Alexander Tin's notes

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July 2, 2024

HHS and USDA press conference on bird flu vaccines and outbreak

Dawn O’Connell, ASPR [00:11:13]

mRNA technology allows for accelerated initial vaccine development and complements current rapid production capabilities.

Moderna’s mRNA pandemic flu vaccine is currently in early clinical development. The timeline may change, but we anticipate starting phase three trials in 2025.

This is a data driven process and requires collaboration with our industry partners and feedback from government partners.

I also want to highlight that while the base award will support a vaccine for H5N1, the contract also supports development and procurement of a vaccine targeting new strains of influenza or other emerging infectious diseases.

This approach enables flexibility to pivot to new threats in the ever changing global public health threat landscape.

…

Eric Deeble, USDA [00:16:52]

Most importantly, we want to continue to reiterate in this forum and in every forum, just how critical enhanced biosecurity is to containing this virus and present preventing its spread among the nation’s dairy herds.

Producers, whether their herds are affected or not, must take extra precautions to limit people coming on and off their farms take appropriate steps to clean and disect equipment, and clothing, and do all that they can in order to enhance biosecurity to limit the spread of this disease.

…

Nirav Shah, CDC [00:23:41]

I’ll start with an update on our current capacity for influenza testing in the United States.

Reassuringly, we have an ample number of H5 specific tests in the public health system for the current outbreak.

As of right now, there are roughly 750,000 H5 specific tests available today. And another 1.2 million such tests coming online in the next two to three months.

This is on top of a robust supply of influenza A test, the general tests, that are available at doctor’s offices around the country.

Those influenza A tests, the more general tests, are the first tier in the approach to testing. And those influenza A tests are plentiful and widely available.

…

Question [00:34:21]

Can you tell me what the capacity is for Moderna to manufacture? How many doses would they be able to do and in what sort of timeframe?

…

Robert Johnson, BARDA [00:34:34]

So at this point, it’s too early to tell. We need to see the data around what the dosing will look like, and that’s true, both for pandemic influenza, as well as for any emerging infectious disease where the ability to manufacture be really be dependent upon the data that we’re waiting to see later this year.

…

Eric Deeble, USDA [00:38:51]

We do know that the vast majority of farms practice biosecurity, and that includes dairy farms, practice biosecurity.

But this is a new and emerging disease that calls for a different set of biosecurity practices or enhancements of specific ones.

So many dairies are already using what’s called the FARM program, and that is a baseline biosecurity, and we’re making recommendations that folks go beyond that and supporting them financially so that they can do so.

…

Robert Johnson, BARDA [00:39:43]

So this, the shelf life, will actually be data driven. It hasn’t been determined yet.

And ultimately that will be an FDA decision on what type of shelf life to get that.

…

Nirav Shah, CDC [00:40:04]

This is all under discussion right now. We are, as we always are as a scientifically driven set of organizations, always evaluating pros and cons of risks, benefits, upside and downside of any potential measure, including vaccination for farm workers.

In this situation, we’re looking at partly the risk, but really, in addition to that, factors like what might demand be based on what the perception of severity is, and then also what what are we intending to vaccinate against?

Vaccines tend to be better at preventing severe disease, rather than transmission. If our goal here is to prevent transmission, for example, which is certainly one of our goals among humans, we’re also analyzing whether there might be intermediate measures, for example, more widespread distribution of antivirals that may achieve that goal even more quickly.

So it’s not so much strictly what the downsides are, but it’s also a question of what the potential uptake might be, as well as what the goal of the overall effort is.

…

Question [00:46:40]

Is there any talk about doing a financial assistance program for workers who may need to take leave if they are sick, or if they do test positive?

I know that’s a concern with $75 a day, for getting the test is one thing, but what if they test positive? Is there additional assistance for them?

And relatedly, is there talk of a campaign for seasonal flu vaccines this fall thinking about reassortment and other concerns like that? Thank you so much.

Nirav Shah, CDC [00:47:11]

I will start with the latter of your questions.

I referenced earlier that I’ve been having meetings with state health officials, epidemiologists, and state health directors to talk about near term, medium term, and long term planning.

And both of the items that you discussed have been on the agenda for some of those meetings, we’ve talked about them with those groups, and we’ve talked about that internally as well.

Again, we, we try to talk about everything that’s a viable option, even if it’s something that we’re not able to actually do.

More to come certainly on the seasonal piece, because we acknowledge that there is both something that’s – it’s important for a group of workers who may not have the steadiest access to healthcare to have a dedicated channel through which to obtain essential healthcare like seasonal flu shots.

We also recognize that there’s a– they are in a particular place in the animal human interface, and may be coinfected, and that there may be epidemiological consequences.

So, more to come, but that’s been under active discussion.

Likewise, with respect to something akin to sick leave, no final decisions on either of those yet, but other than active discussions around both.

…

Dawn O’Connell, ASPR [00:49:48]

They’ve got 4.8 million in bulk that they have begun fill finishing. And our expectation is that those first doses begin coming off the line in the middle of this month.

Every indication is that timeline continues to hold, and we will begin seeing the doses middle of July continuing to roll off through August, which is very efficient from the perspective of our planning.

It was faster than we had initially anticipated. So we’re really pleased that that timeline continues to hold.

…

Nirav Shah, CDC [00:51:21]

We, along with our partners both across the USG, but also with our colleagues, such as those on ACIP, we’re thinking about sort of, as I noted with Alex’s question, what the goal of vaccination might be, first and foremost, for farm worker health.

To reiterate for everyone, the risk that the general population right now remains low and CDC’s assessment of that has not changed.

But with respect to livestock worker vaccination, if our goal is to reduce the number of infections that may occur, we have to wonder whether vaccination is the best route for that, or whether there may be other routes that are faster or even more effective such as, as I mentioned, more widespread use of antivirals.

So question number one is what is the goal we are aiming toward there and is vaccination the right tool to get us toward that goal.

And then if so, then we engage in more of a discussion about the benefits, as well as what the uptake might be.

If right now, H5 is not perceived as a pressing threat among farm workers, and I’m not speculating as to whether it is or not, but if that is the case, then uptake may not be robust.

Rather other mechanisms, again, may be better suited to achieve the goal that we want there. So that’s the evaluation that’s underway.

As has been said before, no final decisions are made, but we are in the process of robust discussion, as we should be for any scientifically driven venture.

…

Nirav Shah, CDC [00:55:36]

Today, we are not aware of any cases of H5 among humans in the area, nor are we aware of any markers of cases among humans, emergency department visits, reports from clinicians, any of those systems that we normally query to an understand what may be happening, none of those has signaled a possibility of H5 infection among humans.

And so if it’s not among humans, what might it be? And we are investigating different hypotheses.

The San Francisco metropolitan area is not known for its dairy industry. So that’s not high on our list of hypotheses.

What is higher on the list is at least one or two live bird markets. Again, I want to stress, this is a hypothesis that is under investigation, but rather than the conclusion, we are working with the San Francisco Department of Public Health, as well as the California Department of Public Health, to better understand whether the timing of those bird markets and the subsequent cleaning of those markets aligns with the wastewater samples.

No conclusions as of yet. We are investigating, however.

July 1, 2024

CMS spokesperson on coverage of donanemab if approved

Alzheimer’s disease is a devastating illness that affects millions of Americans and their families. CMS is committed to helping people get timely access to treatments and improving care for people with Alzheimer’s disease and their families.

In July 2023, CMS began offering broader Medicare coverage for Leqembi (the brand name for lecanemab) under the National Coverage Decision (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease through the Anti-Aβ mAb Coverage with Evidence Development (CED) Study after the FDA granted traditional approval to the drug for the treatment of individuals with Alzheimer’s disease.

Under the NCD, to receive Medicare coverage for Leqembi, or any other anti-amyloid mAb that receives traditional approval from the FDA, people need to: 1) be enrolled in Medicare Part B; 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia; and 3) have a physician who participates in a qualifying study with an appropriate clinical team and follow-up care. The CMS National Patient Registry has been established where clinicians participating in the Anti-Aβ mAb CED Study will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.

There have been three additional CED studies that have been approved by CMS that would qualify for coverage of anti-amyloid mAbs that have received traditional approval from the FDA. All information regarding these CED studies and the CMS National Patient Registry can be found at: cms.gov/medicare/coverage-evidence-development/monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease-ad.

CDC officials at mpox COCA webinar

Agam Rao, CDC [00:09:59]

So at this time, vaccine effectiveness is not waning. Serologic studies have shown vaccine titers decrease a few months after vaccination.

We know that this has gathered a lot of media attention, but levels of circulating titers are not the only marker of protection. There’s other markers of protection, cell mediated immunity, innate immunity, and those things haven’t been measured.

So the actual clinical significance of waning vaccine titers is really not known. It’s typically real world data that helps guide our decisions about policy.

And there there has been some analyses that we performed that were published and that has shown that infections after two Jynneos doses in the United States or breakthrough infections, as we call them, are very rare.

They’ve occurred in less than 1% of people who were fully vaccinated, have been associated with less severe infections when they occur and they’ve occurred at disparate time intervals after vaccination.

So, even as recently as a few weeks after the second dose was administered, all the way to several months or even years after vaccination. Next.

All of this has led to a CDC recommendation that booster doses are not recommended at this time for people who were vaccinated as part of this outbreak. And if you’re interested in seeing more information about the data that went into that, and I’d suggest reading the MMWR publication, the reference of which is at the bottom of this slide. Next.

So just to reiterate, at this time, the vaccine recommendations for people impacted by the ongoing outbreak are unchanged.

People who have recovered from mpox, or people have received the recommended two dose Jynneos series, even if it’s been two years since they were vaccinated, do not need any additional mpox vaccinations at this time.

…

Agam Rao, CDC [00:14:00]

Now, despite this vaccine being available for as long as it has and the interest that was in the vaccine very early on, there hasn’t been that much uptake in the vaccine or interest in getting both doses of the vaccine.

The data on this slide is through January 9th, 2024. But we believe that it’s not too much different at this time. And at that time, only 25% of the people who are recommended to receive two doses of the vaccine had received both doses of the vaccine.

We understand from various focus groups that our experts in the division of STD prevention have conducted that some of the reason might be related to not thinking that mpox is in the news.

But we’re hoping that now that this is on the routine immunization schedule and that clinicians know that it is still a problem in the United States, including causing very severe infections, such as that result in death, that there may be more coverage, vaccine coverage for the individuals most at risk.

…

Meghan Pennini, ASPR [00:29:50]

So I just want to remind everyone for Medicaid and Medicare, because this is within the ACIP recommended immunizations, there is full coverage for all beneficiaries, Medicare and Medicaid beneficiaries that fall within the ACIP recommended populations.

For commercial insurance, so for those who have private insurance, we do expect, and we are hearing, that private insurance plans do intend to fully cover this product, again, likely within the ACIP recommendations.

And just a reminder that these private insurance plans are obligated to cover the first plan year that begins one year after the ACIP recommendations.

So while they’re not fully obligated right now, we are hearing that they do intend to cover, and we are hearing that there is coverage.

…

Meghan Pennini, ASPR [00:30:46]

So for those who are underinsured or uninsured for under or uninsured individuals, we rely on some of the programs, the immunization programs we rely on for other immunizations, such as the CDC 317 and Vaccine for Children programs, and those will be available. So this vaccine will be available under those programs.

Of course, for Vaccines for Children, that provides vaccines for uninsured and underinsured when served in certain clinical sites, such as FQHCs and rural health clinics. That of course in this particular case only applies to 18 year olds, because again of the ACIP recommendation being for 18 years and above.

For those 19 years and above, the 317 program can be used by jurisdictional partners to serve some of those adults. And we do expect the ordering through those programs to open on or near August 1st of this year.

So just a few, in about a month or so. Next.

Of course, Ryan White and other HRSA supportive clinics are also important engagement points for the populations that are at risk. And those can also provide access for under and uninsured populations.

HRSA grant and Ryan White HIV AIDS program funding may be used to purchase and administer Jynneos vaccine. And there’s more information around that, at that link, that HRSA.gov link that’s on this slide.

We’ll also mention that there’s 340B prime vendor programs that are up and running that can offer reduced price to provider sites.

…

Yon Yu, CDC [00:44:34]

Resistance has been identified in over 50 patients with mpox, including those who developed treatment emergent resistance to tecovirimat, 11 in tecovirimat naive individuals, and most recently, a new cluster of tecovirimat resistant mpox variant detected in 18 patients from five states.

…

Agam Rao, CDC [00:59:24]

So at this time there is no recommendation, travel associated recommendation, but the 2022 ACIP recommendations do say that for those who are part of mpox response teams.

And by that, we mean someone who might be traveling to DRC as part of Doctors Without Borders, for example, and providing care to patients with mpox, then those individuals should be vaccinated because they don’t have access to the PPE that we have here in the United States.

As far as people who are working in DRC, it’s still a rare disease in most parts of the country. I think there was something in the chat about south Kivu.

I mean, the State Department really isn’t allowing people to travel to south Kivu for work because it is a conflict region. So I don’t think that in the high concentration regions where there is mpox, people would be traveling for work.

If there is such a situation that arises for someone who is traveling for other reasons, then please do reach out to at poxvirus at cdc dot gov, and we can handle those situations on a case by case basis.

But we’re just not a aware of this happening much if, if at all, and want to keep the recommendation as simple as possible at this time.

CSL Seqirus spokesperson on H5N1 vaccine approval

Checking in to see if there’s any comment to share on what regulatory pathway CSL expects to pursue to authorize use of the pre-pandemic H5 vaccine? Do you know how long that process is expected to take?