addition to influenza A testing.
Now, the ultimate decision about what a jurisdiction opts to test for in their wastewater is up to that jurisdiction, but we are hoping to be able to work with as many as possible, so we have visibility, not just on influenza A, but as you note, specifically on H5.
It’s too early to tell where that will land. But we’re hoping we’ll get more wastewater visibility as we move through the following winter season.
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Nirav Shah, CDC [01:01:05]
Given that this is something where we’re starting from, again, not a lot of awareness because of the novelty and the newness of the situation, I don’t want us to change course so quickly when we have a long road ahead.
So what we’re trying to do is balance the need for information to be disseminated, with the need, not to shift course, just because we haven’t gotten to 100% awareness yet.
We are very open to reevaluating that and making sure we’re continuing to get to where we need to go, but we’re using every single messenger that we can.
Another one that has been very effective has been working with our colleagues at HRSA, both in migrant health clinics, as well as community health centers.
For many farm workers, those are the principal venues through which they receive all healthcare, as well as all health education.
So we’ve worked with them to make sure that they know, when a worker comes in to test for the right things, as well as to get the message out into communities, so that workers know that that’s a safe place to go.
Another venue that we’ve partnered with a number of states on are churches.
In one particular state in the south, they found that churches and other meeting places, markets, things of that nature were a perfect opportunity to brief folks on where things go.
The other option or the other approach where all this comes to head is when we think about fall worker vaccination for seasonal influenza, the same connections that we’ve built thus far will serve us well.
I don’t mean to suggest that the job is done. It’s going to take a lot more time, but we share your concern around the urgency.
Under the Affordable Care Act, all Health Insurance Marketplace® plans, as well as most other private health plans, are required to cover certain recommended preventive services, without imposing any cost-sharing requirements, such as a copayment, coinsurance or deductible.
The HRSA-supported Women’s Preventive Services Guidelines (HRSA-supported Guidelines), as updated on Dec. 30, 2021, recommend that adolescent and adult women have access to the full range of contraceptives and contraceptive care to prevent unintended pregnancies and improve birth outcomes. The HRSA-supported Guidelines also provide that contraceptive care includes screening, education, counseling, and provision of contraceptives, including in the immediate postpartum period.
Although CMS has not released guidance specific to the recent CDC announcement you reference, CMS, with the Departments of Labor and the Treasury (together, the Departments) has previously clarified that plans and issuers are required to cover, without cost sharing, items and services that are integral to the furnishing of the recommended preventive service, regardless of whether the item or service is billed separately. See FAQs About Affordable Care Act Implementation Part 54, Q1. In this guidance, the Departments highlighted that the requirement to cover, without cost sharing, items and services that are integral to the furnishing of a recommended preventive service applies to coverage of contraceptive services under the HRSA-supported Guidelines, including coverage for anesthesia for a tubal ligation procedure or pregnancy tests needed before provision of certain forms of contraceptives, such as an intrauterine device — also known as an IUD — regardless of whether the items and services are billed separately.
Contraceptive care also includes follow-up care — e.g., management, evaluation and changes, including the removal, continuation and discontinuation of contraceptives. The HRSA-supported Guidelines further recommend that the full range of U.S. Food and Drug Administration-approved, cleared, or granted contraceptives, effective family planning practices, and sterilization procedures be available as part of contraceptive care. The full range of contraceptives includes those listed in the FDA’s Birth Control Guide as posted on Dec. 22, 2021:
- Sterilization surgery for women.
- Implantable rods.
- Copper intrauterine devices.
- Intrauterine devices with progestin — all durations and doses.
- Injectable contraceptives.
- Oral contraceptives — combined pill.
- Oral contraceptives — progestin only.
- Oral contraceptives — extended or continuous use.
- Contraceptive patches.
- Vaginal contraceptive rings.
- Diaphragms.
- Contraceptive sponges.
- Cervical caps.
- Condoms.
- Spermicides.
- Emergency contraception (levonorgestrel).
- Emergency contraception (ulipristal acetate).
- Any additional contraceptives approved, cleared or granted by the FDA.
Thanks for contacting the Centers for Medicare & Medicaid Services.
The FDA is responsible for ensuring drugs are both safe and effective. In order to approve a drug, we must determine that the research and data submitted by the sponsor show that the drug is safe and effective for the intended use. As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.
The agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD. We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.
The FDA may issue a Complete Response (CR) letter for an application for a number of reasons, depending on the content of the application. Under applicable disclosure laws and regulations, the FDA generally cannot disclose the reasons for issuing a CR without the sponsor’s consent. The sponsor may, of its own initiative, release the CR letter or consent for the FDA to do so, but the sponsor has not done so at this time.
Wolbachia has been proposed to manage mosquitoes and the diseases they spread in two ways: 1) population suppression, in which an incompatible strain of Wolbachia is introduced into wild populations, and 2) pathogen interference, in which an introduced strain of Wolbachia directly inhibits pathogenic viruses within the mosquito, thereby suppressing virus transfer to humans where those viruses may cause diseases.
The first approach (population suppression) is regulated by EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as a pesticidal use of Wolbachia. On the other hand, the second approach (pathogen interference) would be regulated by the Food and Drug Administration.
Regarding Wolbachia population suppression tools, currently there are two Wolbachia based products that EPA has approved for commercial use, ZAP Males and WB1 Males. The ZAP Males product targets Aedes albopictus (Asian Tiger Mosquito) and was approved in 2017, with full use throughout the U.S. approved in 2023. WB1 Males targets Aedes aegypti (Yellow Fever Mosquito) and was approved in April 2024. Additionally, there is a second Wolbachia product for Aedes aegypti (DAB Males) presently under review (https://www.regulations.gov/document/EPA-HQ-OPP-2023-0070-0007).
EPA is in the process of updating its webpage at https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/emerging-mosquito-control-technologies to reflect the current status.
Indeed, the U.S. has made an offer of 50,000 doses of MVA-BN vaccines to the DRC. In addition to this, Bavarian-Nordic, the vaccine manufacturer, has also made an offer of 15,000 MVA-BN doses.
The government of the DRC is still in discussion with the governments of Japan and other Member States on vaccine donation, and updates on these shall be shared once these discussions are concluded.
Lastly, the vaccine doses already offered are not yet in the DRC, but work to get them there is already underway.
Rosamund Lewis, WHO [00:15:11]
Indeed, clade Ib has demonstrated some mutations, one of which you have mentioned, which suggests that the virus has been circulating explosively person to person, which is indeed what the evidence that is available as this particular–
These provinces and countries have not reported mpox before September of last year, in the case of south Kivu, earlier this year, in the case of north Kivu and just in the last few weeks, month, in the case of the, for eastern neighboring countries.
So it is a virus that is transmitting explosively person to person, as far as we know.
In addition to that, the virus has shown other mutations, which make it necessary to ensure that the correct laboratory protocol is in place to make sure that the clade can be discerned, if PCR is what is being used.
PCR is the standard for laboratory diagnostics, and there are different protocols. And so WHO has some weeks ago put out new laboratory guidance on the protocols recommended by WHO for detection of this particular strain. So the countries are in a position to detect the strain that is – that support is being provided, through the response of WHO with the support of the countries in support to the countries.
At the moment, there is no specific information that suggests that the virus, the clade Ib is more transmissible per se.
It is transmitting through sexual networks, interlinked sexual networks. And we know from the global outbreak that transmission through sexual networks occurs more rapidly.
It doesn’t necessarily mean that the virus itself is more transmissible. However, as the virus does continue to spread, it is also spreading within families and through community contacts, through the other modes of transmission, which we are familiar with, which is direct physical contact, face to face contact, which may involve exchange of respiratory droplets, and of course, what we call fomites, which are things such as beddings and towels, which may be contaminated sharing a bed, for example, in a family setting would also be a high risk environment if someone in that family has mpox.
So the virus is a new strain. It has been now confirmed and documented by scientists, a number of scientists by countries and by WHO, and these are the features that we are aware of so far of this particular new strain.
As to whether it is more severe, so we’ve talked about transmissibility, which we don’t know that it’s more transmissible, but it is transmitting through an efficient mode of transmission.
And as to whether it is more severe, we also don’t know.
It is definitely causing severe disease, and it is definitely causing some deaths, but most of the persons affected so far have been adults. And as you know, children are more vulnerable.
So it is still difficult to say whether this particular strain is less or more severe than the standard clade I, if you will. So that is something that we are definitely looking out for at the moment.
It seems to not be more severe than the standard clade I, but it’s dependent on many factors on context in which it is currently circulating.
So these two features are things that we don’t yet have full information on, which is transmissibility and virulence .
…
Rosamund Lewis, WHO [00:25:18]
This virus is spreading through sexual transmission and through sexual networks.
The DRC, Democratic Republic of the Congo, has good data on the cadres of individuals, if you will, in terms of their profession that are being affected by this.
And whereas there was one third of cases in the beginning of the outbreak were among sex workers, that proportion is now reducing as more people are being affected in the community.
This includes, students, businessmen, people traveling across the borders for different reasons, and those whose whose occupation is not reported.
So we do know that this is transmitting through sexual networks, and we do know that this includes sex workers, which obviously, there are commercial sex activities in the region, which include those necessary for survival for income generation.
And so everything that, Dr Van Kerkhove has said about risk communication, community engagement, and increasing access to vaccines, all remains critical for this outbreak response.
Some children have been affected already. At the moment that proportion is not very great.
But there are cases in areas such as displaced internally displaced persons camps, as well as congregate settings.
So it’s a complex outbreak with myriad manifestations and the response has to be contextualized, localized, to identify those at risk, and provide the information and resources they need to respond to this outbreak.
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Deusdedit Mubangizi, WHO [00:28:43]
Now that the director general has launched the emergency use listing, we will be reaching out to the manufacturers and the applicants to submit applications for evaluation and the emergency use listing team has already been put in place already to review these applications.
And we– they will be screened within one week and the assessment should not take more than one week from acceptance, more than one month from acceptance into assessment.
And thereafter, we shall convene the taking technical advisory group, or the TAG as we refer to it, within one week of the report being available. And the, the TAG will make a recommendation.
Now, should that recommendation of the vaccine be positive, WHO is ready to share the assessment reports with member states to facilitate their authorization and acceptance into countries so that then they can be available for use.
Just to supplement what Maria and others have said, when these vaccines are available, we urge all clinicians, member states that are using them to continue gathering information so that we can actually gather all the information that is needed about the use of these vaccines.
…
Rosamund Lewis, WHO [00:33:55]
Two countries in the African region have already approved mpox vaccines for emergency use.
That is Nigeria has approved the use of one vaccine, MVA-BN, and the Democratic Republic of the Congo has approved the emergency use of LC-16 vaccine and MVA-BN.
This is just to note that those countries have moved ahead with their planning on securing vaccines and the discussions are underway to make that happen.
That will not in any way impede the process of the emergency listing, which is necessary, as multiple countries are now reporting cases at the same time.
…
Rosamund Lewis, WHO [00:35:38]
Risk is risk. WHO does have a method of assessing risk, which can be low, moderate, high, or very high.
And, at the moment, the risk of further spread in the region is moderate for the general population high in the Democratic Republic of the Congo.
And we are reviewing the risk assessment now to bring it up to date with the latest information. And so that will be made available, shortly in, in new communications.
Having said that, we’ve already seen that the virus is now rapidly been documented in four new countries that had never reported before. And we’ve also seen what can happen in the global outbreak that began in 2022, where many countries were affected in a very short period of time.
So, we can’t predict for sure what will happen, but we can anticipate that there are different scenarios and need to be prepared for that risk, and for further spread, in the event that that does occur, which can occur, either in proximity to countries that already have the virus, or of course at further distance, through other modes of travel, whether it be road travel or rail travel, air travel, or foot travel.
So all those modes of travel can of course continue to contribute to the outbreak.
We just want to be also very clear that the standing recommendations that have been in place since August of 2023 do not recommend specific travel measures.
What is recommended is information to travelers and cross-border collaboration between countries on surveillance and on case management.
Other specific travel measures, such as shutting down travel mechanisms or things like that are not being recommended at this time.
They have not been recommended since the beginning of the global outbreak. What we are looking for is supporting countries to support each other through cross-border work, which is necessary to stem the continuing spread of the outbreak.
…
Maria Van Kerkhove, WHO [00:37:47]
I just want to highlight the urgency that we are trying to get across today, right?
There’s a lot of things that are happening with mpox. This is an outbreak that caused a global outbreak. We had a public emergency of international concern. There was some attention to this, that attention waned.
There’s an ongoing outbreak that’s happening. We’re talking about spread.
This virus is being detected, particularly this clade Ib, which we know is more severe than clade II, is being detected in a number of additional countries.
There are certainly increased awareness. There’s increased readiness in countries, which is excellent, and there is increased reporting, but this is detecting circulation. And this is something we wanna act upon now.
All of the things that can be done and reiterate what Mike said, what Dr. Tedros has said, that this can be stopped, if we actually put a concerted effort into this.
We don’t sit here and watch and wait. And we do not want the world to sit and watch and wait until whatever that until is to actually trigger some action.
The time is now, the time was before, but let’s talk where we are actually today and actually make the investment in mpox that is causing significant challenges in many of the countries across the African region.
This is a– we are living in an interconnected world and these pathogens do not respect borders.
So I just want to get across the urgency that we’re trying to say that the action is now, the time is now for us to take much more measures and provide much more support to the African region, to the countries that are affected across the entire spectrum from surveillance, to prevention, to risk communication, to clinical care, to infection prevention control, to R&D, to the use of vaccines. It’s now.
…
Rosamund Lewis, WHO [00:52:48]
We have good data insofar as we are able to secure that data for reported clinically compatible cases, versus confirmed laboratory confirmed cases.
So overall the case fatality ratio of reported cases of the Democratic Republic of the Congo is currently 3.6% that is across all provinces and across all age groups.
We do know that in endemic areas, which is the central north and west of the country, that the case fatality ratio is significantly higher than in the east at the moment.
It is higher partly because many more children are affected. So three quarters of the cases are among children and 88% of the deaths are among children under 15 as well. And there’s an age gradient in the case fatality ratio.
So infants have a high case fatality ratio of over 5%, children under five, have a case fatality ratio, which is a bit lower, under 15 lower still. We have all this data online that you can also look for that there, we can provide that link.
And in adults or children and adults over 15, the case fatality ratio is lower than 3%. So we do have that information.
In the eastern part of the country where it is clade Ib, the case fatality ratio at the moment, is just under 1%. And it remains lower than the other part of the country.
As I said earlier, we don’t know yet if this is because the clade is perhaps less severe as opposed to more severe in terms of clade Ib versus clade I.
But it’s also because it’s almost exclusively, at the moment, most cases are among adults. So we don’t have that demographic of children under 15, under five, and infants currently affected to the same extent. And therefore we don’t have the same number of cases leading to deaths because those are the most vulnerable groups.
However, there are also women who are pregnant, who have been reported to have mpox, that has led to death of the mother in rare cases, and also loss of the pregnancy in other cases.
So there are a number of significant medical, clinical, and public health impacts that can arise as the virus continues to spread.
At the moment, just to summarize, the case fatality ratio overall in the Democratic Republic of the Congo is around 3.6%, higher in endemic areas. And especially in infants in young children, and lower in the eastern part of the country at the moment where spread is more rapid through sexual transmission among adults.
Mandy Cohen, CDC [00:09:13]
What about timing?
We are going to see an updated COVID 19 and flu vaccine, here in just a few weeks.
Flu is actually starting to be available right now. So you can be ordering that, be getting that in to your practice already.
The COVID 19 vaccine should be available within the next number of weeks, maybe the end of August, beginning of September, but right now is a great time to pre-order.
And we’ll have more on that that soon. And then the administration should continue through September, October, November.
…
Mandy Cohen, CDC [00:10:36]
So COVID vaccine available soon, then start giving those September, October, November.
Flu, already starting to be available. We want to ideally administer in the September, October timeframe.
RSV can be doing now or late summer, early fall.
And then again, the infant and maternal, a little closer to the start of RSV season, in the more, in the late September, October timeframe here.
…
Mandy Cohen, CDC [00:20:01]
The last thing I wanted to bring up for you is as a campaign that you may see us running in your neck of the woods, we are going to be able to run some paid advertisement during the season to help folks get ready and then actually motivate to action to get vaccinated.
It’s a campaign called Risk Less, Do More, Get This Season’s Vaccines.
So,you are going to see some of that launch in a few weeks here. Obviously it’s not time yet to get those COVID and flu vaccines. So you’re going to see more of that campaign launched in a bit, but we’ll start with focusing on RSV because, if someone comes in who’s over 75 right now, they can get that one dose of the RSV vaccine and they’re set into the future.
We are going to be working through some paid media, including TV, radio, and print. So maybe you’ll see this in your neck of the woods.
The audiences on the next slide that we’re focused on are not going to be surprising.
Who are the folks that are at highest risk and need to risk left to do more? It’s older adults and folks in long-term care facilities, or our nursing home residents. We want to be making sure we’re really targeting that highest risk group.
So you’ll see a lot of images like the one on the screen where we are making sure to have messages to our older adults and particularly those who are in long-term care facilities.
That all being said, we also want to make sure that we are recognizing that historically marginalized communities continue to see lower vaccination rates than others.
And we make part of this campaign will be to reach out to all adult populations, specifically focusing on our Black, Latino, and rural audiences.
And then lastly, we have a component that will be focused on you all, because we know how important a team member our clinical community is in making sure vaccination happens.
So we’re going to have some ability to do messaging. So you may see some ads and such again, reiterating a lot of what we are covering today.
…
Mandy Cohen, CDC [00:22:10]
Just a reminder that we’ve been talking about fall and winter, but we are having a fair amount of COVID circulating right now.
And just a reminder that we have tools for you to know what’s happening in your community. What is, how many folks are getting admitted to the emergency room based on COVID, what are, what is, are things looking like, so that you know how to potentially change or recommend things particularly for those higher risk patients.
So just know that that COVID is circulating right now.
What we are seeing is while there is a fair amount of COVID circulating, we’re seeing lower levels of emergency rooms and hospitalizations than we’ve seen in the past, which is good.
But we want to make sure we’re continuing to protect each other, particularly those folks who are at highest risk.
…
Mandy Cohen, CDC [00:25:30]
So one of the ways in which we try to understand, get a little bit of a sense of what’s going to happen for our flu season or our overall respiratory season is to look at the southern hemisphere where flu is circulating right now.
And what we, again, it’s never a perfect marker, but what we are seeing, it’s a pretty typical season, meaning it didn’t start too early, they’re seeing what is a pretty typical season.
So not better, not worse, but pretty typical, didn’t start early. So again, we’re anticipating a typical start, which means later in the October timeframe.
However, coming out of the COVID pandemic, we are still recalibrating what these, the start times of these seasons are. So we want to be prepared now. That’s why we’re here at the beginning of August, having this conversation to get ready, get prepared as we get into the season.
We have the power in our own hands to know how bad of a season it’s going to be, right? The more protection we get out there, the more mild the season can be.
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Mandy Cohen, CDC [00:35:15]
For the vast majority of primary care docs, the risk in your patient population is extremely low.
If you happen to work with folks who work on farms or have come into contact with cows or with poultry, you definitely want to have that as a heightened thing that you are looking for, but the– we have not seen a case of human to human spread of avian flu. And that is good news, but we are taking this very seriously.
We do know that farm workers are at risk and those who are exposed to the avian virus directly, but the larger population, the risk is very low.
That all being said, I think it makes it even more important that we focus on getting folks the seasonal flu vaccine this year.
We want to make sure folks have as much flu coverage as we can, right. To protect folks against the known thing that is spreading human to human, and that is seasonal flu.
But we are working very hard to make sure we are protecting workers, that there is testing available.
We– it is a very different circumstance with avian flu than for COVID.
For example, avian flu is something we have known about and been studying and preparing for, for decades.
We have tests, we have treatment that is Tamiflu, and we even have vaccine candidates.
So if we would see any escalation in what is presenting right now, we could also think about a vaccination campaign for farm workers, already, we have that available.
So we have a lot of tools at our disposal, but for general folks in primary care, if you’re not working with the farm community, that is unlikely to be something that you are seeing.
But I do think it puts a bigger emphasis on us wanting to get both seasonal vaccinations for folks as well as our farm worker community,
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Mandy Cohen, CDC [00:38:58]
So we’ve been talking about everything we do can do to prepare, but once we’re in the season, and once we think that there’s a lot of virus circulating there, we we’ve all learned through the pandemic about a lot of different tools that can help us, to make sure that we are reducing our risk of getting those viruses circulating.
So, as you may know, we redid our guidance on this back in the spring. So at the end of the winter season, we looked at our data and said, and simplified our guidance on this.
And we also simplified it to focus on the thing that we know saves the most lives and that’s vaccination. That’s why we spent 90% of our time on this webinar talking about vaccination. It’s what works at what keeps people out of the hospital. It’s what saves lives.
But there are other ways we can also do things to protect ourselves.
One is stay home when you’re sick, right. And I– which I know is hard, to miss that family party or that thing, that work event, but keep your germs to yourself and stay home when you’re sick.
But if you are out, doing things like hand sanitizing, wearing a mask, being, opening windows, improving ventilation, all of those are layers of protection, particularly if you were at higher risk or you are going to be around people who are at higher risk, you want to layer those things on top.
So vaccination as a foundation, staying home, if you’re sick, as a foundation, but then being outside, wearing a mask, using hand sanitizer, right? All of these things add layers of protection beyond that foundation.
And this is the same guidance between COVID, flu or RSV, it’s across any of these viruses.
We did have specific guidance for quite some time around COVID because COVID was something new to us as humans. We hadn’t had previous immunity to it.
Now that most of us have either had COVID, been vaccinated, we are in a– we are different.
The virus is still pretty, pretty transmissible. We’re seeing right now in, in the summer, but we are different. And that is good.
Meaning it is overall less severe than it was when we were first seeing the virus introduced to our communities.
But it doesn’t mean it’s gone. And so we do have to remain vigilant again, vaccination, vaccination, still the best tool here to protect lives, as we go into the season.
“The Biden-Harris Administrations is committed to making sure Americans have access to affordable, quality health care. We are using every tool at our disposal to protect and strengthen access to coverage so individuals and families can maintain access to the health care they need. Since 2021, we have seen a historic number of Americans get health care including a record-breaking 21.4 million people who signed up for coverage through the Affordable Care Act Marketplaces. This is a direct result of the Biden-Harris Administration’s health care policies, such as lowering health insurance premiums by an average of $800 for millions of Americans and expanding Medicaid. We have more work to do to lower health care costs, including by permanently extending enhanced premium tax credits and expanding Medicaid in every state to get more people affordable, quality health care coverage.”
The FDA continues to actively monitor drug availability and work with the company to confirm the supply is stable and help ensure patient access to safe, effective drugs. The FDA is currently working to determine if the available supply of tirzepatide would meet our definition of a Resolved Shortage.
The Federal Food, Drug, and Cosmetic Act defines a drug shortage as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug. FDA tracks shortages at the national level and receives information from manufacturers about their ability to supply the market. We consider a drug to be in shortage when the total supply of all versions of a commercially available product cannot meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the patient level.
The Drug Shortages Database lists product information as it is given to FDA by the manufacturers. This information can be helpful to pharmacies and other bulk purchasers when trying to source specific products, strengths, or vial sizes during a shortage. Although all dosages of a drug may currently be listed as available, the criteria for moving a drug off the Drug Shortages list must still be met. FDA will move a drug in shortage from Current Shortage status to a Resolved status when all the manufacturers are able to meet total national historical demand and the FDA will verify with each firm that they have built enough safety stock prior to resolving each shortage.
Additionally, FDA generally considers a shortage to be resolved and removes the product from the Current Shortage section of the list based on an evaluation of the entire market, assessing whether all backorders have been filled and supply is meeting or exceeding demand. In making this evaluation, FDA may consider, among other factors, affected market share, ability of alternate manufacturers to cover the demand, and confirmed market stabilization.
The FDA cannot provide a general timeline for when a drug may come off the shortage list because each drug shortage is assessed on a case-by-case basis. We work closely with the manufacturers throughout the duration of a shortage and will verify their ability to meet the national demand, as well as whether they have built enough safety stock, before considering it resolved.
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Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, federal facility, or by a physician (503A), as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility (503B). A drug may be compounded for a patient when an FDA approved drug is not medically appropriate to treat them. In these situations, compounding can serve an important patient need. Generally, when an FDA approved drug is in shortage, compounders may prepare a compounded form it if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.
Section 503A of the FD&C Act restricts compounded drugs that are essentially copies of commercially available, but certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.” When an FDA approved drug is on the shortage list, it is not considered to be commercially available. All other conditions of section 503A would have to be met, including compounding pursuant to a valid prescription for an identified patient.
Outsourcing facilities operating under section 503B of the FD&C Act are generally prohibited from making essentially a copy of an FDA approved drug. However, this limitation is lifted in certain instances, such as when an FDA-approved drug appears on the FDA Drug Shortage list. In that case, an outsourcing facility can use a bulk drug substance, also known as an API, to make a drug product that is essentially a copy of what is on the FDA drug shortage page.
Lyle Petersen, CDC [00:07:34]
So these bars show dengue incidence in Puerto Rico over this year.
And as you can see, since about the third week of this year, we’ve been above the epidemic threshold.
And generally when this sorts of things happen, it often portends a large outbreak as we get into the peak transmission season.
Time will tell what will happen.
So, we’ve had about 1900 or 1800 dengue cases reported in Puerto Rico. This is actually a drop in the bucket.
We mainly get reports from hospitalized cases, about 60% of these people have been hospitalized.
The true number of dengue cases is undoubtedly much larger.
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Lyle Petersen, CDC [00:08:53]
So you can see what’s happened in 2022, 2023 and 2019 in the lighter colored lines. Generally travel associated cases.
We do expect to start to increase as dengue starts increasing in the Northern hemisphere.
Most of this giant increase you saw was happening in the Southern hemisphere, as they were in the summer now going into the winter, but now we’re going into our summer peak transmission season.
So in 2024, we’ve had triple the number of travel associate cases, generally at a time when incidence of travel associated cases are low.
But that number has slowly gone down over time, just because of the Southern hemisphere is now going into winter, but we do expect this number to start to increase markedly as the Northern hemisphere starts to get more affected by dengue.
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Lyle Petersen, CDC [00:10:18]
What I want to do now is talk about the response to dengue cases in non-endemic areas.
Now, this is a guidance document that we are in the process of creating. It is almost done. But there’s a few tweaks that need to happen.
But in the meantime, I want to show you basically what this is going to be all about.
So this document will have, talk about three different areas.
How do you in investigate suspected dengue cases?
What happens if you have travel associated dengue cases in your area?
And what happens if local transmission occurs in your area?
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Lyle Petersen, CDC [00:13:30]
So the next would be how do you respond in travel associated cases?
So there’s three things that we consider.
One is our Aedes aegypti or Aedes albopictus present in the area, particularly Aedes aegypti, since that’s a much more efficient transmitter than Aedes albopictus.
The second, are you in an area that’s likely to experience or possibly going experience a local transmission?
And so what we’ve decide kind of arbitrarily defined this is have travel associated dengue cases been regularly reported in your area, or has local dengue transmission occurred in the past in the area?
And this would be primarily places, mainly places in south Florida or southern Texas, but also elsewhere to a lesser probability.
And the other thing is what is the probability of dengue transmission in your area?
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Lyle Petersen, CDC [00:19:41]
So areas with a moderate probability of dengue transmission, one is to inform healthcare providers to consider testing for dengue in patients with compatible symptoms, after excluding more common causes of febrile illness.
This is probably the most difficult part of this guidance because of, obviously, that dengue, many of the symptoms of dengue kind of overlap with a lot of other things that are not dengue.
And so trying to figure out exactly when to test for dengue and when to not test for dengue is a little bit difficult.
So we’re– that’s one of the areas that we’re still working on, on the guidance, when exactly would we recommend testing for dengue?
I mean, in a person who basically maybe hasn’t traveled, so that’s one issue that’s complicated.
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Lyle Petersen, CDC [00:22:57]
If you do have local transmission, you might want to think about increasing surveillance, offering dengue testing and gathering information on recent febrile illness for other household members in particular, and strongly consider enhanced surveillance around the home, particularly if the source of dengue introduction is unknown.
So you can also go door to door trying to identify additional cases, which can help.
And also testing Aedes aegypti mosquitoes for dengue infection using RTPCR.
We get a lot of questions about whether you should do mosquito surveillance around for dengue around local transmission cases.
It’s an adjunct to looking for human cases and it’s also pretty labor intensive. And the more traps you put out, the more likely you are to find it, but it’s not a particularly sensitive way of finding dengue transmission in area.
But if you do find it, it clearly confirms that there is local transmission risk ongoing.
Healthcare provider outreach is important.
If you do find local transmission in your area, certainly you want to warn healthcare workers because we want people to get properly diagnosed and treated, and to be for healthcare workers to look out for it, because they don’t– dengue is clearly not going to be first on their mind when they see a patient in the ED or elsewhere.
And also consider testing for dengue and people with compatible symptoms.
Also reporting is key. We want to know where these cases are important for both the state and local health department, as well as us and to monitor the situation nationally.
And continuing mosquito control educational campaigns as well.
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Lyle Petersen, CDC [00:25:36]
So how can you help?
Continuing to raise awareness about the increasing risk of dengue, particularly among travelers, thinking about local transmission and certainly we’re coming into the peak transmission season for dengue.
So being alert is critical, and also making sure that clinicians are trying to get clinicians to order FDA approved diagnostic testing for dengue.