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CDC can confirm that it has received and tested mosquito specimens from both FL and TX in support of their investigations.
Information on the result of specimens tested at CDC are shared with the states. For additional information on the number of mosquitos sent by the state, results of testing, and locations where mosquitos were collected please contact the state.
So far, all mosquitoes tested have been negative. We generally discuss cases, not suspected, possible or speculative cases.
Please see below from Sarasota County Mosquito Management Services:
Sarasota County Mosquito Management Services sends samples to the CDC weekly. We have sent over 100 Anopheles to the CDC for testing. So far three have come back positive. All three were collected from the same woodlot. Mosquito management has already conducted multiple truck, aerial, backpack treatments in that woodlot to eradicate the Anopheles. Efforts continue to test more Anopheles from all areas of concern as well as treatments.
we are collecting 2x/week since May 23 for a total of 11 shipments. None have been found to be “positive” or infected with malaria/Plasmodium in Manatee County. In addition, we have no humans infected in Manatee County (we are immediately to the north of Sarasota.
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As a point of clarification, within these 11 shipments, there have been approximately 50 individual samples or “pools” submitted. Again …. None have been been found to be positive for malaria in Manatee County.
Peter Marks, FDA [00:05:30]
Now, whether this is an annual formulation where we have an annual vaccine, or whether it will be updated more frequently or less frequently, I think is still something up for discussion. But, I think those of us who are guessing, are guessing that we’ll see, annual updates of this vaccine and that’s kind of the structure that we put forward.
And then the spring, what we did most recently, was decided on what will go into the 2023-2024 formulation of the vaccine in terms of the different, SARS-CoV-2 strains, that’s the virus that causes COVID 19, the strains that will go in and it was decided that we would recommend one of the Omicron subvariants XBB.1.5 which seems to be a very good immunogen against a variety of other COVID causing SARS-CoV-2.
So, this is I think something that we will see now in the fall, we will anticipate that sometime in September, we’ll see these vaccines become available as part of vaccination campaigns.
It will be up to CDC to make recommendations on who receives these, but we would anticipate that they will be either approved or authorized from FDA for the overall population from six months up through all adults.
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Question [00:41:40]
What pharmacies have been contracted with for the bridge program? And I’m not sure how that actually works. Dr. Cha, are they directly contracting through your work? How does that process work?
Stephen Cha, HHS [00:41:55]
Yeah, that’s still a TBD item, that as with all contracting items, until we can say, we can’t say. So, I think we’re working on that now. We’re aware of the need, as Dr. Romero said, about the need for penetration. And so we’re trying to figure out how to get as broad as sweep as possible while working under the contracting tools we have available.
Question [00:42:17]
You’re a small pharmacy, you’re in Bentonville, Arkansas, and you, I just picked Arkansas, Dr.. Romero must be in my mind. And you are interested in the program. Do you contact– do you go on the website? Do you contact the bridge program? How do they get contracts with you all?
Stephen Cha, HHS [00:42:34]
I think we’re trying to put some information out there in the next few weeks.
Question [00:42:38]
Okay. And then once that comes out, we would love to share that with everyone on this webinar. And we’ll share it and we’ll share it with the vaccination collaborative. So as you know, we’ll continue to work with our pharmacy partners to make sure that they’re aware.
Stephen Cha, HHS [00:42:51]
I should also say we’re probably planning to do another one of our large scale webinars. We’ve done a few of these in the past to update on all the information, and that’s why I’m saying next few weeks, timed with that, we’re hoping to put out some more things in black and white that I know are questions on this. But I’m hoping for that in the next few weeks.
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Peter Marks, FDA [00:53:31]
But from everything we’re hearing from the manufacturers, there will be– if somebody wants vaccine, it sounds like there will be plenty of all the different vaccine types that are currently licensed or under EUA available.
Stephen Cha, HHS [00:53:52]
I was just gonna add that. I think the only concern I do have, and I think a concern is overly strong. The thing that we’re trying to watch is the equity issue, to be sure that we know there’s plenty of volume. I want to be sure it’s in the right places. I want to be sure it gets to the right locations. And I want to be sure we’re building on the, I think one of the success that we didn’t talk about this, one of the successes we’ve had in terms of decreasing, certainly the Black White disparity in vaccine equity, I think is something we worked hard on, and we wanna be sure that carries on as we transition and the commercial, this goes to the commercial market that that equity continues.
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Peter Marks, FDA [00:55:29]
Right now we’re in a place where thankfully COVID levels are not really high. I think it’s something to talk to your provider about whether it’s a reasonable thing to get a COVID 19 vaccine now, or just wait until the fall.
As I said, in September, we expect the 2023-2024 formulations to be available, and probably one would want at least two months between getting vaccinations. So we’re getting into the window where it may be, again, talk to your provider, but it may be reasonable to wait until the 2023-2024 formulation is available.
And I do hear, incredibly, thank you for the advice, we do need to keep– we will try to make sure that there are clear recommendations for providers and clear recommendations to the population about what they should be doing.
Natalie Thornburg, CDC [00:09:29]
Since I last talked with you, we’ve changed the cadence of our reporting, and have dropped back to biweekly. So we’re updating it every other week. So we updated last week and then we’ll do it a week and a half from now. And we also changed the bins of– the binning of data. So previously the data had been in weekly bins, and now they’re in biweekly bins.
And the main reason for that is just with continued decreased case counts, we are having decreasing numbers of specimens and in order to remain to maintain power to calculate weighted estimates and to do the Nowcast modeling, which estimates proportions of lineages into the present, it was important to generate those biweekly data bins just for statistical power.
It’s good news though that we’ve had continuing downward and low case count trends since really January of this year. And thus far we’re still maintaining low percent positivity.
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Natalie Thornburg, CDC [00:12:12]
Some of them don’t look like XBB viruses because they have aliases right now, like FE.1.1 or EU.1.1, but alias or nickname are assigned whenever too many numbers are added onto the lineage. So even those that don’t look like XBB viruses, FD.2, EU.1.1, are indeed XBB viruses.
Many of these viruses, actually, even though they descended from different parental lineages, have either very similar or identical spike sequences. So a couple of new lineages were broken out on the data tracker last week. Those include EU.1.1. EU.1.1 is a lineage– is a sub lineage of XBB.1.5, which was the major circulating lineage in the winter. FE.1 is a sublimage of XBB. Its full name is XBB.1.18.1.1. And it contains an additional substitution at residue 456 in spike. And XBB.1.5.68 was also broken out on the data tracker.
And so you can see those three here. They’re predicted to be just above 1% of circulating viruses, about 1% of circulating viruses nationally.
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John Barnes, CDC [00:20:14]
As one additional measure, CDC has been working with clinicians, clinical labs, and state public health labs to increase surveillance of novel influenza A, including H5N1, among people who have had severe respiratory disease in the summer months when influenza circulation is lower and influenza testing may not be as commonplace.
CDC is asking that during these late spring and summer months, influenza A positive samples from ICU that are not typed, subtyped, in the clinical lab, please be submitted to state public health laboratories for subtyping analysis. I should also mention that if you have a BioFire or multi-respiratory panel, like the BioFires panels, and those have no subtype, but are are influenza A positive, those are viruses that we desperately want to see in the public health lab for further analysis.
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Anastasia Litvintseva, CDC [00:38:30]
Diagnostics was slow and challenging and, only on May 28th, the first laboratory in the United States was able to confirm fusarium solani in CSF by metagenomics, that was done by University of California San Francisco. Next slide please.
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Anastasia Litvintseva, CDC [00:40:22]
Unfortunately, there are no cultures as of this moment. All confirmed and most probable cases that were tested with this test had highly elevated beta-D-glucan in the CSF. And there were a couple of confirmations from PCR and metagenomics in the U.S. and Mexico, which all identified fusarium or fusarium solani species DNA in the CSF of these patients. Next slide please.
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Anastasia Litvintseva, CDC [00:42:14]
As far as the laboratory diagnostics of mold meningitis, again, I said it’s challenging and very little is known. Next slide, please.
So the best option is obviously culture. It is a gold standard, having an isolate is really helpful for being able to perform whole genome sequencing, for example, to see whether the Durango and Matamoros outbreaks might have been related. Unfortunately, this case there are, there are no isolates from this outbreak, and overall the sensitivity of culture for fungal meningitis is due to molds, filamentous fungi, is very low. Back in 2012, only 14% of patients were positive by culture.
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Anastasia Litvintseva, CDC [00:43:03]
The best method that we have in our arsenal right now is beta-D-glucan detection, by Fungitell test produced by Cape Cod Associates. This test detects fungal cell wall polysaccharide beta-D-glucan that is present in most fungal cells.
It’s a reasonably common test. It is FDA approved for testing serum. It is not FDA approved for testing cerebrospinal fluid. However, several commercial laboratories are offering BDG testing on CSF. And it was very helpful during the 2012 outbreak, all confirmed cases back in 2012, and to my knowledge, all confirmed and probable cases in this outbreak, are positive by beta-D-glucan in CSF with very high titers.
The limitations of this test is that unfortunately it cannot identify species. All it can tell that whether it’s fungus or not a fungus. Unfortunately, it doesn’t work for all fungi. For example, mucormycosis and a few other fungal groups have different polysaccharide in the cell walls, and therefore it does not work for those fungi, but it does work well for fusarium aspergillus and other molds.
And it’s known to generate false positives as well. Next slide, please.
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Anastasia Litvintseva, CDC [00:44:39]
Our next best option is pan-fungal PCR, which works by amplifying fragments of fungal DNA present in body fluids. And then it’s followed by Sanger sequencing. In the absence of culture, this is a method that can actually identify genus, identify the pathogen down to genus, or sometimes even species complex level. It’s pathogen agnostic. Therefore it can identify multiple fungi present in the specimen. The laboratory that offers clinical testing, by pan-fungal PCR on body fluids, which is located in the University of Washington, they use multiple gene targets to increase sensitivity.
And again, it showed decent sensitivity back in 2012. Initially, the sensitivity of conventional PCR in 2021 meningitis was nearly 30 percent. And then it increased to 40 percent when the assay was converted to a real time format.
It has a few limitations. It’s highly dependent upon the DNA extraction. And for fungal meningitis, DNA extraction is really challenging, because unlike some cases of meningitis, more conventional meningitis, caused by cryptococcus o histoplasma or other yeasts that circulate in cerebrospinal fluid, filamentous fungi do not circulate.
Therefore obtaining this fungal fragments high (inaudible) for extraction is challenging. The best method that works so far is targeting free circulating DNA present in CSF. And that unfortunately requires larger volume of CSF for testing.
Of course, presence of DNA doesn’t always indicate infection. And PCR is highly sensitive to contamination, some results, especially with unusual pathogens can be hard to interpret. Next slide, please.
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Anastasia Litvintseva, CDC [00:46:53]
The newly developed metagenomics next-gen sequencing is a very promising method that unfortunately is only offered by single center in University of California San Francisco. So this method relies on direct sequencing in analysis of DNA.
Again, it may be even more sensitive than pan-fungal– not sensitive. It may be more informative than pan-fungal PCR because it, in many cases, it can identify pathogen down to species level and it’s pathogen agnostic, and it interrogates the entire genome. If pan-fungal PCR relies on specific primers and targets, this method can detect any traces of pathogen’s DNA, and because there’s no amplification, there is lower chance of contamination and higher confidence in the result.
The main drawback of this method, again, high volume of CSF is needed because DNA extraction is really challenging, and it’s a very complex method that’s only available at a single center, right now. Next slide please.
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Anastasia Litvintseva, CDC [00:48:11]
And the final method I wanted to mention is the method that’s only available in Mexico.
Very interestingly, our Mexican colleagues, before this outbreak, already had fusarium specific, real time PCR developed, that specifically can amplify and measure the level of fusarium in body fluids.
It is a commercially available kit in Mexico. It was the first method to detect fusarium solani in this outbreak, and it appears to be sensitive.
The limitations are that it’s, again, only available in Mexico. There is very little we know about this test, including the performance characteristics, and we were not able obtain PCR primers and probe sequences, which appear to be proprietary. Therefore we don’t know how specific this method can be.
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Question [00:49:43]
Wondering if the actual epidural was contaminated.
Anastasia Litvintseva, CDC [00:49:47]
We don’t know this yet. This is a hypothesis, most likely, that the pathogen was injected, it was linked to contaminated medicine, but there is no confirmation yet.
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Anastasia Litvintseva, CDC [00:50:17]
To the best of my knowledge there have been autopsies, the specimens have been sent for culture, unfortunately, there are no positive cultures yet, but in theory it should be possible to culture this organism from tissues, but unfortunately all negative so far.
Matthew Daley, ACIP [01:13:07]
Everyone in the room and on the phone, I think, is probably well aware, on June 15th, 2023, FDA’s Vaccines and Related Biologic Products Advisory Committee or VRBPAC met to discuss strain selection for updating COVID 19 vaccines and came to the following conclusion that, based on the totality of the available evidence presented, the FDA advised manufacturers to develop an updated COVID 19 vaccine with a monovalent XBB.1.5 composition. And by monovalent, it’s just focused on the XBB.1.5, and it would not contain Wuhan strain.
And then there was an anticipation that these updated vaccine doses would be broadly available in the fall. And that following updated vaccine authorizations by the FDA, then the ACIP would convene to review evidence to inform updated recommendations for the use COVID 19 vaccines in the U.S. population.
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Jefferson Jones, CDC [02:07:35]
So this slide shows quantitative antibody data among specimens with detectable antibodies from the pediatric commercial laboratory study on the right, compared with that of previously shown for adults on the left. Both studies used the same quantitative binding antibody assay.
Although the vaccine history is unknown for the children in this study, children age 6 to 23 months were found to have similar antibody levels to those adults who have been previously infected, but unvaccinated, likely because most of these children had also been infected, but unvaccinated.
In contrast, adolescents have similar titers to adults who are vaccinated or have hybrid immunity, likely because many of them are vaccinated and many have hybrid immunity. This may indicate that antibody titers depend more on whether a person is vaccinated or has a history of vaccination than age.
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Ruth Link Gelles, CDC [02:27:38]
It’s become very difficult to measure prior infection in vaccine effectiveness studies. So if you think about the typical person being hospitalized, that’s picked up in one of these studies, they may have had half a dozen prior infections that they did a nasal swab at home and were never reported in their medical record.
And so we’ve done a lot of work in these platforms to look at prior infection, both in the EHR based platforms and in the platforms that actually have an interview and self-report, and we find very similar numbers of prior infections, which is about 15 to 20% with documented prior infection.
We know from the seroprevalence data that that is a huge underestimate. And so, I think because of that, we’ve been very hesitant to try to make conclusions or control for prior infection in our VE studies because it really needs to be treated as a mostly missing variable.
That being said, I mean, I think right now we’re in this context of very high seroprevalence across almost all age groups. And so we really have been interpreting the VE as kind of in the context of the current setting with high seroprevalence. So what can a vaccine do, at the population level, to boost protection beyond existing protection from either prior infection or prior vaccination.
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Megan Wallace, CDC [02:34:35]
The work group also discussed data driven ways to simplify our current recommendations in the future. As demonstrated on this slide, our current pediatric recommendations for initial vaccination are complex, with those six months to four years receiving two or three doses, those five years receiving one or two doses, and those six and up receiving a single dose. Next?
To address some of this complexity, the work group discussed if children ages two to four years continue to need a multi-dose initial series, or could they also move to a single possibly annual dose, like the older population. Next?
This slide shows, with these possible simplified recommendations could look like in the future, with infants and children ages six to 23 months receiving two or three doses of their initial series, while those two years and older would only be recommended for a single dose for their initial vaccination, eliminating much of the current complexity.
Next, in addition to the simplifying our current recommendations, there are data to suggest that those 6 to 23 months would benefit most from a multidose initial series, with data and 2 to 4 year olds looking more like what we see in the older children, this slide, which was previously shown by Dr. Havers, shows the weekly COVID 19 associated hospitalization rates for children and adolescents ages 6 months through less than 18 years. We see that most of the age groups presented here including 2 to 4 year olds have similar hospitalization rates. However, those 6 months to less than 2 years have a notably higher hospitalization rate than the other pediatric age groups over the past year.
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Megan Wallace, CDC [02:37:52]
The work group emphasized COVID 19 vaccines effectively protect children from hospitalization and severe disease from COVID 19, but uptake of COVID 19 vaccines and children remains low.
While we aren’t proposing a vote or policy change now, the work group would be supportive of a move toward a recommendation for a single possibly annual dose in ages two to four years, based on hospitalization rates and rates of seropositivity in this age group in the future.
However, the work group did highlight differences in the transition to a single dose series from a two dose series, compared to a three dose series. Simple recommendations may lead to increased coverage. We will continue to review data and evaluate the COVID 19 vaccine program in the context of evolving epidemiology.
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Megan Wallace, CDC [02:39:03]
Following the meeting, FDA advised manufacturers to develop a vaccine with a monovalent XBB.1.5 composition. We anticipate updated vaccine doses will be broadly available in the fall. Following updated vaccine authorizations, ACIP will review evidence to inform updated recommendations. Next.
As we plan for the fall, COVID 19 vaccines and treatments will likely transition to the commercial marketplace. CDC continues to partner closely with state, local, and interagency partners toward continued successful distribution of COVID 19 vaccines and treatments. During this time, including clarification of processes for ordering shipping and distribution.
Guidance for partners will be published this summer, prior to the transition to the commercial marketplace.
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Evelyn Twentyman, CDC [02:46:56]
This program is actively being set up right now. There are two components and I’ll dive into them a little bit more, since you asked the question.
So I mentioned the first is through existing public health infrastructure. So awardees, in other words, our vaccine awardees, will support and coordinate with their existing adult immunization programs, those include their local health departments and their HRSA supported health centers, to get vaccines to under and uninsured adults. And in this case, underinsured, in case anyone’s wondering what that means means, without insurance coverage of cost free access to vaccine. And then HRSA will also be supporting delivery of vaccines and treatments directly to their health centers, their FQHCs, federally qualified health centers, and CDC will use its authority under section 317 of the Public Health Service Act to purchase and distribute COVID 19 vaccines and allocate operational funds to awardees.
And then there’s a second component that I mentioned of the program, which will be implemented through retail pharmacies. So the pharmacy component, in terms of vaccine, will rely on donated vaccines from manufacturers and administration costs will be covered by the federal government. Pharmacies included in the program will be among those that have previously participated in federal partnerships during the public health emergency and have the infrastructure in place already to administer COVID 19 vaccines and that selection and competition process is ongoing.
Closing gaps in COVID 19 vaccine access is a program priority here. And so I wanted to specifically call out that participating pharmacies will be eligible for additional payments to establish sites in areas with low rates of access or vaccination. I hope that helped as a brief overview of components.
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Sara Oliver, CDC [02:50:35]
I will note that ACIP and VRBPAC had weighed in previously on the harmonization of kind of primary series, as well and simplifying to a single composition. And so we anticipate, moving forward, that as we update the composition, kind of the entire program would move. We wouldn’t kind of do this piecemeal by age. But Dr. Kaslow, if you wanted to say anything else?
David Kaslow, FDA [02:51:00]
That’s correct. That’s the intent. Is to harmonize for all doses, all ages, same composition. So in the fall, that would be the 2023-2024 formula would be an XBB.1.5.
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Agam Rao, CDC [09:34:50]
So over the last several months, CDC has received multiple inquiries about whether additional Jynneos doses will be recommended for people who were vaccinated against mpox last year.
There’s limited data to inform decisions about this. And for that reason, we’re not presenting it for an ACIP vote. However, we’ve been thinking through the available data and discussed it with the work group as well. And the purpose of this presentation is to convey our thinking about this important question that we’re receiving very frequently.
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Agam Rao, CDC [09:40:08]
So the work group concluded from this that the significance of waning circulating antibody levels is unknown. An anamnestic response is elicited two years after the Jynneos primary series. So it might not be clinically significant.
ACIP recommendations for persons at occupational risk for orthopoxviruses was for different exposures than those experienced during the current outbreak. It was for people working with research grade viruses. And so we can’t assume that the same recommendation would be applied for any patients in the current outbreak and cannot assume that patients during the current outbreak would all patients would need a booster dose.
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Agam Rao, CDC [09:40:59]
As Dr. Minhaj has already mentioned, there are three VE studies that we’ve been evaluating, and the VE has ranged for a first dose between 36 and 75%. And for a second dose, 66 to 89%.
Mpox cases among persons who have received two doses have occurred. And this is expected. Vaccines don’t prevent a hundred percent of illnesses usually. And these have been reported as early as August 2022. So they’ve been occurring for since the start of this outbreak, really, that there have been some cases that have occurred among people who have received two doses of the Jynneos vaccine.
And the 2023 Chicago cluster is what raised this alarm a little bit more. People were concerned that this cluster, since it was occurring, mostly among people who received two doses of the Jynneos vaccine, that perhaps it implied that the vaccine would benefit from an additional dose, but we’re not seeing any other U.S. clusters of a similar size, let alone involving this many vaccinated persons.
And then just as a reminder, the Chicago cluster, while we’re still trying to understand the reason for it, there were no hospitalizations among the people who received two doses of the vaccine. They were not typically prescribed pain control medications. The sequences are typical of the B.1 variant of the MPXV clade IIb, and no mutations that would confer increased pathogenicity were observed.
Next slide. So the work group’s interpretation of this data is that a third dose is currently not indicated for the entire population eligible for vaccination, and they turned their– the focus to persons who might have severe manifestations from mpox.
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Agam Rao, CDC [09:43:19]
So this slide shows first our considerations about the safety of a third dose. So the current knowledge is based on two things.
On this slide, we see the data from the same DRC study that I’ve been discussing that evaluated effectiveness. It also evaluated safety. So that study involves HCP and, it shows, as you can see in the at the bottom, increased adverse events among recipients of a third dose that was given at five years after the primary series. So these are individuals who had already received the first and the second dose. They received a third dose five years later, and safety and effectiveness were evaluated.
Now that third dose was, was given to a subset of the patients. It was given to 170 patients while the first and the second doses were given to 706 patients. But you can see from the figure that the percentage of people who experienced some of these adverse events was much higher for those who received a third dose than for those who received a first or a second dose.
A limitation of the study though, is that it was performed in the DRC. And we do not know if the population, if the findings, can be extrapolated to the U.S. population.
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Agam Rao, CDC [09:45:36]
The work group then considered the serologic response data that we have about the response among persons with HIV compared to people who do not have HIV. There is data from two studies about this. So, for nearly 600 persons combined between these studies, with a CD4 count greater than 200, serologic response to the two dose series was equivalent to response in persons without HIV. And the figure here on this slide is just from one of these papers, but both of these papers show this data. I’m not sure why it’s not showing up here actually next slide, perhaps it’s– yeah, there it is.
So this is from one of those papers, but the both studies are showing the same thing. The limitation, though, is that there’s no assessment of serologic response for persons with a CD4 count less than 100. Next slide.
And then, um, we also looked at serologic response to Jynneos among persons with HIV who get that third dose. And for persons with the CD4 count 100 to 500, and a lifetime nadir less than 200, serologic response of three doses is similar to two doses.
And we also reviewed unpublished data. So there was – we’re not presenting that data here, but we received unpublished data from Bavarian Nordic, the product sponsor, for a few, very few, number of patients. And there was no correlation, by our read, between low CD4 count and antibodies after vaccine. It was a very small number of patients, but that was our conclusion from that data.
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Agam Rao, CDC [09:48:25]
And we looked at national reporting and also anecdotal reports. The current knowledge is that, as that, perhaps over 10,000 people have received mpox cases have occurred among persons with HIV, but we have no confirmed reports of severe mpox illness after the two dose vaccine series.
The CDC reviewed data reported from health departments, for people who received two doses of the vaccine, and confirmed none were hospitalized due to severe manifestations of mpox. We actually did spend some time contacting health departments for those places, for those cases, for which the information indicated that the person had mpox, received two doses of vaccine, and there was a hospitalization indicated.
And when we contacted those health departments, they confirmed to us that these hospitalizations were not due to mpox. In one case, for example, due to housing instability, some other issues, treatment for a concurrent STI, they confirmed that were not due to the actual mpox infection.
But I will say that anecdotally we’ve heard that there was a severe case in a patient who did receive two doses of the vaccine. We’d have no details about that case though. We’ve only heard that from a provider who mentioned that they cared for such a patient.
And I can also say that there– we were also contacted by a provider who is caring for a patient with severe immunocompromise who feels that their illness, while appearing necrotic in appearance, the lesions were not disseminated. They were localized to small areas. The patient was managed in the outpatient setting and the clinical team felt that perhaps the severity of the illness was attenuated by the fact that only two– that they received two doses of the vaccine.
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Agam Rao, CDC [09:50:35]
So the work group concluded that there’s no convincing data to indicate patients with moderate to severe immuno compromise would benefit from an additional dose of the Jynneos vaccine. Next slide.
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Agam Rao, CDC [09:52:14]
So the work group’s conclusions were that they were preferring that there’d be no CDC recommendation for a third Jynneos dose at this time, including for persons with advanced HIV or other severe immunocompromise. And they emphasized several strategies instead: encouraging the two dose vaccinations among persons who do not have immunity, that is persons, for example, who have not had mpox.
So persons who have not had mpox and also have not received vaccinations. And they also said that we need to remind people that they can prevent or minimize life threatening manifestations through optimizing immune function, example through HIV antiretrovirals, ideally before there is an mpox exposure.
So if you can find people to give them an extra dose of the vaccine, similarly, you should be able to find people to optimize immune function. And then they also, if someone were to develop severe manifestations of mpox, regardless of whether it’s after a vaccination or not, we do have CDC interim treatment considerations that were published in March of this year about how to manage patients with, at risk, of severe manifestations of mpox that describes how to use the medical countermeasures that are stockpiled by the U.S. government and how to consult CDC for 24/7 consultations. And all of these things might help prevent severe infections and should be considered in combination with vaccines.
David Kaslow, FDA [08:32:49]
Finally, a number of regulatory actions are anticipated in the coming months, as reflected in the current ACIP meeting agenda. The magnitude of the current submissions under review is unprecedented.
So let me end by thanking, on behalf of the office of vaccines research and review, and CBER, ACIP and the many ACIP working groups for their partnership in the work on this very large portfolio of vaccine and vaccine candidates. Thank you.
Grace Lee, ACIP [08:33:18]
Thank you, Dr. Kaslow. I think we were hoping for fewer meetings, but you’re telling us that we have many meetings ahead. So, happy to do the work.
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Camille Kotton, ACIP [08:46:29]
So my no vote yesterday, about the 65 and up, was just that I was hoping for a broader recommendation for all adults, 65 and up, in that I had concerns about the equity piece. We know that when we do shared clinical decision making, that it is somewhat limiting to who gets vaccinated. And I was quite concerned about the equity data that we saw. So I was hoping for somewhat of a broader recommendation.
Nonetheless, the recommendation now that shared clinical decision making be used for all adults, 60 and up, it makes for a more standardized and easy to understand recommendation. So I’m glad about that. I do have also some safety concerns, although I think that there’s real benefit, especially in those high risk patients with multiple comorbidities, we really hope that this will provide good protection for some people who are among the most vulnerable, which includes the estimated three percent of the U.S. that is immune compromised, in whom we often see life threatening disease.
So we do think that it will be a good vaccine for a disease that’s almost as common and significant as influenza. And we really hope for more information on safety and then more information on the lack of booster response that we saw with vaccine, because some of us are wondering whether the vaccine will be useful in the long run, or what things will look like.
I’m excited because there are more vaccines on the horizon, as was mentioned by our colleagues at the FDA. So we’ll have to see if it’ll be one type of RSV vaccine or perhaps some type of multiple vaccines from maybe multiple different providers and approaches. So it’s an exciting field. I am glad to know that we have for the first time RSV protection for older adults.
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Beth Bell, ACIP [12:49:01]
By way of background, and to refresh the memory of the committee, in February of 2023, FDA accepted Valneva’s biologics license application for their chikungunya vaccine and granted priority review, with licensure possible in August of 2023.
As of yet, there is no chikungunya vaccine that has ever been licensed in the United States or globally, and that therefore there are no existing, ACIP chikungunya vaccine recommendations.
So the chikungunya vaccines work group is in the process of developing policy options for ACIP’s consideration for the 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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Nicole Lindsey, CDC [12:53:00]
Today we would like to present some information on value of a vaccine to prevent chikungunya among travelers.
Two surveys have been conducted to assess the value of the vaccine to prevent travel related chikungunya among U.S. persons. The first is a survey conducted by the vaccine manufacturer, Valneva. And the second was a survey conducted by CDC.
I will start by presenting the findings from the manufacturer’s survey.
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Nicole Lindsey, CDC [12:54:16]
Of the participants, only about 18% had heard of chikungunya prior to the survey. After being provided some basic information about the disease, they were asked two questions.
First, how likely would you be to ask a healthcare professional about a vaccine to protect yourself against chikungunya? 72% of respondents said they were very or somewhat likely to ask next. They were asked, if a doctor or healthcare provider recommended the chikungunya vaccine for you, how likely would you be to get vaccinated?
81% responded that they were very, or somewhat likely to be vaccinated, if recommended.
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Nicole Lindsey, CDC [12:57:03]
There were three chikungunya related questions included among the multiple questions on the survey.
The first was, imagine you are going on a trip to another country. You have a 1 in 150 chance of getting a disease. About 1 in 4 people who get this disease suffer from long-term joint pain. A vaccine is available that costs $350 and is not covered by insurance. How likely would you be to get the vaccine?
The second question posed the same scenario, except with a lower risk of infection of 1 in 15,000.
These risks were based on very rough estimates of travelers of risk during an outbreak and background risk at other times. The vaccine price was an estimate based on an average price for a travel vaccine in the United States.
The third question asked what factors were most important to the respondent in deciding whether or not to get the vaccine.
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Nicole Lindsey, CDC [12:58:53]
For the first question, asking about likelihood of vaccination in a high risk outbreak scenario, with responses on a Likert scale. 42% said they were somewhat or very likely to be vaccinated. 26% were unsure. And 32% were somewhat or very unlikely to be vaccinated.
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Nicole Lindsey, CDC [01:08:45]
Finally, I’ll briefly present some information on an additional survey Valneva conducted looking at the awareness of chikungunya and value of a chikungunya vaccine to U.S. travel healthcare providers.
In 2021, an online survey was conducted among 158 U.S. travel healthcare providers who routinely perform pre-travel health counseling and prescribe and or administer relevant travel vaccines. The participants were a mixture of healthcare provider types, including physicians, nurses, and pharmacists, and worked in a variety of practice settings relevant to travel health.
Participants were first asked how familiar they were with chikungunya disease. Only 30% reported that they were familiar with chikungunya and had clinical knowledge of the disease. 20% said they had heard of chikungunya, but didn’t really know what it was. The majority, 51%, were not familiar with chikungunya at all.
Following the first question to gauge knowledge, participants were provided some information on the disease, including its epidemiology, clinical presentation, and the types, and duration of sequelae. In addition, they were told that chikungunya vaccines were likely to be available within a few years. Then they were asked to indicate their likelihood to recommend or prescribe a chikungunya vaccine if recommended by ACIP.
15% reported that they were very likely and another 73% were somewhat likely to recommend vaccination.
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Susan Hills, CDC [01:16:58]
Chikungunya became a notifiable disease in 2015, and cases have been reported to the national arboviral disease surveillance system since that time. Of note, disease cases, but not asymptomatic infections, can be reported through this system.
There were four disease cases among U.S. laboratory workers notified in the eight year period, from 2015 through 2022. One case was hospitalized for observation, but otherwise no hospitalizations or deaths were reported.
Route of transmission was known for three of the cases. For two, a needle stick injury occurred while the researchers were working with and injecting mice. And for the third case, a researcher experienced a forceps prick while dissecting mosquitoes infected with chikungunya virus.
There is a high likelihood that the cases I’ve just described underrepresent all infections in laboratory workers. Disease cases are likely underreported to the national arboviral disease surveillance system. And as I noted, asymptomatic infections are not reportable through this system.
There is no formal laboratory event related surveillance system for reporting these type of events. In addition, there might be a reluctance for authors to publish if an infection was acquired in the laboratory where they are were working.
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Susan Hills, CDC [01:19:36]
I think this needs to be interpreted in the context of the small number of laboratories that might be working with chikungunya virus for research purposes. We actually don’t have a specific number. There’s no way to document that, but I suspect the number of laboratories working with chikungunya virus is relatively relatively small.
I think there is likely to be under reporting. So one case, one disease case, every two years reported is not insignificant, particularly if there’s given, we know that there is a concern about one in four people have chronic arthralgia after chikungunya.
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Susan Hills, CDC [01:25:51]
In addition to Paraguay experiencing a large outbreak, there has been an increase in chikungunya cases in other areas of South America during 2023 and also transmission in new areas.
For example, local transmission of chikungunya virus was reported for the first time ever in Uruguay beginning in April this year. Although Argentina and Brazil have previously reported chikungunya cases, spread to areas outside historical transmission areas, has also occurred this year in these countries.
Data for U.S. travelers for 2023 reported to the U.S. national arboviral disease surveillance system are still preliminary, but cases among U.S. travelers to Paraguay, Uruguay, and Argentina have been reported this year.
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Susan Hills, CDC [01:26:47]
The first point is how rapidly the outbreak evolved and how large it became in a short period of time. I discussed at the February meeting how outbreaks can be explosive and involve large percentages of the population in a short period of time. And that has been clearly demonstrated in Paraguay.
After the outbreak was recognized in October, case numbers gradually increased, with fewer than 10,000 cases reported by the end of 2022. But from the first week of 2023, there was a steep increase in case numbers. And by week six of 2023, more than 50,000 cases had been notified.
Secondly, although the overall hospital hospitalization rate has been less than 10%, and the case fatality rate is very low, at less than 1%, there is clear variation in rates of severe disease by age group, with severe outcomes, a concern for both young infants and older persons.
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Susan Hills, CDC [01:29:21]
Finally, the impact of the outbreak on health services has been very apparent. Several hospitals reported that there were substantial challenges in dealing with patient loads, with about 30% of daily hospital outpatient visits attributable to patient seeking care for chikungunya for most of the outbreak period.
In addition, hospital employees were also frequently infected, with one hospital reporting up to 10% of staff absent on any given day, either because of acute infection or because they needed time to convalesce because of ongoing joint pain.
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Jose Romero, CDC [01:38:07]
I just wanted to remind everybody that it is a potential threat globally and in the United States, due to climate change, and so, introduction of the vector. And as that our seasonal and summer patterns change, this could become more of a threat to the United States.
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Katherine Fleming Dutra, CDC [02:38:50]
The University of Iowa, Rand, and CDC worked together to conduct a value survey, which included 523 participants, of whom 58.1% were currently pregnant and 44.9% had given birth within the last 12 months. The distribution of participants by race and ethnicity are shown here. And 68% of respondents had knowledge of RSV prior to taking the survey. Next?
In this survey, 61% of respondents said they definitely or probably would get an RSV vaccine while pregnant. Next?
Among those who did not respond, that they definitely would get an RSV vaccine while pregnant, safety concerns, lack of RSV knowledge, and concerns about vaccination causing or intensifying RSV infection, were the top reasons for not wanting an RSV vaccine during pregnancy. Next?
Additionally, when asked how many vaccines they would be willing to get in the same healthcare visit, 22% of respondents did not want any vaccines, or were unsure about how many vaccines they would be willing to get during the same visit in the same visit during pregnancy. And furthermore, 17% said they would only be willing to receive one vaccine, 32% two vaccines, 9% three vaccines, and 20% four vaccines.
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Katherine Fleming Dutra, CDC [02:53:09]
The work group overall felt that this is an efficacious vaccine that can prevent RSV lower respiratory tract infection in young infants. However, the work group expressed concern that the Pfizer trial was underpowered to detect a 20% difference in preterm birth. Interpretation of these overarching themes varied.
Some members of the work group expressed concern that the data were insufficient to determine the safety of this vaccine. Other stressed that this vaccine can benefit infants by preventing RSV lower respiratory tract infection and that the difference in preterm births was not statistically significant. Next?
The work group discussed several points regarding preterm birth. The imbalance in preterm birth was most prominent in a single country, South Africa. The imbalance in preterm birth was not seen in high income countries. The imbalance was still present, but less pronounced, when comparing the prevalence of low birth weight. And most pre-term births were more than 30 days after vaccination. Next?
The work group also discussed considering a narrower recommended dosing window. Some expressed support for starting dosing at a later gestational age, within the 24 through 36 week gestation window used in the trial, as this could mitigate potential risk of early preterm birth until additional safety data are available. Others expressed concern that this could leave preterm infants, who are at higher risk of severe RSV disease, unprotected. Aligning RSV PreF vaccine dosing during pregnancy with Tdap administration could improve feasibility and all work group members endorse the importance of post introduction, vaccine safety monitoring, through systems such as VAERS and the vaccine safety data link. Next?
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Katherine Fleming Dutra, CDC [02:55:04]
I would like to provide a quick summary of the proposed clinical considerations for use of the Pfizer RSV PreF vaccine during pregnancy, which are based on the data you have just seen and informed by discussions with the work group.
The proposed dosing interval for RSV PreF is 24 through 36 weeks gestation, and healthcare providers could consider aligning RSV PreF vaccine dosing during pregnancy with Tdap administration for feasibility of implementation. RSV PreF vaccine can be administered with other recommended vaccines, such as influenza and COVID 19, without regards to timing, including simultaneous vaccination on the same day. Next?
For timing of dosing during the year, the work group supported that RSV PreF vaccine should be given to pregnant people during June through February in the continental United States, and healthcare providers can consider offering RSV PreF vaccine year round for ease of implementation. If RSV seasonality is unpredictable, and in jurisdictions with different RSV seasonality than the continental U.S. Next?
And regarding giving additional doses and subsequent pregnancies, currently, there are no data available on either the efficacy of the first lifetime dose during subsequent pregnancies, nor the safety of additional doses given in subsequent pregnancies. Therefore, the work group felt that it was too early to decide whether additional doses should be given in subsequent pregnancies and that additional data are needed to inform whether additional dosing and subsequent pregnancies would be indicated and recommendations could be updated in the future.
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Jefferson Jones, CDC [03:43:55]
So there are three policy questions that the work group is considering, and ACIP might be voting on pending FDA licensure.
The first is related to the maternal vaccine. Should vaccination with Pfizer RSV PreF vaccine be recommended for pregnant people to prevent RSV disease in infants? And the other two are related to nirsevimab. Should one dose of nirsevimab be recommended for infants born during or entering their first RSV season? And less than eight months of age at time of immunization? And should one dose of nirsevimab be recommended for children who are at increased risk of severe RSV disease entering their second RSV season, and less than 20 months of age, at time of immunization.
If both the maternal RSV PreF vaccine and nirsevimab are approved by FDA, and recommended by ACIP, there may be important clinical considerations for use of both products next.
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Jefferson Jones, CDC [03:49:12]
When considering when whether to give both a maternal vaccine and a monoclonal antibody, giving both products was not found to be cost effective, since this was presented just now, the highlights is the cost effectiveness of giving nirsevimab if the mother had been vaccinated, was a little under $670,000 per QALY, if given to all infants, and approximately $485,000 per QALY, if given to infants born in April to September, or months with low transmission. The cost effectiveness of giving RSV PreF to the mother, if nirsevimab will be given to the infant, was more than $10 million per QALY on average. Next.
However, challenges exist, if ACIP recommendations relate to maternal vaccination status. The mother’s vaccination status might be unknown by the healthcare provider of the infant. Transferring documentation of maternal vaccination to the healthcare provider of the infants may be difficult. Although limited maternal healthcare information is available during the birth hospitalization, even less information regarding receipt of prenatal vaccination may be available to the infant primary care providers as an outpatient.
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Jefferson Jones, CDC [03:50:28]
Based on these considerations and feedback from the work group, draft clinical considerations were developed, should both the RSV PreF maternal vaccine and nirsevimab licensed by FDA and recommended by ACIP and CDC.
So either maternal vaccination with RSV PreF or nirsevimab is recommended to present to prevent RSV disease, but both products are not recommended for most infants. There are certain scenarios when nirsevimab should be considered, even if the mother has been vaccinated. The risks and benefits of both RSV PreF maternal vaccine and nirsevimab should be considered by the pregnant person and healthcare provider when deciding on maternal vaccination with an RSV vaccine.
If the mother is vaccinated, nirsevimab can be considered if the infant is considered to have insufficient protection from vaccine, or is at high risk of severe disease. Next?
Scenarios to consider administration of nirsevimab when mother has been vaccinated include, first, when receipt of a RSV maternal vaccine is not confirmed by a healthcare record, such as a state immunization registry, mother’s healthcare record or vaccine card, and relying on a self-report on vaccination should be done with caution as it may be difficult for many people to discern with certainty, which vaccine was received during pregnancy.
Second, when an infant is born within 14 days of vaccination, the infant may have insufficient antibodies for protection. Third, when the infant is born premature, vaccine induced antibodies transmitted to the infant may be decreased, and the infant is an increased risk of severe disease because of the prematurity. Fourth, when a healthcare provider, per their clinical judgment, recommends maximizing protection against severe disease from RSV, because the infant is at high risk of severe disease. And this is particularly important if the infant is born more than three months prior to the peak of RSV season, and may have limited protection from maternal vaccination.
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Jose Romero, CDC [03:55:31]
I was going to make a comment at the end of this session, but thank you for my segue. I can comment about, about coverage. The others, I think we don’t have definitive yet, but you’ve heard about the coverage for RSV PreF vaccine already.
CDC would be strongly in favor of covering nirsevimab under VFC, if it met criteria for FDA and the committee for licensing and for policy. So I think that’s a plus. The rest of these other questions will be answered as we go forward.
I think that if the committee feels appropriate, I mean, it could be listed under a vaccine, under the schedule, if appropriate and there would be further discussion on that issue.
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Melinda Wharton, CDC [03:57:18]
Clearly we’ve been looking at this and talking about it for a long time and with a number of different monoclonal antibodies under development. And, with at least some of them having apparently having indications very similar to vaccines, we do believe it’s appropriate for ACIP to make recommendations for some of them, which is why we’ve been talking about nirsevimab all along.
We have developed some criteria for products that ACIP will consider, and those include, being expected to have population benefit, being feasible to implement within immunization programs, and being expected to have cost that’s in the same range as vaccines. And, I think one of the issues with the monoclonal antibodies used for prevention of COVID, even when they’re being used preventively, as opposed to therapeutically, is the need for repeated administration. And I think we’re envisioning, from an immunization program perspective, we’re probably not looking at a need for every six months or every three months administration.
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Tom Shimabukuro, CDC [04:22:49]
Just want to mention that there, I think, monitoring for nirsevimab will be confounded by co-administration with other vaccines. We anticipate it’s going to be given with other vaccines, either at birth or at well child visits early in infancy. But we deal with that problem for simultaneous administration of other vaccines as well.
So, there’ll be a robust monitoring process in place for nirsevimab to include CDC and FDA, and collaboration between the two agencies, to make sure that safety information is, or the data are analyzed and are made available to the ACIP work group and to ACIP in a timely manner.
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Katherine Fleming Dutra, CDC [04:25:28]
Perhaps I’ll start and then hand it over to Dr. Long. We have had long discussions about whether or not there could, or is not, a biologic plausibility to this.
I think in both the GSK trial where the imbalance was statistically significant, the mechanism for that imbalance remains unclear at this time.
And I think the work group has struggled with the– we showed you these data because they have been difficult to interpret, I think in the same way that you’re looking, there’s more or less concerning pieces to those data. We have asked, as Dr. Long indicated, for summaries of the preterm births that could be reviewed by those with OB expertise. That might be helpful. We have not yet received those. But we will continue to ask.
I don’t know that we have come to a sense of whether or not there is a biologically plausible mechanism. And I think our work group may remain conflicted on different hypotheses.
I don’t know if Dr. Jones or Dr. Long wants to add to that. I’m sorry if that wasn’t a very satisfying answer, but we’re struggling.
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Peggy Webster, GSK [04:28:48]
We have been puzzled by this as well. We have not identified any type of biologic plausibility that could explain the signal. We’ve had conversations with the work group, we’ve shared with them the data that was generated. And that’s about all I can say. We just have not found a biological plausibility reason for the statistically significant imbalance that we identified in our phase three trial.
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Peggy Webster, GSK [04:31:58]
This is Peggy Webster and from GSK. Our study ran from 2020 until we identified the signal in February of 2022. When we evaluated our data, we did see temporal clustering. That occurred between pretty much the months of August and December of 2021. The signal was more pronounced in low middle income countries than in high income countries.
We did look at the– whether RSV infection could have been a factor in the pre-term birth imbalance, and we were unable to find any correlation there. So again, we just have not found a plausible explanation for why we had this temporal clustering, the geographic clustering, of this signal.
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Peggy Webster, GSK [04:34:06]
I can answer for GSK. We did look at COVID infections and were unable to find, again, any sort of association between the pre-term births and the COVID infection or COVID vaccinations.
Alejandra Gurtman, Pfizer [08:38:07]
We are in the process of vaccinating two additional cohorts that received the initial vaccination that will represent revaccination at 301, and then revac– that we’re doing that (inaudible) and revaccination after two years. So that data will be forthcoming.
And in addition, we are conducting the study in immunocompromised participants where we are looking if those who have immunocompromised conditions will require a single dose or maybe two doses given one month apart.
Sarah Long, ACIP [08:38:44]
And when do– and are you studying immunogenicity and or effectiveness or efficacy of second doses? And when do you expect these data to be available?
Alejandra Gurtman, Pfizer [08:38:59]
Thank you. They were studying immunogenicity in those participants after one year and two years after vaccination, and that data hopefully should be ready by first quarter of 2024.
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Leonard Friedland, GSK [09:00:02]
We are currently reviewing our clinical development plan and we’re gonna look to generate additional data that will help inform the optimal timing of revaccination.
So you had asked also about immunogenicity studies. And so I will point out, of course, that our study that I presented today shows that Arexvy is durable with protection over two full RSV seasons, including against severe disease. And also in those vulnerable populations, such as older adults and those with underlying comorbidities. And as mentioned, study 06 does provide important information where a second dose after 12 months does not appear necessary in the overall population.
So coming to the– your question about immune response first, it’s important to recognize that there are no established immune correlates of protection. In our clinical development plan for Arexvy, we have in ongoing phase three immunogenicity trial. And if interested, I can share the data in more details with you in just a moment, but in this ongoing study, we find that the immune response induced by vaccination peaks one month after vaccination, and persists for 18 months at levels above baseline.
When the second dose is given 12 months after the first dose, there are increases in neutralization titers, but they do not restore to the level observed after the first dose. I want to point out that this type of immune response that I’m describing is also described for other RSVpreF protein vaccines, so it’s not unique to Arexvy, and again, as mentioned, further data will be generated to help us explore longer term protection and inform the optimal timing of revaccination.
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Katherine Poehling, ACIP [10:00:45]
One of the things that you highlighted was the importance of duration of immunity. And so I wanted to give both Pfizer and GSK an opportunity to share if they’re going to look at vaccine effectiveness with one dose over three plus seasons, and how are you going to do that? Thank you.
Grace Lee, ACIP (Chair) [10:01:12]
We’ll see if our colleagues from GSK could speak to this. And then from Pfizer.
Leonard Friedland, GSK [10:01:25]
Thank you Dr. Poehling for that question. In study 006, which I presented today, there is one arm that will be followed, who just gets one dose, and will be followed for three seasons. So yes, we will be following for three seasons and we will continue to do additional studies as well. We also have the immunogenicity studies, which are following long term immune response as well.
Katherine Poehling, ACIP [10:01:50]
And could you remind us roughly how many it was in that one arm for that third season?
Leonard Friedland, GSK [10:01:57]
Well, we haven’t received that third season yet. But the patients who were re-randomized to placebo were about 5,000. So we have 5,000 subjects now who received one dose and we will continue to follow them in that study.
Katherine Poehling, ACIP [10:02:14]
Okay. Thank you.
Grace Lee, ACIP (Chair) [10:02:16]
Thank you. And next to our Pfizer colleagues.
Alejandra Gurtman, Pfizer [10:02:17]
Yes. So we are following a subset of participants in the Renoir study who are going to be revaccinated after the equivalent to one year, and then another subset that would be revaccinated after two years. And as I mentioned before, this is immunogenicity. We’re not doing effectiveness in this particular groups because they are too small to get enough cases.
Katherine Poehling, ACIP [10:02:52]
Okay. My question is, are you going follow anybody who received one dose over two, three, four years?
Alejandra Gurtman, Pfizer [10:03:03]
So currently we are following subsets for two seasons only, except for this subset. But after discussion today, we will take into consideration potentially following subjects for longer.
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Camille Kotton, ACIP [10:03:22]
I’d like to thank Dr. Hutton and Ortega Sanchez for their hard work in this field, and we have gone over this data multiple, multiple times in the work group. One of the issues that’s come up is that GSK recently changed what we had been working with for an estimated price. The price that we had been working with for GSK had been about $150, and it was recently conveyed to us that now the price would be $270.
I was wondering, for both companies, if the current prices we are working with for Pfizer, $200, and for GSK, $270 per vaccine, if those are the final prices or if we could have more information because, in voting on this, I’d like to make sure that I do the right thing by the American public and know what we are estimating that we will be paying for.
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Leonard Friedland, GSK [10:04:27]
Thank you for that question. The final price of GSK’s vaccine is still being finalized.
Camille Kotton, ACIP [10:04:34]
Do you have, do you have an estimated date of when we might know that information and is it estimated to be significantly more than $270?
Leonard Friedland, GSK [10:04:45]
Again, the final price has not yet been finalized. We do not have a date when that price will be, but it will be shortly. The vaccine will be priced using a value based approach, grounded in cost effectiveness, and it will ensure that the vaccine offers good public health value.
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Donna Altenpohl, Pfizer [10:05:12]
Similar to GSK, it’s important to note that the list price for Pfizer’s RSV vaccine has not yet been established.
To support cost effectiveness analyses, as part of the U.S. CDC’s evidence to recommendation framework, Pfizer has provided to the CDC a price range of 180 to 270, with the base case of 200. Based on the updated cost effectiveness results, we continue to expect our RSV vaccine to be highly cost effective.
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Helen Keipp Talbot, ACIP [10:05:45]
I’d like to piggyback on Dr. Kotton’s comment. When we are voting today at around 4:30, if you could please come up with a price before then, it would be incredibly helpful, because this is a huge part of what we do.
And as I’ve said before, none of us buy a car unless we know how much it costs. So if you could actually talk and bring something back before 4:30, it’d be incredibly helpful.
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Michael Melgar, CDC [10:31:17]
Here are the results of the modeling work evaluating the number of RSV attributable illnesses that may be prevented per million vaccinations with Pfizer’s RSV vaccine. This was performed by our colleagues at the University of Michigan as part of the economic analysis that was just presented. As in the economic analysis, vaccine efficacy against RSV hospitalizations and deaths was assumed to be equal to efficacy against medically attended lower respiratory tract illness,
Vaccinating one million adults, 65 and older, with a one time dose may prevent approximately 25,000 outpatient visits, 2,500 hospitalizations, and 130 deaths over two RSV seasons. You can see that the numbers of prevented outcomes are lower for adults 60 to 64, especially numbers of hospitalizations and deaths. That’s primarily because there is less existing RSV disease in that group at baseline for the vaccine to prevent, as we saw on the previous slide.
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Michael Melgar, CDC [10:33:17]
When asked regarding the balance of desirable and undesirable effects, the work group majority opinion was that the comparison favors the intervention. However, there was a minority opinion that the balance was unclear. These work group members were concerned about the three reported inflammatory neurologic events in the main phase three trial, as it’s hard to know from three cases if this is a true safety signal or random events.
So now when asked how substantial are the desirable anticipated effects of Pfizer’s RSV vaccine among adults 60 to 64, the work group responded that they were small or moderate. Next slide. As for adults 65 and older, the work group felt the undesirable effects were likely small in adults 60 to 64. And next slide, please. When asked regarding the balance of desirable and undesirable effects, there was no clear majority opinion for this age group.
Some work group members felt that as for adults 65 and older, the balance of benefits and risks favored the RSV vaccine while others felt that the balance favored the comparison, which was no vaccine. Other work group members felt that sufficient safety evidence was lacking to make a determination and that the balance was unclear.
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Michael Melgar, CDC [10:41:03]
And finally, here are the results of modeling work, evaluating the number of RSV attributable illnesses that may be prevented per million vaccinations with GSK’s RSV vaccine. Again here, efficacy against hospitalizations and deaths was assumed to be equal to that against medically attended RSV lower respiratory tract disease. Vaccinating one million adults, 65 and older, with a one time dose may prevent approximately 23,000 outpatient visits, 2,300 hospitalizations, and 120 deaths over two RSV seasons.
You can see that the numbers of prevented outcomes again are lower for adults 60 to 64, especially numbers of hospitalizations and deaths. That’s primarily because there’s less existing RSV disease in that group at baseline for the vaccine to prevent. Next slide, please.
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Michael Melgar, CDC [10:42:35]
When asked regarding the balance of desirable and undesirable effects, the work group majority opinion was that the comparison favors the intervention. However, there was a minority opinion that the balance was unclear. These work group members were concerned about the three reported inflammatory neurologic events in the main phase three, or in– across phase three trials, as it’s hard to know from three cases, if this was a true safety signal or random events. Next slide, please.
Now for adults 60 to 64, the work group felt that the desirable anticipated effects of GSK’s RSV vaccine were small or moderate. Next slide, please. As for adults 65 and older, the work group felt that the undesirable effects were likely small. Next slide please. And when asked regarding the balance of desirable and undesirable effects, there was no clear majority opinion.
Some work group members felt that, as for adults 65 and older, the balance of benefits and risk favored the RSV vaccine while others felt the balance favored the comparison, no vaccine. Other work group members felt that sufficient safety data was lacking and that the balance was unclear.
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Michael Melgar, CDC [10:43:53]
The work group felt that RSV vaccination for older adults could be a cost-effective intervention, but that the cost effectiveness depends on several factors around which there is substantial uncertainty. Work group members felt that the uncertainty is chiefly driven by, one, the ultimate vaccine acquisition cost, which remains subject to change, two, the annual incidence of RSV illness, particularly hospitalization, and three, the duration of protection resulting from RSV vaccination in this population.
Finally, the work group noted that vaccination of older age groups would be more cost effective than vaccination of younger age groups, due to the higher existing burden of RSV disease with increasing age. Next slide, please.
All evidence taken into account, the work group responded that yes or probably yes, both candidate vaccines could be reasonable and efficient allocations of societal resources if recommended for adults 65 and older, compared with no RSV vaccine, though the work group notes that this poll response is contingent on the current vaccine price assumptions that were provided by the manufacturers. Higher vaccine acquisition costs may quickly reduce the cost effectiveness of this intervention. Next slide, please.
Under the same assumptions, the work group felt that probably no, neither vaccine was likely an efficient allocation of resources, if recommended for all adults age 60 to 64.
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Michael Melgar, CDC [10:54:42]
Regarding the impact on health equity of recommending RSV vaccination in adults 60 to 64, the work group opinion was split. Those who argued a recommendation in this age group would increase equity stressed the importance of extending access to RSV vaccination to those in this group at increased risk of severe disease. Those who were concerned it would reduce equity, were concerned that in this age group, adults with already existing access to care and health insurance coverage would be more likely to receive RSV vaccination. These adults would likely not be primarily those in the target population at increased risk.
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Michael Melgar, CDC [11:00:13]
The majority work group opinion was in favor of recommending both RSV vaccines for adults 65 years and older. However, there was a substantial minority opinion not to recommend either vaccine, based on currently available evidence. These work group members were concerned about the population level balance of benefits and risks, considering the uncertainty of the risk of inflammatory neurologic events balanced against the evidence of efficacy, which is lacking in key groups at highest risk of severe RSV illness, including hospitalization.
They felt that it’s imperative to demonstrate efficacy in these groups prior to making a recommendation further.
Some work group members felt that a post implementation safety signal for inflammatory neurologic events, even if caught early, could undermine confidence in RSV vaccines and in vaccines more generally. Next slide, please.
For adults 60 to 64, the work group is not supportive of a universal age-based recommendation, because adults under 65 have lower incidence of severe RSV disease and therefore may benefit less from RSV vaccination. The work group felt that until additional evidence becomes available to the determine the existence and magnitude of a potential risk of inflammatory neurologic events, RSV vaccination should not be universally recommended among adults 60 to 64, as the benefit might not consistently outweigh the unknown risk.
The work group remained closely divided between supporting a shared clinical decision making recommendation with individual risk guidance versus no recommendation. However, selecting between these options, some work group members who selected no recommendation did voice support for a risk based recommendation with a specific list of qualifying conditions rather than shared clinical decision making.
This included a small number of work group members who voice support for a risk based recommendation for all adults, 60 and older, without an age based component.
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Amadea Britton, CDC [11:06:00]
Optimally vaccination of eligible adults should occur before the onset of increased RSV activity in the community. However, the timing of the onset peak and decline of RSV activity varies each year, and RSV seasonality during the COVID 19 pandemic deviated from prior seasons. Next slide, please.
On this slide, we see the timing of RSV seasons over the last six seasons, with epi week on the X axis and weekly count of RSV hospitalizations on the Y axis. The turquoise arrow under the X axis denotes the beginning of January each year. While the peak of hospitalizations was similar from 2017 to 2020, you can see that this seasonality was disrupted by the COVID 19 pandemic, and that the most recent season shown in green had a much earlier peak. Next slide.
Given this variability, the ideal time to start vaccinating cannot be predicted in advance of the 2023-24 RSV season. Providers should therefore offer RSV vaccination as soon as vaccine supply becomes available and should continue to offer RSV vaccination throughout the RSV season to eligible adults who remain unvaccinated.
And although we know there is protection against lower respiratory tract infection, at least through a second season, there are insufficient data at this time to determine the need for and timing of potential re vaccination.
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Beth Bell, ACIP [00:33:32]
I just wanted to make a couple of comments myself, which are pretty consistent with what we’ve been hearing.
First of all, to the point that you made Dr. Lee and Dr. Talbott, the idea of trying to make a recommendation, taking into consideration these beautiful cost effectiveness analyses, having no idea essentially of what the cost of the vaccine will be, is just really very frustrating and unfortunate, and makes it difficult for us to do our job as well as we would like to.
And, clearly the manufacturers know this, but it would be really lovely if something could improve on that topic.
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Camille Kotton, ACIP [00:46:50]
Things I thought about were the high burden of disease and that we can save lives this year. Lives, hospitalizations, we could have a significant impact this year. So that’s why we wouldn’t want to delay further.
The other issue is that there are other vaccines emerging on the horizon. And so this field will undoubtedly change within the next five to 10 years. We’ll learn a lot more. So we’re trying to make a decision as best we can with the data we have now, at this time. And we are also emphasizing equity and good vaccine availability for all people.
So these are all the things that we we thought about in great depth.
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Helen Keipp Talbot, ACIP [00:49:09]
I think the work group really struggled with that, and agree, I think the problem is we saw those six neurologic complications and it is unclear what the diagnoses and cause of those six neurologic complications are, but of note, all six occurred in the active comparator and not the placebo. So it’s really hard to ignore them, even when it may not have been Guillain-Barre, it might have been CIDP or it might have been this or that, because we didn’t see them in the placebo. We only saw them in the active comparator.
So when we look at an age of 60 and say, we’re going to make this equitable, we also might make it lethal to someone who’s not at high risk. Someone who may not be hospitalized for RSV, may then be hospitalized for Guillain-Barre, or whatever neurologic complication it is. So that’s really been the struggle of this group, is the real lack of knowledge of how well does this really work.
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Grace Lee, ACIP (Chair) [12:55:03]
Co-administration both from a immunogenicity perspective, non-inferior, but maybe slightly lower in trend, and then also just from a safety perspective, both of those things give me pause about co-administration, for these particular vaccines.
And again, emphasizing that in the past, while our general recommendations have always recommended concomitant vaccination, because we don’t want to miss any opportunities, it’s really hard to get adults in for vaccination, so I want to acknowledge that it really impacts our ability to deliver vaccines, because it’s really hard to get people in. So it’s a trade off.
But I think in this case, I don’t personally feel comfortable. And so my clinical guidance, similar to Dr. Kotton’s, would be if you have the opportunity to separate them, that’s what I would do. But if for whatever reason, they just want to get it all done, I would be supportive of that too.
I just want to make sure that we’re acknowledging that we don’t have sufficient data in my mind. And I’m noting a lot of the immune mediated diseases are related to, or maybe associated with, co-administration or may not. So further investigation into that.
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Grace Lee, ACIP (Chair) [12:56:55]
My biggest concern of the day is going to be that we typically understand what the cost is when we’re making a recommendation about a vaccine.
And I– while I am very comfortable with the ACIP voting language as is on the slide, I don’t feel like I can make a decision without understanding what the costs will actually be. So looking to the chair of this particular work group, because I don’t know how to move forward with a vote, until we have complete information.
I am fine with moving forward with uncertainty, and we will continue to collect more information as we go around efficacy and safety in the long run. I don’t know how we do this without cost information. And that seems to me, something that’s very imminent, and obtainable, and that information is actually critical because it influences my votes on both of those things.
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Jason Goldman, ACP [01:08:31]
Unfortunately you have to go through a system where you essentially bill the pharmacy, which can be a barrier to care for many physician offices.
I’m also concerned about shared clinical decision making because, in the past, these recommendations have actually made it more difficult to administer vaccines, especially when you consider that many insurance companies will take up to a year to implement the ACIP recommendations for reimbursement. In addition, if it’s not a clear cut recommendation, they may balk at reimbursement, making it even harder.
And the third part is that this may actually hurt equity for those who do not have insurance coverage as previously been stated, there is no vaccine for adults program. So many the 60 to 64 range who rely on employer based coverage may not be able to get their vaccines, because they don’t have insurance coverage.
And finally, really the risk assessment piece of it is a discussion between the physician and the patient can be very difficult to add that burden without clear cut guidelines. So I think shared clinical decision making may actually hurt reimbursement, hurt access to care, and actually decrease equity. So I would hope that the committee can give a very clear cut age based safety recommendation, so that we can implement the vaccines appropriately.
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Phyllis Arthur, Bio [01:10:31]
Secondly, I just wanted to make a point about the fact that there’s generally not been a precedent for companies, manufacturers, sharing their finalized pricing before the recommendation process is complete. So I know the cost effective analysis is extremely important, part of the ACIP process, but generally in the past has been done without necessarily a final knowledge of the last cost that will be given in the marketplace.
It’s also important to note that many patients in both the public and private sector are going to have access to pricing that’s discounted, through various programs as well. So I wanted to just make sure there were a couple of thoughts with regard to the pricing issue and remind people that in general manufacturers try to price to the best possible public health impact.
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Grace Lee, ACIP (Chair) [01:11:32]
I’m a little bit hung up on this, which is, in the past, I feel like it’s either been clearly on one side or the other, in terms of the cost effectiveness. It weighs more heavily for me because of the estimates that are being given, as well as the uncertainty about the price. But generally when it’s in one direction or the other, then I will focus on other domains of decision making and the evidence to recommendation framework.
In this case, at least for me personally, it becomes an important issue for the decision and the vote. And in my recollection, I don’t– while we often are doing these in advance of the approval process, my assumption was that once a vaccine is approved and licensed for use, it usually goes to market. And then we have clarity about whether those assumptions are correct.
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Melinda Wharton, CDC [01:12:39]
We are here for three days and if we had an opportunity to get more clarity from the companies on price before Friday, we could vote with that information in hand. And, I have to say, I do have some discomfort with the committee’s obligation to consider cost effectiveness, absent at least a narrow range of projected prices.
Both of these vaccines were licensed last month. It’s not like they were licensed earlier this week and, from my perspective, it would be very helpful to have more information than we have about pricing before we ask you to vote.
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Jose Romero, CDC [01:13:37]
It is within the purview of the committee to delay the vote if the data is important to you and we can attempt to do that. Sorry, my voice is a little rough still. But I also want to remind the committee that this is not the first time the committee has voted without all the data they’ve had. And I still remember one particular vote, where the director came to address us specifically because of that, that there was a lot of consternation among, and a lot of concern among voting members. And in essence, boiling down his statement, it was, we vote on what we have data for. We monitor these vaccines. And we can modify our data going forward, our vote, in the future.
I want to remind everyone that we have one of the best vaccine safety systems in the world. We have the ability to rapidly acquire information, rapidly assess it, and act on it. We saw that during the COVID pandemic, that system is viable, and is in place, so we can follow.
There was a comment about surveillance. We now, NCIRD, has a fifth division, the CORVD division, that will be tasked primarily with following epidemiology of these respiratory diseases. And we have now dashboards that are available to the public for this. And we will go forward tracking these and looking at not just the incidence, but also the subtypes that are available in the– circulating in our communities.
So I think we’re well poised to monitor this vaccine going forward. And I simply remind you that we have the data that we have, and to delay this, a vote, or to delay your decision based on more data to come, may delay and may deprive individuals of the benefit of this vaccine for years to come.
And lastly, I remind you about the issue of equity, that has always been very important to us. I think that the data has been presented very well by both leads, about how important equity is in deciding who can get this vaccine, and closing the door to this vaccine to one particular age group may disenfranchise our populations.
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Sarah Kidd, CDC [02:04:15]
The proposed language is adults who have received a primary series of trivalent OPV or IPV in any combination, and who are at increased risk of poliovirus exposure, may receive another dose of IPV. Available data do not indicate the need for more than a single lifetime booster dose with IPV for adults. Next slide.
For the clinical considerations, just repeating the situations that put adults at increased risk of poliovirus exposure, or examples that are given.
These examples include travelers who are going to countries where polio is epidemic or endemic, laboratory and healthcare workers who handle specimens that might contain polioviruses, healthcare workers, or other caregivers who have close contact with the person, who could be infected with poliovirus.
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Sarah Kidd, CDC [02:12:48]
In terms of recommendations for, if there is a case of polio detected in the United States or waste water detections, I think it’s challenging to give standard or universal recommendations at this point. I think we would have to work with the health department based on the pattern of detections and the type of virus, whether it was Sabin-like or had enough changes that it was vaccine derived, to make a call of recommendations for boosters at this time.
I think the nice part, the benefit of moving to a uniform recommendation for unvaccinated adults, is that there’s a clear uniform recommendation for unvaccinated adults. There’s clarity of that. We don’t have to split hairs about what is increased risk for those people or not. Go ahead and get those vaccinated.
But in terms of when boosters might be recommended, is I think, something we’ll have to work with health departments and what happens, what the specific situation entails.
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Melinda Wharton, CDC [04:44:13]
We did hear from our colleague, Mary Beth Hans, from CMS, regarding questions you all had earlier. Should the older adult RSV vaccine be recommended by ACIP, coverage would be through part D for Medicare beneficiaries.
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Leonard Friedland, GSK [04:45:00]
RSV vaccine will fall within a narrowed range of 200 to 295 dollars. This reflects the totality of our data reviewed earlier, concluding that Arexvy provides durable efficacy for at least two full seasons in the 60 and over population, including in those with underlying comorbidities and across advancing age.
This reinforces our confidence in Arexvy’s potential to make a significant public health impact. The price of Arexvy will be based on cost effectiveness analyses to ensure efficient allocation of resources.
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Donna Altenpohl, Pfizer [04:45:48]
As we stated earlier today, to support cost effectiveness analyses as part of the U.S. CDC evidence to recommendation framework, Pfizer has provided to CDC a price range of 180 dollars to 270.
We have been consistent with our price range since we first provided our CE analyses early this year. According to the CDC cost effectiveness model shared today, even at the highest end of the Pfizer range for 270 dollars, the Pfizer RSV vaccine would have a cost per QALY of under $180,000.
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Grace Lee, ACIP [04:50:48]
This vote, the amendment vote number one, for those who can recall from this morning, we actually had vote number one, and this is the amendment to vote number one, which we need to vote on first. If this passes, this becomes vote number one, if this does not pass, it goes back to the original vote number one. So just for clarification.
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Melinda Wharton, CDC [04:56:18]
So we have a nine to five vote.
Helen Keipp Talbot, ACIP [04:56:20]
And just to clarify, is this for both vaccines or only for the one that gave us a price?
Grace Lee, ACIP [04:56:26]
It’s for adult RSV vaccines period. So, the amended motion passes, and there is now a recommendation for adult 65 years of age and older may receive a single dose of RSV vaccine using shared clinical decision making.
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Melinda Wharton, CDC [04:58:55]
So we have 13 yes’s and 1 abstention.
Grace Lee, ACIP [04:58:58]
Okay. Thank you. And vote number two passes. So adults 60 to 64 may receive a single dose of RSV vaccine using shared clinical decision making.
Todd Davis, CDC [00:29:17]
Over the years, CDC has developed dozens of these candidate vaccine strains. We generate a master stock that can then be used to grow more traditional influenza vaccines, like egg-based vaccines, to be sure that they grow well in eggs, and that we can do the types of qualification that’s required by the FDA, if we were to use one of these vaccines in a pandemic setting. Next slide.
So just looking at the 2.3.4.4b H5 strains, for example, now you can see we’ve developed vaccines against each of the eight different 2.3.4.4 sub-clades, and we’ve developed six different CVVs specifically for the 2.3.4.4b viruses. And more recently, those 2.3.4.4b’s that have been circulating throughout the Americas. Next slide.
And then finally, a lot of this is also coordinated with other U.S. government agencies like ASPR and BARDA that help us to make decisions about which of these vaccines should be put into our national strategic stockpile. I won’t go through all of these details, but I will just say that currently there’s more than 20 million doses for four different H5 antigenic groups that would cover those viruses that are currently circulating among animal populations. And then another 12 million doses set aside for the 2013 H7N9 viruses, which have thankfully subsided due to the poultry vaccination.
There are also antivirals that are stocked as well as PPE that’s stocked in addition.
Georgina Peacock, CDC [00:20:44]
I don’t have any slides. I have just a few comments. This is sort of still still in flux, as you know, and so we are watching the developments and the potential uses for nirsevimab for the use with RSV and as we saw last winter, there certainly was a lot of focus on RSV, and we are very excited about this potential development.
So I wanted to talk a little bit about what we’ve been doing sort of in the background as we prepare and plan for the final decisions that come out related to licensure by the FDA and then how ACIP will make recommendations after this. So, obviously we are waiting for those policy decisions and once those are known, we will start implementing the directions of those recommendations of ACIP.
And we anticipate this is going to happen towards the end of the summer to early fall. And then we are also obviously, if there is a FDA approval, and then recommendations by ACIP, the other thing potential that can happen is that there would be a resolution for inclusion in the Vaccines for Children program.
So we’ve had a lot of internal conversations at all levels of HHS leadership, working with the CDC director and others, to anticipate what may happen as these recommendations come out. I think one of the things, and Anne Edwards from AAP is going to be talking a bit about the clinical considerations with the potential of this coming out this fall. I think there are quite a lot of challenges that we are working through and we will continue to work through because we’ve got a product that sort of will function as a therapeutic and an immunizing agent at the same time or similar to a vaccine, and thinking through the nuances of that, and then also because of the timing, we’re looking at something that potentially will be approved and not be ready for launch until sort of the middle of this RSV season.
So all of those things are within our considerations and we’re paying close attention to what’s going on on the policy front and getting ready then in the immunization services division to be ready to implement based on what those recommendations are.
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Georgina Peacock, CDC [00:34:32]
It would be very helpful if these can be integrated into the immunization information systems. I do know that, and our colleagues within the part of the division that focus on IIS as well as others, are I think trying to sort through. In some states, it may be that they can’t be integrated into an IIS based on potential state legislation, because of this difference in being classified as a therapeutic versus a as a vaccine. And so I think there are still many issues to be worked out related to that.
I mean, we’re aware of them and trying to sort through what that means for the IIS because obviously there– it would be very helpful to have something in place so that we can look at administration and be able to look at coverage.
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Georgina Peacock, CDC [00:35:27]
As far as seasonality, yes, the– my understanding from talking with colleagues within the RSV working group at ACIP is that the likelihood is this would be used during the RSV season. So in the fall through early spring. And there may be– again, this is all sort of still being worked out, but there could be a recommendation for infants possibly getting it in a birthing hospital versus in an outpatient clinic. And so once those recommendations come out, we would then look at whether– and then of course, the other question is, will this go through VFC or will this go through a different kind of mechanism? And then we would look into whether or not it’s a kind of a pre-booking situation or how we would do that.
We also know, so I mentioned, the likelihood is that this will sort of come maybe mid season, given where we are right now. And so, what it looks like this season versus future seasons may be different. And so I think we need to prepare the immunization community and also the clinical community that maybe there will be kind of a slow ramp up to this.
Meaning, I don’t think we know what the uptake will be. Initially, usually with a new vaccine or a new immunizing agent, it does take some time for there to be adoption of this, to get to the coverage rates that we’re interested in, and so that will be taken into account as well as we’re planning for a potential roll out of this season.
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Claire Hannan, AIM [00:40:23]
I’m just wondering if you could shed any light, if you know, who will make the decision about whether the vaccine will be in VFC or not? Because we seem to be in the wait and see, and it’s just very difficult to prepare in the wait and see mode. So, I’m just trying to understand who is going to make that decision.
Georgina Peacock, CDC [00:40:50]
So I think it’s within HHS. There’s been conversations happening at all levels, up to the secretary’s level. And so, what we can’t do is get out ahead of the FDA and the ACIP. And so– but we are– we’re preparing for that.
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Courtney Lando, AIRA [00:41:24]
I just wanted to comment on the current state of IIS capabilities.
So currently not all IIS are able to capture the administration of passive immunity products. And these products, as mentioned from the presenters today, use different code sets than those that are traditionally stored in an IIS.
So, given that EHRs are one of the primary sources of data for IIS and use the same code sets, the linkage between EHRs and IIS will be critical to making this happen. Often EHR products have to be modified to send new and different codes, and that might be subject to how the products are installed at the local level. So that linkage will be critical.
One other thing to consider it, from the legal perspective, is that often the definition of vaccination or immunization can determine whether or not these products can be included in the IIS. So it’s gonna take some time for that ramp up, but those are some considerations.
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Jeff Duchin, NVAC [00:47:40]
I’m wondering if you could say a few words about what you see as the role of our local and state health departments in the implementation of passive immunization products and particularly the product that we’re discussing now for imminent implementation and what resources may be required at that level. Thank you.
Georgina Peacock, CDC [00:48:04]
So I think, from our perspective, that depends on the recommendation that comes out from ACIP and whether or not that would be included in the VFC, the Vaccines for Children program.
If it is included within the Vaccines for Children program, there would be the resources that we provide to immunization programs across the country, at the state and local level, would use that mechanism in order to support the rollout of essentially a new immunizing agent within the VFC program. If it’s not through that mechanism, then I’m not sure that I can speak to what the role of the state and local health departments would be, but if it’s through VFC, then we would be rolling this out as we would a new vaccine, or a new immunizing agent, similar to what we’ll, and I’ll talk about this this afternoon, but similar to what we’re doing is we’re anticipating the commercialization of the COVID vaccine and the fact that that’s included on the routine schedule now.
Jeff Duchin, NVAC [00:49:24]
Thank you. That’s helpful. Do you anticipate any increase in resources available to do this work? If it does go through VFC?
Georgina Peacock, CDC [00:49:35]
I don’t think I can speak to that at this moment, because I– we don’t have the recommendation yet.
Anne Hause, CDC [10:13:43 AM]
So we are currently working on this next iteration of V-safe. Our goal is to have a very flexible system that will allow us to respond quickly in public health emergencies, but also to enroll people who are receiving any new vaccines that come out over the next few years.
We hope that a fairly agile system and that we can work quickly to add new questions as things and recommendations change. And we will keep everyone posted as to timelines and which vaccines we plan to work with in the fall or next year.
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Robert Schechter, NVAC [10:15:03 AM]
With the introduction of RSV and RSV vaccine, possibly in the fall, in addition to seasonal influenza, COVID-19 vaccine, is it possible that the system will be– would accommodate those three vaccines in the fall?
Anne Hause, CDC [10:15:28 AM]
So our focus is going to be probably on new vaccines or new platforms for vaccines for existing pathogens. We would love to have this system ready for the fall, but we will have to just see how things pan out. That would certainly be our goal. But at this point, I don’t think we can commit to that quite yet.
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Robert Califf, FDA [10:38:07 AM]
So what are we doing at the FDA to deal with this situation?
First we’re working to improve our general approach is scientific communication to the public. This includes more frequent, scientific communication, but also has a major component of improving communication directly to the public professional societies and advocacy groups paying a lot of attention to the best language for the particular audience. All too often in the past, our communications were highly technical and not interpretable by the general public.
Second, when issues arise that either required decisions or complex actions, like recalls or warning letters on tobacco, we routinely consider the opportunity for a, quote, pre-buttal, unquote, anticipating the counter arguments as an essential part of preparing even the most routine scientific decisions these days.
Third, when misinformation appears in a way that we can see that it’s having an impact, we do everything possible to rebut quickly before the misinformation is broadly disseminated. One of the things we’ve done at the FDA is to start a quote rumor control page on our website. It’s designed to prevent false and potentially harmful information by providing specific facts about individual topics that may be trending.
For example, the currently featured topics on our page are COVID 19, sunscreen, and dietary supplements. The page has several other important features as well, including general health information for consumers resources about the FDA and what the agency does. And perhaps most importantly, some basic tools to help stop the spread of misinformation, including ways to report misinformation online. The site also includes a consumer focused set of videos that we produced on how to identify and help stop the spread of health misinformation. Now this website is in its early phase, it is publicly available, but we hope to add to over time.
Fourth, we continue to work on our interactions with the press, as they include all three elements I’ve already mentioned. For example, it’s not unusual to see a headline designed to draw the readership to the article that may not accurately represent the body of the article. And we found that by intervening quickly, we can often get the headline changed to a more accurate representation.
Finally, we’ve commissioned the Reagan Udall foundation to help us develop a long term strategy to deal with this issue. We expect a report– the foundation is working with multiple parts of the ecosystem, including patient groups, public health advocacy groups, the industries we regulate, and the academic community to get input on the strategy.
One thing we’re not doing is suppressing free speech. The first amendment is fundamental to the fabric of the United States. There is however, the looming question of the responsibility of institutions, for example, when a faculty member or employee voices misinformation, and I’m not, um, saying that the government should intervene in those cases. And I’m not saying, I know the answer is to how institutions should handle these situations, but it’s something that we all need to be discussing and thinking about.
Finally, we’re actively working on the issue of the use of AI and large language models in the production and promulgation of misinformation. And if you follow this at all, you’re aware of both the breathtaking possibilities of large language models, but also the extreme risk that can exist through hallucinations and other fabrication of information and, visual representations that look just like the person.
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Kimberly Armstrong, BARDA [03:04:29 PM]
So BARDA continues its work to be prepared for a potential influenza pandemic in light of the high amount of avian influenza circulating globally, including in North and South America.
So BARDA is sponsoring Seqirus sponsored phase two clinical trial, which is randomized, observer blind, and it will evaluate different priming and booster regimens with MF59 adjuvanted H5N8 and H5N6 cell culture derived influenza vaccines. And we are super excited that this study should begin this summer.
In addition, BARDA is supporting GSK in a phase one-two, observer blind, randomized, multicenter trial to evaluate the safety and immunogenicity of different formulations of monovalent influenza A Astrakhan virus vaccine, both AS03 adjuvant system. And again, this study is also scheduled to start this summer.
Both these vaccines are really highly matched to what we’re actually seeing circulating in the birds in North America, which is fantastic news.
So in addition to our ongoing support of currently approved recombinant proteins cell and egg based influenza vaccines, BARDA is continuing to support development of additional platforms that may further accelerate the response to a pandemic such as mRNA.
We are pleased to announce that, in partnership with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, we have partnered with Access to Advanced Health Institute and AstraZeneca to develop pandemic influenza RNA vaccine candidates.
Peter Marks, FDA [09:10:01 AM]
I just want to take this opportunity to say that, although I think we all certainly agree that COVID-19 is not influenza, from a public health vaccination campaign standpoint, in which you need to make tens upon tens of millions of vaccine doses, get them deployed, and get them into people’s arms, and from the standpoint that people go inside, in the United States, during at least in many states in the United States during the months of November through March, it reduces to a similar type of campaign, barring some exceptional development of a resistant virus for us.
So I think we’re what we’re seeing here is I think we are, though it’s not influenza, for practical purposes I think we have really a one chance this fall to get vaccines into arms, barring some need to update further, which we will do, if need be. But that’s, I think, what today’s discussion is about. How to try to best come up with what goes into people’s arms, to offer the best protection during a period when I think we do believe we’ll have waning immunity, at least in, particularly in the older population, but probably throughout the population, as well as potential further evolution of the virus.
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Ruth Link-Gelles, CDC [09:36:53 AM]
I’ve actually broken out here VE against hospitalization from the VISION Network, amongst those 18 to 64 and 65 plus, thank you, yes. So these are updates from what was shared in the MMWR in May. And you can see here, I think, generally pretty similar patterns across older and younger groups. We’ve seen this phenomenon before with COVID where, sort of unexpectedly, VE appears to be higher, more sustained, in elderly individuals, which is not the same pattern that we see in other diseases.
I think this is likely due to some behavioral factors. We know from other studies that older adults have been more likely to continue masking, continue social distancing. So that’s gonna play into VE. We also know that older individuals have lower rates of prior infection, which means the vaccine sort of has more room to provide additional protection. And so I think we’re picking that up here. But for the most part here, we’re not seeing sort of more severe waning in those 65 plus.
I will say we are not powered. We don’t have statistical power here to break out the most elderly age groups, and what we saw back in the era of monovalent vaccines, when we had higher rates of both vaccination and hospitalization, and could break out sort of 65 plus, 75 plus, and 85 plus, that it was really the 85 plus that had the quickest waning, which I think makes sense from literature from other vaccines as well.
Again, we weren’t able to do that here, but if you sort of take that data from the monovalent era, combined with what we know about immunocompromising conditions and so on, it makes sense that sort of the oldest individuals are probably at the higher risk, but we just aren’t powered here to pick that up.
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Kanta Subbarao, WHO [10:52:18 AM]
The second question is about how related these are. So I think I’d really want to emphasize that, unlike the way people think we do this for flu, we really want to achieve the breadth of immunity that would cover these strains and you could see that they are quite related. And so we’re trying to achieve breadth that would cover XBB.1 descendant lineages. And I think that to me is more important than sort of saying exactly which.
So we’re not trying to match exactly what’s going to circulate. We want to provide the breadth of immunity that covers that class of viruses.
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Kanta Subbarao, WHO [11:03:31 AM]
Why would we not go with the most recent virus? Because I do believe that we need some data on antigenic cartography. We need to know how distant it is. We need to know a little bit about the performance of the– of that particular spike, either in infection or vaccination, at least from preclinical data.
So I don’t think we’ll ever be in a situation where we could just jump on the most recent one, because we don’t actually know how different it is from something that we know a lot more about. And so I would like us to continue to have some confidence from the data that we have a sense of what’s happening with, say this XBB.1 descendant lineage, for instance.
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Darin Edwards, Moderna [11:30:42 AM]
In summary, preclinical data suggests that an XBB containing vaccine is more immunogenic against currently circulating XBB variants than the authorized BA.4/5 bivalent vaccine.
Consistent with the minimal antigen differences seen across the XBB subfamily, cross neutralization across the XBB sub-lineage for both XBB containing vaccines was demonstrated.
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Rituparna Das, Moderna [11:39:07 AM]
Preclinical data suggests that an XBB containing vaccine is more immunogenic against currently circulating XBB variants than the authorized BA.4/5 bivalent vaccine.
Our clinical study demonstrates that XBB.1.5 containing vaccines elicit robust cross neutralizing antibodies against all XBB variants. The neutralization titers generated by the XBB.1.5 vaccines are very similar against XBB.1.5, XBB.1.16, and XBB.2.3.2.
The safety profile of the variant containing vaccines continues to be very similar to the previously authorized vaccines, both the original COVID 19 vaccine, as well as the bivalent.
We confirm that Moderna is prepared to provide adequate supply of a new variant containing vaccine for fall of 2023, based on the recommendation made today by the FDA.
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Kena Swanson, Pfizer [12:00:31 PM]
We would like to share our plans for supply of the 2023-24 formula, both in timing and vaccine presentation, based on anticipation that a fall campaign would begin in August and subject to regulatory approval, monovalent XBB formulations would be available.
If a completely different formulation is chosen, this would follow the timeline from strain selection to vaccine availability of approximately 100 days, moving the vaccine availability to October.
The proposed timing of supply in August aims to better align with the timing of the influenza vaccination campaign, where the majority of doses are distributed already by the end of September in the U.S. This approach could help to maximize vaccine uptake and protection against COVID 19 for the fall winter season.
Finally, this fall, we will also be transitioning to a single dose unit as the primary presentation, which should also support improved access and ease of administration.
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Kena Swanson, Pfizer [12:01:43 PM]
In conclusion, the collective preclinical and clinical data shown today support a monovalent XBB containing vaccine for the 2023-24 formula based on three key findings.
First, the XBB cluster of Omicron sublineages continues to dominate the variant landscape, improved humoral and cell mediated immunity that aim to protect against the spectrum of COVID 19 outcomes, and finally, pre-clinical data supporting that an optimal immune response can be achieved with the antigenically similar monovalent XBB adapted vaccines, based on XBB.1.5 or 1.16.
And the current sero-epidemiology, together with collective real world evidence, support a single dose for those five years of age and older, regardless of vaccination status.
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Filip Dubovsky, Novavax [12:25:18 PM]
I’ve shown you data, the vaccinating with XBB.1.5 induces comparable neutralizing responses to XBB.1.5 and 1.16. And that monovalent XBB.1.5 appears to be better than a bivalent.
The U.S. population is well primed with serial infections and serial vaccination today that monovalent XBB.1.5 boosts well, induces comparable neutralizing responses to other XBB subvariants as relevant. And XBB.1.5 is antigenically similar to XBB.1.16 and importantly to XBB.2.3 and furthermore XBB.1.5 induces antibodies that block XBB.2.3 from binding to the human ACE2 receptor and finally XBB.1.5 induces, poly-functional TH bias CD4 cellular response to the other XBB sub variants.
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Filip Dubovsky, Novavax [12:26:05 PM]
Our approach has been to manufacture the vaccine at risk, and we continue to manufacture XBB.1.5 at commercial scale. And, we’re filling this in single dose vials to support the U.S. fall vaccination campaign. The selection of a strain other than XBB.1.5 will result in delay to our vaccine’s availability.
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Filip Dubovsky, Novavax [12:27:43 PM]
We’ve previously talked about for a common protein vaccine like ours, it’s much like the flu timeframes. So we need pretty much six months from when a strain is named to when we can have commercially available product.
Now we have other candidates that we’ve advanced through the manufacturing process. The next one would be 1.16. It’d be available approximately eight weeks after 1.5.
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Time codes past this point off YouTube video, not time of day.
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Jerry Weir, FDA [06:01:08]
I think it’s obvious to all of us now that updating this SARS CoV 2 strain composition of COVID 19 will be a continuous process. It would be great if it wasn’t and that it was stable, but it doesn’t look like it now. Whether the rate of change will continue, none of us know, but we have to be prepared that this is going to be a continuous process.
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Jerry Weir, FDA [06:16:46]
As we outlined in January, we expect an extensive data package from each manufacturer, once a recommendation is made, an extensive data package from each manufacturer to support their vaccine.
Things that you mentioned, like concomitant studies, all of those would be discussed with manufacturers. They would be prepared, I’m sure, to do the studies that we would need to evaluate that type of situation.
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Eric Rubin, VRBPAC [06:54:52]
I think what has been so helpful today is that there’s been a consistent message from all of our discussions, from the CDC, from the FDA, and from the manufacturers. And I think it makes it pretty a pretty simple question here.
The monovalent, there doesn’t seem to be any particular advantage to a bivalent vaccine. XBB is the lineage right now, and there is good cross protection, no matter what antigen is chosen, according to the data that we’ve been shown.
I think that the question of periodic, is it reasonable– Is it reasonable whether or not the word periodic should be in there is a reasonable question. However, I think that we need a new– we need a better vaccine. We should be updating it. And I think it’s pretty straightforward.
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Amanda Cohn, CDC [06:59:00]
Asking if we should be updating the current composition? Absolutely. To a monovalent? Yes, agree. We no longer need the Wuhan strain. And to this lineage? I would agree with that as well.
I think I do want to be careful that we don’t– that we’re clear that this is for this update it’s monovalent. It may not be monovalent in future updates.
And I do agree, I actually think the 2023 to 2024 formula language is more confusing than the periodic update. I think we’re recommending an update. I think the language be, do you recommend an update now? And whether or not that formula will carry through all of 2024? We can’t really say.
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Peter Marks, FDA [06:59:54]
I hate to be contrarian, but, from a public health perspective, people need to be able to understand what we’re actually doing. And there’s only so fast that our manufacturers can actually change things. So in order to make a few hundred million doses of vaccine, essentially, practically, we’re gonna have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different, that it requires us to mobilize tremendous resources to address that strain change.
So for practical purposes, what we’re talking about here, I think we– I– we can strike periodic, but for practical purposes, so that the manufacturers can get on with this and actually label their vaccines, it’s the 2023-2024 formula that they’re making right now. And that’s what’s planned.
That doesn’t mean, just like for pandemic influenza, that something couldn’t happen that could make us need to intercede here. And so I think this is– I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza.
People understand a yearly influenza vaccine. At this point, it may not be yearly, but for all intents and purposes, it looks like probably by next fall, there’ll be further drift from this, and we may have to come back here. And so I think this is our best effort to try to help make things clear.
And I have to say, we have to do better because we have not done a good job date communicating to the American public what’s going on here, because they’re still not getting these vaccines in the way we’d like to potentially see people, even those over the age of 65, get vaccinated. So this was our effort to try to clarify things.
And yes, I think periodic was just meant to mean that this is not going to be– what we end up with today, after today will not be the final. It’s not like MMR. This is not going to be the final formulation for this vaccine forever more. It will probably require another update at some point.
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Peter Marks, FDA [07:06:33]
I think we agree with you completely, that we would probably follow the WHO here, and probably look at this twice yearly as well, because it probably does make sense. And I think our sponsors would probably like us to do this as well, because, I think Dr. (unclear) point was very well taken, that we need to think about not just the Northern hemisphere, but the Southern hemisphere, middle latitudes as well.
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Peter Marks, FDA [07:10:12]
I think no one will disagree, and I certainly won’t, that we need a better generation of vaccines that would offer a better breadth, duration, depth of protection. But I think we’re here right now with what we have.
And until we see that next generation come, which probably is at least, at least probably two years away at the rate we’re going.
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Arnold Monto, VRBPAC (Chair) [07:36:50]
For the 2023-2024 formula of COVID 19 vaccines in the U.S. does the committee recommend an update – no word, periodic, an update – of the current vaccine composition to a monovalent XBB lineage? Yes, no, or abstain.
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Peter Marks, FDA [07:47:12]
I think ideally we’d like to have the composition be similar and I think it’s not unreasonable, in order to guide the discussion at this hour, I think what you heard from the manufacturers is that the XBB.1.5 looks like– it seems to be at the front of the line because of some of what is available in terms of its manufacturing and its properties.
So it might be helpful to hear a discussion of anyone who thinks about that we should consider the other variants instead, because I think that if everyone– just by way of full transparency, if everyone says that there’s no preference in the committee, my guess is that I, although I can’t say for sure, but my guess is we would go back and go towards XBB.1.5.
So might be good to hear discussion of any thoughts for things other than 1.5 in part, because, that would allow the composition to be similar for all of the vaccines to be made available in a very timely manner.And because the data seemed to show that that particular variant seems to have very good neutralization against across this, this group of XBB variants, including 2.3.
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Peter Marks, FDA [07:51:11]
I think the best I can suspect, and I’ll ask Dr. Kaslow to comment too, is given there’s the manufacturing issues, and then there’s the supply issues and other regulatory issues, my guess is we’re looking at something in the September timeframe, for seeing a rollout, but don’t hold me exactly to it, but I think September-ish sounds correct.
Dr. Kaslow, thoughts?
David Kaslow, FDA [07:51:43]
Yep. That’s it. I agree with you Dr. Marks.
And to get back to an earlier conversation, and there’s other evidence gaps that need to be filled in order to get these approved. And some of them may still be in the authorized versus approved status. So September sounds reasonable.
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Arnold Monto, VRBPAC (Chair) [07:57:09]
So, in summary, we in general feel that the XBB.1.5 would be preferred. We don’t have any strong feelings about using other variants, but the fact that most of the manufacturers are ready to work on an XBB.1.5 is an added reason to select this strain or this variant, given the immunologic data.
And we’ve always made the point that we’re not chasing variants. And even if other variants, in this XBB lineage become more prominent, the XBB.1.5 seems to elicit appropriate antibodies.
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Peter Marks, FDA [07:59:50]
What we heard today is that we did hear the recommendation for an updated composition to an XBB containing monovalent vaccine. We did hear the preference for an XBB.1.5 vaccine, and we’ll make a decision quickly regarding the specific composition to recommend to manufacturers for the coming season.
I think our decision obviously will incorporate what we’ve heard today. And I don’t think it will come as any surprise based on the discussion today. And then we anticipate that the manufacturers will be moving forward, with manufacturing and then obtaining data and filings needed to inform our ultimate FDA actions in order to have vaccines evaluated with our safety and effectiveness standards for availability in the September timeframe.
Vivien Dugan, CDC [00:01:13]
A lot of the work that we do at CDC is part of seasonal influenza surveillance. And so we’re tracking and checking and making sure that we know which viruses are circulating in the U.S. and globally each year, but that serves as an exercise for us, for being prepared for pandemic influenza as well. So pandemic influenza can start anywhere in the world. These are often viruses that come out of the animal populations, wild birds, and swine, and can make people pretty sick.
And so I think that as we are ready for seasonal influenza, we had a pretty robust season this year in the U.S., with the co circulation of COVID 19 and RSV, we are watching what’s happening around the world in the Southern hemisphere to make sure that we are ready for whatever may happen in this coming season, in the fall and the winter months.
Question [00:01:58]
So do we anticipate it’s going to be worse? Do we know yet? Are we able to sort of forecast out what we’re expecting?
Vivien Dugan, CDC [00:02:05]
Yeah, it it’s really challenging. You know, I think if you’ve seen one flu season, you’ve seen one flu season. This is one of our many sayings in the flu space. We don’t know.
We do watch and analyze what’s happening in the Southern hemisphere quite a bit. And so we’re seeing activity in Australia, several other countries like Bolivia, Indonesia, as well as Chile that have started in earlier, a couple months, couple weeks to months earlier this year. And so, that could be an indication that we may have an early season, but there’s a lot of factors that play into this from population immunity, available vaccination, viruses change.
You know, when we think about flu, it’s not just one virus, it’s actually three to four viruses each year that circulate around the world. And so that’s always flu season somewhere. So in the Northern hemisphere, it’s our winter, but right now it’s winter in the Southern hemisphere. And so that activity is starting to pick up.
Dr Teresa Buracchio, FDA [00:11:53]
You may have noticed that today’s advisory committee is smaller than is typical. In accordance with relevant laws and regulations, ahead of any advisory committee meeting, FDA reviews the need for recusal of potential advisory committee members.
For some topics like today’s meeting, there can be a greater extent of recusals than for others. In particular, there was a recent submission to the docket for this meeting that included a large number of signatories, and that impacted our decision on the inclusion of several experts for this meeting who had otherwise been cleared to participate in this advisory committee.
Dr. David Weisman, who was to serve with a waiver, which was accordingly posted on our website in advance of this meeting, is one of the experts that was impacted by this submission. I would note that his other activities publicly listed in the waiver are consistent with our policies and procedures for serving on the committee with the waiver, because his expertise and knowledge of this topic outweighs the potential for a conflict of interest created by the financial interests.
Today’s smaller than usual committee reflects these challenges. While this group is small, it contains the appropriate expertise necessary to have a robust discussion on the topic at issued today, I would now like to start the meeting by thanking the committee for the time that they have taken to review the advance materials and for joining us today today to discuss the topics that are under consideration for this application. Your perspectives and input are very valuable to the agency.
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Dr Teresa Buracchio, FDA [00:13:47]
So before describing some of the issues, we will ask you to discuss today, I want to stress that we have not made any final decisions on the approvability of this supplemental application. Our comments in the background package are preliminary and do not yet take into account today’s proceedings.
Our presentations should not be viewed as necessarily indicative of our final decision. The reason we are here today is to gain your input into some of the challenging issues we have faced during our review process, so that we may incorporate it into our decision on approvability.
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Dr Teresa Buracchio, FDA [00:23:22]
Again, no final decision has been made on approvability of this supplemental application. And we very much look forward to the insights you will provide. We have convened this committee because we feel that a final decision requires your input and advice.
MEGHAN PENNINI, ASPR [00:29:56]
We have said, in other forums, that we do expect a transition to commercialization in the fall for the vaccines. So that of course will change the picture. And the timeline for commercialization of the therapeutics, the treatments, the oral antivirals, is even further out.
We have a tentative date for molnupiravir, which is the end of this calendar year, and still working on a tentative date for Paxlovid.
But again, current state of play is we are distributing these products, and we’ll continue to distribute them for, at no cost, of course, because those were procured by the U.S. government.
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JOHN FARLEY, FDA [00:40:26]
The EUA continues and it continues to authorize Paxlovid for emergency use to treat certain eligible pediatric patients. So those are adolescents, down to age 12 and 40 kilograms, and that’s a patient population that’s not covered under the NDA approval at this time because pediatric drug development is still ongoing.
Of course, we’re working with the sponsor to expedite that. And I would expect that you will see approvals over the near future that will begin to step down the age groups.
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JOHN FARLEY, FDA [00:41:06]
So Paxlovid also remains authorized under EUA to ensure continued access for all eligible patients to the U.S. government supply of EUA packaged Paxlovid. And that includes adult patients who are the subject of the approved NDA. Now, just to, to step back for a minute, the EUA packaged Paxlovid, while they are the same tablets, it’s not the same packaging. And when FDA does a drug approval, they consider packaging. And it’s not just kind of what the box looks like.
In this case, there are changes in the configuration in the package, and the EUA product, as you’re aware, there’s a single blister card for every day. For each day there are five blister cards in the pack in the box. And there actually were quite a few medication errors with that configuration, which continue.
Oddly enough, they were mostly by men. And my theory is that actually many women are used to blister cards from oral contraceptives. Men are not, and they would do things like take both ritonavir tablets at night and four nirmatrelvir tablets in the morning. And that was a fairly common occurrence.
So we worked with Pfizer in the course of the NDA to adjust that packaging. So the approved packaging will basically have a blister card for every dose. So it says, this is your morning dose, take everything on this blister card. And hopefully that will reduce some of the medication error risks.
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BRENDAN JACKSON, CDC [01:04:58]
There’s a lot of talk about trying to create a more integrated respiratory disease metric where we’re sort of reaching the end– well, we don’t know– we know that we need to be integrating COVID into other respiratory pathogens. They’re here now, they’re present, we need to get away from COVID exceptionalism.
I can’t give you an exact timeline on that, but it’s something that we’re actively working towards. At the very least, we’ve got a couple dashboards that show COVID, RSV, and flu all together. We can drop those in the chat, as you can see with emergency department visits and hospitalizations, about where those are trending over time.
The longer term– Alex Kallen to talk about the healthcare specifics of– the longer term goal is to have some sort of like widget that could be go on your weather app or otherwise that tells you how much respiratory disease is in your community. And just a super simple thing for the public, certainly healthcare professionals may want something that’s more in depth.
| Location | 31-May-23 | 24-May-23 | Difference |
|---|---|---|---|
| Total | 30450 | 30422 | 28 |
| Illinois | 1471 | 1461 | 10 |
| California | 5763 | 5759 | 4 |
| District of Columbia | 531 | 527 | 4 |
| Texas | 3012 | 3008 | 4 |
| Missouri | 222 | 219 | 3 |
| New York | 4255 | 4253 | 2 |
| New Hampshire | 36 | 35 | 1 |