Alexander Tin's notes

tinalexander.github.io / notes / 2023 / 08 /

Learn more about this site and how to get in touch.


August 31, 2023

CMS spokesperson on Medicare coverage for COVID and RSV vaccinations

The following is provided on background, attributed to the Centers for Medicare & Medicaid Services or a CMS spokesperson:

Thanks to the Inflation Reduction Act, people enrolled in a Medicare prescription drug plan can receive recommended adult vaccines free of charge. Part D plans are required to provide the new RSV vaccines with no enrollee cost sharing when used consistent with ACIP recommendations.

As of June 27, 2023, the list of “recommended” vaccines expanded following the announcement that the Director of the Centers for Disease Control and Prevention endorsed the Advisory Committee on Immunization Practices recommendations for use of new Respiratory Syncytial Virus (RSV) vaccines. This means that RSV vaccines (Arexvy and Abresvo) that became commercially available this summer are covered under Medicare Part D with no cost-sharing for enrollees, if used consistent with ACIP recommendations. If a Part D enrollee is having trouble obtaining RSV vaccine coverage at the pharmacy or doctor’s office, or is charged any amount, they should contact their plan or 1-800-MEDICARE for assistance.

People with Medicare coverage continue to have access to COVID-19 vaccinations without out-of-pocket costs after the end of the public health emergency.

Once the federal government is no longer purchasing or distributing COVID-19 vaccines, people with Traditional Medicare pay nothing for a COVID-19 vaccination if their doctor or other qualified health care provider accepts assignment for giving the shot. People with Medicare Advantage (MA) plans should contact their plan for details about payment for COVID-19 vaccines, but MA beneficiaries will pay nothing for a COVID-19 vaccination if they receive their vaccinations from an in-network provider.

August 30, 2023

Kaiser Permanente spokesperson on RSV vaccinations

The FDA has approved a vaccine for protection against severe illness from respiratory syncytial virus (RSV) that may be administered to people 60 years and older under shared decision-making with their health care provider. The clinical guidance from the CDC states that people with chronic medical conditions are most likely to benefit from this RSV vaccine. Kaiser Permanente expects to begin administering this vaccine in late September/early October and will administer the vaccine according to the CDC’s clinical guidance.

In addition, the FDA has approved an RSV vaccine for pregnant people that would provide protection to infants up to 6 months of age and a monoclonal antibody product that will help protect all infants under 8 months and some older babies at increased risk of severe illness caused by RSV. Kaiser Permanente will administer these immunizations according to CDC clinical guidance after we update our clinical processes to reflect that guidance and when supply becomes available later this fall.

Aetna spokesperson on RSV vaccinations

In accordance with the Affordable Care Act and the Inflation Reduction Act, Aetna covers preventive services such as the respiratory syncytial virus (RSV) vaccine for our Commercial, Medicaid and Medicare health plan members at no cost to the member.

CMS spokesperson on “Medicaid eligibility systems issue”

On background attributable to the Centers for Medicare & Medicaid Services (CMS) or a “CMS spokesperson,” in follow up to CMS’ swift alert and call for action, the agency estimates that already more than a dozen states believe they are impacted by an eligibility systems issue that is preventing them from automatically renewing coverage for eligible children and families, and which was raised in a letter CMS sent to all states on August 30, 2023. Many other states are still in the midst of evaluating their systems, per the CMS’ direction. States have until September 13, 2023, to confirm that the issue does not impact their system, or that they have a plan and timeline for reinstating coverage for impacted individuals and implementing mitigation strategies.

CMS will not hesitate to hold states accountable if the agency determines states are not adhering to federal renewal requirements.

CMS continues to reinforce that it’s unacceptable for any eligible person – especially a child – to be disenrolled from Medicaid or the Children’s Health Insurance Program (CHIP) due to red tape. States should do everything they can to stop this from happening, including taking up the a range of strategies to help keep people covered. For a list of available strategies and their uptake, click here.

Additional Background:

CMS’ letter notes that eligibility systems in a number of states may be programmed incorrectly to conduct automatic renewals at the family-level and not the individual-level. This is an important distinction because individuals in a family—particularly children—may have different eligibility requirements for Medicaid and CHIP. If a state’s eligibility system has the issue CMS has identified, the letter specifies that states must immediately take the following steps to avoid CMS taking action to bring states into compliance: Pause procedural disenrollments for those individuals impacted, Reinstate coverage for all affected individuals, Implement one or more CMS-approved mitigation strategies to prevent continued inappropriate disenrollments, and Fix state systems and processes to ensure renewals are conducted appropriately and in accordance with federal Medicaid requirements. States that fail to take these steps will face compliance action, and may be disqualified from the temporary increase in federal Medicaid funding provided under the Families First Coronavirus Response Act.

For additional information, we also suggest reviewing today’s statement: https://www.cms.gov/newsroom/press-releases/cms-takes-action-protect-health-care-coverage-children-and-families

HHS spokesperson on Bloomberg report about marijuana scheduling

Statement from an HHS spokesperson:

Following the data and science, HHS has expeditiously responded to President Biden’s directive to HHS Secretary Becerra and provided its scheduling recommendation for marijuana to the DEA on August 29, 2023. This administrative process was completed in less than 11 months, reflecting this department’s collaboration and leadership to ensure that a comprehensive scientific evaluation be completed and shared expeditiously.

CDC spokesperson on wastewater detections of BA.2.86

No updates on the Ohio sample confirmation yet.

The only new detection is the New York one you wrote on already, and we don’t have any additional information on it yet.

August 29, 2023

Counties at “medium” or “high” COVID-19 levels

state county county_population report_date week_end_date total_adm_all_covid_confirmed_past_7days_per_100k_level
Florida Palm Beach County 1,496,770 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Hillsborough County 1,471,968 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Pinellas County 974,996 8/28/23 8/19/23 Medium (10.0 to 19.9)
Hawaii Honolulu County 974,563 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Pasco County 553,947 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Sarasota County 433,742 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Osceola County 375,751 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida St. Lucie County 328,297 8/28/23 8/19/23 Medium (10.0 to 19.9)
Florida Alachua County 269,043 8/28/23 8/19/23 Medium (10.0 to 19.9)
Texas Brazos County 229,211 8/28/23 8/19/23 Medium (10.0 to 19.9)

Senior administration official on COVID-19

Senior Administration Official [00:14:46]

The advisory committee on immunizations are gonna be meeting on the 12th of September. We intend to likely take CDC recommendation action the day or shortly thereafter.

And then, as you know, this is for the first time that these vaccines are going be available through a commercialized process, meaning that the federal government is not going to be the primary purchaser of the vaccines anymore. It is going to be purchased, sort of the same way the flu shot gets purchased every year, this COVID shot is going to get purchased, which means people like doctor’s offices, hospitals, pharmacies are ordering those vaccines, and then they’re getting them shipped directly to them.

I just say that as background. So you understand that once we take our regulatory action, when they will become available, sort of for the general public, it will likely take a couple of days after that regulatory action for the shipping and delivery to happen, though I know folks are trying to preposition as much as they can, so that folks have access to it.

…

Senior Administration Official [00:15:56]

Those vaccines will be available in public health departments and in federally qualified health centers on that same timeframe. But again, they have– those entities also have to order, and the things have to ship to the public health entities and to the FQHCs.

For the pharmacies, we’re working with them right now, so that pharmacies like CVS and Walgreens and others will also be able to offer vaccines to the uninsured.

We’re hoping that will start as soon as these others, but we are still working on that, so within the– within a few weeks of the regulatory action being available, we think that it’ll be available for the uninsured, but again, the uninsured have an option on day one through federally qualified health centers, through our public health departments, all across the country. And then within a couple of weeks, we’ll have that same opportunity within our pharmacies as well.

…

Senior Administration Official [00:17:14]

So what we are seeing now is a, you know, end of summer increase in hospitalizations.

Just looking back to last year, we saw that a same increase in hospitalizations, we did see it go down before then went back up again through the fall and winter. We do expect fall and winter virus season to do what it does, which is when we go indoors, and when it’s cold, when folks are– we expect to see more viral transmission across flu, COVID, and RSV.

Right now we are tracking similar to what we saw last summer, but I would say half the intensity. So if last year at this time, I was saying there are about 38,000 people in the hospital this week, at this year, this week, we’re at 15,000. So we are still seeing an increase, but it is less intense than what we saw a year ago.

…

Senior Administration Official [00:28:51]

Confidently we can say that the updated vaccine that is due out in a few weeks is tailored to the current circulating dominant variants. So it has very good effectiveness, again for severe disease, to the current circulating dominant variants.

Senior administration officials on Medicare Drug Price Negotiation program

Senior Administration Official 1 [08:05:35]

This is a critical provision of the Inflation Reduction Act that will finally allow Medicare to negotiate lower prescription drug costs for seniors and for other beneficiaries.

For decades, leaders have been trying to pass laws that allow Medicare the ability to negotiate lower drug prices, but big pharma blocked that from happening. While pharmaceutical companies made record profits and spent hundreds of millions of dollars on lobbying year after year, millions of Americans were forced to choose between paying for the medications they needed to live or paying for other basic necessities.

Under President Biden and Vice President Harris, those days are ending.

…

Senior Administration Official 1 [08:06:15]

Starting in 2026, millions of beneficiaries will be able to benefit from the new negotiated drug prices.

In 2022 alone, 9 million seniors and people with disabilities in Medicare spent 3.4 billion dollars in out of pocket costs on the 10 drugs that have been selected for negotiation. These drugs are used to treat common diseases like diabetes, heart disease, arthritis, blood clots, and certain cancers.

…

Senior Administration Official 1 [08:06:43]

In 2022, the most expensive drugs cost seniors about $6,500 in out of pocket costs per year for just one of these drugs, but big drug companies want to block us from lowering drug prices.

Big pharma and their allies have already filed eight lawsuits against the administration. We are not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life saving prescriptions, just to pad big pharma’s pockets.

…

Senior Administration Official 2 [08:10:48]

Our priority in negotiating with participating drug companies is to come to an agreement on a fair price for Medicare.

In total, the selected drugs account for roughly 50 billion dollars in total Part D gross covered prescription drug costs, or about 20% of total Part D gross covered prescription drug costs between June 1, 2022 and May 31, 2023 and 8.2 million people with Medicare Part D coverage use these 10 drugs to treat a variety of conditions such as cardiovascular disease, diabetes, autoimmune disease, and cancer during the time for which we examined the data.

We will negotiate on behalf of these people and the millions of others with Medicare coverage.

…

Senior Administration Official 2 [08:11:52]

At the end of the day, CMS, drug companies, patients, providers, advocates, and others, we all have the same goals. We want to ensure access to the innovative treatments and therapies people need when they need them.

We are hopeful that drug companies will come to the table and negotiate with us to make this a reality for the American people. But also let me remind you, the law is more the negotiation.

…

Senior Administration Official 1 [08:17:58]

CMS guidance specify the process that CMS used to select the drugs, and CMS selected the 10 highest spending drugs that qualify under the process that was described in the statute and the CMS program instruction.

And so, you know, some drugs that one might have expected to be on the list based on prior year spending data may now have have fallen lower on the list. And because they’re– because utilization may have dropped off in the last year or other drugs may have become more common. And so they rose above it, in terms of total spending.

But any of the drugs that you might have expected to see on the list that aren’t aren’t selected here could be selected in future years under the exact same process.

…

Senior Administration Official 2 [08:19:07]

So CMS followed the steps that are specified in the Inflation Reduction Act, and that were outlined in the guidance that we had put out when we selected the 10 drugs covered under Part D.

So first we determined the qualifying single source drugs under Medicare Part D. This means certain drugs without competition that have been on the market for at least seven years for drug products and at least 11 years for biological products.

Then from there, we excluded certain drugs, such as certain orphan drugs, low spend Medicare drugs, plasma derived products. And again, this is all specified in the law. We then reviewed manufacturer submitted requests to determine whether any drugs were eligible for an exception, because they were a small biotech drug.

From there we identified and ranked the top 50 qualifying single source drugs with the highest gross costs to Medicare Part D to determine the list of negotiation eligible drugs. We also reviewed manufacturer submitted requests to determine whether any drugs were eligible for a delay in selection due to a high likelihood of biosimilar market entry. And then finally, from that, CMS selected the 10 highest ranked negotiation eligible drugs.

So that was basically the process as laid out in the Inflation Reduction Act and in our guidance.

…

Senior Administration Official 1 [08:22:15]

With respect to the lawsuits, as you know, eight pharmaceutical companies and their allies have have filed lawsuits against the administration. The drug companies are running to court to try to accomplish through the courts what they couldn’t get done in Congress, which is block negotiation from happening.

I want to be clear that nothing in the Constitution prevents Medicare from negotiating drug prices. We are moving forward and eager to deliver the benefits of this law to the American people and are not going to let the big drug companies stop us from doing that.

…

Question [08:30:21]

Does this mean that the $35 cap, the prices might actually fall a little bit more from the $35 cap with negotiation? Is that a possibility? I assume the prices would be no higher than $35 per patient.

Senior Administration Official 2 [08:30:37]

Thanks for your question, Tom. This is [Senior Administration Official 2]. You are correct that there is a $35 co-pay cap that will hold. There could be further changes in the out of pocket costs. Even now, today, there are some plans that have lower than a $35 co pay cap.

And overall the purpose of negotiation is to be able to get the fairest price for Medicare, for the taxpayer and for the people who rely on these life saving medications.

August 28, 2023

FDA spokesperson on COVID tests and BA.2.86

Based upon available information at this time, the FDA believes that most existing tests used to detect COVID-19 appear to be effective with this variant. The FDA maintains our relationship with NIH’s RADx program and utilizes their abilities and expertise when appropriate. Not exclusive to our partnership with NIH, the FDA continues to conduct analyses to identify tests for which performance may be impacted for known SARS-CoV-2 variants. The agency will update this page when significant new information becomes available, including when the FDA’s analyses identify tests for which performance may be impacted for known SARS-CoV-2 variants.

Cleveland Clinic spokesperson on COVID testing after BA.2.86 detection

We select a random subset of our COVID-positives which includes both inpatients and outpatients. Cleveland Clinic works in collaboration with the Ohio Department of Health to survey the contemporary SARS-CoV-2 variants in circulation in Northeast Ohio.

CVS spokesperson on CDC uninsured COVID-19 vaccinations

We’re currently talking with the CDC about ways that CVS Pharmacy can support COVID-19 vaccinations for the uninsured and underinsured this fall.

August 25, 2023

NIH’s RADx on BA.2.86 and existing COVID tests

The RADx program has protocols in place, in coordination with the FDA and CDC, to screen new variants when deemed necessary. The information we have to-date on BA.2.86 does not portend issues with existing tests.

This information comes from Todd Merchak, who you spoke to for your recent story on EG.5.

CDC spokesperson on timing interval between COVID shots

Getting a COVID shot now could delay getting the updated one if the data demonstrates to CDC and ACIP that an interval between shots is warranted.

Until then, best for people to consult with their health care professional about what is best based on their individual situations.

Mississippi official on increases in COVID-19 emergency room visits

You may attribute to Dr. Kathryn Taylor, Interim State Epidemiologist at the Mississippi State Department of Health.

Mississippi is continuing to see increases in the number of COVID-like illness presentations in Emergency Departments and urgent care facilities in the state. The increase in cases is likely due to a variety of factors such as schools and colleges starting, high temperatures sending people indoors for activities where they may be in closer proximity to each other, and new variants circulating.

As COVID-19 cases increase, so does the overall COVID-19 exposure risk. Mississippians should continue to be aware that COVID-19 is a concern, stay home when ill, seek care or testing when indicated, and if not already up to date on vaccination, get vaccinated.

WHO official on BA.2.86 so far

Maria Van Kerkhove, WHO [00:33:27]

It depends, if we will change this classification to a variant of interest or a variant of concern, it depends in terms of its circulation. So right now we’ve only seen a few detections. We are not able to estimate its growth rate because we have so little data. We don’t have data yet on severity, or any indication of a change in severity. We don’t see any epidemiologic link between the cases that have been reported, which signals to us that there may be more circulation, but we can’t predict with certainty what will happen with this variant or with any variant.

So we have to make sure that surveillance remains strong. We have to make sure that reporting remains strong so that these assessments can be made.

…

Maria Van Kerkhove, WHO [00:34:21]

Our Greek letters are reserved for those that are classified as variants of concern. And we feel that’s really important. There are a lot of nicknames that are being used for the variants. We understand that, that are being used in the media, but for our communication purposes, we will use a Greek letter when we have a variant of concern and we won’t hesitate to use those Greek letters should they be needed.

…

Maria Van Kerkhove, WHO [00:35:31]

Yes. So BA.2.86 is still considered part of Omicron, although the number of mutations makes it highly divergent from BA.2 and the circulating XBB variants. We have classified it as a variant under monitoring.

It is part of Omicron, and we will give it a Greek letter, should we classify that as– a different Greek letter, should we classify that as a variant of concern.

…

Maria Van Kerkhove, WHO [00:35:54]

In terms of the profile of disease among the individuals who have had BA.2.86, it’s still quite early days. We do know that none of the individuals were immunocompromised, which is quite interesting, we find.

But I think what we would need to make sure we understand is the full spectrum of disease that is caused by BA.2.86. My reservation in giving a lot of detail around this is I don’t want to draw any conclusions coming from eight or nine patients.

We know that these variants that are in circulation, and I think what is important for the general public, is that SARS-CoV-2, any of these variants, any of the Omicron variants that are in circulation, can cause the full spectrum of disease, everything from asymptomatic infection, all the way to severe disease and death.

Your likelihood of developing severe disease and dying is reduced with vaccines, the many safe and effective vaccines that are in circulation, that are in use right now. Early access to clinical care, antivirals, reduces the risk of developing severe disease. So that’s what is important for a general– for the general public in our view.

…

Maria Van Kerkhove, WHO [00:37:04]

We will give a full profile and do a risk assessment of BA.2.86, as soon as we have more information. We expect the number of cases to be increased because we classified it as variant under monitoring.

And there could be more detections in countries from wastewater surveillance, which is something that countries have been utilizing for a year or two, during the COVID 19 pandemic, which is really helpful to understand what is circulating among populations as individual case detection and individual case reporting is reported to WHO.

Federal health officials on fall vaccine campaign

CDC Official [00:05:40]

We anticipate that the updated COVID 19 vaccine will be available in mid-September. We’re going to be encouraging Americans to get their COVID 19 vaccine in addition to their annual flu shot, as well as the immunizations for RSV, for people who are over the age of 60, as well as for infants.

…

FDA Official [00:08:26]

We’re currently thoroughly evaluating the data submitted by manufacturers to ensure the updated vaccines meet the agency’s rigorous standards for safety, effectiveness, and quality. And we anticipate that the updated vaccines will be available in the mid-September timeframe as already noted.

…

CDC Official [00:14:20]

Our intention, certainly, as we look into mid-September, is to have the ACIP meeting in as close as possible succession to FDA action as possible. So to the extent that there is more data that would be coming and that clinicians are looking to CDC for what the ultimate recommendations are for clinical practice, there’s a short of a delay as possible.

So again, our intention, because [FDA Official] and I, and our agencies are joint the hip on this, we are hoping– we will be planning, rather, for the ACIP meeting to happen as close in time as possible to FDA action.

HHS Official [00:15:04]

Can I just jump on that and just say, I think many of you on the call know, but the ACIP and specifically the director’s recommendation does tie to multiple forms of payments and assurances of coverage.

And so critical from, from multiple perspectives aside from of course, the stamp of CDC and ACIP stands on its own as an important step in ensuring that these are of good faith to American people.

…

CDC Official [00:20:36]

Likewise, as to the Pfizer maternal vaccine, which our colleagues at FDA recently took action on, we are working to get an ACIP meeting stood up. We haven’t noticed the date date yet, but it will be in September.

CDC director on waiting to get updated COVID shots

Mandy Cohen, CDC [00:02:47]

So until the fall updated vaccine is available, and like I said, that will be coming in middle of September, those who have never been vaccinated and then some people who are older and higher risk at for COVID infection might be best to get the existing COVID shot now and not wait. The most important thing is talk to your doctor or your nurse practitioner about what’s right for you.

It’s important to note that if you do get the current COVID 19 vaccine now, or in early September, it could delay your ability to get this updated vaccine that’s coming out in the middle of September. So again, talk to your doctor or nurse practitioner.

August 24, 2023

Sion on BA.2.86 detections in wastewater

Switzerland:

embedded image

Thailand:

embedded image

USA:

embedded image

Spain:

Regarding BA.2.86, in week 32, we have detected in one WWTP and at a very low proportion mutations N481K and P621S, that although not restricted to this variant, were only present in lineages no longer circulating. However, we must be very careful with these assumptions.

Germany:

embedded image embedded image

Cao on data for BA.2.86

Should be able to have some data early next week.

Novavax statement on BA.2.86

We believe we will learn more about the BA.2.86, variant in the following weeks, specifically, how much it has spread across the population and, if this strain has an evolutionary advantage compared to the other circulating XBB sub lineages.

Maine CDC on timing of RSV vaccines

On August 21, 2023, the FDA approved Abrysvo for use in pregnant individuals between 32 and 36 weeks of pregnancy. This is the first and only U.S. approval of a maternal vaccine to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV.

The CDC’s Advisory Committee for Immunization Practices (ACIP) is scheduled to meet from October 25-27 when they will decide on the recommended use of Beyfortus for infants and Abrysvo for pregnant women.

August 23, 2023

Ohio spokesperson on BA.2.86 in wastewater

The Centers for Disease Control and Prevention (CDC) recently informed the Ohio Department of Health (ODH) that the state had a preliminary detection of the BA.2.86 COVID-19 variant in one wastewater sample.

ODH is working with the CDC on further evaluation of the sample. As this preliminary detection has not been confirmed, ODH at this time cannot provide any further information.

BA.2.86 contains a number of mutations that make it distinct from other currently circulating lineages. According to the CDC, at this point there is no evidence that this variant is causing any more severe illness.

As always, ODH encourages Ohioans to stay up to date on their COVID-19 vaccinations as the best way to prevent serious illness, and to stay home if they are sick.

FDA spokesperson on tests from Reedley lab

You had asked:

If the FDA has received any complaints related to the tests in the safety communication and

The FDA is not aware of any adverse event-related consumer complaints or reports regarding the affected tests in our safety communication. In 2017, the FDA received a voluntary consumer report through the agency’s MedWatch database regarding false test results from the HealthyWiser UriTest 10 Parameter Reagent Test Strips (MW-5071580).

If the FDA had inspected any of the firm’s facilities in California before they stopped operations.

Prior to the company notifying FDA that it was shutting down operations, the FDA in 2018 inspected the company’s Tulare, Calif. facility and did not pursue any additional actions at that time. That said, and in general, FDA cannot discuss ongoing matters.

To note, the safety communication regarding this recall is not a result of recent media attention or the reported conditions at any facility. This safety communication is to follow up on a recall initiated by UMI in May after the company told FDA it has previously stopped all operations and was no longer providing support for its tests. While UMI initiated a recall to remove undistributed tests from their distributors, UMI did not initiate a recall for tests that were already distributed to consumers. Given FDA’s concerns about these tests, the FDA is issuing this safety communication to consumers and patients as part of its mandate to protect the public health.

Maryland agriculture department on malaria mosquito testing

The Mosquito Control Program let me know that mosquitoes that have been trapped are sent to the State Lab, who will then send them to the CDC.

Virginia health department spokesperson on BA.2.86

The Virginia Department of Health (VDH) was informed by the Centers for Disease Control and Prevention’s (CDC) Traveler Genomic Surveillance (TGS) Program of a preliminary identification of BA.2.86 from a pooled sample voluntarily collected from several travelers arriving at Dulles International Airport (IAD). The identification of BA.2.86 was confirmed by genomic sequencing. The sample is currently at CDC laboratories for further characterization The Traveler Genomic Surveillance Program is anonymous, so it is not possible to identify or conduct additional follow-up with this individual.

August 22, 2023

Maryland health department official on locally acquired malaria

David Blythe, Maryland Department of Health [00:00:04]

This afternoon, the Maryland Department of Health confirmed and reported a locally acquired case of malaria in a Maryland resident of the National Capital Region. The person was hospitalized, but has been discharged and is doing well at home.

And for patient confidentiality reasons, I’m not gonna provide additional information about that person, but– so this would be considered a locally acquired malaria infection. And the particular species of is malaria Plasmodium falciparum.

You might have heard about local acquisition of malaria in Florida and Texas, and that’s a different strain of malaria, that’s Plasmodium vivax. So this is different. This is Plasmodium falciparum.

In Maryland, we have cases of malaria, we have approximately 200 cases of malaria per year, but those cases are associated with travel to countries in the world where malaria is common and what’s different about this case is this person did not travel internationally or to other areas where malaria has been occurring.

…

David Blythe, Maryland Department of Health [00:05:40]

There are differences. There are some differences in how severe they typically are. In this form of malaria, malaria caused by Plasmodium falciparum, can be more severe than the malaria caused by Plasmodium vivax. So that’s one difference.

There are also differences in the treatment. And so the treatment regimens that a doctor would prescribe to treat one could be different from what it would be for the other. So that’s why it’s important to note that difference.

…

David Blythe, Maryland Department of Health [00:07:47]

The counties we would include in the National Capital Region of Maryland are Charles County, Prince George’s County, Montgomery County and Frederick County.

And I note that, but I’ll also note that we do have malaria cases, mentioned those 200 or so a year. We have malaria cases that occur throughout Maryland and probably throughout the whole National Capital Region as well. So, uh, that’s not exclusive to those four counties.

White House official on goals of new pandemic office

Nikki Romanik, White House [00:52:15]

Currently, um, when a outbreak happens or a pandemic, there’s immediate action and there are a number of agencies that want to stand up and get ready and it can be hard to identify a leader, which is why many times there are people like Bob and Demetre, coordinators or czars, or like Dr. Jha over there, they’re brought in to kind of help clarify roles and responsibilities, I would say. And I think that that’s probably one of the reasons why OPPR is standing up.

There are many reasons, but one of the reasons is so that we do not have to keep on bringing in a specific coordinator, but instead we can help identify the leads beforehand, and things can move significantly faster.

I think there needs to be deep interagency coordination from the beginning. It’s a vital to a response. And all agencies, no matter the agency, has a role in deep subject matter in the emergency response in a pandemic.

…

Nikki Romanik, White House [00:54:59]

Our mission is pretty clear. I’m working with Major General Paul Friedrichs, who is an incredible man, and a surgeon. We have kind of a mission– we have an aligned mission. We want to walk in and we want to clearly state the roles and responsibilities so that there’s not really a question moving forward who is the lead where and how everyone can work together.

Before an outbreak, we want to have protocols in place. And more importantly, we want interagency to actually have relationships with each other, all of the interagency, not just HHS, we want it across the entire interagency. We want people to actually have deep, trusted relationships when they’re not in an emergency.

There were a lot of relationships created during COVID and even more in mpox and Ebola and any outbreak that’s ever happened that could potentially have ever come to America, relationships have been built, but it’s always been in a response. What if those agencies actually had relationships outside of a response, and those people were friends outside of a response? I know it seems a little idealistic, but it can happen.

I can get anybody in a room and make them like each other. I can, it’s a goal of mine, always. It is one of our goals. It’s going to take time, but it’s one of the things we want to do.

…

Nikki Romanik, White House [00:56:34]

We also want to build back America’s trust in public health, another lofty goal.

You know, the United States government needs to speak clearly, transparently, and with one voice, when it comes to an outbreak or a pandemic.

People are scared and they need to have very clear communication from as early on as you possibly can. And it needs to be the same communication and it needs to be honest. So, they are a little bit of lofty goals, but that’s kind of going to get us started.

August 21, 2023

CDC spokesperson on ACIP for Pfizer’s Abrysvo vaccine

CDC and our Advisory Committee for Immunization Practices (ACIP) look forward to future discussion around recommended use for Pfizer’s recently approved maternal RSV vaccine, which will provide another tool to help protect against a virus that is the leading cause of hospitalization among infants in the U.S.

Earlier this month, CDC recommended nirsevimab, an immunization against RSV that has been shown to reduce the risk of both hospitalizations and healthcare visits in infants by about 80 percent. As we head into another potentially active fall and winter virus season, it’s important to have products available to help prevent severe RSV illness, especially in higher risk populations like infants. CDC takes the data review process for new vaccine recommendations seriously and will continue working to protect the health and well-being of the nation.

Pfizer spokesperson on new COVID vaccine and EG.5.1

Pfizer continues to closely monitor emerging variants and conduct tests of the Pfizer-BioNTech COVID-19 vaccine with an updated XBB.1.5 monovalent composition against those variants. A recent study in mice showed that our updated monovalent XBB 1.5 vaccine effectively neutralized a number of Omicron XBB variants, including XBB.1.5 and EG.5.1.

Michigan health department spokesperson on BA.2.86

The CDC is closely tracking a new lineage of the virus that causes COVID-19 named BA.2.86, which has many mutations that make it distinct from other currently circulating lineages. So far, cases have been detected worldwide, including a case in Michigan. The patient from Washtenaw County is an older adult with mild symptoms and has not been hospitalized.

Based on the available evidence, it is not known yet what risks, if any, this may pose to the public’s health beyond what has been seen with other currently circulating lineages. We are working with the CDC, which is collaborating with domestic and international partners to gather more information. CDC has not made any changes to their guidance at this time.

Public health agencies continue to investigate COVID-19 cases and test available specimens to understand the spread of COVID-19 in the population. The University of Michigan and the State of Michigan both sequence COVID-19 viruses to detect new variants, which is how this variant was identified.

It’s important for people to use the tools at their disposal, like vaccines and boosters, to keep themselves safe and understand their individual risk. We continue to urge Michiganders to get up to date with their COVID-19 vaccination as the vaccine remains our best defense against serious illness and hospitalization.

CDC spokesperson on EG.5 and XBB.1.5

Vaccination continues to be the best way to protect against severe outcomes of COVID-19. CDC will continue to monitor both the impact of future variants on COVID vaccines, including lab studies evaluating neutralization of the virus and clinical studies to monitor protection against severe disease. Based on the totality of the available evidence and input from the FDA’s advisory committee, it is anticipated that the fall updated vaccines with a monovalent XBB.1.5 composition will best protect public health.

This updated composition is more closely related to variants that may emerge and is expected to prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death. More information on the decision regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons is available on the FDA’s website.

For background.

There is no evidence indicating vaccines will not protect against EG.5. EG.5 lineages is an XBB-lineage virus. The updated vaccines for 2023-2024 will be a monovalent composition targeting XBB.1.5 strain. The XBB containing vaccine proposed for this fall has demonstrated improvement in neutralization against newer Omicron linages such as XBB.

August 17, 2023

CDC spokesperson on BA.2.86

Today we are more prepared than ever to detect and respond to changes in the COVID-19 virus. Scientists are working now to understand more about the newly identified lineage in these 4 cases and we will share more information as it becomes available.

Below is some additional details on background.

CDC is closely tracking a new lineage of the virus that causes COVID-19 named BA.2.86, which has many mutations that make it distinct from other currently circulating lineages. So far, four cases have been detected worldwide, including one case in the United States, and the others in Denmark and Israel. Based on the available evidence, we do not yet know what risks, if any, this may pose to the public’s health beyond what has been seen with other currently circulating lineages. We are collaborating with domestic and international partners to gather more information. COVID-19 remains a priority, and CDC is committed to providing the information necessary to protect the nation’s health.

The BA.2.86 variant will be aggregated with BA.2 on CDC’s COVID Data Tracker. If it increases in proportion and reaches 1% of sequences in the weighted estimate, it would be listed separately on COVID Data Tracker. (As a reminder, weighted estimates are the left portion of the graph and are calculated from sequences. These estimates are not available for the most recent two-week periods because of the time it takes to generate the sequencing data, including sample collection, specimen treatment, shipping, analysis, and upload into public databases.) Nowcast is a model generated from weighted estimates.

Jesse Bloom on BA.2.86 variant and updated COVID vaccines

First, so far only four sequences of BA.2.86 have been identified. Because of the large number of spike mutations in this new variant, it is important for scientists to monitor to see if it spreads more. But at this point the new variant is still rare, and so it is too soon to know if it will just fizzle out or spread more.

Second, BA.2.86 does have many mutations relative to XBB.1.5 at sites recognized by antibodies. This is unlike other new variants (like EG.5.1) which are close relatives of XBB.1.5. So while a XBB.1.5 vaccine would still be a decent match to EG.5.1, it would probably be a fairly poor match to BA.2.86. However, right now XBB-related variants like EG.5.1 are vastly more common BA.2.86, so the proposed vaccine currently remains a good match to most circulating viruses. Again, this is something that it is just important for us to keep monitoring and see if BA.2.86 fizzles out or spreads more.

Finally, I would note that while strain specific neutralizing antibodies (which can be escaped by new variants) provide the best protection against infection, there are also broader mechanisms of immunity elicited by vaccination and infection that provide some protection against severe disease even for very heavily mutated variants. So even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.

Danco statement on appeals court ruling

Danco Statement on 5th Circuit Ruling, August 16, 2023

The Fifth Circuit panel’s decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges. In its rush to reach a particular outcome on the merits, the panel disregarded the actual factual record before the court and second-guessed FDA at every turn—neither of which is consistent with the rule of law in challenges to agency action. Danco will continue to pursue reversal of this injunction.

Danco remains confident in the safety and effectiveness of Mifeprex® and committed to making the drug available as broadly as possible. Because the Supreme Court’s stay remains in place, Mifeprex® (mifepristone) tablets continue to be available under the current, FDA-approved conditions, which includes for use in pregnancy of up to 10 weeks duration, with prescribing after in-person or telehealth examination and dispensing by healthcare professionals, by mail, and from a pharmacy.

The panel’s decision seeks to undo FDA actions that are well supported by extensive safety and effectiveness data from clinical trials and real-world experience in millions of patients, and that are decisions Congress entrusted to FDA. The changes in 2016 and 2021 that the panel would strike down—changes approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits. Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.

Mifeprex® is the most commonly used medication for termination of early pregnancy. Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000. Mifeprex® is ~97% effective in terminating early pregnancy; approximately 3% of women will require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion, or other reasons such as patient request.

August 16, 2023

NIBIB’s RADx on EG.5 variant impact on tests

RADx is actively monitoring and assessing the prevalence and genetic information of many COVID-19 variants, including EG.5 which it has been tracking for months. RADx has not yet incorporated EG.5 into testing protocols for validating commercially available COVID tests, but is preparing studies in coordination with the FDA, in the event that the variant’s prevalence meets established criteria.

FDA official on timing of next strain selection

As previously stated, availability of the updated COVID-19 vaccines is expected in mid-to-late September, pending regulatory action by the FDA and recommendation from CDC. If authorized or approved, based upon the available evidence, the FDA believes these vaccines with a monovalent XBB.1.5 composition will provide the best available protection against the most serious consequences of the disease resulting from currently circulating variants.

We will continue to closely monitor the emerging data in the United States and globally and will base any decision to revisit vaccine composition on those data. Barring the emergence of a markedly more virulent viral variant causing COVID-19, the FDA anticipates revisiting the composition of the vaccine during the first half of 2024 to help ensure that updated vaccines are available, if appropriate, during the 2024-2025 season.

Novavax executive on age expansion for COVID vaccine

Filip Dubovsky, Novavax [00:32:08]

In addition to updating our vaccine for the fall season, we continue to work on expanding our label to include the pediatric population. Please go to slide 13.

Study 503 is our global pediatric age de-escalation study being conducted in children’s six months of age to 11 years of age. Enrollment is complete in the six to 11 year old cohort and the two to five year olds, but is ongoing in the youngest children.

…

Filip Dubovsky, Novavax [00:34:21]

This profile, in addition to our classic recombinant protein technology may be reassuring when parents and providers choose vaccines for children.

We expect to submit these preliminary results to the EUA in the fourth quarter. And while the length of regulatory review is not known, we believe that approval of a EUA amendment could occur in early 2024.

August 15, 2023

Pfizer on EG.5 variant and updated COVID vaccine

Pfizer continues to closely monitor emerging variants and conduct tests of the updated, XBB.1.5-specific monovalent vaccine against those variants, including EG.5 and its related sub-lineages, which are closely related to XBB.1.5. Furthermore, our team of experts is prepared to develop variant-modified vaccine templates, should the need arise and as the data and regulatory agencies dictate. We remain prepared to distribute this season’s COVID-19 vaccine to pharmacies and prescribers by the end of August, pending regulatory action.

Novavax on EG.5 variant and updated COVID vaccine

We expect our XBB COVID vaccine to work against the EG.5 strain given its similarity to the XBB.1.5 strain in the vaccine, and we’re now conducting testing to demonstrate that.

August 14, 2023

Local officials on Universal Meditech facility

Joe Prado, County of Fresno [00:10:52]

So now we’ll start the timeline with December 19th to December 20th. Our staff is pretty much notified from City of Reedley of this situation out there. And we’re really now– we really think this is the same company from City of Fresno. We’re exchanging emails and our team, with City of Reedley, contacted the FBI to really evaluate potential public safety risk.

You know, we didn’t have a lot of information, but what we did know, we needed to make sure that if there was any other jurisdictional authority that needed to be evaluated, the right federal or state agency needed to make that determination, before we really took over any type of response.

And so that’s where the narrative kind of picks up as we start down that pathway there, we’re exchanging– we’re exchanging information with FDA as well. FDA is involved on December 20th and regarding the medical testing kits that are actually on site, and FBI conducted– they brought us all together for a meeting to really start having a conversation.

And at this time, on December 21st, FBI said, everybody standby. Everybody standby, we need to assess what we have here, and we need to see whether or not it will be a federal investigation or not. So we had to stand by and really assess to see what the outcome of the FBI was at this particular time.

…

Joe Prado, County of Fresno [00:13:18]

Moving on into February, we’re coordinating with DTSC, is the Department of Toxic Substances Control, a state agency, they indicated to us that the FBI has given the state and local agencies approval to resume civil investigation. This is now where the FBI is giving it back to us. It is not within our jurisdiction. It is somebody else’s, but it’s not ours.

So now as we start going into February, February 9th is a very key point here. Universal Meditech issues a nationwide recall of its COVID 19 test kits. FDA was involved back in December 20th. You already saw action from the federal government against this company.

You saw that action take place with that – with that recall, that was the FDA because of our collaboration and gaining information from the business owners, being able to move forward with that potential that recall there as well.

On February 24th, we had a multi-agency meeting to really coordinate the investigation of Prestige Biotech. Now we’re learning about Presige Biotech, who are they? What are they? Who owns them?

To this day, we’re still trying to understand it and find that out. And so there’s this indication Universal Meditech own the assets, they’re in bankruptcy, they send it, they say Prestige Biotech owns this asset. And what we really see that is they were just trying to muddle everything up so we didn’t know who had the financial responsibility that we could really go after and really hold them accountable. So that was, I think, a lot of misdirection by this business representative.

…

Joe Prado, County of Fresno [00:18:10]

Those CDPH food and drug branch staff, they went through an embargo, the unapproved medical test kits and medical supplies. This is the only part of the response that is being led by an outside agency. The medical devices is being led by CDPH food and drug branch, and they are in coordination with FDA. All other aspects of the response is at a local level.

…

Joe Prado, County of Fresno [00:24:03]

They were given all this information back in April, the requirements, they were given ample time to respond to it. They even denied, they had infectious agents via email. And that was simply untrue. We had a CDC report that stated otherwise, they had infectious agents on site. That is why we included all that language in those health officer orders.

…

Joe Prado, County of Fresno [00:25:18]

All the investigation we had done to date was sufficient enough to go and destroy these biologicals. And that was, I think, just a testament to our county council, City of Reedley, our environmental health staff, collecting all this information and our federal and state agencies, that exchange of information we’ve had for weeks on a weekly basis. We’ve been doing that early on, has been just instrumental, beneficial for us.

And so we go on site, we destroy biologicals, there’s 36 refrigerators and freezers that were properly removed, transported for destruction by our licensed contractor. We did this July 5th, 6th, and 7th, all in compliance with the abatement order and the judge’s requirements to get it done within 14 days. So as soon as the judge signed that, we had 14 days to get this done, we were able to bring in the right licensed contractor and the right licensure to be able to do this. Not everybody can haul infectious agents and destroy agents.

So what does it look like for biological agents? We’re– these days everybody’s in full personal protective equipment, they take– we take possession of all that material. It is autoclaved. So that is a high steam process. And then it’s taken out for incineration. That was a process that was done with the biologicals. That is a process that when we worked with CDC, we wanted to make sure that was the appropriate protocol to follow. And they confirmed that was the right protocol to follow as well.

…

Nicole Zieba, City of Reedley [00:45:51]

We have got to get this fixed at the federal and state level. Board, I know you wanna do something about this locally. My council wants to do something about this locally. We are not going to fix this at the local level.

This is a problem. These are loopholes with privately funded, fully privately funded labs, even legal labs. Now the one we’re talking about in Reedley is bad actors, bad lab. They did not want us to know they were here. That’s why they moved in under the cover of night. That’s why they never came to the city for a business permit. They did not want us to know they were there. There’s bad actors, but even legal labs, if they are privately funded, something like this could be in every city in the nation and we wouldn’t be able to regulate it the way we should be able to regulate it.

I don’t know about you, but I don’t wanna be buying products where I know there are peed-on pregnancy tests in the desk drawers, right? We have a problem. And instead of pulling people together and stating, hey public, we need to have our federal legislators fix this. Let’s get together and demand that they fix this.

…

Nicole Zieba, City of Reedley [00:47:46]

Right now is the last day of the abatement for the fridges and the freezers. We still have more process to go. The U.S. EPA will come in in short order. Although they have a tangle of regulations they have to follow before they can step onto private property and destroy private property. They will come in in a matter of weeks and remove lab chemicals. These are chemicals that are commonly found in legal labs, nothing unusual has been found.

After that, we then turn it over to the FDA and FDB, the Food and Drug Branch. Those entities will come in, and what we will have remaining in that warehouse are probably half a million pregnancy tests and COVID test kits. Some of which are unauthorized for sure. We don’t know about the other ones.

So altogether, my estimation is that, my hope is that, by the time we enter heavily into fall, this will be another empty warehouse in Reedley like we thought it was for the last decade.

CDPH official on CDC’s Bridge Access Program

Edward Salaguinto, CDPH [00:07:17]

CDC is going to establish contracts with pharmacies to enable them to continue offering COVID 19 vaccines and therapeutics with no out of pocket cost to uninsured individuals. Dr. deJarnette is also going to talk a little bit about therapeutics later.

But, moving on, Walgreens is still in contract negotiations and there’s not much information coming from them so far. CVS is also still in contract negotiations. So more information to come on that. They did tell us they did request that all California locations could be included as well, but that’s still subject to CDC approval for locations.

The other company is eTrueNorth, and they’re also still in contract negotiations. And this company is the company outside of Walgreens and CVS who will participate. It’s the company that’ll enroll independent pharmacies, and they’re still working out details with CDC. They’ve mentioned they are considering all non Walgreens and non CVS community pharmacies that join the program and they can onboard them after CDC has the pharmacy side approval in contracting. Again, every individual location must be approved by CDC.

So CDC did state that the locations that will be participating in the Bridge Access Program will be indicated on vaccines dot com– vaccines dot gov, excuse me, but CDPH is also attempting to gather all of the locations and compile them on the list for you. Hopefully we’ll get that information from all of these partners.

So– so all of these are still in contract negotiation, so it’s really difficult to see what the implementation of this program’s going to look like in pharmacy. So the obvious question next is: when do we expect the contract negotiation is to be finalized for pharmacy? Well, CDC has said they are targeting mid-October date. So information does seem to be trickling in weekly. So I’ll try to inform you as much as I can as we go.

August 11, 2023

HHS secretary on marijuana scheduling

Xavier Becerra, HHS [00:15:01]

On the issue of marijuana, what I can tell you is that the president instructed us at HHS, FDA in particular, to take a look at how we treat marijuana to see if we can update our review of marijuana as a drug and how we can make sure we treat it going forward on a federal level. Places like California have already changed the laws, the federal government has not.

And so we’ve been instructed, and we’re underway with that review as we speak. It doesn’t– it’s not just HHS, it also includes DEA, other agencies, but we’re working together to try to see if we can give the president an answer that’s based on the science and the evidence.

Stay tuned. We hope to be able to get there pretty soon, hopefully this year.

DEA administrator on HHS marijuana scheduling

Rep Matt Gaetz [01:00:42]

So I guess my question is this, why has the Biden administration not taken marijuana off the list of schedule one drugs?

Anne Milgram, DEA [01:00:50]

So Congressman, as you know, the president had sent a letter to the secretary of HHS and to the attorney general to ask for the scheduling, descheduling, process to begin. It’s now with HHS. They are in that process. They start, then they send it to DEA. We have not received it yet.

Rep Matt Gaetz [01:01:08]

That’s encouraging. When do you expect to receive that recommendation from HHS?

Anne Milgram, DEA [01:01:13]

I have not heard of a timeline from them. So I don’t know.

Rep Matt Gaetz [01:01:17]

Well, that’s unsettling, isn’t it? I mean, when you don’t even know a timeline, it doesn’t really make it seem like something’s front of mind.

Anne Milgram, DEA [01:01:24]

We have constant conversations with HHS and with FDA, but we have not been given a specific timeline.

Rep Matt Gaetz [01:01:30]

Will you leave this briefing and encourage HHS to give you a timeline on getting that information to you?

Anne Milgram, DEA [01:01:35]

I will ask.

Rep Matt Gaetz [01:01:37]

Thank you. And when you receive the work product from HHS, is there any basis that DEA would have to oppose the descheduling of marijuana as a schedule one drug?

Anne Milgram, DEA [01:01:49]

So the way the scheduling process works, under the law and the regulations, is HHS does a review. They then send it to DEA. We then do what is known as an eight factor review. There’s an opportunity for public comment as well. And so we go through that part of the process. And so obviously we start with what HHS has provided us. We then go through our own review, and a public comment process. And then we come to a scheduling decision.

CDC official on disease forecasting

Dylan George, CDC [00:14:50]

We launched the center for forecasting outbreak analytics officially in January of this year.

We started as a team of five. Now we have about a headcount of about 50, and it is an impressive group of folks that we’ve been able to bring together. There are people that have left academia, tenure track positions in academia, to come help us build this because they see the mission as so important.

We’ve got– we’re starting to build the tools. We’re starting to build the teams. We’re starting to build the partnerships. So we’re well on our way to actually making a lasting impact. And so it’s exciting to see the progress that we’re making right now.

Question [00:15:25]

Yeah. I can tell you are envisioning a much more rapid effective data to really help with the response, not just at the national level, but at community levels too. Is that right?

Dylan George, CDC [00:15:36]

Exactly. It’s, you know, we take a lot of inspiration from looking at how weather forecasting has transformed over the last 50 years or so. I mean, to the point that we all have mobile devices now, and if you have an Apple mobile device, you can actually see in the weather app, you can see hyper local information about when rain is coming through, what’s the precipitation gonna be like, what is the temperature, what is going to be the humidity. And in a very, very localized way.

We take a lot of inspiration and aspirationally we want to build to that so that we can enable individuals, mayors, and governors to have the information so that they can be empowered to make decisions, to keep themselves, their families and their communities safe from infectious diseases.

August 9, 2023

CDC spokesperson on Jose Romero’s departure

Dr. Romero has had one of the toughest jobs at CDC, leading the center responsible for fighting respiratory diseases through a critical period for all of public health – as we transitioned out of the national COVID-19 public health emergency. His service to the agency and our country is deeply appreciated. We are pleased that Dr. Demetre Daskalakis will serve as acting director for our National Center for Immunization and Respiratory Diseases (NCIRD). Most recently, Dr. Daskalakis served as the Deputy Coordinator of the White House’s Mpox Response, helping to lead the vaccination and public education efforts that halted the advance of last year’s mpox outbreak. He is a nationally recognized public health leader, and we are excited for him to lead NCIRD as we head into the winter respiratory virus season.

WHO officials on EG.5 variant

Maria Van Kerkhove, WHO [00:40:11]

The Technical Advisory Group for Virus Evolution meets regularly to assess this and other variants and the Technical Advisory Group for COVID 19 Vaccine Composition, TAG CO VAC, as you mentioned, also meets regularly.

They will meet again to look at, exactly as you say, what, how are the vaccines performing against the circulating variants? It depends on the studies that are underway and those studies take time.

So it’s a constant iterative exchange of information from researchers, from member states, and those who are producing the vaccines themselves. We can’t predict what TAG CO VAC will recommend in the future. They have to be agile to look at the available data as we go forward, but that is something TAG CO VAC will do regularly to decide whether or not an update to vaccine composition is warranted. And we’re grateful for all of our advisors who are working on that.

…

Sylvie Briand, WHO [00:41:13]

I think the issue of deciding the composition of the vaccine is quite difficult with this virus, which is constantly evolving. And as Maria mentioned, because there is no currently predominant variant anywhere, but a number of co circulating variants, decisions on vaccine composition remains challenging.

But, I think the TAG CO VAC has decided as a strategy to really look to increase the breadth of immunity. And so when we do the virus antigenic mapping, we look at all the viruses that are circulating, and all the variants that are circulating, and we try to select the antigen that will provide this maximum breadth of immunity so that the protection to people is as wide as possible, anticipating that the virus may evolve between the time where the recommendation is issued and the time when the vaccine is produced.

So, really is a strategy to minimize the risk and maximize the protection to people and always ensure that we have the best vaccine possible.

CDC director on COVID vaccines timing and malaria cases

Mandy Cohen, CDC [00:18:40]

While we are not finalized on all the approvals yet, so FDA still needs to do its final work with the manufacturers, as well as the CDC do its final job to make sure we are making full recommendations on who should get those COVID shots.

What I would say is that we anticipate that they are going to be available for most folks by the third or fourth week of September. So in the near term, so there’s work being done now, we think by the end of September, they’ll be available, but there’s some work to do. And again, we got to make sure we hit all of the right marks for it to be available.

What we are anticipating right now, as we look at the data and we see how the virus is changing, we see how immunity changes over the course of the year, similar to flu shots, right? Which we get every year annually. We are likely to see this be– and again, I don’t want to get ahead of the scientists and that are going to do their work in the next few weeks, but we are likely to see this as a recommendation as an annual COVID shot, just like we have an annual flu shot.

And I think that will give more folks clarity about, should they get one or not? Because the answer is like, well, did you get one this year, if not go get the new COVID shot, assuming all of that– again, we’re waiting for the FDA to do its work. We’re waiting for CDC’s experts to do its work in terms of recommendations, but likely where we are headed, so folks can start to think about it, is that this will be an annual vaccine, and again, to make sure that you stay protected.

…

Mandy Cohen, CDC [00:44:08]

You may have heard that there were a few cases this year of domestically acquired malaria. They were the first nine cases that we’d seen in 20 years. So we haven’t seen domestic malaria in 20 years. This year, we saw nine cases, seven of them in Florida, two in Texas. And I was so impressed with the team here at the CDC that really jumped on this issue.

Now CDC deals with malaria in other countries. That’s again, where we are working abroad to prevent a threat from coming here. And so all the work we do in other countries to prevent malaria is why we don’t have malaria here. We need to continue that work abroad, but we have that expertise because we work abroad, we brought it to bear here in Florida, and Texas, so to support the state in everything that they were doing. And they, they did very good work here.

And, but we were able to offer support to the clinicians in the area to make sure they could identify malaria. Malaria is not common, which is a good thing here, but we need to then help clinicians know how to identify and test. We were able to offer lab capacity and testing. There is treat, we made sure treatment was going to be available. And again, we have tools that we can can utilize. We know how to get rid of the mosquitoes that transmit malaria.

So we brought all those tools to bear, and now we’re not out of the window yet, but the good news is, is it’s been four to five weeks now, and we have not seen another case.

August 8, 2023

Texas DSHS spokesperson on COVID-19 increase

So far, we have not noted any significant age group disparities that are unique about this most recent COVID-19 increase. Both adults and children who have not been vaccinated against COVID-19 are at elevated risk of severe COVID-19 disease relative to those who have received vaccinations. We will continue monitoring Texas COVID-19 hospitalization trends.

For context, CDC’s reporting of Emergency Department (ED) patient visits with diagnosed COVID-19 data is based on a different data source than we use for COVID-19 hospitalization data monitoring:

CDC’s ED visits data source is from the National Syndromic Surveillance Program (NSSP): https://covid.cdc.gov/covid-data-tracker/#ed-visits_all_ages_combined Texas DSHS monitors hospitalizations data reported daily from facilities to DSHS. Based on this data source, as of 8/5/2023, the number of hospitalized patients with COVID-19 in Texas (all ages) was 860. Hospitalizations in Texas for COVID-19 (all ages) are on an increasing trend. These data sources vary in both the method of data collection and specific data collected. Both are provisional and subject to change.

FDA spokesperson on COVID-19 vaccines timing

While we cannot comment directly on timing, the FDA anticipates taking timely action to authorize or approve updated COVID-19 vaccines in order to make vaccines available this fall that meet our expectations for safety, effectiveness and quality.

Novavax executives on COVID-19 vaccines timing

John Trizzino, Novavax [00:17:02]

The U.S., as planned, is exiting the pandemic phase and entering a more traditional seasonal vaccine market with many similarities to seasonal annual influenza vaccine distribution.

We have been preparing for commercialization in the U.S. throughout the pandemic phase, and we are ready organization wide for availability of product as soon as September, of course, dependent on our FDA strain specific authorization, and ACIP recommendations for use.

As you would expect, there has been significant collaboration across many U.S. agencies, and within HHS to ensure that this transition is executed smoothly and there is vaccine available for anyone interested in receiving a COVID vaccine.

…

John Trizzino, Novavax [00:18:28]

Our updated XBB COVID vaccine is on track to be in our U.S. facility in September and immediately available for distribution and use upon authorization.

…

John Trizzino, Novavax [00:21:01]

A core focus for us is manufacturing readiness. We have been manufacturing our updated XBB COVID vaccine at commercial scale, which will enable us to supply tens of millions of doses of our vaccine, in line with our planned demand for the fall season.

We expect to have doses in our U.S. warehouse in advance of FDA’s authorization and ACIP’s policy recommendations to ensure that we can quickly ship initial stocking orders to customers in September.

…

John Trizzino, Novavax [00:29:30]

In the U.S., we have initiated the rolling submission of our BLA filing, and we intend to submit the remainder of our data over the coming months.

While full approval via the BLA process will be an important milestone for us early next year, we will be able to sell and market our updated XBB COVID vaccine for the upcoming 2023 fall vaccination season under emergency use authorization.

…

Filip Dubovsky, Novavax [00:57:04]

We’ve submitted the preclinical and clinical packages, and we’re going to complete that file this month.

We previously discussed with the FDA the need for what kind of clinical data we need. And that’s why we conducted the study. The XBB.1.5 data is adequate, not only for the U.S., but globally for approval for the XBB.1.5.

And our plan is to have the product available in time for the FDA, CDC release at the end of September.

…

Filip Dubovsky, Novavax [01:18:32]

The BLA itself is based on the prototype vaccine, 2373, the original strain. So that, as John said is, we have a rolling submission and that’s going in now.

The approval for EUA, for the XBB, is also going in, as I’ve said, we’ve completed a complete clinical roll. And the data I showed you today is the key clinical data for authorization of the XBB variant. There’s no other data in that file other than the data you saw today.

And that’s going to be concluded this month, with expectation for us to be delivering product by the end of September for the CDC, FDA.

Now there’s a subsequent supplemental BLA next year, which will wrap all this up into a single file going forward. So at some point next year, we’re going to be out of the EUA game and in a straight BLA game with this and all subsequent variants.

CDC spokesperson on COVID-19 vaccines timing

Manufacturers are currently updating COVID-19 vaccines for the fall. These vaccines will be updated with the goal of providing the best protection against currently circulating strains. The FDA anticipates taking timely action to authorize or approve updated COVID-19 vaccines in order to make vaccines available this fall. After their authorization or approval, ACIP will meet to make a recommendation outlining use of these updated vaccines this fall.

August 7, 2023

NIH statement on long COVID smell loss

This response can be attributed to NIH: Patients experience many symptoms, the interventions currently tested or in process of being tested may sort effects on many of these symptoms, including loss of smell/taste.

August 4, 2023

CDC spokesperson on Nowcast regional estimates

Because Nowcast is modeled data, we need a certain number of sequences to accurately predict proportions in the present. For some regions, we have limited numbers of sequences available, and therefore are not displaying nowcast estimates in those regions, though those regions are still being used in the aggregated national nowcast. All regions are still displayed for the weighted estimates which are not models but from sequences.

August 3, 2023

Pfizer executives on COVID-19 vaccines timing, combination vaccines

Albert Bourla, Pfizer [00:23:24]

The uncertainty of the exact timing of Comirnaty commercialization was largely removed with the decision by the FDA and CDC to request a change in the composition of the vaccine to address the Omicron XBB.1.5 strains.

We believe this will allow us to commercialize the vaccine in September, assuming the updated vaccines are approved and available by the end of August, of course.

…

Albert Bourla, Pfizer [01:39:10]

So the vaccinations, with a new, will start in September, hopefully of course. What we expect is that we will have approval by the end of the of the August, and we are ready with product already now. So we have– so production will not be an issue.

…

Albert Bourla, Pfizer [01:17:42]

We are very excited about the combinations, right, and the combinations will be flu and COVID, and then hopefully also flu, COVID, and RSV, and we are working on that. And we believe actually that the fact that, if we have a combination with the non RNA included, there will have likely that we expect to have the benefit of better safety profile, because you don’t have to load three products RNA into the single injection, but we will be using only two, COVID and flu. And then we’ll use a protein based vaccine, which is very (inaudible) for RSV, all of that are working very well.

Moderna executives on COVID-19 vaccines timing, combination vaccines

From a “Moderna 2Q 2023 Earnings Call”

Jamey Mock, Moderna [02:07:01]

As I mentioned in my prepared remarks, most of this cost is fixed at this point. We’ve already ordered the raw materials, we’ve already started manufacturing, most of our– we’ve got a lot of supply ready to go as soon as we are able to– as soon as we got regulatory approval.

So that three and a half to four billion dollars is not really dependent too much on the sales outcome. That’ll happen either way.

…

Arpa Garay, Moderna [01:37:07]

As I mentioned earlier, a key determinant for the market size in the U.S. will be vaccine uptake, or shots in arms, during the upcoming September to December timeframe. As I’ve mentioned before, our expected 2023 sales range of six to eight billion dollars will be primarily driven by vaccination rates in the U.S. market.

…

Stephen Hoge, Moderna [00:48:05]

So as you know, we’ve had– as I said, we have six combo vaccines. We have lots of clinical data out there, and we continue to look at new combinations. And if we’re in a situation that we expect to be in, where we have a flu, RSV, and COVID approved, as well as the second generation COVID moving forward, you can be– you can rest assured we’ll be looking at multiple different combinations of those, trying to bring forward options that provide the greatest public health flexibility.

Those studies, once we have the products approved, the monovalent vaccines, those studies are really just immune bridging studies, demonstrating that we can do the combination and achieve non-inferior immunogenicity, and safety in those studies, they can be quite quick, and they also don’t need to be run in the season, as you know, and so our goal is going to be, as we’ve said throughout this year, is to complete the work to move towards approval, filing, and eventually hopefully approval of the three monovalent vaccines, and quickly progressing into the pivotal phase threes for at least one and multiple combos.

Our goal, again, is to be launching those in ‘25 and beyond for the obvious reason that they will improve compliance, deliver more value, and actually decrease the administration cost of healthcare. So, the path is actually pretty pretty clear from here, particularly given the strength of the RSV data, and where we are in COVID, and we hope to be providing an update very shortly on flu that also provides a clear path for ‘24 in the monovalent launches we’ve guided, and then I think we’ll clarify very quickly that we’re starting the phase threes to allow the combo launches very shortly thereafter.

CDC official on variant influenza

Tim Uyeki, CDC [00:33:30]

Since early 2022, we have had 50 states or territories that have identified high-path H5N1 viruses in wild birds. And so most of this was in 2022. Some of it has occurred in 2023, but it’s certainly in every state except for Hawaii, as far as I know. Next slide.

In terms of poultry outbreaks, we had a lot of poultry outbreaks last year, both in commercial flocks, but also backyard flocks. What you see on the bottom left there is 47 states have reported outbreaks, either in commercial or backyard flocks since the beginning of 2022.

But the figure in the lower right is more recent. You can see just in the last 30 days very limited detections and no poultry outbreaks have occurred for several months or at least been identified. So the impact was much greater in the U.S. last year and continued on into early this year. Almost 59 million birds have either died or been culled, depopulated, to control these outbreaks.

…

Tim Uyeki, CDC [00:38:04]

Seasonal influenza A viruses circulating among people binding primarily to alpha2-6-linked sialic acid receptors that are found primarily in the human upper respiratory tract, whereas avian influenza A viruses tend to bind to receptors bearing alpha2-3-linked sialic acid receptors. We call those avian like, and those are present in both the respiratory as well as the gastrointestinal track of birds. So they’re present in respiratory as well as gastrointestinal secretions, feces.

And so, it’s not completely the case that only alpha2-6-linked sialic acid receptors are in the human upper respiratory tract, but we believe that in order to really increase the risk to public health, these viruses, or any avian viruses, would need to be able to bind more efficiently to alpha2-6-linked sialic acid receptors in the upper respiratory tract of people.

And we haven’t seen that to date.

…

Tim Uyeki, CDC [00:50:28]

This year there have been four other cases reported from the U.K. in poultry workers, responding to confirmed H5N1 poultry outbreaks, all asymptomatic, low viral levels, viral RNA levels.

It’s a bit unclear whether those represent true infection or not. My suspicion is the bulk of those asymptomatic cases are attributable to transient detection of viral RNA at low levels and not true infection. I can’t prove that though, but I’m doubtful that those asymptomatic cases, or the U.S. case last year, actually represented true infection, yet met criteria for reporting to WHO under the international health regulations. And I think that was very appropriate to report all those cases.

I’ll say that there are cases of true asymptomatic H5N1 infection that I am aware of, that have been confirmed both virologically and serologically. I think convincing evidence that asymptomatic virus infection can occur. And because these viruses continue to evolve, we do want to know whether or not there’s an increase in asymptomatic infections or mild cases.

…

Question [00:58:58]

Does decrease in bird detections of H5N1, recently, portend a coming end to the current outbreak in the U.S.?

Tim Uyeki, CDC [00:59:06]

I don’t think we know. It’s a great question.

But because it’s wild birds spreading this virus around, and particularly migratory birds, I don’t think we know. And so I think let’s see what happens as birds come south from Canada later this late summer into the early fall.

And whether this becomes endemic in wild birds in the U.S., it’s a bit unclear. Some people think it is. I think it’s not quite clear yet.

But if it does become endemic in wild birds, then I think then poultry outbreaks will continue to occur, at least there will be that potential.

Sanofi spokesperson on Beyfortus at ACIP

· The recommendation from ACIP to include Beyfortus in the CDC’s Child and Adolescent Immunization Schedule means the cost of Beyfortus will be covered without a co-pay, in accordance with the Affordable Care Act (ACA).

· In addition, the ACIP vote to place Beyfortus on the Vaccines for Children program ensures equitable access for babies whose parents or guardians may not be able to afford immunizations. Beyfortus would be provided at no cost to American Indian or Alaska Native infants, as well as infants who are uninsured, underinsured, or Medicaid-ineligible.

· It is important to note that there may be costs related to copays for physician office visits that can vary depending on insurance coverage. Individuals, or their healthcare providers, should contact their health insurance plan to determine coverage and reimbursement requirements as well as adoption timeframes.

ACIP meeting on nirsevimab

Melinda Wharton, CDC [11:04:37]

By way of introduction to the topic of today’s meeting, I’d briefly like to go over two different processes for immunization, passive and active.

With passive immunization, the person receiving the protection is administered pre-formed antibody that comes from somewhere else. Diphtheria antitoxin is still manufactured in horses, but most products for passive immunization come from human immune globulin. And now, some antibody products are made in cell culture systems.

These antibodies can provide excellent protection, but that protection wanes over time, because the antibodies that are given only last so long. Transfer of maternal antibody across the placenta that provides protection in early infancy is another example of passive immunization.

In contrast, active immunization that we see with traditional vaccines come from the response of the recipients own immune system. Thanks to immunological memory, protection is longer than we see with passive immunization, and can be lifelong.

Thanks to advances in biotechnology, we now have the opportunity to prevent infectious diseases with long-acting monoclonal antibodies. When used for passive immunization, these products can provide a level of protection similar to see to that we see with traditional vaccine, but for a limited period of time.

They can be especially valuable when full protection is needed without delay, and when a traditional vaccine is not available. And for some indications, the protection provided by a long-acting monoclonal might be long enough to provide protection during the risk period with a single dose.

For example, for the duration of a respiratory disease season, for a critical part of a pregnancy, or for the duration of travel.

…

Melinda Wharton, CDC [11:06:25]

CDC will prioritize for ACIP consideration those long-acting monoclonal antibodies for prevention of infectious diseases that are expected to address conditions that result in a significant burden of disease to the public’s health, are not expected, based on the characteristics of the product itself, to present significant implementation issues for immunization providers.

I will say, as in that there’s a large number of implementation issues that arise with monoclonal antibodies, as you’ll be hearing later in this meeting, but it’s not due to the characteristics of the product itself, it’s due to other factors and are expected to be priced at a level allowing for incorporation into immunization programs.

…

John Farley, FDA [11:11:31]

FDA imposed two postmarketing requirements, one focused on monitoring the prevalence of RSV variants, including the frequency of known nirsevimab resistance associated substitutions, and the second requirement to phenotypically assess certain RSV A and RSV B substitutions.

Sponsor has agreed to a number of post-marketing commitments. Among these, they include conducting the HARMONY study extension, which will evaluate antibody dependent enhancement of RSV disease, as well as conducting an observational U.S. based long-term study of infants eligible to receive nirsevimab in their first year of life, to assess the impact of RSV disease through day 511 post-dosing.

…

John Farley, FDA [11:12:22]

The FDA has determined that a pharmacovigilance strategy is necessary to support coordinated monitoring and assessment of safety information from data sources across both FDA and CDC. ACIP recommendations will be factored into the final pharmacovigilance strategy, as appropriate.

The full details of this strategy will be finalized in a separate document within 90 days of marketing approval. And this pharmacovigilance strategy may be modified as safety information accumulates during the postmarketing period.

…

Sarah Long, ACIP [11:23:50]

And should there be an RSV maternal vaccine that becomes licensed, we will discuss that, and we’ll discuss it in light of what happens with today’s vote on nirsevimab. But today the sole focus is nirsevimab. Next slide, please.

…

Jefferson Jones, CDC [11:30:16]

As previously presented, this figure shows data from the National Respiratory and Enteric Virus Surveillance System or NREVSS, which is our primary source for monitoring RSV seasonality in the United States. Displayed is the percent of RSV PCR results that are positive from participating laboratories as shown in blue, for the 2017 to 2020 seasons, before the COVID 19 pandemic RSV transmission followed a consistent seasonal pattern with peaks during December to February.

During 2020 to 21, shown in the orange hash line, there was very limited RSV circulation until late spring of 2021, and then activity peaked in late summer of 2021, shown in the yellow line and transmission continued throughout the fall into December 2021. The most recent RSV season is shown in red, with increasing RSV activity starting in late summer 2022, and RSV transmission peaked in October to November 2022.

So to summarize, the 2022 to 23 season began later than the 21 to 22 season, but earlier than pre pandemic seasons, and this suggests an incremental reversion to pre pandemic seasonality with winter peaks. And I’m reviewing these data to highlight the uncertainty in when the next RSV season will start.

…

Jefferson Jones, CDC [11:31:42]

RSV is the most common cause of hospitalization in U.S. infants. The highest RSV hospitalization rates are in the first months life, and the risk declines by month with increasing age in infancy and early childhood.

Prematurity and other chronic diseases increase risk of RSV associated hospitalization, but most hospitalizations are in healthy term infants.

…

Jefferson Jones, CDC [11:37:35]

In a survey of people currently pregnant or pregnant within the last 12 months, conducted by the University of Iowa and the Rand Corporation, on RSV immunizations with CDC, only 33% of respondents thought their baby definitely or probably would get an RSV infection within one year after being born.

Despite being unsure or perceiving RSV risk to be low, respondents were worried their baby would be need to be hospitalized if they got sick with RSV, with a mean response, four out five, with five being most worried. And 70% of respondents said they definitely or probably would get an RSV antibody injection for their baby, if safe and effective.

…

Jefferson Jones, CDC [11:40:25]

I will highlight updates made to the cost effectiveness analysis presented in February. The company has provided an updated estimate cost of product. The list price was estimated to be $495. And the cost for the Vaccines for Children program was estimated to be $395.

Assuming nirsevimab is administered as 50% under VFC, and 50% are private insurance, the average price was $445, and this price is not final at this time, per our understanding.

…

Jefferson Jones, CDC [11:42:16]

The updated base case result of the cost effectiveness analysis is $102,811 per quality adjusted life year saved. The work group felt nirsevimab is or probably is a reasonable and efficient use of resources and a full presentation for this updated cost effectiveness analysis is available in the extra slides.

…

Jefferson Jones, CDC [11:55:57]

The work group felt that nirsevimab use among children aged eight through 19 months, entering their second RSV season, who are at an increased risk of severe disease, is probably a reasonable and efficient allocation of resources.

Like all domains, this is assuming increased risk of severe disease refers to groups recommended to receive palivizumab in their second RSV season by the American Academy of Pediatrics, and also including American Indian and Alaska Native children.

…

Georgina Peacock, CDC [11:58:34]

Suffice it to say, there are a lot of implementation considerations for nirsevimab, and I will walk through those. Some of them we have some mitigation strategies for right now and others we are exploring here at CDC and then with partners out in the field. And we look forward to working with people through these different considerations as we potentially implement this new product.

…

Georgina Peacock, CDC [11:59:05]

One of the first issues that has been brought up is what the definition of vaccine is. And so when we look at the Vaccines for Children program, there is no statutory definition of vaccine in the statute. When we look at the Affordable Care Act, similarly, there is no statutory definition of vaccine, in the Affordable Care Act.

So CDC has determined that nirsevimab is eligible for inclusion in the childhood immunization schedule, and the Vaccines for Children program. It’s important to note, in this area, that some states do have different definitions of vaccine in their state statutes. And this may affect the state purchase of vaccine in places that are universal purchase states. However, it does not affect the use of federally purchased vaccine in states.

…

Georgina Peacock, CDC [12:00:06]

This is a, a costly product. However, as you heard before, there have been cost effectiveness studies to look at this.

If nirsevimab is recommended by ACIP it will be covered by insurance and included in the VFC program. It’s important to make sure that there is equitable access to nirsevimab. And so we understand that the cost of nirsevimab is a potential implementation barrier, particularly for outpatient settings or ambulatory practices.

There is, in the provider agreement for VFC providers, a provision that if a practice has both public and private payers, that they do need to carry stock, so VFC stock and private stock, and we recognize that this may be challenging for some practices. We are working through some potential sort of short term solutions to this, as the ramp up of inclusion of nirsevimab in the VFC program would be occurring. And so those are some of the things that we’re looking at to see, what might be able to be done during this introductory period.

…

Georgina Peacock, CDC [12:01:39]

One of the things that is is helpful for this product is it does look similar to other routine vaccines. So it’s administered intramuscularly with a single dose prefilled syringe. It can be administered simultaneously with other childhood vaccines.

There is a weight based dosing to this, and then the storage and handling is similar to other routine vaccines.

…

Georgina Peacock, CDC [12:02:13]

There have been some questions about scope of practice issues, and different jurisdictions or different states may have different scope of practice statutes related to who can administer injectable therapeutics versus vaccines.

We did do a scan of different state statutes or laws to look at who is allowed to administer therapeutics and what we found that is in most states, it appears that medical assistants who frequently do administer vaccines will also be able to deliver injection drugs.

There is some variability, but this appears to not be a huge issue related to scope of practice.

…

Georgina Peacock, CDC [12:03:23]

So approximately 10% of birthing hospitals participate in the VFC program. There has been a suggestion that this is similar, if it were to be given in the hospital, this is similar to what we do with hepatitis B vaccine. What happens with hepatitis B vaccine is it is bundled into a payment model for newborn care. But it’s important to note that hepatitis B vaccine costs approximately 13 to 16 dollars a dose. And so, it’s anticipated that if this would be included in a bundled payment model, it may take some time for that to be put into practice.

Additionally, in the hospital, there are of course needs and actually this, and I’ll talk about it on the next slide as well.

No matter where the dose is given, it’s important that there be communication and documentation of all the parties involved. So if a dose were given in the hospital, making sure that the primary care provider is aware of that, there are some potential challenges about nirsevimab being entered into immunization information systems, given that it is a therapeutic versus a vaccine. And I’ll discuss some of those issues a little bit later.

And again, if there is eventually also a maternal RSV vaccine that is licensed and recommended, that also adds to this need for communication between maternal records, hospital records, and ambulatory settings or primary care offices.

…

Georgina Peacock, CDC [12:05:20]

Also recognize that an investment initial investment by pediatricians, who are unsure on the demand for the product, may create some challenges. And historically, there is a lag in insurance payment for new products.

…

Georgina Peacock, CDC [12:05:40]

When we move into coding, again, because of the uniqueness of this product, there are some needs to look at the different coding requirements. So, the initial meeting, an AMA decision around CPT codes have classified nirsevimab as a drug or a therapeutic. That means that currently it is associated with an administration code that does not include a counseling component, and it’s not eligible for a standalone counseling component.

What I understand is there are some efforts underway to potentially propose a unique code for this product, that would include some of the counseling components to this, and then also the storage and handling components. And so those efforts are underway as a proposal. And again, there may be some potential challenges in recording the doses in IIS’es.

…

Georgina Peacock, CDC [12:07:21]

I think suffice it to say the IT ecosystem is very complex. There are different partners working on this right now, and we are hopeful that we will be able to get these systems into place, so that this can happen in a timely manner.

…

Georgina Peacock, CDC [12:07:55]

Because a Nici is coded as a therapeutic instead of a vaccine, it could create challenges with internal provider ordering with provision of a vaccine record, and some of the interoperability and data exchange with electronic health records and IIS’es

In addition to this, there are some forecasting issues. So related to the clinical decision support for immunizations, because the dosage is done by weight, and this– the clinical decision support part of the IT system does not have access to the patient weight, that could create some challenges with forecasting doses.

Second season recommendations also may be challenging.

And finally, these clinical decision support systems are unable to take into an account of a maternal vaccination history for forecasting of an infant immunization. So that’s not something that may be relevant right now, but it’s something that we need to be thinking about.

…

Georgina Peacock, CDC [12:10:54]

The question is what will the demand be as this is introduced as a new product? It’s happening at the same time as commercialization of COVID 19 vaccine, and then of course we have seasonal influenza administration happening as well.

So vaccine hesitancy is anticipated and therefore there is a need for counseling around all vaccines and products. And particularly as we introduce new products.

…

Georgina Peacock, CDC [12:22:14]

Just wanted to give you a response on coverage related to the ACA. So nirsevimab will be covered under the ACA as a immunization with no copay, if it is recommended by ACIP.

…

Jefferson Jones, CDC [12:35:54]

Providers should target administration in the first week of life, for infants born shortly before or during the RSV season, shortly before the start of the RSV season for infants aged less than eight months, and shortly before the start of the RSV season for children aged eight through 19 months, who are at increased risk of severe RSV disease.

Now, while the optimal timing for nirsevimab administration is shortly before the season, nirsevimab may be given at any time during the RSV season for age eligible infants and children who have not yet received a dose.

So based on pre pandemic patterns, this means nirsevimab could be administered in most of the continental United States from October through the end of March, and because the timing of the onset peak decline of RSV activity may vary by jurisdiction, providers can adjust administration schedules based on local epidemiology.

For infants born short shortly before or during the RSV season, nirsevimab should be administered within one week of birth administration can be during the birth hospitalization or in the outpatient setting, and infants with prolonged birth hospitalizations due to prematurity or other causes, they should receive nirsevimab shortly before or promptly after discharge.

Tropical climates may have seasonality that differs from most of the continental United States, or is unpredictable. And this may include southern Florida, Hawaii, Guam, Puerto Rico, U.S. Virgin islands in the U.S. affiliated Pacific Islands. Also in Alaska RSV, seasonality is less predictable and the duration of RSV seasons is often longer than the national average. Providers in these jurisdictions should consult state, local, or territorial guidance on the timing of nirsevimab administration.

…

Jefferson Jones, CDC [12:38:26]

The following groups of children aged eight through 19 months are recommended to receive nirsevimab when entering their second RSV season because of increased risk of severe disease: children with chronic lung disease of prematurity, who require medical support, this includes chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen, and this is at any time during the six month period before the start of the second RSV season; children with severe immunocompromise; children with cystic fibrosis who have manifestations of severe lung disease, this includes previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable; or weight for length that is less than the 10th percentile; and American Indian and Alaska Native children.

…

Jefferson Jones, CDC [12:41:41]

CDC will monitor report submitted to VAERS that involve simultaneous administration of nirsevimab with childhood vaccines, and will also monitor the safety of nirsevimab in the Vaccine Safety Datalink, or VSD.

CDC will leverage existing vaccine effectiveness platforms. The New Vaccine Surveillance Network or NVSN is an active surveillance system for acute respiratory infection at seven pediatric medical centers that can assess effectiveness against outpatient and emergency department visits and hospitalizations.

This platform can capture nirsevimab receipt through parent interviews, medical record reviews at the primary care provider and birth hospital, and through state immunization information systems or IIS.

Virtual SARS-COV-2 Influenza or Other Respiratory Viruses Network, or VISION, is a multi-site electronic healthcare record based network that can assess effectiveness against emergency department and urgent care visits, hospitalization and critical illness. Nirsevimab effectiveness analyses will be limited to integrated healthcare systems sites that will have more complete capture of nirsevimab receipt, including through IIS linkage and claims data.

CDC will monitor nirsevimab effectiveness throughout the season. The end of season estimates will likely be most accurate. The power to estimate effectiveness depends on nirsevimab uptake and RSV incidence.

…

Jefferson Jones, CDC [12:43:44]

CDC is planning genomic surveillance of pediatric and adult RSV specimens, including whole genomic surveillance. This surveillance will monitor for changes in the F protein that might result in nirsevimab resistance.

…

Jefferson Jones, CDC [12:46:49]

The work group had a discussion and presentation on this. There is fairly limited data on nirsevimab being co-administered vaccines and immunogenicity.

Per our discussions with expert input from our CDC immunologists, the risk appeared to be low, and both per the FDA label and per CDC’s general best practices for immunization, we felt it appropriate to recommend co-administration of nirsevimab for age appropriate vaccines.

…

Natalie Thornburg, CDC [12:47:40]

Of course there’s not a lot of data. There’s not a lot of data with co-administration of monoclonal antibody prophylaxis with childhood immunization, just because they’re not widely used yet.

There is a little bit of data for infants who have received palivizumab and, there’s no indication that they interfere with vaccine responses. Most of the data that’s available for co-administration and– co-administration of vaccines or inhibition of vaccines, deal with live attenuated vaccines, obviously in this product is not a vaccine, it is a passive immunization product.

So the mechanisms of those inhibitions is not relevant to a passive product.

…

Jefferson Jones, CDC [12:52:23]

I want to emphasize that the trials showed a efficacy of 150 days. There is some data that suggests it may last longer than 150 days. So in those considerations of when to start here’s the data, it shows neutralizing antibodies in blue were those that received nirsevimab who did and did not get a RSV in the and unfilled squares. And then you have the placebo groups in gray. Those filled in triangles are those who received– had confirmed diagnostic confirmed RSV.

So you see the neutralizing antibodies, even up to day 361, are higher in the nirsevimab group that both who did and did not get RSV than the placebo group who did get RSV. So, I think it’s important to try and time it in our considerations when we talked about October through March, that it is shortly before the RSV season is the prime time.

If you give it too early, and while you’re in the peak of the RSV season, there is– you still haven’t given RSV, or RSV has the protection has substantially waned, would clearly be less than ideal, but given this, aiming for shortly before the RSV season, and then as soon as possible if that’s not done.

…

Jefferson Jones, CDC [13:03:56]

We are working on, uh, education and other materials to help our providers that we can provide to them. And we’ll be having future webinars, updated websites, hopefully in the near future.

…

Reed Grimes, HRSA [13:06:55]

For vaccines, the criteria for coverage is typically for, routinely administered vaccines, I should say it’s through the National Vaccine Injury Compensation Program. And that is when a vaccine has been recommended by CDC for routine administer administration to children or pregnant women, subject to an excise tax by federal law, and added to the vaccine injury table by the secretary of health of human services.

So, the vaccine act that governs the Vaccine Injury Compensation Program, does not clearly define, or does not define vaccine. So if all three of those criteria were met, there is a route for potential coverage in the VICP.

…

Jefferson Jones, CDC [13:14:17]

Should a maternal vaccine be licensed by FDA, we will visit that topic at that time.

…

Katherine Poehling, ACIP [13:14:32]

So does that mean we would have to meet and vote again? Thank you.

Jefferson Jones, CDC [13:14:38]

Yes, we would have to meet again to, to vote on a maternal vaccine and discuss any implications for nirsevimab.

…

Georgina Peacock, CDC [01:32:11]

I appreciate all of the comments and the recognition that that implementation is gonna be challenging. So I think one of the things we need to do is recognize that this is a new and very exciting product, that we are working through all of these things, and this is gonna be a transitionary season.

And so, thinking that through, I think some of the things that you all have done here is bring up some of the really important issues related to insurance, related to coding.

I think also the issue around equity, you know, vaccines for children is really an example of a program that has very successfully addressed health equity issues. Over the last 30 years, it provides access to not only children that are on Medicaid, but also children that are under or uninsured, as well as Native American Alaska Native children.

And so, all of these considerations are very important, and I do think that we’re gonna need to work hand in hand with vaccine providers, with physicians, with nurses, with others that are involved in this, as well as our health departments to make sure that we continue to think about how are we going to provide access, as much access as we can, both in this implementation time and then as we move forward.

And so what this season looks like may be different than what it looks like in a couple years. We know with hepatitis B, we started with a different recommendation, and eventually hepatitis B is regularly given in hospitals.

What we may see in the rollout, in the near term, is that more of this is given in an outpatient setting. I think we’re going to have to see how we balance all of these implementation issues and work with you all to make sure that as much access as possible for young infants is going to happen, because it is.

Stepping back, this is a really exciting moment. I know any of us who have taken care of children with RSV, I remember back in residency admitting 20 kids in a night that had RSV. I mean, this is really an amazing time. And so I think if we all work together, we will figure out some of these implementation issues.

…

Grace Lee, ACIP [02:11:06]

So vote number one, infants age less than eight months, born during or entering their first RSV season, are recommended to receive one dose of nirsevimab. I’m just going to ask our ACIP members, if there’s any additional discussion or conversation people would like to have before we open it up for voting. But I appreciate my colleagues already putting on their cameras for the vote in preparation.

…

Melinda Wharton, CDC [02:13:35]

We have 10 yes votes, and it’s unanimous.

…

Grace Lee, ACIP [02:13:43]

With that, we will move on to vote number two. So children age 8 to 19 months who are at increased risk of severe RSV disease and entering their second RSV season are recommended to receive one dose of nirsevimab at the dose indicated there.

…

Grace Lee, ACIP [02:15:51]

So I believe we have 10 yes’s, zero no’s. Dr. Wharton, could you please confirm?

Melinda Wharton, CDC [02:16:02]

That’s correct, Dr. Lee.

…

Grace Lee, ACIP [02:22:29]

Approve the Vaccines for Children resolution for nirsevimab for RSV? It’s been moved and seconded that we consider this vote.

…

Grace Lee, ACIP [02:23:56]

And we have 11 yes’s I believe. And zero no’s. And with that, I believe Dr. Wharton, have we passed the VFC resolution?

Melinda Wharton, CDC [02:24:05]

Yes, thank you. The VFC resolution has passed.

…

Jose Romero, CDC [00:50:28]

I would be remiss if I didn’t say that today is a historic event. I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and wellbeing of children in the United States. I think that this will mark one of the major accomplishments of the ACIP. So congratulations to all of you.

FDA spokesperson about gastroparesis after GLP-1 agonist medications

Diabetic gastroparesis is a complication of diabetes that most commonly occurs in patients with long-standing (5 years or longer) or poorly controlled disease, and its cause is not fully understood. It is unclear whether the GLP-1 agonist medications used in patients with type 2 diabetes contribute to the occurrence of diabetic gastroparesis.

Patients with gastroparesis have not been routinely excluded from clinical trials of long-acting GLP-1 agonists for diabetes indications (including cardiovascular outcomes trials) or chronic weight management indications, and the benefits of these medications may outweigh the risks in some patients with gastroparesis or delayed gastric emptying. For some long-acting GLP-1 products, patients with severe gastrointestinal disorders were excluded from clinical trials and labeling states that use is not recommended in these patients.

The FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process. If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.

For additional information, refer to the following:

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

CDC spokesperson on ACIP for Abrysvo

If Pfizer’s RSV vaccine receives the necessary FDA regulatory approvals, CDC and its advisers will determine the appropriate timing of another meeting to discuss recommendations.

CDC spokesperson about leprosy report in EID journal

The CDC does publish the EID journal, but conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of CDC. So, we would defer to the study authors to discuss this specific report.

CDC is concerned any time we see a rise in case counts. However, CDC does not believe there is a great concern to the American public. The number of persons in the United States with unexplained Hansen’s disease is very small. The majority of the population is genetically immune to Hansen’s disease.

For additional information you may want to reach out to HRSA’s National Hansen’s Disease Program: National Hansen’s Disease (Leprosy) Program Caring and Curing Since 1894 HRSA.

August 2, 2023

Sanofi executives on Beyfortus launch

Thomas Triomphe, Sanofi [00:21:55]

Most importantly, we are fully on track to launch Beyfortus this fall to protect babies going through the first RSV season and to relieve parents and the healthcare systems from the heavy burden of RSV disease.

In the U.S., Beyfortus was approved on July 17th for the prevention of RSV lower respiratory tract disease in infants. Building up on this key milestone, an added ACIP meeting is now set for early next week, on August 3rd, to discuss nirsevimab use for the coming season with both a recommendation vote and a Vaccines for Children program inclusion vote scheduled.

…

Thomas Triomphe, Sanofi [00:41:15]

Registered July 17th, ACIP next week August 3rd, we are very excited and confident about the forthcoming recommendation and the voting. Why?

I think I want to explain that there has been great work with the ACIP over the past few weeks, and we’ve been really reassured by the ACIP recognition of the burden of RSV disease for all infants. So a clear recommendation for all infants is critical, and will be successful, in my view, to ensure equitable access across the population, which is a very important part to look at when it comes to prevention.

So during ACIP meetings in the past, key stakeholders have clearly expressed their interest in ensuring that both and equitable access, and therefore, that gives us confidence. Similarly, we expect inclusion into the VFC program because this decision is critical again, to ensure equitable access for all infants. So moving forward with confidence towards ACIP.

Question [00:42:13]

So I am alright in saying that we we’re the only preventative RSV on the agenda at ACIP next week?

Thomas Triomphe, Sanofi [00:42:18]

We are, absolutely. And the second part of the question, so was on price, very similar to what we said in the past, we want to ensure, and that’s very much linked to the ACIP recommendation, so both go together.

If there is a broad ACIP recommendation, we want to ensure there is equitable access for this product to everyone. And therefore it’ll be a premium innovative vaccine price, well aligned with what was discussed in terms of pricing during the previous ACIP meetings.

AstraZeneca executives on Evusheld replacement

Iskra Reic, AstraZeneca [01:08:05]

So we are continue to rapidly advance AZD3152, which is a new long-acting monoclonal antibody for prevention and treatment of COVID-19 for immunocompromised patient. And I’m pleased to say that SUPERNOVA trial is on track.

As you are mentioning, we did update the trial, and that was as a result of the trial design, and that was a result of the consultation and agreement with the because we believe that it’s the fastest way of how to achieve emergency approval for the the patients in U.S. And currently the trial is updated with the sub-study or immunobridging data.

As a reminder, this is a precedent study design, and will allow us to have the data late this year. Obviously, as we are moving from the beginning with, at pace, we will do our best to deliver AZD3152 to the immunocompromised patient in U.S. by end of this year.

Equally, we are continuing the SUPERNOVA trial with the efficacy end point, and we believe that efficacy data read out will happen in the first quarter of next year, that will allow us to have the approval globally outside of U.S.

On your branding question, thanks for that. I do agree the not having Evusheld brand name for our new next generation monoclonal antibody has its good and bad sides. We are currently into discussion both with FDA and EMA, and we will provide the update on the brand name as soon as we get agreement from those agencies.

FDA official on cosmetics authority

Namandjé Bumpus, FDA [00:14:19]

In a general sense, these are new authorities provided to us through MoCRA, in a variety of areas, that really give us the ability to get just greater understanding even of the cosmetics industry, for instance, through product facility registration, product listing, there now will be requirements for reporting serious adverse events, mandatory recall authority. So there are really enhancements in the work that we can do.

In addition, MoCRA requires FDA to establish regulations for good manufacturing practice or GMP requirements. So that’s something also that we are working on and had a public meeting around. There are also some things included, rule making around labeling of fragrance allergens, and so there are many components that come to us that we’re really enthusiastic about working to implement, and just strengthening the work that we do here around cosmetics.

…

Namandjé Bumpus, FDA [00:15:23]

As far as where we are with implementation. So sunsetted, and announced that we sunsetted, kind of what we had existing, which was a voluntary cosmetics reporting program. And we’re working on developing and rolling out our registration and listing system. We, as I mentioned, had a GMP listening session to hear more from industry so that we can leverage those perspectives as we establish the good manufacturing practices, the regulations that we need to put in place.

As far as implementation, a lot of our timelines are really guided by what is statutory. So for instance, the registration and listing, there is a requirement listed, a statutory requirement, for December 29, 2023, for the system being available and for people being able to register and list there. So we’re following really the guidance that we get from the timeframe that is laid out, the timelines laid out in MoCRA, and there’s some very specific timelines there that are really governing our work and that we’re working to meet.

But in general, lots of new authorities, our first new authorities in over 80 years, and we’re working very hard and very enthusiastic about the work that we can do for public health through MoCRA.

…

Question [00:17:04]

How would you describe compliance with MoCRA requirements so far this year, and what is the best way to describe when and how FDA will begin enforcing any violations that the agency deems?

Namandjé Bumpus, FDA [00:17:18]

So, we’re kind of working through the process and rolling things out over time. And so I would say, continue to follow our website for updates as we have decisions. We’ll also be sure to provide constituent updates, update the website. We also have a mailbox people can send emails to, to kind of ask some of their specific questions.

But what I would say is that we have these kind of statutory timelines and we are working towards those, and in my view, on track to meet them. But, obviously there are, these are all multifaceted things, and lots of things in the air, but we are working hard to meet these timelines that are laid out for us.

We certainly will ensure, as things roll out, that there is reasonable time for implementation by industry. We are listening to people. We hear you, we understand that there’s interest in moving forward. And, we are very interested in that too. So as we’re working to develop these components, we will ensure that folks are aware of our progress, aware of decision making, aware of when things launch, in that we do provide time for the adjustment to be made and for implementation, for instance, for registration listing. But we’ll keep those updates coming. But we want this to work as well for everyone. So we will ensure we have time for implementation for everyone.

…

Namandjé Bumpus, FDA [00:19:13]

We didn’t receive any appropriations for this fiscal year, but are really hopeful for funding to implement MoCRA. And we are, like I said, moving forward and making great progress on it. So of course, when you have additional resources, there is more that you can do. So we are getting it done. It is a priority, my office, we have kind of all hands on deck with folks working on this, but of course, additional resources mean that you can do more to implement things, maybe get more done kind of simultaneously, things along those lines.

So I think that more resources will mean adding to the program as far as how robust it can be, but I want to be clear that we are making progress, even with kind of what we have, and that it is a full and really key priority for our team. And it’s something that we’re really all working on.

CDC spokesperson on H3N2v in Michigan

From: Conley, Kathleen (CDC/IOD/OADC)

Yes that is correct Influenza A H3N2v. Five cases of which were reported in 2022.

This presumptive positive would be the first swine flu case of 2023.

…

From: Tin, Alex TinA@cbsnews.com

And by this year, I meant 2022 – apologies, hit send too fast!

is A(H3)v the same as H3N2v on the FluView, as was already previously reported in Michigan (1), West Virginia (3), and New Mexico (1) in 2022? Or is one more or less granular of a name than the other?

…

From: Tin, Alex TinA@cbsnews.com

Good morning! Thank you for getting back to me

Just one dumb clarification question, is A(H3)v the same as H3N2v on the FluView, as was already previously reported in Michigan (1), West Virginia (3), and New Mexico (1) this year? Or is one more or less granular of a name than the other?

https://gis.cdc.gov/grasp/fluview/Novel_Influenza.html

…

From: Conley, Kathleen (CDC/IOD/OADC)

Good morning Alex,

On July 26, 2023, the Michigan Department of Health and Human Services and Oakland County health departments reported a presumptive positive influenza A(H3) variant virus infection (swine flu) in a person who attended a county fair. A respiratory specimen from that patient was sent to the CDC and was received on July 27. Diagnostic testing conducted at CDC was inconclusive, likely due to the respiratory specimen not containing enough virus.

However, it is likely the patient was infected with an influenza A(H3)v virus given the presumptive positive test results from Michigan, as well as the epidemiologic findings of the local investigation which determined the patient was exposed to pigs within 10 days prior to illness onset at an agricultural fair where influenza A virus was detected among pigs. Additional investigation did not identify respiratory illness in any of the patient’s close contacts or household contacts. No person-to-person transmission of influenza A(H3)v virus associated with this patient has been identified. This case will be reported in FluView and FluView Interactive on Friday, August 4th.

CDC recommends people take precautions to prevent the spread of flu viruses between pigs and people when exhibiting pigs or attending agricultural fairs where pigs are present. CDC guidance for people exhibiting pigs at fairs is available at Key Facts for People Exhibiting Pigs at Fairs CDC, and guidance for fair organizers is available at Issues for Fair Organizers to Consider When Planning Fairs CDC.

Michigan DHHS spokesperson on swine flu case

From Chelsea Wuth of the Michigan Department of Health and Human Services

The CDC was unable to confirm the first case in their laboratory. There can be a number of reasons for this but given the exposure history and history of swine positivity at the fair, they didn’t disagree with the assessment that this presumptive case should be addressed as if they were confirmed. Highlighted link should be most helpful for what you are looking for for occurrences.

Swine flu cases are reported as “influenza, novel” in the weekly Flu Focus reports and the Michigan Diseases Surveillance Reports.

MI Flu Focus influenza surveillance report (michigan.gov)

Current_WSR.pdf (michigan.gov)

Reports & Publications (michigan.gov)