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Nirav Shah, CDC [00:03:27]
First in Colorado, there are a total of nine human cases of H5N1 infection among poultry workers there, all of which have been mild, with conjunctivitis as the predominant symptom.
This includes three cases that CDC confirmed last week from which the genetic sequences have been uploaded.
As of right now, there are no tests awaiting confirmation here at CDC, though it’s important to note that additional cases are a possibility either from this region of Colorado or from elsewhere in the U.S..
These nine infections do not change CDCs assessment of the risk of the general population from H5, which remains low at this time.
That said these cases highlight that certain groups here, poultry workers who focus on depopulating, are at heightened risk of infection.
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Nirav Shah, CDC [00:04:22]
first CDC is announcing a $5 million investment for partner organizations to focus on outreach and education efforts for farm worker health and safety.
Specifically, CDC is allocating $4 million to the National Center for Farm Worker Health, which they will in broad terms use for two goals.
The first is to partner with community based organizations in impacted states to provide training and information sessions about H5N1, and then second to work with key partners in states to increase access to testing, treatment and PPE, and as we’ll talk about in just a moment, the seasonal flu shot.
The relationship with NCFH predates the recent outbreaks of H5 in dairy cattle and serves to expand the breadth and death of NCFH’s work across these communities, which takes me to our second announcement.
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Nirav Shah, CDC [00:05:26]
CDC is investing a separate $5 million for seasonal influenza vaccines for livestock workers for the upcoming respiratory season, seasonal influenza vaccine.
The goal of this initiative is to protect the health and safety of livestock workers as seasonal respiratory viruses begin to circulate.
Preventing seasonal influenza in these workers, many of whom are also potentially exposed to H5N1 viruses, may also reduce the risk of new versions of the influenza A virus emerging.
Now I want to stress once again at the outset that this initiative is for seasonal influenza vaccine, not the H5 specific vaccine.
The seasonal vaccine is the very same flu shot that each of us takes every fall and winter season.
And although the seasonal flu vaccine will not prevent infection from H5 avian influenza, the enhanced effort that we are announcing today to reduce seasonal influenza among livestock workers is important for several reasons.
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Nirav Shah, CDC [00:07:57]
We’ve seen that livestock workers are at risk for H5 infection because of their exposure to animals.
They are also at risk for infection with seasonal flu, just like everyone else in the community.
As such, it’s possible that they could be coinfected with both seasonal influenza viruses that they pick up from the community and with H5 virus, which they might pick up from animals.
Such dual infections while rare could potentially result in an exchange of genetic material between the two different influenza viruses seasonal and H5.
This is a process that’s known as reassortment. And in theory, reassortment could lead to a new influenza virus that could pose a significant public health concern, a virus that has the transmissibility of seasonal influenza and the severity of H5N1.
We want to do everything we can to reduce the risk that the virus may change because of this co-infection and reassortment.
Widespread seasonal influenza vaccine among livestock workers helps reduce this risk.
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Nirav Shah, CDC [00:09:24]
It remains the case that there is not a recommendation to use an H5N1 vaccine at this time.
This is because of the lack of severe illness that we’ve seen thus far, the absence of person to person transmission, the absence of any changes to the virus and reassuringly, the absence of asymptomatic infection in light of the recent serology results from Michigan, where 35 bovine exposed workers all tested negative for any evidence of antibodies.
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Question [00:19:10]
Why not apply the precautionary principle and at least vaccinate the ones that are really at high risk, like the poultry depopulation group?
Nirav Shah, CDC [00:19:18]
And again, we’re not averse to that. There is active discussions going on. There hasn’t been a decision to change our recommendation.
To your point about sort of what what’s the harm, well one, I don’t think we ought to look at introduction of a new vaccine through the lens of why not.
There has to be a strong and compelling case to do something, particularly since this is a new vaccine where uptake may be unknown, and we also want to make sure we’re really using a vaccine that actually achieves the purpose here.
Given the low rates of infection overall, the mild symptoms, the lack of person to person, I don’t think the question is why not do it? I think the question is why do it, given what may in fact be low uptake.
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Eric Deeble, USDA [00:27:16]
There are a couple things that make Colorado a unique set of circumstances.
There is a high degree interest from the governor’s office, as well as a very say unusual set of circumstances related to the geography of Weld County.
There are a lot of dairies in Colorado, about 106 of them in the state, and almost all of them are in this one county and they are all in very close proximity to one another.
And so, there is a lot of sharing of equipment, a lot of sharing of personnel, a lot of movement on and off farms to adjacent farms.
This is just a quirk of history and geography that’s contributed to this unique set of circumstances.
It is also fact that the state veterinarian, and the producers in the state, have come together in what I’ll just say is a remarkable spirit of cooperation and USDA commends everybody who has been working on the ground with both the CDC and USDA epidemiological teams and strike teams in order to help get a better sense of what’s happening.
And, as a result we’re seeing a relatively high rate of testing, and getting really good answers, and really good insight, into the pattern of this disease.
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Nirav Shah, CDC [00:35:18]
We don’t have great data on that.
We’ve talked to a number of individuals who are very active in the migrant health community who have given us varying data points.
Some suggest that it may be higher than the general population given that many agriculture and livestock workers come from countries where vaccination is very commonplace, well accepted, and rates are very high.
And I think the implication of that is that to the extent that livestock workers in the United States have seasonal flu shot rates that are lower than the average population, the reason is access, not reticence. At least that’s the theory that we’re going on.
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Eric Deeble, USDA [00:38:49]
The depopulation efforts in the Weld County facilities were successfully completed, and some of those workers have moved on to other sites.
I would say that we have not changed the recommendations that we have for the use of PPE in workers doing depopulation events, and the PPE recommendations that we have, and this is for caps, face shields, gloves, boots, Tyvex suits, are completely aligned with those recommendations made by CDC for individuals working in similar environments.
I think perhaps I would actually defer to Dr. Shah on this point, there’s a unique set of circumstances in the deep population of one facility in which we saw these human cases could have contributed to perhaps less than perfect adoption of PPE by the workers that were on site.
And that is not to blame them for any action or inaction. It is just a challenge to wear at all times, in a place in which there is high volume fans moving a lot of air, as well as the type of depopulation exercise that was used here, which was the use of what we call CO2 carts, which not get too far into it, but it involved a lot of direct manipulation of birds as you’re picking them up off the floor and placing them into a cart.
And so it may be a combination of an unusual exposure profile coupled with the unique set of circumstances in these barns that led to an increased rate of detection of human illness.
However, the recommendations for PPE remain unchanged.
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Unclear, USDA [00:48:11]
We have been looking at the virus very specifically and monitoring it for any changes.
To date, we have not seen any mutations from the first version of B3.13 that we discovered back in November.
So it has been very stable up to this point.
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Nirav Shah, CDC [00:49:13]
The circumstances and the timing of the exposures were very similar with one another. That is to say high heat conditions, things of that nature.
So we are viewing them as part of the almost a contiguous set of infections, given that they occurred around the same time with similar climate conditions.
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Question [00:50:01]
I was curious your thoughts on maybe how common we’ll see these additional cases and PPE lapses, because, as you know this is not the only heat wave we’re probably going to see this year or in the coming years.
Unclear, USDA [00:50:14]
Certainly being on some of these facilities, and I haven’t exactly visited either one of the facilities in question here, the heat in the area right now is certainly a concern. And if anyone’s worked in PPE at all, they understand the difficulties.
And certainly you’ve got to apply a number of sets, take breaks, but still there’s a potential for breaks in biosecurity just with the amount of heat that’s out there and with the very close work that’s being done, along with the type of work.
Whenever we’re doing depopulation we’re handling those birds individually, of course using the CO2 carts and then in the process of doing cleaning, it does does cause a bit of dust. And certainly you’re going to have to be concerned about again, taking those breaks, making sure you’re managing your PPE in an appropriate manner, making sure it’s intact throughout the day.
But very, very challenging with this time of year. And certainly with the heat as being demonstrated out there where these facilities are located.
Eric Deeble, USDA [00:51:18]
One bit of follow up here is that USDA is working to make PPE available to any producer who requests it through the national veterinary stockpile.
And many of the states are similarly ensuring that producers and their workers have the PPE that are necessary.
We have seen an increase in some of those fog free goggles or face shields that sort of work a little bit better for producers in high heat.
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Question [00:51:52]
Given the CDC’s vaccination program, I’m wondering if this means you think it’s no longer realistic to expect that the outbreak will be contained this year?
Eric Deeble, USDA [00:52:12]
Just on the animal side and all that Dr. Nirav speak to the human side, there’s a lot about this disease that makes us feel as if we can arrest its progress.
And we’ve actually seen some success demonstrated to date.
With this disease, it does not appear to move by respiratory transmission. We know that there are high viral loads in milk, and we’ve identified through close, collaborative research and epidemiological investigation in a variety of states, that we know this virus moves principally with the movement of cattle between herds and then within herds or within communities through the use of either hard or soft fomites, so this may be milk or contaminated clothing on an individual who’s moving between facilities, or the use of hard surfaces like equipment used for feeding animals or milk trucks or other types of vehicles that are moving on and off multiple premises per day.
Given that we have seen a real increase in awareness of producers and an increase in biosecurity, we believe that we can arrest the spread of this disease and ultimately eradicate it in dairy cattle on the farm.
You know, we’re not seeing reservoir populations of wildlife that may contribute to harbor for this disease.
So we’re still confident based on what we’re seeing and the actions that the states and the producers are taking that we can be successful in this way.
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Nirav Shah, CDC [00:53:59]
I’ll stress that no part about this seasonal livestock worker vaccination effort presupposes one way or the other what the viral levels among bovine and poultry may be.
And particularly in poultry where we’ve seen it really take hold, there will still be livestock workers who are exposed and at risk.
So– but we need not even presuppose one way or the other, what it may be, because what we’re doing here is preparedness.
What we’re doing here is planning. We want to be ready.
I’d rather start planning this effort with states and health departments now, rather than find ourselves in October saying, gosh, you know, we should have probably really thought about offering seasonal vaccine in the summer.
And so this is, this is just planning and preparedness 101.
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Question [00:55:14]
In the states with infected herds, are those farms able to sell their milk to processors?
Eric Deeble, USDA [00:55:27]
Lena, excellent question. the answer is an unequivocal yes.
We know that pasteurization effectively kills this virus and that herds that have cattle in them are selling their milk to processors and processors have been very clear in their signal to producers that they’re going to continue to accept this milk because it is safe, and that’s really the important part.
I would make one clarification here: at no point are that are sick allowed to contribute to the human food supply.
So while there are cows that are actively ill with H5N1, they are removed from the milk string, and their milk is not included in the milk that is shipped to processors for pasteurization and further use.
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Question [00:58:24]
Colorado has mandated testing of bulk milk. What prevents USDA from doing that federally and could it have an executive order or some other mechanism to do that?
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Eric Deeble, USDA [00:58:43]
There are a variety of authorities available to USDA, including the issuing of a federal order, which is an action that USDA took early on in the emergence of this disease in dairy cattle in order to limit the spread of a disease, or the movement of an animal interstate, in order to arrest the spread of a disease that’s either of risk to animals, the food supply or humans.
There are additional authorities that USDA could choose to use, including an extraordinary emergency authority that would allow us to go further than the federal order.
But quite frankly, we think that we are seeing very good participation from the states, and a very good action on the parts of the states that are affected, as well state animal health officials. So at this point, uh, that is not warranted.
There are authorities, but we are confident in the work that the state has done. And the partnership between both the state and the federal authorities.
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Nirav Shah, CDC [01:00:37]
Even though there have been additional cases in humans, it’s still a prevalence that is extremely low.
And so I don’t know that it is sufficiently prevalent there to warrant H5 specific vaccination.For example, in the serology series out of Michigan, 0 of the 35 bovine exposed workers that we tested had any evidence of prior infection.
So I grant that there have been an increase in cases, but still not to a threshold where vaccination, H5 specific vaccinations might play a role in driving that down even further.
I think that’s distinct from seasonal flu where we know that exposure happens every single year and the possibility of seasonal exposure, coupled with the rare likelihood that an employee or a worker may have also H5, that’s really the risk that we’re guarding against.
So don’t disagree that there have been an increase, but I don’t know that it meets the threshold quite yet for deploying H5 vaccine in a manner where that vaccine would achieve a purpose.
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Nirav Shah, CDC [01:02:36]
One of the reasons CDC recently amended or issued an emergency use instruction document was specifically to cover for an account for this scenario, John, which provided more regulatory leeway for individuals, as well as our colleagues at ASPR to use Tamiflu in this exact situation.
So we completely agree, and Tamiflu in this respect is a really good intermediate step. And in fact, the data suggests it does an even better job than the vaccine would at reducing the risks of infection.
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Eric Deeble, USDA [01:04:08]
The answer is the epidemiological investigation in Colorado is active and ongoing.
We don’t have a definitive link between the poultry and dairy facilities. Although we do know that it is a similar clade B3.13 that was found in both.
The actual mechanism of potential transmission are all being considered. As I mentioned previously, there’s a variety of hard and soft surfaces that can be implicated in transmission and importantly to note, the dairy facilities and the poultry facilities that are affected are in relatively close proximity, just just a mile or two away from one another, which increases the probability that there is going to be a movement across premises in a variety of different ways.
Sonja Olsen, CDC [00:09:08]
So, although the focus is most heavily on the workers who are exposed to known infected birds or cattle, we also look at closely at these other systems to make sure that there’s nothing, no other indicators, that would indicate that something is going on.
So for example, as part of our routine public health laboratory monitoring, over 36,000 specimens have been tested since March using a protocol that would’ve detected H5N1 or other novel flu viruses, and no cases have been detected through that testing.
So we’ve been in a position where since this outbreak started, we were sort of at the tail end of seasonal flu and going into the summer months when it’s lower.
And so it’s been relatively easy, I think easier, I should say, to look at the indicators of national flu activity, which will change obviously, as we start to ramp up in the fall for more respiratory viruses, be it seasonal flu, or other viruses.
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Sonja Olsen, CDC [00:12:01]
So we recently worked with Michigan to conduct a seroprevalence study, and our role was to help just provide technical assistance, but Michigan was leading this, so they took several dairy farms and enrolled people, 35 people on these farms.
And these are people that were from a number of different counties, worked on these farms, and worked with sick cows.
Most of them worked with sick cows directly and about half or fewer than half had reported using masks or goggles.
And then we take the– so they filled out a questionnaire and then took specimens and tested them for antibodies against H5N1, this specific clade 2.3.4.4b virus, as well as seasonal influenza viruses. And so what we found is that none of these participants showed neutralizing antibodies that were specific to H5N1 virus.
And these are data, as I said, that are consistent with what we know about this virus in seroprevalence studies that even among workers with exposure, seropositivity is low.
So, and I’ll just say that we also tested them for seasonal virus and did find antibodies, which you would expect.
So these findings suggest that asymptomatic infection and people is not occurring and provide support to the current testing approach that we collect specimens or recommend collecting specimens from people who are ill and have been exposed to animals– to sick animals.
Now keep in mind, this is a small study in a single state, so it’s good to get additional data, and Michigan’s collecting more data. And I think some other states are going to as well.
But these are the type of type of data and type of information that are critical to continue to gather during the course of this response.
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Alexis Burakoff, CDPHE [00:00:23]
Since late April, nearly half of Colorado’s dairy farms have been affected by highly pathogenic avian influenza H5N1.
We’ve had one confirmed human case in a dairy worker, which was reported in early July. And we continue to see farms affected and have heard reports of previously symptomatic workers, but have not had any additional human illnesses associated with dairy farms confirmed as of today.
Colorado’s dairy industry and much of our agricultural industry is in the rural northeastern part of the state.
And on July 8th of poultry farm in northeastern Colorado was confirmed to have HPAI, which was subsequently found to be the bovine strain 3.13.
On Thursday, July 11th, late in the morning, we learned that there were workers at the facility who had been exposed to infected poultry and were symptomatic. So we mobilized a team already in the field early that afternoon and tested seven symptomatic workers.
While on site, the symptomatic workers were offered Tamiflu. However, additional symptomatic workers were reported that we did not have capacity to test during that visit.
So on Friday, July 12th, the next day, a larger team returned to the farm and tested more than 40 additional symptomatic workers. The symptomatic workers were again offered Tamiflu, and we also supplied the facility with additional PPE, including goggles.
The most common symptom reported by workers on both days was red, tearing, and irritated eyes, but some workers also reported feeling feverish. Other symptoms reported included, nausea, headaches, sore throat, cough, congestion, and muscle aches.
But it’s important to note that it had regularly been over 100 degrees in northeastern Colorado in the weeks before this event and around this time, and that may have contributed to worker symptoms and may have also impacted PPE use.
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Alexis Burakoff, CDPHE [00:02:04]
Public health, continued to visit the farm throughout depopulation and disposal to offer testing and distribute Tamiflu.
Ultimately Tamiflu is offered to all workers due to the high number of people reporting symptoms and the detection of those initial cases.
A total of six cases of H5N1 were confirmed in workers participating in depopulation at this site. Thankfully all had mild illness and none were hospitalized.
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Alexis Burakoff, CDPHE [00:02:57]
On July 16th, a second poultry facility was confirmed.
Public health sent teams to conduct screening of workers at this facility as well, and to test and provide Tamiflu when indicated.
To date, three human cases of H5N1 have been confirmed associated with depopulation activities at this facility.
Notably, the number of symptomatic people reported was lower at this facility, the second premises, and the decision was made not to offer post exposure prophylaxis or PEP widely, although Tamiflu was distributed to all symptomatic people during screening activities.
Again, in this case, all three cases reported conjunctivitis, in this case, without any other symptoms.
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Alexis Burakoff, CDPHE [00:03:37]
Overall, as of July 25th, we have reported 10 confirmed human cases: that one associated with dairy and nine with poultry depopulation in 2024. And we have tested approximately 118 individuals since May of this year.
As I mentioned, all illness has been mild and all cases have had direct contact with infected cows or chickens. So there has been no evidence of person to person transmission at this time.
Depopulation and disposal activities have finished at the two poultry facilities associated with human cases, but workers are still in the 10 day monitoring period after exposure.
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Alexis Burakoff, CDPHE [00:04:25]
We’ve also seen a number of cats testing positive for H5N1 in the same region of Colorado, and continue to follow up with their household contacts as well.
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Question [00:09:02]
What are you recommending to pet owners in Colorado who allow their pets to roam freely, particularly in these areas?
Alexis Burakoff, CDPHE [00:09:11]
So I think our public messaging on the cat piece and the messaging to veterinarians is still underway. But I can absolutely circle back with our public health state vet and see if we have any examples that are shareable.
If not now, then I imagine we will soon.
DEMETRE DASKALAKIS, CDC [14:05:13]
Thank you for the question. I’ll start by saying that it’s the sort of quality systems that grew from the experiences in COVID that actually were able to detect an issue of manufacturing issue with the test.
Very importantly, the test, with its manufacturing issue, does not have any propensity towards false negatives or false positives, and in close collaboration with the FDA, we know that the tests that are out in the world are actually very usable to be able to detect avian influenza.
So I’ll just go back and say, really, the quality systems that grew from the experience in COVID identified the issue. And we have– we are resolving the issue. And like, I said, the kits that are out there–
REP BRETT GUTHRIE
Can you share what the issue is?
DEMETRE DASKALAKIS, CDC
Sure. There are three components to the assay and two of the components work normally, and one of the components sometimes would result in an inconclusive test.
Any inconclusive test, or positive test, on those kits then come back to CDC for detect– for confirmation. So this very rare issue was identified through the quality systems that we’ve developed.
And all of the tests that happened in the field were ultimately again checked at CDC and confirmed. So that manufacturing issue is being resolved. We’re replacing that component in the kit.
And again, those tests that are in the field are 100% usable and not prone to false negatives or false positives.
Regarding the new case at the second poultry farm, are you able to confirm what symptoms they had?
Saturday’s presumptive positive case had conjunctivitis.
Q: Regarding the ICCPUD and NASEM reviews of alcoholic beverages (https://www.dietaryguidelines.gov/alcohol/info#what-stage-is-the-process-in-now-), does DGA expect to publicly share and interpret the findings? If so, will that occur in December at a DGA meeting, or at another meeting or venue?
The scientific reviews on adult alcohol consumption and health are being conducted by a Department of Health and Human Services (HHS) Committee and the National Academies of Sciences, Engineering and Medicine (NASEM) working on complementary tracks. Both projects will include opportunities for public participation and will include external scientific peer review. These efforts are under way and slated to be completed by the end of December 2024. Each will result in a report with findings, not recommendations on alcohol consumption. These findings will be considered by HHS and USDA as the Departments develop the next edition of the Dietary Guidelines.
Q: I also saw the timeline on this page (https://www.stopalcoholabuse.gov/research-resources/alcohol-intake-health.aspx) but it wasn’t clear to me when “DGA scientific report” will be published this fall and how it will relate to the findings in NASEM/ICCPUD.
A: The 2025 Dietary Guidelines Advisory Committee’s Scientific Report will be released later this year. The Committee’s report will provide the review of the current state of nutrition science and includes independent, evidence-based advice for HHS and USDA to consider as the Departments develop the next edition of the Dietary Guidelines. This report will be separate from the reports summarizing the findings of the ICCPUD and NASEM reviews of the evidence on alcohol. All will be considered by HHS and USDA as the two departments develop the Dietary Guidelines for Americans, 2025-2030.
CDC’s wastewater team has confirmed that the rise in Wastewater Viral Activity Levels (WVAL) is genuine and not a result of the baseline recalculation. There is a slight increase in WVAL due to the recalculated baseline, along with a corresponding small increase in historical values; however, the sites did not go from low to high “overnight”. The WVAL has been steadily increasing since mid-May. The July 4th holiday caused a delay in data reporting at many sites, so when this data was reported the following week, it may have created an impression of a sudden surge when it had been rising all along.
Nationally, wastewater data has been showing increasing SARS-CoV-2 wastewater viral activity levels for the past few weeks. This week, the national level is high, but remains lower than the peak from this past winter respiratory season. Regionally, SARS-CoV-2 wastewater viral activity levels are highest in the West.
CDC recommends that everyone take steps to protect themselves and others from COVID-19. It’s important to stay up to date with COVID-19 vaccines. CDC recommends everyone ages 6 months and older get an updated COVID-19 vaccine to protect against serious illness. Additionally, practice good hygiene by covering your coughs and sneezes, washing or sanitizing your hands often, and cleaning frequently touched surfaces. Also reduce the risk of germ spread by improving air quality. It helps to increase airflow by opening windows to bring in fresh outside air, purifying indoor air, or opting to gather outdoors.
Were the two new Colorado bird flu cases among the workers who had been previously offered post-exposure prophylaxis with Tamiflu?
They were recommended to isolate and offered Tamiflu at the time they were tested.
The U.S. Department of Health and Human Services, in coordination with federal, state, local, and private sector partners, is working to assess the impact of the Crowdstrike outage on patient care and HHS systems, services, and operations.
HHS Secretary Xavier Becerra has amended the April 19, 2013, Determination of a Significant Potential for a Public Health Emergency pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act for Avian Influenza A.
The 2013 determination has been amended to include additional influenza type A strains that have the potential to cause a pandemic.
This amendment to the 2013 determination is being done as a part of HHS’ preparedness efforts and no changes have been made in the avian flu public health risk determination.
Just wanted to check in to see if you have updated figures to share on the number of people tested and positive?
At this time, we have no updates regarding test results.
Also specifically interested if any have been tested who were contacts, but not workers.
CDPHE offers testing to anyone who has symptoms of avian flu and was exposed to infected or potentially infected animals or humans. We continue to test symptomatic workers as needed.
To answer your question, the FDA has initiated sample collection and analysis and more information will be provided in our advisory as it becomes available.
Weld11 housed 1,790,800 chickens, all of which need to be depopulated to meet USDA requirements.
We received confirmation from USDA that this strain of HPAI is connected to the genotype circulating in dairy cattle. We don’t yet know how the transmission event occurred. We are requesting epidemiology support from USDA to determine if we can identify the mechanism of transmission
Yes, the workers who tested positive were responding to the avian flu outbreak at a commercial egg layer operation (Weld11).
Here is a notice that we developed shared with members on June 28 to make them aware of FDA’s announcement. As an association, we don’t track who might be selling any specific product.
FDA Issues Alert for Diamond Shruumz Products After Illnesses Reported NACS (convenience.org)
The total number of cases identified in Iowa so far are 3; none of these cases are children.
Nirav Shah, CDC [00:07:45]
CDC’s assessment of the risk to the general population remains low, and CDC has not changed its recommendations.
For example, CDC is not recommending H5 specific vaccines for livestock workers given the mild symptoms that have been noted thus far, and the absence of any changes to the virus’s genetic makeup that would suggest that the risk to human health is increased.
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Nirav Shah, CDC [00:09:42]
Our preliminary analysis of the genetic sequence of the virus recovered from a patient from this poultry farm is reassuring, largely because it does not show concerning changes of the sort that I noted earlier.
The sequence is very closely related to two sequences from infected chickens from the farm where the worker was likely exposed. And in addition to that, one of the virus’s subunits was 100% identical to the Texas and the first human case from Michigan.
In addition, our analysis has not revealed any genetic changes to the virus that erode the effectiveness of medicines like Tamiflu.
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Nirav Shah, CDC [00:10:29]
Understanding why an outbreak occurs at a particular time and place is a key question in this situation.
Environmental factors may have played a role.
At the time that transmission is thought to have occurred, Colorado was experiencing 104 plus degree heat.
Now the barns in which culling operations occur were no doubt even hotter. All of this makes PPE use a challenge.
Now there were large scale industrial fans that certainly helped keep the barns cool, but those fans also spread things like feathers around, which are known to carry the virus.
In addition, the culling method that was used here entailed workers moving from chicken to chicken, increasing the degree of interaction with each potentially infected bird.
This confluence of factors may play a role in explaining why this outbreak occurred, where it did, and when it did.
Though, I want to stress that our investigation is underway still, but these factors do highlight a pathway for prevention specifically through even more systematic use of PPE, as well as engineering controls to help reduce exposure risk.
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Eric Deeble, USDA [00:13:24]
USDA’s Animal Plant Health Inspection Service, more commonly called APHIS, can confirm the poultry depopulation operation is in county with dairy herds that have tested positive for H5N1.
As Nirav mentioned, genomic sequencing of samples from the poultry operation confirms the same type of genotype of HPAI that is in the nearby dairy herds.
The raw sequence will be uploaded to NCBI this week and should be available Friday. Publication of polished sequences with complete metadata will take an additional three to four weeks.
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Eric Deeble, USDA [00:14:10]
Affected workers have been isolated and poultry depopulation efforts continue in order to stop the virus production and mitigate further spread.
All decisions regarding this effort are being made while balancing human health and safety and animal health and welfare.
Right now, USDA considers it very important for depopulation to continue to stop virus amplification and shedding prevent further spread and to reduce the viral load in the environment.
If depopulation were to be paused, workers would still be required to care for and feed animals, prolonging their exposure risk for the workers.
This is critical as depopulating the entire facility, given the ease of transmission of most poultry and the lack of treatment for HPAI in poultry.
…
Eric Deeble, USDA [00:15:25]
We anticipate depopulation efforts at this facility will be completed over the next 10 to 14 days.
Although as our colleagues from CDC mentioned, this work is ongoing.
…
David Boucher, ASPR [00:18:26]
Colorado placed an order for 500 courses of Tamiflu from the SNS this past weekend. Those were overnighted to Colorado and were delivered just before dawn Sunday morning. That concludes the updates.
I want to add just a really quick note about numbers. You might hear two numbers, connected to Tamiflu. I want to kind of explain that really quick so that there’s no confusion.
Colorado ordered 500 courses. Our practice here at the SNS is to avoid shipping partial containers, so things don’t bounce around a little too much.
So again, just to, to be very crisp on the numbers, the request that we received was for 500 courses, we sent full cartons, so Colorado actually received 528 courses of Tamiflu.
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David Boucher, ASPR [00:20:36]
No changes to those timelines that we reported.
We do have, as we said before, a number of pre-filled syringes, and then we’re doing fill of additional bulk. We had said that those would– manufacturing would start to be completed later in July, on course for that, and then completion of all that manufacturing will happen in August.
So no changes to that timeline.
As we we’ve said, when we’ve reported this in the past, though, I do want to kind of just clarify that we’re talking about manufacturing timelines to actually use doses.
We would need to have a, a reason obviously, but then also a regulatory pathway to do that, some type of regulatory mechanism authorized or approved by the FDA.
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Julie Gauthier, APHIS [00:26:02]
We have approximately 160 people working on the farm on the depopulation activities. That includes the producers, employees, contractors, USDA employees, and the people working on depopulation are required to wear Tyvek suits, white paper suits, N95 respirators, goggles, boots and gloves.
The difficulty with wearing all that gear in that kind of heat, you can imagine. And it was made more difficult by those the fans pushing the air, made it hard to keep those goggles and N95 respirators in place.
So the team out there is trying to find other solutions to improve their ability to keep their PPE on their faces.
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Julie Gauthier, APHIS [00:27:08]
The method that was chosen to depopulate this barn is CO2 gas using carts. The carts can hold several dozen chickens typically.
And so it’s a very, very manual, difficult, laborious process to pick up each chicken and place it in the cart.
So there’s a lot of hands on to do this.
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Eric Deeble, USDA [00:30:37]
There are 1.8 million birds at this facility, which makes it a large layer facility, not the largest one in the country, but a significant facility.
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Nirav Shah, CDC [00:30:56]
Our colleagues at the Colorado Department of Public Health and Environment there, the state public health agency, have been working on contact tracing.
Many of the individuals as we’ve seen in other farms are together at work, but also together outside of work, which makes contact tracing a little bit more feasible, that they’ve made progress there.
And as CDC recommends at the discretion of local health officials, close contacts of confirmed cases are also being offered Tamiflu where appropriate.
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Nirav Shah, CDC [00:32:23]
So with respect to this particular poultry farm in Colorado, the uptake of testing has been strong.
We’ve tested approximately– obtained samples from approximately or close to 60 people from the farm who were symptomatic, all of whom were symptomatic. And those specimens have been processed either in Colorado or the ones that were positive in Colorado, that subsection have been sent to the CDC for confirmation.
And so we’ve seen strong uptake of testing across this particular farm in Colorado.
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Eric Deeble, USDA [00:41:04]
The answer is yes, we do believe that we can eliminate this within the dairy herd.
And there’s a couple of things that we know about this virus from the epidemiological investigation that began in Michigan and has continued throughout.
And that includes the fact that there is, as Nirav mentioned, movement with associated with a spread of the disease associated with the movement of cattle, and then within local communities, through the movement of individuals, vehicles and shared equipment.
We’re not seeing any indications of reintroductions from say wild birds or wild animals. And so we understand that this moves with the cattle and with the people that are closely associated with them.
So enhanced biosecurity should get us to a point where we can arrest the spread and hopefully in the future, we may get a vaccine which can further facilitate the elimination of this disease from the national herd.
But all the signs that we have are, with good biosecurity, with good farmer participation, we will be able to eliminate this.
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Eric Deeble, USDA [00:45:45]
It’s imperative that I mention it here, no milk from a sick animal was ever introduced into the human food chain.
But we do know that cows shed this virus over the course of about 30 days, and they eventually recover.
But as they do, there is the potential that it can spread from cow to cow, either on milking equipment or on individuals or other types of shared equipment that are in and around dairy barns.
We have seen no indication of respiratory transmission, and when we have studied this in a controlled environment, as part of our efforts to understand the science of this disease and the way in which it can spread, could potentially spread from an animal, we’ve seen very, very poor, uh, respiratory transmission in scientific– and so we have no indication that that’s occurring in the field.
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Nirav Shah, CDC [00:51:22]
As part of any typical clinical investigation, in addition to the ongoing public health investigation, we would endeavor to figure out what’s going on with them, what virus they have, and this has happened throughout this particular outbreak.
Indeed, it happens in just about every respiratory outbreak, more broadly, not speaking of the Colorado case, because I haven’t seen the full complement of testing data, but more broadly what we’ve seen in this outbreak, given the viruses that are circulating at this time of the year right now, when individuals have had a high index of suspicion for H5, but have eventually tested negative, what they’ve often had is another very commonly circulating respiratory virus like rhinovirus, which has come up quite a bit.
Many of those tests would be done at the local clinical level. For example, your regular doctor’s office can test for a lot of these common respiratory viruses and those data would not be regularly reported to CDC, but it may be something that local health officials or local conditions may have.
But the short answer to your question is, yes, it’s not just a simple binary. Do you have H5? And if not, then godspeed.
This is clinical care in addition to public health care and as a clinical matter, it’s important to try to figure out what’s going on because there indeed may be other treatments that are available.
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Nirav Shah, CDC [00:53:30]
It’s not that mathematical. It’s a number of factors that we are weighing on a series of essentially sliding scales.
And so the factors in general involve changes to the virus, and changes to the way in which the virus exerts potential human disease.
So for example, if we were to see significant changes in the ability of the virus to transmit from person to person, that would go in one direction.
Another factor that we keep a close eye on going back to the earlier discussion is the severity of illness that the virus causes indeed because influenza vaccines in particular are really well suited to reduce severe illness, changes that suggest that for example, hospitalization rates were starting to increase because of H5 infection would move us in one direction.
I want to stress that, for example, right now, in the cases that we’ve seen in the recent outbreak, both in bovines, associated with bovines, and associated with poultry, there have been no hospitalizations.
And then finally, if we were to see genetic changes to the virus that may suggest a decreased susceptibility to medications like Tamiflu, that would take us in one direction.
So as you can see, we’re always weighing these factors and discussing how they land.
I do want to stress that these discussions are ongoing. We talk about this quite a bit. And that’s what the American public should expect of a response that’s fundamentally one that’s rooted in science.
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Eric Deeble, USDA [00:56:14]
USDA is very interested in helping to facilitate the development of a vaccine.
And we welcome, both the submissions from the research community, as well as from the commercial marketplace, in helping to develop a vaccine that is effective, that will help us to arrest the spread of this disease within the national herd.
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Nirav Shah, CDC [01:01:13]
It was not a hundred percent of people who had respiratory symptoms. About 70.
Julie, we’ll follow up with you with the exact data, but it was not a hundred percent.
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Nirav Shah, CDC [01:02:32]
Not a hundred percent of the individuals in Colorado had respiratory symptoms, not 100% of the individuals in Colorado had eye symptoms, either.
It was only about 73% of the individuals in Colorado who had eye symptoms.
So not uniformly respiratory, not uniformly eye related.
Chris Beddard, BD [00:27:38]
We initially expected this to be temporary in nature, but after working with the vendor and doing some additional investigation analysis, we determined that the issues were more complex, and limit our ability to supply blood culture vials to meet our global demand.
We have been working very closely with the supplier and we have actions in place to improve production and output. We anticipate that to support us through the next two months as we move forward through the summer.
We’ve been additionally managing our global supply throughout this challenge via a manual allocation process, improving our distribution transit times, and optimizing our production schedules to meet supplier shipments.
We’ve also discussed, or we’ve also deployed, a strategy to work with our supplier previously of glass media vials. We’re going to be temporary sourcing the glass bottles for our BD BACTEC Lytic Anaerobic Culture vials. And as soon as we have the clarity on dates, we’ll provide another supply update, by the September timeframe.
So this is an active, evolving situation. Again, we’ll be coming back out to our customers by September of 24.
We are looking at this time because we expect to have the confirmed consistency in our output by our vendor, but also have timelines and volumes for glass bottles in the United States, and potentially other markets as we think about the challenges on a global basis.
I would like to also mention that we’ve been working very closely with the FDA throughout this challenge, exploring all options to improve our supply, including providing our supplier with communication to their material vendors, to reinforce the need, the priority prioritization, and the availability of required components to help us with the BACTEC bottle production.
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Question [00:52:02]
What is the approximate percentage of blood culture bottles that will be unavailable? So for example, is there a 10% shortage of normal demand, a 50% shortage of normal demand? Any idea on that?
Chris Beddard, BD [00:52:14]
It’s an evolving situation. We don’t have percentages that we are supplying to the market right now.
I would suggest that whoever asks that question, maybe directly work with their sales rep and we can have a one-on-one discussion on that.
There are no broad communications as it relates to percentages. As I was saying, every week, we’re managing this appropriately for what we are able to provide to our customers in the U.S. So there’s not a overall percentage that we are stating overall.
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Chris Beddard, BD [00:53:15]
Once we have the consistency from our vendor, which with all of the work we’re doing, we believe will be shortly in the August timeframe. That’s really what our goal is. If not sooner, as soon as we believe that the consistency is there and we have a projection and an outlook, we’ll communicate back to our customers.
The other piece with bringing the Lytic anaerobic media back in glass, we are accelerating that availability for our customers to do validation as required. As soon as I have the dates that I feel I can a hundred percent confirm to our customers, I will bring those out as well.
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Question [00:54:37]
Is there any indication that this shortage will expand to other products or is it just unique to this?
Chris Beddard, BD [00:54:44]
I can’t answer for any other company. All I can say is that this vendor is unique for BD BACTEC vials, the plastic vials. So, there are no other BD products that are impacted from this vendor. So it’s unique to the BD BACTEC vial.
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Question [00:57:52]
Are there any studies being performed currently around extending expiration dates for the bottles that laboratories already have?
Chris Beddard, BD [00:58:02]
So we’re working with FDA on certain SKUs to extend the timing.
I don’t mean to keep asking people to contact their sales rep, but the sales rep would then just would actually forward the questions to my team and myself that we can answer those questions individually for every customer.
But we have talked to FDA about the ability to do that so more to come, but it’s really based on an individual laboratory and the SKU or media type they have on hand.
Yesterday (July 15), the Colorado Department of Public Health and Environment distributed post-exposure prophylaxis (PEP) antiviral medication to more than 150 workers who had potential exposure to infected poultry at a commercial egg layer operation in Weld County.
On Thursday, July 11, CDPHE mobilized a team to test seven symptomatic workers at the facility who had been exposed to infected poultry. On Friday, July 12, a larger team returned to the farm and tested an additional 46 symptomatic workers.
The testing process is as follows — CDPHE’s State Public Health Laboratory does initial testing and declares presumptive positives, then sends the sample to Centers for Disease Control and Prevention. There it is re-tested and confirmed as positive. To date, we have had four cases confirmed, and we have one outstanding presumptive positive awaiting CDC confirmation. We are continuing to test symptomatic workers as needed, including 16 symptomatic workers who were tested yesterday. The State Lab will run the samples, per the process described above.
All of the workers who had been exposed to infected poultry and were symptomatic reported mild symptoms. They were instructed to isolate and offered Tamiflu. They are currently being monitored. CDPHE continues to follow CDC guidance, which is to test and provide antiviral treatment to anyone who reports symptoms and has recent exposure to infected animals.
CDC continues to state that the risk to the general public is low. So far, we have not seen evidence of person-to-person transmission. However, as our response is ongoing, we continue to monitor for genetic variations in the virus and changes in transmission patterns.
The State Emergency Operations Center, CDPHE, CDC, USDA, and the Colorado Department of Agriculture are working with the facility to assess use of personal protective equipment. We are working with the facility to come up with sustainable recommendations for their workforce during these summer months.
The first doses are scheduled to roll off the line next week with the remaining doses following through August. There are multiple steps that need to occur as part of this process and so far, all remain target. However, other steps besides the fill and finish of the vaccine, such as policy and regulatory decisions, have to occur prior to product being released for public use.
At this time, CDC’s evaluation is that the overall risk to human health is low. Vaccination has not been recommended for any segment of the population and the U.S. government continues to monitor the situation.
Attributable to a CDC Spokesperson
Four human cases of highly pathogenic avian influenza (HPAI) A(H5) (“H5 bird flu”) virus infection in the state of Colorado have been confirmed by the Centers for Disease Control and Prevention (CDC). This includes all three presumptive-positive cases reported by that state on Friday, July 12 and a fourth specimen that was later found to be presumptive-positive by the state on Friday. CDC also is aware of an additional (fifth) presumptive-positive case in Colorado that will be confirmed at CDC once the specimen arrives. All cases were in farm workers who were involved in the depopulation of poultry at a poultry facility experiencing an outbreak of HPAI H5N1 virus. A CDC team is on the ground in Colorado, supporting their assessment of the poultry outbreak and associated human cases. Given current information, CDC believes that the risk to the public from this outbreak remains low. These cases again underscore the risk of exposure to infected animals. There are no unexpected increases in flu activity otherwise in Colorado, or in other states affected by H5 bird flu outbreaks in cows and poultry.
Background on Cases
These workers reported symptoms after being exposed to H5N1 virus-infected poultry. All workers who tested positive reported mild illness. The workers reported conjunctivitis and eye tearing, as well as more typical flu symptoms of fever, chills, coughing and sore throat/runny nose. Additional cases may be reported and subsequently confirmed as monitoring and testing is ongoing.
CDC has deployed a multidisciplinary bilingual field team of nine people including epidemiologists, veterinarians, clinicians and an industrial hygienist to Colorado to support their public health response to the outbreak among poultry farm workers. There is ongoing monitoring of workers as part of this assessment and additional specimens are being tested – work that is a continuation of the close partnership between human and animal public health officials at the local, state and Federal levels.
These are the first cases of H5 virus infection in poultry workers (as opposed to dairy workers) since 2022. The first ever U.S. case of H5 in a poultry worker was reported in Colorado during April 2022. On July 3, 2024, Colorado also reported a case of H5 in a dairy worker on an affected farm, so that state is experiencing ongoing H5N1 outbreaks on dairy and poultry farms.
The designation of the influenza virus neuraminidase (the N in the subtype) is pending influenza genetic sequencing at CDC. Attempts to sequence the virus in the clinical specimens are underway and will be made available within 1-2 days if successful. Additional analysis will look for any genetic changes to the virus that could alter the agency’s risk assessment.
CDC’s recommendations related to H5 have not changed at this time. An assessment of these cases will help inform whether this situation warrants a change to the human health risk assessment.
CDC has more than 170 staff deployed to the agency’s H5N1 Response. Updates will be provided as information becomes available.
Questions: What counties where the patients who were sickened by the counterfeit Botox? Was the source of the counterfeit Botox in California ever identified?
CDPH Response: One case occurred in San Diego County, where the patient allegedly sourced the counterfeit botox from an online international retailer. The second case occurred in Los Angeles County, and, in this case, no information was provided regarding the source of the counterfeit botox.
NMDA examined the claims of suspected HPAI-positive cases at a licensed raw dairy farm in the state. NMDA was only made aware of these claims last week, and we responded as soon as soon as we were made aware.
We have determined through follow-up with the herd veterinarian, that the livestock at the farm did not have symptoms of HPAI and therefore were not required to be tested during the timeframe that has been in question (early May). The cows were treated for an adverse reaction to a change in feed, which was not considered an illness. No further investigation is ongoing.
A definitive source was not identified in this investigation. Texas cases resided in Collin and Harris counties.
Questions:
Was the case in an adult or a child?
Have any additional cases been identified in Montana?
Responses:
The individual was an adult.
DPHHS’s investigation is ongoing.
Indiana has a total of 5 confirmed cases; there are no cases under 18 years of age.
Lyle Petersen, CDC [00:08:44]
So what’s happening is with dengue?
As I mentioned, it was brought into the Western hemisphere in the United States in the in the 1600s, but you can see from this slide, which shows dengue incidence in the Americas from 1980 onward, it’s been going up and up and up.
And in 2023 was by far a record year for dengue. And then the bright red bar is what’s happening in 2024, so far.
And even though we’re only halfway through the year, we’ve surpassed, we almost doubled or more than doubled what happened in 2023, which was the previous record.
So you can see from this dengue is getting worse and worse and worse with more than 9.6 million cases already reported in the Americas through June 20th, next slide.
And the– and so now the, in the Caribbean, most of the cases that went in 2024 were in the Southern hemisphere, because that was their summer, but now we’re entering summer in the Northern hemisphere and this is what’s happening in Puerto Rico.
And on this side, you’ll see a gray line, which is the average incidence of dengue by week and in the squiggly blue line there near the gray line is what happened last year. And then the darker blue line is what’s happening this year.
So the same thing that’s happening now in the Caribbean happened earlier in the year in South America. And that red line indicates what we call the epidemic threshold.
So we’re way above the epidemic threshold already. And we haven’t even gotten anywhere near peak dengue season in the Caribbean, which generally occurs around September, October.
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Lyle Petersen, CDC [00:10:45]
So with all of these cases of dengue occurring throughout the tropics in South America, you know that any traveler can bring dengue back into the United States. And we typically see about 1,600 to 1,800 imported dengue cases a year that we actually identify.
And this year we’ve about tripled that number so far.
So many more people are coming back with dengue into the continental United States and anywhere under where there is the vector mosquitoes, Aedes aegypti or Aedes albopictus, an imported case can then cause local mosquitoes to get infected. And then cause local cases of transmission of dengue.
Fortunately outbreaks of dengue primarily happen in southern Texas, southern Florida, but as indicated on this map, they can happen anywhere. And most recently, occurred in California and in Arizona for the first time ever.
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Lyle Petersen, CDC [00:11:50]
So why is dengue going up so much? And there’s a variety of factors.
Back in 2003, the Institute of Medicine developed this convergence model indicated on the right indicating that a variety of social, political, economic factors, genetic factors, physical, environmental factors, and ecological factors combine and interact with humans and microbes to cause these emerging events.
And many of the topics that they outlined as drivers for disease emergence are now happening with dengue.
So for example, with climate and weather, we are experiencing heat waves, like none other right now, and warmer weather promotes viral transmission in mosquitoes.
We’re also changing ecosystems, but as I mentioned, we’re also living in more crowded places and people are more traveling around which for a human mosquito human transmission cycle, if you want to spread dengue, have people move around and that’s exactly what’s happening.
Next slide. So, uh, this just illustrates what I’ve already mentioned previously. There’s been a rapid increase in human travel. And so any airline passenger who picks up dengue one place, can go to another place and spread that virus, through mosquitoes that bite that that person.
Also increasing urban populations, as we mentioned. About more than half the population, now the planet, now lives in urban centers.
And since this is a human mosquito human transmission cycle, when you start crowding people together, along with the Aedes aegypti mosquito, which likes to live in crowded urban environments, you have the perfect storm for spreading this virus in populations.
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Lyle Petersen, CDC [00:39:02]
I think the one thing is that it’s clear that the methods that may have worked in the past no longer work.
And, I think this resurgence of dengue is a good example.
At one point because of yellow fever, people tried to get rid of the Aedes aegypti mosquito in the Western hemisphere, which is an invasive mosquito, and they were actually pretty successful and they got rid of it in many countries around the world with DDT. And, obviously we don’t want to use DDT anymore. There’s widespread insecticide resistance, for example.
So we really need new methods of control that will work in modern environments. And we’ve had some success with some of these.
For example, if you infect Aedes aegypti mosquitoes with a bacteria called Wolbachia, which is present in about 40% of all insects, so it’s around anyway. And if you spread these mosquitoes with Wolbachia around, it’s been shown that, for some reason that nobody really quite understands, when these mosquitoes are infected with Wolbachia, which is a parasite of mosquitoes, basically what happens is these mosquitoes are much less likely to transmit any viral infection, such as dengue, yellow fever, whatever.
And so people, when they put these Wolbachia infected mosquitoes out in environments, like in Indonesia, we’re doing this in El Salvador now. And in many other countries like Brazil.
What it shows is that dengue incidence goes way, way down. And so it’s a– and once Wolbachia is in those mosquitoes, it stays there and gets passed on from generation to generation.
So once you do it, you can really reduce the rate of dengue. So that’s one good example of how a brand new intervention that’s environmentally friendly can really reduce incidence of some of many of these viral diseases.
Diamond Shruumz-brand products have been recalled and should no longer be available for sale. We’re still in the process of conducting recall effectiveness checks to ensure these products are no longer being sold.
We of course can’t comment on future compliance action.
Do you know how many cases have been linked to consumption of Diamond Shruumz in Arizona?
9 cases total, 6 meeting the health department case definition for reporting.
Do you know if any have been in children?
2 children meeting case definition, 2 children with mild exposures not meeting case definition.
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For the children meeting case definition, do you know how they were classified and if they were hospitalized?
Yes, those cases were identified as major and admitted.
As of July 9, 2024, the Pennsylvania Department of Health has recorded two adults (no children) becoming sick due to the nationwide Diamond Shruumz product recall.
As of July 1, there are about a dozen suspect cases in Georgia. DPH is still in the process of reviewing medical records so that number is likely to change. As of now, we are not aware of any suspect cases in children.
Is it known which of the products the person ate, before they died?
Yes, however, we are unable to comment on specific details regarding the specific Diamond Shruumz products regarding the ND case reported. There is a risk of serious illness after consuming any of the recalled Diamond Shruumz chocolate, cones, or gummies.
Were they hospitalized with any specific symptoms?
The individual was not hospitalized.
We cannot address the specific symptoms of the ND case reported. Nationally, reported symptoms can include: seizures loss of consciousness confusion sleepiness agitation abnormal heart rate high or low blood pressure nausea vomiting
North Dakota Health and Human Services, with the Poison Control Center, has identified a death that could potentially be associated with Diamond Shruumz products. Investigations are ongoing.
Have contacts of the case been identified? Have any reported symptoms or been tested?
CDPHE and the local public health agency are conducting follow-up investigation activities with this case, including assessment of household contacts, and will conduct additional testing if needed. No household contacts have developed symptoms.
There is no evidence of person-to-person transmission of this virus at this time.
Why were testing results inconclusive at the state?
Sometimes, a test result comes back borderline or inconclusive because there may not be enough virus in the sample to definitively detect the virus 100% of the time. Samples have to be tested more than once to confirm inconclusive results, and we partner with CDC to do that. It’s part of our quality assurance process.
Is it known if the case was wearing PPE when working with dairy cows?
CDPHE provided personal protective equipment to the facility where the individual worked. We are still gathering additional information about the worker’s exposures and PPE use.
Dawn O’Connell, ASPR [00:11:13]
mRNA technology allows for accelerated initial vaccine development and complements current rapid production capabilities.
Moderna’s mRNA pandemic flu vaccine is currently in early clinical development. The timeline may change, but we anticipate starting phase three trials in 2025.
This is a data driven process and requires collaboration with our industry partners and feedback from government partners.
I also want to highlight that while the base award will support a vaccine for H5N1, the contract also supports development and procurement of a vaccine targeting new strains of influenza or other emerging infectious diseases.
This approach enables flexibility to pivot to new threats in the ever changing global public health threat landscape.
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Eric Deeble, USDA [00:16:52]
Most importantly, we want to continue to reiterate in this forum and in every forum, just how critical enhanced biosecurity is to containing this virus and present preventing its spread among the nation’s dairy herds.
Producers, whether their herds are affected or not, must take extra precautions to limit people coming on and off their farms take appropriate steps to clean and disect equipment, and clothing, and do all that they can in order to enhance biosecurity to limit the spread of this disease.
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Nirav Shah, CDC [00:23:41]
I’ll start with an update on our current capacity for influenza testing in the United States.
Reassuringly, we have an ample number of H5 specific tests in the public health system for the current outbreak.
As of right now, there are roughly 750,000 H5 specific tests available today. And another 1.2 million such tests coming online in the next two to three months.
This is on top of a robust supply of influenza A test, the general tests, that are available at doctor’s offices around the country.
Those influenza A tests, the more general tests, are the first tier in the approach to testing. And those influenza A tests are plentiful and widely available.
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Question [00:34:21]
Can you tell me what the capacity is for Moderna to manufacture? How many doses would they be able to do and in what sort of timeframe?
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Robert Johnson, BARDA [00:34:34]
So at this point, it’s too early to tell. We need to see the data around what the dosing will look like, and that’s true, both for pandemic influenza, as well as for any emerging infectious disease where the ability to manufacture be really be dependent upon the data that we’re waiting to see later this year.
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Eric Deeble, USDA [00:38:51]
We do know that the vast majority of farms practice biosecurity, and that includes dairy farms, practice biosecurity.
But this is a new and emerging disease that calls for a different set of biosecurity practices or enhancements of specific ones.
So many dairies are already using what’s called the FARM program, and that is a baseline biosecurity, and we’re making recommendations that folks go beyond that and supporting them financially so that they can do so.
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Robert Johnson, BARDA [00:39:43]
So this, the shelf life, will actually be data driven. It hasn’t been determined yet.
And ultimately that will be an FDA decision on what type of shelf life to get that.
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Nirav Shah, CDC [00:40:04]
This is all under discussion right now. We are, as we always are as a scientifically driven set of organizations, always evaluating pros and cons of risks, benefits, upside and downside of any potential measure, including vaccination for farm workers.
In this situation, we’re looking at partly the risk, but really, in addition to that, factors like what might demand be based on what the perception of severity is, and then also what what are we intending to vaccinate against?
Vaccines tend to be better at preventing severe disease, rather than transmission. If our goal here is to prevent transmission, for example, which is certainly one of our goals among humans, we’re also analyzing whether there might be intermediate measures, for example, more widespread distribution of antivirals that may achieve that goal even more quickly.
So it’s not so much strictly what the downsides are, but it’s also a question of what the potential uptake might be, as well as what the goal of the overall effort is.
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Question [00:46:40]
Is there any talk about doing a financial assistance program for workers who may need to take leave if they are sick, or if they do test positive?
I know that’s a concern with $75 a day, for getting the test is one thing, but what if they test positive? Is there additional assistance for them?
And relatedly, is there talk of a campaign for seasonal flu vaccines this fall thinking about reassortment and other concerns like that? Thank you so much.
Nirav Shah, CDC [00:47:11]
I will start with the latter of your questions.
I referenced earlier that I’ve been having meetings with state health officials, epidemiologists, and state health directors to talk about near term, medium term, and long term planning.
And both of the items that you discussed have been on the agenda for some of those meetings, we’ve talked about them with those groups, and we’ve talked about that internally as well.
Again, we, we try to talk about everything that’s a viable option, even if it’s something that we’re not able to actually do.
More to come certainly on the seasonal piece, because we acknowledge that there is both something that’s – it’s important for a group of workers who may not have the steadiest access to healthcare to have a dedicated channel through which to obtain essential healthcare like seasonal flu shots.
We also recognize that there’s a– they are in a particular place in the animal human interface, and may be coinfected, and that there may be epidemiological consequences.
So, more to come, but that’s been under active discussion.
Likewise, with respect to something akin to sick leave, no final decisions on either of those yet, but other than active discussions around both.
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Dawn O’Connell, ASPR [00:49:48]
They’ve got 4.8 million in bulk that they have begun fill finishing. And our expectation is that those first doses begin coming off the line in the middle of this month.
Every indication is that timeline continues to hold, and we will begin seeing the doses middle of July continuing to roll off through August, which is very efficient from the perspective of our planning.
It was faster than we had initially anticipated. So we’re really pleased that that timeline continues to hold.
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Nirav Shah, CDC [00:51:21]
We, along with our partners both across the USG, but also with our colleagues, such as those on ACIP, we’re thinking about sort of, as I noted with Alex’s question, what the goal of vaccination might be, first and foremost, for farm worker health.
To reiterate for everyone, the risk that the general population right now remains low and CDC’s assessment of that has not changed.
But with respect to livestock worker vaccination, if our goal is to reduce the number of infections that may occur, we have to wonder whether vaccination is the best route for that, or whether there may be other routes that are faster or even more effective such as, as I mentioned, more widespread use of antivirals.
So question number one is what is the goal we are aiming toward there and is vaccination the right tool to get us toward that goal.
And then if so, then we engage in more of a discussion about the benefits, as well as what the uptake might be.
If right now, H5 is not perceived as a pressing threat among farm workers, and I’m not speculating as to whether it is or not, but if that is the case, then uptake may not be robust.
Rather other mechanisms, again, may be better suited to achieve the goal that we want there. So that’s the evaluation that’s underway.
As has been said before, no final decisions are made, but we are in the process of robust discussion, as we should be for any scientifically driven venture.
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Nirav Shah, CDC [00:55:36]
Today, we are not aware of any cases of H5 among humans in the area, nor are we aware of any markers of cases among humans, emergency department visits, reports from clinicians, any of those systems that we normally query to an understand what may be happening, none of those has signaled a possibility of H5 infection among humans.
And so if it’s not among humans, what might it be? And we are investigating different hypotheses.
The San Francisco metropolitan area is not known for its dairy industry. So that’s not high on our list of hypotheses.
What is higher on the list is at least one or two live bird markets. Again, I want to stress, this is a hypothesis that is under investigation, but rather than the conclusion, we are working with the San Francisco Department of Public Health, as well as the California Department of Public Health, to better understand whether the timing of those bird markets and the subsequent cleaning of those markets aligns with the wastewater samples.
No conclusions as of yet. We are investigating, however.
Alzheimer’s disease is a devastating illness that affects millions of Americans and their families. CMS is committed to helping people get timely access to treatments and improving care for people with Alzheimer’s disease and their families.
In July 2023, CMS began offering broader Medicare coverage for Leqembi (the brand name for lecanemab) under the National Coverage Decision (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease through the Anti-Aβ mAb Coverage with Evidence Development (CED) Study after the FDA granted traditional approval to the drug for the treatment of individuals with Alzheimer’s disease.
Under the NCD, to receive Medicare coverage for Leqembi, or any other anti-amyloid mAb that receives traditional approval from the FDA, people need to: 1) be enrolled in Medicare Part B; 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia; and 3) have a physician who participates in a qualifying study with an appropriate clinical team and follow-up care. The CMS National Patient Registry has been established where clinicians participating in the Anti-Aβ mAb CED Study will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.
There have been three additional CED studies that have been approved by CMS that would qualify for coverage of anti-amyloid mAbs that have received traditional approval from the FDA. All information regarding these CED studies and the CMS National Patient Registry can be found at: cms.gov/medicare/coverage-evidence-development/monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease-ad.
Agam Rao, CDC [00:09:59]
So at this time, vaccine effectiveness is not waning. Serologic studies have shown vaccine titers decrease a few months after vaccination.
We know that this has gathered a lot of media attention, but levels of circulating titers are not the only marker of protection. There’s other markers of protection, cell mediated immunity, innate immunity, and those things haven’t been measured.
So the actual clinical significance of waning vaccine titers is really not known. It’s typically real world data that helps guide our decisions about policy.
And there there has been some analyses that we performed that were published and that has shown that infections after two Jynneos doses in the United States or breakthrough infections, as we call them, are very rare.
They’ve occurred in less than 1% of people who were fully vaccinated, have been associated with less severe infections when they occur and they’ve occurred at disparate time intervals after vaccination.
So, even as recently as a few weeks after the second dose was administered, all the way to several months or even years after vaccination. Next.
All of this has led to a CDC recommendation that booster doses are not recommended at this time for people who were vaccinated as part of this outbreak. And if you’re interested in seeing more information about the data that went into that, and I’d suggest reading the MMWR publication, the reference of which is at the bottom of this slide. Next.
So just to reiterate, at this time, the vaccine recommendations for people impacted by the ongoing outbreak are unchanged.
People who have recovered from mpox, or people have received the recommended two dose Jynneos series, even if it’s been two years since they were vaccinated, do not need any additional mpox vaccinations at this time.
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Agam Rao, CDC [00:14:00]
Now, despite this vaccine being available for as long as it has and the interest that was in the vaccine very early on, there hasn’t been that much uptake in the vaccine or interest in getting both doses of the vaccine.
The data on this slide is through January 9th, 2024. But we believe that it’s not too much different at this time. And at that time, only 25% of the people who are recommended to receive two doses of the vaccine had received both doses of the vaccine.
We understand from various focus groups that our experts in the division of STD prevention have conducted that some of the reason might be related to not thinking that mpox is in the news.
But we’re hoping that now that this is on the routine immunization schedule and that clinicians know that it is still a problem in the United States, including causing very severe infections, such as that result in death, that there may be more coverage, vaccine coverage for the individuals most at risk.
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Meghan Pennini, ASPR [00:29:50]
So I just want to remind everyone for Medicaid and Medicare, because this is within the ACIP recommended immunizations, there is full coverage for all beneficiaries, Medicare and Medicaid beneficiaries that fall within the ACIP recommended populations.
For commercial insurance, so for those who have private insurance, we do expect, and we are hearing, that private insurance plans do intend to fully cover this product, again, likely within the ACIP recommendations.
And just a reminder that these private insurance plans are obligated to cover the first plan year that begins one year after the ACIP recommendations.
So while they’re not fully obligated right now, we are hearing that they do intend to cover, and we are hearing that there is coverage.
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Meghan Pennini, ASPR [00:30:46]
So for those who are underinsured or uninsured for under or uninsured individuals, we rely on some of the programs, the immunization programs we rely on for other immunizations, such as the CDC 317 and Vaccine for Children programs, and those will be available. So this vaccine will be available under those programs.
Of course, for Vaccines for Children, that provides vaccines for uninsured and underinsured when served in certain clinical sites, such as FQHCs and rural health clinics. That of course in this particular case only applies to 18 year olds, because again of the ACIP recommendation being for 18 years and above.
For those 19 years and above, the 317 program can be used by jurisdictional partners to serve some of those adults. And we do expect the ordering through those programs to open on or near August 1st of this year.
So just a few, in about a month or so. Next.
Of course, Ryan White and other HRSA supportive clinics are also important engagement points for the populations that are at risk. And those can also provide access for under and uninsured populations.
HRSA grant and Ryan White HIV AIDS program funding may be used to purchase and administer Jynneos vaccine. And there’s more information around that, at that link, that HRSA.gov link that’s on this slide.
We’ll also mention that there’s 340B prime vendor programs that are up and running that can offer reduced price to provider sites.
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Yon Yu, CDC [00:44:34]
Resistance has been identified in over 50 patients with mpox, including those who developed treatment emergent resistance to tecovirimat, 11 in tecovirimat naive individuals, and most recently, a new cluster of tecovirimat resistant mpox variant detected in 18 patients from five states.
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Agam Rao, CDC [00:59:24]
So at this time there is no recommendation, travel associated recommendation, but the 2022 ACIP recommendations do say that for those who are part of mpox response teams.
And by that, we mean someone who might be traveling to DRC as part of Doctors Without Borders, for example, and providing care to patients with mpox, then those individuals should be vaccinated because they don’t have access to the PPE that we have here in the United States.
As far as people who are working in DRC, it’s still a rare disease in most parts of the country. I think there was something in the chat about south Kivu.
I mean, the State Department really isn’t allowing people to travel to south Kivu for work because it is a conflict region. So I don’t think that in the high concentration regions where there is mpox, people would be traveling for work.
If there is such a situation that arises for someone who is traveling for other reasons, then please do reach out to at poxvirus at cdc dot gov, and we can handle those situations on a case by case basis.
But we’re just not a aware of this happening much if, if at all, and want to keep the recommendation as simple as possible at this time.
Checking in to see if there’s any comment to share on what regulatory pathway CSL expects to pursue to authorize use of the pre-pandemic H5 vaccine? Do you know how long that process is expected to take?
- Under the terms of the agreement, CSL Seqirus will fill-finish and deliver approximately 4.8 million doses of pre-pandemic vaccine that is well-matched to the H5 component of the currently circulating strain of H5N1.
- CSL Seqirus are in discussions with the FDA regarding the review and approval process. We will work to follow the necessary regulatory pathways for this pre-pandemic vaccine. Due to the confidential nature of these conversations, we’re unable to disclose any additional information.
- We’d recommend reaching out to BARDA for further information on this matter.