tinalexander.github.io / notes / 2023 / 07 /
Learn more about this site and how to get in touch.
Thanks for your patience. The Alliance can provide this official comment:
“The Long COVID Alliance is both encouraged and concerned by the announcement today from NIH about their upcoming launch of clinical trials under the RECOVER initiative. We welcome the NIH’s efforts to finally fund much needed and long overdue trials on Long COVID, which has left tens of millions of Americans severely disabled. Today’s announcement unfortunately leaves many important questions unanswered and seems fraught with the same lack of transparency that has become all-to-familiar with RECOVER and its $1.15 billion budget. We continue to voice serious concern about the trial design and process transparency, given the historic and ongoing omission and invalidation of the patient voice and experience, some of which we have seen through released or proposed manuscripts. If the patient community had been made a full and respected partner in this process, we would have seen a very different set of priorities and clinical trials. Additionally, the Alliance is concerned that the NIH has not presented a timeline for results: They have highlighted that enrollment will begin over the next several months, likely meaning that results to benefit many millions with Long COVID are still at least a year away. By then, Long COVID will have been with us for over four years, an unacceptable wait for patients to see meaningful results from this billion dollar investment.”
I’m glad NIH is finally funding much needed clinical trials on Long COVID, which has left millions of Americans severely disabled, however I have serious concerns, because patient input on the research priorities and trial designs was largely ignored.
For example, to study cognitive impairment, which research shows is related to reduced blood flow to the brain when standing, inflammation, and coagulation problems, NIH chose to study what is essentially a computer game, not a treatment that actually addresses the underlying biology that is causing cognitive impairment in Long COVID. This is a huge let down for patients.
NIH was late to start the clinical trial planning process, and then once it started in fall 2022, there was so much pressure to get these trials launched quickly that patient input was often sidelined.
There is a difference between patient engagement for public relations purposes, and meaningful patient engagement. There hasn’t been meaningful patient engagement for most of these trials.
Rachel Levine, HHS [00:07:43]
Today, HHS is announcing the official formation of the Office of Long COVID Research and Practice to continue current efforts to lead the whole of government response and coordinate across the federal government in the areas of research clinical practice supports and services, as well as public education.
…
Larry Tabak, NIH [00:10:42]
A single treatment is unlikely to work for everyone. Now for any clinical trial investigators define how success will be measured or how they will know if a treatment works for its intended purpose. And unfortunately, a high percent of interventions evaluated and clinical trials fail to reach the threshold of success.
The Recover trials are focused on treatments for some of the symptoms that patients report are among the most burdensome. The trials can test multiple treatments simultaneously and be quickly adapted to evaluate new therapies. They are designed not only to stand on their own, but also to inform one another while each trial focuses on certain symptom clusters, they also collect data about the impact of the intervention on a broad range of symptoms.
Collectively, this integrated set of trials could inform clinical care and a broad range of long COVID patients. Our hope is that these treatments will work. However, we may learn that some interventions do not provide measurable relief, and this will also inform patient care. Importantly, we can be confident in the conclusion that emerge because, as always, we have taken a scientifically rigorous approach in designing these trials.
…
Walter Koroshetz, NIH [00:15:03]
The clinical trials has developed platforms to actually address each of those symptom clusters, not with one drug, but a platform where multiple different treatments can be tried, some drugs, some non-pharmacological treatments, until we see where the successes are.
Now, we haven’t actually been able to understand what are– what are the actual determinants of different patient symptoms in terms of their underlying biology. There are a number of drivers that there is some evidence for, but not clear cut at this point.
…
Kanecia Zimmerman, Duke University [00:18:17]
The trials will be phase two trials. So the goal of these trials is to evaluate safety and efficacy of interventions.
We want to see whether or not the interventions are gonna work to help with long COVID symptoms, but also to make sure that those interventions are safe. We also will be learning how the interventions might actually be working in the bodies. So what’s the path of physiology that’s allowing these things to actually work or what’s happening, done to prevent it from working.
All of these things hopefully will be learned within these phase two trials. These two trials are smaller in general, they’re usually 100 to 300 participants per intervention, but this allows us to kind of get to our goal, not only evaluating the intervention, understanding whether or not works, evaluating the safety and understanding how things are actually working.
These trials are, are designed as, as Walter mentioned, to be within platforms, so that we can rapidly and efficiently understand and add additional interventions as we learn more. So if one intervention doesn’t work, we can rapidly add something else to this particular platform.
…
Kanecia Zimmerman, Duke University [00:22:29]
We anticipate that the RECOVER sleep protocol– sorry, RECOVER Neuro protocol will be launching actually within the next couple of weeks. The other protocols will be in probably two to three months.
…
Kanecia Zimmerman, Duke University [00:23:15]
So these are phase two trials, so they certainly are smaller than our– the phase three kind of confirmatory studies. Phase two trials in general include approximately 100 to 300 participants per intervention, and sometimes per arm.
The viral persistence protocol is looking to enroll approximately 900 participants because there are three different arms. Each of the protocols or the platforms have different inclusion criteria.
One of them obviously is that the patient has to have some description or display of long COVID. But there are a number of specific other inclusion criteria that would be for each of those specific trials.
…
Kanecia Zimmerman, Duke University [00:24:53]
We are building the ship while sailing it in some ways. So certainly we are attempting to fast track these trials, but we do know that there are a lot of things that have to happen for trials to launch. Some of those things are the development of the protocols, agreement, we’ve had a number of different people who’ve been involved, from patient communities to experts in the field, even understanding long COVID itself. So what is it that we’re studying? How do we isolate it to something specific that we can identify and then study to evaluate, whether or not, there are accurate measures, accurate endpoints, etc.
That process then goes through multiple governing bodies specifically, looking at the groups like the DSMB, the data safety monitoring board, who needs to make sure that they also feel comfortable that the trials and the studies and the protocols as they’ve been designed, not only will help us get to an answer, but will also keep people safe. And in some cases there also needs to be evaluation by the Food and Drug Administration.
So this process certainly takes a long period of time, but we have been working very hard to make a– to get to this point.
…
Larry Tabak, NIH [00:28:46]
The trials that are currently planned are funded through completion. Obviously there’s a lot to learn and, given the wide breadth of clinical symptoms, there’s no question that multiple additional interventions will be need testing in the future as the opportunities arise.
…
Walter Koroshetz, NIH [00:31:00]
The IVIG is looking at the potential for autoimmune cause of– but there’s also a drug, Ivabradine, that we’re testing the autonomic POTS protocol. And that is to kind of control heart rate, which is one of the major troublesome features in postural orthostatic tachycardia syndrome, or tachycardia is a word for fast heart rate.
…
Adrian Hernandez, Duke University [00:32:37]
So, in terms of the Stanford study, so I guess, as was publicly announced that was stopped early. It was not stopped due to any safety concerns. We don’t have the full results of that study, so they’re still closing out the study and completing follow for all the participants in. And so we hope to see those results at the beginning of the fall or mid or late fall.
As regarding the Paxlovid study or Vital, certainly we take into consideration anything that comes out that’s emerging data externally or within the Recover cohorts, for instance, it is an adaptive platform study so that we need to make adjustments or adapt, we can do so.
The final comment is that we know in science, in general, there is often different interventions that are tested in different populations or different durations. And so you may have different results. And so of note, for the Vital study or the study that’s being launched for Paxlovid here in Recover, it does have a different population and different elements in terms of how we’re studying the intervention here with Paxlovid. And Kanecia can add anything in terms of differences.
Kanecia Zimmerman, Duke University [00:33:59]
Now, one of the major differences is the, certainly in addition to the inclusion and exclusion criteria for the particular participants, the endpoints, as Adrian mentioned, but also the duration of the drug is different in this particular trial.
We’re actually doing a longer duration of Paxlovid, just trying to get at that idea of viral persistence, and knowing that if it’s been there and causing symptoms for a prolonged period of time, we really want to try to give it the best shot possible while still being within the realm of safety.
…
Kanecia Zimmerman, Duke University [00:44:25]
We did have the initial study that was designed and we were able to get some good feedback from Food and Drug Administration, as well as others, to really beef up the design and make sure that we were getting the answers that we needed.
The current design tests not only 15 days of Paxlovid, but also 25 days of Paxlovid, to evaluate this idea of viral persistence and whether or not longer durations in fact are better than shorter durations.
With the help of the Food and Drug Administration and with, lots and lots of experts across the country, we did come to a sample size of 900 because this is a phase two trial, as opposed to the original larger trial that we designed.
…
Walter Koroshetz, NIH [00:50:05]
So each of the potential treatments came in with preliminary data and a rationale. And then we had an expert group that formed around each of these platforms and the expert group and the neurocognitive space chose these three as the most promising to test.
The Mount Sinai has been very active in treating people with long COVID and they have a come into a Recovery battery that they’re using and have a pilot study. The Brain IQ was recommended by a number of different applicants, based on its previous track record.
And then the transcortical stimulation something that’s a little out of the ordinary, but it’s being studied in many labs around the country. We’re actually doing a trial in and seeing if it helps post-stroke recovery. The idea behind it is that it– the electrical stimulation enables the brain to form synapses more quickly and accurately in concert with a rehab type program. So that’s kind of the rationale behind these three.
…
Kanecia Zimmerman, Duke University [00:51:37]
As far as the neuro study itself, we expect that it will be launching in a couple of weeks. It’s a several week long study. So we’ll take, you know, several months to get to our point of getting results from that.
Mount Sinai, as Walter mentioned, has a pilot program that’s ongoing, they’ve had some preliminary results that have come out, as you mentioned, also, there is their program, their cognitive training program, is based on a track record of proven success in other disease states as well. It’s been modified somewhat for patients with PASC, but they have been successful in, in their initial evaluation. We expect that over the coming weeks, we would have some initial results from their pilot study as well, and use that modify things as needed, given the flexibility of these trials.
…
Walter Koroshetz, NIH [00:58:20]
It’s safe to say that, uh, the other issue that we all are grappling with in any of these trials is to make sure that everything we do is safe and the patients are monitored so that there are no untoward effects. And the particular concern with regard to exercise is a signature of ME CFS, which is called post exertional malaise.
And that just to be simple explanation is that people who have trouble with exercise and fatigue, a lot of the other symptoms that go along with long COVID, their symptoms may go up and down and on a good day, for instance, they may try and go out to the store and carry their packages home, something you wouldn’t really think of as being, you know, big exertion, but for them that’s a, could be a really good day for them to be able to do that. The problem is that some of those folks experience basically a crash where the next two or three days they feel terrible and they can’t get out of bed.
So that’s kind of a simple explanation of the problem that in any kind of an exercise trial in long COVID, we have to be really, really careful that we’re not making people worse. And so I think the group is really working on how to do that, how to be really monitoring everything. So everything’s safe and picking people right, understanding the protocol, and how it’s working before you open it up to people who may have more risk of that kind of a problem.
So I think that’s the kind of thing that, as I said in the beginning, these are hard problems, and it’s really important to do things right, because they can really backfire if you just pull the trigger quickly. And so that’s what I think that the group is doing now.
…
Walter Koroshetz, NIH [01:01:06]
So for the sleep study, so it turns out that sleep architecture is, can be very disturbed, post COVID, and some people have trouble that they have un-refreshing sleep.
And so we’re testing melatonin, which is a sleep promoter, and light therapy, which is, can also be used as sleep promoter, and an educational coaching system to coach people on how to really get sleep health, for those who are having trouble with un-refreshing sleep.
Now, some people also on the other hand have the opposite kind of a problem where they have daytime sleepiness and there we’re testing modafinil, which is a alpha adrenergic agonist, kind of a mild stimulant. We use it in neurology for other conditions and another drug called solriamfetol, which is a neuroepinephrine uptake blocker. And these would, if they work, will make people more vigilant during the day
And the autonomic study. Is that the other question?
So the autonomic study is testing intravenous immune globulin. So that’s an immune suppressant. It’s used for instance, in people who have Guillain Barre syndrome, which is an autoimmune attack on their nerves.
And the thought here is that the postural orthostatic tachycardia syndrome, could potentially be related to a autoimmune attack on the autonomic nervous system.
And the other drug is ivabradine, which is a drug that is used in chronic heart failure. And it can lower the heart rate, which is the one of the problems in postural orthostatic tachycardia syndrome.
Mandy Cohen, CDC [00:15:41]
We are looking right now at what’s happening with flu in the southern hemisphere.
Flu happens earlier, for them, season wise. So right now they’re having a pretty, I would say, average flu season, which is good news so far, but we’re watching it closely to see if anything changes.
Senior HHS Official 1 [00:08:10]
This entire call, including remarks and QA, will be on background attributed to a senior HHS official.
…
Senior HHS Official 2 [00:09:59]
I wanted to level set a little bit and make sure folks know that it will be months before we start seeing data on where people leaving Medicaid are going, because the Medicaid renewal process runs through June 2024. We won’t have final coverage numbers until the process is completed.
That being said, we are laser focused on making sure that people have health insurance. This continues to be an all hands on deck effort. We are working with our partners in the public and private sectors to directly reach Medicaid enrollee and help them complete their renewals. And if appropriate, we will connect them to other coverage. People deserve healthcare, and it is our top priority to ensure that Americans have access to health insurance.
…
Senior HHS Official 2 [00:11:57]
The secretary has issued a third letter to all states, reminding states, again, of their obligations under federal law and further urging states to review the initial data we are releasing today to ensure that all options to streamline the renewal process for people have been advanced. If states aren’t complying with the law, we have tools to enforce it.
…
Senior HHS Official 3 [00:13:04]
We’re posting data today that shows where the first set of states that started Medicaid renewals in the first two months, so March and April, what what their data are. You’ve already seen likely some version of those numbers. States have posted various pieces. They’ve been compiled by a range of our partners and the community.
This is the official version of those old data today. It’s all posted on medicaid.gov. It gives the public a really transparent view of the Medicaid renewal process, how states are doing on their operations, like call center, wait times, and the like.
…
Senior HHS Official 3 [00:16:14]
We are from here on out going to be updating this data every month, the official version, if you will, after cleaning through making sure that it accurately reflects each state’s data. And then in September, we’re going to be able to start sharing actual transition data. It will still be early, of where people who disenrolled from Medicaid went, again, [Senior HHS Official 4] will go through some early indicator data that we have, shortly.
And to that point, it’s important to note that the data that you’re seeing here today, that you’ve been looking at across states, is only one part of the story. Many people leaving Medicaid will continue to receive coverage through their employers, through the marketplace, Medicare, etc. And so we will have more data in the coming months, as folks transition to other forms of coverage. And as we then, with a lag, get that data, and can report out on that.
Again, you’ve seen a version of the numbers that we’ve gone through, and what’s really important is this type of granular data, this official version, and the things that we intake from states and digging on there, along with other credible information from the community there, what we’re using every day to scrutinize and monitor what’s happening on the ground in every state to take action in individual states where needed.
…
Senior HHS Official 3 [00:18:50]
You’ll also see when you dive through some of the data tables, that the percent of people that a state successfully renewed automatically using electronic data sources, we call that ex parte renewals, really ranges across states, from single digits up to 65%, and call center performance metrics vary a lot as well.
The second thing to note, the data shows clearly that some states are doing better than others. There is variation in state performance and in state outcomes, and we’re calling on every governor and the secretary’s letter to governors today continues that, to ask states to do everything in their power to keep eligible people covered. It’s clear that some states need to take more action to improve, and we can talk more about that. And we put out many policy waivers and flexibility. Most of the states have taken us up on them.
…
Senior HHS Official 3 [00:21:32]
Arizona, Ohio, and Connecticut, for example, have the highest rates of being able to successfully auto-renew people based on electronic data sources. And we want to continue to build on that list, with all states and we are requiring and digging in with states to make sure that they are following the federal regulations on auto renewals. It is a substantial area of focus for us at CMS.
…
Senior HHS Official 4 [00:23:18]
We are using all of our tools to ensure that, when individuals get redetermined for Medicaid and CHIP, they end up in the right coverage. Again, whether that’s continued Medicaid or CHIP or, for those folks that are no longer eligible that they make that successful transition, to Medicare, employer coverage, or the marketplace.
For those individuals no longer eligible, coverage transitions are, unfortunately, not seamless. This is our reality. They take time and effort, and active steps on the part of the individual. The very initial data that we’ve been seeing from states and marketplaces that we are posting today is square one of that coverage transition journey.
…
Senior HHS Official 3 [00:28:14]
I would say our team had to do substantial cleaning with states of the data. We actually think this data and this level of transparency is incredibly important, both for unwinding in the future. And many of these metrics have never been collected or consistently measured before.
We’ve encouraged states, for the past year to, well to be as transparent as possible, as soon as they had numbers to post them online, for the public, for advocates, for the community to see, and then to work with CMS to make sure that states were meeting the data reporting standards that we outlined as part of federal statute. So, we certainly had quite a fair bit of work to do, since this was the first time ever that states have reported these really critical metrics to the federal government.
And so, this is the official version of many versions that you have probably seen states posting individually, and others helping to aggregate up.
…
Senior HHS Official 3 [00:29:16]
There is a detailed PowerPoint you can see that those through a ton of historical data on what historic churn and coverage loss, or folks losing coverage or, enrollment for Medicaid and coming back on, or going to other forms of coverage. The really key takeaway historically is, there was always a lot of what we call churn, and 17 million people lost coverage, or disenrolled from Medicaid in 2018, on an annual basis.
But for us right now, our goal is to make sure that everybody has a chance at either knowing what’s happening and maintaining eligibility for Medicaid, or successfully, as [Senior HHS Official 4] noted, transitioning over to other forms of coverage that they’re likely eligible for. And that really is a huge part of our focus with states.
…
Senior HHS Official 3 [00:33:04]
We will be updating this data every month. So, next month in August, we will post May data, and the month after that, June data, and so on and so forth. And as [Senior HHS Official 4] mentioned, um, earlier, too, as soon as we start to have data on knowing when definitively where folks that are disenrolling for Medicaid have transitioned to, we are going to start reporting that as well.
For the cases that are pending at the end of each month, that is one of the areas of data we’ve been working through with the states. Our hope is to be able to find some simple way to report out on that and to have the states report out what on what’s happening. Obviously this is a rolling process. So every month there are pending applications that states are working down, and there’s the next month’s report. So we’re trying to find a way to keep it all quite useful for folks and manageable.
And that is a subject of what the teams are going back and forth on what states.
…
Senior HHS Official 3 [00:38:06]
And as I noted before, we’ve spent the past few years putting out a lot of these policy options that we can’t force states to take up, but are urging.
Florida is the only state in the country that has not taken us up on any one of those policy options. And we have continued to push Florida, Texas, and every state, to take up every one of those policy options that will, by definition, help keep eligible people enrolled in the program.
…
Senior HHS Official 3 [00:39:12]
I think it is really important to have the official version. I think we had a question earlier about, you know, how accurate the initial data releases from each state are. That really varies. And it’s important to have an official source of truth that we know is accurate. And you really can see things presented in one place, and compare the states on a whole range of metrics against each other. That’s important.
We believe for the public and for providers and advocates and others in the community. And we think it’s also really critical for our team. And I would emphasize our team and others are constantly using both this data. And certainly we like everybody else are looking at the raw data that the states are posting, whether that’s fully accurate or not. But that certainly informs I think where our partners in the community and, so do we, dive in with states.
…
Senior HHS Official 3 [00:40:46]
I think it’s too early to determine exactly that, because each state has a different cadence of how they’re doing things. I think the bottom line is clear though, we want to make sure that folks stay covered, whether that’s through Medicaid or all the work to make sure folks get over to employer sponsored coverage and Marketplace.
And our push with every state is not only to follow the federal minimums, which we’re holding people’s feet to the fire on, but really as the secretary has continued to call governors to do, states need to do everything and their power above and beyond the federal minimum, to help keep eligibility people in Medicaid, or to help folks successfully transition to other forms of coverage.
The FDA is aware that the CDC is working with the Florida and Texas state health departments on an investigation of locally acquired cases of malaria in their respective states. The FDA is working closely with CDC and blood collectors to monitor reports of locally acquired malaria and to help ensure the continued safety and availability of the nation’s blood supply.
All blood donors are currently asked about a history of malaria, and routine measures used to determine blood donor eligibility prevent individuals with symptomatic infections from donating blood. For example, blood donors must be in good health and have a normal temperature on the day of donation. At this time, the FDA has not recommended additional precautions or deferrals from blood donors in areas of the United States with reported locally acquired malaria transmission.
Information on the Agency’s recommended donor deferrals as it relates to the risk of transfusion-transmitted malaria can be found here.
Recent emergency department (ED) data indicate that COVID-like illness is increasing across all age groups in Louisiana. No COVID-19 healthcare-associated infection clusters have been reported recently among ages 0-11 which may be an indication that this age group is experiencing a greater increase in COVID transmission compared to other age groups. However, it is important to note that ED data can reflect differences in healthcare-seeking behavior across different age groups.
On background:
The U.S. Department of Agriculture’s Agricultural Research Service (ARS) has completed initial testing of four highly pathogenic avian influenza (HPAI) vaccine candidates. While improved biosecurity measures have vastly reduced the number of detections of HPAI in the commercial sector in 2023, ARS began testing for vaccine candidates in recent months as part of USDA’s commitment to leave no stone unturned in the fight to mitigate this virus. ARS scientists evaluated two HPAI vaccines developed in-house by USDA and two commercial HPAI vaccines. The first study results showed that the four vaccines reduced oral and cloacal virus shedding significantly and provided 100% clinical protection, but more research needs to be conducted to evaluate the duration of immunity in chickens from the different vaccine candidates through this fall and winter.
ARS scientists have also continued to work on vaccine testing. A second study is currently underway with live vectored vaccines and we anticipate results from this study will be available in early fall. This study includes two commercial vaccines that are licensed in the U.S. and a vaccine developed by ARS.
USDA continues to estimate an 18-24 month timeline, under a best case scenario, before having a vaccine that matches the currently circulating virus strain, available in commercial quantities, and that can be easily administered to commercial poultry. USDA will continue the collaborative efforts with poultry farmers and companies on education, training and implementation of the comprehensive biosecurity measures proving to be a best defense against HPAI.
Currently, biosecurity measures remain the best, most effective tool for mitigating the virus in commercial flocks, and improved biosecurity measures by the commercial industry have vastly reduced the number of detections compared to previous outbreaks. There has been one confirmed case of HPAI in the United States since May 18, 2023. In contrast, there were 64 confirmed cases of HPAI from May 18, 2022 through July 24, 2022. Also, since April 19, 2023, there has been one commercial premise confirmed positive for HPAI. As of July 13, 2023, 31 states are considered HPAI-free according to World Organisation for Animal Health standards compared to three states last year at this time and 17 states three months ago (April 13, 2023). More information about APHIS’ efforts to work with industry as well as state and other federal partners to manage the outbreak can be found here.
Jamie Carson, Sarasota County [00:01:43]
We had a case that was first identified as a positive malaria case May 24th. We’ve continued to have additional cases. And as of today, we have confirmed seven cases of malaria in Sarasota County that we believe to be locally transmitted. Three of those seven cases occurred in homeless individuals. All cases occurred in north Sarasota area, and our focus continues to be on the areas of the neighborhoods of DeSoto Acres and Kensington Park. All individuals have been treated and are recovering.
To put into some context about the situation cases are identified in our local healthcare system and treated immediately. However, cases are not considered confirmed until the laboratory samples have been verified in the state public health laboratory and with the CDC.
It’s important to note by, that by our local public health response and that our local mosquito management services response, happens immediately upon the potential of a suspect case, that we do not wait for it to be confirmed. So our response actions occurred immediately upon there being a potential case.
…
Jamie Carson, Sarasota County [00:02:47]
Because of the extended timeline for the parasite to move from human to mosquito and back to humans, the mosquito borne illness alert will remain up until we approximately eight weeks without any new cases. So if you’re tracking that, our last positive case was July 13th, we’re looking at a potential eight weeks that would put us about the September 7th mark.
…
Audrey Lenhart, CDC [00:06:57]
The goal of sequencing the genome of the parasites that were found in the individuals and in the mosquitoes is to just confirm that we do have a closed transmission loop.
If we find genomes that are sufficiently similar between what we’re seeing across the human patients, as well as in the mosquitoes, that just increases our level of confidence that it was a closed transmission loop that, once we don’t see more cases, that the transmission has truly stopped.
…
Audrey Lenhart, CDC [00:08:38]
We do think it’s going to take a bit longer. The team in the lab back at CDC is trying out some new protocols to try to do this in a way that will be able to link both the parasites from the humans to the mosquitoes. And this is something that’s going to take several more weeks to be optimized and for results to be generated.
…
Jamie Carson, Sarasota County [00:10:36]
So outreach continues to all the homeless services, through all the homeless service organizations, with information, repellent, and as well as mosquito bed netting and distribution. And I have some numbers for you.
Over a thousand cans of repellent have been provided to those individuals who are homeless, especially focused in those areas of Desoto Acres and Kensington Park, and as well as 60 bed nets as well so far.
…
Audrey Lenhart, CDC [00:12:07]
I just want to echo what Jamie was saying that it really is an exceptional operation that Sarasota has for mosquito control and it’s a tribute to their fast action and continued action that the mosquito populations were reduced significantly and that this outbreak wasn’t worse than what we’ve seen.
From: Wuth, Chelsea (DHHS)
That is all of the information I have at this time.
…
From: Tin, Alex
Okay, thank you for getting back to me.
Are you able to confirm if they were hospitalized?
…
From: Wuth, Chelsea (DHHS)
Alex,
The swine flu patient is alive. They were an exhibitor at the Oakland County Fair.
There was one additional case of melioidosis identified in Mississippi in January 2023 through routine clinical testing. This case resides in the same Mississippi county as 2 other cases from 2020 and 2022. There have been no additional reports or alerts from CDC besides the alert released in July 2022 after the bacteria that causes melioidosis, Burkholderia pseudomallei, was identified in the soil samples from [Mississippi : HAN Archive - 00470 Health Alert Network (HAN) (cdc.gov)](https://urldefense.com/v3/https:/emergency.cdc.gov/han/2022/han00470.asp;!!Om87Lau1Cg!JVYx7PjpLllZxmL9ZEJO8LD2XQ_b1OWHX8fP1UNQKL83O3Jq0lNzR4FLoSF1YJXVZ65lNAaCWeUs4w$). A manuscript describing the first two cases and the epidemiologic/environmental investigations is expected to be published this year. CDC continues to work with health officials in Mississippi to monitor for additional cases and learn more about where the bacteria may be found in water and soil in the Gulf Coast state.
U.S. COVID-19 rates are still near historic lows after 7 months of steady declines. Early indicators of COVID-19 activity (emergency department visits, test positivity and wastewater levels) preceded an increase in hospitalizations seen this past week.
The U.S. has experienced increases in COVID-19 during the past three summers, so it’s not surprising to see an uptick. At this time, CDC’s genomic surveillance indicates that the increase in infections is caused by strains closely related to the Omicron strains that have been circulating since early 2022.
CDC’s guidance for individual and community actions around COVID-19 are tied to hospital admission levels, which are currently low for more than 99 percent of the country. To check COVID-19 hospital admission levels in your area and see CDC’s related prevention advice, visit www.cdc.gov/coronavirus/2019-ncov/your-health/covid-by-county.html.
From: Tantibanchachai, Chanapa
That’s really all I have to share right now, but I’ll keep you updated!
From: Tin, Alex TinA@cbsnews.com
Thank you!
Can you confirm if an FDA team is on site, and what role they are playing?
Sent from my phone (202) 381-7107
From: Tantibanchachai, Chanapa
Hi Alex,
Please see our statement on this: The FDA is aware of this incident and are grateful that the plant’s employees are unharmed. We are following the situation closely as it evolves and are working with the company to understand the extent of the damage and any potential impact to the nation’s drug supply
Thanks, Chanapa Tantibanchachai, M.S. (she/her/hers)
Dr. Alison Ridpath, CDC [00:04:00]
None of the cases reported recent international travel. At this time, there is no evidence to suggest that the events in Florida and those in Texas are related to one another.
All eight individuals with locally acquired vivax malaria are adults and the clinical presentation for all have included fever. 88% were hospitalized. To date, all eight individuals have received oral antimalarial treatment, including medications to prevent relapse disease, which we’ll review in more detail later, and all have recovered.
..
Dr. Alison Ridpath, CDC [00:08:23]
Since the 1970s, the number of imported malaria infections reported in the U.S. have increased steadily predominantly due to increases in U.S. residents traveling to malaria endemic countries. In our most recent complete data from 2018, almost 2,000 malaria infections were reported. That would be more than five cases on average diagnosed per day in the U.S. However, most of these infections occur during the summer months due to increased international travel.
Importantly, malaria is a potentially serious illness and there were between six and seven malaria attributed deaths in the U.S. each year from 2018 to 2020. Although malaria cases dipped early in the COVID 19 pandemic because of reduced travel, our preliminary data show that the number of malaria infections has rebounded in 2022 to reach pre-pandemic levels.
Patrizia Cavazzoni, FDA [00:08:19]
So you ask how significant the advisory committee’s recommendations, am I correct?
So we really greatly value the input of the advisory committee experts, when we determine that we need that input as part of their review of an application.
And so, obviously we listen very carefully to what we heard from the advisory committee.
At the end of the day, when we take, make decisions about approval, we have to rely on the data and we need to ensure that the data meet the standards for approval. So it all comes down to the data.
Having said so, it was very informative for us to hear the perspectives of the advisory committee on this particularly complex application.
…
Question [00:14:21]
During the advisory committee, the FDA had concerns with the data that the sponsor submitted. How did they resolve these concerns enough to approve the drug?
Patrizia Cavazzoni, FDA [00:14:33]
So I will get us started and also invite Dr. Murray to chime in. I think that the data were particularly complex– this was a complex review, where ultimately the review team had decided that we needed to have input from the advisory committee. And we really leveraged the information that we got from the advisory committee to also help us sort of work through some of those outstanding questions.
At the end of the day, we took back what we heard at the advisory committee, we relied, as I said, on the data that is really foundational for us, and put all that against the standards that we have to– that the data have to meet for us to determine that the drug can be approved. And we concluded that the data were– did support approval based on, on those standards. Karen, Dr. Murray, do you have anything to add?
Karen Murray, FDA [00:15:50]
Just a bit. So, the applicant conducted multiple consumer behavior studies to support their application. And the question is referring to one of those studies called Access that did have some data concerns, namely, that it appeared that people wrote down that they had taken more tablets than they were actually dispensed. And so that made us question whether we could rely upon the data from that study.
However, we had plenty of other information from the other consumer behavior studies that were conducted as a review, to support the study, as well as five decades of use of the product, and also literature information. So we had plenty of data upon which we could rely.
And in terms of the data from Access, although we couldn’t answer certain questions with it, we could get information from it about safety and also about the incidence of pregnancy in a real world use setting.
So we had, in the end, sufficient information to feel scientifically confident that the benefits of the use of the product and the non-prescription setting outweigh the risks.
Patrizia Cavazzoni, FDA [00:17:13]
And one of the things that I would like to sort of add, that at the end of the day, the sort of the most important outcome that we are interested in when evaluating oral contraceptives is the Pearl index, which is a standard measure of contraceptive efficacy. And, as you heard earlier from Dr. Wen and Dr. Murray, the Pearl index for the non-prescription norgestrel was in arranged similar to what is seen– has been seen with other oral prescription oral contraceptive agents.
…
Karen Murray, FDA [00:18:32]
The drug is approved for use by all people who can– who have reproductive potential, all people who can become pregnant. So there is, under the approval, no age limitation.
“The Department’s wastewater surveillance is active and ongoing, and remains a critical component of the State’s COVID-19 and polio response. One year since the first case of polio was reported in New York State, the Department continues to be vigilant in its approach to identifying the virus in communities. In fact, the Department has expanded the program’s capacity and is now performing critical first-stage testing for polio at its own Wadsworth Center, which greatly increases the capacity and timeliness of testing. At this time, the Department has no plans to discontinue its wastewater surveillance for the poliovirus as it is an important public health tool, providing information on where and when the virus may be found.”
Additional Information:
Following the New York State Department of Health’s identification of a case of paralytic polio in Rockland County in July of 2022, Department officials quickly adapted the existing wastewater network—partnering with CDC and local entities—to test for poliovirus. These monitoring activities, now based at the Wadsworth Center, enable the State to assess communities for signs of circulating polio and prioritize the public health response to residents in areas most at risk.
Please see our latest press release detailing the $1.7 billion investment in Wadsworth Center in Governor Hochul’s enacted budget, here.
Please see the Department’s press release from January announcing the expansion of the wastewater surveillance program, here.
In addition to COVID-19 and polio, the Department is exploring the possibility of expanding its wastewater and environmental surveillance to include other potential public health threats under its research portfolios.
Chiquita Brooks Lasure, CMS [00:16:50]
Dan Tsai will tell you a little bit more about what we’ve been doing, including examples of some of the actions we’ve taken to ensure states follow federal requirements. I do want to be upfront about one thing in this discussion. We are not gonna name states at this time. At this moment, states have been working very collaboratively with us and proactively and where we have found problems. We want– they’ve been able to address them. And so we want to keep those lines of communication open.
Our priority is getting people covered and keeping people covered. However, if the day comes where stays fail to comply, we won’t hesitate to make that information public.
…
Dan Tsai, CMS [00:19:00]
We are very concerned about the level of terminations, meaning dis-enrollments that we are seeing across in the country. And in particular, we’re very concerned that the majority of people that have been– that have lost coverage have lost coverage for what we call procedural reasons. Meaning the state has not affirmatively been able to identify that someone is ineligible, but the individuals have not responded. And that could be due to lack of awareness, wrong addresses people not getting a Medicaid renewal form in the mail.
We want to make it clear. We are using every lever that Congress has given us to hold states accountable, to following all the federal requirements for Medicaid renewals. Federal regulations outline a range of processes that all 90 plus million people enrolled in Medicaid are entitled to. And we are using those levers and holding states accountable to following every one of those pieces.
…
Dan Tsai, CMS [00:20:48]
If we find a violation, and when we have in a range of states, I want to be clear, we are not pulling punches in terms of making sure that folks are holding to what they’re required to from a federal regulatory standpoint and ensuring that individuals are held.
I would emphasize, as with every one of those situations to date with states, where we’ve identified an issue, and directed states to pause procedural terminations, reinstate people and make remedies, our states have responded to that. They have complied and we have collaboratively identified ways to make fixes while holding enrollees harmless. And so that’s a very important point to emphasize.
…
Dan Tsai, CMS [00:26:12]
We’ve never had 93 million people enrolled in the program and had to renew, had to have states renew that number of folks, where states have not run renewals for over three years, that is unprecedented.
And second, just to underscore what the administrator noted, business as usual in the past included a lot of eligible people losing coverage for a period of time for procedural reasons, and then coming back onto coverage at a later point. That’s not something we believe we should accept the status quo in terms of folks having to go uninsured for a period of time. And we want to make sure we’re pushing our state partners, our public and private partners, all of us, to think about Medicaid enrollment and maintaining coverage, or transitioning to other coverage, in a different way.
So it’s much more equitable with how the rest of the world experiences healthcare coverage.
…
Dan Tsai, CMS [00:27:49]
We’ve had about a half dozen states where we have affirmatively identified an issue and required them to pause procedural terminations and reinstate individuals and, or, make other fixes it.
The situation varies by state depending on what the particular issue is. And I think second, what I would note is we are in discussions with probably a dozen other states, exploring a range of things that have come up. They require sometimes pulling case records and assessing what’s happening to help identify if there are other violations of a federal requirement, that we would then require the states to take the actions I mentioned.
…
Dan Tsai, CMS [00:30:38]
It typically involves one of the handful of pieces. For example, one of the things we are already focused on, and we have noted in our policy waivers that we put out to emphasize this, is that all individuals are entitled to receive a best attempt by the state to first match with electronic data sources to help auto renew someone if, to use that example, right, if some– the state had an income amount on record, could ping up against recent data sources and confirm that income level is still the same.
Individuals are required by regulation, or states are required by regulation, to auto renew those folks and send those folks the notice that they’ve been successfully renewed. One of the most common things we’re seeing is, due to a range of system glitches, certain populations don’t actually, the electronic data matching failed. Those individuals did not receive what they’re entitled to, which is the best chance of being able to match against data sources, and therefore you don’t have people chasing the mail.
And so where we’ve identified that that has been one of the most common issues where folks have had to pause procedural terminations and reinstate people.
…
Dan Tsai, CMS [00:32:28]
So we’re going to be making all of that data public, as soon as we– each– usually the states submit that to us, and we find a range of errors in what the state has submitted.
But we expect very shortly, for example, to release the full view of data, which compiles all the information we’ve been seeing at the state level. It reports on all the metrics that are required by statute for states enough to report out on. And it also allows us to report out on some of the operational metrics that we’re seeing at the individual state level, things like call center wait times and such.
So, folks should stay tuned. That will be coming very shortly.
…
Dan Tsai, CMS [00:33:36]
So on the first one, it really varies by state and how quickly they were or are able to remedy the issues. In some cases we have states taking an extra 90 days because that’s how long it takes for them to make a correction in their systems, such that individuals get the due process they’re entitled to. So really depends on how fast the state can remedy whatever issue
…
Dan Tsai, CMS [00:36:21]
So we will be releasing not only aggregate, but state level data that has been quality checked, very shortly, in the coming very small number of weeks
On the overall results, I think we had put out a fact sheet earlier that indicated, for the initial set of renewals, what we were seeing was about 45% of people being successfully renewed, and about a third of, or so, folks being disenrolled with the majority of those being due to the procedural terminations that I mentioned.
And on the question of where folks are getting to for other coverage. I think that the administrator just touched on that. We are seeing an uptick operationally in volume at the ACA marketplaces, healthcare.gov. There’s a lag in the data, but we will have more specific data matching this fall to be able to quantify how many people transition to other forms of coverage.
Our goal, to underscore, is to make sure that we are preserving as much of the gains in historically low uninsurance rates as possible.
…
Dan Tsai, CMS [00:38:20]
Most of those are actually outlined by Congress in the statute that was passed at the end of last year. The most salient financial lever that we’ve been using to date, and states have been responding to, is the federal statute clearly says that the enhanced federal funding for state Medicaid programs that states are receiving during this period is tied explicitly to the state following all of the federal requirements.
So in the instances we, the administrator and I mentioned before, where we have been holding states accountable, identifying violations, required states to pause procedural terminations, etc. What those, what states understand is, if they do not do that, their entire enhanced federal match for the quarter that’s been outlined by statute is at risk. And that is significant amount of funding.
…
Dan Tsai, CMS [00:42:02]
I think the number of varies by state, but in some states, it is in the tens of thousands of people where we identified an issue and the state was required to reinstate.
…
Dan Tsai, CMS [00:49:28]
First, formally yes, those are the only two states. I would note that we are in collaborative discussions with Montana on whether or not any of those policy waivers would make sense for that state. And so, if so, there would only be one state across the country [Florida] that has not taken up any of the many policy waivers and flexibilities we have put out.
I am told the patient in this latest case, like those before, was treated at an area hospital and is recovering.
CDC is not conducting drug resistance testing for the locally acquired malaria cases at this time.
Surveillance testing to identify gonorrhea strains with resistance or reduced susceptibility to antibiotics has increased across Massachusetts since the January 19 Clinical Alert.
In the first 4 months post-release of the announcement, the State Public Health Lab received over four times the usual volume of gonorrhea isolates for susceptibility testing but has not identified any additional cases with resistance or reduced susceptibility.
For awareness, Massachusetts Department of Public Health epidemiologist, Dr. Heather Elder, is scheduled to give an oral presentation on this finding at the STI & HIV World Congress in Chicago next week (https://stihiv2023.org/wednesday-july-26th/).
Wade Brennan, Sarasota County [00:01:05]
This is also a reminder that Anopheles is the vector of malaria. That is our target during this situation. They’re coming from permanent bodies of water that have a lot of vegetation around them.
So if you have ditches, canals, flooded woodlots, things like that, that have a lot of vegetation around the edges, please contact lake management professionals to take care of the situation.
And then also, if you have water lettuce, that’s a huge producer of Anopheles. This is the main thing that we’re looking at. This is what our crews are focused on, but when it comes to private property, we need everybody’s help.
The other thing that, as we’re going through this, we still need everybody to be diligent about avoiding mosquito bites. This is critical. This is strictly a human to mosquito transmitted virus. If we can stop either the mosquito side or the human side, normally we need both efforts, to really minimize this going any further. And so it’s critical everybody wears repellent, if they’re going outside, everybody avoids activities at night, if you can possibly do so, if you cannot, you can wear long sleeve shirts, long sleeve pants, and repellent.
On top of that, it’s just so important, if we can stop those mosquito bites, we can stop this [parasite] from going any further or persisting. So that’s what our– that’s what we’re really focused on
At the same time, department of health is providing the homeless with mosquito netting and additional repellent as well, because we have a lot of different people that are being exposed to mosquito bites, is at the same time. So we’re trying all different avenues to minimize the risk of this getting and continuing any further.
…
Wade Brennan, Sarasota County [00:03:14]
The transmission cycle is a long transmission cycle. So it’s going to take up to 14 days for, if a mosquito bites an infected human, it’s going to take up up to 14 days for that mosquito to incubate the parasites in their body, spread from the mid gut out to their salivary glands. At that point, when the mosquito bites you and injects you with saliva, and the parasite can be in that saliva, that’s how transmission occurs.
So then it’s another 14 days on top of that. So at a very minimal, we’re looking at 28 days, and then normally there’s gonna be an additional 14 days for the second person to start feeling those symptoms.
So yes, I know it’s– we’re seeing it and we’re playing it week by week, but we have to realize that a lot of activity happens and it was out there a month ago. And so we’re just finding out information about that who else has been infected
…
Wade Brennan, Sarasota County [00:04:58]
Water lettuce is an exotic plant that is not– not native to Sarasota or Florida for that matter. And it’s very invasive. And what it does is it floats on the top of the water and it chokes up water systems. It’s one of the things that storm water’s constantly targeting, we’re constantly targeting, but in private ponds, we need to make sure that homeowners are also targeting it as well.
It forms a lot of cups. And the other thing that happens is it doesn’t allow mosquito fish to eat the Anopheles. So, one of the things that we’re refocusing is we’re going through, we’re looking at aerial photos now, we were looking at aerial photos before, but now we’re redoing that, and seeing if there’s any area that we possibly could have missed and making sure that we’re double checking everything in this area of concern.
So that’s our current, uh, stage that we’re at right now. We’re also expanding our mosquito fish release. Mosquito fish are not perfect when it comes to Anopheles. That’s something that happens with the species, but it’s– we’re doing everything that we possibly can to minimize those risks.
…
Wade Brennan, Sarasota County [00:06:22]
The water lettuce forms the cup on top of the water, blocking the mosquitoes fish access to the actual mosquito themselves. It makes a little home for them to where predators cannot prey on the Anopheles. And so it creates this perfect little niche that can actually thrive on.
…
Wade Brennan, Sarasota County [00:06:55]
It is a, a major relief to– that we’re being able to contain it, because this is a mosquito human transmitted disease and humans do move around. We know that, I mean, I drove to work today.
But the thing is, yes, it’s still in that area. And that’s critical for us to be able to focus on the Anopheles populations and because there’s a lot of efforts going on. So the, the closer area or the smaller area, we can focus those efforts, the better job we can.
…
Question [00:07:45]
I saw that there were two cases among the homeless population. Were those the earlier on ones, like late May, early June, or have– are those more recent cases?
Wade Brennan, Sarasota County [00:07:57]
Those cases have been intermixed, along with our other cases. There’s no trend.
…
Wade Brennan, Sarasota County [00:08:23]
We’re going back because the other thing is pesticides have a certain span of effectiveness. So the other thing is we have to go back to everything. That’s why this is a daunting task for us, but we’re up to the challenge. So we have to go back and make sure those areas that we’ve already treated aren’t starting to reproduce mosquito problems that we already took care of in the past.
…
Wade Brennan, Sarasota County [00:11:16]
With Anopheles, since they like the habitat of woodlots, canals, these permanent bodies of water, a lot of times, if we have a lot of rain, that’s our perfect situation because we might have some more flushing. So those water systems are actually gonna flush the Anopheles out and really reduce our populations as well.
It’s when we have this intermittent rain or no rain that it’s our biggest battle with Anopheles. And so we’re also using different types of pesticide because Anopheles aren’t our typical, they like to reside at the very top of the water. So sometimes we have to use mosquito surfactants and other types of larvicides as well.
CSL Seqirus is a global leader in influenza vaccines and related pandemic preparedness and response and has been working together with BARDA in a longstanding partnership for more than a decade, which has included numerous R&D and manufacturing activities in support of BARDA’s pandemic preparedness objectives.
Over the past year, outbreaks of highly pathogenic avian influenza (HPAI) A(H5) viruses among wild and farmed birds, as well as commercial poultry, have been reported in the U.S. and other parts of North and South America, as well as across Africa, Asia and Europe. In response to this BARDA has requested the manufacture and clinical assessment of the H5N8 vaccine candidate to support its pandemic preparedness program.
As such, BARDA selected CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study which has now begun recruitment. Additionally, the trial will examine the value of a heterologous vaccine regime using a combination of H5N8 and H5N6 doses compared with a regime of H5N8 alone.
For more information, please do take a look through the press release issued by BARDA, here, and our press release, here.
From: Harrison, Christopher J.
I agree with your comment. The usual peak activity in even years that we had seen for most of the last decade went into hiatus during the 1st year of the pandemic due to social mitigations, masking etc. Then it picked up again in 2022 when things were more “normal” socially. I expect the biennial peak again in 2024. But the seasonality may not be as focused, i.e. the usual late summer and fall peak time may spread out more and start earlier in the year as it did in 2022 .
Of note we are talking only about PeV-A3 subtype. Other PeVs that mostly infect children up to 5 years old and cause mild GI and respiratory disease are not tracked as well as PeV-A3 due to the mild disease and no specific treatments. So only research surveillance would pick any of them up. The testing is too expensive to run for an “everyday” GI or respiratory illness anyway. As a side note, PeV-A1 is the most common PeV in the US in most surveillance studies and circulates every year but we have no published data on it since 2018 so we don’t know but expect that it also was down in 2020.
It is only cost effective to test hospitalized young infants at present. I agree that many clinicians are still not tuned into this virus. At CM however, automatic testing of CSF in the young infants is the rule during late summer and fall, so the clinician only needs to do the usual work up in that age group (spinal tap for viral testing) for a febrile hospilatized infant and PeV-A3 testing gets done automatically. It’s why KC seems a hot bed for PeV-A3 because it is tested routinely.
…
From: Jackson, Mary Anne
The year 2022 was the year that the CDC alerted physicians to what we had been documenting for a very long time. The disappearance during the pandemic was typical of many viruses (influenza, RSV most notable) during that timeframe, but then picking back up on 2022. NO cases this year yet and we’ll be very interested to see what 2024 brings. I still believe that most pediatric practitioners do not identify or confirm cases so there is still more to be done in education.
We have not. Usually, these clusters happen every other year. We are tracking that way again.
The vaccine will be available for older adults ahead of the 2023/24 RSV season in the US, which typically starts ahead of winter months.
It will be broadly available in about a month from now.
Cost of nirsevimab, how much or when will be ultimately decided
Our goal remains to work closely with payers and authorities to determine an appropriate price point based on cost effectiveness and implementation in all infants. We expect Beyfortus to be priced similarly to an innovative pediatric vaccine series, in accordance with the value and innovation it delivers.
We anticipate sharing more information about the price of Beyfortus as we get closer to the RSV season.
When nirsevimab expected to launch in U.S. market
We plan to launch in time for the 2023-2024 RSV season.
Potential for preferential recs for Pfizer’s Abrysvo over Beyfortus
We anticipate ACIP recommendations will be available in time to launch Beyfortus for the 2023-2024 RSV season.
While we cannot speculate on how the ACIP working group will vote, we have been encouraged by the unanimous vote from the FDA AMDAC advisory committee on June 8 in favor of Beyfortus for all infants in the first RSV season. During their discussion, the panel members expressed appreciation for the robust data presented across the three pivotal clinical studies of Beyfortus.
Thanks for your patience on this. Please see below from Sarasota County Mosquito Management Services:
Yes, all the positive pools we have found have came from the same woodlot. They were Anopheles crucians. Only the midgut was positive not the salivary glands.
Thanks for your call, see the below statement from Sarasota County Mosquito Management.
Sarasota County Mosquito Management Services continue to focus treatments and surveillance efforts in North Sarasota (Desoto Acres and Kensington areas) where there have been confirmed malaria cases and infected mosquitoes and areas that have long-lasting standing water. Multiple truck, aerial, backpack treatments have been conducted to eradicate the Anopheles. Staff are also working in a mile outside those areas. In addition to treatments, there is also continued testing of Anopheles from the area of concern. Sarasota County Mosquito Management Services sends samples to the Centers for Disease Control and Prevention weekly.
All Sarasota County residents are encouraged to continue to protect themselves from mosquito bites.
Avoid being outside between dusk and sunrise. Wear repellant and loose-fitting long-sleeved shirts and long pants. Drain any standing water on your property. Remove aquatic vegetation from ponds, lakes, canals, ditches and anything that holds water for a long time and has overgrowth of vegetation.
For more information on Mosquito Management Services, mosquito-borne illness, spray missions or to submit a service request, call 311 or visit scgov.net/mosquito.
The FDA has received the letter, is reviewing the concerns outlined in the letter, and will respond to the Senator directly.
Caregivers and families should be aware that there are many different types of products with variable amounts of caffeine available on the market. We encourage caregivers and families to read a product’s label before giving the product to their child. Many packaged foods, including beverages and dietary supplements containing caffeine, voluntarily provide information on the label as to how much caffeine they contain. Consumers should take care when consuming for the first time a new packaged food containing added caffeine if the amount of caffeine in the food is not declared on the label.
While there’s wide variation in both how sensitive people are to the effects of caffeine and how fast they metabolize it, healthy adults generally may consume up to 400 milligrams a day without dangerous, negative health effects. There is no set level of caffeine for children, however the American Academy of Pediatrics discourages the consumption of caffeine and other stimulants by children and adolescents.
In general, the agency monitors the marketplace of FDA-regulated products and takes action as appropriate, including collaborating with the Federal Trade Commission regarding marketing claims.
Dear Alexander,
Thank you for your interest.
In short, no, malaria free certification of the USA will not be revoked because of the reported cases.
To revoke malaria-free certificate of any country, malaria transmission in that country should be re-established. According to our definition: A minimum indication of possible re-establishment of transmission is the occurrence of three or more indigenous malaria cases of the same species per year in the same focus for 3 consecutive years. This is not the case in USA.
For reference, please kindly see attached the 2nd edition of the Certification manual (Preparing for certification of malaria elimination. Second edition.). In the section 4.7. GRANTING AND MAINTAINING CERTIFICATION (pages 19-20) it is indicated that:
Countries should immediately report any indigenous cases or outbreaks to WHO so that the Organization can advise on further action to prevent re-establishment. A minimum indication of possible re-establishment of transmission is the occurrence of three or more indigenous malaria cases of the same species per year in the same focus for 3 consecutive years. As certification represents recognition of a considerable operational achievement by a country, a careful investigation and consultation with the TAG-MEC will be conducted before a country’s malaria-free certification status is revoked.
The FDA routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs. As a general matter, the FDA does not comment on third-party research or individual reports but may evaluate these as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.
Clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events with Wegovy; however, suicidal behavior and ideation have been reported in clinical trials of other weight management drugs. For this reason, the US prescribing information for Wegovy contains a Warning and Precaution for suicidal behavior and ideation. The FDA monitors the safety of a drug throughout its life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs and if newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.
1. Is there any potential geographic origin identified for where the malaria outbreak in Florida may have been imported? Curious, for example, if that’s something that can be determined through molecular analysis.
CDC is working to conduct genetic characterization of the parasites associated with these cases, including genomic sequencing. Results of sequencing are shared with the states. Please refer to the local or state health department for specific information on testing results.
2. After the 7 cases in 2003, is it accurate that the previous largest malaria outbreak was 30 cases in 1988?
Since 1957, when CDC’s Malaria Branch started conducting malaria surveillance, 63 outbreaks have occurred, constituting 156 cases (annual range: 1–32) that were a result of locally acquired mosquitoborne transmission. This report includes information on previous outbreaks: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5513a1.htm. 1988 was the largest outbreak of locally-acquired malaria cases in the U.S. since 2003.
Reported cases 1988 and 1989: Transmission of Plasmodium vivax Malaria – San Diego County, California, 1988 and 1989 (cdc.gov)
Dr. Sylvie Briand, WHO [00:12:59]
So indeed, we are monitoring very carefully H5N1 viruses, not only in birds, but also in other mammals. And, for example, more recently in cats, because some outbreak have been reported in Europe in cats as well.
So this monitoring is done globally with our partner agencies, FAO and WOAH as well. And we have networks of laboratories at the human animal interface who are sharing information on the virus and monitoring the evolution of these viruses across the different species.
What it means? It means that we are collecting those viruses, doing genomic sequencing on some of them, and also comparing the results of the analysis of the virus with the epidemiological information, because what is very important with those H5N1 infection is to see how much it affects a different animal population as well. So, we are monitoring this, we have done an assessment of these virus in the last vaccine composition meeting. And we have secured seed viruses in different WHO collaborating centers. And those viruses would be used if we need to develop vaccine, H5N1 vaccine.
So, and we will review these viruses at the next vaccine composition in September. And we will see if there is a need to update those seed viruses in the coming months. But for the time being, as the evolutions we have seen, is not so different that what we have seen previously, and it doesn’t deserve yet to change the virus that we have put in the library of virus for potential vaccine production.