tinalexander.github.io / notes / 2024 / 09 /
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Jeanne Marrazzo, NIAID [00:15:13]
We’ve all been hearing about this summer wave. I personally know about four people who are down with COVID this week. It seems like it’s really pretty much everywhere you look.
The data suggests that after this summer wave, which again continues to be offspring of the Omicron family, we’re probably seeing a little downturn, but I don’t think we really know what’s going to happen.
This is a very, very, in some ways predictable, as you can see from those peaks and valleys, but in some ways, very unpredictable virus.
We’ve been fortunate not to see escape variants, mutants that are not going to be covered probably by the current booster recommendation, and certainly not resistant to Paxlovid, as far as we know, or Remdesivir, but you know, it is still something that we have to worry about.
[00;05;09]
Based on elections of Part D plan, sponsors, approximately 99% of people with Medicare enrolled in a standalone part D plan in 2024 are currently enrolled in a standalone part D plan offered by a plan sponsor that opted into the demonstration for 2025. I know that’s a mouthful.
But in terms of your question about exact plans.
So there’s 818 standalone part D plans in 2025, and 782 are participating in the demo, and the 36 plans that did not opt into the demo were all standalone part D employer plans, also called part D employer group waiver plans or EGWPs, and as a reminder, EGWPs are not part of open enrollment, and employers negotiate premiums with plans.
But yes, 782 out of 818.
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[00;06;06]
We had projected that the demonstration would cost about 5 billion dollars, and that is still the case.
As [official] said, the vast majority of plans are participating, and so we expect the demonstration to cost about 5 billion dollars, which is about 3% of total expected part D spending
…
[00;13;25]
So the IRA premium stabilization has really been effective in its intent, and I think that the one thing that we were seeing was additional variation in the PDP market, so the way that the IRA stabilization worked is it really stabilized across markets.
So it was both the average of the MA PD and the PDP premiums.
And, as we’ve said, we saw additional variation in the PDP market.
So the demonstration we put in place was to address that variation which we think that, as you can see, it is addressing that that variation.
We are– This is consistent with prior transition periods where CMS also implemented demonstration programs. And I think, as you can see, there continues to be stable premiums and choice in that market.
…
[00;15;15]
But again, I think the more important thing that’s in the fact sheet is that represents 99% of enrollment.
So that’s why it’s essentially the entire market.
As a part of our work to protect human health and the environment, EPA assesses safe levels of certain chemicals in drinking water and sets standards to protect communities. Fluoride is one such chemical. Fluoride is an element that in some places can be found naturally in water and may also be added to the water by drinking water systems to promote strong teeth and prevent tooth decay, especially in children. Under the Safe Drinking Water Act, EPA sets limits on what is allowed and what is recommended. EPA’s maximum contaminant level goal (MCLG) and enforceable maximum contaminant level (MCL) for fluoride are 4.0 mg/L. EPA’s secondary maximum contaminant level (a non-enforceable standard) is set at 2.0 mg/L. These levels were developed to prevent potential negative impacts of too much fluoride to bones and teeth in young children. EPA’s standards apply to all drinking water systems and limit the amount of fluoride present in drinking water from either added fluoride or naturally occurring sources.
EPA is in the process of reviewing the district court’s decision. While the decision finds a risk sufficient to trigger regulation under the Toxic Substances Control Act, it is important to note that the court does not “conclude with certainty that fluoridated water is injurious to public health,” and defers to EPA’s expertise as to how to evaluate and regulate fluoride appropriately moving forward. The agency, in coordination with the Department of Justice, will consider all options going forward to determine next steps. From day one, this Administration has taken actions to protect people’s health that follow the science and the law. EPA staff includes some of the best experts and scientists in the world and they will be crucial to whatever next steps the agency takes.
All tests distributed through COVIDTests.gov and ASPR programs meet sensitivity and specificity requirements established by the FDA. ASPR has prioritized procuring tests that are affordable, accurate, and manufactured domestically. COVID-19 tests from ASPR’s last procurement in September 2023 are now being distributed directly to health centers, long-term care facilities, food banks, other community hubs
“As previously shared, in July FSIS suspended inspection by the Virginia Department of Agriculture and Consumer Services at the Boar’s Head facility in Jarratt, Virginia, which meant the facility must remain closed until and unless we were confident they could produce safe food for their customers. On September 13, the company announced its decision to indefinitely close the facility. Despite the closure, FSIS’ investigation into factors that contributed to this outbreak, including but not limited to an in-depth look at other Boar’s Head facilities, will continue in the interest of best protecting public health.
We take very seriously matters of public health and corporate accountability, and an investigation into this matter remains underway and ongoing. We are also placing particular focus on state inspection models, including where policy changes are needed to prevent oversight gaps.
In addition to taking a holistic look at Boar’s Head establishments across the country, our investigation will include a top-to-bottom review to determine contributing factors that led to the outbreak at this particular facility, what needs to be improved, and if there are lessons learned that could be more broadly applied to ready-to-eat meat and poultry facilities.”
1) Yes, iHealth is supplying COVID-19 tests to HHS for this season. The tests are part of the remaining quantity from the specific number agreed upon in our previous contract with HHS. More details about the contract can be found here: https://www.hhs.gov/about/news/2023/09/20/biden-harris-administration-awards-600-million-bolster-us-manufacturing-covid-19-tests-announces-re-opening-covidtestsgov.html
2) While we are actively supplying tests, we do not have the exact number of remaining tests being delivered at this time– as they are supplied incrementally over the course of the contract.
Aptitude is not supplying HHS tests this season and ASPR has not reached out about participating in the program.
As an element of your story, it’s pity that HHS is not offering people access to high quality at-home molecular tests at this time, despite availability. I’d be happy to talk with you more about this.
Mandy Cohen, CDC [00:11:19]
You’re gonna hear a lot of numbers and data, and those are very important to tell you about why these vaccines work, to make sure that you are risking less severe disease.
But let me talk to you as a mom, a wife and a daughter.
I wouldn’t recommend something for the American people that I wouldn’t recommend for my own family. You’re going to see me get my flu vaccine today. And my daughters who are 10 and 12, we have an appointment for them to get their flu vaccines. They’re going to get their updated COVID vaccine. I’m getting my updated COVID shot next day. I could have gotten both today. I’m just choosing to get them on different days, whatever works best for you. My husband’s getting vaccinated.
But I want to want to also remind that my parents who are both over 70, I want to make sure we’re celebrating the holidays together. They are both getting their vaccines again.
I wouldn’t recommend something for the American people that I wouldn’t do for myself and for those that I love.
So I hope as we head into the season, which again, we predict to be similar to last year, we know the power is in our hands, and so we want to make sure we’re doing everything we can to get folks vaccinated.
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Mandy Cohen, CDC [00:35:01]
I want to lead by example. It’s why I got vaccinated today with my flu shot.
I want to encourage folks that you can get your flu and COVID on the same day. I happen to be getting my COVID shot next week, but feel free to get both in the same day.
And I think we all as leaders want to lead by example. And that includes all elected officials.
And I know I want to make sure the president and the vice president are well protected as we go into this season. So I look forward for them getting their vaccines as well.
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Natalie Brand, CBS [00:38:23]
First of all, since we saw this COVID surge this summer, what are we expecting for caseload in the fall? I know that you said we’re expecting a typical year, but COVID specifically given this summer surge.
Mandy Cohen, CDC [00:38:35]
Sure. I’ll start and then I’ll turn it over to Dr Daskalakis.
But we are, right now we saw an increase in cases or I should say viral transmission of COVID over the summer, similar to what we saw last summer.
But what we’re seeing now is per case that we’re seeing is less hospitalizations and less death, which is good.
It tells us that we have underlying immunity. It’s not that this virus isn’t changing, because it is, and is actually changing faster than flu, but it does tell us we have some underlying immunity that is decreasing the amount of hospitalizations and death.
But if you ask me to stack rank COVID next to flu, COVID is still causing more hospitalizations and death than flu.
And so if you are someone who has regularly gotten their flu shot, you want to add COVID to that because COVID is still causing more hospitalization and death, even though it’s lower.
So we’re seeing summer waves and it’s telling us that COVID is not confined to the winter like flu and RSV are, it can be a year round disease, even more important for us to stay updated on our vaccine, and doing it now ahead of the winter, when we do expect more hospitalization and more death from both COVID and flu, now is the right time to get vaccinated.
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Demetre Daskalakis, CDC [00:40:08]
When you think of a vaccine that we use the word match often, it’s really about sort of the depth and breadth of the immune response that the vaccine generates.
And so, the selection of in COVID of a JN.1 lineage antigen in the vaccine really looks forward into what could happen with variants, but also looks back in terms of our immune history.
So, I think given what circulating, even some of the new variants that are Twitter stars, though not stars in our Nowcast yet, I think we are forecasting that the current COVID vaccine will be really good in terms of, in terms of depth and breadth, at preventing some of the worst complications of COVID.
Flu, same, I think that again, every year, um, one of the important things that we do is monitor what’s circulating and based on what we’re seeing today and what we’re seeing in other parts of the world, we think that this– that the flu vaccine will also provide the depth and breadth to protect the population.
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Mandy Cohen, CDC [00:41:11]
We worked very hard with manufacturers to make sure that we weren’t in that same place going into this year. And the good news is we’re not.
So we see a very ample supply of the monoclonal vaccine for infants. So again, recommending, starting, right now for our for our babies under eight months to get that RSV immunization.
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Mandy Cohen, CDC [00:42:29]
Right now is the best time to get your updated flu shot, your updated COVID shot. We are here at the end of September, but through October, but it’s also not too late.
Say you missed the October window, get it in November. The important part is getting these vaccines.
They’re the single most effective thing you can do to protect yourself and your family, your community.
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Demetre Daskalakis, CDC [00:43:03]
One of them I’ll start with the sort of most common thing that we do is a lot of engagement.
So making sure that we talk to organizations and populations that we serve to really understand better how we can provide the information that they need so they can make informed decisions about their health.
I think the other part is that we have a lot of different survey tools, and I think that we do get a lot of different sort of answers as to why people are less frequently getting the flu vaccine.
One that sticks out to me is convenience. And so I think that there’s a lot of sort of conversation about how effective it is, what are the side effects? So those are also players, but one of the big ones is it’s just not convenient.
And so I think we’re here to make the point that there’s a lot of places where you can get a flu vaccine and a COVID vaccine, including your clinicians’ office, including pharmacies.
And so if we can sort of expand people’s vision that, if they’re able to go to the grocery store with the pharmacy or the pharmacy to pick up their toothpaste, if there’s an opportunity to get vaccinated, I think that since COVID so many opportunities have emerged to address some of those issues.
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Demetre Daskalakis, CDC [00:48:37]
In in fact, today we’ll be posting our first national immunization survey data that will give you the very earliest view in terms of what’s happening with flu, COVID and RSV vaccination.
Additionally, we will continue to publish data around our emergency department visits. This is one to watch the space. We have some very exciting innovations coming in terms of how we’re sharing about the respiratory season. And so really watch that respiratory virus channel for some really new and exciting changes.
Additionally, we’ll continue to report on hospitalizations, and will continue to publish our forecasts. That both includes a forecast for the season, which I think Dr. Cohen really summarized very well, but then also a estimate of where we are in terms of progress for COVID during the COVID season publishing, a view into what our near future will be based on what we’re seeing today.
No, Lucira by Pfizer is not contracted for this initiative.
Yes, we are currently supplying 8 million Covid-19 rapid antigen tests to HHS. We manufacture everything here in the US. We are also one of the lowest priced tests via Amazon.com and Walmart.com. We recently received our FDA 510(k) for our Covid-19 Rapid Point of Care test.
The Georgia Pathways to Coverage demonstration expires Sept. 30, 2025. Therefore, the state of Georgia has time before the expiration of the currently approved demonstration authorities to meet the regulatory requirements to request an extension, if the state intends to do so. Should the state choose to seek an extension of the Pathways to Coverage demonstration, CMS will work with the state and review any request in accordance with federal rules. CMS does not provide comment before or during the review process. We refer you to the state Medicaid agency for questions about Georgia’s application plans.
CMS has been working with the state to develop and execute a Monitoring Protocol and an Evaluation Design, per the approved terms and conditions for the demonstration. Additionally, CMS and the state have worked together to develop monitoring and evaluation activities to allow CMS and the public to understand better the demonstration’s implementation progress, as well as its effects on beneficiary enrollment and coverage, using as complete and up-to-date information as possible from the state’s experience implementing the demonstration. CMS remains committed to meaningful monitoring and evaluation to inform its understanding of the coverage received through the demonstration and early health care utilization patterns. CMS and the state continue to work toward finalizing the demonstration’s Monitoring Protocol and Evaluation Design and collecting meaningful data on the demonstration’s effects.
More information about the current demonstration, including monitoring reports, can be found here: medicaid.gov/medicaid/section-1115-demo/demonstration-and-waiver-list/81441.
Erika Wallender, FDA [00:08:26]
Although nursing home and assisted living residents make up just 2% of the U.S. population that’s over 65 years of age at any given time, last respiratory virus season, nearly 20% of hospital admissions captured in our COVID and RSV surveillance systems were among long term care residents.
And in the National Health Surveillance Network data, nursing home residents had up to eight times greater rate of COVID 19 related hospitalizations compared to U.S. residents 70 years of age and older.
We also know that individuals over 65 years of age have the highest risk of influenza hospitalization.
What is contributing to this disproportionate risk?
While we know long term care residents are at high risk of respiratory virus infection, due to living in group settings with communal activities and long term care residents, more commonly have risk factors for severe respiratory illness, such as older age in particular those over 75, diabetes, chronic kidney disease, chronic lung disease, coronary artery disease, and stroke.
Based on the data available, we are able– we are predicting a U.S. respiratory virus season for 2024 to 2025 to have a similar severity to last year.
Since COVID 19 continues to circulate, we expect the burden of severe disease due to respiratory viruses to continue to exceed the levels of the pre pandemic years.
And as we still have regularly reported data on COVID 19 related hospitalizations among nursing home residents, we do see that similarly to last year, hospitalizations among residents with a positive SARS-CoV-2 test have already begun increasing this year with similar to higher numbers of hospitalizations in July and August of this year, compared to the same months last year.
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Evelyn Twentyman, CDC [00:13:38]
This slide shows you the recommended timing for each of these vaccines, but let me give you just the headline here: for older adults, the time for COVID, influenza, or RSV vaccines is now.
Go time is now to get our older adult residents protected against these viruses.
If you have residents that either can’t or won’t be vaccinated now, or as you admit new residents who haven’t had these vaccines, do continue to offer them throughout the year.
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Evelyn Twentyman, CDC [00:19:49]
If you’re a healthcare provider working in a long-term care facility or otherwise serving long-term care facility residents, just know that you are your resident’s most trusted source of information on vaccines. They care what you think, and we know that you care about them because you’re here today. So thank you for everything that you are doing to encourage their vaccination. Next slide, please.
Strong provider recommendations. In other words, recommendations from you, can increase resident confidence in vaccines. In making your recommendations, you can be specific, be clear, be attentive to their concerns. And if they don’t accept vaccination after one discussion, don’t give up, try again later.
If a resident or family member declines vaccines once it doesn’t guarantee they always will. Continue the conversation. Next slide, please.
Here, we’re showing you the benefit of continuing the conversation. This study that we’re showing you right here showed that some patients needed to be offered the COVID 19 vaccine up to 11 times before they decided to be vaccinated. So don’t give up, continue that conversation and it can have benefit for your residents.
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Evelyn Twentyman, CDC [00:52:51]
People may wait up to three months after their symptoms of active COVID 19 disease resolve, or up to three months after a test, a positive test, if they didn’t have symptoms at all.
Now that’s not a requirement. So no worries if a person, if a resident, wants to be vaccinated sooner, but we do know that history of recent infection is associated with some protection against additional infections.
So those are our recommendations right now.
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Evelyn Twentyman, CDC [00:57:04]
For most people, the minimum interval between their last, 2023-2024 COVID 19 vaccine, and this new one that has just been recommended is two months. However, there are some important exceptions, including for those with moderate or severe immunocompromise.
We’re working diligently to bring this ‘first-of-its-kind’ innovative and convenient self-administrated flu vaccine to consumers and look forward to launching FluMist Home as soon as next flu season. We will plan to share further details closer to launch.
This will be the first influenza vaccine available for delivery and administration at home. To ensure a seamless customer experience and proper public roll-out of the first flu vaccine given outside of the medical home, it requires extensive collaboration across a variety of external stakeholders and partners.
Does the state believe the infections are from a specific cluster? Wondering if the recent increase is linked to a specific location or event.
Since January 1, 2024, there have been 162 cases of whooping cough in Oklahoma, which is the highest number of cases since 2017 when 207 cases were reported. Of those 162 cases in 2024, 60 have occurred in Health District 4 of the state.
Can you describe the age distribution of the cases? Wondering how many of them are school-age children or teenagers.
Age range for cases statewide have ranged from 1 day to 86 years with the median age being 9 years.
QUESTION 1: How many Oropouche virus cases have been confirmed in the state?
ANSWER: One travel-associated case of Oropouche virus (OROV) has been identified in California, but the risk of transmission in California is low. The biting midge species that is primarily responsible for the spread of OROV in humans is not present in the western U.S. Preliminary data suggest other potential vectors of the virus, including a widespread mosquito species that is present in California, have lower transmission potential. The CDC has reported this case via the national arboviral surveillance system.
There are currently outbreaks of OROV in Latin America and the Caribbean. Individuals traveling to those regions should take precautions to prevent insect bites. Please see the CDC Oropouche website for more information.
QUESTION 2: Have any been hospitalized or diagnosed in pregnant women?
ANSWER: The individual was hospitalized and not pregnant.
For your second question, Public Health is conducting door-to-door information outreach with local vector control agencies to enhance surveillance and engage residents in the immediate vicinity where cases have been identified. Outreach teams have been visiting residents in the neighborhood of the identified case to share information about dengue risk in English and Spanish – and other languages as needed - and encourage residents to take protective measures against mosquitoes. Our teams are also offering free dengue testing to all visited residents. With the detection of two additional cases in the region, Public Health will expand our outreach response to additional households within a 150-meter radius of the newly identified cases, which is the typical flight range of mosquitoes that transmit this virus. We ask residents who are visited by our Public Health outreach teams to allow our staff to share information with them and help us by responding to a short survey to assess if anyone in the household has symptoms or a recent history of travel. Public Health is also sharing information with providers and encouraging them to stay vigilante for dengue fever and test for and report suspect cases of mosquito-borne diseases.
Lastly, we suggest you reach out to the San Gabriel Valley Vector Control District to learn more about what they are doing in the community. Here is their website: https://www.sgvmosquito.org/
“The Department has been tracking a number of pertussis cases across the state and is monitoring the situation in coordination with local health departments. Pertussis, also called whooping cough, is a serious lung infection caused by bacteria that is very contagious and causes coughing fits. Complications are more common in infants and young children. The best way to prevent pertussis is to get vaccinated. Those who are unsure of their vaccination status or the vaccination status of their child should contact a health care provider.”
Additional Information:
Please see the following breakdown of cases by age in New York State (excluding New York City) from our communicable disease system, through the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Reports (latest data available from here.) Forty percent of the pertussis cases this year in New York State (excluding New York City) have occurred among individuals 15-19 years of age. The Department has not identified any pediatric pertussis-related deaths this year. Pertussis cases, New York State, excluding New York City, Week 1 through Week 37, 2024
Pertussis cases, New York State, excluding New York City, Week 1 through Week 37, 2024 |Age (yrs)|Number of cases|Percent of cases| |———|—————|—————-| |<1 |80 |7 | |4-Jan |130 |12 | |9-May |93 |8 | |14-Oct |201 |18 | |15-19 |448 |40 | |20-29 |45 |4 | |30-39 |18 |2 | |40-50 |33 |3 | |50-59 |17 |2 | |60+ |47 |4 |
For New York City data, please reach out to the New York City Department of Health and Mental Hygiene directly at PressOffice@health.nyc.gov.
Regarding your question about whether the infections are from a specific cluster, we are not seeing evidence of a specific cluster or location or event. Cases have been identified all over the state and among children and adolescents in various settings. The State Health Department recommends the following steps to protect against pertussis infection:
Follow appropriate vaccination guidelines and consult with a health care provider to ensure immunizations are up to date.
Get tested and seek treatment at the first signs of pertussis symptoms, especially if you have young children at home or come in contact with children in other situations (e.g., work, recreational activities).
If possible, avoid close contact with others if you or your child is sick. Stay home, and follow good cough hygiene techniques, including hand washing and covering your mouth when you cough.
Keep infants under the age of one away from anyone who has a cough or other symptoms of pertussis, if possible.
Be prepared to cooperate with the local health department to help them track the disease and contact friends, schoolmates, and others who may benefit from preventive medicine.
For additional information about pertussis, visit the State Health Department web site at: http://www.health.ny.gov/diseases/communicable/pertussis/fact_sheet.htm
The final report is expected to be completed around the end of 2024 or early 2025. No additional open meetings are planned for this project.
1. Has the number or kinds of tasks conducted at the plant changed over the past decade? Or was it routine for 2,127 tasks to be conducted there in a year?
2. How long had VDACS been inspecting this location for Talmadge-Aiken?
As the details of these ten years of data would be held within the USDA FSIS records system, we recommend you contact FSIS with this request. The Jarratt facility has operated under the Talmadge-Aiken program for several decades.
Are you able to share an updated figure on enrollment in Pathways to Coverage?
Current active enrollment number is 4,923 as of 9/13/2024.
Is there a comment or statement to share on whether DCH is currently planning to apply for an extension for Pathways to Coverage?
Georgia intends to review all options available to ensure the continuation of the Pathways program.
When the database lists that a drugmaker was “Reverified 09/16/2024” like it does for semaglutide (https://dps.fda.gov/drugshortages/activeingredient/semaglutide-injection) does that mean that FDA has “reverified” the manufacturer’s claims about availability?
Is it accurate to say that FDA, on that date, also reverified that the product overall was still “currently in shortage”?
“Reverified” by our definition means no change in the information and applies to all the presentations listed under a certain company. So, yes to both.
What’s the best way to describe the population that VT’s samples come from? For example, are they hospitalizations from the local community, or another demographic?
The majority of our SARS-CoV-2 samples come from hospitals located in the southwestern region of the Commonwealth of Virginia including Augusta Health, Centra Lynchburg General Hospital, and Carilion Roanoke Memorial Hospital. Unfortunately, we do not have demographic data on these patients, so we don’t know whether the patients were hospitalized or, for example, if their samples were collected during an emergency department visit.
How does XEC compare with the other strains that have been detected in your lab? I’ve seen some talk online that it’s closely related to KP.3.1.1, which has been dominant for a while.
XEC appears to be a recombinant virus consisting of two circulating variants KP.3.3 and KS.1.1. In particular, XEC has a number of specific lineage-defining mutations that help us with its classification as compared to other lineages including KP.3.3, KP.3.1 and KS.1.1. We do not see a particular trend. We should keep on eye on the samples coming and continue genomic screening more broadly.
The close contact’s onset of illness was the same day as the case’s. The symptoms reported were weakness and dizziness, followed by mild nausea and diarrhea.
The possible opportunities of exposures for close contacts were also evaluated as part of the investigation. There was no known direct or indirect contact with wild birds, domestic poultry, cats, cattle (including no consumption of raw dairy products), or other wildlife by the case and close contacts.
What is the CDC’s awareness of the XEC strain?
XEC is the proposed name of a recombinant, or hybrid, of the closely related Omicron lineages KS.1.1 and KP.3.3. Please continue to check the COVID Data Tracker for updated information on the common variants we’re seeing in the U.S.
Does the CDC have numbers on if the XEC strain has been recorded yet in the U.S. and, if so, how many cases?
While specific cases cannot be associated with specific variants, CDC continues to monitor the emergence of variants in the population. Please continue to check the COVID Data Tracker for updated information on the common variants we’re seeing the U.S.
Is the CDC aware of any symptoms outside of the usual COVID symptoms?
CDC is not aware of any specific symptoms associated with XEC or any other co-circulating SARS-CoV-2 lineage.
And, as always, how does the CDC best recommend preventing against COVID and the XEC strain?
CDC recommends that everyone ages 6 months and older should get a 2024–2025 COVID-19 vaccine.
Getting the 2024–2025 COVID-19 vaccine is important because:
Protection from the COVID-19 vaccine decreases with time. COVID-19 vaccines are updated to give you the best protection from the currently circulating strains.
At this time, we anticipate that COVID-19 treatments and vaccines will continue to work against all circulating variants. CDC will continue to monitor the effectiveness of treatment and vaccines against circulating variants. There are other actions you can take to help protect yourself and others from health risks caused by COVID-19 and other respiratory viruses.
Immunizations are available for all three major fall and winter respiratory diseases – flu, COVID-19, and RSV (for groups eligible for RSV immunization).
Washing hands and improving airflow in the places where people live and work are important to lowering risk from respiratory viruses. Effective treatments are available for those who get flu or COVID-19 and are recommended for those at higher risk for severe illness. Treatment can reduce severe illness, hospitalization and death. If you have symptoms of a respiratory virus, stay home and away from others until at least 24 hours after both your symptoms are getting better overall, and you have not had a fever (and are not using fever-reducing medication). Resume normal activities and use added prevention strategies over the next five days. Everyday actions like masking and physical distancing can provide an additional layer of protection. Tests are available that can quickly detect these respiratory viruses so patients don’t delay treatment and other actions that can protect their family, friends, and coworkers. About Respiratory Illnesses | Respiratory Illnesses | CDC
There are no reported Oropouche cases in NJ.
Novo Nordisk continues to supply all Wegovy® dose strengths to the U.S. market.
Four of the five dose strengths (0.5 mg, 1 mg, 1.7 mg and 2.4 mg) are now available but we will continue to manage shipments of the 0.25 mg starting dose of Wegovy®, to responsibly initiate patients on treatment consistent with our commitment to patients and focus on continuity of care.
We have served over one million U.S. patients with Wegovy® and total weekly prescriptions have more than doubled since January 2024. We take our responsibility to meet the needs of people living with obesity and the healthcare professionals who treat them very seriously. We have made significant progress improving Wegovy® supply while maintaining a clear focus on supporting patients who require care to start and stay on this medicine. We continue to expand our global production capacity, which has been running 24 hours a day, seven days a week. We will invest DKK 45 billion in capital expenditures this year, compared to DKK 25 billion in 2023.
We are here to drive change for people living with this misunderstood, stigmatized disease, and partner broadly to break down barriers to obesity care. Detailed information about U.S. Wegovy® supply is available on WegovySupply.com, which is updated as new information becomes available.
Agam Rao, CDC [00:14:30]
We do have modelers at CDC who are looking at data and they’ve deduced that the risk is low to the general U.S. population.
And even in their extreme scenario where the household secondary attack rate could be 30%, so that’s double the previously considered worst case scenario, that most simulated outbreaks in the U.S. would be small.
66% had less than or equal to five cases. And 73% had less than or equal to 10 cases.
Both simulated outbreaks had minimal spread between households. 72% affected less than or equal to three households.
So modeling suggests even with extremely high secondary attack risk, household transmission, including cases in children, most likely involve 10 or fewer MPXV clade I cases with minimal spread between households.
And just as a caveat, you all know that there’s modeling data in general when it comes to complicated situations abroad countries that involve conflict regions countries, as large as the Democratic Republic of Congo, data’s imperfect, but based on the information that we have so far, including via some of our colleagues who are in these countries who are trying to collect data, this is what we are recommending. And this is what we are concluding at this time.
If there’s more data that becomes available, that could change, of course, but this is what we feel at this time.
…
Agam Rao, CDC [00:17:55]
Although there’s been spread of clade Ib cases outside of DRC, these appear to be limited at this time. Mortality has been low. Cases appear to predominantly be associated with sex in countries with sustained transmission, particularly with sex workers.
The risk in the U.S., including to children is expected to be low for a lot of different reasons, but we are actively monitoring this situation, and will revise estimates if for some reason that changes.
And the risk to travelers at this time primarily seems to be associated with sexual behaviors while traveling. And we want people to be aware of that.
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Agam Rao, CDC [00:21:29]
So we are waiting to receive the final data from NIH’s study involving 12 to 17 year olds, which will possibly be completed at the end of next month.
And, we are hoping to reconvene the ACIP work group to discuss that data. And, to perhaps discuss it more with the ACIP during the February ACIP meeting.
This is a vaccine that was only licensed for for adults, because it was intended for occupational risk. And, and that’s preceding this entire global outbreak. It was intended for occupational risk.
All of the studies, all the data was in 18 and over.
And so now this NIH study is there. It will help us understand, but regardless of that, um, as Dr. Wina has pointed out there, isn’t– there hasn’t been any safety concerns with the younger children who have received it as post exposure prophylaxis.
And since 2022, CDC has recommended it for adolescents who might have the same sexual risk factors for which the adults are recommended to be vaccinated as part of the ongoing global outbreak of clade IIb.
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Agam Rao, CDC [00:34:36]
We know that there’s been a lot of questions and concerns about whether protection is waning.
And, that’s somewhat based, it sounds like, on lab research that has showed antibody levels to decrease within six months after the initial primary series is administered.
And we at CDC have also seen that in our data, but the real world data that we have access to doesn’t seem to show that that’s the case.
And Sathesh also has done some studies that indicates that perhaps it’s more than antibody levels, it’s cell mediated immunity, innate immunity, other other aspects that might play a role in providing protection mpox. And I’ll let him speak to that because that’s not my area of expertise.
But long story short, we’re not sure the clinical significance of those antibody titers waning.
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Agam Rao, CDC [00:37:17]
We have unpublished data from a study that we lead in the Democratic Republic of Congo that Sathesh could speak to more if there’s more questions, but that also seems to suggest that at least five years there seems to be an anamnestic response to exposures when they occur.
But there’s more that needs to be done to analyze that data a bit more. And we are evaluating a seven year time point as well.
But all of this together is to say that we just are not seeing a signal to suggest that there needs to be a booster dose right now. And so we are not recommending booster doses except for those people at occupational risk.
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Peter Weina, FDA [00:39:27]
This vaccine is not a vaccine that causes sterile immunity. This is something that is probably more appropriate to label as disease modifying.
We don’t have really good data to support the fact that it absolutely positively stops all presence of the virus in the body.
And the breakthrough, the vast majority of the breakthrough infections that have happened have been relatively mild cases.
So, remember that just because you have an antibody level doesn’t necessarily mean that you’re going to have sterile immunity and getting boosters isn’t necessarily going to increase that vaccine efficacy across the board.
I saw that CDC said today there was a close contact of the case that was sick and was not tested. Do you know why the contact was not tested? Is it known if the contact had symptoms before or after when the case patient developed symptoms?
The timeline plays a large factor in this. This close (household) contact of the single H5 case would not have been detectable through our routine flu surveillance system like the case was. The case was hospitalized and tested during hospitalization, unlike this close contact who was never hospitalized or tested. We then learned of the case because our state laboratory received the specimen for initial testing and subsequently learned of this patient’s close contact and their symptoms, which was, at this point, too late for PCR testing to occur effectively. The onset of symptoms for both the case and the case’s household contact occurred on the same day. The possible opportunities of exposures for this close contact were also evaluated as part of the investigation.
Kim Armstrong, BARDA [00:37:20]
In terms of influenza, the BARDA team has been working really hard to prepare the nation for anything that might come from the recent H5N1 infections that have been encountered zoonotically in the United States.
So we continue preparedness activities under the NPIVS to be ready – NPIVS is the National Pre-pandemic Vaccine Stockpile – to be ready for potential public health interventions against H5N1, if vaccine recommendations change, but the risk to human health is low and vaccination is not recommended for any segment of the population at this time.
As part of its preparedness efforts, BARDA is filling approximately 4.8 million doses of previously manufactured bulk vaccine. This equates to 2.4 million courses as this is a two dose vaccine.
There was a BARDA sponsored phase two randomized double blind clinical trial to assess safety and immunogenicity of Sanofi’s H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with both ASO3 and MF59. And enrollment has just started in August.
In addition to ongoing support of currently approved recombinant cell and egg based influenza vaccines, BARDA is continuing to support development of platforms that may further accelerate the response to an influenza pandemic, such as mRNA.
So BARDA under the rapid response part partnership vehicle has awarded an other transaction agreement to Moderna.
So they released the solicitation in the first quarter of FY 24, calling for proposals for accelerating and development and licensure of mRNA based pandemic influenza vaccines.
So a project was awarded under this agreement to Moderna to rapidly develop and license mRNA based pandemic influenza vaccines by leveraging Moderna’s mRNA seasonal influenza vaccine candidate in late stage development and existing capabilities.
The project will focus on phase three clinical trials to collect data, supporting regulatory approval of the vaccines and establish a mechanism for rapid response to a public health emergency.
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Karin Bok, FDA [00:45:39]
Next week we have a new VRBPAC meeting coming up.
We are interested in discussing next generation pertussis vaccines and how we can think about regulatory pathways for a vaccine that hopefully is as effective as the whole cell pertussis with a safety profile, as good as or better, as the acellular pertussis.
So we’re gonna discuss specifically CHIM models, control human infection models, as a possibility to evaluate these vaccines in the future.
Nirav Shah, CDC [00:07:05]
The individual, who had significant underlying medical conditions, presented with acute symptoms of chest pain, nausea, vomiting, diarrhea, and weakness, and was hospitalized for reasons related to those underlying medical conditions.
The individual was not severely ill, nor were they in the ICU. They were treated with antiviral medications, subsequently discharged and have recovered.
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Nirav Shah, CDC [00:08:43]
Our investigation is looking to other aspects of this case. For example, characterizing the virus’s genetic sequence, which is underway at CDC.
That said, the concentration of viral RNA in this person, or what’s called the CT value was extremely low. And because of this, we have not been able to generate a full flu genome, including the neuraminidase or the N part of the virus. That’s why we’re just calling this H5 at this juncture.
Now we’re throwing everything we’ve got at this, but ultimately a full sequence may not be technically feasible because of the low concentration of viral RNA.
The data that we do have, and that have been generated thus far, show an H5 virus that is closely related to the H5 virus circulating among dairy cows.
We are continuing to look for evidence of genetic changes that would suggest, for example, an increased potential for spread.
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Nirav Shah, CDC [00:11:23]
Now, while while Missouri continues its investigation, it’s important to note that their state epidemiologists and their hospital staff took immediate action when the presumptive H5 positive was identified by the state lab.
They swiftly initiated contact tracing of potentially exposed individuals in all relevant settings. And as of right now, no additional cases have been identified.
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Nirav Shah, CDC [00:11:50]
Our influenza surveillance system is designed to find needles in haystacks and as this case and others show it is working.
But here in this case, we found such a needle, but we don’t know how it got there. Our investigation is continuing and we will keep everyone updated as we learn more.
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Nirav Shah, CDC [00:12:20]
As you all are aware back in July, we announced an opportunity for agricultural workers to receive seasonal influenza vaccines.
We are focused on states with positive dairy herds. And right now we’re working with 12 jurisdictions on their approach to outreach education and vaccination of agricultural workers.
We anticipate that this effort will kick off in October and we’ll have more updates as we proceed.
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Nirav Shah, CDC [00:15:03]
Surge testing, early in an emergency, we should be moving testing to commercial labs since that’s where most of us get tests for everyday health concerns anyways.
This new arrangement helps CDC do just that, to scale up test availability more quickly and earlier, rather than in an emergency and third pay for those tests.
Often commercial diagnostic testing gets hung up on things like billing codes and insurance status and reimbursement rates.
This new arrangement allows CDC to pay for diagnostic testing in emergencies, making it seamless for individuals to be tested.
Now we know that when the next response with laboratory needs arises and nowadays that’s all responses, we’ll need to have contracts in place with commercial labs.
Today’s announcement does that now, rather than in the middle of an emergency, we’re doing what we should do on the front end, rather than in the midst of a crisis.
We anticipate putting at least 5 million dollars on this contract by the end of this month. And we can scale that to up to 118 million dollars over the next five years, if needed.
Fundamentally, what this approach does is add the commercial laboratories to the CDC team in a sense they are all wearing the CDC jersey now.
In the past, we added them to the team too late in the game, that changes today.
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Nirav Shah, CDC [00:23:43]
Missouri has not invited CDC. That said, CDC has been in very close contact with health officials in Missouri, on an almost daily basis by phone, by video conference to provide technical assistance, support, direction.
And then of course our laboratory folks have also been working with their team.
So they have not invited us on site. But again, we are very closely connected with them on a daily basis of the investigation is unfolding.
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Nirav Shah, CDC [00:26:45]
No, this is not a situation where we think that their influenza manifested in these particular symptoms.
However, the symptoms that are present here were perhaps caused by other underlying medical conditions.
And then upon evaluation by medical personnel, became apparent that influenza and respiratory testing was also warranted.
So this is not a new presentation of the flu.
Those that I noted, the chest pain, the nausea, vomiting and diarrhea, which can be caused by any type of respiratory illness, were probably more caused by other underlying medical conditions.
And so, again, I’m not trying to be cryptic, but I want to balance that line between not compromising patient confidentiality.
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Nirav Shah, CDC [00:30:21]
We’ve not seen any evidence of person to person transmission.
None of this individual’s close contacts have any evidence of onward transmission.
None of the individuals that this individual came into contact with have developed any signs and symptoms.
So we haven’t seen any evidence of it at this time.
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Nirav Shah, CDC [00:31:46]
We’ve discussed obtaining serology specimens from this individual, as well as any and all of their close contacts where they consent to do so.
We are not quite in the window for when serum or serology would, where a patient’s body would have developed the antibodies that would be detectable by serology tests.
It usually takes a little bit more time for the body to develop those antibodies in response to having been exposed.
So this is something that is on the table when the timing is right. We’re not quite there yet.
Now with respect to, but again, we’ve discussed it with Missouri and they’re ready and equipped to do so provided the patients and the individuals who are close contacts consent.
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Nirav Shah, CDC [00:33:20]
It’s a theory under investigation, but we don’t have any evidence that it was direct contact with animals here, but more broadly as more animal species exhibit and harbor H5, the possibility of animal human interaction goes up and thus the possibility of human cases goes up.
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Eric Deeble, USDA [00:36:26]
We do know from the three sequences that have been completed, and again, we expect to be able to complete the additional five sequences sometime towards the end of this week or over the weekend, that this B3.13 variant is very closely related to what we’re seeing in other herds.
And additionally, there’s nothing in the sequencing that we’ve done on those initial three samples that would lead us to believe that it was transmitted in a novel way.
And again, this variant is unique in that it has only to our knowledge been transmitted between herds through the movement of animals or individuals and equipment.
So we don’t see anything in the sequence that would indicate that it was spread by wildlife or migrating birds or similar.
So while we don’t know the answer yet, we do know that CDFA is working very hard to trace this back, as they have discovered additional affected premises.
And again, they’re up to eight now, it becomes increasingly complex to figure out what, or who, or how the virus might have been introduced into California and where it might have come from. But they are working on that now.
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Nirav Shah, CDC [00:43:31]
The CDC asked and recommended that state public health laboratories keep that normal process of influenza subtyping. That’s the term for it. That they keep that rolling through the summer because of the– because of what was happening with H5.
And so every one of those results, , if it sends up a flag that it’s not the typical seasonal flu, every one of those results gets immediately flagged, scrutinized, investigated, and sent to CDC. That’s exactly what happened here. And that’s how we came to know about this case.
That machinery does not, did not stop over the summer because of CDCs recommendation.
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Nirav Shah, CDC [00:50:29]
Dr. Daskalakis and I, I’d say 50% of our time speaking with one another is about the, what ifs and where do we go from here?
And that’s what folks should expect happens at the CDC. Again, we’re not prognosticating we’re planning.
And in this particular situation, if we were to detect some, any degree of human to human transmission in this case, or more generally in any situation, there are a number of things that we’d want to consider.
Of course, the first is understanding what that risk group is, because if we want to give advice, say for folks to get tested or to start taking antivirals, we need to be able to characterize what that risk group is. Are they a particular type of worker? Do they have a particular medical condition? So that’s a continuation of the shoe leather epidemiology that we would continue to do to characterize what’s happening.
But then we have other levers available to us. If we were to see a high degree or any degree of human to human transmission, for that matter, we would start thinking about prophylaxis using medications like Tamiflu.
And then if we were really to see an explosion of that sort of thing, that’s when we start down the process of vaccination.
Now, whether it’s targeted vaccination, say to a group of workers or more broad scale vaccination as was contemplated back in 1976 with a swine flu outbreak, that’s very situation dependent.
The other thing we look at is not just the transmission as you asked, but also the severity, so that also plays into it.
So there’s a lot of moving pieces on that sliding scale.
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David Boucher, ASPR [00:59:53]
As you all have seen, in the recent months, we’ve talked about two different actions we’ve taken under the national pre pandemic influenza vaccine stockpiling program.
We have labeled prefilled syringes, that we have available, and we have also filled existing bulk and antigen.
Those actions are just about complete. We’re doing a little bit work on the last lot of the bulk fill.
But those multidose vials, prefilled syringes, have cleared company release testing and are now back in the stockpile.
They’re vendor managed stockpile.
Again, I want to just emphasize that these vaccines have not been approved or authorized by the FDA.
So while manufacturing is complete, they’ve cleared all of the release testing those specs, we would need regulatory action to actually use these vaccines.
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Question [01:00:49]
It sounds like the Missouri patient and their contacts have been cooperative with the investigation. Is that a fair way to put it?
Nirav Shah, CDC [01:00:56]
Yes, I think that’s right.
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Nirav Shah, CDC [01:01:10]
So these questionnaires, they really cover the waterfront of what potential exposures might look like.
So the initial interviews, the initial questionnaires look at things like direct contact with wild birds, livestock, poultry, pigs, milk consumption, household, travel attendance at public gatherings.
Then the follow up ones really dive even more deeply into things like potential environmental exposures around the house and around the yard.
So any wild birds or animals that have been seen around the yard, use of birds eaters, recent yard work, gardening, lawn mowing, detailed questions about the types and sources of dairy products and meats that have been handled, prepared, eaten.
And then of course, we talked a little bit earlier about just overall exposures at things like fairs, petting zoos.
So they really cover the waterfront.
Administering these questionnaires, I will say, takes takes a while. And so we’ve been really pleased with the cooperation of both our colleagues in Missouri, as well as this particular individual.
Question [01:02:16]
And so were infected pets or undercooked me part of those questionnaires. Can you just specifically address those two theories? Thanks.
Nirav Shah, CDC [01:02:22]
Meat is. Let me turn to Dr. Daskalakis, to see if he knows offhand. If not, we’ll get back to you, Alex.
Demetre Daskalakis, CDC [01:02:34]
I’m sorry. Didn’t hit the mute button right.
I can tell you that the questionnaire does include questions around domestic animals and pets, as well as wild animal exposures.
And on meat, we’ll have to get back to you.
I believe that it does include a pretty thorough rundown of food exposures, including raw milk and meat, but, well, I’ll have to confirm that for a fact.
Nirav Shah, CDC [01:03:01]
I can confirm that one, Demetre I’ve got that one here in front of me. And so yes, Alex, we can confirm it does go deep on meat products that have been handled prepared or eaten from a variety of different protein sources.
Question [01:03:14]
And then, I’m sorry, just one last question on this.
So can you, of that questionnaire you’re talking about, when you say there’s no evidence, does that mean that you are still investigating some of these avenues and you just haven’t finished it yet?
Or, I mean, have you been able to rule out all of these avenues so far? Thanks.
Nirav Shah, CDC [01:03:31]
Demetre, I’ll let you characterize where Missouri is, or where we are with Missouri on that.
Demetre Daskalakis, CDC [01:03:38]
Sure. So I think, you know, like any epi investigation, if there’s no clear answer, people go deeper and so I think there’s questionnaires that you ask and then there’s also additional sort of information that could be potentially important, like really tracking where people’s food sources were if they had any food from any other source restaurant, other facility.
So I think that that’s sort of where we are, that the couple first couple of passes are that there’s no overt exposure.
But I think Missouri is working really hard to go deeper into the epi to see if there are any unperceived exposures that are possible.
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Eric Deeble, USDA [01:05:08]
The rate of spread amongst herds within states and the spread between states seems to have slowed considerably. And we attribute that primarily to a greater understanding amongst producers, and state animal health professionals, about the need for biosecurity, as well as the implementation of the federal order, which restricts the movement of lactating dairy cattle between states.
There are states that have chosen to take more robust postures, as it relates to bulk milk sample testing. And we’re seeing this, again in California as they continue with their investigation, at this point we feel quite comfortable with the way in which the testing is being done.
We have excellent partnerships, with the states that are affected, and those states that are unaffected. And at this point, we feel that things are progressing quite well. We do not understand how H5N1 got into the affected premises in California. But I have a high degree of confidence in the CDFA, and the work that they’re doing, to help uncover that.
And if there is a novel way in which it was introduced beyond the movement of an animal, or individuals and equipment, we’ll be certain to address that in additional recommendations to producers.
Jeanne Marrazzo, NIAID [00:28:31]
We heard that there was another case of H5N1 in Missouri.
I’m actually quite nervous about that case. I think that, from what we know, as you probably heard in the news, this case had no known link to exposure to H5N1.
It was a person with underlying predisposition to pulmonary infection, but no contact to anything that could remotely be linked back to a likelihood of H5N1 exposure.
The CDC, I was on a call this morning, is continuing to try to sequence the relative relevant parts of what they got.
Unfortunately, the CT value for the isolate that was retrieved was 38. So they’re really not gonna be able to probably assemble very much of the genome.
That said, it’s almost certainly consistent with the bovine strain. So it is not a mistake it’s real.
And you know, there are no herds infected with H5N1 in Missouri, which further contributes I think to the mystery.
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Jeanne Marrazzo, NIAID [00:29:58]
It’ll be interesting to see now that birds are migrating back from the Arctic, what their situation is.
It looks like the mortality rate in migrating birds has probably leveled off a bit, which gives us some hope.
I think that they’re not gonna be perhaps as contagious, perhaps, we don’t really know, maybe that’ll decrease the likelihood of a spill over event. We really don’t know.
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Jeanne Marrazzo, NIAID [00:45:40]
I can tell you the H5N1, I do have more details, some I can’t share, but I will say that if there was suspicion of human to human transmission, the threat level would be elevated considerably.
So there is at this time, no evidence to suggest human to human transmission.
But that is of course our worst fear, because once you go there, then obviously all bets are off.
Robert Ford, Abbott Laboratories
These are medically necessary products that save lives, and Jim, we have a history of developing products for premature babies across all of our portfolio for decades, not just in nutrition, but in medical devices. We develop cardiovascular devices for congenital heart failure, in our medicine business, we do it.
So the decision to pull a product is not an easy one, but if the system that’s in place today is not going to value the science and the data, if the system is not going to value what health care professionals that spend their lives treating these babies, if those aren’t going to be respected and taken into account, then yeah, we have to think about at least what is the implication of removing a product.
Now, I’m hopeful I don’t have to do that. I’m hopeful those that can make decisions to ensure that there’s a reliable and consistent supply of this product, that they take action, but it’s something we’ve had to contemplate.
Jim Jones, FDA [00:44:41]
We say this routinely, that the food safety system in the United States is based on both the government and the industry following the rules.
And so, if the industry, if a manufacturer is going to choose not to follow the rules, they’re going to likely have some opportunity to get away with it until they’re caught.
It’s sort of like in any laws we have in the United States, if there’s someone who’s just choosing, I’m not going to follow the rule, whether it’s about speeding or jaywalking or any rule, there will be a period of time where they’re going to get away with it.
Obviously that’s not what we’re looking for, but we need everybody in the system to be playing their role and for the manufacturing community, it’s about following the rules that have been created. And for us, it’s about setting clear and enforceable rules and then also doing enforcement.
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Jim Jones, FDA [00:47:10]
It would be a pretty egregious violation for us to go straight to some form of civil penalty, which is what you’re referring to, where there’s a dollar amount associated with it.
And then, the scope of the violation would inform the size of the penalty.
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Jim Jones, FDA [01:05:56]
We do not even remotely the same presence in communities as local law enforcement do.
These products, these ingredients used in food, make the food adulterated.
We have the opportunity periodically to take them off the market. But again, we’re not going to have nearly the presence in communities that local law enforcement would have.
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Question [01:08:32]
Why do thousands of illegal products remain on the market? Even though FDA has only authorized a sale of roughly three dozen e-cigarette products.
Brian King, FDA [01:08:41]
So very succinctly there’s three major factors. One is the sheer size of this marketplace, which is unprecedented.
We alone have received applications for 27 million products.
We also need time to conduct investigations, which requires resources, which why we need more.
The latter is also the legal implications and in order for us to seize products that would require thousands and thousands of individual seizures that would then result in thousands and thousands of cases in federal district courts across the country, which would be untenable.
And so the realities are that we continue to make progress. We’re making a dent, we’ve done a lot of first of their kind actions, but we need more resources and we need other agencies to step to the table as well.
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Rep Kim Schrier [01:51:53]
I was wondering if you could just talk about the impact to clinical care for these very low birth weight, extremely premature babies, if these, one of these two cow milk based preterm infant nutritional products were to leave the U.S. market. And then also if you could touch on it, are there FDA barriers to getting donor breast milk to these high risk infants?
Jim Jones, FDA [01:52:20]
Thanks for that question. We are very concerned about the potential for, we do not know that it will happen, but the potential for one or both of the manufacturers to leave that market, for business reasons. So that’s very concerning to us.
Secretary Becerra has asked our colleagues at the NIH to pull together a group of experts, neonatologists and others, to give him a report about the risks and the benefits associated with these products.
That report is due to the secretary, next week.
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Brian King, FDA [02:01:43]
I just want to start and reinforce that FDA has not abandoned the menthol product standard.
Indeed, we remain, it’s a priority for us. We followed through rule making processes and it’s presently with the White House and it continues to be a priority for us.
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Jim Jones, FDA [02:29:12]
We have been pretty clear, I think, in the last year or so that, that we think that there is, there are a number of studies that shown an association between ultra processed foods and some adverse health outcomes, but an association, we do not think there, the data right now is robust enough to demonstrate causality.
And that, therefore what we need is more research to more definitively answer that question one way or another. We’re not saying it does, there is causality. We need better research to inform the question of causality between ultra processed foods and a range of chronic disease associated with diet.
So at this workshop, what we are going to be doing is to begin to build out what would the research agenda look like to answer the question related to causality?
So ultimately we will need this research if we’re going to be able to answer the question of what do ultraprocessed foods do as it relates to a range of diet related chronic diseases.
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Brian King, FDA [02:37:28]
I think one important thing to consider is whether the products are accurately declared or not.
And what we know, particularly through our recent seizure action we did at the border at LAX airport, of 18 million dollars of illicit products, is 99% of them were misdeclared, which means that we’ve got to open boxes.
And it’s not just import alerts, for accurately declared content. That said, if you want to open boxes, you need resources and you need people. And that’s also why we need Customs and Border Protection as a key partner here.
So we’ve– we’ve had some actions already. I’m hopeful there’ll be more with a new task force. But we are unresourced given the magnitude of the situation and we also have to make sure that all the key players in this space are committed to making it a priority as well.
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Jim Jones, FDA [02:56:47]
We are working very diligently on our proposed rule that would require front of pack labeling as you’ve described.
It is within a relatively short period of time before it’ll be submitted to the Office of Management and Budget for their review.
So we are very confident that by the end of this calendar year, we will have a proposed rule.
Rep Jan Schakowsky [02:57:07]
So when do you think– what’s the deadline now?
Jim Jones, FDA [02:57:10]
We are hoping to have this package submitted to OMB with the next couple of weeks and they have a 90 day review period, which would have us, so with a proposed–
Rep Jan Schakowsky [02:57:17]
What was the problem?
Jim Jones, FDA [02:57:20]
I wouldn’t say that there’s been a problem.
The amount of analysis necessary to support this rule making is quite extensive.
And so it’s really been grinding through all of the work to pull this package together for the proposed rule.
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Jim Jones, FDA [03:00:13]
Within the next couple of months, we should have a proposed announcement related to red dye number three.
But as it relates to other chemicals that are authorized for use in food, or there as contaminants again, I go back to, we are going to be having a public meeting in a couple of weeks.
That’s again going to describe how we propose to select chemicals for review.
We want to make sure we’re working on those that have the potentially the greatest risk and the process that we will use to evaluate those chemicals.
So again, we are very interested in having a much more ambitious post-market chemical review program at the FDA.
Do you know if any of the contacts of the H5 case that was announced last week were also symptomatic? Were any tested for H5N1 as well?
All contacts remained asymptomatic throughout the observation period.
Question [07:00:08]
So this is gonna be a long hypothetical. I apologize in advance.
Suppose hypothetically, the drug was approved with labeling that dictated it should be only used in women with uncomplicated UTIs who had demonstrated or a set of criteria for meeting a category of very high risk, for example, a positive ESBL culture within a month or something like that. And the sponsor was required to do a postmarketing study to demonstrate that the prescribing behavior at some acceptable performance criteria met that restriction.
If following through on the rest of the hypothetical, the postmarketing study then demonstrated that the stewardship effort had been a failure, at that point, what options does the agency have available to it?
The context for my question is that I have been told informally in this room and by different parts of the agency, that, in fact, there’s not really a mechanism for withdrawing approval based on post marketing, unless it’s a safety concern at the individual patient level.
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John Farley, FDA [07:01:50]
There will probably be a multi component response with various media forms involved.
I’m thinking through the question. I think it’s a good one.
I think what would happen, so because, I think the agency was gonna focus on the tools that we have sort of in the label itself, but I don’t know that that’s going to address your question.
Your sort of your hypothetical is sort of in a postmarket setting, there’s a lot of inappropriate use going on, basically.
Question
My impression as– my personal impression is that the committee is struggling with the ability of protections that are built into the label to protect the community at large against practice that results in the emergence of antimicrobial resistance, carbapenem resistance.
And so I’m trying to find out, if in fact this plays out that way and we see yet again that labeling is ineffective, do we have a way of correcting that error or is it– is there a lack of an option?
John Farley, FDA [07:03:12]
I don’t think there’s a lack of an option.
The scenario is kind of twofold. So the first situation is data that’s demonstrating that there’s a fair amount of use that most physicians would regard as inappropriate use. And that scenario one, I think in that case, we would, first of all, work with the sponsor.
The labeling is a joint process. We have to agree. But they are as committed as we are to ensuring that use is appropriate and there may be additional changes in the wording of indication, etc.
FDA as well as professional organizations have the ability to communicate with physicians around that. So that would be something that we could do because I think we’re in a setting where I think the general sense of the committee is there is an unmet need for a product like this. So there are some patients that are potentially benefiting.
Of course, if we get full resistance throughout the population, that’s going to be a different story.
I think the second scenario is if there is microbiologic population data that that seems to indicate that the drug is driving resistance in some way.
And FDA does regard resistance as a safety concern. And so we would have more tools at our disposal at that point, rather than just labeling and communication.
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John Farley, FDA [07:21:53]
I think what I would point out is that labeling is not insignificant.
And, so the next month or two, the agency and the sponsor are going to work very hard on that to address what we’ve heard from you today.
It’s not insignificant. I mean, the prescribing information that the FDA writes ends up in all sorts of electronic tools that physicians use at the bedside every day, that’s where that data comes from. It comes from the label.
Secondly, I think with electronic health records systems, they are programmed to pop up things that are relevant to the label. For example, if there’s a limitation of use that says this shouldn’t be used as step down for complicated urinary tract infections, and somebody is writing that, that’s generally going to pop up in the EHR system to educate physicians on the spot as they’re writing the prescription.
So hopefully that helps.
I’m optimistic that that labeling does make a difference. And that’s why we’re having this discussion today.
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Lindsey Baden, AMDAC (Chairperson) [07:34:50]
Overall, I have the sense from the committee, that for certain circumstances where this agent may be beneficial to our patients, there’s a high risk of off-label use, significant community risk to amplification of resistance, particularly CRE, there’s individual risk to that amplification, not just community risk, mitigation is likely the center on, in a timely identification of who’s at highest risk, whatever tools sort of make sense for that, that are available.
Post-marketing surveillance will be essential as this is a dynamic problem. So the solutions will have to keep up with the evolutionary pressures.
And if there is some mechanism for regulatory review with some period of time and some new data with postmarketing studies to be able to further refine the label and the education and the optimization of its use, I think that is sort of what I heard, is multiple themes from the committee.
And, if that doesn’t provoke questions from the agency, I think from the committee’s discussion, my sense is we share your enthusiasm for new treatments for our patients, we are concerned with how this will fit in so that it doesn’t create new problems for us, and we appreciate the agency’s hard work and really trying to think this through and get as much input as possible, including from us.