tinalexander.github.io / notes / 2023 / 11 /
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Mandy Cohen, CDC [01:01:41]
I would say that we are in full swing of RSV season. We are seeing a lot of RSV, particularly in the southern part of the country, so we’re near peak is what I would say for RSV.
With that, we are also at the beginning of flu season, so we’re not having early flu. We’re actually having a pretty typical– what I would say typical flu season. We do expect to see a lot more flu cases over the course of December and January. So please do make sure that you’re getting your updated flu shot and check what’s happening in your communities.
But that being said, even though those are both going up and we’re at the peak of RSV, COVID is still the respiratory virus that is putting the most number of folks in the hospital and taking their lives.
So it’s about 15,000 people in the hospital for COVID and about a thousand people dying per week across the country.
Related to COVID, we are seeing an uptick in COVID. Remember we had a late summer wave of COVID. We came down from that. We are going back up again, which we expect again, after a lot of travel and gathering at Thanksgiving, but to remind folks, never too late to get that updated COVID vaccine and as well as making sure that we’re getting access to testing and treatment.
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Mandy Cohen, CDC [01:03:44]
And from that survey data, we see about 16% of Americans have gotten the updated COVID vaccine. And that’s not enough. I’ll say that right now.
I’ve been doing as much as I possibly can to be going around the country again, meeting with folks, answering questions, explaining the importance of vaccination, but it’s not enough. And I look forward to continuing to work with Congress and and other partners to make sure that we can help folks know what tools are out there and have them use them to protect themselves.
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Mandy Cohen, CDC [01:14:47]
We have been working very closely with manufacturers. I personally have been on the phone, maybe dozens of times with the teams, to work to accelerate the supply.
The good news is we actually were able to have about 70,000 additional doses accelerated. We do expect additional doses in the January timeframe, but there were manufacturing delays here.
And so what CDC has done in addition to working with the manufacturers, is to put out guidance to make sure we are using the supply that we do have, and we have many hundreds of thousands of doses, but that we do use those doses for the highest risk children, and making sure that, for example, those who are under the age of six months are even at higher risk and make sure that they are getting prioritized for these doses.
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Rep Paul Tonko [01:15:45]
Is there anything that Congress should be doing now to help alleviate current and future pediatric RSV vaccine shortages?
Mandy Cohen, CDC [01:15:55]
I appreciate that question. I would probably need to get back to you on what would be most helpful. We’re working through that right now.
And these, you know, as I shared earlier, the RSV immunization is a long acting monoclonal. It is a different production cycle than a traditional vaccine. It takes longer.
There are decisions needed right now to make sure even next season that we are in an adequate place that we’re working with the manufacturers on.
So let me take that back to the team and see if there are other things we need to deploy here.
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Rep Dan Crenshaw [02:01:04]
There’s a lot of overlap here. I mean, what is the difference between ASPR and CDC?
Mandy Cohen, CDC [02:01:10]
Well thank you, Representative Crenshaw.
So CDC does provide the scientific evidence and technical expertise, particularly related to infectious disease and other health threats.
ASPR provides emergency response, so I would say, to any kind of threat, a hurricane, to an infectious disease threat. So they can bring in resources, whether it’s people or stockpile resources, but it’s really CDC and that technical expertise that decides well, where do you deploy it? How? For what purpose?
So it’s a partnership. You can’t have one without the other. And we do work very, very closely together to make sure that we’re coordinated.
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Mandy Cohen, CDC [02:03:49]
I was able to share some information earlier that there were a number of inaccuracies in the report that was put together from this.
Again, state and local authorities are, as you were saying, are in charge as well as FBI, FDA.
CDC’s role was to come in and do an investigation related to select agents. When we were invited and asked to do that, we did respond. We sent a team, they were there for two and a half days, did an extensive review.
What we found was no select– no evidence of select agents, and really what was compelling, as I reviewed that information, was it wasn’t– that they didn’t have any equipment that would have allowed folks to work with select agents.
So not only do we see the freezers and the paperwork–
Rep Dan Crenshaw [02:04:29]
But how long did it take from the request for CDC to actually come, because I thought it took like a Congress person from California to get CDC there.
Mandy Cohen, CDC [02:04:36]
My understanding is that when we were asked, we deployed.
Rep Dan Crenshaw [02:04:39]
Okay, select agents, very specific. I’m under the understanding that if a vial of something is not labeled, that you don’t test it?
Mandy Cohen, CDC [02:04:48]
So we do have limited authority in some of this space.
But what we did was go on premises again, do a two and a half day investigation. We did not see any evidence of select agents at this lab.
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Mandy Cohen, CDC [02:11:07]
I want to address where you were talking about related to Ebola. When we heard, after the fact, that someone said something was labeled Ebola, we took 300 pictures. We did not see one–
Rep Paul Dunn [02:11:17]
It was on the front of a refrigerator.
Mandy Cohen, CDC [02:11:19]
We didn’t see that. We asked folks to say, do you have a picture of that? Could we validate that for someone else? No one could validate that for us.
Mandy Cohen, CDC [10:31:35]
Obviously it is really important that CDC continues to do our global work and do this scientific diplomacy.
What we know as of right now, today, of what’s happening in China, they are having an increase in some of their respiratory illnesses. They’re seeing it in the northern part of their country, they’re seeing an uptick in their pediatric population.
What we do know as of, again, as of today is we do not believe this is a new or novel pathogen that we believe this is all existing, meaning COVID, flu, RSV, mycoplasma, and, but they are seeing an upsurgence.
We do have an office, CDC does, in China and our officials have been in touch with our counterparts to make sure that we’re understanding the situation there.
They were sharing back with us, again, not a novel pathogen–
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Mandy Cohen, CDC [10:47:22]
Not a novel virus. Again, we have been in close touch with our counterparts in China, and that information has been corroborated with other counterparts across the U.S. government, but also with our European Union partners as well. So we feel confident that that information has been corroborated.
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Rep Brett Guthrie [10:54:03]
Is China responding to the World Health Organization? I know you have people in China that are dealing with their Chinese colleagues. Do you think the World Health Organization is responding in a way that it should? And do you think China is working with them to perform what, from what you can corroborate?
Mandy Cohen, CDC [10:54:18]
Yeah. I don’t know firsthand about the WHO and China interactions. Our information is direct from our team who are in our China office with our counterparts, but my understanding from WHO, is that China has been sharing information related to this. And, so again, another way to corroborate.
Brendan Jackson, CDC [00:10:07]
RSV is really in full swing, especially across the south. It may even hopefully be peaking in parts of the south, but very high, and then hitting the rest of the country.
Flu is very much on its way up the south, again, leading the way except for Puerto Rico and Alaska who were ahead before, and now, but the rest of the country is starting to catch up.
And then COVID is sort of a mixed bag, it’s increasing overall. And, I’ll show you some specific data there.
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Brendan Jackson, CDC [00:11:07]
This is the map of this is the combined chart of flu, COVID, and RSV trends in emergency department visits through NSSP. This is actually like ED coded visits with these three pathogens.
So the overall line is definitely increasing.
We’re well below where we were at this time last year, because it was such an early season last year, but we’re very much on the upswing with flu just getting started, RSV underway, and you can see COVID kind of ticking along right there and there’s differences by area.
The Midwest seems to be having a bit more of an increase, as of late, but it’s still kind of still kind of wobbly for now, similar kind of chart for percent positivity, where you see RSV and flu really taking off there in particular.
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Brendan Jackson, CDC [00:15:59]
This new variant BA.2.86 just appeared on our Nowcast today for the first time.
Now we’ve been tracking this thing since August. We were sort of worried when it first came out. What does this mean? It’s so different.
So far, it’s not meant a whole lot. It’s not a surprise that it showed up on our Nowcast finally, it just finally got common enough to be there. And we just were providing that context to say, “hey, it’s here. And here’s what you need to know. And we agree with the WHO assessment, which we contributed to that the public health risk based on available data seems to be low for both this variant and JN.1, another one that people are following.”
So when it comes to, you’re going to see headlines probably in the next 24 hours saying new COVID variant, what does it mean for you? Not a whole lot at this point.
It may become the dominant variant of these. It, chances are, it probably will given the growth rate, but it does not seem to be a game changer. Something always becomes dominant.
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Kevin Chatham Stephens, CDC [00:24:32]
With the end of the PHE, that limited our ability to receive complete COVID 19 vaccine administration data.
And so now survey data are the primary source of data for tracking vaccination coverage for COVID 19, RSV, and flu, and we’ll be incorporating additional data sources such as healthcare claims data to provide additional insight and help kind of sketch out the rest of the vaccine coverage landscape.
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Brendan Jackson, CDC [00:33:30]
There was a lot of talk and many of you participated in some of those discussions over earlier in the year.
Should we move away from those COVID levels or just something different?
In the end, we are where we are, where you– we still have to– so the COVID community levels went away just because they were dependent on cases and the national case data went away in terms of ability to track that effectively, nationally.
But it turned out that the hospitalization levels were driving almost all of that. And so we just pivoted that same guidance to COVID hospital admission levels.
Got the link to that in the chat here.
And actually just, there’s been a lot of questions over this fall, too, about ‘is CDC going to be changing guidance related to COVID? Are we moving more to a pan respiratory approach?’
It’s not something that ended up happening for this fall. Definitely still being considered for the future, no specific timeline or anything like that, I’m sure there’ll be lots of outreach if that happens, well before that anything happens.
So again, nothing changing right now. Those COVID hospital admission levels is really where we’re at.
And, just as a reminder, you know, the bar to get to those levels is pretty high, understanding it does just include COVID, it doesn’t account for flu and RSV. So we understand that jurisdictions, if they’re seeing strain in their own areas, they may need to– they may want to make different choices than that, but this is at least the floor saying, ‘Hey, if we get to this point, we really do recommend, uh, more masking out there.’
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Brendan Jackson, CDC [00:35:06]
On the isolation and quarantine, there is not anything immediately in the works right now.
We know there’s been a ton of questions, but it’s just not something being updated right now.
And we’re talking in the community.
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Question [00:39:32]
People are wondering if there’s going to continue to be a recommendation for gowns, for care of patients with COVID 19, or if there’s going to be a move to more droplet and standard infection control like they have for flu. Can you comment on that?
Heather Jones, CDC [00:39:51]
I can. Thank you, Chris. And thank you for that good question.
At this time we do not have any planned updates right now.
We are still recommending the same PPE for COVID 19, and I’ll share in the chat a very easy simplified kind of directional tool from Project First Line that you can share with your partners. And it’s really easy and informative of what PPE has recommended for COVID 19.
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Heather Jones, CDC [00:41:41]
Earlier we did look at community transmission, hospitalizations, but we’ve now kind of pivoted to allow the facilities to determine if, not only based on what you’re seeing in your community and in your facility, but also what type of patients or residents are you caring for.
So do you care for those that have– are more immunocompromised? If you do, you may consider having everyone to use source control and not only for COVID 19, the link that I shared is for COVID 19, but as far as masking, that’s universal for the respiratory virus season.
So I recommend that they look at this link for the most updated.
The last major update was in May of 2023. And at this time there are no anticipated changes to those recommendations, but we do continue to ask for you to share with those facilities about using a risk assessment, so they understand what kind of patients and residents that they’re caring for.
Since CDC’s first post on BA.2.86 in August 2023, the proportion of infections caused by BA.2.86 has slowly increased. In the CDC Nowcast posted Nov. 27, 2023, BA.2.86 is projected to account for 5-15% of currently circulating variants. Currently, JN.1 is the most common version of BA.2.86 in the U.S. CDC projects BA.2.86 and its offshoots like JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences. At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States.
I can confirm there has been one death, an accidental overdose, that involved tianeptine. To my knowledge this is the only tianeptine-related death in 2023. I do not have any information about the brand.
Were the tianeptine supplements sold in NJ gas stations branded only as “Neptune’s Fix” or other brands as well?
More than half of the reported poisonings were attributed to products sold under the name “Neptune’s Fix;” one was reported as “Pegasus Silver.” The remaining cases did not report specific brands. The products were purchased at gas stations, a deli, a vape shop, a tobacco shop, convenience stores, and online. However, gas stations remain the most commonly reported location of purchase.
How many total poisonings has NJ identified related to this brand?
Between 6/17/23 and 11/19/23, the NJ Poison Control Center, NJPIES, received 23 total calls regarding tianeptine exposures in New Jersey.
Dollar Tree removed WanaBana Apple Cinnamon Fruit Purée pouches from store shelves and locked its registers to prevent sale due to a voluntary recall initiated by WanaBana USA. We are committed to the safety and integrity of the products we sell. If customers have this recalled product, they are advised to stop using it immediately and return it to the place of purchase for a full refund.
Attributable to the FDA, an FDA official or an FDA spokesperson :
1. What countries is FDA screening incoming shipments of cinnamon from?
The screening of imports for adulterated cinnamon is part of our ongoing investigation of and response to the elevated lead levels in cinnamon applesauce pouches. As a matter of policy, the FDA generally does not pre-announce investigatory actions. The FDA encourages manufacturers that import cinnamon and products that contain cinnamon to implement necessary preventive controls to ensure their products do not contain elevated levels of lead and to take the necessary steps to ensure their suppliers also adhere to the same safety standards.
2. Have all cinnamon-containing pouches tested by FDA in the investigation contained the high lead levels, or just some?
The FDA collected and tested a finished product sample of recalled WanaBana Apple Cinnamon Puree from Dollar Tree and detected elevated levels of lead. The level detected in the FDA sample of WanaBana apple cinnamon puree is 2.18 parts per million (ppm), which, for context, is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.
Most children have no obvious immediate symptoms of lead exposure. If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.
3. CDC previously said reported cases were ages 1 to 3 years. Is that still the case for the current 34 adverse events now reported?
The aggregate information collected from consumer complaints and CFSAN Adverse Event Reporting System (CAERS) reports submitted to the FDA indicates that most patients fall between 1-4 years of age.
Most children have no obvious immediate symptoms of lead exposure. If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.
As a reminder, unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, there is no method to link exposure to heavy metals to a specific source, which can make establishing a causal relationship difficult. The FDA relies on self-reported information submitted by healthcare providers and consumers as an initial step in determining if a product is a potential shared source of exposure. These data are often imperfect and lack crucial details.
Lisa Bollinger, Merck [00:58:04]
RCC and UCC are serious diseases. Chronic cough has a prevalence of approximately 5% in the U.S. adult population and a subset of approximately 5 to 10% of those patients presenting for care have RCC UCC.
Most patients are women over the age of 50, and these patients suffer a high disease burden with impact on their physical, social and psychological wellbeing.
Female patients may have the added burden of cough induced stress urinary incontinence.
There are no FDA approved treatments.
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Lisa Bollinger, Merck [01:00:02]
In the intervening period, gefapixant was approved in Japan, Switzerland, and Europe.
Merck has resubmitted the application and did that in June of 2023.
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George Philip, Merck [01:26:55]
In their briefing document, FDA pointed to a potential relationship between taste AE reporting and efficacy measures, asking if this impacts the efficacy of gefapixant.
This is important to evaluate and Merck has looked carefully at the trial data.
What we observe is that the data actually do not support that efficacy is driven by the tastes AEs.
In the phase two dose escalation trial, protocol 10, we explored doses from 7.5 to 200 milligrams.
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Lisa Bollinger, Merck [01:59:42]
In the gefapixant trials, the results were statistically significant for their original count and with the recount, the treatment effect was consistent with their original analyses.
The magnitude of effect was a decrease in cough frequency of approximately 60% consistently observed across both phase two and phase three studies.
There are no approved treatments for RCC UCC and no established treatment effect for products used off-label.
We have conducted multiple responder analyses, and they all support the primary efficacy endpoint.
We have even looked at increasing thresholds in these analyses, and they consistently show a greater effect for gefapixant over placebo.
The onset of cough reduction with gefapixant occurs at least as early as our first assessment, at four weeks, with durability shown through 52 weeks.
And the analysis of the patient reported outcome showed consistent improvement for patients and was statistically significant in protocol 30, the trial powered for this key secondary endpoint.
The safety of GEIX is well-characterized and tolerated by patients. The majority of patients stayed in the trials, despite the taste related adverse events.
Gefapixant is a first in class peripherally acting medication to treat RCC UCC offering patients a safe alternative to off-label treatments.
Based on the totality of data, and applying this framework, we conclude that the group differences are clinically meaningful.
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Rachel Bean, FDA [03:01:26]
We question whether these small treatment effects can be considered meaningful.
Next, I would like to take this opportunity to summarize the clinical efficacy findings.
Across endpoints related to cough frequency or PROs patients improved whether they were treated with gefapixant or placebo. There was a small reduction in the primary endpoint of cough frequency relative to the large placebo response.
The relative reduction in geometric mean ratio achieved marginal statistical significance in only one of the two pivotal trials, though the point estimates of the treatment effect are similar.
Because the primary endpoint summary measure is difficult to translate clinically we assess the median change in absolute cough frequency, and found that gefapixant yields a reduction of one to two coughs per hour, beyond the effective placebo.
We conducted exploratory analyses to examine these effects on cough frequency. We analyzed correlation between the changing cough frequency and the PGIC score.
And we found that coughing less often did not correlate with feeling better since the start of treatment.
We conducted analyses in search of a subgroup of patients with increased responsiveness to gefapixant whom providers could identify in clinic and target for therapy.
No such group was identified on subgroup analyses based on demographics and baseline disease characteristics.
Evaluation of thresholds for reduction in cough frequency higher than 30% did not suggest a substantial benefit.
Given these results, it is unclear whether the defect detected effect of gefapixant beyond the large placebo response is meaningful or perceptible to patients.
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George Philip, Merck [03:12:55]
We understand that gefapixant has a pharmacologic effect of efficacy, pharmacologic effect of taste AEs.
In order to tease apart, those effects, the best place to look is in the placebo group. So if we can call up the slide that shows the placebo group comparison with versus without a taste AE? I think that’s the point of your question. Slide up.
What we see in the slide is that patients with the taste related AEs did not have more benefit that patients without.
This shows a within group comparison of those patients with and without taste AEs in the placebo group, where the reduction from baseline at 52% and the patients without taste AEs was larger, actually, numerically than the reduction in the patients with the taste AEs.
So clearly the hypothesis that somehow reporting a taste AE is driving efficacy is not evident when we look at the data in this comparison, that does not have the confounding of the dual pharmacologic effects.
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George Philip, Merck [03:42:56]
In the placebo group, there was no evidence of greater efficacy present in those with the taste AE.
We could expect however, these effects to travel together in the gefapixant group, slide up.
What we see is that the same metric that you saw with the placebo group now in gefapixant, improvement from baseline, if we can bring the slide up for the cough frequency, please, is numerically greater, slide up please, for gefapixant. 64% improvement from baseline versus 56% without a taste AE.
So as expected a larger improvement from baseline, but if in fact reporting the taste AEs was having a substantial effect on efficacy, we might have expected perhaps even a larger contrast between these two subgroups. What we see here clearly is a difference, but one that is easily explained by the activity of the drug.
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Stacy Chin, FDA [03:55:14]
So both we and the applicant have looked into it.
And how the both gefapixant and placebo group who did or did not have taste AEs responded on the various endpoints.
And our takeaway is that it it’s an unquantifiable uncertainty. We just do not know how that may have impacted potential unblinding or bias in this study.
And in our mind, it takes on more importance because the treatment effect size is rather small between the placebo and gefapixant groups.
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Jaclyn Smith, University of Manchester (via Merck) [04:01:01]\
So the way we understand the placebo effects in these studies, a great deal of it comes from other therapeutic areas, but there is some evidence in cough as well. Slide up, please. Thank you.
So the placebo effect, as we understand it is, is multifactorial. And there are probably three main things to mention.
There is some non-specific factors about being in clinical trials that improve patient symptoms, but the other two main ones that we think are important here that may have increased between phase two and phase three, are the expectations of the patients and regression to the mean.
So what we know about the neuron pathways that mediate cough, include the central nervous system, both cortical and sub subcortical areas. And we have evidence in patients and in healthy controls that there are descending inhibitory pathways present in this patient group and even in a healthy cough reflex, which are capable of inhibiting cough in response to cognitive processes, such as expectation.
And I understand the concern that these patients have been coughing for 10 years, and not responded to previous other treatments. But I think we have to put this in context in the patients were enrolled to these studies, with the knowledge that previous trials had shown positive findings in patients just like them, who hadn’t responded to previous therapies.
So I think the level of expectation here that here’s the first therapy that is gonna work for your refractory unexplained, chronic cough did have an effect here.
And then the last thing that I think I should mention is regression to the mean.
The patients recruited into the phase three studies had a greater severity of their cough compared to the phase two B. So on the cough severity of visual analog scale, their severity was approximately scored at approximately 70 millimeters.
And so that increases the possibility of some of the placebo– some of the effects we see in the placebo treated arm being due to regression of the mean.
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Paula Carvalho, PADAC [06:55:05]
I think everybody agrees that, that this is a huge unmet need, and everybody understands the complete discomfort that these patients have and how this can be so detrimental in life changing for them.
We again– we’re a little bit of uncharted territory, because we don’t have prior experience with the interpretation of these kinds of results. We don’t have a good precedent for endpoints.
And we are hearing loud and clear that endpoints do need to be rethought and reconsidered.
There’s concern about the small effect on the cough reduction. And there’s been quite a bit of discussion back and forth about the PROs and the cough reduction, but that is an issue.
Finding the right endpoint does need to be reconsidered. There’s a very small, absolute difference in the mean median coughs per hour.
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Mark Courey, PADAC [07:34:39]
I wish I could have voted yes, but the balance of the literature suggests that patients with chronic nonspecific cough will have a response to treatment up to 50%, regardless of the type of treatment you give them.
You have a group of motivated patients who want to participate in a study trial, and they go through all of the pains, I don’t think– and you have a 57% response rate among the patients on placebo, the subjects on placebo, and a 63% response rate, and the patients on drugs.
I don’t think that is a significantly big change over what’s to be expected.
In addition, two thirds of the patients on medication had some sense that they were on the medication, so that would affect their expression of cough symptom severity or in frequency and their reports on the patient reported outcome measures.
Given all of that, I don’t think the level of evidence supports that the drug makes a significant difference.
It’s unfortunate. I am concerned that if the drug is readily available, it could lead to a delay in diagnosis of other things, other illnesses, because cough is– while it can be very debilitating, is a symptom, not a disease in and of itself.
And so I think this would delay the evaluation of the patients for other diseases. It could be potentially harmful that way.
We need a more objective measure of cough frequency and severity.
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Paula Carvalho, PADAC [07:37:21]
I also voted no, and I very much had wanted to vote yes.
And, I agree with other comments the panel members have made including how huge of a burden of disease this is and how really we do need to keep trying.
Getting some endpoints, getting perhaps different timings, perhaps tying the result of different symptoms as Dr. Courey mentioned with cough and urinary incontinence, and keeping on with trying to find a solution for these patients, because this is going to be hugely important.
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Leonard Bacharier, PADAC [07:38:13]
I similarly voted no, despite my wish to have been more positive.
I was largely influenced by the inconsistency in the primary outcome after the validation of the primary outcome capture system led the second trial to not meet nominal significance.
I think we’re really at a loss for what an outcome really would compel us that an agent in this condition made our patients meaningfully and predictably better.
As mentioned, I think the risk profile on the patient level is actually pretty low. I think the– I wasn’t terribly concerned about the risk of unblinding because I don’t think that was the driver here.
I think the driver of all we saw here was a very robust placebo effect amongst a group of highly motivated patients, more so than anything else.
You know, I think that the issue here really is studying these not quite orphan conditions, but these conditions that don’t have robust pre-established outcomes. And I applaud the sponsors for doing their very best to try to get at this.
But I think we need a better outcome measure that I think more completely captures what we’ve heard throughout the day about the various aspects of this disease. And I’m not sure I know what that is, but I do have a sense that this discussion should have shind some light on where the sort of clinically meaningful aspects might be.
And I think further work to further refine those and then study those is important.
You know, my heart goes out to this patient population who remain in hope for a therapy that would make a difference, but I am just concerned that we don’t want to be providing just hope, we want to be providing predictably effective pharmacologics that are likely to make meaningful differences.
And I am like many of the group concerned that the magnitude of effect, in given all the other factors was just less than would’ve been more compelling.
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Brian Garibaldi, PADAC [07:41:15]
I too voted no.
And I think really what it came down to for me was, you know, there was a small benefit with some uncertainty as to the cause of that benefit.
I think we’ve recognized that the PRO tools in particular we have are imperfect and probably need to have better anchors.
I think is as Dr. Bacharier and Dr. Courey mentioned, you know, we do need to have better markers of efficacy just beyond mean or median cough per hour percent change in frequency of cough.
And I think my hope is from the data that’s already been presented and from the validation of being able to quantify cough that some of that data may already be available to try to better align with PROs and really come up with a better assessment of what’s what’s actually happening in terms of changes, and not just frequency of cough, but character durations vary in ways that may be quantifiable, that can get around the placebo effect that we saw.
I struggled also with the fact that almost 70% of patients probably knew they were having a side effect that happens very commonly in patients on drug that happens in many patients within two days of taking the drug. And I think that makes it really hard to know exactly what’s driving that small difference between the placebo group and the folks who got drug.
And again I, when we were thinking about risk benefit, I think we would all agree that this is, if you set out to design a drug that was going to be efficacious in this disease, you’d want to have– you’d hope for a much more robust effect in above and beyond what you get from the placebo effect.
And, I know we didn’t get that here and, and trying to kind of manage that disappointment and really balance what the true effect is versus the small risk profile, I think that was really challenging.
So this– I wanted to vote yes, for a number of reasons that already been discussed, but I think right now the, the data is not where I feel that this should be something widely available and used for patients with this chronic and debilitating condition.
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Nicole Hamblett, PADAC [07:43:37]
I also voted no, for three primary reasons, one being the overall small clinically or small meaningful effect, with the cough frequency.
Second was the lack of consensus between the sponsor and the agency regarding the meaningful of the PROs.
And then third, just the inability to conclude that the small differences aren’t due to the unblinding.
I think when we think ahead, in terms of what data do we need, I think as long as we have a study drug that is at risk for potential unblinding, then we need designs and we need endpoints that are robust to that.
Maybe it’s taste matching. If that’s not feasible, then we really do need to invest in more objective endpoints.
I think the PROs are extremely important, but when there’s that risk of unblinding, we’re also going to need to invest in those objective endpoints I think Dr Courey mentioned. Is there an objective measure of incontinence and so forth?
And I’d also like to see, moving towards consensus on the meaningfulness of the PROs, if it’s not these PROs, is there another fit for purpose PRO that needs to be developed specifically for this population?
But lastly, I just want to conclude in that, it is very disappointing to vote no, however, I just want to speak to the value of these trials and to everyone who participated in them, because I do feel like they provide a roadmap for how we are going to develop these therapies moving forward.
So thank you to our community that participated in these trials.
…
Cheryl Coon, PADAC [07:45:27]
I wish that these trials showed that this is the therapy that patients are desperately waiting for, but I also had to vote no.
Only one of the two adequate and well controlled trials achieved statistical significance on its primary endpoint. And the effects appear to be fall.
Small effects can certainly be meaningful, but there is an absence of data indicating so.
I appreciate what the committee’s patient representative said in the discussion around question number one, that a small benefit can make a big difference in the quality of life to patients. I absolutely agree with that.
And unfortunately that’s where the evidence is lacking.
So regarding the evidence that could be collected to show a benefit is clinically meaningful, in an ideal world, I’d like to see interviews done with the individuals who have the experience on the therapy to understand if the changes that they experienced in the cough frequency and in other outcomes were meaningful to them and how so.
Putting it into kind of that metric of how is this impacting your daily life? Are you able to get back to the things that you’ve had to give up, given your chronic cough condition?
In these interviews, you could also gain an understanding of what changes are meaningful on the PGIS and PGIC to inform anchor based analyses and to help inform that discussion in the future between the sponsors and FDA.
And then there could also be gaining an understanding the impact of in this case taste related disturbances and how tolerable the treatment would be considered in a long term setting.
…
Jennifer Schwartzott, PADAC [07:47:10]
I voted, yes, but I will admit I was greatly on the fence, and I was really wishing there were other options.
I am a patient, so I have a different viewpoint than everyone else, but I’ve been debating to myself what level of effectiveness does– should a medication have to recommend it to go to market.
With this drug, any reduction of cough symptoms for many patients would be worthwhile to them as long as the risk is low, which I felt that it was.
So, I wanted to give the patients a chance to have– give them something that could potentially work at least a little bit until the perfect drug comes along, which hopefully won’t be that far from now.
But I also felt that the medication would need much further study, which is why I was on the fence about voting yes.
And it needs follow up. It needs– the protocols need more definition as we’ve discussed.
I hope that the company and other companies are going to see the benefit of this and see the need and continue to work to help these patients because they deserve a cure or at least a treatment and sooner rather than later.
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Edwin Kim, PADAC [07:49:06]
I voted no. It seemed that participants– my rationale is that it seemed that participating in the clinical trial provided a benefit, but specifically reading the question of does the evidence demonstrate that gefapixant provides the benefit, and that’s where I get stuck.
With the large placebo effect, It’s hard to differentiate how much effect that the medication itself provided. Similarly, the PROs there might be some benefit, but it seemed to be similar in the placebo as well as in the actual treatment group. And so not being able to differentiate a compelling difference from the treatment from placebo is why I voted no.
Moving forward, that would be sort of the recommendation, is there a way to separate out the placebo effect from the treatment itself, whether that might be in a clinical trial design?
I’m not sure if some sort of crossover design or something like that might be able to tease out placebo versus an actual medication effect or specifically there’s been discussion about outcomes. And in my mind, I do wonder if going back to actually how the medication is supposed to work.
So it’s supposed to suppress cough. And so I wonder if outcomes could be more built around that. And so perhaps could there be a type of study or outcome that is actually measuring response to triggers?
So, many of the patients describe certain situations triggers, whether it’s perfume, dust, things along those lines that would reliably trigger cough.
And so perhaps that would be a way to really demonstrate that the medication itself more than a placebo effect, the medication itself is actually making a difference in decreasing that frequency of cough. And then perhaps there could further correlates to sort of the other quality of life type metrics.
…
Matthew Rank, PADAC [07:50:59]
I voted no. I want to thank everybody for excellent presentations, particularly the patients who spoke at the open public forum.
My vote is driven by the small and uncertain benefit of the intervention relative to the placebo, the overall small effect size, the uncertainty and consistency across both the primary outcomes across pivotal trials, as well as the uncertainty about the PROs.
Moving forward, I had similar thoughts that similar thoughts to what Dr. Kim had articulated just before me, that very, very large placebo response, I think, is something that needs to be understood.
And I think study design perhaps run in, perhaps cross, there may be some ways to either exclude people who are likely to have a large placebo effect and then narrow down the patient selection where you’re getting people who have potentially the benefit from a drug like this or other future drugs, and be able to measure that more clearly.
…
Emma D’Agostino, PADAC [07:52:14]
I voted no, for all the reasons that we’ve heard, the small decrease in both the objective and subjective measures were really what drove my vote, particularly when considering the responses paired with the high placebo response, just were not enough to me to demonstrate clinical meaningfulness.I
meaningfulness.I also was really thinking about the two thirds or so patients that experienced taste AEs. And even though I absolutely agree that the drug would be safe, with the 20% dropout rate in the trial, I’m not sure how that would really translate to use in the clinic, if you have a drug with a pretty small benefit and what appears to be a real tolerability issue.
And then moving forward, as we’ve heard from others, I think really thinking about rethinking the end points to capture what’s most meaningful to patients. So rethinking that cough frequency, maybe instead of– instead of looking at overall frequency, through 24 hours looking at cough clusters, something to really capture the most meaningful minimizations of cough.
And then, I agree that taking a closer look at urinary incontinence, I think in the sponsor document, the sponsor briefing that we had, sorry, in the FDA briefing that we had, we saw language that there was a little bit of skepticism in the use of urinary incontinence as an outcome specific to cough.
But I do want to just put it out there that as someone with a different cough condition, I would assert that if we saw a reduction in cough specifically, I would absolutely expect to see a reduction in urinary incontinence.
So I would put that as a highly meaningful endpoint, especially given what we heard from the patients today.
And then one other piece that we didn’t talk about at all today, but that I was struck by just reading all the data, was we had 52 week endpoints for all of the PROs, but not any of the objective endpoints. So it would’ve been nice, especially for the 027 seven study, to see objective data beyond 12 weeks, which of course we can’t go back and redo, but I would’ve loved to have seen some durability beyond 12 weeks.
I think that was everything that I was thinking about.
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Scott Evans, PADAC [07:55:00]
I voted no.
I am surprised at the outcome of the vote and how dramatic it is considering how much I struggled with this vote.
I do think that the count data is likely valid. And I do think this agent likely does something. But at the end of the day, I struggled with the small effect size relative to the placebo effect and the apparent lack of correlation, at least clear correlation, with the PROs. That’s what drove my vote.
I am a pulmonary clinician. I see patients with chronic cough. I understand the need. I am sympathetic to the folks that presented today.
But I do want to be careful didn’t resist my own urge to think that something’s better than nothing, because I think we are establishing precedents here.
And if we adopt the wrong markers and outcomes, I think we actually may limit our ability to identify the best drug.
…
Sally Hunsberger, PADAC [07:56:19]
So I– everything that’s been said, I totally agree with, so I will just go rapidly through.
I just want to thank the sponsor for doing this study. I think all of them were, were really well designed studies. Unfortunately, the placebo effect was so large that it made it difficult to really be able to interpret the data.
I appreciate the speakers and it really helped me to understand the so and the FDA’s report I think was really helpful.
So, I think, the science here is really strong. I hope that this no vote doesn’t discourage the continued search for treatments for this population. So I– and I do think that what we need is better endpoints that better match what the public speakers said were the issues. And maybe then we will be able to see and effect.
…
John Kelso, PADAC [07:57:23]
I voted no, because the pre-specified primary endpoint was achieved in only one of the two studies, because the absolute treatment effect, the difference in cough counts was so small that it is likely not of clinical significance.
And in terms of trying to assess that clinical significance, I found the patient global impression of change data to be most relevant, where there was a virtual overlap between treatment and placebo. So it appeared that the patient’s assessment was in fact that there that there really was no difference in getting the drug versus the placebo about whether their impression was if they had had an improvement in their cough, which then casts down on tiny absolute measured difference.
I think that the comments that have been made about other parameters that might be studied going forward are all appropriate, but I also think that had this drug been more effective, we would’ve seen it in the data that was selected.
So I think the right kind of data is being collected in terms of counting coughs and patient cough, the patient reported outcomes in terms of these cough scales and whatnot.
So I think if this medication had been more effective, it would’ve also been more apparent even in the data that was collected in this study.
Robert Califf, FDA [00:40:35]
I, despite all my vaccinations, I’ve got a URI. I was really looking forward to spending some time with many old friends at this meeting, but probably best not to infect a bunch of people.
…
Robert Califf, FDA [00:54:28]
But in addition to the small crappy trials issue, I think there’s an increasing, concerning issue of incursion of observational comparisons using real world data done outside of the sunlight that we’ve pushed so hard for in the structure regulated traditional clinical trials world.
And more and more of this is being done by data aggregators who are not at all susceptible to the sunshine and who are informing health systems and others about the best course of actions and ways that affect patient care and decisions just as much as traditional clinical trials do.
And right now we have no solution for that problem. And we’re sort of at square one in that regard, they’re not registered anywhere.
So we’re sort of where we were before clinical trials dot gov.
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Robert Califf, FDA [00:57:54]
This is one that is very troubling, but I would guess that all of our institutions, for those of us that are in healthcare institutions of any kind are doing the same kind of thing in one way or another, this is the articles that STAT put out about United Health in the last couple of days where algorithms are being used to guide how long people stay in particular facilities, which would be a good use of data.
But again, it’s an example where it’s not a randomized trial. It hasn’t been done in the sunlight. The only reason these articles came out is that there were sort of whistle blowers in the organization.
And again, I don’t know how accurate the STAT articles are, but I certainly have seen many examples where the most common use of patient data in health systems is to figure out who you want to have in your system and who you’d rather move on somewhere else, being tailored to profitability.
So, if we look at the future, of course, given what I’ve just said, I want to emphasize, again, a lot of progress in traditional clinical trials world. I think we’re on a good course. What NIH is doing is fantastic.
But if we only look at what’s under the lamppost, I’m very worried.
Question [00:27:39]
The voucher process and requirement for patients for eTrueNorth pharmacies to access Bridge vaccine is a multi-step online process that introduces barriers for people who are not tech savvy or speak another language.
Are there any plans to simplify the process?
Erin Abramsohn, CDC [00:27:58]
Absolutely. And that’s not the first time– I mean, I appreciate that question, not the first time that we’ve heard it.
We’ve talked it through with eTrueNorth a couple of times.
They do offer assistance with that program. They’re aware that that does present barriers for individuals, some more than others.
So they have a 1-800 number that people are able to call and they will walk through it and they will do it for the individual if they call and provide the information, eTrueNorth will walk them through it and provide, do the actual voucher for them.
They have what they consider a workaround for that. Right now, I don’t think there’s a plan or an ability for them to change it on their side, but we are continuing to have that discussion with them.
…
Sarah Meyer, CDC [00:40:43]
Just to kind of highlight, again, that only the Pfizer vaccine is recommended for use in pregnant people. The Arexvy GSK vaccine is not approved or recommended in pregnant people.
The reason I’m highlighting that is because we are starting to hear of administration errors where a pregnant person gets Arexvy instead of Abrysvo.
That vaccine is not licensed in pregnant people. So we’re, in our messaging, we’re really trying to emphasize when we talk about the maternal RSV to really specify which one we’re talking about so that people go to pharmacies or other places and there’s not– that reduces the risk of administration errors.
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Sarah Meyer, CDC [00:42:24]
I know people are aware, this is limited supply currently, particularly with the 100 milligram dose prefilled syringes, the shortage is a little more severe there.
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Sarah Meyer, CDC [00:43:09]
The key points we’re trying to emphasize is immunize now. RSV season is underway. We don’t want people– the common question we get is, should we save up some doses for those infants born later in the season?
And our answer is no, use the doses you have on hand now, because this is a peak time for vulnerability, and we don’t want to get to the end of the season and still have doses left that we could have used now.
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Sarah Meyer, CDC [00:44:00]
People shouldn’t give two doses of 50 to try to make up for a 100 milligram dose or to give a dose that would be 200 milligrams to another infant.
Conversely, we don’t recommend splitting doses, so taking a 100 milligrams and trying to create two 50 milligram doses out of that.
Use the 50 milligram doses for their indication and the 100 milligrams for theirs.
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Sarah Meyer, CDC [00:56:43]
We understand how frustrating this is, especially for the people on the front lines.
I think there’s a lot in flux and I think a lot of the borrowing flexibilities were meant to be helpful for this first season, especially just given all the implementation challenges that were anticipated before we even knew about the shortage.
And I think, there came a realization that it’s hard to have a borrowing policy if you have no doses to borrow. And so I think it’s– I think the intent of some of that communication was really trying to clarify and help it make sense for people, or give a clearer picture of where we’re at.
But just understand that it’s frustrating and things have evolved a lot.
…
Sarah Meyer, CDC [00:58:47]
History of RSV disease shouldn’t really be taken into account when making decisions about RSV immunizations and that’s the vaccines, that’s also the infant nirsevimab, in general.
We have gotten questions around if, in this setting of supply constraints of nirsevimab and a baby’s just had RSV, and I think we’ve given some, use your judgment to prioritize, maybe that baby is not as high priority.
But I think in general, we don’t advise taking into account history of RSV infection when making vaccine decisions. We know that there’s different strains, antibodies wane, there’s many factors to determine your level of immunity to future infections and things like that.
CDC and FDA conveyed to the manufacturers the demand and the urgent need for additional doses. We explored options to get more nirsevimab into the market and were able to identify a batch that was awaiting final clearance and then worked with FDA to expedite processing.
We are continuing to advance AZD3152 to help protect vulnerable patients like the immunocompromised who face up to 14x greater risk of hospitalisation from COVID-19 than the general population, even after repeated doses of COVID-19 vaccines. The Phase III efficacy trial is now fully enrolled; the trial will assess the potential benefit of AZD3152 in protecting immunocompromised patients in an environment with many variants in circulation. We aim to make AZD3152 available as a new option for COVID-19 as quickly as possible subject to trial readouts and regulatory reviews.
Xavier Becerra, HHS [00:02:15]
Big thanks to all of our team that’s on this call because of the work that they’re doing and that they continue to do with you all, and biggest thanks obviously to each and every one of you who have made this all work.
The fact that today we can prepare for the holidays and most of us feel pretty safe, I hope you’re still wearing mask when you need to, I hope you’ve gotten that updated vaccine, but for the most part, I think Americans feel like we’re back to before we saw COVID and it ever existed in our lives, and we know what we need to do.
And those are the good aspects of all this work that we’ve done is we know what we can do to stay safe.
And we thank you for making that a part of what you do every day and of your life.
…
Xavier Becerra, HHS [00:03:00]
I should start by saying that I just got back from a cross country trip last night, DC to California, where I had my 90 year old mother with me.
I have responsibility, my three siblings and I, we take care of my mom. She lives here in my home and she traveled cross country with me.
Not easy traveling with a 90 year old, but we did it, and we were masked on the plane.
There weren’t many people masked, but we were, thank God.
Actually, she’s the one that brought out the mask first and reminded me because the last thing I need is for her going into Thanksgiving to have contracted COVID because it’s someone on a plane or even perhaps me.
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Xavier Becerra, HHS [00:04:52]
You should be able to get that vaccine without having to worry about cost. And that’s why we stood up the Bridge Access program. More than a billion dollars.
We got the commitment from the president to make sure he protected those COVID dollars during the sweep that Congress did, of some of our COVID funding. we made sure to keep some of that money, so we could reach out to those who were uninsured or underinsured.
We made sure that we were protecting everyone from having to make payment. And so today we can continue to say that you’ll have access to the COVID vaccine free either through your own private insurance, through other means that you have, or through this Bridge Access program, for those who otherwise can’t afford it.
…
Nirav Shah, CDC [00:17:35]
So the first place to go to look for a site that’s participating in the Bridge program is Vaccines dot gov.
But you can also go directly to the websites of say our pharmacy partners, Walgreens and CVS, and a lot of independent pharmacies via eTrueNorth, and you can go directly to Walgreens or CVS website, find a shot, and then make sure that they are open and they’ve got an appointment ready for you. Folks can then take advantage of the Bridge Access program that way.
The Bridge Access program has been off to a strong start. As of this morning, close to 525,000 people have received their COVID shots just via the pharmacy channel in the Bridge Access program. Close to 525,000. So we’re off to a strong start, but we’ve got to, as the secretary noted, we’ve got more work to do in front of us.
…
Stephen Cha, HHS [00:19:38]
A lot of you talked about partnerships, which I think is especially critical in this year.
And I want to be clear, where a lot of this, the funding and the ability to promote is now moved out of HHS’s hands into the private sector, those partnerships from all of you is gonna be even more critical this year.
So partnerships across providers and pharmacies, with CDC and Dr. Shah and CDC have some limited advertisements launching. And I think they’re hosting bunches of stakeholder engagements as we go, as well as partnerships with industry to promote that vaccine confidence.
Partnerships with community health centers and public health, including community clinics and community vaccination clinics were possible.
…
Stephen Cha, HHS [00:22:04]
Number one, COVID vaccines have been the backbone of our defense, saving millions of lives, keeping folks out of the hospital, giving us all a little bit of peace of mind. And along with tests and therapeutics, as well as the RSV and flu vaccines, we have the tools and systems we need to protect yourself, protect the ones you serve, and your employees.
And in particular, right now, the reason we’re having this call right now, as we head into this holiday season, when families will be gathering, we are continuing to encourage Americans, particularly older adults and people with disabilities, to get their COVID-19 vaccine, in addition to the annual flu shot and the RSV immunization.
Now with the vaccine distribution, shifting to the private market, it’s a lot different than it was last year.
HHS and all of our comments components such as CDC and CMS here today stand ready to partner with all of you. And we’ll do all everything under our power and our resources to support this effort.
But it just really underscores why we’re doing this, that we need everyone to step up and do your part to get yourself vaccinated, get your teams vaccinated, and get the people you serve vaccinated.
Sherri Berger, CDC [00:09:17]
I currently serve as a senior counselor. I’ve been at CDC for just over 27 years and I have one month left and I will be departing the agency.
So, I was given the privilege to talk about my favorite subject here at CDC, which is the budget.
I worked on the federal appropriations process for many years before serving as the chief operating officer.
…
Sherri Berger, CDC [00:09:58]
So I was asked to talk about the COVID rescission, which is really driven by something called the fiscal responsibility act or the FRA, not to be confused with the IRA that was passed the year before.
This bill did result in a rescission or returning of COVID supplemental funding from CDC.
Of course it was across the federal government, but I’m only going to talk about the funds that were provided to CDC.
…
Sherri Berger, CDC [00:10:28]
No, these funds did not address what had already been obligated.
So if a state or local health department, a public health partner, had money in hand, even if they had not yet spent that money, meaning they hadn’t actually used it, those dollars were not rescinded.
What was rescinded is money, I would say, sitting at the government bank that had not yet been obligated.
All of these dollars had plans, they just hadn’t all been obligated. So in some instances it might have been a multi-year grant program and we were putting out, I don’t know, let’s just say hypothetically, 200 million a year for a disease intervention specialist program for tracking down STD cases to improve our workforce for contact tracing.
So maybe we had a chance to award the first three years and we had not yet awarded the second two years. Those are the kinds of dollars that were rescinded.
The other thing this bill did, that’s not nothing to do with COVID, it actually put spending caps in place for the federal appropriations process. And I’ll talk for a second about that at the very end.
…
Sherri Berger, CDC [00:13:19]
So here at CDC, this was the approach that we took once we received the final word, which was we had to make some tough decisions.
We had to go back through all of our approved spend plans and figure out what needed to be stopped completely, where we might be able to do some of the work, but not all of it, and where we were able to potentially use other COVID dollars or base resources to continue our commitment.
And that process took longer, I think, than many of our jurisdictions and partners had hoped. I think they expected we were going to have answers overnight. And they had been waiting for months for answers, but we did work through this process.
…
Sherri Berger, CDC [00:14:19]
These are examples of programs that either ended completely due to a lack of funding, like the disease intervention specialists, or we had to scale them back, like the public health AmeriCorps.
So I provided a list of these programs for you. I could explain a little bit about what some of them are. I think you’d probably be most familiar with the first bullet because that was in the press.
The money that was to go to the jurisdictions to modernize, not to run these systems, but to modernize the systems was rescinded.
The next two bullets are really about outreach and education about vaccines, to increase vaccination rates and to address some of our challenges around equity, and those dollars were rescinded.
The next couple of bullets were really about our work overseas, building the capacity to do better surveillance and early detection of COVID around the world.
Disease and intervention specialists we talked about.
The laboratory data exchange program is really as exactly what it says. It’s about improving our ability to get lab data from jurisdictions and labs around the country, and then public health AmeriCorps, which is near and dear to my heart. We were able to start with COVID dollars, but unfortunately after next year, there’ll be no more funding for that program.
…
Mandy Cohen, CDC [01:12:32]
I do want to say one program I’m super excited about was built during the pandemic was working with AmeriCorps and building a public health AmeriCorps, which I think was really exciting.
I think it builds on sort of the tenants of community health workers and using folks who are trusted in their community to be able to do the public health work that is needed.
I think that’s an exciting piece of work that we’ve been able to extend. But again, this is where within the confines of authority and funding, we’d love to be able to do even more there as we go forward.
Attributable to the FDA, an FDA official or an FDA spokesperson:
The FDA takes patient privacy very seriously. Therefore, the FDA cannot disclose specific patient or health care provider information submitted with adverse event reports. To date, no deaths have been reported as being linked to this investigation.
Unlike outbreaks of foodborne illnesses linked to pathogens, there is no national monitoring system established for monitoring toxic element exposure, so the FDA relies on self-reported information submitted by healthcare providers and consumers as an initial step as part of determining if a product is a potential shared source of exposure. These data are often imperfect and lack crucial details. Since this issue was first reported by state partners, the FDA has received additional reports of illnesses and is working to evaluate those complaints.
Peter Marks, FDA [00:20:03]
I think we actually need to aim very high. I actually think that we are more likely to find vaccines that can reduce transmission, than we will be to find vaccines that are able to be pan SARS-CoV-2 viruses.
In other words, I think it’s more likely that we can find a vaccine that’ll have 95 or 100% effectiveness against some number of strains, and potentially stop transmission or reduce it by at least 50 to 75%, which is probably what you would like to see if you, even by 50% would not be a bad thing at all. That’s pretty good.
But I think that’s more likely than this kind of goal of trying to find something that’s gonna cover every last coronavirus that comes up. It’s just that biology’s too smart. And the nucleic acid rearrangements that this virus can do will mean that we’re probably going to still have to have strain updates, but being able to figure out how to make a vaccine that is able to reduce transmission and actually have that measurable effect, I think that is within our reach.
…
Peter Marks, FDA [00:21:34]
I think that one of the issues that we really lack are good assays for cellular immune response, and we can help from the government perspective in that regard.
And then the private piece is that there are a lot of vaccines, very good vaccine developers interested in this space, but having each of them develop their own like tool, that’s not going to actually help help everyone.
And it’s certainly not going to help a small company that might have a really great vaccine, that just doesn’t have the wherewithal to spend the millions of dollars that it would take to actually get to the types of assays that are really needed here.
We used humoral immune response during the COVID pandemic because it was the tool we had at hand. We went to the toolbox, that was the big hammer at the top. We took it out. We did not try to make a new hammer, or search for a ball pein hammer or something else. We just went with what we had.
Here is more information on the recall: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye
Related to the recall mentioned above, below is our statement:
Due to safety concerns identified by the FDA, we have removed applicable Rite Aid branded recalled products from our store shelves. Customers can return applicable recalled eye drops to Rite Aid locations for a refund.
Thanks for reaching out – below is our statement. We do not have additional information to offer at this time.
Upon receiving notification by the FDA, we immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio. Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter._
Natalie Thornburg, CDC [00:07:02]
Why do I need to collect, retain, and send SARS-CoV-2 specimens to our state labs and then have them ship them to CDC if they’re already being sequenced locally?
And the answer to that is, at least for right now, because we don’t know the long term evolution rate of SARS-CoV-2, how often we’ll need to reformulate COVID 19 vaccines, policy bodies have established frameworks to look at the vaccine formulations once a year, twice a year, until we know if we need to consistently update vaccine formulations.
And getting those specimens will help us determine how antigenically similar viruses that are circulating now, versus vaccine formulations.
And two of those bodies are the WHO technical advisory group for vaccine composition.
This group meets twice a year they’re meeting in early December. And then I believe they usually meet– they’ll probably meet in about May, where they look at what viruses are circulating, what does vaccine formulation look like right now?
And they utilize data from viruses that have been generated from clinical specimens to determine how closely related they are to the vaccine formulation and make recommendations about vaccine reformation.
Very similar to that group, FDA VRBPAC has established a similar process. Thus far, they have done it in June. They did this in June 2023, and they did it in June 2022 as well. To look at similar questions, were circulating viruses to vaccine formulations, and at least this past summer, they made the recommendation that the vaccines be reformulated from bivalent an XBB formulation.
And then ACIP is coordinated by CDC, and ACIP develops recommendations on how to use vaccines.
So FDA makes the recommendations on the formulation and does the approvals, and then ACIP makes the recommendations on how to implement those vaccines.
And in September of 2023, ACIP recommended that the new XBB formulation of COVID 19 vaccines be used for all persons this year, greater than or equal to six months of age.
So why those clinical specimens are important to make it to the state labs and then to CDC is that we need that primary clinical specimen to generate a virus isolate.
And then those virus isolates are used for neutralization assays, either with human post vaccination sera, or can be used for generation of clean sera, and also used for neutralization assays.
…
Natalie Thornburg, CDC [00:10:18]
So for those primary clinical specimens, the specimens need to be in a viable state.
So they need to be in a media that doesn’t inactivate the virus, and that helps stabilize it for isolation in cell culture.
And they need to be held at a temperature that supports viability, usually cold frozen or ultra cold and not heat treated before they’re frozen.
And then those clinical specimens right now make their way to CDC through state laboratories. So from the clinical labs, choose state laboratories who sometimes sequence them locally and then ship them onto us, or if they don’t sequence them locally, they just ship them straight to us.
And we generate the viral isolates for neutralization assays and analysis, and that is through our NS3 program and the kind of data that we look at during FDA VRBPAC, the WHO work group, and CDC ACIP is shown here in a slide.
…
Natalie Thornburg, CDC [00:17:05]
Another guidance document that we’ve added is some preliminary recommendations about RSV surveillance guidance.
I would categorize that in the middle genomics surveillance bucket, not phenotypic surveillance bucket, and that is probably not necessary for a virus like RSV.
Why are we initiating RSV surveillance guidance? Well, there are new vaccines in monoclonal antibody prophylactic products that have been approved and recommended for older adults and young infants. And we need to initiate viral surveillance, really genomic surveillance, and not full phenotypical surveillance, to help us track vaccine and prophylactic performances.
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Natalie Thornburg, CDC [00:21:37]
A couple of states have reached out to us and said they’re interested in starting their own sequencing efforts. We absolutely support this, and we’ll be happy to work with you if you’re interested in doing that.
Otherwise, what we’re asking is voluntary submission of a very small number of specimens to CDC, with CTs below 28.
What we’ll do with those sequences is not isolation of viruses, but we will do some genomic surveillance, obviously and we’re asking for just quarterly shipments of those specimens. And again, this is a voluntary participation.
We just want to get an idea of diversity across different states. We don’t expect a lot of diversity.
What we know of, from the little bit of sequencing has been done, is there tend to be circulation of A and B viruses at the same time, but the diversity, but there’s minimal diversity of the A viruses circulating and B viruses circulating during a season.
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Todd Davis, CDC [00:41:59]
So as part of our updated sample submission guidance for this coming flu season, some of the additional recommendations for sample submission include looking at unsubtypeables.
So we really want to be sure that, anytime there’s a virus that fails to produce a positive subtyping result, but that is influenza A positive, those are the types of samples that we really want to see quickly.
They often are related to zoonotic infections, or if they’re inconclusive results, such that the CT values might be dramatically different from the influenza A matrix gene component compared to a seasonal H3 or H1, that’s oftentimes an indication of a possible swine origin variant virus.
As I mentioned earlier in the talk, we’re very interested in looking for any indication that the B Yamagata lineage continues to circulate. As I said, we haven’t confirmed its presence since March of 2020. And so we we’d like for all influenza B positive samples that fail to produce a positive genotype result be sent to the CDC and any samples that test positive for B Yamagata we’d like to be sent for additional characterization and confirmation, and especially sequencing, to be sure that it is in fact a B Yamagata virus.
We’re very interested in co-infection. So anytime that there’s a nonstandard test result that indicates a mixture of influenza A subtypes, or influenza A and B viruses, these are often indicative of live attenuated influenza vaccines that have persisted and result in those co-infections or real time results that could be possible co-infections.
And then finally the potential zoonotic infections, and additional subtyping that’s required to detect H5 and H7 presumptive positives.
Thomas Lingelbach, Valneva [00:22:37]
With regards to supply, we have already agreed with the FDA on the lot release protocol.
We have launch material ready that will go through as respect to procedures, final labeling and packaging, and should be available very early on in 2024 in the United States.
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Juan Carlos Jaramillo, Valneva [00:23:41]
I think for us is one of the most important parts is looking at now, with the approval, especially with a final label, is working with ACIP as we are being asked to provide information and data to them.
As you have probably seen, there will be an ACIP recommendation in February of next year. And, we’re working closely with the ACIP working group lead in order to make sure that the timelines are kept from our end.
With regards to the launch teams in the U.S. are well prepared. And we’re looking forward to having this product on the market, as soon as possible, and benefit into the people that need it the most.
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Thomas Lingelbach, Valneva [00:27:39]
All discussions around, be it military, be it potential stockpiling, those discussions of course, have been initiated, and will be further intensified now that we got the approval.
But in order to manage expectations, we do not expect anything right now prior to ACIP, based on our own experience from Ixiaro, but also from other vaccines I’ve personally worked on, it would take a bit longer for the U.S. military to come up with their respective vaccination recommendations and potential procurement plan.
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Unclear, Valneva [00:28:43]
I’ll start off first with the pricing.
I think that we, during the ACIP working group, I believe held in October of this year, they were discussing around how the health economic model and also the budget impact models were being looked at.
So currently we are anticipating that our price will be similar to other travelers vaccines in the U.S. So this is also something that we are finalizing at the current moment with that.
Regarding, yes, we’ve taken the uptakes and also looked at the marketplace around travelers. And we are mimicking, in certain certain launch activities, where we are targeting specific travel agencies and travel departments in the U.S.
And this is how we expect to enter the market hopefully soon.
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Thomas Lingelbach, Valneva [00:30:47]
We have launch material ready. We are going through the lot procedure, lot release procedure right now, and then labeling, packaging.
And then we expect early next year arrival of the product in the United States, very early.
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Question [00:31:15]
How many doses in the launch stock do you currently have?
Thomas Lingelbach, Valneva [00:31:21]
So me– I need to follow it up– I don’t want to give you a wrong answer, but I would say definitely more than sufficient, but we can follow up, because I don’t want to give a wrong number here.
Natalie Thornburg, CDC [00:11:53]
Those weighted estimates are used to calculate growth rates, which we use to predict into the present tense.
And the reason that we do that is because it takes time to collect a specimen, identified it as SARS-CoV-2 positive, get it to a laboratory that can perform whole genome sequencing, actually perform that whole genome sequencing, which is multiple days, maybe a week, get it analyzed and then get that data to the CDC or into a public repository.
And so that lag time – in that lag time, we utilize the actual sequences to calculate those growth rates into the present or Nowcast.
So the data on the right is modeled data modeled into the present tense. The data bins are bi-weeks. We update them every other week on Fridays.
This week, we were delayed one day due to a holiday. And then on Thanksgiving week, we will also delay it one day and be posted the following Monday.
But typically it is posted with all other data on Friday mornings.
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Natalie Thornburg, CDC [00:12:57]
What you can see is that the most– the HV.1 lineage virus is predicted to be the most prevalent virus lineage circulating nationally, with EG.5 predicted to be the second most prevalent, but they have overlapping confidence intervals.
So they’re approximately predicted to be approximately equal nationally.
It looks like there’s a lot of diversity in the circulating viruses, but there is not, because we use aliases now with this PANGO lineage of genomics, meaning once you get a large number of numbers after the letters, in the name designations, an alias will be assigned to it and that’s assigned in order not necessarily relevant to its parental lineage.
And so all, really all of these lineages, with the exception of BA.2 right there and CH.1.1, everything else on this data tracker are XBB lineage viruses, and they are very, very similar to each other, often with identical spike sequences, with zero, one, two, three changes in the spike protein in comparisont to the current vaccine formulation.
So right now the vast majority of viruses, 95, 99% of circulating viruses are very, very similar to the composition of currently available vaccines.
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Natalie Thornburg, CDC [00:14:31]
The lineages that are growing fastest include HV.1, and that just took over, is predicted to be the most prevalent lineage.
HK.3 lineage virus, and JD.1 lineage viruses.
If you scroll down beneath the map on the data tracker, you can see a dendogram, this is not a true phylogenetic tree, but just shows you the relationship of viruses.
And these two are some, they’re HV.1 and HK.3, they are some of the faster growing lineages, they are sub lineages of EG.5 with an additional change.
And then you have JD.1, which is a sub lineage of XBB.1.5 virus.
Jim Jones, FDA [00:10:07]
In my two months here, it’s all being reinforced with personal firsthand experience. It really is a remarkable and remarkably talented and committed group of people.
And I’ve seen that in play just in just two months, over and over again, whether it was, we were working all day on a Saturday to effectuate a recall, or making sure that we had a document ready to roll out on a Monday.
And people here are remarkably– they’re both talented and committed.
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Jim Jones, FDA [00:47:54]
Maybe this beginner’s luck, and not that this is going smoothly because these issues are always by their very nature difficult to get your arms totally around, but that state of North Carolina brought this issue to us on a Wednesday in October.
The staff did humongous work to make sure that the science was– because there were some anomalies, how information was collected, it was not sort of necessarily how you would do things by the guidance book.
So they did do all the vetting that they needed to do by Friday afternoon, they had it to me, we had a recall on– a voluntary recall from the company on Saturday.
So I think that kind of clarity of decision making, they knew where to go, it just– we were able to go from knowledge to recall within four days.
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Jim Jones, FDA [00:48:48]
Now you got to figure out sort of where exactly and what other than WanaBana may be impacted.
And so now you’re into, you’re in investigative mode, we’re working with the state health departments, some cases, the state ag departments, our colleagues at the CDC, trying to make sure we understand, we have a theory that we can’t get too far out on it, about it. And it may involve suppliers outside the United States.
But we are aggressively trying to get to the bottom of it.
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Jim Jones, FDA [00:49:21]
It’s theoretically possible we have our arms around it right now. It’s theoretically possible that one of the ingredients that may be what’s behind this is in products that we don’t even know about yet, because you know, we didn’t sell this product to– we weren’t the supplier to somebody in another country manufacturing something that may not even be applesauce.
But we are– this is a very high priority for us and we are investigating aggressively. I hope we have our arms around this.
Again, we’re working with our state partners to dog this wherever it goes.
And ultimately I think it would be useful to do a retrospective gold wash around lessons learned. I think you can always learn from these experiences.
But I think that that we’ve been aggressive and responsive, but like I said, we’re not the ones who introduced this into the food supply. And so, you know, our ability to be a hundred percent confident around exactly where it is– that’s just a lot of leg work and investigative work and partnering, and we’re trying to do all of those things and, and hoping we can get this thing wrapped up quickly, meaning out of the foods supply.
Rahul Gupta, White House [00:08:20]
Overdose deaths have flattened in 2022 and 2023, after sharp increases from 2019 to 2021.
Now that’s progress and it is important to recognize that, but we still have a long way to go. And today’s data underscores this point.
The bottom line is that we’re dealing with a historic and unprecedented epidemic and it requires historic and unprecedented funding to match this scale, and President Biden’s supplemental funding request will help us get there.
The president is calling on Congress to devote new funding to this effort, including more than 1.5 billion to strengthen addiction, treatment, overdose prevention, measures, and recovery support services, and 1.2 billion to counter fentanyl trafficking.
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Rahul Gupta, White House [00:10:23]
This is that this is not a red state or a blue state issue. It’s America’s issue.
And that is why it’s part of President Biden’s bipartisan unity agenda for the nation.
And it is time for Congress to come together and to find common ground to save American lives.
48 million Americans across every state are counting on them.
As both the nations drug policy director, and a doctor who has delivered addiction care firsthand, I am calling on Congress to act immediately.
Congress must pass President Biden’s funding request to help save American lives. The American people deserve no less.
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Miriam Delphin-Rittmon, SAMHSA [00:16:31]
Also of note, this year’s survey contains new data detailing modes of marijuana use and information about illegally made fentanyl.
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Senior Administration Official [00:26:17]
There are many variables within the current NSDUH that can be compared to 2021 data.
We will be doing follow ups or short reports and analysis to look at some of that. So there are many variables that can be compared. There’s some variables that can’t be compared because of the way that the variable was updated and defined. But by and large, many of the variables can be compared.
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Senior Administration Official [00:26:54]
We are unable to compare substance use treatments, mental health treatments, nicotine vaping, and marijuana vaping from 2021 to 2022, because of changes in the survey and methods, modules that they’re in.
And in terms of some of the early estimates that we’re seeing between the two that are a little different, we see that marijuana use and marijuana use disorder is up from 2021 to 2022. And we also have seen that something that we would’ve hoped to have seen gone down, haven’t, such as youth suicidality.
Those are some early findings, and we really do look forward to sharing more.
The detailed tables that we’ll release with our national report later on today will re-release 2021 estimates. And those are the estimates that should be used from comparing 2021 to 2022.
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Senior Administration Official [00:28:02]
So unfortunately with two years of data, we can’t talk about trends yet. It’s a little early, but we definitely plan to when we accumulate more years of data, go back to looking at those trends. But until then, we will do these comparisons let people know how we are faring from year to year.
Collette Fitzgerald, CDC [00:15:55]
It’s important to point point out one other development at the agency since the last CLIAC meeting.
In May 2023, CDC lost approximately 1.3 billion in funding as a result of the American Rescue Plan recission, which impacted many different agencies in the U.S. government. The rescission, which involved funds at CDC that have not yet been specifically obligated, affects programs across CDC and the agency is reassessing priorities and focus to make the greatest impact on our mission.
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Collette Fitzgerald, CDC [00:32:57]
In light of the recent American Rescue Plan funding recission, DLS is committed to helping the One Lab initiative thrive, despite a loss of approximately 27 million dollars in funding.
This change will limit the number of new training resources that CDC can produce each year. It is also uncertain whether CDC will be able to fund year three of the One Lab cooperative agreement with external recipient partners.
So the next phase of One Lab will center on reprioritization.
DLS also lost approximately 127 million in rescinded funding related to the career pathways in public health laboratory science internship and fellowship program, that is primarily funded through our cooperative agreement with APHL.
DLS successfully obligated enough funding to the cooperative agreement to keep the career pathways program moving forward, but related workforce development activities were hampered and reprioritization is ongoing.
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Tim Stenzel, FDA [01:05:26]
So, we’ve been working hard internally and with external stakeholders at the FDA to work towards ways to address the current epidemic of overdoses. There are more than one drug. Fentanyl is one of the most important ones that has led to an excess cause of death. And we’re happy here to, this is a fully at home performed test, with results in five minutes from a urine sample. And we see that there’s a lot of interest in this area, so we expect that additional point of care and at home tests will be available.
Xylazine is a new drug or relatively, we are aware of it, we’re newly aware of xylazine being an important drug. It being primarily used in the veterinary space, but now being cropping up in various locations across the country, there is no current cleared xylazine test, but there appears to be interest. And the FDA is very interested in authorizing these tests as well.
Beth Bell, ACIP [00:18:49]
There is no chikungunya vaccine ever licensed in the United States or globally, and there are no existing ACIP chikungunya vaccine recommendations.
The chikungunya vaccine’s work group is developing policy options for ACIP consideration for use of chikungunya vaccine among U.S. persons at risk of chikungunya, including travelers, laboratory workers, and residents of U.S. territories and states with, or at risk of, transmission.
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Beth Bell, ACIP [00:20:58]
There will not be a vote today. The anticipated vote will be at the February 2024 ACIP meeting if the vaccine is licensed in the interim.
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Susan Hills, CDC [00:22:36]
Chikingunya is caused by Chikungunya virus, which is an alpha virus.
The mosquitoes that spread the virus to humans are Aedes Stegomyia species mosquitoes, primarily Aedes aegypti and Aedes albopictus.
And in addition to mosquito borne transmission, other uncommon modes of chikungunya virus transmission include through exposure to the virus in the laboratory, intrauterine and intrapartum transmission, and bloodborne transmission through needle stick injury.
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Susan Hills, CDC [00:23:07]
Chikungunya virus occurs in tropical and subtropical regions, as you can see on the map on the right, that shows areas with current or past transmission of chikungunya virus, and it has caused large outbreaks throughout most parts of the world.
Attack rates in outbreaks are often high with one third to three quarters of the population affected.
Clinical illness is characterized by the acute onset of fever and polyarthralgia, which is often severe and can be debilitating. Although serious complications can occur such as neurological illness, myocarditis, or hepatic renal disease. They’re rare, and mortality is less than 1%.
In the absence of specific antiviral treatment, the approach to management typically involves rest, fluids, and use of analgesics and antipyretics.
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Susan Hills, CDC [00:24:33]
The chikungunya vaccine is a live attenuated vaccine and is manufactured by Valneva.
It has a single dose primary schedule and initial licensure will be for adults aged 18 years and older.
The vaccine is currently under consideration by FDA and is not yet licensed anywhere in the world.
There are currently no existing vaccine recommendations from ACIP or other vaccine advisory groups around the world.
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Susan Hills, CDC [00:25:48]
Chikungunya is of public health importance globally with hundreds of thousands of cases reported annually. And with a particular concern when outbreaks occur, because they can have substantial consequences related to morbidity and also impact on health services.
However, for U.S. persons traveling to areas with transmission, the risk and therefore public health importance is variable, as transmission varies substantially from location to location and from year to year.
Although there is likely substantial under diagnosis, about 100 to 200 chikungunya cases are reported annually among U.S. travelers.
The greatest risk for travelers is when outbreaks occur.
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Susan Hills, CDC [00:27:49]
Of note, there were no efficacy data. And this approach for vaccine licensure would’ve been logistically very challenging because outbreaks are unpredictable and their duration can be relatively short.
In the absence of efficacy data, we reviewed immunogenicity data. However, there is no correlate of protection.
In considering the data we noted that the approach being used for licensure of the vaccine is through the accelerated approval pathway. With this approach, demonstration of effectiveness is based on clinical trials, showing the vaccine has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
There is a post licensure requirement for vaccine effectiveness studies to confirm the clinical benefit in the clinical trials. The marker of protection used was based on a neutralizing antibody titer estimated from a validated non-human primate model.
There were two studies providing evidence for short term protection from disease after vaccination, one randomized controlled trial and one lot to lot consistency study that did not include a placebo group.
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Susan Hills, CDC [00:29:01]
There were a total of 622 subjects in the two studies, and their seroresponse at 28 days after vaccination was at least 98% in both studies.
None of the 96 subjects in the placebo arm of the randomized controlled trial had a seroresponse.
The evidence used to evaluate long-term protection after vaccination was from one study, which included 360 subjects at 12 months after a single dose of vaccine, a seroresponse was detected in 99% of subjects.
Based on these data, we considered the desirable anticipated effects were large.
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Susan Hills, CDC [00:33:02]
So overall for these five outcomes, the only event where an arthralgia or arthritis outcome was reported at a significantly higher rate in the vaccinated group compared with the placebo group, was any arthralgia within 10 days of vaccination.
However, in assessing these outcomes, the work group noted that the number of subjects in included in the studies was too low to adequately assess potentially rare events like severe or persistent arthralgia, arthritis, or new onset or worsening osteoarthritis.
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Susan Hills, CDC [00:33:56]
The work group noted that there were high seroresponse rates through at least one year after vaccination and no serious safety concerns identified in the clinical trials that have been performed to date, that included approximately 3,500 vaccinated individuals.
In addition, vaccination can prevent a disease that can result in severe arthralgia during acute illness, rare, serious complications, and sometimes long term arthralgia.
However, we noted that healthcare providers should discuss the desirable and undesirable effects with individual travelers in the context of the disease risk at their destination, their activities and personal factors, such as age and underlying medical conditions.
As with any vaccine rare, serious adverse events can occur. And for some travelers, even a low probability of a serious adverse event might be higher than their disease risk. So vaccination should be targeted to travelers at higher risks for disease.
Overall, the work group determined that the risk benefit assessment will vary substantially and inversely with transmission intensity and other factors, and is favorable if the vaccine is used in line with our proposed recommendations.
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Susan Hills, CDC [00:35:24]
The overall certainty of evidence for short term and long term protection after vaccination was low.
Certainty was downgraded based on very serious indirectness because the likelihood of protection from disease was based on immunogenicity data in the absence of vaccine efficacy data. There’s no established correlate of protection and demonstration of effectiveness for vaccine licensure was based on a surrogate endpoint, reasonably likely to predict clinical benefit, and results will require post licensure vaccine effectiveness studies to confirm the results.
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Susan Hills, CDC [00:41:35]
A cost effectiveness analysis for chikungunya vaccination of travelers has not been conducted.
Most travel vaccines are not cost effective. And chikungunya vaccine for travelers is not likely to be cost effective because a number of U.S. travelers needed to be vaccinated to prevent one case is high.
However, the work group noted that cost effectiveness considerations are less relevant for a travel vaccine because the decision on vaccination is for an individual traveler and not being made for the population. So broad resource allocation decisions are not being made.
And because the vaccine is typically paid for by the traveler themselves, and it’s often not covered by insurance.
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Susan Hills, CDC [00:45:30]
Our draft recommendations for the live attenuated vaccine currently under consideration by the FDA for licensure are that chikungunya vaccine is recommended for persons age 18 years and older traveling to a country or territory where there is a chikungunya outbreak.
In addition, chikungunya vaccine may be considered for the following persons traveling to a country or territory without an outbreak, but with evidence of chikungunya virus transmission among humans within the last five years.
The groups are older persons, for example, are older than 65 years. Particularly those with underlying medical conditions who are likely to have at least moderate exposure to mosquitoes and persons staying for a cumulative period of six months or more during a two year period.
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Susan Hills, CDC [00:44:03]
One topic the work group discussed was that disease risk is highest during outbreaks and vaccination will be of most benefit for travelers during an outbreak.
However, a challenge might be a delay in awareness of an outbreak with travelers potentially exposed during high risk periods in the early stages of an outbreak. To address this as best as possible, CDC will post information on outbreaks on the CDC website as soon as we become aware of outbreaks.
Although we discussed this as a challenge, most of the work group members did not think it would be appropriate to address the issue by recommending vaccination to every traveler, traveling to any destination with risk of chikungunya, because there would likely be an adverse risk benefit assessment given the variable and often very low risk for travelers, and because of the substantial differential between risk during outbreaks and at other times.
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Susan Hills, CDC [00:46:43]
There was a large outbreak of chikungunya in Paraguay during 2023.
On the left, you’ll see a graph that shows that among all U.S. travelers to destinations with risk of chikungunya, fewer than 1% traveled to Paraguay.
However, on the graph on the right, you’ll see that among all U.S. traveler chikungunya cases reported to date during 2023, 26% of them, or 18 of 69 cases have been among persons who traveled to Paraguay.
These data clearly demonstrate the substantially higher risk for travelers during an outbreak.
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Ellen Shannon, Valneva [01:03:04]
I can comment on the price question. We do expect that the price of the vaccine will be in line with the other travel vaccines on the market.
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Katrin Dubischar, Valneva [01:03:33]
We have actually, uh, generated some additional immunogenicity data in older adults, where the sample goes up to roughly above a hundred.
We continue to see very high seroresponse rates that do not differ from younger adults.
And, in terms of the population that was studied, I can just support the answer that Dr. Hills gave, that the study population was a generally healthy adult population, but that we included also participants with underlying diseases for long as those were stable or controlled.
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Ellen Shannon, Valneva [01:04:37]
We are going to be in line with a previous presentation by Dr Hills.
She had presented into the ACIP in June, and it was in the range of her analysis, approximately $350 cost to the patient, or in that vicinity, slightly less.
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Susan Hills, CDC [01:10:20]
Our draft recommendation for ACIP members consideration is chikungunya vaccination is recommended for laboratory workers with a potential for exposure to chikungunya virus.
The recommendations will be presented with additional text to provide clear information for implementation, including noting that a local institutional biosafety committee should undertake a risk assessment of a potential for exposure to chikungunya virus for each laboratory worker working with the virus, considering the type of work to be performed and the biosafety level at which work will be conducted.
And the vaccination is not necessary for workers handling routine clinical samples who should routinely use standard practices for handling patient samples.
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Susan Hills, CDC [01:12:30]
So you are correct that it takes just one mosquito bite, but it needs to be an infected mosquito. And, what we do see is that there are millions of travelers to areas with the risk for chikungunya virus transmission each year. And we really only see 100 to 200, as I said, reported cases this year. We’ve seen about 70 cases of chikungunya virus transmission.
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Susan Hills, CDC [01:13:50]
So we are trying to weigh up that and we didn’t really want to specify the location either, just because the Aedes aegypti mosquito is a very domestic mosquito, so it can be found around homes, it breeds in containers, like flower– vases, the base of flower pots, and trash that’s lying around.
So it can be very high intensity in urban areas, unlike some of our other diseases like Japanese encephalitis, for example, that are more a risk in rural areas. So, we– that’s sort of the thinking the work group went through to get to our traveler recommendations.
Kevin Chatham-Stephens, CDC [00:06:51]
Really the potential for limited nirsevimab availability should be considered when deciding on maternal RSV vaccination or nirsevimab.
And we do understand that there have been reports of some access and other issues with the maternal RSV vaccine. And we’re actively looking into that as well.
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Kevin Chatham-Stephens, CDC [00:09:14]
Although the VFC operations guide and this addendum reiterated previous and longstanding policy for bidirectional borrowing, it is likely not practical and not feasible to allow borrowing during times of supply constraints.
So while there are supply constraints for nirsevimab, VFC supply stocks should remain prioritized for VFC eligible children, and we strongly recommend that health departments take into consideration the supply in their jurisdiction and use their borrowing provisions for nirsevimab with caution, prioritizing supply for VFC eligible children while supply constraints exist.
And please note that some state immunization programs don’t allow borrowing.
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Ayanna Santos, Sanofi [00:14:26]
What we’ve seen since we started shipping at the end of September is that the level of demand has been higher and faster than what we anticipated based on innovative pediatric immunization launches in our recent history.
So specifically for the 100 milligram dose, the demand exceeded the supply that would’ve been available for the whole season within just weeks of shipping.
And now, due to the demand for the 50 milligram dose, we’re carefully managing the distribution in the private market to fulfill existing orders and to provide equitable access to the remaining doses.
So we are still shipping both doses right now in the private market to fulfill those existing orders, and we will continue to do so through November and December. New ordering has stopped for both doses.
However, for the 50 milligram dose, we will resume ordering through our direct ordering platform for limited allocation on November 16th.
We will be reaching out to providers regarding any pending shipments and then the potential for limited allocation for the– towards the end of this year.
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Ayanna Santos, Sanofi [00:23:14]
We are working very closely with AstraZeneca, our alliance partner, who’s in charge of manufacturing to identify any opportunities that exist to bring additional doses for this season.
As you may know, it’s a very long cycle for manufacturing monoclonal antibodies to bring doses to the market, but we are working together with them as well as with the CDC and the FDA to identify any opportunities there.
So we will definitely notify the AAP and the community here at large, that if there’s anything that changes, when, if more doses can become available.
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Question [00:30:16]
If we have a supply of nirsevimab in our clinics or our hospitals, should we focus on administering it all now, or should some be saved until we’re further along in the season?
Meredith McMorrow, CDC
So I would recommend, we give all available doses to eligible infants now.
RSV season has clearly started in the U.S. It’s approaching peak levels in some regions particularly here in the southeast, where CDC is located, and nationally, it typically peaks in December and January.
As you’ve heard from the manufacturer, there will be additional doses that are being delivered through both the private sector and through our colleagues through the VFC and the public sector.
And so we just want to make sure that it’s really important to get as many of these doses out and into children.
It’s important that our high risk infants are prioritized, and that we have controls in place to make sure that those providers that won’t get additional orders are able to protect their populations, but we also need to recognize that infants that are gonna be born later in the season will have the opportunity to be protected by maternal vaccination as well, and that it’s really important to encourage pregnant people who are between 32 and 36 weeks gestation to receive the RSV vaccine.
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Meredith McMorrow, CDC [00:33:14]
So there are multiple factors that determine an infants immunity after infection with RSV, and therefore we normally wouldn’t use just infection status to determine whether or not they should receive nirsevimab, if we had an adequate supply.
But given this current situation of limited supply, I think it would be reasonable, and we’ve talked to our colleagues at the AAP COID, and they concur, that we should we should consider limiting nirsevimab in children who have already tested positive for RSV as their risk of lower respiratory tract infection with a second or subsequent RSV infection is much lower.
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Kevin Chatham-Stephens, CDC [00:45:20]
So we’re getting data in a variety of ways, and I’ll kind of highlight a couple of them.
One is through the national immunization survey, you may have heard of this before. It was– it’s been something that we use quite frequently to report out COVID 19 vaccine coverage amongst other vaccines. So this– this survey asks questions about both receipt and intent to receive RSV vaccine among pregnant persons, as well as ask mothers of infants under eight months, if the child has received nirsevimab, or if the parents intend for the baby to receive nirsevimab.
So in both cases they’re asking about, has the person gotten the vaccine, or do they intend to get the vaccine? So lots of greater information there.
The sample sizes for these to date are small, and it may take several months for the data to accrue to provide meaningful results, that can be posted online, but we are tracking those data for sure.
In addition, in a national survey of pregnant pregnant persons that’s scheduled for April of next year, so April 2024, we’ll include some questions about maternal RSV vaccination, as well as an intent for the child to receive nirsevimab as well. So once again, trying to get at both the maternal vaccine and nirsevimab.
And then we’re also conducting focus groups of pregnant people, as well as interviews of healthcare providers who take care of pregnant people to really assess knowledge, attitudes, behaviors, and practices regarding vaccination during pregnancy.
And then finally with a variety of different partners, we’re working to get kind of informal feedback from folks out in the field, folks who are boots on the ground, who are dealing with these issues day in day out once again, so we can keep our pulse on this topic and find out some solutions.
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Manisha Patel, CDC [00:50:11]
One is that the there’s no supply issue with maternal RSV vaccine. Like there are vaccines, and again, this is Pfizer, it’s not the GSK vaccine, right? So we’re talking about Abrysvo, not Arexvy.
But as we know, as we move through implementation, there are challenges. It’s an expensive vaccine, and so some OB GYN providers don’t carry it, because it is expensive. At the pharmacy side, some states need to have prescriptions for it.
So I mentioned a couple of these barriers because it’s absolutely accurate that there are barriers also for maternal RSV vaccine, but we’re working very closely with our pharmacy partners as well as ACOG, ABOG, other OBGYN, AAFP for example, to help understand what those recommendations should be.
Answers below:
How many cases have been reported to the department, if any? 1
Are you aware if any were hospitalized in the state? The individual was not hospitalized
Do you know which brand (e.g. Wanabana or another label) was consumed? Wanabana
Question [00:19:34]
We are a couple that are over 65. We are going to be traveling in December. We received our flu shot in September. We received our RSV shot at the end of October. We received our what’s the next one again– COVID? COVID, thank you. COVID was this past week.
My question is we are going to Las Vegas where obviously there are large crowds, large venues if we go into theaters, we’re traveling on a plane. Should we be wearing masks as well while we are traveling to Vegas, home from Vegas, six hour flights, roughly five, six hour flights?
Mandy Cohen, CDC [00:20:28]
Good, wonderful question. But first let me say very well done. You’ve gotten all three of those vaccines, so you’re protected going into the season, but we know that is one layer of protection.
The good news is we have multiple ways in which we can continue to protect ourselves from these viruses. Certainly vaccine is a strong thing you can do ahead of the season. It builds up antibodies, but particularly depending on your age and your underlying health conditions, you may want to layer on additional things that help protect you from getting sick.
And remember, these vaccines are meant to stop the worst of what this virus could bring, meaning hospitalization or death. It doesn’t necessarily protect you from getting it in the first place, but there are additional things we can do to even prevent us to try not to get the virus.
You mentioned masks, that is absolutely a tool that works. Masks do work to protect you from being able to– to protect you from circulating viruses that are in the air.
I would also say, make sure, and it’s hard, particularly when we have a planned trip, stay home if you are sick and it’s important, if you do feel sick, get tested.
And the reason you want to get tested is because we have treatments for flu for COVID and you want to get those treatments right away, because like vaccines that can save your life, treatment also can save your life.
So on your trip to Las Vegas, I would take some rapid tests with you. You can order them for free from COVID test.gov. You can order them right now, because if you do come down being sick, I’d want you to get tested right away so you would know, should you go go to urgent care and get treated, because that could save your life as well.
So all of these things, testing treatment, masks, and I’d say improved ventilation so while you’re in Las Vegas, the weather is nicer there, get outside, right? Those are ways in which you can reduce– doing activities outside, reducing your risk of virus spread.
So in particularly the older you are, or the more underlying medical conditions, you’re at higher risk. So the higher risk you’re at, the more of these layers you want to add on: vaccines, testing, treatment, masks, ventilation, right?
So all of these– don’t forget washing your hands, all of these matter to protecting yourself, and you want layer as many as you can cause one, you don’t want to be sick on your vacation, and then you also don’t want it to give it to others.
So if we use all of these tools, you’re going to be doing great.
Demetre Daskalakis, CDC [00:05:18]
So I’ll start by saying that we are in a very different place this year than we’ve ever been in terms of how we can approach these three viruses. There are more ways than ever that we can use to protect our health.
So first we have safe and updated vaccines. And so I think everyone’s familiar with the flu vaccine. That’s something that we’re used to every year. We now have an updated COVID 19 vaccine, and I think we’re going to get used to that one, just like we’re used to the flu as something that’s going to happen with some frequency.
And then we also now have new vaccines and other immunizations against RSV, which we’ve never had before.
So along with the vaccines, we also have available and effective treatments for flu and COVID 19.
So important to note, there is no specific treatment for RSV. So in terms of flu and COVID 19, there are drugs called antivirals that reduce the risk of severe illness, hospitalization, and death.
And also there’s some data that with COVID, they even prevent some of the longer term complications that some people experience.
We also have rapid antigen tests. So these tests that are available and can be used at home for COVID can quickly detect COVID 19 so that people can make their own decisions.
And as you may have heard, these tests are also available for free right now through the U.S. government.
And additionally, we have everyday actions, the things that we’ve learned during the pandemic, that we know work.
So covering our coughs and sneezes, always good advice, regardless of the infection to wash your hands, really good advice across all sorts of infections.
Wearing a mask may be right for some people and could be one strategy, having good air quality is right for everyone, and another thing that’s right for everyone is if you’re not feeling well, it’s really good to stay home, because that way you’re able to take care of yourself, but you also prevent some of the opportunities to transmit some of these respiratory viruses to the folks around you.
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Demetre Daskalakis, CDC [00:19:20]
Ideally we recommend getting vaccinated by the end of October, but as evidenced by my current talk, we don’t quit even though October goes away, because flu hasn’t landed.
So as long as there’s flu activity, it’s not too late to get the shot. So if you haven’t gotten the shot or the folks that you represent or counsel or work with, haven’t gotten the shot, it is in fact, perfect timing to get the shot.
And even if flu activity lasts until May or June, which it usually does it, we will sing the same song and say, continue to get vaccinated if you’ve not been vaccinated before. Additionally, though, this is getting a little deeper in the weeds.
Mandy Cohen, CDC [00:03:17]
So I’ve been traveling all around the country. So I’ve been hearing from folks that same thing to say, ‘ugh, isn’t COVID over?’
And unfortunately it is still here with us and still making folks very sick. And the two reasons you want to get the updated COVID vaccine?
One, is this virus has changed, and you want to have the updated protection that matches the current way in which the virus is circulating. So that’s one.
And second, the protection you may have gotten from having COVID before or being vaccinated before decreases over time. So this is the way to boost yourself back up to the most protection, particularly ahead of Thanksgiving, when we know we’re going to travel, we want to protect each other and ourselves in this moment.
So ahead of Thanksgiving, get yourself vaccinated.
Question [00:04:02]
And if we do head into the territory in these holidays, where there is an uptick, should people be masking? You know, when they’re indoors, are we back at that stage?
Mandy Cohen, CDC [00:04:10]
Well, we have many layers of protection.
Obviously we’re talking about vaccines today because ahead of the holiday, that’s what you can do proactively.
Once we get into the season, you want to make sure you’re doing things also like staying home if you’re sick and if you’re sick testing yourself, because remember we have treatments for flu for COVID and treatment could save your life.
And so we want also folks to get those four free tests from the federal government, you can go to COVID test.gov and get tests right now.
But yes, then there are other layers of protection that we’ve known and used: washing your hands, opening a window, gathering outside, and yes, masks do work.
The FDA became aware of this issue and worked quickly to alert healthcare providers via a safety communication and other outreach to ensure those administering the vaccine were aware. We’re actively working with Moderna to communicate with healthcare providers to ensure the correct dosage of vaccine is administered in individuals 6 months through 11 years of age.
The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine.
…
It wasn’t clear to me how FDA identified that this dosing error was occurring.
The FDA received questions from stakeholders about the dosing issue on October 29, and contacted Moderna to discuss and better understand the issue. The agency has worked quickly to alert healthcare providers through safety communications and other outreach to ensure the correct dosage of the vaccine is administered to recipients. We will continue to provide any updates necessary to ensure the health and safety of the public.
Also, is it still accurate that “no serious adverse events were identified related to a dosing error for the vaccine”?
The FDA has reviewed reports to the Vaccine Adverse Event Reporting System (VAERS) regarding this issue. No serious adverse events were identified related to a dosing error for the vaccine. We received reports of mild adverse events consistent with safety profile of the vaccine, such as fever and fatigue.
| Week ending | RSV | Difference |
|---|---|---|
| 9/16/23 | 1290 | 45 |
| 9/23/23 | 1949 | 659 |
| 9/30/23 | 2514 | 565 |
| 10/7/23 | 3424 | 910 |
| 10/14/23 | 4373 | 949 |
| 10/21/23 | 5756 | 1383 |
| 10/28/23 | 7339 | 1583 |
| 11/4/23 | 7671 | 332 |
Robert Califf, FDA [01:30:58]
I’ll make one final point. This is a really delicate one that you all have alluded to, and it gets to the very nature of how, whether, and when we can respond to false claims and attacks on our work and activities.
As the report accurately points out, misleading information that tends to more often be sensational or emotional, often gets more attention than straightforward factual information. It also tends to spread faster.
Mark Twain is often quoted and I’m not sure he was the one that really said this, but the old quote, a lie travels around the globe while the truth is still putting on its shoes.
There’s another related issue, which is that the actions taken by the parties who are attacking and undermining our societal institutions like FDA can often prevent us from doing our job by putting limits on what we can say. You all have alluded to this. It’s a very delicate issue.
And clearly, I want to be clear, does not include suppressing other people’s right to speak. We’re not in that. We don’t do that. And it’s not part of our activity.
But where do we go from here?
We got to develop better and new and better ways to cut through and counter the misinformation and disinformation so we can meet our responsibilities and provide the public with the knowledge it needs to make informed decisions about health.
While this report is not an examination per se of the FDA’s work in this area, it does offer a number of options that we will take seriously and build upon, what we’re already doing to strengthen our response and help ensure we continue to be a trusted, reliable voice that can cut through the noise.
There’s some who would say the problem is far too big for us to respond to. And those who are committed to undermining science or diminishing trust in government scientific institutions are too numerous and too well financed to overcome.
I won’t deny this as enormous challenge and can seem perplexing at every turn. It feels like a hydra, that mythical multi-headed serpent who would grow a new head every time one was chopped off, but it’s essential that we try not just for the working reputation of the FDA, but the very health of our nation.
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Robert Califf, FDA [01:33:23]
This is a challenge that goes to the structural foundation of our society. And it’s a job far too big for anyone agency to take on, but we got to respond.
And I actually, every day right down now, as I think about this problem, a very simple statement that’s attributed to George Moore, a winner is a loser who tried one more time.
I would argue right now, we’re not winning this battle, but with people like you, if we keep trying, we’re going to figure it out.
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Robert Califf, FDA [01:36:59]
We have a deficit that is a special one at the FDA, is that often we have information which by law we cannot reveal.
And, one thing for sure about people that work at FDA, they follow the law. We have– we work by a rule book.
And, so there are times when we have information that literally it’s illegal for us to reveal it.
Now, I personally believe that this has gone too far, that we need to work with Congress and fix some of the laws so that there can be more transparency.
You know, I always hearken back to clinical trials.gov. I was a clinical trialist for most of my career, and it never made sense to me that human experiments should be considered proprietary, commercially protected information by companies.
You got to do an experiment on human beings? That should be publicly available.
Now that’s a law and it is publicly available, but we can’t break the law.
And the second part of this, which is– really makes our lives very difficult is that we often know about a decision we’re going to make, and I’ve heard you all say, it’ll be better to know ahead of time, but it’s illegal for us to reveal that decision until the moment we do it because many of our decisions affect stock prices.
And we have to reveal all the information to everyone at the same time. We can’t even reveal it to the people that let’s say work for the company that’s going to be involved.
And so considering all these things, it’s a challenge, but I think it’s plain language.
Dylan George, CDC [00:07:42]
For example, with the fall respiratory season coming forward, we have put out an outlook of what should we expect in terms of hospital burden for all of the major pathogens that are creating a respiratory disease going forward.
We have really tried to make a strong effort in talking to our state and local colleagues so that they are aware of what we’re putting out before we put it out.
And then also very importantly, getting feedback from them on that assessment and how it’s affecting them in their local jurisdiction in different ways.
For example, I was talking with a state health official two weeks ago about our assessment and she was telling me that it was exceptionally helpful for her then to take that assessment and go talk to the hospitals in her jurisdiction and have a really targeted discussion of, are you prepared for that level of hospitalization? If not, what can we do to help going forward?
And so that gives a scenario planning factor of what is the level we potentially could expect going forward, and then people can plan accordingly.
So people have been using this information to have very targeted conversations about, are we ready or are we not ready?
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Dylan George, CDC [00:09:46]
It’s been interesting as we’ve been reporting out on that assessment, essentially the assessment is we anticipate that there’s going to be more hospitalizations than what we saw pre pandemic. And we also anticipate that there’s gonna be some hospitalizations on the level of what we experienced last year, but about on that same order of magnitude.
And the interesting thing about that assessment is we’ve been talking particularly with our state and local jurisdiction and partners, is that it’s the realization that we’ve got three major pathogens now, whereas we had two before and everybody kind of intuitively understood that, but it’s all of a sudden now it’s like, once you state it and put it down on a piece of paper, it’s like– it really became visceral for folks.
It’s like, oh my gosh, we do need to start thinking about how to prepare for it much more effectively.
And then as we pointed out in our assessment, even a moderate level of COVID added to influenza and RSV is going to cause more stress than severe situations where we had severe flu and RSV combined before.
We need to be thinking about this, even with a moderate level of COVID circulating and causing hospitalizations, we’re going to have to shift into a new gear in terms of preparedness for how we’re actually doing this year on year.
Now I will be the first one to admit that whether or not COVID is seasonal, whether or not we’re gonna have the same level every year, that’s an open science question.
Pragmatically though, until we see otherwise, we should be prepared that it will be a seasonal disease going forward. Like I said, I will be the first one to admit it’s an open question, scientifically, whether or not it will be, or it won’t be.
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Dylan George, CDC [00:23:49]
On the seventh, we’re going to come together as all of representatives from all of the networks on a kickoff meeting, they’re gonna be here in DC that we’re gonna be talking about this and showing an opportunity for everybody to be face to face with everyone, meet everyone for the first time, and then to discuss what we’re gonna be doing across the network to try to come to a more synthetic whole of what we’re gonna be going forward.
Then on the eighth, we’re going to be talking on the Hill with what we’re trying to accomplish and making sure that our partners in the Hill that have appropriated dollars to actually make this happen are aware of what their dollars are going towards and to show who and where and what we’re building in this network going forward.
Robert Califf, FDA [00:15:04]
Although I know traditionally this meeting has been focused on cures with new therapies, I’m all for that. I’m proud of the fact that ever in the world I go, people say the FDA is the best, the U.S. is far and away the leader in innovation, we don’t want to back off on that at all.
But I would argue that the phase 1, 2, 3, and variations of it that we use to move things along, it works pretty darn well, but when things go on the market, we have no system to generate the evidence that we need to know what to do.
So we have all these questions that are left on the table, like what, which is better? What really is the right dose? What are the subpopulations where the benefits really outweigh the risk? How do we combine the therapies? How long should we give it? None of those questions are answered for almost all drugs that or devices that come on the market, approved by the FDA.
The FDA is tasked by law with saying this is safe and effective for a particular indication in a particular population. That’s what you need to prove. Then the label gets written and we need an evidence generation system for the postmarket phase.
But of course that’s not the FDA’s primary mission. And so that will take a ecosystem and a community, which I know is something that you’ve been working on.
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Robert Califf, FDA [00:16:53]
The FDA has a primary role in nutrition. I’ve become– I’ve been reading a lot about ultra processed foods.
There’s an argument going on the FDA doesn’t act in something like this unless there’s definitive evidence, but I would argue for things like nutrition, that same evidence generation system that would be good for post market drugs, let me just throw in dietary supplements into that, if you could do these studies at a low cost and get the answers, we’d know what to do.
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Robert Califf, FDA [00:18:52]
I’ve sort of been waiting on Monica to get confirmed.
You know that we’ve worked together and gotten to know each other well.
I’ve got a little brother with cancer right now. She’s been a tremendous personal help. And so I’ve been able to see the heart and grit that she has.
I think, to be a cancer surgeon, you sort of have to be tough.
…
Robert Califf, FDA [00:19:30]
We need to generate that evidence and we all need to play a role like, what are the little things CMS can do on a grand scale to encourage clinicians to participate in research? What are things NIH can do to change its portfolio just enough that our mammoth academic medical centers pay more attention to the kinds of clinical studies that really make a difference for health outcomes?
And then across the board, you know, you’ve worked on this, the use of AI and virtual methodologies to reach people who right now are have a hard time getting to the clinic or the research clinic to generate that evidence.
So I think we’ve got to have that target and we all need to be focused on it.
We’re doing a little exercise now.
I think if you looked in sum at what all the federal agencies and all the voluntary agencies and foundations are putting into what I would call the postmarket system, it’s a lot of money, but it’s not directed towards a common goal or a system.
…
Robert Califf, FDA [00:22:31]
I know we have a limited time. We could talk about this for a long time.
Number one, we have to up our game at the FDA in terms of speaking to people in playing English or Spanish or whatever language that they can understand, rather than speaking in the way we’re used to speaking in the past, which is speaking to doctors or the industries that we regulate.
People don’t understand well what the FDA does. So we’ll do that to the best we possibly can. And there’s a Reagan Udall foundation report. I would refer people to that just came out, that lays that out.
But then we’ve got a really depend on non-government entities to pick up their game too.
I think– I’m not defeatist. We’re going to keep trying within FDA and within government.
But the reality is that the misinformation purveyors are at it 24 by 7.
We have jobs to do, our communication budget is very limited, we have great communication people who are here, but there’re just a few of them relative to the vast expanse of the internet out there.
So we need consortia out in the real world, universities, medical centers, industry, voluntary foundations, to create a network that’s devoted to promoting the truth.
The third thing I’d say is I do think that I’m swung over now that fighting misinformation is actually probably going to be an unsuccessful strategy.
But one thing I learned in my work at Alphabet, I think I learned this correctly, the biggest single factor is just how much people hear of one part of it.
So the example I’ll use, if we put out one press release, that may have a huge impact on the industry, the stock price, whatever, but what the public is hearing is 24 by 7 counter messaging.
And so that means you got to have the share of that voice reaching people in the way they’re used to getting information, if you’re going to change it and gain trust.
And so that network that’s involved needs to be very personal. It needs to be in the community, interacting with people in a way that they can best receive information.
In close collaboration with FDA, we have taken measures to create awareness of the potential for counterfeit products. We have developed a company press statement that is posted on our U.S. corporate website and includes a guide for identifying counterfeits. We have provided communications to a number of stakeholders, including wholesalers and pharmacists to ensure they are aware of the situation and also able to identify a potential counterfeit semaglutide injectable product. We are also making semaglutide.com available as a resource hub for US consumers, healthcare providers and retailers to provide information about responsible use of semaglutide, including how to recognize a counterfeit product.
At this time, the FDA has no new information to share regarding reports of adverse events related to counterfeit semaglutide.
The FDA will investigate any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats.
While we understand certain drugs are in short supply and patients are having difficulty obtaining their medication, the FDA urges patients to obtain prescription drugs only from state-licensed pharmacies that are located in the U.S., where the FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. FDA’s BeSafeRx campaign helps consumers learn about how to safely buy prescription medicines online. FDA recommends patients to talk to their doctor if they have questions about their medicines.
We also continue to raise awareness among consumers and healthcare professionals about the dangers of counterfeit drugs: Counterfeit Medicine FDA.
Statement by National Pork Producers Council on Carbadox:
Carbadox has been safely used for over 45 years in the United States. It is a vital product to treat gastrointestinal disease (swine dysentery) in young pigs, improving their health and welfare. With few interventions available, Carbadox is essential. It is not considered to be medically important to human medicine and is not a concern for antimicrobial resistance in human pathogens. The sponsor of this product has provided extensive research data to FDA showing the safety of Mecadox. NPPC will continue to support the sponsor and advocate for producers’ continued access to critical swine health products.
Debra Houry, CDC [00:01:31]
CDC is urgently calling attention to the need for healthcare providers, public health systems and communities to step up their efforts to address newborn syphilis. These efforts must reach people where they are so that every mother and baby get the support they need to stay healthy.
While the measures we are urging could have a profound effect on many people and families, truly reversing these trends will require increased focus and resources already strained public health systems. And the escalating STI epidemic have brought our nation to a tipping point with newborn syphilis.
Healthcare and public health systems are scrambling to prevent moms and babies from slipping through the cracks any way they can to truly address this epidemic. We need better infrastructure and new tools to prevent STIs.
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Laura Bachmann, CDC [00:04:30]
The reality is the rise in syphilis in the past several years means most of us live in areas that are now considered to have high rates of syphilis among women of reproductive age. This means providers must seize on opportunities to address syphilis before pregnancy, by offering to screen more sexually active women and their partners on a regular basis, as well as continuing to offer testing to people with other risk factors for syphilis.
We also know that overall missed opportunities to prevent newborn syphilis during pregnancy are due to a combination of individual and system level barriers to timely syphilis testing and treatment. These barriers may include lack of ongoing health coverage living in healthcare or maternal care deserts, transportation limitations, challenges posed by substance use disorder, housing, instability, poverty, and racism.
And while newborn syphilis cases are increasing nationwide and across every racial and ethnic group, some communities, including those of people who are Black, Hispanic, and American Indian or Alaska Native are experiencing the brunt of the newborn syphilis epidemic.
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Laura Bachmann, CDC [00:16:18]
We are at the, we have right now the highest number of congenital syphilis cases that we’ve had in more than 30 years. So the number of cases continue to increase. And we’re really at a tipping point now with congenital syphilis.
And that’s again, why we’re bringing attention to the issue through the Vital Signs, as well as some of the additional measures we’re recommending that providers and public health professionals take in the field to address the epidemic.
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Laura Bachmann, CDC [00:19:14]
As you point out, we are in the middle of a Bicillin shortage nationally.
CDC has issued guidance around prioritization of Bicillin for pregnant people.
Just to reiterate, Bicillin is the only recommended treatment for pregnant people. There are alternatives for people who are not pregnant.
And so we have issued guidance to help providers in strategizing around this in areas where they are experiencing shortage. Not every area in the country is experiencing a shortage.
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Robert McDonald, CDC [00:20:38]
The increases that we’re seeing over the past year are continuing the trajectory that we’ve seen over the past 10 years.
So as we’ve seen syphilis going up among women, we’ve seen syphilis going up in babies.
So as long as you’re seeing increases in women having syphilis, you will continue to see the increases of syphilis among babies.
And that is why we’re recommending really looking at geographic risk, when you’re assessing a patient, whether or not they should be tested for syphilis.
…
Robert McDonald, CDC [00:21:11]
As for the Bicillin shortage question, up until this point, we’ve received no reports of anyone who have not been able to get access to Bicillin for treatment during pregnancy.
And so CDC works closely with states to make sure that they can be linked up with Bicillin in the case of someone who was pregnant.
Lael Brainard, White Hous [01:41:22]
Medicare Advantage serves over 30 million American seniors. Medicare advantage brokers and agents are supposed to help seniors find plans that best meet the needs of those seniors. But currently some large Medicare Advantage insurance companies are wooing brokers and agents with lavish perks like cash bonuses and golf trips to incentivize them to steer seniors to those large plans. That’s not right.
Seniors should get the plan that is based on their needs in their best interest. Not based on which plan has the biggest payoff for marketers.
Today’s proposed rule would, if finalized as proposed, tighten limits on broker and agent compensation to make sure seniors get access to the plan that best meets their needs rather than the best perks for the broker.
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Xavier Becerra, HHS [01:45:59]
We’re going to improve Medicare managed care plans by curbing predatory market practices and inappropriate steering that distorts healthy competition among all the different plans. The proposed rule we’re announcing will help people with Medicare select and then enroll in coverage options that best meet their healthcare needs.
This helps close loopholes that allow Medicare managed care plans to inappropriately inflate agents and brokers commissions by adding junk fees.
We are intent on ensuring that Medicare enrollment, the process itself, helps individuals who are searching for a Medicare option that best meets their needs. We don’t need a system that just funnels people into certain insurance plans and further just consolidates the market.
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Chiquita Brooks Lasure, CMS [01:49:20]
Many people with Medicare rely on agents and brokers to help them make the best choice about their healthcare coverage. However, we are concerned that some Medicare Advantage plans are compensating agents and brokers in a way that may circumvent existing payment rules inappropriately, and anti-competitively, steering people to enroll in plans that do not best meet their needs leading to further consolidation in the Medicare Advantage market.
This is bad for people, bad for consumer choice, and bad for competition.
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Senior Administration Official [01:54:33]
We have had limits in the past on what brokers have been compensated, but there were a number of activities that were outside of compensation. So some of the examples that you heard Lael mentioned were being offered outside of compensation.
So we’re broadening the definition and putting it, those things, under the cap.
The following responses are on background and attributable to the Centers for Medicare & Medicaid Services (CMS) or a CMS spokesperson:
CMS firmly supports a robust biosimilars market and believes that the policies for implementing the Medicare Drug Price Negotiation Program will help support biosimilar entry and price competition.
Sections 11001 and 11002 of the Inflation Reduction Act (IRA) (P.L. 117-169), signed into law on August 16, 2022, established the Medicare Drug Price Negotiation Program (Negotiation Program) to enable Medicare to negotiate maximum fair prices (MFPs) with participating manufacturers for certain high expenditure, single source drugs and biological products. On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the 10 drugs covered under Medicare Part D selected for the first cycle of negotiations, including Stelara. On October 3, 2023, CMS announced that drug companies that manufacture the first 10 drugs selected for the Negotiation Program have chosen to participate in the program, including Janssen Biotech, Inc., the primary manufacturer of Stelara.
On October 31, 2023, Amgen, Inc., received a license from the Food and Drug Administration (FDA) for Wezlana (ustekinumab-auub), a biosimilar biological product for Stelara. The FDA licensure of a biosimilar biological product for Stelara does not, standing alone, change Stelara’s status as a selected drug for the first cycle of negotiations currently. However, CMS has now determined that Wezlana has been licensed using Stelara as the reference product, and CMS will continue to engage in its monthly review process to determine if Amgen, Inc., has engaged in marketing of Wezlana.
If CMS finds that Wezlana is marketed, the timing of that product’s marketing would affect when Stelara is removed from the selected drug list as well as whether or not any agreed-upon MFP would apply (and if so, for how long):
If Wezlana is found to be marketed on or before August 1, 2024, no MFP would apply in 2026, and Stelara would cease to be a selected drug on January 1, 2027. If Wezlana is found to be marketed between August 2, 2024, and March 31, 2026, any agreed-upon MFP would apply in 2026, and Stelara would cease to be a selected drug on January 1, 2027. If Wezlana is found to be marketed between April 1, 2026, and March 31, 2027, any agreed-upon MFP would apply in 2026 and 2027, and Stelara would cease to be a selected drug on January 1, 2028.
During any period in which an MFP for Stelara is not in effect due to licensure and marketing of a biosimilar competitor, the price of Stelara will not be legally constrained by the requirements of the Negotiation Program created by the Inflation Reduction Act.
For more information, please see sections 30 and 70 of the Revised Guidance for Initial Price Applicability Year 2026 published on June 30, 2023.