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Are you able to clarify what the vaccines are being filled into, e.g. vials or pre-filled syringes?
The existing bulk will be filled into vials.
Is it accurate to say that the vaccines had already been produced as ‘bulk’ and are now just being filled and finished?
That is accurate. The filled vials will leverage bulk antigen and adjuvant that has been manufactured and stockpiled as part of ASPR’s influenza preparedness efforts under our National Pre-pandemic Influenza Vaccine Stockpile (NPIVS) program.
The FDA is actively engaged with federal partners, as well as industry, in assessing the currently U.S.-approved pandemic influenza vaccines, as well as the evaluation of potential vaccine candidates, should the need for vaccines arise.
The FDA has approved three H5N1 vaccines for use in the U.S. The manufacturers of those vaccines are Sanofi Pasteur Inc., ID Biomedical Corporation of Quebec, and Seqirus, Inc.
While CDC’s current risk assessment to the general public is low, if it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory pathways to take the appropriate steps to ensure vaccines are available in the timeliest manner possible.
Please refer to FDA’s Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines.
As we always do during emergency responses, the FDA works with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development and availability of medical countermeasures needed to support response efforts.
The Pennsylvania Department of Agriculture notified DSHS in March that they had received a complaint about the apricot kernel product. The manufacturer of the products is located in Texas. DSHS collected samples at the food manufacturing facility in April. The DSHS Lab does not test for amygdalin, so we worked with the FDA to send the samples to the Virginia Division of Consolidated Laboratory Services for testing. Once we received the results from Virginia, we submitted a request to the FDA for a product/label safety assessment since there are no established action levels for amygdalin in food in the United States. FDA determined that the levels of amygdalin in the products can be harmful to consumers. DSHS referred the investigation to the FDA for enforcement action.
DSHS posted an alert on the DSHS Food Alerts and Recalls webpage: Food Alerts and Recalls Affecting Texas Texas DSHS. You’ll want to check with the FDA on the status of their investigation.
Eric Deeble, USDA [00:17:49]
In addition to this new funding, APHIS is also standing up a voluntary dairy herd status pilot program.
The pilot program aims to create additional testing options for producers with herds that have tested negative for three weeks in a row to further reduce H5N1 virus dissemination, provide opportunities to test herds that are not known to be infected, and to expand our knowledge of the disease.
This is how it’s going to work. Producers from states enrolled in the first phase of this program who choose to enroll their herds and who test negative for H5N1 for three consecutive weeks, using on farm bulk milk or similar milk samples, will be able to establish that their herd is at negative status. Herds that continue to test negative weekly from their milk banks will maintain a monitored unaffected herd status and will be able to move their lactating cows without additional pre-movement testing.
The main benefit for farmers who choose enroll in the H5N1 dairy herd status program, is that once they can demonstrate their herds are free of H5N1, they will be able ship their cows at the time they prefer, and without testing individual animals, knowing that their entire herd is free of the disease.
APHIS is working with state animal health officials to identify states to participate in the pilot phase of this program, which will begin the week of June 3rd, and we have a great deal of interest from a number of states.
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Nirav Shah, CDC [00:23:36]
This individual that we are reporting today did not have conjunctivitis. They did, however, and it’s important to note, they did have watery eyes and eye discomfort. That is not pertaining to conjunctivitis, but it is important to note that these are all common and previously reported symptoms of influenza generally and novel influenza in particular.
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David Boucher, ASPR [00:30:49]
When we’re looking at the timeline for fill and release of– release testing for the 4.8 million dose equivalents, those will be– the manufacturing will be complete later this summer.
I do want to decouple availability and manufacturing completion, because there is of course that regulatory component that would be needed to either approve or authorize actual use of the doses.
So just want to be clear on that point.
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David Boucher, ASPR [00:31:21]
And again, on prioritization, at the moment, there is no recommendation for vaccination. If that changes in the future, we would be looking at the population for whom vaccination would be recommended and then making any decisions on prioritization at that time.
To be– I think it would be premature to speculate on what that might be right now though, given it’s not recommended at this time.
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Nirav Shah, CDC [00:31:50]
With respect to the contours of the timeline, as well as other particulars on this patient, I’d refer you back to Michigan.
We at the CDC really follow and respect the state’s call on what level of information we disclose and what level of information we go out with. And so I’d refer you back to Michigan on that one please.
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Nirav Shah, CDC [00:33:29]
Our scientists are working to ensure or determine whether there was enough genetic– whether there were sufficient amounts of virus in the specimen that we received, such that we are able to do sequencing.
We will know more about that probably in about a day or so, whether we’ll be successful at sequencing, and again, that turns on whether the specimen we receive has sufficiently high levels of virus, or as what you know as a CT value, to enable and allow for sequencing.
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Nirav Shah, CDC [00:38:32]
We’re really, really pleased that the state of Michigan has made progress with respect to understanding the serological history or the serology. Let me break all that down for everyone.
Right now, CDC has been working with states, state health departments, and state agriculture departments around a series of interconnected studies that would help us understand three questions.
Question number one is what is the risk right now of an individual worker who’s interacting with affected dairy cows?
The other question is, what is the historical risk of whether somebody may have been infected previously on the farm?
And then the third is what features occupationally lead to a higher likelihood that a worker who works with dairy cows may become infected with H5 virus.
We use PCR tests to understand the first one of those. We use serology or antibody tests to understand the second one, looking backwards. And we use an interview questionnaire to understand the occupational risks that might predispose somebody who works with cows to being infected.
We at CDC, our role in that is to prepare all of the methodologies, documents, study materials that any public health entity may need to actually carry out that study. And we’re agnostic as to who is actually doing the study.
In the case of Michigan, the state health department is taking the lead, and I commend them for that leadership. In other instances, we’ve had discussions with county health departments or in some cases having CDC come out.
What matters to us is getting the study done, not so much who’s conducting it.
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Nirav Shah, CDC [00:43:47]
The one area in which we have zeroed in is in Kansas, which as folks may be aware, there’s been a particular site that’s been at a high level for two consecutive weeks.
We’ve spoken with the state health department there to understand whether there’s something, any contours that we’re missing on the human side, thankfully, nothing to date.
We’ve also worked with our agriculture colleagues to understand better what might be going on from an agriculture side. Ultimately, the analysis turns on the particulars of wastewater system.
You know, there’s an old adage in the wastewater world, which is, if you’ve seen one water system, you’ve seen one water system. Every one of these is different with respect to how open they are to the sky, whether there might be wildlife material in them, whether the water tables or water systems are connected with runoff from processesors, and so on and so forth.
So the investigation is underway. It’s definitely shaping how we spend our public health energy. But there’s more data to come still.
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Nirav Shah, CDC [00:47:51]
Let me be clear, we’re still learning more about this patient’s clinical and medical history. So I’m not ruling out that there may have been lower respiratory symptoms.
What I’m saying is that that investigation clinically is underway. Thus, the symptoms that we are aware of are more typical of upper respiratory symptoms, things like cough, and so on and so forth.
That said the emergence of respiratory symptoms, as I mentioned, is not atypical. We have seen them before with novel influenzas, including with H5.
But what the presence of respiratory symptoms tells us is that the exposure risk is higher. Simply put, someone who’s coughing may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis.
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Nirav Shah, CDC [00:49:41]
All indications are genetically right now, this is still an avian virus. It has not shown signs genetically or epidemiologically of mammalian adaptations that would facilitate greater transmission.
We are on the lookout for those symptoms or changes, but the mere fact that this individual displayed some respiratory symptoms, again we should be alert, but in and of itself is not a cause to change course or suggest that we’re at an inflection point.
It is a cause and a reason to remain alert.
Beyond what is in this attached release, we are not disclosing additional information. The worker was not wearing PPE, and the symptoms were respiratory. We know the exposure was from an infected cow.
Medetomidine hydrochloride is a non-opioid sedative and analgesic that is the active ingredient in some FDA-approved drugs for use in dogs. The FDA does not currently have an import alert in place for medetomidine hydrochloride. For more information, visit: FDA Approves New Combination Drug for Sedation in Dogs FDA
From: Tin, Alex
Do you know if the Sioux County flock with H5N1 is linked to the B3.13 genotype that is circulating in dairy cattle?
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From: McDowell, Don
Sequencing efforts are ongoing at USDA’s National Veterinary Services Laboratory in Ames.
Jeanne Marrazzo, NIAID [00:10:46]
The conjunctivitis case in this current description or this current quote unquote outbreak in some ways is not new.
There was an outbreak of conjunctivitis in the Netherlands about 20 years ago now, or so.
Remember that you’ve got alpha two three sialic acid receptors in the conjunctiva. So conjunctiva technically is more receptive to these avian flu strains.
So I think the, the question is, is that gonna be enough? No, I think other things are going to need to happen to make this particular virus, as Dr. Monto said, much more invasive for us, and that’s going to involve probably not only sort of a more efficient binding through those sialic acid receptors, but additional changes in the polymerase, the PB two gene, you mentioned the human case had one change that is pretty typical of mammalian adaptation, but I think you’re probably going to need some more for it to really efficiently get into the respiratory tract.
The other thing is some people think that it’s going to need to mutate more so that it is more efficiently transmitted in air droplets. There are some changes that happen to the confirmation of the virus, under shifting pH. And if that is modified at all, you may have more trouble transmitting it through aerosol. So I think those are a few things.
And then we can’t of course forget the hemagglutinin changes that I mentioned regarding carbohydrates. So it’s possible that the mammary gland may provide more of that opportunity.
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Jeanne Marrazzo, NIAID [00:12:27]
What I worry about a lot that we’re, I don’t think people are talking very much about, are the peri-domestic animals on the farms.
So if you read that an emerging infectious disease paper that came out last week, they did a detailed analysis of at least one necropsy of a cat. The cat had very impressive central nervous system infection, disseminated infection. A number of cats on farms have had clearly had clinical encephalitis. Number of cats have died.
So this concept that you’re going to keep pigs separate on the farms from cows separate on the farms from the humans who go between them, I worry very much that with the animals, like the cats, possibly the dogs, whoever else running around, that’s going to be very tough to do.
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Jeanne Marrazzo, NIAID [00:14:01]
I learned a lot about how cows are moved around the country. So it’s not sort of the pastoral view that you have on the organic milk cartons of the little cow that stays in its pasture and is milked by the little children.
In fact, cows are raised in a certain area to get to the point where they are milk able or likely to produce milk. They’re often moved to large milking facilities, right? With a lot of transmission potential through infection at the udders, because of the milking parlors are big there’s– there’s a lot of milk that goes on the floor. They use very high pressure hoses to wash the floor, which presents the opportunity for significant aerosolization.
So it’s not quite as controlled an environment. And then the cows are often shipped back, to other places for various other parts of their season or their lives. So when you look at the spread of many of these cows that have been detected in these herds, many of them have come from cows that probably were originally infected in the initial Texas outbreak.
So you can trace them back.
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Jeanne Marrazzo, NIAID [00:28:38]
The other thing we are really involved in, although it’s in very early stages, and as Lindsley knows in particular, it’s in an area that we are very invested in, is looking for monoclonal antibodies, especially in sera from people who’ve been vaccinated to those H5N1 strains to try to isolate what the most potent either monoclonal or even broadly neutralizing antibodies might be.
So, that’s been gearing up. Again, it’s going to be a little bit more time of course than what we’ve got on the shelf, but I think it is important to go down that road depending on what’s going to happen in the next six months.
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Arnold Monto [00:25:48]
A lot of work has been done by NIAID and other groups, again, because of the concern 20 years ago or so about spread. And that’s why we have H5 vaccines in our stockpile. And we’ve had studies about antigen sparing and all sorts of things using adjuvants.
We’re also in the new era of mRNA and I haven’t, as yet, seen very much in terms of a monovalent H5 vaccine. We’ve had experimental vaccines developed, which contain multiple hemagglutinins, including H5, but I think that’s something we really need to be following.
Part of the problem with a pandemic is you have to respond quickly and you’ve got to go what’s on with what’s on the shelf initially.
We were very lucky to get a vaccine in under a year with COVID. We may not be lucky again with another pathogen. With flu, it usually takes a while.
In the 2009 pandemic, we were fortunate because FDA could use a strain replacement, and we didn’t need an adjuvant, although it was adjuvanted vaccines were used in Europe for administrative reasons, more than scientific reasons.
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Jeanne Marrazzo, NIAID [00:30:35]
Can I ask you question, Dr. Monto, about treatment?
So, a lot of people are very interested in whether nirmatrelvir, the half of Paxlovid, might be active against these viruses because we got a lot of Paxlovid in the stockpile.
So do you have any thoughts about that? People are looking.
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Arnold Monto [00:32:02]
I wonder whether this is the first time we’ve had this occur. If there hadn’t been a few things happening, we wouldn’t have detected that this was just low milk production in dairy cattle, since this is a global virus, a global pathogen.
If you’re having human cases in Cambodia, I can’t believe there haven’t been cases that have been missed in dairy cattle or in cattle.
That’s the other thing, all the attention is being given to dairy cattle. There’s no difference in terms of receptors in beef cattle. And they’re often on the same farms and everything.
All of these domestic animals are shipped around the country. A lot of work has been done to follow swine influenza and the pigs are shipped from North Carolina to Iowa because of the– because it’s easier to ship the cattle than to ship the feed that they’re given and for other economic reasons.
So we are dealing right now with a situation where we need both more information, more data, more concern about the problem, but a realization that this virus has been trying to get into humans and to spread in humans for at least 25 years. And it hasn’t made it yet.
We even had in the 2005 period, human infections from backyard flock and Egypt, and Southeast Asia, and cases didn’t even spread when there were household infections. And the hypothesis never proven was that the receptors may be different individuals, because blood relations tend to get transmission, but not others in the same household.
So we really don’t understand a lot of this, but to agree with you, we shouldn’t be panicked by this and to– we need to remember that a wakeup call is only useful if you do something about it while you’re awake.
From: Tin, Alex
Thanks for getting back to me.
Does that mean no suspect or presumptive cases too? Or just none confirmed?
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From: Lyle, Steve @ CDFA
No suspect or presumptive.
Screenshot from Tavis Anderson’s presentation
Tavis Anderson, USDA ARS [00:16:27]
So the next question was, how did this happen? We detected it with this National Animal Health Laboratory Network, but within that sort of March 25 to April 10 window, we went from a single confirmed case to hundreds. And if you work with viruses, you may not be surprised by this dynamic, how one case can spread really quickly. But in animals, we were sort of wondering what was driving this dynamic.
In this case, we addressed it using some field epidemiology, and also some statistical techniques. And this is work conducted by the Epidemiologic Investigation Services. So they basically have a team in which when there’s an outbreak, they get deployed. So folks from Colorado, California, all of a sudden get shipped to Texas, Michigan and wherever else, and they do contact tracing and diagnostics in the field.
And one of the things that they worked out is, very early on, there was a single dairy location, this Texas 001.
The animals at that location had no clinical signs, asymptomatic infections, and so what happened, those dairy cattle then went out to three different locations, B, C and D. There was also circulation within a little sort of pod where Texas then was associated with New Mexico. And in this panhandle of Texas, the Texas farms, the New Mexico farms essentially are just a big blob.
So even though they’re labeled Texas and New Mexico, it’s just a dairy cattle farming region. And those borders are just artificial constructs. And there was also a poultry premise that was linked into a little transmission chain up here on the right, but this B, C and D was seeded by animal movement, from the Texas location of asymptomatic animals. And then once it got into that, B, C and D locations are represented here left to right then there was additional animal movement.
Again, this was movement of animals that were asymptomatic. Normally what you can expect is that in any given year, a dairy farm may restock up to 20% of its herd. And then on any given day, there could be a couple of, or tens of thousands of dairy cattle moving around from one location to the next.
Now this is standard and modern agriculture, pigs do it, dairy cattle do it, beef cattle do it, animals move. And when they’re moving, they’re taking their viruses with them. In this case, this wasn’t a deliberate choice from the producers. All of the animals were asymptomatic. And then once they got into these regions, you can start seeing they they’re forming little transmission clusters between different premises.
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Tavis Anderson, USDA ARS [00:28:25]
Now some ongoing work at the National Animal Disease Center. This has just been completed, with the results being processed now. And I think that there might be some sort of release of these data in a couple of weeks.
There was an inhalation study and an intra-mammary inoculation study in the containment facilities, the BSL-3 ag facilities we have here on campus. And all of that data is being processed to try and understand how this virus is being transmitted potentially. And once it’s in the animal, what is it doing?
We have samples taken every single day. So we can also detect evolution from day 1 to day 14. So hopefully we’ll have some more answers there on the animal side for everybody shortly.
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Tavis Anderson, USDA ARS [00:32:35]
Active surveillance has been occurring within the NIH CEIRR centers. So each of the different CEIRR centers has domestic and international influenza surveillance projects.
So within our center, we’re actively surveilling swine farms. We’ve got six to eight farms that we’re going out and just taking samples every single month from pigs and people who are working on those farms. Obviously that’s for pigs and wild birds and people, and that the interface specifically.
Dairy cattle are a unique host. And so it would require a similar type of strategy to establish relationships with farms, which could take a little bit of time to build the trust with the farm workers, which could potentially take even longer, and then get them to commit to long term passive sampling.
So basically when they go to work, getting them to blow their nose into a tissue, bag it, when they leave work, blow their nose into a tissue, bag it, and submit that every day or once a week, and then also the sampling on the dairy cattle as well.
So I’m optimistic. But in the short timeframe, it’s tough because a lot of the farms are reluctant to do that type of surveillance without existing relationships.
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Andrew Pekosz, JH-CEIRR [00:34:01]
I think a lot of people believe that surveillance networks can just descend on any geographic area, on any particular location, and be up and running in a heartbeat because it’s all about testing and sequencing and right?
But the relationships that you have with institutions, with farms, with individuals are incredibly important for all of our existing surveillance networks that are established. And so, you know, I think, some of the comments about, we need more surveillance, which I completely agree with, but why aren’t we doing it more right now, sort of minimizes the complexity of being able to do this in an effective way.
Because you can just as easily cause some place to shut down and not want to talk to you if you don’t approach the surveillance efforts in the right way. So Tavis’ last point was so important. All of our existing surveillance networks for flu all are based on years of interactions and trust and commonality built with these local organizations that can’t be reproduced or set up in a day.
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Tavis Anderson, USDA ARS [00:35:43]
I think that what happens next is what our APHIS colleagues are working on.
So if you were to detect HPAI that’s associated with a sort of a point source, what do you do to then the region of dairy cattle farms around there? Do you go in and are you able to make any implementation and any change?
And I think that’s where they’re trying to think about the downstream regulation.
Eric Deeble, USDA [00:18:02]
In the interest of scientific inquiry and to further reaffirm consumer confidence, USDA scientists initiated a series of studies on ground beef and beef muscle samples.
While we have not detected virus particles in any of the beef samples that have been assessed, a study was conducted to determine at what cooking temperatures H5N1 could be killed in meat. Again, in the interest of scientific inquiry.
To conduct the study, USDA researchers inoculated ground beef patties at a very high concentration of H5N1 virus surrogate. Once inoculated, the ground beef patties were cooked at different temperatures. Researchers found that there was no virus present in the burgers cooked to 145 degrees internal temperature, or roughly medium, or 160 degrees, which equates with a well done burger, which is the recommended cooking temperature.
USDA is also in the process of testing beef muscle samples from cull dairy cows condemned at select FSIS inspected slaughter facilities. These results are forthcoming, and we’ll share them as soon as we’re available.
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Nirav Shah, CDC [00:21:16]
From CDC, we’ve read those reports, although we’ve not received them firsthand. Suffice it to say, our longstanding recommendation against consumption of raw milk remains in place.
It is even more important, in the context of individuals who might be seeking raw milk, under the mistaken belief that it may provide some degree of protection against H5. Just the opposite is true.
Raw milk is unsafe at any speed. And the notion that you could protect yourself against H5 infection by consuming it is erroneous. There are much safer ways to protect oneself, namely avoiding raw milk.
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Nirav Shah, CDC [00:24:33]
Likewise we have not yet had any individual farm workers who have availed themselves of the $75 compensation that we’ve offered to participate in CDC studies.
And that’s largely because we have not yet, in the past week, identified any farms or farm workers that were willing to participate with us.
We’re not giving up hope. We are in constant conversation with a number of states. We’re getting closer, but as of yet, nothing across the finish line.
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Nirav Shah, CDC [00:30:01]
The outreach to farm workers is through multiple facets. Some of it is through farm worker organizations, particularly those that specialize and focus on migrant farm worker health. We do that not alone, but in partnership with our USDA colleagues and particularly our colleagues at HRSA, because they often operate community health centers that are close to the proximity of where many of these farms are.
So between CDC, USDA, and HRSA and partnership with farm worker and migrant health organizations, that’s one large avenue for outreach.
The other is that the state and local level, it’s often state and local health departments, veterinarians, community health workers who have direct inroads, direct access to the farm workers themselves. And we we’ve been able to work with those groups to get them messages, one pagers around how to use PPE, what the risk is out there.
So it’s not any one particular approach, but we’ve used the federal angles with connection with HRSA, and then at the state and local level with the farm worker organizations on the ground.
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Eric Deeble, USDA [00:31:18]
The one cull carcass that was known to be infected, that had visible lesions in the lung, subsequent testing of that carcass revealed no virus present in any of the muscle tissue or tissues commonly consumed by humans.
I know that ongoing, there are right now outstanding about, 75 additional samples that we are testing, in order to increase the degree of confidence that we have that even animals that may have contracted H5N1 and recovered continue to be safe to consume.
On the issue of the degree to which we understand the etiology of this disease and the way in which it moves from cow to cow, we still strongly suspect direct mechanical transmission, and that could include, teat cups, towels, wipes, spray bottles, milking heads, and some of the other mechanical aspects of dairy milk production that do come in direct contact with the animal.
That’s an area of very intense investigation right now as we try to give farmers the best information that we can about improving biosecurity within their own operations.
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Eric Deeble, USDA [00:37:11]
There were a variety of different cooking temperatures and different cooking time intervals that were used as part of this experimental study.
And cooking to, I believe it was 120 degrees, did show that there was virus still in the cooked hamburger patty, although at much, much reduced levels.
However, again, just to reinforce the point, these are all experimentally infected burgers. We are doing this in the interest of determining the effectiveness of cooking on killing the virus, but we have not found in any of the samples taken at slaughter or from retail meat packaging to have any virus present.
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Eric Deeble, USDA [00:43:50]
We have gotten no concerns with the current level of testing capacity through the NAHLN system. Our folks are reporting that they’re testing well below their capacity right now, with additional capacity for surge testing, should we ever to do a point where that’s necessary.
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Eric Deeble, USDA [00:45:21]
So first I’m gonna caveat, and just say, as a reminder, the tests that are done at the NAHLN labs and then confirmed through the NVSL are complex, right?
We were getting multiple samples that may be collected from a single animal. Those samples could be tested independently or pooled. Some of the samples are tested more than once. So that test numbers don’t necessarily equate to the number of animals that are being tested, or even the number of animals that are positive.
So with that caveat being made, from May 6th to the 12th, NAHLN labs reported 1,100 PCR tests of which 278 were non-negative. Non-NAHLN labs reported one positive sample during that same time.
About 600 of the PCR tests were conducted for pre movement testing, about 450 of the PCR tests were conducted on clinical animals, and about 44 PCR tests were conducted for health monitoring of animals known to be infected.
There were additionally five PCR tests that were conducted for other purposes, including quality control.
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Nirav Shah, CDC [00:48:09]
We certainly would like to be offering and conducting more testing on farm workers, particularly those who have been on or working with cows that have tested positive. It is not a requirement we would like to be doing more in partnership with the workers and the farm worker organizations.
But at this time, CDC does not have any such requirement in place.
We have no plans at this time. We’d like to be doing this on a voluntary basis in close cooperation with the farms, the farmers, and the farm worker organizations. So we have no plans at this time.
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Unclear, FSIS [00:52:30]
The 75 muscles were taken, they were collected from dairy cows that went to slaughter and were condemned upon antimortem for pathologies that we thought might be similar to what you would see in a virus and virally infected cows. So pneumonia and other systemic conditions.
And we targeted establishments that were in the states that have had herds that were positive.
Question [00:52:59]
So these animals were sick, but not definitely positive for H5N1?
Unclear, FSIS [00:53:05]
They were not definitely positive for H1. And they were exhibiting conditions on anti– postmortem that our veterinarians who are out in the slaughter establishments thought might be a respiratory type issue or a flu-like symptoms in pathologies, when looking at pathology, not the actual animal. And they’re all condemned for those reasons.
From: Tin, Alex
Michael, wondering if you’d be able to tell me whether any suspect H5N1 dairy cattle herds have been identified or tested in the Kane County area.
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From: Claffey, Michael
Hi Alex, I checked with our folks – and the answer is no. I imagine you are familiar with this USDA page which lists states where there are confirmed cases: https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/livestock
Due to Congressional rescissions of COVID-19 funds in the FY 2024 Further Consolidated Appropriations Act, difficult decisions had to be made about the future of CDC activities supported by those funds.
In August 2024, CDC’s Bridge Access Program for COVID-19 Vaccines will end.
o Since September 13, 2023, the Bridge Access program has provided over 1.4 million free COVID-19 vaccines to uninsured and underinsured adults through retail pharmacies, community health centers, and public health departments across the country.
o The Bridge Access Program demonstrated the importance of maintaining equitable access to free COVID-19 vaccines for adults that are uninsured and underinsured.
o CDC remains committed to supporting equitable access to vaccines regardless of insurance status.
o Built on the success of the Vaccines for Children program, which has provided more than 1.3 billion non-influenza vaccines to kids across the country, CDC’s Vaccines for Adults proposal, part of the FY 2025 President’s Budget, would give uninsured adults free access to recommended vaccines. If enacted by Congress, this program would reduce disparities, protect communities from vaccine-preventable diseases, and enhance and maintain the infrastructure needed for responding to future pandemics.
o The Bridge Access Program will provide free COVID-19 vaccines until August 2024 to people who are underinsured or uninsured. Until August, people can find where to locate a free COVID-19 Bridge vaccine at www.vaccines.gov.
After August, there may be a small amount of free vaccine available through health department immunization programs, but supply would be very limited. We don’t yet know if the manufacturers will have patient assistance programs.
From: Tin, Alex TinA@cbsnews.com
Are you able to share any details about the additional dairy cattle case that was confirmed by USDA for May 9 in Texas? For example, location and date of symptom onset. Wondering if it is accurate to say that the case reflects ongoing transmission within the state, or maybe just a sample that was bottlenecked at the lab, etc.
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From: Texas Animal Health Commission Public_Info@tahc.texas.gov
The TAHC is unable to share specific case related information to protect the privacy of owners and producers. Overall, this case reflects that there is still virus present in the environment, detected in milk through ongoing testing efforts. The testing timeline was only slightly more lengthy than typical for these types of cases, and would not necessarily reflect “bottlenecking at the lab” or other related issues.
2024-05-13_fda_foia_2024-1227encl2.pdf
Secretary Vilsack misinterpreted the reporter’s question. From April 29-May 5, the first week of Federal Order implementation, NAHLN laboratories reported 905 PCR tests, of which 112 were presumptive positives. Non-NAHLN laboratories did not submit any testing numbers during this week. We estimate that at the current rate, the NAHLN laboratories are conducting approximately 80 more tests per day than prior to the implementation of the Federal Order. For awareness, since the start of this event, more than 7,500 tests have been run between the NAHLN and NVSL. However, because multiple samples may be collected from a single animal, those samples may be tested independently or pooled, and some samples may be tested more than once. This figure also includes testing for other purposes such as research studies. As such, it is difficult to use the number of tests conducted as a measure of animals tested. Counting tests provides a much less accurate picture than counting affected herds.
Maggie Baldwin, Colorado Department of Agriculture [00:23:30]
So we don’t know the exact incubation period in dairy cattle, meaning we don’t know exactly from the time dairy cattle are exposed to the time they become ill from the virus.
We don’t know the exact mechanism of transmission, so we don’t know whether it’s being shed and spread in the milk because there’s high loads of virus in that milk, or whether maybe there’s a short respiratory phase of this virus. We don’t know what that mechanism of transmission and dairy cattle is, but there’s a lot of really great people that are working on studying that to give us a better idea of that.
And once we know that, we are hoping that that’s gonna also help us stop the transmission. When you know the mechanism of transmission, you can put measures in place to prevent spread.
We also don’t know how long are the dairy cattle shedding this virus? So once they become infected, how long are they going to continue to shed that virus? And we also don’t know yet the risk of this virus impacting non lactating dairy cattle, or other livestock species. We really don’t know yet. And there’s a lot of questions about that, and there’s a lot of work going into that.
12;26;59;14 XAVIER BECERRA, HHS
Nirav, am I correct that tomorrow we’re going to be hosting a call to reach out to folks who have contact with workers to again further inform them of these particular efforts?
12;27;14;10 NIRAV SHAH, CDC
Indeed. Not just tomorrow, although even throughout this effort, we have been meeting regularly with farm worker groups, advocacy organizations, because they are a trusted linkage between us and public health, us and agriculture, us and the workers themselves.
Indeed, our ask to state health departments in connection with the distribution of PPE was that they specifically work with farmworker advocacy and health organizations within their states because of that trusted linkage.
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12;29;29;13 TOM VILSACK, USDA
Well, what I think what we know is, and the concern obviously, is trying to contain the spread and eventually allow for specific herds ultimately to have the virus sort of peter out and eventually have that herd be virus free, and then over time, hopefully as we reduce the risk, ultimately have the dairy industry virus free.
In order to do that, the first step in the process, because of the fact that we saw spread because of the transmission and the transportation of cows from Texas to other states was to prevent that from occurring, which is why we issued the federal order.
We don’t necessarily have jurisdiction today over what happens inside the state. States are now considering and thinking about the possibility of preventing movement of sick cows or movement of cows without negative tests.
We obviously encourage that and support that, and as we discussed with states, the nature of their interest in doing that will look for ways and opportunities for USDA to be helpful.
This is a state call. And to the extent that we can restrict as much movement as possible, we think that is a good idea.
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12;31;28;10 TOM VILSACK, USDA
Well I think first of all, we are working collaboratively with CDC. Many of the meetings that have been discussed and identified here during this call, we have been joint participants or had similar meetings with the same groups to convey the importance and necessity of cooperation.
We’ve also encouraged the state veterinarians, who are a trusted source and state ag officials, who are also a trusted source, to be able to amplify to support and encourage producers to be open to this. And I think the key here is continued education.
Producers obviously look at this circumstance and they see this as an animal health issue, an animal health issue that for most cows basically resolves itself over seven to ten days. So they may not fully appreciate and understand the approach that public health officials need to take in this circumstance.
So it is important for the public health officials at the state level, for the state veterinarians, for state ag officials, for us to essentially communicate that it is in the long term best interest of the industry and all of us to make sure that we have as much information as possible.
As I said before, the more we know, it informs what we do and what we need to do, as we learn more, we can expand the opportunities for assistance and help.
And so that is basically what we are doing now. We are having these conversations. I’ve had the opportunity to travel to Michigan for example and speak to producers there. So it’s an opportunity for ongoing continued dialog in making sure what we understand the point of view of producers and the point of view of public health officials in terms of this circumstance and situation and then looking for ways that we can provide encouragement.
So that’s one of the reasons why we are suggesting a reimbursement for the PPE or the uniform laundering that some facilities, some operations may embrace, in exchange for their cooperation with CDC in a workplace study, in a farmworker study. We’ll look at continue to look for ways that we can build that bridge.
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12;38;56;19 TOM VILSACK, USDA
Well, we now know that there are 42 herds in 9 states.
We essentially were trying to find ways in which we could speed up the process of testing and being able to provide information, so it — we found out that a change that we had incurred in the system wasn’t actually as efficient as we thought it would be.
So it looks like this is a significant increase. Actually, this has been in the works for a while. It’s just basically us getting information out.
It’s still 9 states. It’s still in the same 9 states. And that’s the most positive thing about where we are.
And again, as we do the sequencing, we understand and appreciate that the key now is to make sure we’re restricting as much as we possibly can the movement of these lactating cows so that we can ultimately allow sort of the virus to peter out, eventually have that herd become virus free, eventually have the industry become virus free.
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12;39;57;28 NIRAV SHAH, CDC
With respect to your question about the enhanced epidemiological surveys and studies we’d like to do, the best way to think about this is this is a continuation of work that we’ve been doing.
For example, a few years ago, we did a parallel or analogous study with respect to poultry workers and we published that study as well. We want to replicate that same methodology now with dairy farm workers.
And the way I think about this is in doing these studies we’re trying to do two things: we’re trying to look forward as well as look back. The look forward is to work with individual workers who are on farms with affected cattle and swab them on a serial basis, as well as conduct a deep dive interview to determine what types of occupational factors might predispose somebody to being later detected with H5.
For example, in the poultry world, we’ve seen and data from the U.K. has found that culling, individuals who are involved with the culling of the chickens, are at a higher risk than those involved with other activities. We’d like to develop the same body of knowledge with respect to dairy workers.
That’s the looking forward piece. The looking backward piece involves conducting the same type of interview, but this time coupling it with serology studies. So look backward to see what types of work experiences might have predisposed somebody to having been exposed to H5 in the past.
We are announcing and we are making compensation available to workers in the amount of $75 for participating in that interview as well as providing a nasal swab and a blood sample for serology. Workers can participate in any extent of that they wish. They need not do all in one. They can pick and choose, of course, we’d prefer that they participate in all of them.
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12;45;27;10 TOM VILSACK, USDA
We’ve had I think approximately 80 that have been tested up to this point. I don’t have the number of positives but we can— we’ll get back to you on the number of positives, but approximately 80.
But obviously, it’s taken a while for folks to basically understand the federal order and we’re going to get, I’m sure we’re going to continue to see a number of tests on a day to day basis.
FDA’s later VRBPAC meeting will not affect Novavax’s ability to deliver a COVID-19 vaccine this fall. We have data which demonstrates good cross-reactivity between our JN.1 vaccine and KP.2, which is a JN.1 variant. We have manufactured JN.1 consistent with the recommendations and are on track to deliver an updated vaccine this fall. Additional data is being presented as a part of today’s earnings presentation.
“The herds detected in Michigan have been due to sick cows; relationships among herds are still being explored. In some cases, we have identified plausible paths of introduction from other positive herds in Michigan. In other cases, we have not identified any connections to other herds.”
Hi Alex, not much we can share yet but see our company responses below your questions in blue
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Will FDA’s later VRBPAC meeting affect Pfizer’s ability to deliver a COVID-19 vaccine this fall?
We are aware of the VRPBAC date change. We remain focused on working with the FDA on the composition of the 2024-2025 COVID-19 vaccine formula and fall vaccination planning in the US.
Has Pfizer generated any data regarding FLiRT strains like KP.2, either in terms of current vaccine or candidates?
Yes
CDC is tracking SARS-CoV-2 variants KP.2 and KP.1.1, sometimes referred to as “FLiRT,” and working to better understand their potential impact on public health. Currently, KP.2 is the dominant variant in the United States, but laboratory testing data indicate low levels of SARS-CoV-2 transmission overall at this time. That means that while KP.2 is proportionally the most predominant variant, it is not causing an increase in infections as transmission of SARS-CoV-2 is low. Based on current data there are no indicators that KP.2 would cause more severe illness than other strains. CDC will continue to monitor community transmission of the virus and how vaccines perform against this strain.
Robert Califf, FDA [00:30:01]
We’ve talked about one health for a long time. The fact that we all live in a world in a universe where animals and humans are more and more connected because of international transportation. The fact that more people are living closer to farms and on farms, but this is a real example of one health.
Just roughly speaking. It’s always a little more complicated than just the first take on it. But essentially the agriculture department regulates the cows. We regulate the milk at the FDA and the CDC has primary responsibility for the health of the workers, on the dairy farms. And so we all have to work together, across these organizations and agencies to take care of things.
And, there’s so many aspects I can’t go through at all, but primarily from the FDA perspective today, we are accountable for the milk. So when we heard about the problem, we needed to launch a program of testing the milk to make sure that it was safe, knowing that it was likely that there were more infected herds than we initially knew.
And in fact, that’s what we found. As you well know when we looked at just milk before pasteurization, that is the raw milk coming into the into the bulk tanks, about 20% of a national sample turn out to have fragments of virus in it. And then the question was, is this infectious virus, or is it essentially, fragments of dead virus that had been taken care of by pasteurization? We had a good reason to believe pasteurization would work because of a hundred years of pasteurized milk. And in fact, it did, we found no evidence of live virus.
And I’m pleased to say, there are many NIH and agriculture department researchers around the country, universities who were also looking and we all found the same thing, but now, the other part that we’re accountable for at HHS and within FDA is the countermeasures in case this does jump to humans. So we got to have testing, got to have antivirals, and we need to have a vaccine ready to go.
So we’ve been busy getting prepared for, if the virus does mutate in a way that jumps into humans on a larger level.
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Robert Califf, FDA [00:32:30]
Throughout all of this, because there’s so many agencies involved, countless hours of phone calls and Zoom conferences to make sure that we’re all coordinated all in an environment where, let’s just say, it’s not easy to get access to the farms because, you know, people are understandably protective of the environments in which they work.
So, a lot of work across the agencies here, and I feel like it’s been a good example of how one health can come together.
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Robert Califf, FDA [00:39:38]
Unfortunately, there is no– there’s no absolute barrier that can be created, but there are elements of protection that are important, like farm workers, if they’re on a farm with infected cattle, and one good thing here, the cattle don’t die. The mortality rate of cows is with this virus is less than 1% from what we’re told. So the cattle will recover.
But the workers need to be protected with PPE, just like, we all went through with hospital workers with COVID when you’re around animals that are infected in the poultry industry, as you may know, they’ve already been through this. And the use of PPE is just routine in the poultry industry, but this is new for the cattle industry.
And so there’s a lot of work to be done to get to the right place there.
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Robert Califf, FDA [00:45:10]
We do have some hurdles. And I’ll just say, well, beyond that, you also know that the states play a huge role in the management of the safety of the food and farms in particular.
And so we’re constantly in touch with all the regulators in the states and every state system is different in terms of how it’s configured. So access to the farms, for example, is something that really has to be negotiated through the states, the farmers, and the owners of dairy farms are more comfortable with people that they know that are in their states.
So all this has to be coordinated. I feel like we’re doing a good job of that.
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Robert Califf, FDA [00:46:15]
The pasteurized milk is absolutely no problem to test because we just have– we have people that go to stores and buy milk off the shelves anyway, for all sorts of other testing.
As, as I’m sure you know, from the state that you’re in, you have all these cows, the milk goes into bulk tanks, which is a mixture of a number of cows. And that’s a very sensitive area because it does point if they’re infected cows as to where the infections are.
And technically it’s no problem, but we want to make sure that we have trust. And so, there’s negotiation that needs to go on to make sure that there’s a safe way to handle the data and that people are not going to be castigated if they happen to have an infected herd.
So we’re working through all that state by state.
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Robert Califf, FDA [00:47:22]
As you might imagine, we’ve expended a lot of resources in the absence of any additional funding and we’re keeping track of that and looking at potential sources within, in our case within HHS, for example.
I think it’s predictable that we’re going to be in a new environment for milk in particular because of this virus, the way it’s affected other species as it sort of cycles around.
And, one thing about cattle, there are always new cattle coming up, so there are always going to be naive cattle that are susceptible to getting infected.
So it’s predictable there’ll be a need for resources.
We’re keeping track of things. And as we get a handle on what we need to do going forward, we’ll keep you completely informed about where we stand, including the reserve opportunities within HHS.
Wenqing Zhang, WHO [00:17:05]
We do have a system in place, if human to human transmission occurs, and if a pandemic starts, the system will be triggered to have to take a serious response.
As Maria said, that there’s ongoing risk assessment and there’s an update of candidate vaccine viruses.
So for the current H5N1 in cows, we have two, but it will also need to bear into mind, there are also other place of H5 virus circulating, and we also have candidates for these other clades of H5 viruses. And it’s not only H5. They could also be H7, H10.
So all these candidate viruses are being updated by the system and being distributed to vaccine developers. So once the situation warrants, they will be triggered into action to scale up the production.
Also to add that this system also producing reagents to enable the release of the vaccines to add that, for the seasonal influenza, there’s influenza program in place. So the deployment system also in place in countries that could be used for the pandemic response.
As Maria said, that if we look at the seasonal vaccine production capacity, we will be able to, of course, on the assumption of the similar antigen dose, as well as the egg supply, for example, all smooth, we will be able to have more than 8 billion doses. That’s the best scenario of estimate.
And this is only taking into consideration of the existing platform, licensed platform, there are also other novel platforms under development, and there are also vaccines in trials.
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Mike Ryan, WHO [00:19:14]
That global network of laboratories who work all around the world, including our colleagues at CDC Atlanta, are extremely vigilant in the way they’ve shared information and specimens through the PIP framework and to have candidate vaccines in place and to have manufacturers in place ready to produce vaccine.
And you may ask out there, well, why don’t we just produce a vaccine now? Well, first of all, we got to make sure it works against this clade, which we believe it does. And again, I think our colleagues at CDC in Atlanta are testing human sera of people previously vaccinated with H5 vaccines to look for that cross reactivity and make sure that the candidate vaccines would work.
And secondly, we produce hundreds of millions of seasonal flu vaccines every year, and we would have to switch production. So it’s not– you can’t just press the button and begin producing pandemic H5 vaccines. You have to stop producing your seasonal vaccine and all of you out there know how lifesaving that vaccine is both in the Northern and Southern hemisphere.
So this is not a– this requires a very careful consideration, as Wenqing said, to determine whether this virus does switch.
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Wenqing Zhang, WHO [00:36:42]
When we are talking about risk assessment, we need to be very specific. Risk on what? Risk associated with what?
So here we are talking about that virus at moment, circulating detected in cows in the U.S. The risk of this virus to become human to human transmissibility, transmissible in humans, this is a risk assessment we were talking about, and we assess that the risk is low.
But at moment, this is this form of the virus. And we know influenza virus is constantly changing. So if for this virus to become a pandemic virus, it will undergo a lot of changes so that it could transmit easily among human to human.
You also asked about whether the next pandemic could be harmless, or basically whether it’ll be mild or severe. So first, as I mentioned, for the pandemic influenza virus, we need really need to take one step back, not just to that particular clade at moment in the U.S., B3.13, we also need to bear into mind, there are also other clades is called 2.3.2.1c is also circulating and infecting humans in Southeast Asia. That’s H5.
In addition to H5, I already mentioned we had H7, we have H10. So these are avian viruses. Aside from avian viruses, we also have swine viruses is called a variant, which caused the 2009 pandemic.
So the global system, we basically keep all these virus under monitoring and continuing doing the risk assessment, continuing update the candidate vaccine virus, so that when situation warrants, the response could be triggered immediately.
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Helen Branswell, STAT [00:39:21]
Do you have a word yet whether the suspected Ebola case in Burundi is actually Ebola and, any details about, I think there’s a suspected second case. And while we’re talking, can you tell me, where is vaccine and can it be deployed quickly to the region if it’s needed? Thank you,
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Abdi Mahamud, WHO [00:39:48]
Thanks, Helen. We are aware of two suspected viral hemorrhagic fever cases from southern (unclear), Democratic Republic of Congo, that were referred to Burundi.
The first case that passed away was a nine year old child, passed on second May. Samples was collected from there, and immediately the government have started the investigation and collecting samples, on second May.
So far, we received a few challenges with their flight in transporting to samples and the team, the country of this ministry was able to send us samples to DRC in Goma to be tested. As we speak the lab is conducting the test, and hopefully the government will announce whether it’s negative or not.
But as you know, we have to also send us samples to a WHO reference lab for the final confirmation.
Because of the detection of the suspected virus, the government increased the surveillance and announced and improved surveillance led to detection of several cases. We had the second child suspected eight year old, in a stable condition. Initial samples also taken by that child as we speak right now is in a stable condition.
Contact tracing have started, almost 20 contacts for the first case, 25 contacts. But more importantly is the situation in DRC. As you’re aware, DRC has been responding to multiple outbreak of Ebola. They do have the response capacity and they’ve started the investigation, send a multidisciplinary team there and contacting where the child came from, around 75 contact has been traced and the team is out in the field.
So in summary, there’s close collaboration between the two countries, our team there in the field office, regional office are supporting the government. And once we have, we will share with you.
And we’ll really like to appreciate the ministry of health in Burundi, which came out with all the information in a transparent way and all the teams that have been supporting this investigation.
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Question [00:47:02]
On SARS-CoV-2, can you tell us more about KP.2 and vaccines, is anything being done to look at KP.2’s mutations against antibodies or in vivo?
And then on H5N1, can you expand a little bit on that kind of production ultimatum you were talking about earlier? You know, why is it not possible simply just to fold that CVV into a new seasonal quadrivalent? Thanks so much.
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Wenqing Zhang, WHO [00:47:45]
Yes. So with regards, why we cannot just click the button and put the virus, change the virus itself. So there are couple reasons here.
First is that, as probably you know, that at moment, all the vaccine productions are ongoing to produce seasonal vaccines. And, there should be a situation that warrants that is there a need to stop the seasonal of vaccine production, switch to the pandemic vaccine production, and also in the vaccine production, the plants they would need to clean out, then would need to take certain procedures in order to start replacing with the pandemic CVVs itself.
So this is a reason there’s a process in place and also associated with that is a risk assessment, whether this situation really warrants a stop of seasonal vaccine production and switch to the pandemic, just to end up with every year seasonal influenza also kills more than 620,000 at least every year.
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Maria Van Kerkhove, WHO [00:49:01]
So the first part of the question asking about KP.2, so KP.2 is a descendant lineage of JN.1. JN.1 is dominant worldwide. Based on all of the sequences that are shared with online platforms like GISAID.
These are analyzed by our technical advisory group for virus evolution. So KP.2 has its descendant of JN.1 and has additional mutations in the spike protein. I won’t read them out. And there are other emerging SARS-CoV-2 variants.
I just want to point out that JN.1 and these continues to evolve. So we’re going to keep seeing these other variants in circulation.
Based on the information that we have, and the sequences that have been shared, there’s about 8% of the sequences globally that are this variant, this KP.2, and the prevalence varies by region for lots of different reasons, based on the other waves of infection that have happened, the other variants that have circulated, and the amount of circulation of this virus.
The first sequences that were reported were in January this year. So it’s been circulating for some time, and we expect these percentages to change.
Just wanted to highlight that our technical advisory group for COVID 19 vaccine composition recommended that future formulations of vaccine do include JN.1, but also we state that countries should be using all available, safe and effective COVID 19 vaccines, according to SAGE recommendations, primarily focusing on people who are most at risk for developing severe disease.
So it’s one that we are watching. It’s one that we are monitoring. And again, reiterate the need for continued surveillance of SARS-CoV-2 in people, around the world, so that we can monitor this evolution of this virus. The virus is circulating in all countries. It continues to evolve. And for us to do risk assessments on SARS-CoV-2 remains critically important.
As announced, the May 16, 2024, meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024. The FDA, along with its public health partners, carefully monitors trends in the circulating strains of SARS-CoV-2. As has happened since the emergence of COVID-19, we have recently observed shifts in the dominant circulating strains of SARS-CoV-2.
The additional time will allow the agency to obtain more up-to-date surveillance data and other information on the circulating strains of SARS-CoV-2 to better inform the committee’s discussions and recommendations of which strain(s) to include in the 2024-2025 Formula for the approved and authorized COVID-19 vaccines intended for the U.S. market.
DACA recipients who would have been included in any change to Medicaid, will be covered under the Marketplace. As noted in the Fact Sheet released on May 3: “We expect that individuals who would have been eligible for Medicaid or CHIP under these proposals, including DACA recipients, will be eligible for Health Insurance Marketplace coverage with financial assistance or BHP coverage if they meet other eligibility requirements. The ACA allows noncitizens who are ineligible for Medicaid due to their immigration status to access financial assistance, such as Premium Tax Credits (PTC) and Cost Sharing Reductions (CSRs) through a Marketplace plan even if their income is below 100% of the federal poverty level (FPL).”
In addition, as noted in the final rule, CMS received a large volume of comments, many in favor, and some opposed to a definition of “lawfully present” that includes DACA recipients. CMS is not finalizing a “lawfully present” definition for Medicaid and CHIP at this time. Rather, CMS is taking more time to evaluate and carefully consider the comments regarding the proposal with respect to Medicaid and CHIP.
(See discussion, beginning on pg. 5 of this final rule: public-inspection.federalregister.gov/2024-09661.pdf)
Currently, CMS does not have a timeline to finalize changes to DACA eligibility in Medicaid and CHIP.
Kimberly Dodd, MSU VDL [00:06:58]
So we’re a pretty big laboratory. We have about 150 faculty and staff, and we run a million tests a year. Now the vast majority of that is routine testing.
So again, we’re an animal health laboratory. We support the MSU Veterinary Medical Center, which is the teaching hospital for the College of Veterinary Medicine. But we also support veterinarians and veterinary clinics across the state, actually around the country, and in 25 countries. So we do a lot of routine diagnostic testing.
One of our areas of specialty is endocrinology. You might be aware that dogs and cats often have thyroid disease, for example. And so that all sits in our wheelhouse.
So that’s the vast majority of what we do on a daily basis, but at the same time, we are part of the National Animal Health Laboratory Network or the NAHLN. That’s a network of 63 academic state and federal laboratories that serves as the first line of defense in the case of incursion of a high consequence animal disease like high path AI.
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Kimberly Dodd, MSU VDL [00:09:03]
So as members of the NAHLN, we are constantly preparing for potential disease outbreaks. We do tabletop and functional exercises in our state, in our region, and nationwide exercises as well. Our goal is always to understand what is the potential needs for diagnostic testing, going to be in the case of widespread outbreak and how do we ensure that we’re prepared to ramp up that testing?
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Kimberly Dodd, MSU VDL [00:09:54]
So we’re constantly looking to be able to rapidly detect an emergence of, again, a high consequence disease threat.
When that does happen, and we detect it, that’s when we move into sort of outbreak response, which for us is surge capacity. It means ramping up high throughput testing to be able to provide rapid diagnostic test results to veterinarians, state and federal officials, industry as quickly as possible.
That outbreak testing includes not only identifying additional facilities or premises that might be infected, but also being able to do active surveillance. So for example, when we know we have a commercial flock that’s infected with high path avian influenza, we perform surveillance of all facilities in that immediate area, just target our surveillance there, to detect any potential additional cases.
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Kimberly Dodd, MSU VDL [00:11:40]
So I’m knocking on wood as I say this, but that we’ve really been very lucky in the last several years to have dealt with relatively small outbreaks of disease.
The last biggest outbreak where we really ramped up testing was actually during COVID, where our laboratory, like veterinary diagnostic labs across the country, ramped up high throughput testing to support COVID testing in people.
We were also testing animals, but because public health laboratories were so overwhelmed, we really stepped in and I think that’s a– I’m a veterinarian and a virologist by training, and I’m really passionate about the work that veterinary diagnostic labs do. And I think we did a really great job of stepping in and supporting. We’re built for that.
We are built for big herd level or population level outbreaks, more so I think than probably some public health laboratories might be, and that’s not meant to be a criticism. It’s just our job is to look at animal health, population health at that level. And so we really are just set up to be able to provide high throughput testing.
Also because we’re looking at things from a population perspective, sometimes we can use population level sample types to be able to get a read of an entire population rather than having to test every single person like you would in sure in a human health outbreak, if that makes sense, or we can pool samples from multiple animals because we know if they’re all part of the same flock or same herd, that one, if one is positive, the herd or flock is positive. And that’s really the question that we’re asking.
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Kimberly Dodd, MSU VDL [00:14:11]
What we do in these sorts of circumstances is that we have people who are cross trained, sort of within the infectious disease areas in the laboratory. They might not normally work on viruses, but in the case of an outbreak like this, they’re trained to perform that required testing for high path AI.
So we’re really leveraging all of our people who are especially trained and require special approvals from USDA to perform this testing. We’re leveraging all of the people across the laboratory who have this training to perform the testing.
We’re still able to maintain all of our routine diagnostic testing, at this point.
And again, this is one of the beautiful things about working in the National Animal Health Laboratory Network is that while we’re responsible for our state, we have the opportunity to leverage additional capacity at other states within our region or across the country if needed.
And I say that because Michigan is– we’re a little bit at the heart of this outbreak right now, along with a couple of other states, because we have recent detections in our commercial layer and turkey facilities, we have the dairy cattle situation. And then we also have– we are also providing all of the testing for wild birds in this region. I think we’re covering six or eight states at this point.
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Kimberly Dodd, MSU VDL [00:16:54]
I feel like I can give you a question today that’s going to be different than it will be tomorrow, and different than it would’ve been yesterday.
So I’d say that we are seeing in terms of identification of new herds, or testing potential infections of herds, that stayed pretty consistent since it was first detected in dairy cattle in Michigan. So we’re evaluating, if there are animals displaying clinical signs.
And I think it’s important to note that in this case, the dairy cattle have a drop in milk production. They go off feed. Maybe they have a fever, but on the whole they recover. So they are not– the severity of the disease is very different than it is in poultry. And in these dairy cattle, there are a lot of things that can cause drops in milk production.
So we are doing a lot of testing to evaluate whether or not those clinical signs in our dairy cattle is associated with high path avian influenza or not.
I would say that the we’re in week two of the new federal order for interstate movement testing. And so I think it’s really too early to stay just how much testing that’s going to be.
It’s been pretty steady for the first seven days of the order. But we’ll see how that evolves with time.
And then the worried well, what we sometimes refer to as worried well testing, or I think we’re still sort of understanding what other requirements are going to be, so some sale barns, for example, are requiring testing before animals come to the sale.
So it’s sort of based on different circumstances, testing may be required. So at this point, I’ll be honest, I think it’s just still– as this situation evolves and we collectively as a country get our arms around just how widespread this is, I think it will inform what our testing requirements, testing approaches are going to be.
But I can say that at this point in our laboratory, we are– we have people who are working very hard, but we are comfortably able to meet all of the testing demands we have.
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Kimberly Dodd, MSU VDL [00:19:34]
I’m thinking about the pre movement testing we’ve done. I’m thinking about some of the other testing.
The other bit of testing that we’re doing, actually, that I didn’t mention is we’re working with researchers at MSU, in the College of Veterinary Medicine, with our department of agriculture and USDA, as well as some farmers to be able to track affected herds and better understand how long these animals are shedding for.
Are they shedding solely in the milk or are there other ways, because we really want to try to better understand how this virus is being transmitted within and across different herds, so we can better put into place response measures.
So I can tell you we’ve performed hundreds of high path avian influenza tests in dairy cattle, but it’s covers a very broad spectrum of testing purposes, if that makes sense.
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Kimberly Dodd, MSU VDL [00:21:06]
So for dairy cattle, the preferred sample type is milk. So as long as they’re lactating, the recommended sample type is milk and that can be for pre movement testing or that can be if the animals are sick.
And samples come to us and in plastic tubes that we are then able to pull samples from and we bring those tubes into the laboratory and utilize a small portion of that sample to be able to start that testing process, which requires a series of PCRs. I think we’re all familiar with PCR post COVID.
We do three rounds of it. The first one is to identify that the animal is infected with an influenza A virus. The second one confirms that it’s H5. And the third one confirms it’s the specific strain in question. So we’re performing three tests on every sample.
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Kimberly Dodd, MSU VDL [00:22:33]
So what we’re doing is that, if animals meet the case definition or how the clinical disease has been described in dairy cattle, the first thing we do is test for high path avian influenza.
Once we rule that out, the samples will then get rolled into downstream testing, whether it’s culturing for potential causes of mastitis, for example. So we track it, we follow it in that way.
We work closely with our veterinarians to get a sense of the clinical science they’re seeing so that we can develop a diagnostic strategy that makes the most sense, and most efficiently gets us to the right answer. It would be, in a perfect world, great to be able to test every single sample for every single possibility.
But obviously we want to be efficient and, and cost effective in the work we do.
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Kimberly Dodd, MSU VDL [00:23:52]
We are doing and like, we do sort of refer to it informally as worried well to some degree, but we are– we do want to perform that testing to get an understanding of how many asymptomatic animals there are out there.
The problem is that, again, that sample type is milk. It seems the virus seems to really like mammary glands. And so that’s where we find the highest level of virus in an infected animal is in the milk itself.
So if we have animals that aren’t lactating or beef cattle, for example, we don’t necessarily have a great sample type to be able to definitively say whether– we don’t have the same.
Do you have any figures on how many heads have been tested, or how many tests have been conducted so far?
We have conducted approximately 600 influenza A tests on samples from cattle.
What is the best way to describe the pace of samples needing to be tested? Is it increasing?
Sample submissions have slowed since the Federal Order but we expect them to increase slightly and remain fairly consistent.
What share of your tests are from suspect cases versus interstate travel requests?
As one of the first states to have influenza A detected in cattle samples, most of our samples have been from suspect herds. Moving forward, we expect that most submissions will be a result of interstate movement.
So far we have 5 cases this year. You would have to reach out to the LHDs for information on international travel. 2 Washtenaw, 1 Wayne, 1 Oakland, 1 Detroit
https://detroitmi.gov/news/one-case-measles-confirmed-detroit-resident This was the most recent case.
The Ohio Department of Health tracks more than 100 reportable conditions on its dashboard, Summary of Infectious Diseases in Ohio.
Click on “visualize” and then you can filter by date, condition you are looking for, and by county. In your case, select the date range beginning January 1, 2024 and to May 1, 2024 (the most recent data available, the dashboard is updated weekly).
Under reportable condition, unclick “all” and select “measles – imported from outside Ohio” and then “measles – indigenous to Ohio.” Make sure to hit “apply.”
You will see Ohio has had five total cases in 2024, four indigenous to Ohio and one imported, or travel-related. The travel was international.
You also can filter conditions by the epi curve and by demographics.
Currently, the Kansas State Veterinary Diagnostic Laboratory (KSVDL) has tested 163 samples, primarily for interstate movement, that have all been negative. Twenty-one percent of these samples were from suspect cases; all were negative. With the federal order enacted on April 29th, testing is increasing.
Do you have any figures on how many heads have been tested, or how many tests have been conducted so far?
As of May 2, 2024, the Ohio Department of Agriculture’s (ODA) Animal Disease Diagnostic Laboratory (ADDL) has tested 57 samples from cattle. This excludes the confirmed premises in Wood County.
What is the best way to describe the pace of samples needing to be tested? Is it increasing?
Yes. It is increasing due to the USDA-APHIS Federal Order requiring testing for interstate movement of lactating dairy cattle.
What share of your tests are from suspect cases versus interstate travel requests?
All samples tested as of May 2, 2024, have been for animal movement. This excludes the confirmed premises in Wood County.
We have no additional confirmed cases.
As of May 6, we have one confirmed case of measles in our state in 2024. And this is related to domestic travel.
I think our news releases DHS Confirms Case of Measles in Dane County and Measles Case Investigation Update will offer any additional details you may need.
Do you have any figures on how many heads have been tested, or how many tests have been conducted so far?
As a veterinary diagnostic laboratory, client confidentiality is of the utmost importance to us and is part of our operations policies. The USDA may be able to provide you with nationwide testing data. We report all of our test results to the USDA.
What is the best way to describe the pace of samples needing to be tested? Is it increasing?
Yes, our sample volume is increasing.
What share of your tests are from suspect cases versus interstate travel requests?
We receive samples for both situations - suspect clinical cases and Interstate movement.
There have been 61 tests of dairy cattle; The pace of samples is steady; The testing that has been performed is for sick cows.
Todd Davis, CDC [00:40:01]
So the Centers for Disease Control and Prevention still considers the risk to public health to be low. You know, this is a virus that after sequencing now more than several hundred viruses from cattle, we don’t see any molecular changes that would indicate increased possibilities of infection or transmission from person to person.
So we still consider this public health risk to be quite low. I think some of the exceptions may be those that have prolonged unprotected exposure to infected dairy cattle. So I think there are some likely risk associated with occupational exposure.
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David Swayne, OFFLU [00:42:07]
I’ll just start off saying that, just to make sure we all are on the same page. You know, the first cases that were diagnosed were in dairy cattle in Texas. This particular virus has already mentioned by Maria is a specific genotype. So it is the 2.3.4.4b, but it has reassorted in North America with our low path avian influenza viruses. So what we see in dairy cattle is the B3.13 genotype, which makes it, when you look at the eight gene constellations, a virus that is not identical to what is circulating other parts of the world.
So in the risk assessment that would need to be taken that information need to be taken to account, that the risk may be different in other parts of the world, because it’s not the exact same eight gene reassortant that we had in dairy cattle.
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David Swayne, OFFLU [00:43:55]
The mechanism of the transmission between cows is currently unknown, but based upon field observations, it would suggest that the transmission probably occurs in the unique environment of the dairy parlor, either through the mechanical transmission, through the milking process, or because there’s continual cleaning going on in the dairy parlor, there are large droplets produced from that washing down process.
So those are two leading theories or hypotheses, but they are not at this point proven hypotheses of how that transmission occurs.
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Todd Davis, CDC [00:45:13]
So in the United States, when a confirmed dairy farm has been detected and that detection is done by the U.S. Department of Agriculture at the state level, the veterinarians will report those confirmed dairy farms to state public health departments, and then the state public health departments will take actions to monitor individuals on those farms where there have been confirmed dairy cattle.
And so that can be in the form of active monitoring where the names of workers are provided to local or state public health departments. And then those individuals could be monitored for up to 10 days post exposure. And then there’s also quite a lot of passive monitoring of individuals as well, where state or local public health departments provide information and educational materials to those dairy farm workers, to those dairy farms, that do have confirmed outbreaks of H5N1, so that they have information that would allow them to do self-monitoring.
And so, we understand there’s quite a lot of self-monitoring for illness, and from the U.S. CDC’s perspective in working with state and local public health departments, we know that there’s been more than 220 individuals monitored and more than 30 persons that have been tested for influenza A with only one person having been detected as positive for H5N1, among those more than 220 individuals that have been monitored.
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Todd Davis, CDC [00:47:06]
So there obviously is a lot of interest in understanding the potential for seroprevalence studies.
Currently, the influenza division is working with state and local public health departments to initiate serology studies in farm workers. So we hope to have more information on this very soon. So those studies are being initiated shortly.
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David Swayne, OFFLU [00:48:04]
So, up to my knowledge, there has not been any data released, but there is ongoing investigations looking at serology, both in the herds that have been affected, as well as outside those affected dairy herds, and also looking at serology in beef cattle to see if there has been any exposure or infections there.
So currently that, as to my understanding, is ongoing work. Not only the USDA is involved, but also individual universities and individual state departments of agriculture, as they try to get a handle on the epidemiology.
There’s a fairly large workforce. I know that from USDA and many of their partners, with epidemiologists on the ground, trying to figure out these issues, and serology is one of the most important components that’s being investigated.
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Richard Webby, WHO CC (St Jude Children’s) [00:48:59]
There’s some evidence that, you know, that at least cows that have, I guess cleared this disease, they do produce an antibody response that’s detectable by sort of the standard assays. So as David said, I’m not– there’s lots of work going on in this space, but it does appear that, at least the assays are fit for purpose in this particular case, which is of course a good thing.
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Richard Webby, WHO CC (St Jude Children’s) [00:49:28]
No evidence that swine are involved in this particular instance at all. A number of people have done some experimental infection of pigs with some of these 2.3.4.4b H5 viruses with the results sort of ranging from very little replication to reasonable replication, but transmission not being highly robust. So, right now, pigs don’t seem to be playing a role in the 2.3.4.4b. Certainly not in terms of spread at any level.
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David Swayne, OFFLU [00:50:11]
Right now there is the HI, is of course our gold standard test for looking for antibodies against the hemagglutinin, but it is not a common test used outside of reference laboratories.
But there has been several groups that are looking at validation. I think some of them have actually completed their validation studies of using the ELISA, various different ELISA tests, as a surrogate for the HI test, and those results look pretty good. So it will probably be that most of the serology will be done using ELISA tests, as opposed to HI that will be the conducted in cow.
2024-05-03_cdc_cdph_public-records-act-021033-021624_part2.pdf
The dairy worker came to one of DSHS’s field offices to get tested and did not disclose the name of their workplace.
There is currently no evidence to suggest the virus is present in muscle tissue of dairy cattle that have tested positive for HPAI. The pathology of the virus has shown that it has an affinity for the mammary tissue. The retail ground beef testing was exploratory in nature. For the ground beef retail testing, FSIS identified the states that had herds affected with HPAI. The sampling was intended to provide an immediate answer about the safety of ground beef. As mentioned, it is being done in conjunction with other beef safety studies. Together these studies are meant to produce data and expand our knowledge related to H5N1 in cattle and beef, particularly in the interest of scientific inquiry.
From: Morgan, David, DOH
The New Mexico Department of Health (NMHealth) is among the many state agencies around the country coordinating with the Centers for Disease Control and Prevention on developing surveillance protocols to better understand the virus.
NMHealth is offering no cost testing for symptomatic people at risk for avian influenza. To date, three people have been tested – all negative.
…
From: Tin, Alex TinA@cbsnews.com
Okay, thank you for getting back to me. Do you know if they tested positive for any other respiratory viruses?
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From: Morgan, David, DOH
Those tested did not test positive for any other respiratory viruses either.
From: Tin, Alex TinA@cbsnews.com
Two small follow ups about a line in the last situation update re: H5N1
https://www.cdc.gov/flu/avianflu/spotlights/2023-2024/avian-situation-update.htm
Assess the severity of illness and transmissibility of the virus under different scenarios by infecting ferrets and assessing the outcome. Ferrets are used as a model for people because they get sick and spread influenza viruses in a manner similar to humans.
What’s the best way to describe how long it will take until these experiments are completed? Will they be released as a preprint?
…
From: Reed, Jasmine (CDC/IOD/OC)
This process will take several weeks. We will share findings as quickly as we are able to and will follow-up with you once there is more information to share.
From: Tin, Alex TinA@cbsnews.com
Can you clarify which states the samples were from?
Does USDA plan to test additional samples from future states with infections?
…
From: SM.OC.Press Press@usda.gov
The samples were collected from 8 of the affected states - all except Colorado as the samples were collected prior to Colorado having any confirmed affected herds.
In regard to your second question, I would point you to the two additional studies and we will share results when we have them.
The herd remains asymptomatic for the disease being attributed to HPAI across the country. Asymptomatic for lactating cattle would mean that they are actively lactating.
The Ohio Department of Agriculture (ODA) is not collecting samples or sampling retail milk in Ohio. The FDA is sampling retail milk from a limited set of geographically targeted areas as part of its national commercial milk sampling study in coordination with USDA, though the targeted areas are unknown to ODA.
The short answer is yes, it would eventually be able to be traced back to the affected herd.
This would take extensive testing to trace it that far. We would be able to trace a particular gallon of milk back to what is called a “bulk tank”, which is a tank of milk that is delivered to the bottling source. These bulk tanks include milk from multiple dairies, so we would have to test cows from all of the dairies whose milk was in the bulk tank.
Don Prater, FDA [00:16:30]
These additional preliminary results further affirm the safety of the U.S. commercial milk supply.
The FDA is continuing to identify additional products that we may test. We’re also continuing to test samples of pooled, raw milk that has been routed to pasteurization and processing for commercial use. This will be used as a basis to characterize potential virus levels that pasteurization may encounter and will be used to inform our studies to further validate pasteurization.
These important efforts are ongoing and we’re committed to sharing additional testing results as soon as possible.
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Rosemary Sifford, USDA [00:26:01]
Some of the patterns that we’ve talked about before continue to hold true. It appears that there is a single spillover event in the Texas panhandle geographic region from wild birds into dairy cattle. The wild birds are believed to be the initial source of the infection in dairy cattle, and then cattle movements spread the virus into other dairy cattle herds, and then subsequently into poultry flocks.
Affected herds are still seeing approximately 10% of the herd that display symptoms, and those cattle that display symptoms generally return to near their previous production levels, after they recover from the virus, which is taking around two weeks. We also continue to see that most cows do recover with palliative treatment with little or no associated mortality.
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Rosemary Sifford, USDA [00:33:25]
Our focus is on identifying the currently affected herds and being able to work with them to eradicate the virus from the herd. But we do have plans to do some serologic testing to try to understand the overall scope including previously infected herds.
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Demetre Daskalakis, CDC [00:34:58]
The number of people who are being monitored at any one time tends to be very dynamic. So as you know, you’ve heard from Dr. Sifford, as herds resolved their illness, the monitoring period for people also goes away.
So I think we– I’ll start by saying, our local partners have been working to monitor over a hundred people and, again, the testing number is dynamic, but again, it’s over 20 people who have been tested. It’s around 25, but again, that number is dynamic because, as they’re monitoring, there’s a very low threshold for individuals to get tested.
I don’t have in front of me how many folks had conjunctivitis, in terms of the folks who have been tested. I don’t know the answer to that question at this time.
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Don Prater, FDA [00:37:27]
We are aware, because there are so many different dairy products, there are probably a few more products that we would look at just so that we make sure that we’ve got a good national sample. And so any additional results we will make available as soon as they become, uh, available to us.
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Emilio Esteban, FSIS [00:40:30]
We are very confident in the meat supply that it is safe. There’s a lot of inspection process that we have right now that make sure that each animal gets inspected before slaughter and all cattle cartridges must pass inspection after slaughter, before they go into the food supply.
So as far as the testing is concerned, we are doing three separate sampling efforts. The first one is we collected ground beef at retail from the affected states. The second is we are testing beef muscle samples from culled dairy cows also in the affected states. And then we have a third study which has to do with testing the effectiveness of cooking beef patties to make sure that the cooking kills the virus.
So for the first one, which is the retail samples, the samples have been collected. They’re currently at the lab NVSL, and we don’t have the results yet. We will be sharing them with everybody as soon as they are available.
For the second study– and if any of those samples become positive, we would actually have to do a calculations to see if what we find is live virus or not.
For this second study, the beef muscle from culled cows, we’re collecting that for research purposes and to make sure that the virus is not spread throughout the entire animal.
And for the third one, the cooking beef study, we’re basically cooking beef patties at three different temperatures to document that cooking kills the virus. Again, I want to emphasize, we are pretty sure that the meat supply is safe. We’re doing this just to enhance our scientific knowledge, to make sure that we have additional data points to make that statement.
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Demetre Daskalakis, CDC [00:43:11]
So just to be clear monitoring, what I’m referring to monitoring, really is about a sort of symptom monitoring, and this is very similar to what happens in the setting of a poultry outbreak.
And so the state health department has various systems that they use to monitor the health of individuals who are exposed. It can range from individual conversations on the phone, texts, apps, platforms for folks to text in on their symptoms.
So I think that generally the way that this goes is that, when a herd is detected, the state interacts with their agricultural colleagues, as well as the farms, and then reaches out to the farms to make sure that whichever monitoring is the most appropriate for the setting and system that the state uses is the one that they use to monitor the health of workers exposed on the farm.
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Question [00:46:18]
For Dr Prater, have you been able to trace back how the H5N1 positives ended up in retail milk? I mean, is this coming from asymptomatic cows?
And for Dr. Sifford, given from what you’re hearing from producers, do you think it’s possible we’re past the peak in places like Northwest Texas?
Don Prater, FDA [00:46:41]
So, FDA is working with our federal partners to analyze the initial data that we’ve collected through this survey of retail milk.
We recognize that processors can receive milk from hundreds of different farms, which may cross state lines. We would defer to USDA to speak about anything on the assessment of the current animal health epidemiologic situation.
So we’re continuing to look at this information and we’ll be sharing any further analysis as we have it. Thank you.
Rosemary Sifford, USDA [00:47:14]
Yep. And this is Rosemary Siford with USDA. We do– all of the evidence from our epidemiologic work, as well as our genomic sequencing, indicates that there was a single spillover event in that Texas panhandle region. And so we– that event has passed and we do not see any evidence of additional spillover events.
Our work, through the testing for movement, will give us a more clear picture of any herds that might be still affected, but asymptomatic at this point.
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Vivien Dugan, CDC [00:49:03]
I think that this would be an interagency discussion, but the general aspects that we always look for, not just for making a vaccine recommendation or in that space is changes in the genetic code, the genetic and antigenic properties of the viruses that are circulating, any changes that would impact our current countermeasures, so CVVs, candidate vaccine viruses, our antiviral medications, as well as our diagnostics, and also any changes in the virus that are circulating that would suggest better adaptation to mammals.
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Rosemary Sifford, USDA [00:50:52]
The initial spillover event in that geographic region likely was not an individual herd, but a number of herds in that region. And then animals from those herds moving to other herds in other states were the initial movement of the virus.
And then there has been subsequent movement from those subsequently affected herds. So not that– not that there was a single herd, but a group of herds in that region that were where the original spillover event occurred.
…
Don Prater, FDA [00:52:54]
So we are continuing to analyze the results of the retail milk survey. So just a reminder that we identified some PCR positives, and we followed up with the, a inoculation test that did not detect any live viable virus. So that’s an important point.
We are analyzing the information that we acquired from tha survey. It’s important to point out that milk purchased in a particular state doesn’t mean that it was produced or processed in that state. In fact, milk could be from cows on a farm a few states away, processed, pasteurized in a different state, and available for purchasing in yet another state.
So we are continuing to look at that analysis. We’re sharing that with our federal partners. And we will have something more to say on that in the days to come.
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Don Prater, FDA [01:02:42]
We are looking at that as part of our studies to validate the pasteurization parameters. So it’s important that we have some indication of what viral load might actually be sent to a pasteurizer so that we can assess the effectiveness of the pasteurization criteria.
So we are looking at that through a collaboration with our state partners.
