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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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.
…
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.