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It’s important to remember that in the time period the veterinarian is talking about there were lots of respiratory viruses circulating in humans. DSHS tested dairy workers who had symptoms consistent with flu (both with and without conjunctivitis) and only the one person was positive for H5N1. The people tested volunteered to be tested. It’s likely there were other people with symptoms who did not want to be tested so we cannot say with absolute certainty that no one else contracted H5N1. We can say for sure that there were people sick with other respiratory viruses working on dairy farms.
HPAI has been detected in dairy cattle in 9 states, but there have been no cases in PA. The Department, working with industry stakeholders, Centers of Excellence, PA Diagnostic Lab System, and USDA, are vigilant and working in real-time to respond to this situation as it continues to evolve. PA is prepared to respond to any suspect or confirmed positive cases on dairy farms and has implemented additional import requirements to prevent movement of this virus into the state.
FDA is handling retail milk testing. PA has not tested milk in a retail setting as milk that has undergone pasteurization is safe to drink. However, should a positive sample be detected, the state would be able to trace the origin of it and be able to implement proper protocols to keep that milk from entering the commercial supply.
Tami Skoff, CDC [00:04:08]
So starting in the late 1940s, the U.S. began vaccinating with whole cell vaccines or DTP. However, in the 1990s, we transitioned away from whole cell vaccines to a safer version of the vaccine called an acellular or DTaP vaccine. DTaP is currently recommended as a three dose primary series with doses given at two, four and six months of age, and then two booster doses given at 15 to 18 months and four to six years of age before children start school.
In 2005, reduced dose dose Tdap vaccines were licensed in the U.S. for use among adolescents and adults. A single dose of Tdap is recommended at the preferred age of 11 to 12 years. And a dose of TD or Tdap can be given every 10 years for the decennial TD booster.
Additionally, pregnant women should receive a dose of Tdap during every pregnancy preferably during the early part of 27 to 36 weeks gestation. This recommendation has actually been in place in the U.S. since 2012, and has been very effective at reducing the burden of infant pertussis.
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Tami Skoff, CDC [00:06:37]
In 2012, we had over 48,000 cases reported in the U.S., and this was the largest post vaccine introduction peak that we’ve observed.
And this increasing slow, but steady increasing trend really continued right up until the start of the COVID 19 pandemic in 2020, after which of course we saw a large drop. And this is highlighted in the graph in the upper right hand corner.
So there are likely many factors contributing to this increase that we’re observing in the U.S., including changes in pertussis diagnostic tests and reporting, increased public and provider awareness. But we believe one of the driving factors and one of the largest contributors is waning protection from acellular pertussis vaccines. Numerous studies have shown that the duration of protection is shorter for acellular vaccines compared to the previous whole cell vaccines that were used in the U.S.
Next slide. So here, I just want to take a closer look at pertussis trends during the pandemic years. So as I noted on the previous slide, the increase in pertussis that we are observing continued right up through the start of the COVID 19 pandemic in 2020, after which we saw the dramatic decline in reported pertussis, which was similar to trends observed in other nationally notifiable diseases.
And while we are starting to see a bit of an increase in reported cases as of 2023, we’re still not back to pre pandemic levels, as you can see here.
So in the box in the upper right, I’ve included case counts to date in 2024. And if we compare this to the same time period in 2023, we’re up about 140%. So if this trend continues, we should surpass 2023 case counts.
So I will note while I’m talking about trends in the U.S. that you know, many countries now around the world are seeing increases in pertussis. And in fact, in Europe, they’re actually seeing really large increases around many European countries right now. And it’s interesting that a lot of these European countries are surging at a much quicker rate than we’re seeing in the U.S.
So we’ll– it will be important to continue to monitor trends moving forward.
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Tami Skoff, CDC [00:08:52]
So this slide shows national pertussis incidence stratified by age group. And as you can see here, infant shown in dark green, have the highest burden of disease.
However, in recent years, we’ve observed a pretty significant drop in disease in this age group, which we believe is a result of a successful maternal vaccination program during pregnancy.
The incidence of disease among the other age groups has been fairly comparable over time. However, I want to draw your attention to the mid 2000s, where we saw an increasing burden of disease among children, seven to 10, and these are represented by the grade line. So this increase in this age group actually coincided with the aging of the first acellular vaccinated cohorts of children.
Again, this highlights this issue of waning immunity from acellular vaccines.
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Tami Skoff, CDC [00:09:45]
I just wanted to end on a slide showing pertussis mortality. Here, we present pertussis deaths by age group in the U.S.
The vast majority of pertussis related deaths in the U.S. continue to occur among infants less than three months of age shown in blue. And so this is really why we are promoting the maternal vaccination strategy.
So moms should be getting a dose of Tdap during every pregnancy, as this has been shown to be a highly effective strategy at preventing disease in young infants.
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Question [00:37:01]
In the pertussis presentation, you stated that pertussis has a high vaccination rate, but is poorly controlled. Is this because of different strains of pertussis that are circulating that the vaccine doesn’t cover?
Tami Skoff, CDC [00:37:15]
So while there have been some changes to the Bordetella organism, such as the loss of pertactin, which is one of the antigens in some of the licensed vaccines in the U.S., studies have shown that that hasn’t impacted the effectiveness of vaccines.
And so I think one of the biggest challenges right now, and in what we think is driving, this is the waning immunity. So the acellular vaccines do not have the duration of protection that the whole cell vaccines had. And so we are seeing a lot of kids aged kids that are fully vaccinated, that are, you know, a few years out from vaccination are getting disease.
With that said, I will say that the presentation of pertussis in vaccinated people is much less severe than in unvaccinated people. So even though these kids still get disease, it’s not nearly as severe as in the unvaccinated. So waning immunity is a problem. And a lot of the pertussis research community is working to develop next generation pertussis vaccines that will really have a longer duration of protection.
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Question [00:49:48]
Will ACIP be rereviewing data about the waning of pertussis vaccine effectiveness?
Tami Skoff, CDC [00:49:55]
So that’s a good question. So the ACIP was active between 2010 and 2012 when we had the large resurgence in the U.S. and we were first starting to identify this issue with the waning immunity from the acellular vaccinated cohorts.
And at that time there was a lot of discussion about this. Should we be recommending additional vaccines for adolescents, additional boosters for school-aged kids? And the thought at that time was, with Tdap, we were only getting a good two to three years protection, and you would be vaccinating every couple of years. And given that these kids and these older kids are vaccinated, have less severe disease, our emphasis really from an ACIP perspective, was let’s focus on developing vaccines with longer duration of protection, but in the meantime, really focusing on the maternal immunization strategy and providing protection to those at highest risk for severe morbidity and mortality, so the young infants.
So it has been discussed. I don’t think there’s any current plans to discuss it again. I think there are vaccines moving forward in the pipeline. Hopefully in the next few years, we’ll have vaccines with longer duration of protection available.
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Tami Skoff, CDC [00:56:33]
The diseases are coming back, but also I think pertussis is a good example of, you know, the clinical presentation has evolved too.
And I think in the setting of waning immunity and we are seeing more and older individuals and oftentimes I’ll hear from clinicians, we don’t think about pertussis in older individuals or they come to healthcare much later when some of the diagnostic tests aren’t accurate.
So I think also thinking about the evolving epidemiology and changes in clinical presentation is important as well.
USDA has administered over 2000 tests on samples taken from cattle over the course of the past month. The testing numbers include multiple samples/tests on the same animal, pooled samples, or tests run multiple times on one sample – the number of tests is not a direct correlation with the number of animals tested nationwide. As of April 30, 34 dairy herds have been impacted by H5N1. For context, there are more than 26,000 dairy herds nationwide.
To our knowledge, no, none of the NIAID-funded CEIRRs are testing retail beef—just the USDA.
Jeff Shuren, FDA [00:08:50]
While developing this final rule, the FDA considered the large volume of comments received on the notice of proposed rule making. And in light of that input, we adjusted the phase out policy in a manner that better serves the public health.
This includes targeted enforcement discretion policies for certain categories of IVDs made by a laboratory. After this phases out, the FDA generally will expect IVDs manufactured by either a non laboratory or a laboratory to meet the same requirements, though certain IVDs manufactured by a laboratory may fall within one of the agency’s target enforcement discretion policies.
And through these target enforcement discretion policies, again, for certain categories of IVDs made by laboratory, we expect patients and healthcare professionals will continue to have access to these tests they need while having greater confidence that the tests they rely on are accurate.
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Jeff Shuren, FDA [00:11:49]
The agency’s economic analysis estimates that the benefits of the phase out policy outweigh the costs.
These benefits include an anticipated reduction in healthcare costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims and from therapeutic decisions based on the results of those tests.
Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs while facilitating continued access to critical tests patients rely upon.
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Rachel Roubein, The Washington Post [00:14:07]
I was wondering if you’d be able to give some examples of tests, with what you described as sort of the second enforcement discretion, in a healthcare system where there’s an unmet need of patients and there isn’t currently an FDA authorized test. What are some examples of tests that would fall in that kind of jurisdiction?
Jeff Shuren, FDA [00:14:30]
Well, certainly, and we lay this out in the preamble for the rule. I’ll mention it as well, we will also be issuing additional guidance to further expand upon the information that we’re providing today.
So, for an unmet need, we consider and LDT for an unmet need where there’s no available FDA authorized IVD that meets the patient’s needs.
So this could be because there’s no FDA authorized IVD for the disease or condition, and that could be for rare disease, for example.
Second there is an FDA authorized IVD for the disease or condition, but it’s not indicated for use on that patient or, there’s a unique attribute that needs to be added to the LDT to meet the patient’s need.
Or there’s an FDA authorized IVD but it’s not available to that patient. So for example, you could have an LDT for use on pediatric patients when the FDA authorized IVD as indicator for use on adults only.
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Jeff Shuren, FDA [00:16:46]
We believe that the phase out policy, again, with these target enforcement discretion policies will sort of strike that right balance on better protecting the public health, assuring safety and effectiveness of IVDs that are LDTs, but again, avoiding undue disruption to the testing market.
So we received many comments on the notice of proposed rule making, including on the proposed phase out policy and the preamble. And we included these additional policies as a result.
So what we did is we kind of determined, and this includes for IVDs offered as LDTs currently on the market, based on benefit risk consideration, we balanced the benefits of FDA oversight with other considerations specific to the test that would fall under the policy.
So in the case for the enforcement discretion policy of currently marketed IVDs, first marketed before issuance of the rule, this was intended to address concerns that the perceived cost of compliance with the requirements otherwise in the rule could lead to widespread loss of access to beneficial IVDs on which patients currently have relied.
That said, if we identify problems with the tests, we can move forward to take action against them. And again, if modifications that– certain modifications like modifying the intended use on that test are made, that also would trigger additional oversight on the test.
So we think this overall strikes the right balance.
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Elizabeth Hillebrenner, FDA [00:28:40]
We did get many comments from the docket from different patient groups, including groups representing patients, caregivers, family members, and providers for those with rare diseases. And, this has been incredibly helpful in shaping some of the policies in the final rule– in the preamble to the final rule.
In particular, what we learned from the comments in the docket is that oftentimes these patients end up at integrated healthcare facilities to– because they have these rare conditions that their needs are not being met elsewhere, and they end up in these integrated healthcare systems that then often will create a test in order to meet the needs of that patient that they are presented with, looking for answers.
And that informed the development of the policy around LDTs for unmet needs and patients being treated within an integrated healthcare system.
USDA is confident that the meat supply is safe. USDA has a rigorous meat inspection process, where USDA’s Food Safety and Inspection Service (FSIS) veterinarians are present at all federal livestock slaughter facilities. FSIS inspects each animal before slaughter, and all cattle carcasses must pass inspection after slaughter and be determined to be fit to enter the human food supply. While we have multiple safeguards in place to protect consumers, we recommend consumers properly handle raw meats and cook to a safe internal temperature. Cooking to a safe internal temperature kills bacteria and viruses in meat. (specific recommendations are available online at: Safe Minimum Internal Temperature Chart Food Safety and Inspection Service (usda.gov).
To verify this in the context of H5N1, USDA is working on 3 separate beef safety studies related to avian influenza in dairy cattle: 1) sampling ground beef at retail in the affected states; 2) beef muscle sampling of cull dairy cows condemned at select FSIS-inspected slaughter facilities; and 3) ground beef cooking study. For the first, samples are being collected at retail outlets in the states in which dairy cow herds have tested positive for H5N1 influenza virus. The samples will be analyzed by APHIS using polymerase chain reaction (PCR), which indicates whether any viral particles are present. For the second sampling effort, FSIS is currently collecting muscle samples at FSIS-inspected slaughter facilities of cull dairy cattle that have been condemned for systemic pathologies. Similarly, the samples will be analyzed by APHIS using PCR to determine presence of viral particles. For both retail and at slaughter samples, any PCR positives will be evaluated for live virus by ARS. Finally, ARS will be conducting the beef cooking study and will using a virus surrogate in ground beef and cooking it at different temperatures to determine log-reduction of the virus. Results from these studies are forthcoming and we will share information as it becomes available.
The FDA remains committed to issuing the tobacco product standards for menthol in cigarettes and characterizing flavors in cigars. As we’ve made clear, these product standards remain at the top of our priorities.
“Two full years after releasing proposed rules backed by extensive scientific evidence – and more than a decade since the FDA began examining menthol cigarettes – the administration has failed to take decisive action to remove these deadly, addictive products from the market. The administration’s inaction is enabling the tobacco industry to continue aggressively marketing these products and attracting and addicting new users.”
Emma Price, CDC [00:00:38]
The tears were contaminated with a bacteria: carbepenemase producing, carbapenem resistant, Pseudomonas aeruginosa. And this pattern of resistance had never before been found in the United States.
And this was concerning because the bacteria is carbapenem resistant and carbapenems are a class of antimicrobials reserved for resistant infections. There are limited treatment options for patients that have carbapenem resistant infections.
The second point of concern is that this bacteria produce carbapenemase. Carbapenamase are enzymes that degrade carbapenem antibiotics, and they’re encoded on mobile genetic elements like this yellow circular plasmid here, and carbapenemase producing organisms or CPOs can spread these resistance genes easily.
So this yellow plasmid can move to other bacteria in the environment, thus amplifying the spread of carbapenem resistance.
So now that this bacteria has been introduced into the U.S. from the artificial tears, this resistance could spread.
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Emma Price, CDC [00:02:05]
During March to June of 2023, the New Jersey Department of Health was alerted of two additional outbreak linked cases. But oddly enough, these were not human cases. The outbreak strain was isolated from two dogs. We’ll call them Watson and Crick.
The canine isolates were highly genetically related to the outbreak strain in people.
Watson and Crick were separately owned and they had not interacted with each other, but they were hospitalized at the same small animal veterinary hospital.
Watson was being worked up for a chronic cough. Her isolate came from a bronchial or an airway swab, and she lived with three other dogs at home.
Crick’s isolate came from an external air swab. He was being worked up for recurrent ear infections and he lived with no other pets.
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Emma Price, CDC [00:03:01]
Both samples were sent to an academic veterinary diagnostic laboratory for culture and sensitivity testing and because the labs saw an uncommon resistance pattern, they sequenced the sample, which isn’t routinely done by veterinary labs, and uploaded the results to a national database, which triggered an alert to CDC and then to us at New Jersey.
So we wanted to understand how the strain got into the dogs so that we could stop further transmission events. And because both dogs were seen at the same veterinary hospital, that’s where we focused our investigation.
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Emma Price, CDC [00:04:15]
So starting with the obvious, we asked if the owners used the outbreak associated brand of artificial tears on themselves or on their dogs, but neither dog owner recalled using the tears, although we do acknowledge the difficulty of recalling over the past year.
We asked if the owners or dogs had been admitted to or visited human hospitals, but both owners were healthy and neither owner nor any of the household members had been hospitalized. And even the dogs had not visited as therapy animals.
And because this pattern of resistance has been seen in other countries, we also asked about international travel and no one had traveled internationally since before March 2022.
And then we wanted to see if the dogs or other patients at the veterinary hospital received artificial tears, But a review of the hospital purchase records showed that the hospital did not stock the outbreak associated brand.
So then we also wanted to see if other tear products were used other than the outbreak associated brand. And we found that Crick was prescribed and received over the counter artificial tear product. It was not the outbreak associated brand, but it is possible that there’s other products that are contaminated, that we hadn’t identified.
And we also looked at patient overlap at the facility to see if veterinary hospital transmission was possible such as through contaminated hands or equipment. And we found that was possible because Watson and Crick visited the surgery preparation area and the recovery area of the hospital, although on different days, and Crick and one of Watson’s housemates also saw the ophthalmologist at the hospital.
So it’s possible that transmission happened in those areas.
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Emma Price, CDC [00:06:21]
Our site visit uncovered gaps related to infection prevention and control.
We found limited hand hygiene resources. Ideally there would be hand sanitizer in each room or treatment area mounted on the wall. There was also limited availability and just general lack of use of personal protective equipment, especially gloves.
Gloves, ideally, would be readily available for use, such as mounted on one of these walls in the treatment area and exam room. There was also storage of clean equipments and supplies within the splash zone of sinks, which could lead to contamination of these products.
And then there was also visible soiling and dust accumulation on reusable shared equipment and devices.
And I do just want to take a moment to note that these findings aren’t specific to this vet hospital. This is part of a wider lack of emphasis of infection prevention and control in the veterinary setting.
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Emma Price, CDC [00:09:48]
So fortunately both dogs are doing well and we know of no other animals involved in this outbreak.
However, we do know that it’s time we start preparing for CPOs in the veterinary setting to prevent spread among animals and then also possibly back to humans.
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Emma Price, CDC [00:12:00]
We did have concern just because of the close shared environment, sharing water balls, food balls, and dogs interact very closely licking each other as well. So certainly concern for transmission there.
Fortunately Watson was doing well, but there is of course concern that she could have been colonized with this. So, we tried to balance our recommendations with what was feasible for the owners and also what would protect the owners as well.
Fortunately, the owners were not immune compromised, but we did alert them to the fact that there could be potential transmission to them, and to alert their physicians as well for future healthcare visits. And ideally keep the dogs away from other dogs in the future, which we understand is a difficult thing to do.
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Emma Price, CDC [00:13:49]
The samples were actually sent to an academic veterinary diagnostic laboratory, not to the state laboratory.
And because they had a grant and a veterinary microbiologist works there and he did his great due diligence and uploaded the results, that’s how we got the notification because the strain matched the outbreak strain.
So it was quite serendipitous in a way, but also really points to the one health connection and the needs to have surveillance of CPOs in veterinary settings.
Right now, they are not reportable as CPOs are not reportable in animals, in New Jersey, but we are working on our protocols to include that.
I can’t really speak to other states. I think it might differ. I know in Pennsylvania where the samples were sent, the lab did to then go and send out a letter about this.
But certainly something that we are working on, because it’s important that we start alerting people about this.
“Novavax has been developing and manufacturing a monovalent protein-based JN.1 COVID-19 vaccine at-risk to ensure readiness for this fall. Today’s recommendation by the WHO Technical Advisory Group on COVID-19 Vaccine Composition is an important step to help ensure access to a non-mRNA protein-based vaccine option for those at highest risk globally.”
Yes, NIAID can confirm that both Ohio State University and St. Jude’s Research Hospital, affiliated with the NIAID-funded Centers for Excellence for Influenza Research and Response, performed those activities as described in pasteurized, retail milk samples, and no live H5N1 virus has been detected to date. Those findings were shared with the FDA, USDA, and CDC as part of their broader surveillance and national testing efforts in connection with the H5N1 outbreak in U.S. dairy cattle.
Rosemary Sifford, USDA [00:15:22]
This slide has all the virus sequences lined out so that you can see that all the virus sequences in this genotype are highly similar. There are two distinct ancestral branches with three wild bird and one skunk that’s in the red.
The recent human detection in Texas is purple and then very closely related and ancestral to current dairy sequences, but it suggests an unsampled population.
All dairy samples fall in a distinct branch together with minimal genetic variation. And those are all the green branches that form the flower.
There are several remarkable features of the virus that have been characterized to date. It remains very much an avian virus with no significant changes compared to other genotypes. In other words, it’s not becoming a bovine virus.
The viruses are highly similar, representing more of a clonal expansion versus different independent introductions as has been seen among the majority of poultry detections prior to this event, on a distinct ancestral branch of the genotype relative to the dairy detections, and they share a common ancestor.
All samples on the dairy branch, six snips, not present in the skunk samples. The skunk shares four snips with a wild bird that has 12 additional snips. The skunk sequence has T271A mutation associated with mammalian adaptation. Mammalian adaptation mutations, including T271A have not been detected in dairy cattle to date.
This New Mexico skunk was detected on February 23rd, and did not have the potential to be the source of the virus in the detected dairy cattle.
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Rosemary Sifford, USDA [00:23:31]
It is still early and we do still continue together information to make sure that we can understand as completely as possible how the virus is moving.
But what we can say at this point is that there is a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herd, so that leads us to believe that the movement with, through the cattle, is most likely associated with milk, whether that be through the actual process of milking or just from contamination from milk from a cow with a high viral load to other cattle.
In herds that are outside the geographic region, that appears to be where the first spillover event happened from birds into cattle. Those herds are very consistently showing epidemiological links to herds within that geographic region. So we believe it has moved with the cattle, with lactating cattle, from those herds into the other herds.
For this reason we are strongly encouraging producers to limit movement of cattle, particularly lactating cattle, as much as possible. And as I mentioned yesterday, we just implemented the federal order to require testing prior to interstate movement.
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Rosemary Sifford, USDA [00:27:35]
From the samples that we have so far, which admittedly is a small number of samples from the GI tract, we do not see any significant shedding.
We’ve sampled different tissues from cattle provided to us from FSIS, and we are seeing still concentration in the milk and the mammary tissue as the highest tissues where we see viral concentrations.
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Rosemary Sifford, USDA [00:29:17]
The human who was sampled has a sequence that appears to be a predecessor to those that we have found in cattle. Our interpretation at this point is that that means likely that that person became infected through a herd that we did not receive any samples from for testing.
As I mentioned, there were herds that had clinical signs in that geographic area before we had the first herd that we had positive H5N1 test results in. And so it is– that we think is the strongest hypothesis at this time with regard to the infection for that person.
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Rosemary Sifford, USDA [00:32:27]
At this point we do not have very much information with that regard. What I can say is that we have had one herd of cattle that did not have any clinical signs that tested positive in that herd. Cattle had been moved into that herd from a herd that had subsequently had clinical signs and positive cattle.
However, the herd that received cattle to date has not had any clinical signs. So we do know that the virus can be present in cattle, not exhibiting clinical signs, but we are just getting underway with those studies to give us an idea of the opportunity for viremia either ahead of or after clinical signs.
So we should have more information about that in the coming weeks.
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Sonja Olsen, CDC [00:42:07]
As of today, there are affected herds in 33 farms across eight states. And there are also six detections in cats confirmed on various dairy farms and also wild bird confirmations on some of the farms.
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Sonja Olsen, CDC [00:46:49]
I want to acknowledge that the situation in cattle is a little different than that in poultry.
If dairy cattle are ill and we have known exposure, though we know what the illness– we know that the illness in cattle can go on for several weeks. So that puts workers at an ongoing risk. And thus, the period for monitoring will be longer.
In situations where the cattle are not showing signs of illness, but testing positive, it gets a little less clear on how to define this exposure period. So these are just examples of some of the challenges we’re working through and highlights understanding why knowing the routes of transmission from cattle or the environment or milk is so important to be able to begin to make informed decisions about the risk to humans and how best to protect workers.
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Vivien Dugan, CDC [01:07:25]
So when we dive down a little bit deeper and look at the sequence data, we did obtain sequence data from the conjunctival specimen, but not the nasopharyngeal specimen from this individual.
And that to our experts suggest a lack of a respiratory infection. And it also aligned with the cycle threshold or CT values that were obtained by realtime RT PCR on the specimens for 18 CT value for the conjunctival specimen and 33 CT value for that nasopharyngeal specimen.
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David Boucher, ASPR [00:09:22]
Just want to touch quickly on some of the prior efforts that we can leverage, specifically the procurement of personal protective equipment, PPE, and antivirals.
Both of these are available in the strategic national stockpile, which is managed by ASPR. Regarding general availability, these products are obviously available on the commercial market, and this is the first avenue of sourcing.
We are not tracking any supply chain issues for any of the items that I’ll be discussing here. That said want to make you aware of a few safety nets we have in plac at the federal level.
Before that, personal protective equipment is often available also at the state and jurisdictional levels. So please be aware of that.
At federal, my colleagues at the U.S. Department of Agriculture manage the food safety inspection service or FSIS and the national veterinary stockpile or the NVS, both of those also maintain a supply of PPE. Here at ASPR, we do have a significant supply of PPE in the SNS talking about goggles, face shields, gloves, a lot of other reserves that can be tapped into if we need to step in and supplement other sourcing channels.
So all of this really to say simply that appropriate use of PPE right now really should not be unnecessarily limited by supply issues.
Shifting over to antivirals, I think you’ve heard earlier in the discussion, from Dr. Dugan, that the virus that we’re tracking right now does not carry any of the genetic markers that we would commonly associate with resistance to the available antivirals for influenza. What this means is that the use of these antivirals for seasonal influenza would also be available for the treatment of infections caused by the H5N1 clade that we’ve identified in wild birds, poultry, and some mammals, including of course here, the focus dairy cattle.
We do have several of these antivirals in the SNS. We have oseltamivir, the branded name of that when it’s Tamiflu, we have a zanamivir or Relenza, baloxavir or Xofluza, and then lastly Rapivab or peramavir.
Oseltamivir is the most commonly prescribed antiviral for influenza, and thus it is the majority of the SNS inventory. As with the PPE, we’re not seeing any supply chain issues associated with these antivirals, and of course we have identified just one human case of H5N1 associated with the spread among dairy cattle.
We do, however, just want to make everybody aware, we have tens of millions of courses of Tamiflu that can be used to supplement commercial sources in alleviating any supply bottlenecks, if we need to do that.
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David Boucher, ASPR [00:15:04]
Regarding vaccine availability, spend a couple minutes just talking about that. As Dr. Dugan mentioned, we do have two CVVs that are well matched to the H5N1 virus that we’re tracking in dairy cattle. Those are the two with the really long names. Commonly we’ll call those Astrakhan American Widgeon.
We have completed initial fill of some doses. We’re working right now with our colleagues at FDA and our industry partners to determine if there’s an appropriate regulatory pathway for use of these doses, if we need in the current response.
If there is, these doses would be the first wave of doses that would be used. At this level, we’re talking about total quantities in the hundreds of thousands. This would most likely roll out in tranches of several hundreds of thousands at a time.
I mentioned the bulk antigen manufacturing and adjuvant stockpiling. We have also completed that for these CVVs, if we needed additional vaccine above that hundreds of thousands that I mentioned, we could mix and fill this bulk material into final vials or syringes, and these doses would then be kind of that second wave of doses available.
In this part, we’re talking about up to about 10 million doses. If we needed to move beyond this, we would be able to leverage existing contracts with manufacturers and enter into large scale production. This is where we would be able to build a supply and vaccine sufficient to provide doses to a wider swath of the country.
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David Boucher, ASPR [00:26:02]
So, I mentioned we partner with the manufacturers of the seasonal influenza vaccines. The great advantage that gives us is that we’re using licensed platforms. We can quickly pivot to a different clade and plug it into that. It makes the regulatory path a lot of the manufacturing, a lot easier.
The downside of that though is that it does leverage those same lines that are used for seasonal production. So, the things that we’re weighing right now, when we make the– when we’re trying to evaluate the decision of when to go, it is obviously the situation on the ground.
The risk to humans is first and foremost, the resourcing required to do it, and then the potential side effects, if we disrupt seasonal production. We would obviously not want to do anything that that causes shortages of the seasonal vaccine. So those are all the things that we’re weighing right now.
And it’s a very– you can see there’s a lot of variables that go into making that decision.
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Don Prater, FDA [00:48:30]
We’ve just received some results a few minutes ago and we’re still analyzing them, but at a top level, it looks like about one in five samples, maybe with some preponderance for areas from known herds. And so we’ll have more to say about this as we complete our investigation.
This is just coming in this morning, in fact, and just want to remind that the PCR positive results representing viral fragments would necessarily need to be analyzed to determine whether there represents any viable virus that pose a risk to consumers. It’s important for us to get this information.
Also, we remind that early work by the NIH investigators indicate an absence of viable virus in their studies of retail milk. So that’s helpful. And then of course, we’re following very closely CDC’s food safety group, as well as its surveillance team to make sure that they’re monitoring any emergency department data, flu testing data for any unusual trends in thus far. We haven’t seen anything come up there.
So overall, even with considering these results, we haven’t seen anything that would change our assessment that the commercial milk supply is safe.
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Don Prater, FDA [00:43:28]
So what are the types of studies that FDA is participating in? There’s a whole variety of studies that might be going on, some of which FDA are participating in. These benchtop pasteurization studies using spiked milk and milk from affected cows. Also the pasteurization validation studies that I mentioned, with a pilot scale pasteurizer. Determining viral load in raw milk that could be presented to processors. This might be different than what we see in a clinically infected animal. We would expect it to be. And then also a survey of avian influenza inretail products. As I mentioned before, followed by viral isolation in eggs.
These are some of the studies that FDA is looking at in partnership with our colleagues at USDA Agricultural Research Service. Next slide.
So the pasteurization validation studies, we are looking at some of the most common time and temperature pasteurization combinations, including a high temperature short time. This is a method that uses 72 degrees centigrade for 15 seconds.We’re also looking at this in both spike milk samples, as well as samples from clinically infected cows. And then the other type of study that we’re looking at, I mentioned before, involves say pilot scale, continuous flow pasteurizer, and it will be informed by some additional data that we are doing in a double blinded study.
Let’s move to the next slide.
So, why do we need to determine that? Because there will likely be a different viral load that will be encountered by the pasteurizer. And so we are working on a double blinded study, utilizing some samples that are collected under our grade A program. They’re sent to a third party lab and then ultimately for blinding, and then ultimately, they will go to the USDA ARS lab, where we will follow that same procedure looking at PCR detection, followed by quantification in live bags that will help us to generate the information that will inform our pasteurizer study. Next slide.
Retail dairy product sampling. So we are looking at retail samples of various milk and milk products. And again, hopefully the USDA ARS lab is conducting the quantitative PCR, looking for detection of genetic material and followed up by quantifying for any potential live virus via an egg culture. Next slide.
Might be the last slid. Also on this landscape. So I mentioned that FDA is working on this, our colleagues at NIH through their investigators are working on this. There are important questions to be answered, looking at viral levels and different fractions of milk. So the skim milk versus the cream, looking at potential ingestion of raw milk through, from effective cows and rodents, some work on pasteurization validation, very similar to the bench top test, there’s other work ongoing at universities, and then importantly as have already been discussed, APHIS epidemiologic investigations and the CDC and state epidemiologic investigations of farm personnel will also provide important information.
Don Prater, FDA [00:08:12]
U.S. government partners have been working with deliberate speed on a wide range of studies, looking at milk along all stages of production on the farm during processing and on shelves using established discipline methodologies used previously to confirm pasteurization effectiveness for known pathogens.
This work is a top priority and we are proceeding in an efficient step-wise and scientific fashion to ensure the continued effectiveness of the federal state milk safety system.
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Mike Watson, APHIS [00:12:25]
Today we’ll be releasing a federal order, and the order is intended to further protect the U.S. livestock industry from the threat posed by highly pathogenic influenza.
And the primary focus of the order initially will be on lactating cattle, but we will certainly have the opportunity to expand beyond that as necessary.
So the federal order is gonna require laboratories and state veterinarians to report to USDA any dairy cattle that test positive for avian flu or any type of influenza A.
The testing will be done at the or national animal health laboratory network.
Dairy cattle moving interstate must be tested for avian flu or any type of influenza A before movement. No dairy cattle positive for avian flu virus may move interstate without conditions specified by APHIS.
And producer premises must undergo investigation and movement tracing for herds of positive avian flu cases, if they intend to move any other cattle across state lines.
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Mike Watson, APHIS [00:13:26]
So requiring the positive test reporting will help USDA better understand this disease and testing before interstate movement will spread of the virus.
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Mike Watson, APHIS [00:13:58]
Additionally, we continue to see affected cows recover after supportive care with little to no associated mortality. However, over the past several weeks, USDA has noted a few things that have been the impetus for us to issue this federal order.
That includes spread between cows within the same herd, spread from cows to poultry, spread between dairies associated with cattle movements, and cows without clinical signs that have tested positive for the virus.
Also on April 16th, USDA APHIS microbiologists identified a shift in the H5N1 sample, this is one sample from a cow in Kansas, that could indicate that the virus was mutating for adaptation to mammals.
However, CDC conducted further analysis of the specimen sequence and their assessment is low risk over all, of this one sample that has that change.
Additionally, APHIS’ national veterinary services laboratory found H5N1 in a lung tissue sample from asymptomatic coal dairy cow that originated from an affected herd was sent to slaughter.
That coal dairy cattle was condemned by USDA’s food safety inspection service during inspection, and did not enter the food supply.
The one sequence shift and the one dairy cow with H5N1 in the lung tissue so far appear to be isolated events.
However, the novel movement of H5N1 between wild birds and dairy cows requires further testing.
We need time to develop a understanding to support any future courses of action. So this federal order is critical to increasing information available for USDA.
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Nirav Shah, CDC [00:17:43]
Now to date 23 people have been tested by states for avian flu and states have also been actively monitoring 44 people who are considered exposed and at risk for infection.
So far, there has been one human case in the current outbreak reported in Texas following exposure to dairy cattle.
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Nirav Shah, CDC [00:18:43]
In addition, we constantly monitor clinical laboratory testing data. And so far we have not identified any unusual or concerning patterns at the national, the states or the local level.
In addition, CDC has not identified any out of the ordinary influenza related emergency department visits, even when we compare areas where H5 has spread among cattle against areas where it has not.
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Jeanne Marazzo, NIAID [00:21:34]
We are providing scientific support to the Department of Agriculture, the CDC, the FDA, and the Department of Health and Human Services in connection with the emerging H5N1 influenza situation in dairy cows.
Specifically, we are doing this through our six U.S. based centers for excellence for influenza research and response known as CEIRRs.
Since 2007, the CEIRRs have played a major role in U.S. pandemic preparedness efforts by studying several key factors: influenza’s natural history, how flu viruses transmit from to humans and therefore evolve and adapt, and the immunological factors that can determine influenza severity.
The CEIRRs also provide a research infrastructure to address influenza outbreaks and assist in emergency response.
In the current H5N1 situation, NIAID mobilized the CEIRRs through its risk assessment pipeline to conduct studies to characterize the virus and evaluate the connection, if any, between the infected dairy cows and milk.
Specifically, these studies include PCR testing of retail pasteurized milk samples to determine if H5N1 virus is present. And if so, finding whether it’s live virus by trying to grow it in cell culture and in embryonated chicken eggs.
CEIRRs researchers are also measuring virus levels in whole milk components, derived from infected milk, such as cream and pellets, conducting heat in activation studies of infected milk samples to understand how heat inactivates the virus, and investigating the stability of virus on environmental surfaces, such as steel and plastic.
Experimental results from CEIRR network scientists are reported in real time to NIAID. And we quickly share these with our lead government and regulatory partners for analysis as part of their broader surveillance and testing efforts.
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Mike Watson, APHIS [00:32:17]
We are also working with our state partners, where they can potentially have some– a mechanism to test intrastate movement as well, but our is focused strictly on interstate movement.
And in terms of the results, it’s a typically one to three days. So it’s relatively quickly, relatively fast to get those results back. We’re also working on developing additional tests, where we could get quick results.
These tests could be used in the field and hopefully get more immediate results for the producers. So that’s not available yet, but we hope those will be available here in any near future.
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Don Prater, FDA [00:34:43]
We are conducting that analysis now, and we will be ready to share results in the coming days.
We have, I think confirmed, what some of the other groups have found that there are PCR positives, but we still are processing the current samples and we be ready to share that in the coming days.
JoNel Aleccia, AP [00:35:06]
I mean, just to be clear that milk from shelves in the U.S.– you are waiting for the results of that. You haven’t found it yet in milk, taken from grocery store shelves, is that correct?
Don Prater, FDA [00:35:20]
We have found PCR positive results and milk from grocery store shelves, and we are conducting further analysis to see if those positives actually reflect any live virus that would pose a result of, uh, risk to consumers.
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Jeanne Marazzo, NIAID [00:36:04]
What the PCR testing that was done by our investigators was performed on a relatively small number of retail milk samples.
And they also detected positive PCR for H5N1. They then went on to do what we talked about before, which was to determine whether it is live, likely infectious virus, by growing it or attempting to grow it in both cell culture and the embryonated chicken eggs I mentioned before.
And the results that those investigators got indicated that the PCR positive material was not alive. In other words, it did not infect the eggs or the cells.
I want to emphasize though that while this is welcome news, the effort studied a small number of samples that is not necessarily representative of all retail milk. So to really understand the scope here, we need to wait for the FDA effort that, uh, Don just mentioned.
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Question [00:37:19]
Can you clarify more details about those positive samples? You said you found in grocery store shelves. I mean, what state, when did you get those results? What kind of product was it? Any details you can share would be helpful?
Don Prater, FDA [00:37:32]
Yeah, thanks very much for the question. We are tracking a variety of, uh, surveys that have been performed.
To our understanding, some of these surveys are local or regional. And so for that reason, we wanted to conduct a nationwide survey.
We don’t have information to share, but it will be coming out very shortly. And, u that’s what I can share at this point. We– that that will be a more representative survey.
Question [00:37:59]
And then second, can you tell us more about why you think this milk wasn’t diverted from the milk supply? I mean, did it come from an asymptomatic herd or farms not following your guidance to discard milk? Help us understand what you know about where this milk came from?
Don Prater, FDA [00:38:15]
One of the things that’s really important here is to understand the history, natural history of the disease, which includes not only animals in the symptomatic phase, but also animals that are in the asymptomatic or convalescent phase.
So that information, that’s being collected by our colleagues, is really helpful. Currently we believe that milk from symptomatic cows which is not entering the milk supply.
We are also monitoring very carefully the fact that agent from asymptomatic or convalescent cows, the potential for that to enter the milk supply.
We believe that pasteurization will inactivate that level of virus. But it’s important for us to understand the natural history of the disease. It’s also important for us to understand the quantities that might be coming from asymptomatic animals.
Question [00:39:11]
And I’m sorry, just one last follow up on that. So are you able to tell where this milk came from, that had this fragment?
Don Prater, FDA [00:39:19]
Right now, we will be able to look at information that we are collecting as part of this. Our traceability information is good, but it’s not perfect.
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Helen Branswell, STAT [00:43:44]
We’re hearing reports of some farmers that are refusig to let USDA officials on site to do testing. Is that true? And if it is, does USDA have the power to require an operator to let them on the site?
Mike Watson, APHIS [00:43:45]
We’ve had some– there has been a little bit reluctance for some of the producers to allow us to gather information from their farms.
That has been improving here most recently. We have been able to gather information from a number of facilities at this point in time. And, you know, with the federal order going into place, this is going to really help us address any gaps that might exist in terms of us being on the farm versus knowing what’s happening with the cattle.
So as again, as cattle move interstate, we’re going to be able to get all the information we need. And if there are infected cattle on a particular premises, we will have the ability now to make sure we can go into that facility and follow up with additional testing, epidemiological gathering, those kind of things.
So, to answer your first question. Yes, there was a little bit reluctance from some producers, but we have been able to work with a number of them and now with a federal order in place that will expand even further.
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Patrick Thomas, The Wall Street Journal [00:49:17]
In terms of when there is a positive test, is there any read yet on if this is gonna have an impact on the milk supply, given when there is a test, if it doesn’t enter the food supply, is that milk destroyed or dumped? Is there any sense of how that’s impacting the milk supplies or do you expect it to as, is this appears to keep spreading?
Mike Watson, APHIS [00:49:36]
I can start. Right now, we’re not seeing any significant impacts.
The springtime is a time where there’s excess supply. Spring flush is what it is, I guess, referred to. And so right now we’re not seeing any challenges.
But I think, to answer your question, this is why we are really trying to gather as much information as possible over the next few weeks to few months, going back to our original premise that this is a spillover from wild bird migration.
Want want to have this opportunity now before the fall migration to have a better understanding of what happened, what may have happened, and ensure that we can have protection, for producers, come the fall.
So, right now, we don’t see any significant issues.
And I’ll ask my colleague at FDA if there’s anything I missed there, but, again hoefully we’ll have opportunity to have more measures in place, measures in place by the fall, based upon information we gather here.
We are currently aware of five cases in King County that appear to be linked to this ongoing national investigation. However, FDA is currently investigating and has not confirmed if the cases are a result of a potential counterfeit or mishandled product or a result of Botox side effects. The five people reported receiving Botox (botulinum toxin injections) at a cosmetic spa. None of the individuals were hospitalized.
FDA is the best source of information on these cases and others around the country that may be associated.
Consumers should report suspected counterfeit Botox products to FDA at 800-551-3989, or through www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.
Health care professionals and consumers should report adverse events related to the use of any medications, including suspected counterfeit medications to FDA’s MedWatch Safety Information and Adverse Event Reporting Program
If systemic botulism is suspected, health care professionals should call the patient’s local health department immediately.
The CDC also released this information which may be helpful. https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections.html
Tom Vilsack, USDA [00:12:09]
I think it’s important to underscore that school meals matter. They matter for the students who consume them, in some cases, in many cases, in far too many cases, it is often the only meal or meals that youngsters may get during the day. It matters to them and to their families.
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Tom Vilsack, USDA [00:12:49]
We have quality partners that we work with in connection with school nutrition, and that’s the school nutrition experts, the folks on the line, the school nutritionist folks who every single day care deeply about the kids they serve. And we have tried to be a good partner with them, with unprecedented support over the last several years, as they’ve faced a multitude of challenges with supply chain. We also recognize the important role that industry plays, specifically when they can participate to reformulate foods, to meet the new standards. A good example is the dairy industry’s work on reduced sugar and flavored milk.
And I think all of this is designed to ensure that students have quality meals and that we meet parent’s expectation that their children are receive healthy and nutritious meals at school.
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Tom Vilsack, USDA [00:14:11]
This is a rule that’s based on science and very consistent with, and needs to be consistent with the dietary guidelines. The rule that was formulated with a significant amount of feedback. Over 136,000 comments were received during the comment period.
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Question [00:25:19]
I’m wondering if you can expand a little bit on why you decided against limiting flavored milk for K-5, K-8 schools. And then also, can you address what will happen to schools who fall short of meeting these guidelines this fall or in the coming years? Thanks so much.
Tom Vilsack, USDA [00:25:37]
Well, the challenge, I think, is to make sure that children have access and actually consume milk. And I think most school nutrition officials would tell you that youngsters certainly gravitate towards the flavored milk option.
I think the key here was that we worked with the industry, knowing that we were going to be focused on added sugars, and challenged the industry and the industry stepped up to the challenge and basically is working on making sure that the flavored milk will in fact have limits on added sugar by the fall of 2025. And I think it’s just basically we want to make sure kids have access to to milk. It’s an option and choice, and it’s one that many, many children choose. That way they get the vitamins and the minerals that they need.
Given the structure of this rule, that will over time provide for weekly consumption limits on added sugars, we thought that it could fit within the decision making that would be made at the local level. Obviously it’s a decision that each school district can make whether to offer the flavored milk or not.
But I think one of the reasons they might is because they will probably find that it’s consumed more frequently by the children.
To your second question, Cindy if I could ask you, I think we would continue to work with with school districts, and the expectation and anticipation is given the transition period that we have built into the rule, that we’re going to see compliance.
As has been indicated, the industry is already working on providing many of the products that will meet the standards, and will continue to be a good solid partner.
But Cindy, if you want to add anything to the question about what happens if the standards aren’t met?
Cindy Long, USDA [00:27:38]
Yeah, no, I think as Secretary Vilsack noted, that the gradual nature of the rule, along with the extensive input and work we’re doing with industry, is really designed to make schools be successful with the new standards, which is our goal.
But with respect to what happens if a school, you know, despite its best intentions, isn’t quite there at a particular point in time. I want to emphasize that one of the things we were able to do during the pandemic was to provide flexibility so that schools wouldn’t face financial penalties if they weren’t able to meet every aspects of the standard.
Well, I want to share with you that we have made that flexibility permanent, in our regulations about school meal oversight. So going forward, if a school is working towards the standards and trying, but is falling short in some way, states are no longer required to automatically take a financial penalty to the school.
The state has the ability to work with the school, to help us bring us into help work with them, and let them have a little more time if they needed. And so financial penalties would be only reserved for folks that were willfully or much more seriously violating the program.
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JoNel Aleccia, AP [00:29:26]
The press release says USDA will require only one sodium reduction, not the three incremental reductions that were proposed last year. And I think last year, the proposal would’ve reduced sodium by 30% by the fall of 2029. So how are– how is this new single reduction– what level does it reduce it to?
Tom Vilsack, USDA [00:29:52]
I’m going to get this. I hope I get this right, but if I don’t, Cindy Long can correct me.
By the fall of 27, a 10% reduction on sodium on breakfast and a 15% reduction for lunch.
Congress basically provided a rider to the budget process, which basically instructed us to essentially provide this. So it’s a very,– it’s very consistent with the congressional directive. In other words, Congress directed us to do this.
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Cindy Long, USDA [00:34:02]
When the rule publishes tomorrow, there will be a detailed impact analysis as there always is with a major rule. And it’ll show that the cost associated with this rule are very, very modest, compared to the overall size of the program. I believe it’s on the order of maybe something like 1% over the five to 10 year projection period.
Yes, we are investigating the source of the counterfeit product and that is ongoing. CDC is handling information about patients, case counts, etc.
I can certainly let you know once we have an update on that.
Pursuant to section 381.0031(6), Florida Statutes, and Rules 64D-3.036 and 3.041, of the Florida Administrative Code, information contained within a required case report or collected as part of an epidemiological investigation is confidential and exempt from provisions of section 119.071(1), Florida Statutes. While the case information is confidential and exempt, I would like to provide you with further information around your request.
The Department’s Division of Medical Quality Assurance (MQA) licenses and regulates over 100 license types and over 1.4 million licensed health care providers. Florida law requires that health care workers practicing in the state must be appropriately licensed. The unlicensed practice of a regulated health care profession is a felony in Florida. The Unlicensed Activity Unit (ULA) of MQA here in Florida is unique when compared to other states across the nation, as it is the only dedicated unit focused on investigating alleged instances of unlicensed health care activity. All unlicensed activity allegations, regardless of profession, are taken seriously and reviewed for legal sufficiency. Patients are encouraged to check the license status of their health care providers by visiting www.FLHealthSource.gov and clicking on “Verify A License.”
We would appreciate it if you would communicate this information to the community to ensure unlicensed activity in Florida is reported. If unlicensed activity is suspected, make a report by calling 1-877-HALT-ULA or emailing HALTULA@flhealth.gov.
Thank you again for reaching out to the Department and please do not hesitate to contact me with further questions.
Melanie Fontes Rainer, HHS [00:19:33]
So the rule is actually meant to help when women travel.
We know, as a result of Dobbs, that people have to travel to receive lawful reproductive healthcare. And so when a woman travels from one state where the care might be banned to another state to receive lawful reproductive healthcare, no matter what that healthcare is, whether it’s a pill or it’s a procedure, it’s just a medical examination, that when that woman goes home, her medical records will be protected, herself, her home providers who literally had nothing to do with the care she received in the first instance, they’ll be protected. And they’ll be able to say, no, you cannot have this information.
And the provider in the state where she traveled will also be protected from folks reaching in to go after that type of medical care, which is one of the main goals of this rule, so that women can seek care even in the face of the patchwork of laws we have now across the country, how people receive care.
Xavier Becerra, HHS [00:20:29]
Can I just add real quickly on that?
We have no illusion that everything that the president has urged us to do with our authorities is going to undo Dobbs.
Dobbs took away rights. Until we have a national law that re institutes Roe versus Wade, we’re going to have issues, but that doesn’t stop us from doing everything we can to protect every American’s right to access the care they need and to have the privacy they need.
Understanding again, Dobbs had consequences.
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Emma Beavins, Fierce Healthcare [00:23:34]
Can you speak to any changes that are in the final rule as compared to the proposed rule from stakeholder feedback you got on the proposed rule?
Melanie Fontes Rainer, HHS [00:23:42]
Sure. So one of the areas we got a lot of comments on was the exact example I used earlier. So, someone travels from state A to state B to receive lawful care, and then they go home to state A.
And what what’s happening is on the ground in state A, law enforcement may be going to state A and saying, we want this information, we want this data. And that state A, those providers, they didn’t provide the healthcare. It’s their patient. And they assume it was probably lawful, but they didn’t provide the healthcare.
And so the final rule has a presumption of legality in those instances, just those instances to help take some of the burden off providers and to make it more workable for those providers would be one change.
I think generally speaking the rule is mostly finalized as it was in the proposed rule. Not a lot of huge changes.
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Chelsea Cirruzzo, Politico [00:24:37]
I know some Democrats had asked that the final rule required that law enforcement have a warrant to request this information, but the proposed rule required a subpoena or a lower threshold. Has that changed in the final rule?
Melanie Fontes Rainer, HHS [00:24:50]
So we did receive incoming from some senators specific to that point.
The final rule doesn’t get to requirement for a subpoena or a warrant. Those things are under the existing HIPAA privacy rule and they continue to operate in the same way.
However, this is a really important step. We know that we can do more in the space and we’re happy to work with our partners in Congress to think about how else to protect privacy, right?
This is a really critical action that will help people feel safer when they go seek care. It’ll also help providers.
I’ve spoken to many providers who, I mean, you’ve probably heard the same thing who say I live in, ‘we’ll just pick on California, but I live in California. But when I go home to state X, I’m really worried about what’s gonna happen to me.’ Right?
And so we know that there’s a lot of those instances and that we have to do more in this space to think about healthcare.
Jamie Jonker, NMPF [00:52:15]
These are what are typical things that are being seen in the affected dairy cattle. They are multiparous. So what that means in dairy language, they are second lactation orolder. They are often 150 days in milk or longer.
And when a herd gets infected, we see about 10% of the dairy cattle having clinical symptoms. So 10% of the lactating cattle.
But there’s minimal mortality. And the mortality that seems to be occurring in dairy animals that have the clinical symptoms are the effects of secondary infections, secondary opportunistic organisms, that are infecting these animals that have high path AI.
We see decreased activity. So there’s a drop in rumination and rumor hyper motility. There’s a decline in feed intake. There’s a decline in water intake. There’s a decline in general, physical activity. Many of the early herds where this have occurred have activity monitors on their animals, and monitors within the milking systems that show a decrease in yield and consistency.
The milk itself becomes thicker, often yellowish to brown and resembling a gloster. Some animals are showing flakes in milk, which are generally an indication of mastitis.
Severe cows are affected in all quarters, but in some animals it’s only one or two of the quarters, and so it’s not in necessarily affecting the entire mammary gland.
There is widespread increase in milk conductivity, again a monitor about milk quality.
These animals when they become sick, they are separated from the general herd as best as possible. As you can imagine on a farm with 2,000 cows, you have 200 or so animals that become sick and separating them out into the hospital area can be challenging, because the farms are not set up to anticipate having a consequence like this where 10% or so of the herd is having clinical symptoms.
When these animals are becoming clinically ill, there is no specific treatment for high path AI in dairy cattle. So they are being treated for symptoms.
They are being– animals are being drenched to help rehydrate them. When they have secondary symptoms like fever, they’re being given NSAIDs or other other things to help with those symptoms. But there’s no specific treatment regimen today for high path AI and dairy cattle.
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Jamie Jonker, NMPF [00:55:25]
When a farm has an outbreak, the general timeline? It takes a little bit less than a week to peak incidence.
So when this gets into the herd, it’s rolling through very fast. We’re having a tapering at about two weeks. And so it’s also a very quick issue in the dairy farms.
However, it does take around 30 to 45 days for those clinically infected cows to recover fully from the process. And that being said, we have some cows that do not fully recover milk production, in that month to a month and a half period.
Some animals actually essentially shut down milk production from this and become a dry animal. We do not know if that is a lasting condition, until we start having some of these animals freshen back in to the herd. And that could be as much as six months from now.
And so there’s still a lot more to learn about the lasting impacts of this on some of the clinically infected animals.
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Jamie Jonker, NMPF [00:56:39]
There have been some abortions associated with this, but that again has not been a consistent sign.
That is a secondary issue that may or may not be directly related to high path AI, or could be related to a secondary infectious organism.
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Jamie Jonker, NMPF [00:57:55]
So that initial introduction most likely comes from migratory birds. But the exact route of that will probably remain a bit of a mystery because it took six weeks or so to figure out that it was actually high path AI in the original affected herds. And so, being able to trace back to that precise spillover event may remain a bit of a mystery.
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Jamie Jonker, NMPF [00:58:21]
Cows don’t fly, but we have had additional herds identified in seven other states after that initial announcement on March 25th. So that does mean that it is spreading in other areas in some capacity.
There have been some animal movements from the affected areas in Texas to several of those other states. And that may be one route of transmission that is still being investigated as part of the epidemiological investigation process.
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Jamie Jonker, NMPF [00:59:01]
We are seeing this in our lactating animals, but we are not seeing this in our calves, our growing heifers, our pregnant heifers, or in dry cows that have been dry prior to infection in the herd.
And so it’s very unique displayed dairy animals, acting in the mammary gland, seemingly more like a mastitis than a respiratory issue that is more typical of an influenza.
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Jamie Jonker, NMPF [00:59:50]
There have been one egg layer in Texas, three egg layers in Michigan, which have been confirmed to have high path AI H5N1, the same consistent genetic clade from the original, migratory bird introduction.
Those farms have been in close proximity to affected dairy farms. And so there could be lateral flow from the dairy farms to these poultry operations, to these egg laying operations. This could be such things as transfer of the virus through fomites, such as on clothing or on vehicles.
Again, we, this process is still unfolding. And so there is more research to be done to see if there has been this lateral flow from dairy farms to these operations. But this is changing how the dairy industry is looking at biosecurity on our farms.
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Question [01:36:51]
Are there studies in process or direct studies of the impact of pasteurization on the virus in milk and questions about whether or not there should be concern about low temperature pasteurization in terms of safety of the milk supply. So wondering if you could comment on that quickly.
Jamie Jonker, NMPF [01:37:12]
That’s an excellent question. Obviously there haven’t been studies previously because this is the first time we’ve seen it in dairy cattle.
And so, where we are today, the Food and Drug Administration believes that the varying interlocking on farm and in processing plant activities are keeping our milk supply safe.
Part of that is the work that’s been done on pasteurization and eggs. It’s showing that pasteurization inactivates high path AI at about 60 degrees Celsius.
Our most common pasteurization in the dairy sector is called high temperature, short time, that’s at 70 plus Celsius. And then the practice of diverting milk from sick animals or normal milk from animals is another part to that.
That being said, yes, there are– there is research being done. FDA is working with USDA and land grant universities to answer these questions. What is the ultimate impact of pasteurization? And looking at things like where does the virus reside in the milk matrix? Looking at some of the technologies that are used such as reverse osmosis and other ultra filtration processes that are done in plants that separate out. And so that work is underway.
We hope that information will be available shortly, and I’m not going to define what shortly is.
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Jamie Jonker, NMPF [01:40:49]
There’s certainly a lot of serological work that’s being done on clinical animals, animals that may be asymptomatic, work in other dairy animals that do not seem to be impacted. So, dry cows, springing heifers, young stock, this– it’s– we have a lot more questions and answers, because we’re still actually so early in this process.
But there’s a lot of great work being done by the many dedicated professionals across the U.S. on that.
Rep Andy Harris [01:34:13]
I’m just going to ask one simple question. You know, it says that, one of the five part test, the drug must be accepted by qualified experts. And even under the two factor test, it says that a qualified expert organization have opined in favor and government agencies is one of them.
Did the FDA consult with Dr. Volkow at NIH. I mean, she is the head of the institute for drug abuse. Did you consult with her about the wisdom of rescheduling marijuana?
Robert Califf, FDA [01:34:40]
NIDA has role in the process. And–
Rep Andy Harris [01:34:46]
This is a very specific question, doc. Did you discuss this with Dr. Volkow?
Robert Califf, FDA [01:34:52]
The agency discussed it with NIDA. I’m not sure about the– I talk with Dr. Volkow all the time so–
Rep Andy Harris [01:34:58]
And you’re aware that she is adamantly opposed to making marijuana more broadly available and rescheduling it?
Robert Califf, FDA [01:35:08]
I’m aware of her opinion, that she is.
Rep Andy Harris [01:35:09]
Okay, good. Because I would hope that we think that she is like the expert in the country on it, and I hope you would’ve taken that into consideration, but I suspect you took it in very minor considerations having come up with that recommendation, to reschedule marijuana.
I just think– I just think it’s a dangerous move, and very uncharacteristic of the FDA, which deals with drugs. I would ask like which drug is it that you suggested rescheduling, THC, CBD combinations.
Kentucky Department for Public Health is aware of one Kentucky resident who had botulism symptoms following injections of botulinum toxin A (known as Botox). This individual is recovering and investigations are ongoing. It is important for those who are considering botulinum toxin injections to seek a qualified medical provider who receives medication from a United States licensed manufacturer. Botulinum toxin A should only be injected by licensed physicians, physician assistants, nurses or dentists who have undergone specialized training in giving these injections.
We, along with Adams County Public Health Department and the Denver Department of Public Health and Environment, are investigating a case of botulism-like illness. An unlicensed provider in Adams County injected a patient with what was purportedly botulinum toxin.
The New York State Department of Health is not aware of any cases in New York State outside of New York City. Please contact the New York City Department of Health and Mental Hygiene at pressoffice@health.nyc.gov to inquire about numbers within the City. The Department also encourages anyone who believes they may be impacted by the counterfeit product to contact their primary care physician and local health department.
Robert Califf, FDA [00:38:06]
I’m a cardiologist and I practiced in North Carolina for 35 years. I probably have seen more people die from tobacco related illness than almost any physician because I was an intensivist who dealt with the end stage of the disease. This is a top priority for us. But when we make a final rule, it goes through an intensive interagency process. And that’s where it is right now. I can’t give details about dates at this point.
I’ll just say from the point of view of the FDA and me as an individual, given what I’ve seen in my life, we’re talking about over the next 30 years, probably 600,000 deaths that could be averted. And most of these as you duly note, are in African American people who have been targeted by the industry for the sale of these products.
So I’m with you all the way, but I can’t give details about the interagency process.
Rep Barbara Lee [00:39:09]
Okay. The interagency process is cumbersome. But I mean, we have an idea, some based on prior experience with rule making. Six months? A year? Three years? I mean, do you have a sort of a timeframe?
Robert Califf, FDA [00:39:29]
Whatever decisions are made, this, you know this doesn’t sit around for three years. But I can’t give an exact time. I really am prohibited from doing that.
Rep Barbara Lee [00:39:40]
No time frame. I mean, do you think by the end of the year?
Robert Califf, FDA [00:39:47]
It’s one of our top priorities, so I would sure hope so.
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Robert Califf, FDA [00:35:13]
I think we need to work with Congress to come up with a way to deal with this specific problem that cuts all of the red tape that we have to go through. Because if you think about it, it’s not as if people don’t see it coming in. It’s just, if you went, I would urge you to go and just look, do a tour of the international mail facility, and see the work that has to go into documenting every single item that comes in.
And there are many legal tricks that are used on the way in, like when I made my last trip to an import space, the boxes full of vaping products were labeled as lanterns. That creates a legal problem for us because we have to go by what’s on the label. Then it takes weeks to get that fixed and through the legal process. And by then, there’s a timeframe by which if we don’t do something, the product goes on through.
And so, you know, my general theme, what I’ve come to realize, pardon the sports analogy, but at FDA we’re like referees. We have a rule book, which you write as Congress. And I would at least urge you to think about this particular issue as one by which a specific rule might allow the referees to act quickly without all the things that are bogging us down.
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Robert Califf, FDA [00:58:59]
I believe the solution to the problem is what we’ve already discussed.
If there’s one thing that seems to be bipartisan here, it’s that these vaping products from China are not good for this country. They’re not even – they’re flavored. They’re not even sold in China to Chinese people.
I think what we need is help from you to have a system that allows us to do this efficiently, to deal with it. There are 300,000 retail stores selling these products. We can’t be in every one of them.
And let me just mention two things related to what you said.
Our budget is basically fixed, it hasn’t grown. And we get no user fees from the vaping industry. It’s totally– the budget is totally funded by user fees. The vaping industry has gotten off scot-free from paying the user fees. So the money that we’re spending to deal with the vaping industry is taken from other sources because there is no specific money to deal with the vapes.
So we have a request in to have user fees that would allow us to put many more people on the ground. But again, as I’ve thought about this, a lot, particularly as this problem has grown, I think the solution needs to be something that gets rid of– that makes it possible to move efficiently, to stop this before it gets into 300,000 retail shops.
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Robert Califf, FDA [01:01:03]
I do feel compelled just to point out, this is my opinion. I’m sort of thinking over the last few nights, it’s not an administration policy at this point, but it just seems kind of obvious that if we’re going to deal with this particular problem– and I wanna distinguish it from other products like the pharmaceutical products where we can’t just cut them off because they have benefits. Like I– my hypertension is treated by generic drugs that originate in other parts of the world.
But flavored vaping products have no health benefit. And so it seems like there could be some agreement about how to efficiently take care of at least that problem.
So, I’ll continue to work on it and look forward to working with you, whatever the right solution is.
CDC is reporting one case from New Jersey , a woman from Passaic County (18-40 year age group), who was hospitalized, but has since been discharged and is recovering. No additional information is available due to privacy concerns.
No other cases have been identified in Illinois, but we have asked anyone with a similar experience to call their local health department.
The preprint manuscript provides a more detailed look at the genetic signatures for the clade I mpox variant circulating in Kamituga, in South Kivu, DRC. It is important to note that this is a pre-print, meaning it has not yet undergone peer review, and it is possible that the information could change after formal peer review.
This virus and this outbreak were already previously shared in two preprint publications: https://doi.org/10.1101/2024.03.05.24303395, March 5, 2024 and https://virological.org/t/novel-clade-i-genome-sequences-from-the-ongoing-mpox-virus-outbreak-of-kamituga-in-south-kivu-province-democratic-republic-of-congo/956 Feb 15, 2024. This strain was already previously reported to contain a deletion in a specific part of the genome that might impact how well the CDC Clade I test works. This strain is still expected to test positive using CDC’s nonvariola orthopox (NVO) test, which is the primary test being used to diagnose mpox in LRN and most commercial labs across the United States.
For labs also running Clade-specific testing, CDC recommends the NVO test be run alongside any clade-specific PRC tests. Any unusual findings (for example, an NVO positive but Clade II negative) would prompt a deeper look at the sequence to see if it might be due to Clade I.
CDC continues to receive and test samples from U.S. mpox cases diagnosed by the NVO test, and we are taking a deeper look at the clade and any mutations.
NO CASES OF CLADE I MPOX have been detected in the United States.
Massimo Pacilli, Chicago Department of Public Health [00:20:06]
The index case was early– it was March 7th. We sort of immediately recognized it seated in a shelter that’s housed around 1,800 individuals who are not sort of organized in family units. It’s a large congregate setting.
So lots of opportunities for individuals to be in the same space, and families and children to interact, and therefore continuous exposures.
In that setting, we recognized the immediate need to deploy vaccination so that, within the next three days, we were actually able to go on site and deliver nearly a thousand vaccines. And that sort of– it takes about two weeks or 21 days to get sort of the full immunity benefit from those doses. But we certainly have seen the benefits in subsequent sort of infectious periods.
And so initially in this setting, we saw sort of the result of there the initial exposures in a cluster of cases, and then a second wave with sort of a peak around March 24th, that represented probably the exposure of that first wave. So that represented a little bit the peak of cases presenting.
And then after that, we are really are starting to see the benefit of those vaccinations. We’ve gone back and sort of deployed second doses, which is sort of– they can be administered 28 days after the first. And we’re really seeing the effect of this population being better protected and therefore less cases presenting.
We’re down to this week we have yet to record a case. The last one was with a rash onset of last week.
But again, hard to tell sort of the end of an outbreak, but we certainly see the protection of this community in this setting and sort of a– we’re certainly at the tail end of those cases presenting.
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Massimo Pacilli, Chicago Department of Public Health [00:22:11]
I think the other question was related to individuals infected with measles who may have received a vaccine before. So, as I was saying, measles vaccine is quite protective, but again, no vaccine is sort of a hundred percent protective, although it’s certainly even for those who end up being infected, there is sort of a lessening of the disease and a lessening of the spread that results from it.
I think what’s unique and why we see sort of a higher proportion of individuals who have received dose with measles in this setting is because– like that’s– sometimes observed sort of in family units when the exposure is really intense, right? We have these family units where a kid is perhaps infected and then caretakers are really around the case continuously.
Well, the situation is not that dissimilar in a large congregate setting. In this setting, we’re observing continuing protracted exposures. And so it is not completely unexpected to see a higher proportion of individuals who may have had a dose end up being infected with measles.
So I think that begins to explain sort of that proportion being a little bit different as the result of the uniqueness of the setting.
What is the source of the image that is attached to the notice on the website?
FDA’s web notice has more information on the images: https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states
When was the earliest case reported who received the counterfeits?
CDC consults on patients who experience signs and symptoms consistent with botulism through our botulism consultation line all the time, but CDC saw an increase in consultations related to botulinum toxin injections in 2024. CDC began hearing reports of potentially counterfeit product in late March and started coordinating the multistate investigation last week.
Can you clarify how many of the patients were exposed in a licensed healthcare setting?
Licensure requirements vary by jurisdiction, so we recommend reaching out to the state or local health departments involved to determine licensure requirements for providers and settings.
Thanks for reaching out. Currently USDA has decided to continue to name the disease H5N1 HPAI in cattle.
Mark Lyons, USDA [00:07:46]
We saw this clinical syndrome kind of presenting in dairy cattle where dairy cattle would go off being, we would see decreases in their milk production, low grade fevers. That kind of is where this started as we started some of those conversations with the states.
From there, we found the detection of the HPAI in some of the milk samples collected from those animals.
It is still at this point, I would say unclear whether the underlying etiology really is HPAI in cattle causing this illness, or if the illness is predisposed in animals being able to pick up HPAI in their milk secretions. That’s the piece that we’re still really trying to understand. And that’s the epi work that we’re really leveraging with our field staff, and our state partners at this point.
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Mark Lyons, USDA [00:08:36]
From what we are seeing in that initial epi work, we’re seeing some sort of lateral transmission possibly occurring within these herds.
At this point though, we’re kind of thinking that may be more related to a mechanical transmission component that’s happening, since this is really kind of isolated to those dairy animals at this stage. And predominantly it’s isolated even further to those lactating dairy cattle.
So we’re really trying to go back onto some of these farms, look at the process in the milking parlor, really kind of hone in, is there a mechanical transmission happening that this is more related to like a mastitis type event of high path transmitted mechanically between cattle and a process?
Our team’s also been working heavily to create epi questionnaire that we’re taking out to the field staff, taking out to these farms and better understand, how we see the HPAI moving within.
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Mark Lyons, USDA [00:11:23]
One thing of note, the cattle that do, uh, show this clinical syndrome do recover in one to two weeks is what we’re being told and what we’re actually seeing in the field.
So even though there is that lateral transmission occurring within the herd, the herd usually clears the infection within one to three weeks. But again, not something that we really have a full understanding on. And are continuing to do some studies to better understand that.
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Suelee Robbe-Austerman, USD [00:15:31]
The samples that we’re used to testing are swabs. And, when we tested milk, the milk was a little bit more challenging for us to test. These cows, clinically, had very thick milk.
They would go off feed and produce a very thick milk and it was very obvious they would segregate them into the sick pen. And, we would test that milk and have challenges with inhibition.
So laboratories ended up having to dilute the milk and we’ve added some various enzymes. And one of the things that we’ve been using is molecular transport media that contains like guanidine thiocyanate to break up some of the material within milk, to be able for us to get accurate PCRs.
The CT values in the PCRs in milk have been remarkable. We’ve seen PCRs as with, as low of a CT value as 10, and typically are in the teens. So we occasionally may see a clinical cow with CT values in the 20, but most of the time they’re in the teens.
When we’ve obtained, nasal swabs or respiratory samples from these cattle, we’re not seeing those CT values. Most of the time, those swabs are negative. Occasionally we get CT values in the thirties, but we have not been able to successfully sequence or recover a virus yet from a nasal swab, although we suspect it’s very early stages.
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Suelee Robbe-Austerman, USDA [00:17:37]
So when Dr. Lyon said that this is behaving differently, that is– that is most likely the reason with those CT values in the milk. It, just makes sense that that is the fluid that is– that that would allow for the most risk of transmission to cow to cow.
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Mark Lyons, USDA [00:24:39]
We don’t know at this point, the mechanical transmission in fomites piece. It may be the same process.
We’re terming it mechanical transmission at this point, because if there is– if it is spreading in the process of the milking parlor, it may be that on those fomites, whether it’s the clothing, whether it’s the gloves, towels, whether it’s in the dipping cups, whether it’s in the suction cups, that’s the piece that we don’t know. But we think there may be an active transmission occurring at that stage.
Again, as we continue to get more epi information, as we continue to get different details from the farms, we do hope that we’ll be able to kind of hone in on, is it truly fomite or is it more specific to an actual active transmission process in the parlor.
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Mark Lyons, USDA [00:25:56]
I don’t know that I would say cow to cow specifically, because we haven’t seen any true indication that the cows are actively shedding virus and exposing it directly to other cows.
As Dr. Robbe-Austerman said, we’re not seeing a lot of CT counts in those nasal swabs that kind of indicate viruses actively there. And it’s moving between the cattle that way, which again, so that’s where we’re really looking at as that lateral transmission piece of something is moving it within the herd.
It may not be cow to cow specifically.
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Mark Lyons, USDA [00:28:17]
So the herd in Michigan had animals that came from the Texas. One of the Texas herds in Michigan cattle did end up having infection later on.
Again, we don’t necessarily know that the cow gave it to the other cow, or if there was that human intervention piece where there was a lateral transmission occurring through that milking process.
So the cow may not have given it to the cow.
But there was a, there was a transmission that did take place in that lateral mechanical space.
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Mark Lyons, USDA [00:30:37]
Generally were seeing only about 10% of the milking herd really affected in a lot of these reported cases. And it’s a very– like there’s not been any mortality shown in this. So we’re looking at 10% of the herd affected and no real mortality associated.
Most cattle do respond within that one to two weeks span.
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Suelee Robbe-Austerman, USDA [00:33:03]
So this virus is 3.13 in the GenoFlu pipeline.
It’s not a common virus, but it’s very much a descendant of the viruses that have been dominating the flyways in the Pacific and the central flyways at the United States.
The cow viruses so far have all been similar enough that it would be consistent with the single spillover event or a couple of very closely related spillover event events.
We are not seeing any different viruses in the dairy cows that can’t relate back. So, so far, we don’t have any evidence that this is being introduced multiple times into the cows.
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Suelee Robbe-Austerman, USDA [00:34:46]
We’re able to confirm the epidemiology when we know cows move from one affected farm to the next, we’re able to see that evidence within the sequences.
So again, it’s very consistent to a single spillover event and then spread based on cattle movement.
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Suelee Robbe-Austerman, USDA [00:35:30]
We haven’t formally developed some active surveillance plans around the peri-domestic wildlife in the barns and stuff, but that’s planning.
We have tested skunks on or near the premises. We have tested, you know, wild birds. And of course the cats on these dairies have been affected and. And the cats have a high level of mortality on these dairy farms, if they’re– and most of them we assume are being allowed access to some of this milk.
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Suelee Robbe-Austerman, USDA [00:37:10]
In fecal material, we have tested and the vast majority of those have been negative. Some have had very high CTs, but based on our experience, we would not be able to rule out contamination because they’re being tested on the same plate as very hot milk.
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Suelee Robbe-Austerman, USDA [00:37:56]
We have really been encouraging our laboratories to be open to testing animals with clinical signs.
We did have a laboratory go back in their archive and test samples from abortions, which as you know, many times abortions remain undiagnosed.
And so they tested all the abortions submitted to their laboratory from January through March. And all of those were not detected.
We have not had any reports of sick beef cattle, but we’re confident that with our NAHLN laboratories, they would, if they did get a non-negative, they would send that to us.
We have authorized testing for sick pigs and we, those so far, have all been non-negative, although there’s– sorry, all negative, although we have very limited samples yet collected from swine in the areas.
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Suelee Robbe-Austerman, USDA [00:41:23]
All I can say is so far with virus isolation, when we’ve tested whole blood, we are not detecting.
So right now there’s no evidence that we have that suggests that this virus is systemic at this point in time. So we’re testing cows that have very low CT values in the milk, but their whole blood is negative. And that suggests that this virus has tropism for udder tissue and maybe the epithelial udder tissue.
We don’t know that yet, but right now we don’t have evidence that the virus is actively replicating within the body of the cow, other than the udder.
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Christine Szablewski, CDC [00:44:07]
There have been some discussions about doing some studies to look at asymptomatic persons, to see if there’s any kind of serologic evidence or even nasal canal infection in those farm workers.
But right now, those are just discussions.
What I can say is that when we first saw the outbreaks of high path AI in poultry herds, we did publish us do a seroprevalence study, and we did publish that and I will drop that into the chat.
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Suelee Robbe-Austerman, USDA [00:45:39]
I don’t think that we have full clarity.
We do have one dairy that had a confirmed poultry that have the same genotype. We have sequenced the poultry.
There were no cows that were sequenced because we didn’t know at the time. And so– but that sequence is very consistent and like, it basically is that– I don’t want to call it an ancestral sequence because this virus collects snips fairly quickly, but it is very consistent.
And all of the detection so far in cattle are clustered around that.
What we know we need to do is try to figure out what virus within the clade and this genotype have the ability to infect mammary tissue in cows. And I think that’s one of the hot topics that is being discussed among our scientists.
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Mark Lyons, USDA [00:47:48]
And again, we’re seeing– we’re only seeing this occurring in those lactating dairy animals at this stage, which again, pushes it back into thinking that there’s more of that lateral transmission occurring related to that milking process.
And as Dr. Robbe-Austerman said earlier, well not seeing the virus really circulating systemically through the animals at this point, based on the samples that we do have, which again, kind of points back to there’s that affinity to that mammary tissue pointing to that milking process, playing a larger role in the transmission than maybe some other pathways.
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Suelee Robbe-Austerman, USDA [00:58:57]
I do want to point out that our reported goat event that occurred in the state of Minnesota is a different genotype. And we did test milk in those goats and the milk was negative. So that genotype performed typically like we would expect, which is neurologic disease.
So this virus is different. And so– but we need to understand if this virus actually has a broader species tropism than just cattle. So there’s a lot of questions that we’re currently trying to answer. And it’s a really broad effort.
The patient worked directly with sick cows at a dairy, so the virus was most likely transmitted through that close contact. We are working with other agencies to provide guidance to dairies about precautions they and their workers can take to minimize the risk of transmission from animals, and we are asking dairies to encourage workers who are sick to get tested.
USDA is confident that the meat supply is safe. As always, we encourage consumers to properly handle raw meats and to cook to a safe internal temperature. Cooking to a safe internal temperature kills bacteria and viruses, like influenza, in meat.
Please refer to our latest press release and FAQ document for additional information.
The virus is the same clade as seen in other wild birds and aquatic animals. There have not been any changes to the virus that would make it more capable of spreading human to human. We continue to analyze viruses from bovine specimens as they come in.