tinalexander.github.io / notes / 2023 / 12 /
Learn more about this site and how to get in touch.
CDC is aware of the WHO’s recent classification of JN.1 as a Variant of Interest (VOI). The SARS-CoV-2 Interagency Group (SIG), which is responsible for classifying variants in the United States, continues to classify JN.1 under BA.2.86, which is a Variant Being Monitored (VBM). We will continue to monitor variants, including JN.1 and provide updates when information changes.
Just wondering if you’d be able to clarify whether the counterfeit Ozempic that FDA recently seized is believed to be from the same source that Novo Nordisk describes in this release having being purchased at a retail pharmacy: https://www.novomedlink.com/content/dam/novomedlink/semaglutide/June-16-2023-Company-Statement.pdf
Hi Alex – thanks for reaching out. No, this is separate case. Please see our statement here: Novo Nordisk Warns Consumers about Counterfeit Ozempic® (semaglutide) injection 1 mg in the U.S. (novonordisk-us.com)
Laboratories within the National Animal Health Laboratory Network, along with USDA National Veterinary Services Laboratories, are conducting sequencing.
Common causes of canine infectious respiratory disease complex have been identified in many of these cases. As of now, the testing has not indicated the presence of a novel pathogen or single infectious cause among these cases.
Greetings,
I wanted to follow up with a question regarding this line in the JN.1 risk evaluation:
A study from Belgium in ≥65-year-old patients has reported no difference in the odds of hospitalization with JN.1 compared to non-BA.2.86 variant (OR: 1.15 [0.74-1.78]) (11). On the contrary, preliminary data from Singapore indicated lower risk of hospitalization and severity in BA.2.86 elderly and younger cases (12). However, data are currently limited.
Are you able to provide more details into what JN.1 was being compared against, and over what time period, to determine the odds of hospitalization and severity?
Alex, what we understand is that this was preliminary information shared with TAG-VE ahead of publication. WHO had permission to include it in the risk evaluation. The publication will follow.
Novavax has data in both mice and nonhuman primates that show that our vaccine induced cross-neutralization against JN.1 in animals primed with bivalent prototype/BA.5 vaccine and boosted with XBB.1.5 (similar to what has previously been shown for responses against XBB.2.3, XBB.1.16, FL.1.5.1, EG.5.1, and BA.2.86).
Here’s what we can say now, though should have data in the coming weeks:
Pfizer continues to closely monitor emerging variants and conduct tests of the updated Pfizer-BioNTech COVID-19 XBB.1.5 monovalent vaccine against JN.1.
Although there are not currently any COVID-19 tests authorized by the FDA for self-collection of throat swabs, the FDA is open to reviewing tests with novel sample types. As with all devices, the FDA would evaluate them for both safety and effectiveness, including considering any possible safety concerns regarding self-collection of throat swabs. Self-collection of throat swabs is more complicated than nasal swabs – and if done incorrectly, can potentially cause harm to the patient.
Attributable to the FDA, an FDA official or an FDA spokesperson:
Following up on yesterday’s update, are you able to clarify what other theories FDA is considering or has ruled out so far in terms of the lead contamination?
The FDA is still working to determine an exact cause or point of contamination at this time and cannot comment further. We do plan to provide updates for this incident as they become available on the FDA.gov webpage.
Also, are there additional steps that Ecuador’s ARCSA could be doing, but isn’t, to support FDA’s investigation into whether it was economically adulterated?
While FDA is continuing to coordinate with the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), FDA cannot speak to specifics regarding the investigation activities conducted by Ecuadorian authorities, and so would defer to officials from Ecuador on determining what their steps in the investigation and any regulatory actions might entail.
The median age for the current cases is nearly 2 years old with blood lead levels ranging from 3.5 to 33.3 micrograms per deciliter (µg/dL), however there are reported cases in children up to 9 years old. It’s important that parents contact their healthcare provider about getting a blood test for lead if you or your children may have consumed recalled products, regardless of age.
Xavier Becerra, HHS [00:05:58]
We’re pushing states where children disenrollments are highest to have them do more.
Today, I’m sending a letter to nine states, five with the highest percentage of children’s coverage loss, and five with the highest absolute number of children’s coverage loss.
One state unfortunately fits both categories, which is why there are only nine letters going out.
In the letter, I’m asking these nine states to do a number of things.
First adopt additional strategies we’ve developed, including the new guidance and resources published today to make renewals for children easier and for their families as well.
We’re calling on removing barriers that make it difficult for families to transition to CHIP coverage, if they are no longer eligible for Medicaid coverage.
We on reducing call center wait times and partner with pediatric providers, managed care plans, schools, and community organizations to reach additional families in need.
And we call on expanding their Medicaid programs if they have not done so already to ensure everyone has access to affordable coverage options that qualifies and that they don’t fall into the coverage gap.
The Medicaid expansion program under the ACA has been one of the greatest lifelines for Americas who otherwise would not have coverage for health insurance.
…
Xavier Becerra, HHS [00:07:23]
And as all states unwind from the Medicaid continuous enrollment provision, that was in place during much of the COVID 19 public health emergency, we all have to do everything we can to keep people from losing their coverage, but especially our kids.
That’s why today I’m urging governors and other leaders in these nine states where disenrollments of children have been highest to ensure that no eligible child loses their health insurance due to red tape or other avoidable reasons.
It really is time, now that we see these numbers, to make children’s health a priority. Our kids deserve nothing less.
…
Chiquita Brooks Lasure, CMS [00:08:47]
Our message today is critically important. State choices matter, and we are urging states to take every possible step to help protect children’s access to health coverage.
We’ve already made dozens of strategies and options available to states to do just that and approved roughly 400 of these options across the country to make renewals easier for families.
And today we’re announcing that these options that we’ve developed will be available through the end of 2024 to give states every opportunity to protect children and families going forward for millions of children and their families across our country.
…
Dan Tsai, CMS [00:12:17]
We took a close look at how state policy choices are affecting kids, what the data says about kids coverage through Medicaid renewals were starting, and how states can make things better for children and families.
And today really marks the first time CMS is putting out this level of detailed information on how Medicaid enrollment is changing for children and youth, through Medicaid renewals, and what’s driving that.
And as you’ve heard, the data reinforces the core of a call to action, and that is quite simple, state choices matter.
…
Dan Tsai, CMS [00:19:25]
All of these strategies and policy options are optional. We cannot force a state to take these up.
So we are strongly urging states to take these up.
But CMS has and will continue to hold states firmly accountable for following federal Medicaid renewal requirements. And so whenever we identify an actual violation of a regulatory requirement, we have been clear to states that they need to pause their procedural disenrollment and to hold individuals harmless.
…
Dan Tsai, CMS [00:22:14]
What we’re showing in the data is two things here.
One, when we look at children and youth and young adults, and the impact of Medicaid unwinding and renewals and coverage, as you noted, we are seeing the impact of Medicaid expansion, where a child that was 18 and turns 19 throughout the pandemic, and is going through unwinding in a state that has not expanded Medicaid, they very well may not have other options and could be falling into the coverage gap.
That explains about a quarter of the disenrollment of people who were kids at the outset of the pandemic, but three quarters or more in some states of the disenrollment for kids is all for people that are, that were kids at the start of the pandemic, they are still kids.
And those strategies that we’ve outlined very materially will help those kids maintain coverage.
Attributable to the FDA, an FDA official or an FDA spokesperson:
The FDA can confirm that one of the theories the agency is exploring regarding the high lead levels in the recalled cinnamon applesauce pouches is the potential that the cinnamon contamination occurred as a possible result of economically motivated adulteration. As this is an ongoing investigation, the FDA can only confirm this is one of the theories at this time. Additional investigation needs to occur before FDA reaches any conclusions. The FDA will continue to keep the public updated as the investigation unfolds. Again, the FDA can confirm that this is one of the theories the agency is exploring at this time.
Natalie Cataldo, FDA [00:09:27]
Since the last state’s call, we have been in coordination with Ecuadorian authorities and we’re finalizing the inspection at Austrofoods facility in Ecuador.
And as some of you guys have probably seen from our latest FDA web post, Austrofoods receives their ground cinnamon from a supplier called Negasmart, which is also in Ecuador.
And, during the inspection at Austrofoods, FDA did collect cinnamon samples, and these were sourced from Negasmart, and those samples are being finalized and we expect to share those final results early next week.
And then based on the investigation, we have sent a list of questions to Ecuador’s regulatory authorities, to obtain some trace forward information for Negasmart and their cinnamon supplier, which is a grinder, so they’re processing the cinnamon in Ecuador.
For product actions, FDA is continuing to work with Dollar Tree headquarters to ensure an effective recall. FDA coordinated an effort, in conjunction with state and local partners, to canvass U.S. Dollar Tree stores for recalled product, and then remove the recalled product, if it’s within that state or local authority.
And then as of today, recalled product has not been reported as being seen on shelves in Dollar Tree locations since the 8th of December.
And currently FDA has an import screening in place for ground cinnamon and cinnamon sticks and then products that are other than the recalled product from Austrofoods, and so far, no samples other than the recalled product have been found to have elevated lead levels.
…
Natalie Cataldo, FDA [00:18:55]
What I can say is that when we conduct our trace forward and our trace back investigation and we get those records, we will definitely be putting that on our web post and be sending out an incident update to the ICG, which is our FDA partners, and they’ll be disseminating that information to all the states, so that information will for sure be available for you all.
We have an investigation that is ongoing right now at the firm in Ecuador. So yes, we have an inspection going on. And, as far as – where the contamination is occurring, unfortunately FDA does not have jurisdiction over a lot of the firms that have been named so far in our trace back, because they don’t import into the United States.
So we’re relying on what Ecuador is giving us. And that’s– they’ve had a change of leadership recently and it’s taking a little bit of time for us to get that information, but we’re a little bit limited on what we can provide to everyone on this call and also what we’ve been given so far.
…
Natalie Cataldo, FDA [00:35:03]
We have November 2022 because that is when Austrofoods began, started producing that product. So there was no product with cinnamon being produced by that firm before November of 2022. Does that make sense?
…
Scott Pauley, CDC [00:12:49]
So you saw, we have gotten our website up and running.
We’re currently working on trying to get the routine and timing for reporting down. As we’ve talked about before, we’d like to get all of the line lists by the end of the day, each Friday, that gives us the ability to review the data and then be able to post and update the website on Tuesdays, which gives us, I think, a, a very good routine of updates for that.
And, if we have some other updates that are coming up due, but if you have any other communications needs, please feel free to reach out through the clip programs to us or through NCEH outbreak, at cdc.gov.
One of the updates we have in work for the website is a more plain language explanation of the case data. That one has been approved. We’re just working on getting it updated to the website. So that should be up probably tomorrow morning.
And then also we’ve been working on a list of frequently asked questions, that is going through our process right now for review. Hopefully we’ll have that ready to post to the share file site where the case data, or the case definition and the reporting instructions were. And we’ll send an email out about that as well, to let you know, when the FAQs are up to help answer any questions that anyone might have, through that method as well.
Mandy Cohen, CDC [00:13:15]
So all that being said, we’re excited about these tools, but on the next slide you can see here, is that we aren’t seeing the uptake in vaccines that we would like to see.
We’re seeing about 7 million fewer flu vaccines administered to adults this year compared to last year. And for COVID vaccines, we’re only seeing about 16% of adults getting the updated COVID vaccine.
On the RSV front, we have information about the vaccine for older adults, and again about 15, 16% uptake for that.
And we acknowledge that is too low and it is one of the reasons we wanted to have this conversation.
…
Demetre Daskalakis, CDC [00:41:06]
Since we are in the middle of the respiratory season, we’re going to learn more about the efficacy or the vaccine effectiveness of these current vaccines as we go further in the season. And I think importantly, I think CDC has been really committed to sharing that information in real time as we get it. So that is a spoiler alert that as we’re getting data on these, we will make sure that we share.
So first thinking about the COVID 19 vaccine, the updated shot, looking at the laboratory data, looks like it has really good effectiveness against current circulating variants or strains. If we go backwards in time and think about the bivalent vaccine, it was about 65% effective against COVID 19 hospitalizations in the two months after getting the dose.
So flu vaccines vary similarly, based on what we are seeing in the genomics of circulating viruses, as well as what we expect to be the effect of this flu vaccine, the updated flu vaccine.
This year, it looks like it should cover most of the strains. Important to say, CDC, continuously monitors what’s circulating both domestically and abroad so that we can give a view into what we expect the flu vaccine is going, how it will function into season.
Looking at last season, it was a pretty good flu vaccine in terms of how it was able to take flu from wild to mild, as we like to say around here at CDC, and among kids, it prevented about three quarters of flu related hospitalizations and in adults about half. So, if it tracks to that, we’ll be very happy. So it’s looking like it’s a great thing to remember to do this year as well. And, as we learn more, we’ll share.
Peter Marks, FDA [12:36:20]
These treatments represent a major advancement in the field of gene therapy for patients with sickle cell disease, a rare and debilitating blood disorder, affecting approximately 100,000 people in the United States.
Casgevy and Lyfgenia are the first FDA approved cell based gene therapies to treat sickle cell disease in patients 12 years and older and Casgevy is also the first FDA approved treatment to utilize a novel genome editing technology called CRISPR Cas9. The use of that technology is particularly exciting as it more broadly signifies an innovative advancement in the field of gene therapy.
And in fact, CRISPR Cas9 was the subject for which the 2020 Nobel prize in chemistry was awarded
With the approvals of Casgevy and Lyfgenia, we now have two safe and effective treatments for sickle cell disease that have been thoroughly evaluated by FDA and today’s approvals demonstrate the continued momentum of this promising new area of medicine.
The potential of these products have to transform the lives of patients living with sickle cell disease is enormous.
…
Nicole Verdun, FDA [12:39:36]
So the black box warning in the Bluebird label specifically was for myeloid malignancies, for two cases in particular of AML, that happened during the clinical trial for sickle cell disease.
And, so two patients actually ended up having death as a result of their malignancies. And so we thought that that rose to the level of a black box warning.
Vertex at this time has not had malignancies that have occurred. And so for that reason, we did not think that it warranted a black box warning at this time.
Peter Marks, FDA [12:40:21]
But the bottom line, this is Peter, just to finish up adding to that, is that obviously, as we have follow up time that elapses, we’ll just have to see what comes up with these therapies.
They are– they do have different mechanisms of action. So we’ll just have to see what comes up with time.
…
Nicole Verdun, FDA [12:42:32]
In terms of the follow up, we have reached an agreement with both sponsors to conduct long term followup studies for 15 years. But in addition have encouraged, with the label, to continue to monitor for malignancies lifetime for– for the rest of a patient’s life after they receive these therapies.
And so, specifically that involves getting blood counts and also monitoring of the bone marrow. And we have some– have had significant conversations with the sponsors who have both agreed to that follow up.
…
Nicole Verdun, FDA [12:47:47]
In terms of curative intent, with the long term follow up studies that we have have discussed with the sponsor that are 15 years, in addition, we will be looking at efficacy over time. And, I think that that will be quite informative.
Both therapies that were approved today, through slightly different different mechanisms, do decrease the number of vaso occlusive events and have the potential to take a sickle cell patient who has had several of these events to have not have any of these events.
And so I think over time, in terms of getting to that place, where we’re saying, at what point are we curative? We have to just sort of follow over time, but they’re quite encouraging. And the results of both trials were quite encouraging as well.
…
Peter Marks, FDA [12:49:34]
My suspicion is that most providers will be thinking of this for patients who are in the hospital at least several times a year. And not just somebody who has had a painful crisis and been managed as an outpatient.
Although it’s not labeled exactly that way, I think in terms of a benefit risk calculation, that’s how it will be put forward.
And I think just to inform you right, although the population is 100,000 people with sickle cell disease in the country, probably the population that really fits this is probably 20% of that, in terms of people who have more frequent crises and who end up in the hospital more frequently.
Whereas many sickle cell patients, patients with sickle cell, living with sickle cell disease, do so with only occasional crises.
So this is really for those whose lives have been significantly impacted, who sometimes potentially look like they’re gonna suffer end organ damage, from their sickle cell disease.
Sarah Owermohle, STAT News [00:26:26]
I wanted to ask you about march in rights, because they obviously– and reasonable pricing, but they obviously dominated your confirmation process, and Senator Sanders really wanted assurances out of you that you would use them more broadly.
And you said, during your hearing, that you believe that Americans deserve a fair return on investment for taxpayer funds. So now that you are a director, I mean, how are you thinking about potentially using these more broadly? And how would you be– how would you go about doing that?
Monica Bertagnolli, NIH [00:26:54]
So I think the core, and I truly share Senator Sanders concern over this, the core is that there’s big concern, particularly about high prices and the burden that they place on patients and their families.
And the fact that we cannot let anything, we can possibly have an influence on, interfere with everybody being able to get the treatment that they need.
So for me, the entire issue is about delivering, making sure, that we can deliver the treatment that people need.
The cost of treatment is one component, as is geographic access, etc. So we’ve talked a little bit about that.
March in is a tool based– that is based on legislation that has been given to the NIH director as one of the things that can help increase access in particular situations where there is a need.
But you know, what I will affirm over and over is that I will use every tool I possibly can with the goal of obtaining the access that our patients need.
And March in, if I am to ever apply that, it will be according to principles that allow it to really achieve that specific aim.
Finally, you know, I think that this is something where being able to– I also have the benefit of being able to work with partners across Health and Human Services, across the rest of government, and with partners in Congress to really make the wisest possible use of decisions such as this.
Amy Kirby, CDC [00:35:30]
We have just this week launched this new metric, called the wastewater viral activity level.
One of the real challenges with wastewater data is that, although what we measure is the concentration for SARS-CoV-2, it’s of RNA in wastewater, that concentration is not comparable between sites because the design and operation of the wastewater system itself influences the number that you get.
So we have to use other metrics to make the data as comparable as we can. And now that we have nice historical data to pull from, we’re able to put together this wastewater activity level.
So we look at the last year of data from a site, and determine what the 10th percentile is of concentrations and set that as the baseline for that site. And then our viral activity level, wastewater viral activity level, is the number of standard deviations above or below that value.
And the advantage here is that it gives you a very interpretable line. It’s a linear scale. So it works very well for the public. Also it aggregates very well. So you can take the median of that wastewater viral activity level, and look at state trends or regional or national trends, which is what you’re seeing here.
…
Amy Kirby, CDC [00:41:43]
We aren’t going to be able to test everything. Waste water has potential for a lot of things, but we have to be judicious in the use of our limited resources. And so how do we make choices about what we can use wastewater surveillance for?
And we expect this to be an iterative and ongoing process, because certainly we can use it for pandemic preparedness, that is what it was designed for a pandemic. So having it in place for the next one, should that happen, will get us there even faster.
But we’re also thinking about how can we use this for emergency response. So, I come from the field of water quality. So I think about, what do we do in the wake of large floods, where we start being worried about waterborne infections. If we have wastewater surveillance in those areas, you could think about a local short term activation of the wastewater surveillance system in that area to look for things like shigellosis or norovirus that we get concerned about in the wake of these types of emergencies.
Other emergencies have similar infectious disease concerns.
We’re interested in using this to understand more about emerging infections.
A really great example here is enterovirus D 68, where we see these bi-annual cycles of severe infection in children, but we really don’t know much about community infections outside of those periods of severe cases.
Wastewater surveillance may allow us to get a better idea of what’s going on with those infections, even when they’re very mild or asymptomatic.
And finally, as Dr Houry indicated, there are applications here for bioterrorism and potentially biopreparedness. So we’re working with some of our partners to understand where those have potential and how we can best connect to those systems.
…
Amy Kirby, CDC [00:45:14]
For example, I get a lot of questions about Ebola, and for Ebola, we know that there’s very few, if any asymptomatic cases, symptom onset is very soon after infection, and so although we likely could detect it quite easily in wastewater, by the time we had that data in hand in the U.S., a person would already have sought medical care and would likely already be diagnosed clinically.
So we’re not getting any added value by wastewater for that.
…
Amy Kirby, CDC [00:53:24]
The coverage question I think is excellent. And one that we’re really wrestling with
In the central states where you are noting that we don’t have a lot of coverage, there’s also not a lot of wastewater treatment plants in those areas. So if you look at the map of treatment plants, there’s also a hole there.
But how can we address that? Are there other ways around that? Do we need to oversample those few waste water treatment plants that are in the central area because we know we don’t have a lot of other coverage there? Are there communities that use like shared septic systems that we might could treat like a treatment plant?
I think we can put some creative thought into that and I would– that’s one of the things that we really welcome input from the board on how best to address that.
…
Amy Kirby, CDC [00:55:42]
CFA is leading on that for COVID. And we’re working with the respiratory virus response for COVID and then we will have flu and RSV data very soon. So we’ll be adding that as well.
It gets more complicated as you get into other pathogens. And so this is a process that we’ll have to go through with every new pathogen that we add because their existing surveillance is quite different.
For example, we’re thinking about norovirus next year and antimicrobial resistance genes, and those all have very different clinical surveillance systems, but we’re working on how to integrate those internally so that we can make sure that the sort of pathogen programs at CDC have access to the data and understand what it means and how to use it.
But we’re also thinking about how can we present that externally to people so that whatever they come to the CDC page looking for, if they come looking for information on norovirus, they see clinical and wastewater data.
If they come looking for wastewater data, they get all of the things that we do. So however they come to us, they’re going to see the data that’s relevant to that question.
CDC’s working on a new, um, sort of backside for their website that makes that much easier. So looking forward to seeing how we can integrate that going forward, but I also think improved communications around wastewater surveillance, and as you say, translation into action, both for the public as well as for public health and clinical practitioners is going to be really important.
Mandy Cohen, CDC (recording 1 of 3) [00:09:52]
As of today, we are not seeing anything that is atypical in terms of pneumonia related emergency department visits.
But we do know that there are a lot of kids going to the emergency department with respiratory illnesses like RSV, and flu, and COVID.
…
Mandy Cohen, CDC (recording 3 of 3) [00:00:16]
The manufacturers had delays in their production process which led to limited supply.
We’ve been working to accelerate what we can to get additional doses for this season. The 70 thousand was a first effort. There have been additional doses that have been released and we do expect more doses in the early January time frame as well.
So we’re– we do still expect more doses, but we still know that they’re– this keeps us in a place of limited supply for this season.
It is why CDC issued guidance to target those doses to the most high risk babies, babies who have underlying lung disease, who are younger, who were born as premies, to our Alaska Native population who are at higher risk.
So we are trying to make sure that we are focusing those limited doses on our both high-risk kids.
And I should say we continue to work with manufacturers nearly daily to work to accelerate additional doses.
As you know this RSV immunization is a long acting monoclonal antibody. So it does have a different production life cycle than a vaccine. It does take longer to produce and it is just a different way of producing than vaccines and does take longer.
So that that’s the time cycle here, but we continue to work with manufacturers to do everything we can to accelerate. We expect more doses in January, but we will still see the limited supply for the season.
…
Mandy Cohen, CDC (recording 2 of 3) [00:05:02]
In terms of how we monitor respiratory illness overall, which includes viruses and bacteria and fungal infections, we use data that comes to us from our emergency departments across the country, more than 80% of them report in on a daily basis of what folks are are coming in with, from those sources.
We also are able to look at laboratory data. And at this time, what we are seeing is quite typical of this moment in the winter respiratory virus season.
So we are seeing typical patterns as well as typical pathogens that are causing sicknesses in our kids and frankly at all ages. So we are seeing COVID and flu and RSV as well as some pneumonia, but nothing outside the typical of what we would see.
Obviously we’re gonna continue to monitor these trends, but they are pretty typical of what we would see at this point.
…
Mandy Cohen, CDC (recording 2 of 3 [00:06:22]
We’ve been in touch with the folks in Ohio, and again, we are seeing similar trends that they would typically see during this season. Hospital capacity is fine. Children are recovering at home.
These are pathogens that are known to us – flu, COVID, RSV, mycoplasma. There’s no evidence that any of those increases are connected to other outbreaks nationally or internationally.
So we will continue to monitor it, but we don’t see anything yet at this moment that is out of the ordinary.
…
Mandy Cohen, CDC (recording 2 of 3) [00:09:05]
We have been in touch with the folks in Ohio.
And what I would say is we are seeing respiratory illnesses that can be caused by viruses or bacteria.
So we are seeing flu, we’re seeing RSV, we’re seeing COVID, and we’re seeing mycoplasma, which is a bacteria.
So the first three are viruses flu, COVID, RSV, all viruses, mycoplasma is one type of bacteria that can cause pneumonia, it’s often referred to as walking pneumonia, but then there are other bacteria, strep and others that can cause pneumonia.
So what we are hearing from Ohio, that again, there have been no reported deaths. Most of these cases are receiving treatment and recovering at home as you reported, either because they’re being treated for the bacteria with an antibiotic, or they’re being treated with an antiviral for the virus they have.
There is no evidence again that these are atypical from what we would see at this moment in time.
…
Mandy Cohen, CDC (recording 2 of 3) [00:10:42]
I want to reiterate that hospital capacity is fine. And again, we’re not seeing strains at the children’s hospitals in Ohio.
These are from pathogens that we know, we want folks to get treated for, and again, pretty typical of what we would see at this season.
…
Mandy Cohen, CDC (recording 2 of 3) [00:12:14]
We’re also in touch with private labs regarding testing for pneumonia.
Based on our assessment today, at this point, we’re seeing activity that is very typical for the season. Again, typical means we are seeing more respiratory illnesses, more flu, more COVID, more RSV, and more pneumonia, but typical for what we’re seeing.
So there’re not any patterns across the country that we are seeing that are out of the ordinary, but we continue to monitor.
…
Mandy Cohen, CDC (recording 2 of 3) [00:12:51]
In terms of our ability to corroborate, so we work with our international partners to, in terms of making sure that what we are hearing is also similar to what they are seeing as well, being in touch with our Chinese counterparts in public health, in academia, in health delivery systems.
And we were, what we have all been able to ascertain, is that there is no novel pathogen, not a new pathogen here, but this is all related to upticks of known viruses and bacteria in their pediatric population.
Maria Van Kerkhove, WHO [00:12:00]
We are seeing, in general, an increase in respiratory infections around the world.
We do tend to see increases in children, because they’re the school age children in the northern hemisphere, we’re entering it’s the autumn already, and we’re entering the winter months. So we are expecting to see increases in acute respiratory infections.
Mycoplasma pneumonia is not a reportable disease to WHO, so we tend to track this information through reporting systems and through discussions with our member states.
We have seen as we, you and I had discussed earlier or last week, we are following up with the situation in China. And again, they have seen overall an increase in acute respiratory infections due to a number of different pathogens, including influenza, which is on the rise, mycoplasma pneumonia was on the rise for the last couple of months, and now seems to be a little bit on the decline.
We’re following up through our clinical networks and working with clinicians in China to better understand resistance to antibiotics, which is a problem across the world, but is a particular problem in the Western Pacific and Southeast Asia region.
We do– one of the things we are following up on, in terms of the acute respiratory infections is looking at burden in healthcare systems. So it’s one thing to see arise in these types of infections, particularly in school-aged children, but also to monitor the severity in looking at the healthcare capacities around the world, to be able to deal with these types of infections, looking at what are the treatment options that are there. And there are many antibiotics that are available for mycoplasma pneumonia.
I don’t have the specifics on the rates around the country, around the world, for this particular bacteria, but we have seen outbreaks of mycoplasma pneumonia in a number of countries over the course of many different years.
…
Maria Van Kerkhove, WHO [00:14:55]
So we are continuing to track the variants around the world, and BA.2.86 was recently classified as a variant of interest. It was formally a variant under monitoring.
Within BA.2.86, includes this further sub lineage of JN.1.
Globally, we have about 10% of the sequences that are reported to public platforms are BA.2.86 and its sub lineages.
In terms of our assessment, there’s still very small numbers, so I don’t have the exact number of sequences in this grouping, but it’s around 4,000, just over 4,000 sequences globally.
It has a growth advantage, but this is what we expect from variants that are classified as variants of interest.
In terms of severity, we don’t see a change in the disease profile of people infected with BA.2.86 and its sublineages, including JN.1, but it is one of course to watch.
When we look at severity, we are looking at any changes in hospitalizations. We are looking at any changes in disease presentation, and we don’t see that, for this particular variant of interest and its sub lineages.
So again, anyone who is infected with SARS-CoV-2, including BA.2.86 and its sub lineages can cause the full range of disease, everything from asymptomatic infection, all the way to severe disease and death.