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February 29, 2024

FDA’s adverse event reports of alopecia after GLP-1 RAs

2024-02-29_fda_foia-2024-180.pdf

CDC official at advisory committee discussing measles

Demetre Daskalakis, CDC [08:12:39]

And then finally, I just want to highlight measles. So again, a foe that we know.

So as of February 22nd, 2024, we have 35 cases of measles this year in 15 jurisdictions comparing to 58 cases of measles last year in 20. So that is not a good slope of the curve in terms of where we’re going with measles.

And remember measles is imminently preventable with safe and effective vaccines and it’s populations and environments where coverage is low, where we’re at risk.

As we see more importations, we are a global community. As measles continues to increase in other parts of the world, these importations continue to happen. And when they land places where coverage is low, we are at risk for ongoing larger outbreaks.

CDC advisory committee on GBS after RSV vaccines

Tom Shimabukuro, CDC [09:33:10]

Clinical trials are generally too small to assess the risk for rare adverse events and due to the small number of GBS cases and size of the pre-licensure studies that is not known at this time whether these GBS cases or other neuro-inflammatory events occurred due to random chance, or whether RSV vaccination might increase the risk of these events.

Post licensure safety monitoring of RSV vaccines is ongoing in V safe, VAERS, VSD and other non CDC systems.

…

Tom Shimabukuro, CDC [09:43:41]

On January 19th, 2024, a data mining alert for disproportional reporting was detected in FDA empirical Bayesian data mining for the Pfizer vaccine and GBS.

No data mining alert for the GSK vaccine and GBS has been detected to date.

EB data mining is product specific and analyzes product specific vaccine adverse event pairings compared to the overall VAERS database.

…

Tom Shimabukuro, CDC [09:44:16]

We’ve received 37 preliminary reports as of February 16th.

6 are currently under review. 7 have been excluded based on medical record review. 1 report was verified, but was excluded due to onset, after 42 days.

That leaves us with 23 verified GBS reports by medical record review of which 15 or after the Pfizer vaccine and eight after the Arexvy vaccine.

The median age in these reports was 71 years with an IQR, interquartile range of 63 to 75.

There was 1 report in a non-pregnant female in her fifties who received Pfizer. So that report is either given off– that vaccine is either given off label or an error.

The median time to onset was nine days with a range 1 to 22 days.

There were 14 males, 9 females, none were pregnant. There’s 1 death in a patient in his seventies, a male who received the GSK vaccine.

…

Tom Shimabukuro, CDC [09:47:57]

So the reporting rate for the Pfizer vaccine in the 21 day risk window is 4.6 cases, or 4.6 reports per million doses administered.

And for the GSK vaccine, 1.1 reports per million doses administered.

If you move down to the next major column, this is the 42 day risk window. The reporting rate is the same for Pfizer because all those cases had onset within 21 days. And I mentioned there was one case with a 22 day onset. So that adds another report to the GSK cell there. You see, you go from 7 to 8 from 21 to 42 days.

And so for the reporting rates in the 42 day risk window for the Pfizer vaccine, it’s 4.6 reports per million doses administered. And for GSK 1.2 per million doses of administered.

…

Tom Shimabukuro, CDC [09:51:20]

So we’re using this as our background again, because the mRNA COVID 19 vaccines are not associated with an increased risk of GBS, we can consider this the background incidence of GBS in a vaccine accepting population.

So when you convert that to per million doses in the 21 day risk interval, if we were going to use that as an expected for RSV, that would be 2 cases per million doses administered with a range from the 95% confidence interval of 0.7 to 4.2. And for the 42 day risk interval, 5.2 cases per million doses administered with a range from the confidence interval of 2.8 to 8.9.

So based on VSD data, that’s what we would expect to see as a rate for RSV vaccines, if we assumed that there was no increased risk from vaccination, next slide.

So this is the same table that you previously saw with the VAERS reporting rates, but now I’ve put this far right column, which shows the expected rate per million doses administered. So you see for using in the 21 day risk interval for the Pfizer vaccine, the VAERS reporting rate was 4.6 per million doses administered. And the expected rate based on VSD data would be 2 per million doses administered with a upper bound of the confidence interval at 4.2.

So that point estimate for the reporting rate is elevated for the Pfizer vaccine.

Then for GSK it’s 1.1 per million doses administered, and compared to the expected rate of 2, and that falls within the 95% confidence interval.

For the 42 day risk window for the Pfizer, again, it’s the same 4.6 per million doses administered. The estimated expected rate based on VSD data is 5.2 with a confidence interval, 2.8 to 8.9. And then for the GSK vaccine, it increases to 1.2 per million doses administered because we had that extra case at 22 days.

And that reporting rate is not elevated when you compare that to the background in VSD.

The caveat here is that we know that there is under reporting in VAERS. So those observed VAERS reporting rates are likely an underestimate of the true reporting rate– of the true rate.

…

Tom Shimabukuro, CDC [09:55:37]

I’m gonna give you some quick early rate data from the Vaccine Safety Datalink, which is our active surveillance system.

This is used for rapid cycle analysis and research. It has about 13.5 million individuals across the sites that you see there. And that includes about 2.8 million adults, 60 and older, next slide.

So, this table shows the observed VSD GBS rates following RSV vaccination at adult 60 and older through December 30th, 2023.

VSD has identified 4 GBS cases within 1 to 84 days of the GSK vaccine. All 4 cases of undergone medical record review, and been adjudicated in the table.

There, you see the rates, these are straight rates, for the GSK vaccine in the 1 to 21 day risk window and the 1 to 42 day risk window. And these rates are 9.5 per million doses administered, in the 1 to 21 day risk window, and 14.3 per million doses administered in the 1 to 42 day risk window.

Qualitatively, I will say that these rates are higher than rates that we’ve observed for high dose influenza and for Shingrix. The caveat there is this is very early data based on a small number of cases and a small number of doses administered. And there’ll be additional information on other vaccines in subsequent presentations in this session.

The fourth cases is absent from the table because that was classified as is level four and its pending additional review.

Currently, no cases of GBS have been observed after the Pfizer vaccination, but only about 10% of all vaccinations in VSD have been with Pfizer. So VSD will continue to monitor the safety of RSV vaccines and adults age 60 and older, and formal sequential safety analysis will be March 2024 using a vaccinated concurrent comparison group, which is similar to what we did for COVID next slide.

…

Tom Shimabukuro, CDC [09:57:51]

So to sum things up, local and systemic symptoms were the most commonly reported adverse events following either of the RSV vaccines.

Monitoring in VAERS indicates a higher than expected number of GBS reports following the Pfizer vaccine, but VAERS is subject to the limitations of passive surveillance.

GBS cases were observed in the pre-licensure clinical trials for both the Pfizer and the GSK vaccines and GBS is included as an adverse event in the labels of both vaccines.

Early data from VSD suggest a potential for an increased rate for GBS after the GSK vaccine, but additional analyses are needed to further assess this potential risk. Insufficient doses of the Pfizer vaccine have been used in VSD to inform risk.

Monitoring for GBS, following RSV vaccines and FDA and CDC population based active surveillance systems, is in progress. CDC and FDA will continue to monitor RSV vaccine safety in VAERS and CDC will continue to monitor in V safe.

…

Patricia Lloyd, FDA [10:00:22]

We used a retrospective cohort analysis with a historical comparator group. And the data were from the Centers for Medicare and Medicaid Services or CMS administrative claims, data and enrollment information, derived from CMS Medicare shared systems data, Medicare parts A, B, and D.

And the study population included all CMS Medicare beneficiaries, age 65 years and older, enrolled in fee for service and part D on the day of their first observed RSV vaccination.

…

Patricia Lloyd, FDA [10:02:54]

Approximately 2 million RSV vaccine doses were administered with approximately 680,000 doses for Abrysvo 1.4 million doses for Arexvy.

GBS was observed for both vaccines post RSV vaccination. There were 13 cases following vaccination with Abrysvo and less than 11 cases following Arexvy.

An elevated incidence rate ratio was observed for GBS following vaccination. For Abrysvo, that was 6.4 and for Arexvy, 2.76.

We observed an elevated risk by age groups and sex, but the number of cases were small by subgroups. So less than five.

…

Patricia Lloyd, FDA [10:03:38]

Applying our PPV adjustment based on multiple imputation, we observed an elevated incidence rate ratio observed for GBS following vaccination with Abrysvo, which was 6.9, and a non statistically significant elevated incidence rate ratio observed for GBS following Arexvy vaccination of 2.8, apologies.

The GBS rates following 1 million doses, assuming a 1 to 42 day risk window following Abrysvo, was 25.1. And following Arexvy, 10.0.

…

Patricia Lloyd, FDA [10:05:52]

Using a self-controlled case series design is planned and will provide more conclusive evidence of the potential risks following RSV vaccination.

…

Tom Shimabukuro, CDC [10:09:58]

Due to the uncertainties and limitations, these early data cannot establish if there is an increased risk for GBS after vaccination in this age group.

A more robust, active surveillance in population based systems is ongoing and analyses from these systems will be better able to determine if an increased risk for GBS after RSV vaccination is present.

And if so, the magnitude of the risk.

I just want to assure the, the committee that CDC and FDA will remain vigilant in our monitoring of RSV vaccines as we do for all vaccines and timely and transparent communication is a priority. And we will share additional findings on RSV vaccine safety as the data become available.

…

Tom Shimabukuro, CDC [10:11:36]

We’re continuing to, to gather data in our Vaccine Safety Data link system, which is our population based system, which can be used to assess risk and assess causality.

We plan to start conducting our formal sequential safety analysis in March, so soon. And that’s gonna be done using the vaccinated concurrent comparison group, which compares vaccinated people to other vaccinated individuals, and is a very robust method that was very successful during COVID.

And I think you heard from my FDA colleague, Dr. Lloyd, that they’re going to be conducting a self-controlled risk interval, which uses, where people serve as their own controls and is also a robust method.

So we’ll– some of this depends on how much exposure, how much vaccination is occurring in our systems. We’ll start conducting our analyses in VSD shortly. And, we’ll be happy to brief the work group and the full ACIP as those findings become available.

…

Michael Melgar, CDC [10:30:57]

These are the age stratified results for GSK’s Arexvy vaccine. As we saw before, the preventable illnesses per 1 million vaccinations were lowest in adults, 60 to 64, who are at the lowest baseline risk of severe RSV disease.

For those adults and across all age groups, the numbers of preventable outcomes exceeded the range of GBS observation rate for this vaccine. And again, the observation rate has not been adjusted for background GBS rates. So not all observed GBS cases can be assumed to be associated with vaccination.

Next slide.

And here are the age stratified results for Pfizer’s Abrysvo. For this vaccine as well, the estimated number of preventable outcomes in each age group exceeded the observation rate of GBS, including in the youngest age group of adults, 60 to 64.

…

Michael Melgar, CDC [10:33:49]

In summary, from a population perspective, the benefits of RSV vaccination are estimated to outweigh the potential risk of GBS in adults 16 older, however, estimated benefits of RSV vaccination vary by age group and RSV incidence.

Estimated benefits likely also vary by individual level risk of severe RSV disease and by the timing of vaccination relative to the RSV season. And there are substantial uncertainty in estimates of both benefit and risk.

…

Michael Melgar, CDC [10:37:31]

This all acknowledges a discussion that we need to continue to have with within the adult RSV work group.

Surely, a case of outpatient disease is not equivalent to a case of Guillain-Barré syndrome. So that is not a fair comparison.

Certainly, there are some hospitalizations for RSV that are only two or three day hospitalizations and are not equivalent to a case of Guillain-Barré syndrome.

There are some cases of Guillain-Barré syndrome that are devastating, that result in prolonged ICU admissions, and are some cases of Guillain-Barré syndrome, as we’ve heard, even reported after RSV vaccination, cannot determine a true association, that did result in death.

So, where on the scale of this severity of RSV attributable would one put Guillain-Barré syndrome, I think is a question for interpretation probably somewhere in the spectrum of hospitalization to ICU admission.

I will note again, just given the opportunity that when we’re listing in hospital deaths and quantifying them, we are omitting out of hospital deaths, that are attributable to RSV. And that’s a future direction that we hope to explore.

…

Leonard Friedland, GSK [10:39:29]

GSK expresses concern in the representation of vaccine efficacy for the two licensed RSV vaccines in today’s ACIP presentation RSV vaccination older adults benefit risk discussion.

We note that some slides state the vaccine efficacy estimates are not directly comparable for both vaccines, yet it is not clearly stated on all representative slides that there are no head-to-head studies of the two licensed vaccines, nor is it stated on all representative slides that the follow up time in the second season, after the initial vaccination, differs significantly for the two vaccines.

It’s important to note the vaccine efficacy data for GSK’s vaccine represented in slide 10 is over a complete second RSV season with six months, medium follow up in that season while the vaccine efficacy for the Pfizer vaccine represent a mid-second RSV season with much shorter follow up in that season.

Vaccine efficacy may be expected to decline the longer the time from the initial vaccination.

Data from GSK’s pivotal RSV adult vaccine efficacy trial showed vaccine efficacy against lower respiratory tract disease for Arexvy is 81% through mid second season with a median follow up of 14 months from vaccination and vaccine efficacy is 75% through a complete second season with a median follow up of 18 months from vaccination.

Use of similar time of follow up vaccine efficacy for both vaccines in the benefit risk slides will show a more accurate representation of a substantial clinical impact of Arexvy.

…

Reema Mehta, Pfizer [10:41:53]

Pfizer remains committed to achieving the safe use of our products and collaboration with our stakeholders and partners for the betterment of patients and public health globally. And we acknowledge that the assessment of risk is a multifaceted process.

Given the multiple sources of uncertainty for GBS, some of which include the background rates of GBS among adults who received the vaccine co-administration with other vaccines, seasonality of GBS and underlying conditions at the time of vaccination, such as concurrent infection age at the time of administration, comorbid conditions, and even the differences in the distribution of the vaccine in the various health settings, and finally the system and methodology limitations with respect to being able to attribute causality.

So we agree with the CDC and FDA that the assessment of post vaccine GBS is complex. The findings are preliminary, and these important considerations can have meaningful impact on the analyses.

Pfizer is committed to the continuous monitoring and evaluation of the safety of Abrysvo. In addition to our routine pharmaco vigilance monitoring activities, we are conducting four different post-approval safety studies to ensure robust and continuous monitoring of GBS. And we believe this type of surveillance will provide additional data on the safety profile of Abrysvo, including the incidence and risk factors of GBS.

We will continue to share our findings with CDC, FDA, and other stakeholders as they become available. And with over 3 million administrations in the older adult population to date, we believe Abrysvo is safe and effective and provides protection against RSV and its complications.

Consistent with CDC and FDA, we are here to support ACIP in their recommendations and have the common goal for the need for the more robust data to inform decision making with the ultimate goal, to reduce the public health burden of RSV amongst older patients.

We look forward to our continued partnership to ensure the optimal use of Abrysvo while prioritizing patient safety. And we thank you for your time and dedication to public health.

…

Amadea Britton, CDC [10:49:26]

While our concern of a genuine association between GBS and RSV vaccination may be increasing, there is insufficient evidence currently to confirm this association or to estimate the magnitude of increase.

Assessing the risk for GBS in more robust analyses and active vaccine safety surveillance systems will be crucial and is underway.

…

Amadea Britton, CDC [10:49:50]

The sensitivity of these surveillance systems means we are getting information before it is possible to definitively interpret it. So how can we be responsive to what we are learning while still accounting for this uncertainty?

Overall, the work group, endorses that any increase in potential risk of GBS should be placed in the context of the benefits of RSV vaccination, using our best understanding of the data we have available now.

Just a moment ago, Dr. Melgar summarized that from a population perspective, the estimated benefits of RSV vaccination outweigh the estimated risk for adults 60 and older. Benefits of RSV vaccination vary by age group and RSV incidence, and benefits likely also vary by individual level risk and by timing of vaccination relative to the RSV season.

We also saw data from Dr. Woodruff demonstrating that adults with certain chronic conditions are at increased risk of severe RSV disease even at younger ages.

…

Amadea Britton, CDC [10:55:08]

A majority of work group members express that the balance of estimated benefits outweighed potential risk for all adults, 60 and older. However, the work group expressed that estimated benefits most clearly outweighed potential risks among adults 60 and older, who are at increased risk of severe RSV disease.

This includes adults who are 60 and older with chronic medical conditions, such as chronic lung diseases, heart failure, immune compromise, those of advanced age, and those living in long term care facilities. Next slide.

…

Amadea Britton, CDC [10:59:34]

In the interim, the work group wishes to affirm the importance of the RSV vaccination program.

RSV is a disease that causes significant morbidity and mortality among persons across the age spectrum.

The work group is cognizant that premature changes in the RSV vaccination program based on preliminary data, have the potential to limit access.

…

Amadea Britton, CDC [11:00:41]

The 2023-2024 RSV season overlaid in dark blue here has returned to near pre-pandemic patterns. Next slide.

With this change, the work group concludes it is now advisable for providers and patients to consider timing of RSV vaccination as part of shared clinical decision making discussions.

This is a result both of the return to predictable RSV seasonality, and as a way to maximize benefits of RSV vaccination as we continue ongoing safety monitoring.

For most older adults, benefits will be highest when RSV vaccination is given in the late summer or early fall, just before the onset of RSV season, so that vaccine recipients experience highest protection during the times of peak RSV transmission over the fall and winter.

In addition, because clinical trial data suggests that protection will wane over time, vaccinating just before a season starts also maximizes protection for subsequent seasons, for which the vaccine offers protection. Next slide.

This means that for adults ages 60 years and older, who remain unvaccinated and who decide with their healthcare provider to get an RSV vaccine, the best time for vaccination will be just before the start of the next RSV season.

To clarify the updated consideration is not a transition to a formal seasonal recommendation for RSV vaccination. This offers maximum flexibility and patients with infrequent healthcare contact may benefit from every opportunity to vaccinate.

This is importantly also not a recommendation for annual re-vaccination. While re-vaccination may be recommended in the future, for now adults are only recommended a single dose.

Consideration of timing means when to time that single dose. In most of the United States RSV vaccination will have the most benefit if given in the late summer or early fall.

…

Amadea Britton, CDC [11:02:56]

In general, in the continental U.S., RSV season onset is between September and November. Next slide.

This means that the ideal time to get vaccinated to ensure protection by the start of the RSV season will be August to October in most of the continental United States. Next slide.

…

Amadea Britton, CDC [11:03:36]

I’ll share other upcoming policy considerations being discussed by the adult RSV work group. Next slide.

At the June 2024 ACIP meeting, the adult RSV work group may address the potential FDA approval of Moderna mRNA 1345 vaccine for use in adults, 16 older, the potential FDA approval of GSK RSV vaccine for use in adults aged 50 to 59 at increased risk for RSV disease, and consideration of whether shared clinical decision making remains the preferred policy option.

…

Amadea Britton, CDC [11:06:21]

We have heard feedback from many partners that shared clinical decision making has been challenging to implement.

Today, the work group continues to endorse shared clinical decision making as we learn more about the estimated benefits and potential risks associated with the currently available RSV vaccines.

However, the work group has begun reviewing evidence to deliberate on changing the current recommendation for adults 60 older from shared clinical decision making to a universal recommendation among adults older than a specific age cut cutoff, for example, 75 and older, and a risk based recommendation in adults, 50 and older up to that age cutoff.

…

Amadea Britton, CDC [11:07:09]

The first ever respiratory virus season in which there were vaccines available to protect older adults against RSV disease is coming to a close.

This is a new vaccine program and remains an evolving landscape with the potential for new products and expansion of current products into new age groups.

Data from the season is still incoming. Over the coming months, CDC and the work group will be analyzing these data to inform discussion of future RSV vaccine policy for older adults.

Data from pre-licensure clinical trials and early findings from post licensure vaccine safety surveillance suggests the potential for increased risk of GBS after RSV vaccination in older adults. However, these early data are insufficient to confirm if there is an increased risk assessing the risk for GBS following receipt of the RSV vaccine among older adults and more robust analyses in active vaccine safety surveillance systems will be crucial and is underway.

Currently the work group continues to endorse the benefits of RSV vaccination for adults 60 and older, especially those at increased risk of severe RSV disease, using shared clinical decision making.

Benefits can be maximized by administering RSV vaccine just before the start of RSV season. And the work group recommends that timing of RSV vaccination should be a part of the shared clinical decision making discussion.

…

Amadea Britton, CDC [11:21:29]

The one slide I skipped, the considerations for a risk based recommendation, the work group has expressed that it sort of would do two separate things.

The first is really target those people who are younger adults that are at increased risk while potentially avoiding people that are younger and healthier adults that have really low risk of severe RSV disease, in consideration of if the safety signal persists.

But the other thing is that explicitly outlining risk conditions may be easier for providers to implement because as you guys saw from the NIS data, one of the issues is that there’s not necessarily a healthcare provider recommendation.

And so if there’s a universal recommendation in those risk groups, it may be easier than for practices and providers to implement rather than a specific– that rather than having to implement shared clinical decision making. So those are sort of two separate considerations for the risk based recommendation.

Reported measles cases through Feb. 29 in the United States

At least 40 cases confirmed or suspected, as of Feb. 26, across 17 states.

CDC tallied 35 cases in 15 states as of Feb. 22. Last year had 58 cases across 20 jurisdictions.

1. Pennsylvania (3)

Only three total cases, as of Feb. 23.

2. Virginia (1)

Only one total case, as of Feb. 23.

3. New Jersey (1)

Only one total case, as of Feb. 23.

4. Georgia (2)

No additional cases, as of Feb. 23.

5. New York (2)

Unclear if additional cases.

6. California (2)

No additional cases, as of Feb. 23.

7. Maryland (1)

Unclear if additional cases.

8. Ohio (5)

Unclear if additional cases.

9. Minnesota (3)

Unclear if additional cases.

10. Arizona (3)

Unclear if additional cases.

11. Florida (10)

Unclear if additional cases.

12. Louisiana (2)

Unclear if additional cases.

13. Washington (1)

Only one case, as of Feb. 22.

14. Indiana (1)

Unclear if additional cases.

15. Missouri (1)

Only one case, as of Feb. 23.

16. Michigan (1)

Unclear if additional cases.

17. North Carolina (1)

February 28, 2024

North Carolina Department of Health and Human Services on measles investigation

The North Carolina Department of Health and Human Services reminds families that vaccinations are an important part of overall health and well-being, especially as children. The increased number of measles cases in the U.S. in recent weeks is reflective of a rise in global measles cases and a growing global threat from the disease. There has not been a reported case of measles in North Carolina since 2018. NCDHHS is aware that a person in Guilford County is being investigated for potential measles infection. NCDHHS’ Division of Public Health is working closely with local health departments to ensure readiness to detect and respond to any possible measles exposures in North Carolina.

Vaccine-preventable diseases, such as chicken pox, meningitis, measles, pertussis (whooping cough) and others are still seen across North Carolina. Keeping children up to date on vaccinations is the best way to keep them healthy and reduce unnecessary absences from school. Children who are uninsured can still be vaccinated at low or no cost through the Vaccines for Children program which offers free vaccines to children through 18 years of age.

See attached for school-specific vaccination rates from the Annual Kindergarten Immunization Compliance Report for the most recent year available. The MMR vaccine is a required vaccine in North Carolina and vaccinations are checked upon entry to school. The CDC also tracks MMR vaccination coverage through the National Immunization Survey (ChildVaxView) and through state-reported Kindergarten immunization reports (SchoolVaxView).

According to the National Immunization Survey, 90.1% of children born in 2020 had received at least one dose of the MMR vaccine by 24 months of age compared to 91.4% nationally. According to CDC’s Kindergarten immunization coverage estimates, 93.8% of North Carolina Kindergarteners were reported up to date on the MMR vaccine in the ’22-’23 school year, compared to 93.1% nationally. While statewide coverage remains high in North Carolina, it is important to note that coverage levels vary locally, with some counties and school settings having lower vaccination coverage that leaves these communities more susceptible and at higher risk to a measles outbreak.

Reported measles cases through Feb. 28 in the United States

At least 39 cases confirmed or suspected, as of Feb. 26, across 17 states.

CDC tallied 35 cases in 15 states as of Feb. 22. Last year had 58 cases across 20 jurisdictions.

1. Pennsylvania (3)

Only three total cases, as of Feb. 23.

2. Virginia (1)

Only one total case, as of Feb. 23.

3. New Jersey (1)

Only one total case, as of Feb. 23.

4. Georgia (2)

No additional cases, as of Feb. 23.

5. New York (1)

Unclear if additional cases.

6. California (2)

No additional cases, as of Feb. 23.

7. Maryland (1)

Unclear if additional cases.

8. Ohio (5)

Unclear if additional cases.

9. Minnesota (3)

Unclear if additional cases.

10. Arizona (3)

Unclear if additional cases.

11. Florida (10)

Unclear if additional cases.

12. Louisiana (2)

Unclear if additional cases.

13. Washington (1)

Only one case, as of Feb. 22.

14. Indiana (1)

Unclear if additional cases.

15. Missouri (1)

Only one case, as of Feb. 23.

16. Michigan (1)

Unclear if additional cases.

17. North Carolina (1)

CDC spokesperson on measles outbreaks genotyping

Yes, CDC is supporting the Florida Health Department, who is the lead in this investigation.

CDC is one of the four APHL-Vaccine Preventable Diseases Refence Centers that can provide laboratory genotype sequencing to help better understand potential links among cases. This support is available to all health departments.

CDC advisory committee on chikungunya vaccine recommendations

Susan Hillis, CDC [11:27:27]

I wanted to remind you that the vaccine was licensed through the accelerated approval pathway. Traditional approval would have been very challenging for the chikungunya vaccine and clinical development would likely have been substantially delayed if this approach was necessary.

This is because it would have been difficult to conduct an efficacy trial with a disease endpoint because chikungunya outbreaks are unpredictable and their duration can be relatively short. In addition, there’s no established immunologic correlate of protection.

As a result, the accelerated approval pathway was endorsed for licensure of chikungunya vaccines at an FDA VRBPAC meeting in 2019. FDA can grant accelerated approval for products that are for serious conditions, and that fill an unmet medical need.

With the accelerated approval pathway (inaudible) and be completed by March 2028. And a pragmatic randomized control trial for effectiveness and safety in adults in an endemic area, which is planned for initiation by October 2025, for completion by July 2029.

…

Susan Hillis, CDC [11:29:42]

I’d like to begin with a brief reminder about the key aspects of chikungunya as they relate to the potential use of chikungunya vaccine, and consideration of recommendations.

Chikungunya is caused by chikungunya virus, which is an alpha virus. The key vectors that spread the virus to humans are Aedes aegypti and Aedes albopictus mosquitoes. These mosquitoes mainly feed in the daytime with peak activity in the early morning and late afternoon.

In addition to mosquito born transmission, other uncommon modes of chikungunya virus transmission that have been documented include intrauterine and intrapartum transmission, bloodborne transmission, and transmission after exposure, exposure to virus in the laboratory setting.

Chikungunya virus is typically transmitted in tropical and subtropical regions. Although occasional transmission in temperate areas has occurred.

As shown on the map on the right, there are approximately 120 countries and territories globally where transmission has ever been documented. The virus periodically causes large outbreaks, and when they occur, attack rates are often high with one third to three quarters of the population affected.

Peak virus transmission is usually during the wet season related to an increase in mosquito populations. And each year several hundred thousand disease cases are typically reported from endemic areas.

Clinical illness is characterized by the acute onset of fever and joint pain, which is typically severe and can be debilitating. The joint pain usually involves multiple joints and is most common in the hands and feet that can also occur in more proximal joints.

Other symptoms can include headache, rash, myalgia, and anorexia.

In the absence of specific antiviral treatment, the approach to management typically involves rest, fluids, and use of analgesics, and antipyretics.

Serious complications can occur, which are fortunately rare that can include myocarditis, hepatitis, acute renal disease, and neurologic illnesses such as Guillain-Barre syndrome meningoencephalitis. Deaths are also rare and are reported mostly in older adults, particularly those with comorbidities, as well as young infants infected perinatally or by mosquito bites.

Acute symptoms of chikungunya usually resolve in about 7 to 10 days. However, some patients have a continuation or relapse of their joint symptoms in the months after acute illness, and experience other symptoms such as fatigue.

…

Susan Hillis, CDC [11:33:09]

Among U.S. travelers, chikungunya is a reportable disease in the United States, and approximately 100 to 200 cases of chikungunya are reported annually. Although there is likely substantial underdiagnosis and under reporting.

Infections are most commonly acquired in Asia and the Americas, with specific locations of acquisition influenced by local transmission patterns, which vary from year to year.

Unquestionably, the greatest risk for U.S. travelers for acquiring chikungunya is traveling to an area with an outbreak.

The data on this slide provide an example to demonstrate the higher risk of chikungunya for U.S. travelers visiting an area with an outbreak.

In 2023, there was a large outbreak of chikungunya in Paraguay. On the left, you see a figure that shows among all U.S. travelers to destinations with risk of chikungunya, fewer than 1% traveled to Paraguay. However, on the right, you’ll see that among all U.S. traveler chikungunya cases reported in 2023, 25% or 20 of 80 were among persons who traveled to Paraguay.

So these data clearly demonstrate the substantially higher risk for travelers during an outbreak.

…

Susan Hillis, CDC [11:37:42]

We’ve also looked carefully at the adverse events of arthralgia and arthritis after vaccination, because arthralgia is a key feature of clinical illness with chikungunya virus infection. And the vaccine is a live attenuated vaccine.

So in the GRADE assessment, we included five arthralgia or arthritis related outcomes. Overall 17% of subjects reported any arthralgia as a solicited adverse event within 10 days of vaccination, which was significantly higher than the rate of 5% in the placebo arm.

However, severe arthralgia, persistent arthralgia, arthritis, and new onset or osteoarthritis were not reported at significantly higher rates in vaccinees.

Finally, I’d like to discuss, chikungunya like adverse reactions after vaccination because the vaccine is a live attenuated vaccine, as I mentioned, as I’ve mentioned several times, one of the safety outcomes of interest has been chikungunya like illness after vaccination.

The work group had previously reviewed data based on these types of events, which were defined and referred to by the manufacturer as adverse events of special interest.

During FDA’s review, they requested a re-analysis of adverse event data based on a revised case definition that was less restrictive than the manufacturer’s in terms of timing of onset of timing of onset of events, clustering of symptoms, and duration of the events.

The revised case definition identified subjects with fever and at least one of arthralgia or arthritis, myalgia, headache, back pain, rash, lymph adenopathy, or certain neurologic cardiac or ocular symptoms that occurred within 30 days after vaccination.

The definition is what is used to define chikungunya like adverse reactions in the warnings and precautions section of the package insert, as I mentioned earlier.

With the re-analysis of data from the pivotal clinical trial, based on this definition, 11.7% or 361 of 3,082 vaccine recipients met the definition for having a chikungunya like adverse reaction compared with 0.6% or 6 of 1033 of placebo recipients.

Most symptoms were mild or moderate, but severe reactions that prevented daily activity or required medical intervention, or for fever was a fever higher than 102.1 degrees Fahrenheit were reported by 1.6% of vaccine recipients compared with no placebo recipients.

Prolonged reactions, which were those with a duration of at least 30 days were reported by 0.5% of vaccine recipients and no placebo recipients.

The work group closely reviewed the data from this new revised analysis, but noted, we had already considered the reactogenic nature of the vaccine previously and had looked closely at similar events, including severe and prolonged arthralgia when conducting the GRADE analysis. We also noted that some other reactogenic vaccines have similar rates of adverse events.

…

Susan Hillis, CDC [11:42:41]

The vaccine is very immunogenic, but also reactogenic.

…

Susan Hillis, CDC [11:42:48]

So now I’ll present the draft recommendations for ACIP’s consideration. These are very similar to the recommendations presented in October, when I presented the ETR framework, with some minor modifications based on suggestions from ACIP members.

Chikungunya vaccine is recommended for persons aged 18 years or older, traveling to a country or territory where there is a chikungunya outbreak.

In addition, chikungunya vaccine may be considered for the following persons traveling to a country or territory without an outbreak, but with evidence of chikungunya virus transmission among humans within the last five years.

And they are persons aged older than 65 years, particularly those with underlying medical conditions who are likely to have at least moderate exposure to mosquitoes, or persons staying for a cumulative period of six months or more.

…

Susan Hillis, CDC [11:43:43]

To clarify what is meant by an outbreak in the language of the recommendations, an outbreak will be defined as occurring when CDC posts information on an outbreak on the CDC website.

A notice will be posted as soon as CDC becomes aware of an outbreak. And a similar process is used in relation to a cholera and for the cholera vaccine recommendations with information posted when cholera outbreaks occur.

…

Susan Hillis, CDC [11:44:13]

The second part of our proposed recommendations is a shared clinical decision making recommendation for certain individuals traveling to an area with documented human cases, but without an outbreak, with the relevant groups of individuals being those older than 65 years, particularly with underlying medical conditions, with likely moderate exposure to mosquitoes, as well as travelers who will travel for a cumulative period of six months or more, whether that is at one time or based on very frequent travel to risk locations.

There is more uncertainty in the risk benefit assessment in these cases. However, there are likely to be circumstances where some individuals might reasonably choose vaccination or some providers might wish to recommend it in these circumstances.

It’s appropriate for there to be a conversation between the healthcare provider and patient about the risks and benefits, including the likelihood of exposure based on factors such as activities, time of year, and duration of travel, the disease and its potential severity, the vaccines efficacy, and the possibility of vaccine associated adverse events.

This approach also allows a traveler’s personal perceptions and tolerance of risk to be taken into account.

…

Susan Hillis, CDC [11:45:27]

To provide additional information on why we selected the respective groups for the shared clinical decision making recommendation.

In regard to older persons, we know that among adults, the key risk factors for severe chikungunya disease are older age and underlying medical conditions. And the key risk factors for chronic arthralgia after chikungunya include older age and preexisting joint problems, which are also more likely in older persons.

The risk for higher morbidity and mortality in older persons is supported by data from the 2023 outbreak in Paraguay. Although overall risk for hospitalization and death from chikungunya is low, there is a markedly higher risk for older persons.

The graph shows data by age group with a number of hospitalizations in the blue bars and the case fatality rate in the dark blue line. And the data clearly indicate the higher risk for hospitalization and death in those over 65 years.

The second group known as a group for consideration of vaccination based on shared clinical decision making is travelers who have cumulative period of travel of six month or more.

Although the key risk factor for chikungunya virus infection among travelers is the intensity of transmission far more so than the duration of travel, if there is equivalent transmission in different areas, then the cumulative duration of exposure becomes important.

Additionally, even though a destination might be a low risk environment overall, transmission patterns can be unpredictable over the longer term. And there is likely to be some seasonal variation in mosquito activity that might impact risk.

And finally, U.S. expatriates in locations with risk might not have access to a vaccine if the risk in the country were to increase, or an outbreak began, because at the present time, the vaccine is only licensed and available in the United States.

So the work group considered a shared clinical decision making recommendation was also appropriate for this group.

…

Susan Hillis, CDC [11:47:51]

The rationale for the timeframe is that given the challenges and deficiencies in surveillance, a five year timeframe provides an interval that allows reasonable confidence that there is transmission in a certain location or conversely that there is insufficient transmission for there to be a concern for travelers.

The tool to provide this information will be a map which shows countries with reported chikungunya virus transmission among humans during the last five years. And it’ll be posted on the CDC website and a mock up example is there on the right.

…

Susan Hillis, CDC [11:48:29]

The language of the recommendation refers to moderate exposure.

Text will be provided with the recommendations that indicates moderate exposure could include travelers who might have at least two weeks cumulatively of exposure to mosquitoes in indoor or outdoor settings. And it does not include travelers who might have limited exposure to mosquitoes, for example, those traveling for business and likely to be mainly in mosquito protected indoor settings.

…

Susan Hillis, CDC [11:49:06]

We aimed to develop recommendations that balanced the desirable and undesirable effects of vaccination based on consideration of all the disease and vaccine factors.

The recommended component of the recommendations aims to target the travelers with highest risk where the benefits of receiving the vaccine almost certainly outweigh the risks.

There may be considered recommendation aims to include groups with higher risk where the work group did not think a specific recommended recommendation was justified because there is more uncertainty in the risk benefit assessment, but where some individuals might reasonably choose vaccination and some providers might reasonably wish to recommend it, and where a discussion and decision making based on a conversation between the provider and patient would be valuable.

…

Susan Hillis, CDC [12:12:09]

The work group summary is that the benefits of vaccination likely outweigh the risks for the small group of laboratorians working with live virus, given the potential for them to acquire chikungunya virus infection, which can result in severe polyarthralgia during the acute illness and possibly chronic arthralgia.

And our draft recommendation is the same as that presented to ACIP in October last year as part of the ETR. And it is that chikungunya vaccination is recommended for laboratory workers with a potential for exposure to chikungunya virus.

The recommendations will be presented with additional texts to provide clear information for implementation, including noting that a local institutional biosafety committee should undertake a risk assessment of the potential for exposure to chikungunya virus for each laboratory worker, working with the virus, considering the type of work to be performed and the biosafety level at which work will be conducted.

And that vaccination is not necessary for workers handling routine clinical samples.

…

Susan Hillis, CDC [02:13:32]

So chikungunya vaccine is recommended for persons aged 18 years and older traveling to a country or territory where there is a chikungunya outbreak.

In addition, chikungunya vaccine may be considered for the following persons traveling to a country or territory without an outbreak, but with evidence of chikungunya virus transmission among humans within the last five years: persons aged older than 65 years, particularly those with underlying medical conditions who are likely to have at least moderate exposure to mosquitoes, or persons staying for a cumulative period of six months or more.

…

Melinda Wharton, CDC [02:15:40]

This motion, this passes, 12 yes, with 1 abstention.

…

Susan Hillis, CDC [02:16:06]

So the language is chikungunya vaccination is recommended for laboratory workers with potential for exposure to chikungunya virus.

…

Melinda Wharton, CDC [02:17:39]

This passes unanimously, 13 yes.

…

Wilbur Chen, ACIP [02:20:44]

I would like to comment on the vote for the chikungunya vaccine.

First licensed vaccine in the U.S. but I think that the burden of disease is global. I’d like to hope that the discussions that we had today will not negatively affect the consequences of implementation of the vaccine globally around the world.

I’d like to, of course, continue to see additional vaccines for other mosquito born agents here in the U.S. and around the world as well. Thank you.

Florida health department statement on measles outbreak

You have recently covered the measles outbreak in Florida. As such, please see the statement below as of February 28, 2024.

While details of epidemiological investigations are confidential, many media outlets are reporting false information and politicizing this outbreak. To ensure the communities we serve are correctly informed, we are providing Floridians with the following clarifying information:

97% of students at Manatee Bay Elementary have received at least one dose of the MMR immunization. Outbreaks are occurring in multiple states, and the national immunization rate for measles is less than 92%.

When measles is detected in a school, it is recommended that individuals without history of prior infection or vaccination stay home for up to 21 days. This is the period of time that the virus can be transmitted. This recommendation has been made at Manatee Bay Elementary. There have not been any additional cases present at Manatee Bay Elementary since February 15, 2024. As such, the end of the infectious period is still March 7, 2024. This may change as epidemiological investigations continue.

The Department has also worked with Manatee Bay Elementary to educate parents on measles and ensure that any parent who is concerned for their child, regardless of their immunization status, may choose to keep their children home and utilize continuous learning during this time.

The Department is dedicated to protecting all Floridians as investigations continue. Due to the high immunity rate, as well as the burden on families and educational cost of healthy children missing school, the Surgeon General’s current guidance ensures that parents or guardians are able make the best decisions for their families regarding school attendance. I have attached a copy of the Surgeon General’s letter alongside the fact sheet provided to parents at Manatee Bay Elementary regarding measles.

CDC advisory committee on additional COVID-19 vaccine recommendations

2024-02-28_cdc_acip-covid-voting-language.png

Camille Kotton, ACIP [08:49:22]

It is devastating to see how many elderly and then immunocompromised are being admitted to hospital, are in the ICU, and are dying from COVID 19.

It is shocking to see that only 30 to 40% of the higher risk populations, at least for elderly, and I think it’s a similar number for immunocompromised, are getting the updated vaccine.

I would encourage at this meeting that we provide clarity on the recommendation for an updated vaccine and for immunocompromised in September, we said that they could get two doses of vaccine, at least two months apart, but I think we really need to provide the community with clarity on that because people don’t understand what that recommendation means.

And for me, this is a life and death situation for many of the patients that I take care of.

…

Lisa Prosser, University of Michigan [09:15:39]

Using updated inputs for hospitalization and seasonality adjusted vaccin vaccine impact were as follows.

Vaccination averts substantial morbidity and mortality as demonstrated through estimated disaggregated outcomes shown in the supplementary slides.

ICERs for 50 to 64 year old age group and 65 and older age groups remain robust to changes in parameter inputs across possible ranges.

The ICERs for the 18 to 49 year old age group remain sensitive to changes in parameter inputs, more favorable for higher vaccine impact, higher risk of hospitalization, and critical illness.

Results for a two dose strategy were not economically favorable for the 18 to 49 year olds or 50 to 64 year old age groups across plausible parameter ranges.

For the 65 year and older age group, ICERs are sensitive to probability of hospitalization, costs, and seasonality, and results were more favorable in scenarios with higher risk of hospitalization, lower costs, and alternate seasonality.

…

Megan Wallace, CDC [09:27:15]

The reason we’re asking this policy question is because there is a precedent for older adults to be recommended for an additional dose at least four months after the fall dose recommendation.

Following the initial booster dose recommendations in the fall of 2021, an additional dose was recommended for those 50 years and older in May of 2022. Then following the bivalent dose recommendations in the fall of 2022, an optional additional dose was recommended for those 65 years and older in April 2023.

Now, as you all know, ACIP recommended the 23-24 formula COVID 19 vaccine in September and today we’re discussing if an additional dose should be recommended in older adults this year.

…

Megan Wallace, CDC [09:38:28]

The effectiveness of an additional dose in older adults has been demonstrated by past additional dose.

Among adults aged 50 years and older eligible to receive an a second original monovalent mRNA COVID 19 vaccine booster dose, VE for COVID 19 associated ED UC encounters during the BA.2 period was 32% at 120 days or more after the third dose, but increased to 66% seven days or more after the fourth dose.

VE against COVID 19 associated hospitalization was 55% 120 days or more after the third dose, but increased to 80 seven days or more after the fourth dose.

Additionally, in a large cohort of nursing home residents, receipt of a second original monovalent mRNA COVID 19 booster dose during the circulation of SARS-CoV-2 Omicron sub variants was 74% effective at 60 days against severe COVID 19 related outcomes, including hospitalization or death, and 90% against death alone, compared with receipt of a single booster dose.

…

Megan Wallace, CDC [09:50:55]

When those that had already received the 23-24 COVID 19 vaccine were asked if they would receive an additional dose of the 23-24 COVID 19 vaccine, if it was recommended for them, there was relatively high intent across the board.

But this was particularly true for those 65 years and older, in which 68% reported that they would definitely would get another dose if it was recommended.

…

Megan Wallace, CDC [09:53:42]

COVID 19 vaccines are now available on the commercial market. They’re covered by private and public insurance and available through the Bridge Access Program and Vaccines for Children for those that are uninsured or underinsured.

An ACIP recommendation would be needed for insurance coverage of an additional dose of 23-24 formula COVID 19 vaccine. Insurance coverage is generally required under either a should or a may recommendation.

…

Megan Wallace, CDC [09:56:03]

In the absence of an ACIP recommendation, additional doses might be an out of pocket cost.

Therefore, those able to pay for an additional dose may have access, while others do not. Next slide.

In summary, COVID 19 vaccines are currently on the commercial market and an ACIP recommendation would be needed for insurance coverage of an additional dose.

An additional dose recommendation would leverage existing infrastructure and vaccine product. However, it would add complexity to the current recommendations, which could enhance vaccine and system fatigue.

…

Megan Wallace, CDC [09:58:02]

Cost effectiveness of an additional dose in older adults is highly sensitive to COVID 19 associated hospitalization rates and anticipated rates in the coming months are uncertain.

COVID 19 associated hospitalization rates in older adults that are higher than those seen last year would increase the cost effectiveness. However, lower COVID 19 hospitalization rates would decrease the cost effectiveness.

Estimates that approximate cost effectiveness for those with high risk conditions such as underlying conditions or advanced age are more favorable. Next slide.

When asked is an additional dose of the 23-24 formula COVID 19 vaccine in older adults, a reasonable and efficient allocation of resources, the work group response was probably yes.

…

Megan Wallace, CDC [10:00:23]

A may recommendation would provide flexibility for older adults to obtain an additional dose if they or their healthcare provider feel they would benefit.

The most benefit would likely be in those with underlying medical conditions, advanced age or circumstances that may increase risk such as being a nursing home resident.

An additional dose, in adults 65 years and older, may restore protection that has waned. However, this will be a smaller, incremental benefit on top of the protection that is still being provided by the initial 23-24 formula COVID 19 vaccine dose.

The cost effectiveness of an additional dose depends on COVID 19 hospitalization rates in the coming months and the patient risk factors for severe illness due to COVID 19.

Finally, as COVID 19 epidemiology changes with time, additional dose recommendations may not be needed in the future.

…

Megan Wallace, CDC [10:01:34]

It acknowledges that risk of severe illness took due to COVID 19 continues throughout the year for older adults, despite upticks during the winter months.

The work group also acknowledged that this would have a smaller, incremental benefit compared to that from the initial 23-24 COVID 19 vaccine dose in the fall. It also may decrease vaccine confidence in the benefits of a single dose of 23-24 COVID 19 vaccine and additional recommendations may increase vaccine fatigue, potentially reducing uptake of vaccine next fall.

…

Megan Wallace, CDC [10:04:40]

The work group did have considerations of other age groups, including the 75 year and older age group.

One of the key drivers that that led to dropping it down to 65 was the equity concerns that a 75 year and older age group would likely cause inequities for those in minority groups that that are still experiencing severe illness in the 65 to 74 age group.

…

Megan Wallace, CDC [10:07:43]

The question about seasonality, I think is a really good one. And I think it’s one that we are all asking because I think it would certainly inform the recommendations.

I think this last year we saw much lower rates in the spring and summer than we did the previous two years. But I think, I think we all feel that things with COVID are still unpredictable, particularly as new variants arise.

So I hope that we are moving in the direction of getting more flu-like where there’s a really clear season, but I don’t think that we are there yet.

If others know more than me– I believe the Southern hemisphere is seeing similar to what we are seeing, where there’s year round circulation, but it is higher in the typical respiratory virus months for them.

…

Matthew Daley, ACIP [10:16:21]

I don’t know that I have a perfect answer and because there was some disagreement or at least difference of opinion on the part of the work group.

I mean, in some ways, a may recommendation is a reflection of some difference of opinion on the part of the work group. You know, I think we all recognize that communication is key and how strongly a provider endorses this in their practice is really important.

And we also recognize that now there’s a lot of different settings where vaccination is occurring, since this is also happening in pharmacies, for example. And, that might not entail a long conversation. It might not be with a pharmacist who knows somebody’s individual sort of health status.

So in some ways, the– because there was a difference of opinion on the part of some work group members that is in some ways reflected in the may. That doesn’t mean that that’s necessarily the decision where we need to land, but I think it’s an acknowledgement of that.

So let me just mention a couple of those who had more reservations.

There was a work group member who said, I’m not sure it’s needed. Okay? And I think that’s a reflection of how much burden is there going to be in April, May, June, July, August. I think that’s a question of that.

And then the question of harms came up a little bit and the harms, again, posed by this work group member were not in terms of specific adverse events, following vaccination, but just this, this more theoretical concern about whether that sort of blunts your immune response next fall. And so it was really more about theoretical concern there.

So that was some of the difference of opinion on the part of the work group. And that’s, I think part of what’s reflected in a may recommendation.

However, we all recognize that communicating this is a challenge and that it might be harder to communicate a may recommendation than it should recommendation, in which case you can just say, you know, you should get your vaccine today and then perhaps it’s not as long a conversation.

…

Demetre Daskalakis, CDC [10:20:59]

As we sort of approach the vote, I just wanted to step in and just talk a little bit about the may versus should for a moment, which is so that the note– and I just wanted to sort of echo what Dr. Daley said, which is that the may sort of provides the sort of permissiveness for people who are already very connected to vaccine and interested in vaccination.

So I think that the note from Dr. Cotton that we need to do better in terms of communicating the importance of the initial dose, I think is completely true.

I just want to say that more absolute statements around vaccines sometimes will create a chilling effect for the folks who haven’t been vaccinated. So just sort of putting it out there that in this scenario, it may be worth thinking about the population who we’re talking about, which are folks who have already been vaccinated, who are like suggestible for vaccine, and who will likely take this recommendation sort of on the value of an additional dose is something that may be right for me.

So I just want to put that out there as you all have the discussion and move to a vote.

…

Camille Kotton, ACIP [10:22:18]

Could you provide additional information backing that statement up?

Because as a clinician who provides a tremendous number of vaccines to adults, I have not necessarily found that to be true in my practice.

And for me, when the CDC says, ‘may,’ they think, ‘oh, may? Like may doesn’t really mean anything. That doesn’t mean me. It doesn’t mean I need to do it.’ And ‘should,’ is quite clear.

And so I am concerned. Although I definitely believe that what you say is true, I would like additional data to back up what you have said.

…

Megan Wallace, CDC [10:27:58]

The should recommendation from the fall for everyone to receive a single updated dose still stands.

So that is not being replaced by this in any way. We still want everyone to get their updated 23-24 vaccine.

So this would just be for this specific group that has already been vaccinated if they should receive an additional dose.

…

Wilbur Chen, ACIP [10:30:49]

Having seen the data, I was really struck by the fact that, even though there is a waxing and waning of the burden of disease, that it really did not completely disappear. And I think it probably lost to a lot of even clinicians, that there are a significant amount of hospitalizations and deaths, even at the nadir of the summer.

So it doesn’t ever completely disappear. That burden of disease, seeing the risks associated with age and other underlying conditions also motivated me to see the importance of how that second booster dose could have a significant improvement in the population that receives that.

So, I was in favor of the change to the should.

Having heard that this is really only this vote is applicable to a very small portion of the population. We’re not talking about the unvaccinated and we’re not talking about those– so I’m now stuck at, actually, thinking that may language would be okay with me.

However, I still want to make clear that vaccination is extremely important and whatever we can do to improve language overall, to increase clinicians to be motivated to give a very strong recommendation to their patient population, in addition to all patients understanding the importance of vaccination, would be a goal.

So– but I don’t think that that’s what we’re voting on today. It’s really only a very small segment.

…

Matthew Daley, ACIP [10:35:17]

There’s still this uncertainty every year that passes, we learn more, but there is this uncertainty. And I think, certainly one thing that would be persuasive to me is if there were not much disease burden over the spring and summer, but we just haven’t seen that.

So there is disease out there to prevent, and yeah, that is vaccine preventable.

And so, but I’m still trying to reflect on why we landed on a may recommendation last spring or not.

I think in terms of harms again, I would come back to that in a way too. And, I think there wasn’t major concern from the work group that there would be harms in this strategy. So there was a comfort level with that.

But again, there was a little bit of a, is it really is it really needed? And if so, for whom? Sort of a difference of opinion.

So I don’t think this would be going completely against the work group sentiments, but I just wanted to express that. And again, I wanted to reflect on why we landed on a may last year or not.

And it was related, I think, to uncertainty about multiple aspects also uncertainty about waning, not just epidemiology.

…

Sandra Fryhofer, American Medical Association [10:38:31]

One of the things that’s impressed me so much is the fact that COVID is not, does not have the seasonality like flu, that we’re still having many hospitalizations, still having many deaths as we’re transitioning out of flu season.

And there, as Dr. Daley said, there’s still much disease to prevent.

I appreciate Dr. Daskalakis’ comment about the people that are against vaccines and how a should recommendation might affect them. However, a should recommendation does support vaccine confidence and our belief that this vaccine will save lives, prevent hospitalizations, prevent deaths.

The other thing I worry about with the shared clinical decision making, a may recommendation, is many people are getting these in the pharmacies, and there’s still a little confusion about what the pharmacies can and cannot administer.

They don’t have the knowledge of a patient’s medical conditions and chronic illnesses like their personal physician or provider does. So, I’ve been– I was very impressed with Dr. Cotton and Dr. Long’s comments, and it sort of changed the way I think about this voting language.

…

Lakshmi Panagiotakopoulos, CDC [10:50:51]

However, COVID 19 related hospitalizations had already begun to increase before the ACIP vote on the use of the updated 23-24 vaccine.

Furthermore, the vote and recommendation was also made only weeks before a larger increase in cases, which limited the vaccination and outreach that could be done prior to the surge. Next slide.

So what happened from a programmatic perspective after the fall updated 2023-24 COVID 19 vaccine policy vote?

Uncertainty around the recommendations prior to the meeting made planning for state and local vaccine programs challengin.

Vaccine orders had to be placed prior to knowing the groups for whom the vaccine would be recommended, stakeholder presentations, provider toolkits, and webpages, all had to be updated after the recommendation was made, which limited the available window for communication of the recommendation prior to the respiratory virus season.

There were also reports of issues with vaccine access, including among those at highest risk of severe illness.

…

Lakshmi Panagiotakopoulos, CDC [10:55:09]

This slide now shows the revised timeframe for the 20 24 25 COVID 19 vaccine vote and recommendation at the June meeting, allowing for more lead time between when a recommendation is made to when vaccines are manufactured and distributed.

This slide shows the possibility of the WHO TAG CO VAC in mid to late April, followed by FDA VRBPAC in May, and a potential ACIP recommendation in June.

The proposed plan for 2024 would include a June ACIP meeting to review the evidence for updated COVID 19 vaccine recommendations, which includes WHO and FDA antigen selections, manufacturer studies and immunogenicity data, cumulative effectiveness and safety data epidemiology from current and prior years uptake from current and prior years and cost effectiveness.

ACIP would then vote on the updated COVID 19 vaccine recommendations in June and the 2024-25 formula will become available as regulatory actions are taken by the FDA and vaccines are distributed by manufacturers.

…

Lakshmi Panagiotakopoulos, CDC [10:59:17]

It is unlikely there will be more data between June and September that would influence the updated COVID 19 vaccine policy decision.

…

David Kaslow, FDA [02:08:16]

First of all, only 40% of people over 65 years of age have received the indicated dose in the current package insert for the 2023-24 formula.

The biggest public health impact would likely would likely come from increasing the number of 65 year olds and older getting that indicated dose.

Second, there are suggestive data of longer duration, particularly against the outcomes that are most important, severe disease and death, in those who have had multiple exposures to the spike protein, be it by infection or vaccines. And in the current context, I think what we’re seeing in 65 years and older is they have already had multiple exposures to that spike protein.

Third, there’s a paucity of evidence with both mRNA vaccines and the protein based vaccines given at this time in the ongoing pandemic. The context of receiving an additional dose now is quite different than what it was earlier in the pandemic.

As presented, the preexisting immunity is quite robust now, and quite different than what it was early in the pandemic.

Fourth, if an antigen update is recommended this year, that’s an if, and if it’s available in September, then giving an additional dose of the 2023-2024 formula, the current formulation any later than June this year may not be optimal.

So based on the current context and the available data, this seems truly a may recommendation supported by what is basically level three evidence.

…

Melinda Wharton, CDC [02:12:47]

The motion passes 11 yes, 1 no, 1 abstain.

…

Matthew Daley, ACIP [02:21:26]

I want to reflect on the COVID vaccination vote and just make a couple quick points.

One is that I personally would’ve felt comfortable with a should or a may recommendation and we voted for a should recommendation.

But Dr. Kaslow, the points that you raised don’t go away after we walk out of this room. And so I feel like I want to make sure that we can take those back to the work group and discuss those because as I conveyed the work group had a difference of opinion about where we landed and whether that is we have you come to the work group or we just take those points and discuss them, because we’re gonna have this decision for years to come including in June.

So I just want to highlight that it’s a reason for us to pause and as we’ve talked about, it’s a reason for us to be humble.

Sanofi spokesperson on availability of tetanus vaccine

A supplier is discontinuing production of tetanus/diphtheria vaccine. Because of this, there may be more healthcare providers ordering Tenivac® (Tetanus and Diphtheria Toxoids Adsorbed). Sanofi is taking steps to augment its available U.S. supply of Tenivac®.

The Centers for Disease Control and Prevention state that Tdap vaccines can be substituted for all but the rarest of cases where the pertussis component is not to be used.

MassBiologics on decision to stop tetanus vaccine production

Thanks again for reaching out. The decision to stop production is not related to previous issues regarding the FDA’s request for data.

The clinical indications of similar vaccines have led to a reduction in demand.

February 27, 2024

Measles cases in Maricopa County, Arizona

I can’t speak for outside of Maricopa County, but at this time, we have three total cases that have occurred in Maricopa County this year. You can see our releases and other info at Maricopa.gov/measles.

Measles exposures investigation by Chicago Department of Public Health

I’m getting in touch with regards to an inquiry you sent our way earlier today following up on measles exposures in Chicago. I can confirm that CDPH has not identified any additional cases of measles among Chicago residents, noting that CDPH can only speak for Chicago residents and not necessarily people in Indiana or other Illinois jurisdictions who may have been exposed as well. If you have any other questions or follow-ups on this topic, please feel free to reach out to me directly.

Additional measles case at Manatee Bay Elementary

UPDATE FOR TUESDAY, FEBRUARY 27, 2024 – MANATEE BAY ELEMENTARY SCHOOL

Broward County Public Schools (BCPS) has been informed by the Florida Department of Health – Broward of one additional confirmed measles case involving Manatee Bay Elementary, bringing the total number of cases at the school to seven. The latest affected individual has not been on campus since February 15. The District and school continue to work closely with the Health Department regarding the confirmed cases. This morning, BCPS Superintendent Dr. Peter B. Licata provided an update. See link below:

https://www.eduvision.tv/l?eLtRetR

Additional measles case in Miami County of Ohio

Yes we had a second case in Miami County that is linked to the other 2 cases. All cases are under the age of 18. We were monitoring this person as part of the original exposure and are confidant that there is no further exposure to the public from this third case.

February 26, 2024

Reported measles cases in Missouri for 2024 so far

We have had one case in Missouri in 2024, and the details from Clay County are here:

https://www.clayhealth.com/CivicAlerts.aspx?AID=186

Reported measles cases in California for 2024 so far

QUESTION: Wanted to double check to see if any additional measles cases have been reported in the state? The most recent count I could find was from Feb 14, wanted to double check if this was still accurate: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/measles.aspx

RESPONSE: Yes, the count posted on the website is correct. There have been no additional cases reported since 2/14.

Reported measles cases in Washington state for 2024 so far

To date, there’s been one reported/known measles case in Washington state so far this year

Reported measles case in New York City for 2024 so far

To: Tin, Alex TinA@cbsnews.com
Sent: Friday, February 16, 2024 4:35 PM
Subject: RE: [EXTERNAL] Measles case?

International > From: Tin, Alex <TinA@cbsnews.com> >
Sent: Friday, February 16, 2024 4:35 PM >
Subject: Re: [EXTERNAL] Measles case? > > Received, thank you. > > Are you able to confirm if it was international travel or domestic travel?

Reported measles cases in New Jersey for 2024 so far

There was one confirmed case of measles in NJ earlier this year. Please see: https://www.nj.gov/health/cd/topics/measles.shtml

Reported measles cases in Virginia for 2024 so far

According to Meredith Robinson, VDH’s Vaccine-Preventable Disease Coordinator, there has been one (1) confirmed measles case in Virginia since January 1, 2024.

Reported measles cases through Feb. 26 in the United States

At least 37 cases confirmed or suspected, as of Feb. 26, across 16 states.

CDC tallied 35 cases in 15 states as of Feb. 22.

1. Pennsylvania (3)

Only three total cases, as of Feb. 23.

2. Virginia (1)

Only one total case, as of Feb. 23.

3. New Jersey (1)

Only one total case, as of Feb. 23.

4. Georgia (2)

No additional cases, as of Feb. 23.

5. New York (1)

Unclear if additional cases.

6. California (2)

No additional cases, as of Feb. 23.

7. Maryland (1)

Unclear if additional cases.

8. Ohio (5)

Unclear if additional cases.

9. Minnesota (3)

Unclear if additional cases.

10. Arizona (3)

Unclear if additional cases.

11. Florida (10)

Unclear if additional cases.

12. Louisiana (2)

Unclear if additional cases.

13. Washington (1)

Only one case, as of Feb. 22.

14. Indiana (1)

Unclear if additional cases.

15. Missouri (1)

Only one case, as of Feb. 23.

16. Michigan (1)

Unclear if additional cases.

CDC testing official on clade I mpox preparedness

Christina Hutson, CDC [00:16:44]

In 2023, we saw a dramatic increase in the number of suspect cases. There were over 14,000 suspect cases and 660 deaths.

And then in 2024, this number needs to be updated, but we’ve already seen over 1,000 cases with 101 deaths.

This is seen in 23 out of 26 provinces, as you can see in the picture on the right. So almost the entire country of DRC is reporting suspect mpox cases. And I say suspect because most of them have not been tested by laboratory tests.

They’re only being called mpox based on the clinical presentation. And this is because DRC has very limited testing that is occurring. During 2023, only around 9% of all cases were tested.

The other concerning flags we saw in 2023 is that there were cases in urban settings where we typically haven’t seen mpox. And then also cases along borders, really raising some concerns about spread to other countries.

…

Christina Hutson, CDC [00:17:52]

So the transmission in DRC is quite different from what we see in the U.S. and also different from what we’ve historically seen in the DRC. And really the main, demographic group that is being infected in the DRC seems to be in children. And that’s also where most deaths are occurring and this is less than 15 years.

So that is actually what we historically have seen, but we’ve also seen transmission due to sexual contacts and sex trade workers, primarily these are women’s sex trade workers. So not exactly the same outbreak setting that we saw start in 2022. But concerning again, because we haven’t seen sexual transmission of displayed in the past.

…

Christina Hutson, CDC [00:18:40]

So I mentioned that only 9% of the, the specimens have been tested.

And then we have seen some sequence data come out of the DRC that does continue to support that there are zoonotic introductions of this virus and not necessarily sustained human to human transmission occurring, but we are lacking a lot of information.

This is a very limited number of assessments that are being sequenced.

…

Christina Hutson, CDC [00:19:18]

So going into the U.S. preparedness in case we do have a case of clade I, next slide.

So today there are still, thankfully, no cases of clade I mpox detected in the United States or anywhere outside of endemic countries within Africa.

However, we are raising awareness about these concerning flags that I mentioned, with these outbreaks in the DRC. And so to do this, we did issue a HAN in December where we’re encouraging clade specific testing in DRC travelers, we’re encouraging vaccination because right now only one and four of eligible individuals within the U.S. have received a Jynneos vaccine, and then messaging that prevention, both vaccination and treatment, are expected to perform similarly for clade I, as we’ve seen for clade II.

We also put out a travel health notice alerting about the outbreak in the DRC and increasing our clinical outreach.

…

Christina Hutson, CDC [00:25:45]

There’s no commercial labs that we’re aware of offering clade I testing, but as I mentioned there, Quest is one commercial lab that offers a multiplex that looks for clade II and orthopox generic target.

So we can use that if you have an orthopox positive clade II negative, that should be treated as high suspicion for clade I.

It could be a mutation, but we definitely want to do additional testing to confirm. So although it’s not specifically clade I testing, it very much helps us under those surveillance efforts to see if we have any clade I circulating.

FDA’s Jim Jones at webinar on nutrition with journalists

2024-02-26_fda_foia-2024-1810-TR.m4a

Jim Jones, FDA [00:03:03]

This summer, we plan to issue a proposed rule on FOP labeling.

The proposed rule would be based on extensive research and stakeholder input.

Front of package labeling has the potential to be a very useful tool to provide information for busy consumers, especially those with lower nutrition knowledge, to make nutritious food selections more easily when grocery shopping.

We completed a literature review, two rounds of focus groups and an experimental study to help us choose a label to propose.

The research so far has told us consumers prefer simple interpretive FOP labeling schemes.

The Reagan Udall Foundation public meeting in November provided us with an important opportunity to hear from a variety of stakeholders and the general public.

We heard at the public meeting that there’s wide interest in FOP labeling across sectors of society, industry, healthcare, consumer public health groups, and academia. And we are carefully considering the input we’ve received as well as lessons from international experiences.

If implemented, FOP labeling would complement the nutrition facts label and work with other labeling efforts to provide information to help consumers more easily make nutritious food choices.

…

Jim Jones, FDA [00:10:25]

I can tell you that on our website, you can go and see the labels that we tested.

I can’t tell you which one we are going to propose, but you can get a general sense of them.

I will say that what we learned in our testing, and the one that we selected, is the one that consumers best understood, and would therefore be able to make an informed choice.

And so we really went with what did people say, where we were trying to convey a specific message, they understood that message, so they’d be empowered to make a healthier choice.

So it– our label will line up with what consumers say they understood the best.

…

Jim Jones, FDA [00:11:34]

Historically, manufacturers have been able to use the term as they have chosen, as long as they met the standard. Some of them just incorporate it into the name of the product.

We believe that it would be help– more helpful for consumers if we were to come up with a label or a logo, so that a manufacturer could actually put on a logo, and so you could recognize it across products.

They wouldn’t have to use it, but our experience is that they probably would.

So after we finalize the rule, we’re going to be working with manufacturers and consumers to develop a logo that a manufacturer could then put on a product that was qualified, which would make it easier for consumer to understand that that product has been evaluated against a criteria and it meets the criteria for healthy.

So this will be some of a two step process, first create the standard and then come up with a logo or a label that could be used by manufacturers that meet the standard.

Question [00:12:39]

I guess, next months a year? Is that– is there a timeframe?

Jim Jones, FDA [00:12:45]

No, I believe we will be able to finalize the standard itself this spring.

I think the logo development will follow anywhere 6 to 12 months later.

The creation of the logo doesn’t require regulation. It really is about– it’s kind of– it’s almost like a– working with consumers and manufacturers about what logo would best communicate this and be easily recognizable.

And it’s more of a marketing activity as opposed to regulatory.

…

Jim Jones, FDA [00:24:44]

So the original, there is already a regulation on the books, it was established in the 90s, that set criteria for saying food is healthy.

We are basically updating it to reflect current science.

So then there are about 3%, rather small percent, 3% of manufactured foods are eligible for it. As I said, some of them just use– they use it in their name. And so you could– I don’t wanna like call out any particular product, as opposed to saying this meets FDA’s criteria for healthy.

We think that we could really sort of energize the program, the use of this, by actually coming up with a logo.

But the other thing I do want to say is that all fresh fruits and vegetables are, and will be, eligible for the claim. It really is sort of a way to motivate manufactured products and a relatively small percentage of manufactured products meet the current definition.

That will probably change marginally when we update the definition. It’s really an updating of an existing standard.

The part to me that’s actually is exciting is coming up with a logo that could then be used for marketing purposes for products that meet the standard.

Because right now, as I said, it’s sort of, as a company you can use sort of what language you want as long as you are eligible.

…

Jim Jones, FDA [00:29:13]

So we’ve been in the manufacturer of the Wanabana product, the Austrofoods food plant. We’ve been there for an inspection.

And essentially the spice producer who sold to Austrofoods is where we don’t have authority, but I think that we’ve actually done a good job, we have prevented them from bringing anything into this country.

We know who their customers are. We know– we have import alerts for any of those products and actually they now don’t have any customers.

By naming them, we in effect we’re– had let the world know to be– to have your eyes wide open about this supplier.

So although we can’t go, we can’t like prosecute the cinnamon seller to Austrofoods, I think we’ve been effective at doing what we want to do, which is to keep their product out of the country.

We have that– we have asked– it’s unrelated to specifically your question, but the authority that we asked for about a year ago from Congress is to give us authority to require testing of heavy metals in children’s products, which would’ve been a useful tool to have had in place a year ago.

But I think that the authority related to this company is I don’t think totally the issue. I think the issue is do we have the authority to keep their products out of this country? And I think we do.

…

Jim Jones, FDA [00:39:50]

At the point of sale, consumers are making decisions in a nanosecond and, and a nanosecond doesn’t really allow for that turning the bottle around, turning the packaging around and spending time, trying to ascertain, what is this telling me?

There is– there are consumers who are doing that and of that we are appreciative, that they do that.

But what we have learned from consumer research is that at point of sales, it is a snap judgment, and you’ve gotta be able to give people information in a snap, that they can process in seconds.

And we think that there is a fair amount of evidence from other countries and from the testing, we’ve done similar testing, literally testing how long it took people to understand a mock label.

And so this is a little bit different. It’s giving information, but information in a way that we have evidence that people are able to process in the way in which they are making decisions at the point of sale.

February 23, 2024

Pennsylvania health department on measles cases

As of February 20, 2024, the Pennsylvania Department of Health recorded three measles cases in 2024. Additionally, nine measles cases were recorded in 2023. It is important to note that all cases from 2023 and 2024 are preliminary and subject to change.

ASPR remarks at vaccine advisory committee meeting

Kim Armstrong, ASPR [00:14:41]

The mpox outbreak that started in May 2022 is still ongoing as of February 2024, but has waned in terms of case numbers per day in terms of domestic cases, however, caseloads in Sub-Saharan Africa remain an issue and the Democratic Republic of Congo is experiencing a significant increase in cases of clade I mpox.

As a part of our smallpox preparedness, BARDA is increasing its supply of the U.S. stored inventory of Jynneos, the smallpox and mpox vaccine. The vaccine continues to be made available to jurisdictions for the ongoing mpox response.

BARDA continues its partnerships to develop better and more rapidly produced pandemic influenza vaccines that shorten pandemic influenza response timelines, and increase vaccine accessibility to ensure the nation is prepared to respond to the next influenza pandemic.

Protocol development for a BARDA sponsored randomized double blind phase two clinical trial to assess the safety and immunogenicity of egg based H5N8 influenza vaccine at different antigen dose levels, and adjuvanted with ASO3 and MF59 continues. Study start is projected for summer of 2024.

And finally, under Project Next Gen, BARDA in partnership with Luminary Labs will launch two prize competitions that will provide prize based awards to partners that will one focus on the formulation of RNA based vaccines on microneedle patches, and two, accelerate the development of single dose vaccines that can support a rapid pandemic response.

Measles cases confirmed or suspected so far through Feb. 23

1. Pennsylvania

2. Virginia

3. New Jersey

4. Georgia

5. New York

6. California

7. Maryland

8. Ohio

9. Minnesota

10. Arizona

11. Florida

12. Louisiana

13. Washington

14. Indiana

15. Missouri

16. Michigan

Broward County Public Schools on no new measles cases

As we close out the week, Broward County Public Schools would like to thank Manatee Bay Elementary School’s parents, families and staff, as well as the entire community, for the support and understanding provided over the past several days. The District also thanks the Florida Department of Health – Broward for its support and continued guidance.

As of today, Friday, February 23, there are NO new confirmed measles cases at Manatee Bay Elementary or any other District School to report. The total number of confirmed cases at Manatee Bay Elementary remains at six. The school will continue with all the preventative measures that have been implemented, such as enhanced cleanings at the school, and remains in communication with its families. The District will also continue to provide updates, as needed.

Georgia Department of Public Health on earlier measles cases

No additional cases. The first case had travel history in the Middle East; the second case was an unvaccinated family member.

Clermont County Public Health spokesperson on measles case

The case in Clermont County is considered a potential measles exposure, pending further investigation. It has not been confirmed at this time. Through our disease investigation, we have not found any links to any of the other confirmed cases in Ohio.

Broward County Public Schools on measles outbreak cases

Yesterday, Tuesday, February 20, Broward County Public Schools was notified of one additional confirmed measles case at Manatee Bay Elementary School. This brings the total number of confirmed cases to six. At the request of Florida’s Surgeon General, the District has shared the attached announcement and guidance with our parents and guardians at Manatee Bay Elementary School.

Ohio health department on measles cases

Ohio has had three confirmed cases of measles in 2024, in Miami, Montgomery and Richland counties. The cases in Miami and Montgomery are linked; Richland was not.

Please note that the Ohio Department of Health (ODH) is assisting Clermont County health officials in investigating a potential case of measles there. That case is not confirmed.

We encourage all Ohioans to get the measles, mumps, rubella (MMR) vaccine, as the two-dose vaccine regimen is 97% effective against the measles virus.

February 22, 2024

HHS advisory committee session on school immunization policies

Darlene Huang Briggs, Network for Public Health Law [00:02:54]

During the pandemic, we came together to track and address the various attacks in state legislatures and courts across the country against the various uses of public health authority, especially emergency authority to mitigate the rapid COVID 19 next slide please.

So the network in partnership with the National Association of County and City Health Officials documented the coordinated backlash against public health authority in state legislatures. In these early reports, we saw efforts to outright prohibit or shift or limit fundamental public health powers, and more generally to upset the balance of those powers for the collective good with individual liberties.

These efforts happened across the country and were successful in rolling back public health powers in over half of states, think things like bans on employer vaccination requirements or mask mandates, as well as blocking the use of business closures or quarantine and shifting power from the executive branch to the legislature for decisions that require public health expertise.

And it will come is no surprise to all of you, but the very clear through line Act for Public Health saw in all of these efforts to undermine public health expertise was that vaccines continue to be a target and a bellweather for navigating changes to public health authority more generally. So next slide, please.

Last year we narrowed our legislative tracking focus to a subset of vaccine bills. And what you’re seeing here is that data set from our friends at Temple University’s Center for Public Health Law Research. They have systematically coded and visually mapped school vaccine and provider scope of practice bills identified by the Association for State and Territorial Health Officials from January to May of last year. They’re currently working on an update through the end of 2023. And so what have they found? Next slide please.

Out of 196 total bills introduced, which sought to change existing school entry requirements and the availability of non-medical exemptions and to revisit who determines which vaccines are required for school entry, only 11 of those bills were ultimately ended.

Most expanded scope practice for additional healthcare providers to administer vaccines and just three prohibited various school entry vaccination requirements.

…

Darlene Huang Briggs, Network for Public Health Law [00:07:16]

There are a number of more recent troubling trends to the use of public health authority and for vaccine mandates specifically. The free exercise clause of the first amendment is at the center of these legal challenges.

…

Georgina Peacock, CDC [00:19:38]

So at the state and local level, enforcing school immunization requirements is really a key strategy to encouraging vaccination catch up and school immunization requirements were enacted and enforced in 1977 and really were a driving force behind high immunization rates in schools before the COVID 19 pandemic.

These requirements have played a significant role in measles being declared eliminated in 2000. And obviously what we’re seeing today, in the media and in different places, does raise some concerns.

But we know that when MMR vaccination coverage drops below 95%, communities are at risk for outbreaks.

HHS advisory committee session on immunization shortages

Joe Figlio, ASPR [00:14:40]

The demand and supply is stabilizing, right? The COVID cliff has happened and things have dropped off considerably.

However, as soon as this week, as recent as this week, we had an issue with, and it’s still continuing, things like electrical switch gear. So other other components used to build new facilities, the biggest lead time item now is electrical switch gear and other electrical components.

So that is still one of the top lingering issues in the supply chain that we see.

…

Tonya Villafana, AstraZeneca [00:31:25]

The novel approach required years of prep to ensure that we had scale, that we could meet the scale, and that we would have broad deployment of the antibody.

Manufacturing an antibody can take up to 12 months to complete, with numerous steps, including creation of the drug substance, so where we need to secure raw materials, like the other speakers were referencing, creation of the drug product, which requires fill finish capacity, and securing components or enough components such as syringes, stoppers, and needles which we need to have on hand to be able to have the drug product.

We delivered this season 2 million doses of Beyfortus globally. So we actually delivered more than we had anticipated, or were asked to deliver by initial demand forecasts.

And the complex process that has to– we have to undergo to ensure demand is met needs significant advanced planning, as I mentioned before.

The unprecedented demand that we’ve seen in Beyfortus in the U.S. has thus required us to ensure that we are planning to increase the supply and meet demand and scale up production is on the way for the next season, where we would have Beyfortus implemented. So I’m talking about the 24-25 season, right now.

And our ability to do this is really dependent on the collaboration and partnership with Sanofi, our partner, and also as you can see on the slide, the White House, FDA, CDC, and other stakeholders in this process to ensure that we could meet the needs fully for the next season.

…

Jeanne Santoli, CDC [00:43:35]

CDC purchases vaccines for its routine programs using contracts for pediatrics and adults.

So this includes, we’ve got flu vaccine contracts, COVID 19 vaccine contracts and then contracts for the other vaccines that are used. And each contract includes a requirement for manufacturers to provide advanced notice of vaccine supply issues as soon as they become aware that they will have an inability to fill orders timely.

The contracts also require manufacturers in the event of a shortage to demonstrate reasonably equal treatment between the public and private sectors. And so with these requirements, CDC is provided with some visibility about upcoming issues, and also is able to set expectations about equity between the public and private sectors when there is a supply constraint.

…

Jeanne Santoli, CDC [00:44:30]

Once CDC receives notification from a manufacturer about an anticipated problem, we then seek permission to share confidential information with manufacturers of alternative products who may be in a position to mitigate the situation.

So the information is quite limited. It’s sort of need to know information such as the size of the gap and the anticipated timeframe of the gap. And the information that’s shared is really for just internal discussions, among key planning staff. It’s not to be shared widely within the company and it’s not to be made public.

We also maintain a regular point of contact and communicate as needed with CBER’s product shortage coordinator and CDC staff meet with stakeholders to review and update messaging, and that includes provider organizations, public health organizations, FDA colleagues, and CDC disease subject matter experts.

And then lastly, we maintain a public facing webpage on which we post information about supply shortages of routinely recommended vaccines, next slide.

…

Jeanne Santoli, CDC [00:45:58]

I just wanted to talk about a few strategies for mitigating a vaccine shortage.

The first strategy involves the pediatric vaccine stockpile program. This is part of the Vaccines for Children program, and it allows CDC to use VFC funding to purchase and manage stockpiles. The stockpiles are dynamic storage and rotation stockpiles, they’re held by the manufacturer so they can rotate through manufacture inventory, and that ensures vaccine viability in the stockpile and it reduces waste.

The target size for the stockpile is defined as a six month supply of VFC vaccine usage and the stockpile contracts that we have with manufacturers allow us to loan stockpile vaccines to them to mitigate shortages and vaccines are then replaced following the shortage. Next slide.

A second strategy is controlled vaccine ordering. So when supply is reduced, CDC implements ordering controls in the public sector to mitigate the effects of the shortage and these controls place limits on the total number of vaccines that each jurisdiction can order and jurisdictions are then responsible for making important decisions about how much vaccine will be made available to individual providers and to provider types.

Ordering limits are calculated to facilitate jurisdictions, having an access to an equitable share of the vaccine or product that’s available. And so they actually mirror the relative proportions of each jurisdiction’s ordering for similar vaccines and or similar cohorts when supplies are not constrained.

Manufacturers also often implement ordering controls in the private sector. The approach that they use varies by manufacturer, and it also takes into account direct ordering as well as ordering through wholesalers and distributors. Next slide.

Finally, if there’s insufficient vaccine available to fulfill ACIP’s recommended vaccination schedule, then interim vaccine recommendations can be issued by CDC and an interim vaccine recommendation is a temporary change in the recommended schedule that’s made to conserve limited supply recommendations may either temporarily target limited supply to high risk individuals, or may reduce the number of doses in a multi-dose series.

…

Jeanne Santoli, CDC [00:52:33]

As a new product, nirsevimab is not yet held in CDC stockpile. So stockpile was not an option here, but a number of actions were taken. You’ve just heard about some of this, but there was collaboration between the USG and the manufacturers to manage orders and increased national supply.

And this collaboration occurred at multiple levels of all of the involved organizations and, you know, remarkably an additional 300,000 doses were made available in the public and private sectors during this first season. And that actually reflected a 30% increase over what was planned and was very important in trying to meet some of the unanticipated demand and then discussions, which were ongoing, included a major focus on planning for the next season, because while there was a goal to manage the current season as best as possible, it was understood that starting to plan early for the next season was a key strategy.

CDC provided guidance on prioritizing nirsevimab in mid-October with a focus on the hundred milligram presentation that was most constrained. And then ordering controls were implemented in the public and private sectors to facilitate equity across the country because initial ordering was significantly varied and uneven across different parts of the country. Next slide.

Maricopa County spokesperson on new measles cases

Thanks for reaching out. Yes, these cases are linked to the exposures announced earlier this month.

At least 29 measles cases so far through Feb. 22

1. Pennsylvania

2. Virginia

3. New Jersey

4. Georgia

5. New York

6. California

7. Maryland

8. Ohio

9. Minnesota

10. Arizona

11. Florida

12. Louisiana

13. Washington

Federal health advisory committee on vaccines

Rachel Levine, HHS [00:08:44]

Unfortunately, measles, one of the most contagious diseases, has made me very concerned.

I appreciate NVAC’s proactive approach over the years in sessions about localized outbreaks and preventative measures we can take to prevent measles.

While measles had been eradicated in the United States more than 20 years ago, we have seen recent cases in several states in 2023 alone, a total of 58 measles cases were reported in 20 jurisdictions around the country. And this year CDC has confirmed more cases.

Most of these cases were among children and adolescents who were not fully vaccinated to protect them from getting measles if exposed.

As you well know, measles outbreaks can happen anywhere people are unvaccinated or under vaccinated. While most children in the United States are up to date with their measles vaccinations, too many of our children still need protection.

Recent data from the CDC show that 91% of children under age two years have received the recommended two doses of the measles, mumps and rubella vaccine. This is lower than the Healthy People 2030 goal of 95%.

Additionally, some communities have even lower vaccination coverage that puts them at greater risk for outbreaks.

I look forward to hearing more about the presentations from the speakers today as the committee discusses both the global surge and measle cases and recent outbreaks in Idaho and Pennsylvania.

I also want to encourage the healthcare providers participating in the meeting today to be on the alert for patients with febrile rash and measles symptoms, such as cough, coryza, and conjunctivitis, and those who recently traveled abroad, especially to areas with ongoing measles outbreaks, to be effective in our disease prevention goals.

We must also fully use them to get more people vaccinated. For example, requiring vaccination for kids in school, a topic on your agenda is key to reducing preventable illnesses.

Other evidence-based approaches that promote uptake of vaccinations include patient reminders and recalls, standing orders and incentives to patients and families to overcome hesitancy, a healthcare providers strong and clear recommendation as described in NVAC standards for immunization practice, are central to promoting vaccine uptake and reducing vaccine hesitancy.

…

Natasha Crowcroft, WHO [00:26:29]

If you look through the top panel in this, what really jumps out is the big peak in 2019. That was a very bad year for measles globally. We have– that there were more cases in that year than we’d seen since 1996.

So we had this very, very big outbreak year. And then following that year 2019, you see the numbers really fall away. And that reflects the impact of the pandemic with shut with lockdowns and reduction in international travel.

What’s concerning us right now is if you see 2022, cases went, started to go up, and then in 2023, they went up further and we’re a little bit concerned we’re now in the same or similar position to what we see epidemiologically in run up to that 2019 year, where suddenly we had this explosion of cases. And that’s, that’s, what’s troubling us right now.

…

Natasha Crowcroft, WHO [00:27:32]

What we’re also seeing that accompanies this concern about the pattern in cases is an increase in outbreaks. So the number of large or disruptive outbreaks, which is defined as a country with an instance more than 20 per million, that has increased from 32 in the whole of 2022 to 51 in 2023.

There have been ongoing large or disruptive outbreaks in the African region. So the more recent increase has actually mainly been observed in these Eastern Mediterranean region and the European region, and to some extent in Southeast Asia, but we’ll hear more about Euro shortly next.

…

Natasha Crowcroft, WHO [00:28:14]

The reason for this, why is it happening? Well, we really haven’t seen the recovery in measles vaccine coverage globally, as we’ve seen for other antigens.

So DTP coverage rose to within 1% of its pre pandemic levels, but measles containing vaccine, the first dose coverage remain 3% below the pre pandemic peak. And we already know that that was not high enough because we need 95% coverage in the routine program to avoid outbreaks. So we are still a way off that globally.

And if you go to the next slide please, what we see in low income countries is actually backsliding. So, rather than not recovering as well, we actually see a fall backwards. So we’ve lost 7% in our coverage in low income countries. We’re already way behind in low income countries, but they’ve fallen even further.

…

Natasha Crowcroft, WHO [00:29:48]

What we’re seeing is that more than half of the countries in the world will be at high risk of measles outbreaks by the end of 2024. And about half of those are lower middle income countries.

It adds up to 142 million children under five being susceptible to measles, and most of those live in low or middle income countries, and 62% in settings where we identify those countries to be at highest or high risk of an outbreak by the end of this year.

So we are, we are really looking at this year with a great deal of concern and hoping that we’re going to be wrong because this is a prediction we don’t know what’s gonna really happen, we’re hoping that that action will be taken to catch up and fill these immunity gaps, urgently, to prevent outbreaks occurring.

…

José Hagan, WHO [00:45:55]

During the current resurgence, we’re seeing that there’s a predominance of cases under age five. There are some cases among older children and young adults, accounting for age distribution of the population, it’s still overwhelmingly the youngest children.

This is very different than what we saw during the peak of the 2018-2019 resurgence. And that was a much wider age range that was affected, including older children and adults. And that really reflected, what Natasha referred to, which is this residual immunity gaps across multiple birth cohorts, resulting from sins of the long past and this relative period of peace time in our region with very low levels of endemic transmission, where this population immunity gap was not challenged by large scale importation of the virus.

What we’re currently experiencing really is the results of accumulation of susceptible children who were not reached by immunization programs that were impacted by the COVID pandemic.

…

José Hagan, WHO [00:47:07]

We are experiencing a number of outbreaks in the European region. Most predominantly, this is in the Eastern part of the region and central Asia, but it’s affecting most of the countries to some degree or another.

These outbreaks began in 2023. And for the most part, we see a plateau in Europe except for an overwhelming outbreak in Azerbaijan. There have been ongoing outbreak response activities. And I think hopefully we’ll see the impact of those in the next couple of months.

But you know, these outbreaks are really revealing vulnerabilities, particularly these middle income countries and the need for us to really better understand the subnational inequities and overcoming the uncertainties and denominators that make national immunization coverage not reliable, as many of the affected countries really report actually very high coverage at the national level.

…

Christine Hahn, Idaho Division of Public Health [01:02:53]

We had a young adult male who traveled internationally.

I will say, we did not release the country because it is a rural community. We thought it could be identifying, but it was in the European region, in one of the countries alluded to by one of the previous speakers, and returned to back to Idaho on September 13th.

…

Christine Hahn, Idaho Division of Public Health [01:07:07]

We do know that the public concern is pretty low. We were surprised we thought would get a ton of media attention around our measles outbreak.

And it was really, they certainly reported on it, but there really wasn’t– we actually watched our MMR to see if we’d see a bump, after all our press releases and blogs, and we did not see a bump in MM after that at. Very disappointing.

We have a high exemption rate and we are concerned that as you all know, exempted kids do not necessarily mean unimmunized kids. We think some of these are parents that just don’t want to report anything about their children’s health or healthcare to a school.

But we are concerned that that same reflection of parents that don’t necessarily want the government in their business is going to maybe make it challenging for us moving forward to try to improve vaccination rates and maybe hopefully reduce exemption rates in those communities.

…

Christine Hahn, Idaho Division of Public Health [01:08:04]

This hasn’t been explicitly commented upon yet, but I think people traveling to let’s say Africa or Southeast Asia may go to travel clinics and make sure they’re up to date on their immunizations, but travelers going to the European region, from the United States, don’t necessarily think that way and may not be getting their MMRs before European travel.

…

Shara Epstein, Philadelphia Department of Public Health [01:24:21]

I’ll just mention our vaccination rates in Philadelphia, like across the nation fell during the COVID pandemic, but are back on the upswing no.

93% of our children, six and older, are up to date on their vaccine. 97% of our school-aged children at seventh grade are up to date on their MMR vaccine.

I think our cases here in Philadelphia, while they clustered in a daycare that was accepting of unvaccinated children, were not in a kind of specific community.

They– people had whose children who were not vaccinated, who were included in this outbreak, had various reasons for not vaccinating. They weren’t– they weren’t consistent.

And, in fact, I’ll mention that a lot of the kind of preschool children actually had older siblings who were vaccinated. So these weren’t kind of long held beliefs in most cases about not vaccinating, which may be different than some other outbreaks.

…

Shara Epstein, Philadelphia Department of Public Health [01:27:58]

We’ve also discussed that extensively.

Our initial case was, while too young to get routine vaccinations, would have been old enough to get an early vaccine for travel, and could have prevented our whole cluster, had they done that. So that’s something we’ve discussed a lot and are very interested in.

…

Natasha Crowcroft, WHO [01:28:30]

If I should go ahead and answer the question about why measles vaccine hasn’t caught up as quickly as diphtheria, tetanus, and pertussis, I think it is age related.

We generally find that coverage at a global level and in many low income countries gets lower, the older the child.

So, DTP being given to young infants, and generally we’re talking about the first dose of measles vaccine given at nine months, although seeing in some countries given in at 12 or older, but for the countries we’re talking about, it’s generally nine months.

So we already have a problem with a drop off. And then if we have a system that isn’t working that well, then it finds it even harder to recover for those older children.

On top of that, many low income countries really struggle to immunize children in the first year of– in the second year of life. So, they– the essential program of immunization was originally really just for children under one. And even though there’s been a recommendation for immunization to be whole of life, and for children to be eligible for their infant vaccines up to five at very least, actually moving those changes along in the field has proved quite challenging in some settings.

So, I think that’s the other reason that if a child has delayed their dose for one reason or another, is just very, very hard to reach them in the second year of life in some countries.

Minnesota health department on measles infection

I’m just following up to let you know, since you asked earlier this week, that a third measles case has been confirmed in MN. The new case was confirmed in an unvaccinated cousin of the child with the initial case, so once again, the risk to the public remains very low.

Our website has been updated:

Measles Disease Statistics - MN Dept. of Health (state.mn.us)

CDC advisory committee meeting on public health issues

Dylan George, CDC [12:52:36]

Through the ongoing collaboration with our colleagues in NCIRD, the data office, EZID, and the global health center, we have used wastewater and syndromic data to develop state level forecasts for COVID 19.

We have found by layering in wastewater data, we see more accurate forecast. Now this makes complete sense because it’s a leading indicator of what’s going on with circulation in the community. And it helps us know when there’s going to be peaks or troughs, going forward.

This has been a major advancement that wouldn’t have happened as fast if it weren’t for CFA being in existence.

We’re also making advances on how we use data and improve our forecasting capabilities broadly.

CFA has refactored the code that was used for COVID forecasting by the response team making– we’ve made it much more robust, portable, reproducible, and efficient.

The models that are used for COVID 19 forecasting, they run 10 times faster and with better data processing, so partners can respond to future outbreaks more quickly and more efficiently.

…

Kate Wolff, CDC [00:05:54]

So we ended up with about 160 discrete actions that are bucketed in all of these areas. And I’m really excited to tell you that, right now, we’re– we’ve completed more than 75% of those actions with the remaining 25 on track to be completed over the course of this next year.

Some of the actions, and I’ll talk specifically through, some of the critical areas, but we have things that were sort of one and done pieces of, like changes to a specific policy or making sure that the right communications people were involved in the right response activities. You know, those sorts of changes internally.

We also have a lot of actions that are requiring ongoing implementation efforts. So we are monitoring the implementation of those actions, continuing to iterate as appropriate.

And as Mandy discussed this morning, really looking at the next chapter of moving forward to be that strong foundational base of operational excellence across CDC, that will help us really succeed in the priority areas that we’ve identified as an agency.

…

Kate Wolff, CDC [00:07:51]

So one of the places that really came to light through the process that Mary and Jim and others worked through was to make sure that our– we’re getting science out faster.

This is something that Deb– Deb and team have worked very closely on, and with our team at the office of science, and the clearance process is a place where we’re really seeing the improvement here.

Our process now has allowed us to cut review times in half. And we have improved– we have 120% CDC wide improvement in our clearance rate. So we’re really proud of this.

And then I think the other place that you’re seeing this is other ways that we’re communicating science.

So as part of our respiratory virus response, this fall, we were posting weekly updates on our website of here’s what we know about the latest variant or here’s the latest update about vaccination. Here’s what we’re seeing in the data. So really trying to use all of the tools that we have available to us to communicate the science that we have.

…

Kate Wolff, CDC [00:11:10]

Our website has hundreds of hundreds of thousands of webpages on it. And we have been working really hard to go through every single one of those to make sure that the information that we have available to the public is useful and meaningful and appropriate for that audience.

We are relaunching our website here this spring. And so we’ll keep you all posted as those websites get updated, but we’re expecting that we’ll have a reduction of at least 64% of our current content as part of this process, and to no raise any alarm, we are archiving everything, so we will still have everything available.

And so we can go find anything that we would need, but at least, we expect that this will really enhance the usability of our website for a broad public.

…

Kate Wolff, CDC [00:20:28]

That’s a great flag, and is something that we are actively looking at right now related to the graduated response framework, because it does, in some ways box us in right, as you know, when it gets implemented.

So, you know, this year, just as an example, when we came out of the public health emergency last spring, coming into this fall and winter respiratory virus season, we as an agency were thinking about how do we organize ourselves when we don’t– we’re not in an emergency, but we have an issue where we need all hands on deck and across agency systems.

So what ended up happening and what I think worked well though I know we need to make some tweaks as we think about it going forward, is that NCIRD set up a respiratory virus response group, and that included all of our enterprisewide functions.

So data, lab, science, comms, OCU, our operations folks, Leandra, and our office of health equity, plus the flu team, the COVID team, the RSV team plus Les’s team plus all of senior, you know, everybody was really invited to sit at that table and participate.

And, it wasn’t a formal response structure. Like there were pieces of it that mirrored it, like we ended up setting up, you know, a a channel for our comms folks, right. To make sure that everybody was getting the communications materials.

We had regular meetings that went through a sit rep, and then here’s the issue, so learning some of those lessons, but sort of without as much of the formal structure of an IMS system. And I think that worked well for us with the one caveat that this is an agency that when something says response in the title, they feel a certain way about it, right? And you behave a certain way, so we’re going to work through some of that going forward, but that all hands on deck on something that wasn’t technically an emergency was a somewhat of a new feeling for folks.

And, I think we learned a lot of good lessons there. That’s all to say that we’re trying to think through now, the graduated response framework, and see if we can figure out what– how we make that fit.

And similarly thinking about the mpox response, and now thinking about the next mpox response, like what’s– what’s the right way to lean in, make sure that we are organized and prepared and leaning in, so we’re ready should we need to go into that emergency phase, in a way that is not, everybody’s not constantly in an emergency response, so it’s a tough balance. I don’t know Deb, if you wanna say anything else about that.

Deb Houry, CDC [00:23:42]

No I mean, I agree with what Kate said.

I think, we’re just trying to get past– people react to the word response as well, you know, cause it– we’ve heard from some of our staff that get PTSD when we’re talking about response, because they feel like they’ve been in response for a bit.

So how do we more routinize it and be prepared. And so I think that’s what we’re trying to do is make sure people have enough awareness, but it is being more programmatic in nature where we can.

Florida health department on measles advisory

The Florida Department of Health (DOH) is continuously working with all partners to identify close contacts, including Broward County Public Schools and local hospitals. Pursuant to Section 381.0031(6), F.S., all information contained in epidemiological investigations is confidential. This includes details regarding cases or exposures.

Due to the high immunity rate in the community, as well as the burden on families and educational cost of healthy children missing school, the Surgeon General has deferred the decision to keep children home from school to parents/guardians. Broward County School District has prepared to provide continuous learning to children at Manatee Bay Elementary whose parents/guardians choose to keep them at home until the end of the infectious period. At this time, the infectious period ends March 7, 2024 - this is subject to change. The Surgeon General’s recommendation may change as epidemiological investigations continue.

Attached, please find the measles health advisory published by DOH-Broward.

Louisiana health department on measles cases

this isn’t an international case. They traveled to another state

…

Should have said cases – plural.

Broward County Public Schools on measles outbreak

Yesterday, Tuesday, February 20, Broward County Public Schools was notified of one additional confirmed measles case at Manatee Bay Elementary School. This brings the total number of confirmed cases to six. At the request of Florida’s Surgeon General, the District has shared the attached announcement and guidance with our parents and guardians at Manatee Bay Elementary School.

February 21, 2024

Florida health department on measles outbreak

2024-02-20_florida-health_manatee-bay-measles.pdf

CDC spokesperson on Florida measles outbreak

We are not commenting on this current outbreak in FL and whether unvaccinated children should be excluded from attending school in person during measles outbreaks. What we have said:

CDC is aware of measles cases in Florida and is supporting the Florida Health Department, which is the lead agency in this investigation.

CDC can provide laboratory genotype sequencing to help better understand potential links among cases.

CDC will continue to provide outreach and education to clinicians, helping them understand how to recognize, report, and properly contain measles.

Measles can be brought into the United States by travelers infected while in other countries. Most importations come from unvaccinated U.S. residents.

CDC recommends all children receive measles vaccines, according to the recommended immunization schedule, to provide maximum protection.

February 20, 2024

Copy of FDA response to FOIA request 2022-3738

2024-02-20_fda_foia-2022-3738_abbott.pdf

Ohio health department spokesperson on measles cases

The two measles cases in Ohio were unrelated. Measles cases are increasing internationally, which raises the risk of measles infections in the United States.

We encourage all Ohioans to get the measles, mumps, rubella (MMR) vaccine, as the two-dose vaccine regimen is 97% effective against the measles virus

Minnesota health department spokesperson on measles cases

I checked with my colleagues and as of this morning, there are no new cases.

Georgia health department spokesperson on measles cases

DPH confirmed a second measles case in an unvaccinated family member of the original case in late January. There were no additional exposures associated with either case.

February 16, 2024

Old FOIA responses by CDC to previous requests I filed

2021-08-24_cdc_21-00766-FOIA.pdf
2021-10-14_cdc_21-02373-FOIA.pdf
2022-05-25_cdc_21-01298-FOIA.pdf

Interesting FOIA responses by CDC released on reading room

2024-02-16_cdc_reading-room_23-01261-FOIA.pdf
2024-02-16_cdc_reading-room_23-01738-FOIA.pdf
2024-02-16_cdc_reading-room_23-01749-FOIA.pdf
2024-02-16_cdc_reading-room_23-01831-FOIA.pdf

Reported measles cases so far in the United States

  1. Philadelphia, PA (Jan. 8) first in 2024, linked to outbreak from 2023
  2. Philadelphia, PA (Jan. 8) second in 2024, linked to outbreak from 2023
  3. Northern VA (Jan. 13, Jan. 24) international travel, no secondary
  4. Camden County, NJ (Jan. 13, Feb. 6) not linked to Philadelphia, no secondary
  5. Philadelphia, PA (Jan. 16) third in 2024, linked to outbreak from 2023
  6. Atlanta, GA (Jan. 18) international travel
  7. Atlanta, GA (after Jan. 18) relative of above case
  8. New York, NY (Jan. 31, Feb. 16) international travel
  9. Los Angeles, CA (Feb. 1) international travel, arrived on TK 009 from Istanbul
  10. Silver Spring, MD (Feb. 1) international travel
  11. San Diego, CA (Feb. 2) international travel, 1 years old, not linked to Los Angeles
  12. Montgomery County, OH (Feb. 3, Feb. 3) recent travel, child
  13. Dakota County, MN (Feb. 7) international travel, 16 months old, see secondary below
  14. Unknown, OH (Feb. 10) locally acquired
  15. Dakota County, MN (Feb. 12) sibling of index above
  16. Maricopa County, AZ (Feb. 10, Feb. 12) international travel
  17. Unknown (from CDC tally)
  18. Unknown (from CDC tally)
  19. Unknown (from CDC tally)
  20. Unknown (from CDC tally)
  21. Broward County, FL (Feb. 16) elementary school

New York City spokesperson on measles case

Measles is always a cause for concern and as soon as a case is identified, the city takes action to identify anyone who may have been exposed, provide guidance, and connect people with appropriate resources. The single most important thing we can do to be safe is to get vaccinated.

New York State spokesperson on measles case

There are currently no cases of measles in New York State outside of New York City. For details on measles cases in NYC, please inquire with the New York City Department of Health and Mental Hygiene.

Additional Information:

Measles is a highly contagious respiratory disease caused by a virus that is spread by direct contact with nasal or throat secretions of infected people, via person-to-person respiratory transmission, or touching a contaminated surface and then touching the eyes, nose, or mouth.

To prevent the spread of illness, the Department is advising individuals who may have been exposed and who have symptoms consistent with measles to contact their health care provider, a local clinic, or a local emergency department before going for care.

The single best way to prevent measles is to be vaccinated. Individuals should receive two doses of MMR vaccine to be protected. If a person is unsure if they are immune they should contact their healthcare provider.

The Department carefully monitors for potential measles cases and is prepared to respond if a case is detected.

Please see our measles webpage for more information.

CDC spokesperson on measles importations

Currently large outbreaks are ongoing in many Asian, Middle Eastern, African, and European countries. Because measles remains a common disease in many parts of the world, we are seeing cases brought into the United States by unvaccinated U.S. residents following international travel.

Declines in measles vaccination rates globally have increased the risk of larger measles outbreaks worldwide, including in the United States. When community protection drops, we know that unvaccinated people are at risk. To prevent measles infection and importation, all U.S. residents should be up to date on their MMR vaccinations prior to international travel. The measles vaccine is highly protective. One dose of the MMR vaccine provides 93% protection against measles and two doses provide 97% protection. For more information, visit Plan for Travel - Measles CDC.

February 15, 2024

Federal health officials at House hearing on COVID-19 vaccines

Rep Mariannette Miller-Meeks [11:49:55]

I understand that the FDA has recommended periodic updates to vaccine composition. As we have seen with influenza, a clear framework for strained selection supports the timely availability of a diverse supply of COVID 19 vaccine platforms.

I believe that multiple FDA approved vaccine options can play a role in preserving consumer choice of products and ensuring equity of access, both of which can contribute to increased consumer acceptance and uptake of vaccines without forcing Americans to receive a specific option.

Can you please speak to how the agency is taking steps to ensure vaccine manufacturers have the essential time needed to adapt their products accordingly and scaled up production for vaccines for new virus variants?

Peter Marks, FDA [11:50:42]

Congress member Miller Meeks, thanks very much for that question.

I would certainly agree with you that at FDA, we take seriously the need to have choice among vaccines, because that will allow a greater vaccination rate because we understand that some people may not feel comfortable with certain types of vaccines. They may want a more traditional vaccine, rather than a newer vaccine.

That’s why we’ve been continuing to work with manufacturers to try to make sure that when we roll out the next update, we will have a diversity of choice, of at least more than one type of vaccine that will be available.

So you will see, as we move into the spring, we will, as you’ve noted, go through a strain selection process. We’re already having dialogue with manufacturers to help them get prepared because there’s a lot of pre-work that they can do at risk to prepare for this, so that we can hopefully have the choice that you’re talking about.

February 14, 2024

FDA commissioner at National Press Club event

Robert Califf, FDA [00:13:19]

Let me just offer you a recent example of a situation where the focus on the sensational took precedence on this topic.

Several weeks ago, media outlets from around the world reported on the Florida surgeon generals unfounded call to halt to COVID vaccines. It was a splashy news story, easy to report and filled with conflict, albeit unmerited.

In fact, only a few weeks earlier, the FDA publicly shared a letter we sent to the Florida surgeon general on the precise, underlying issue he raised. We outlined the implausibility of it and reinforced the thorough scientific assessments that give the FDA confidence in the quality, safety and effectiveness of the vaccines. No drama, just facts.

Not surprisingly only one or two reporters wrote about it then.

Make no mistake, it’s important for the public to understand a range of views to help inform their own opinion, but too often, the panoply of stories to which people are exposed causes them to lose sight of the underlying issues that would enable them to live longer free of hospitalization and disability.

Instead they’re often given equal or a greater print or air time to a relatively small but persistent group of stories and opinions that have the benefit of generating controversy, even when those reports are based on views that disagree with and do not represent the vast majority of expert opinion.

This trend of both side ism and free balance, it’s not a new issue. You know about it.

In the example, I just noted the stories were about one outspoken surgeon general who opposes vaccine. A simple review of the landscape reveals that almost all other surgeon generals and state health officials support the widespread use of vaccines.

…

Robert Califf, FDA [00:35:54]

Well, one day I look forward to giving all my thoughts on the lawsuit, but it’s a case in action, so I’m very restricted in what I can say beyond what I’ve already said multiple times.

I think the beauty of the American system, which is the envy of the world, is that we have a strong FDA with about, I don’t know, a handful of us, maybe five or six who are political appointees. All the rest are full-time civil servants with no financial conflict of interest, under heavy scrutiny, who have no mission other than the public health of the U.S. and who have expertise in weighing the risk and benefits based on the evidence.

They did that for mifepristone. The answer’s been consistent at the FDA. It’s not changing. We stand behind the science. And I have also already publicly expressed worry about eroding that.

And I know people who depend on good knowing that the medicines they’re taking are safe and effective have expressed worry that undermining that civil service weighing of risk and benefit based on evidence could really have bad consequences for the future.

…

Robert Califf, FDA [00:42:58]

So one thing we’re very worried about, and throughout HHS, is that right now the wealthy and highly educated are basically getting access to this treatment and people who may need it the most can’t get access. That’s a concern.

But you mentioned that, what’s being told to the public and we regulate the advertising done by those who make the drug and sell it. But we don’t regulate third parties who start clinics and sell things over the internet.

And I’ve recently been noticing a number of these ads that don’t give the whole risk benefit story, and we don’t have authority to really regulate these folks. So it’s an interesting component of it.

February 13, 2024

Oregon Health Authority spokesperson on changes to COVID-19 guidance

Thanks for reaching out, we do appreciate your patience. Regarding data OHA provided to ASTHO on COVID-19, we mentioned not seeing any disproportionate increases in the severity of illness since we changed the state’s isolation guidelines.

Our change in isolation recommendations last year was very much evidence-based and informed by our understanding of transmission. This change acknowledged that isolation alone (i.e., in the absence of additional protective measures such as universal masking) was doing almost nothing to halt transmission at the community level.

Here’s some information we shared with the New York Times that may help with your coverage –

Data points to support no disproportionate increase in community transmission or severity: Hospitalizations - below is a graph of COVID-19-associated hospitalization rates in Oregon as well as three additional jurisdictions (CA, CO, NY). Of note, no disproportionate increase was observed in Oregon’s hospitalization rates following the May 2023 policy change. These data are from the COVID-NET interactive dashboard: https://www.cdc.gov/coronavirus/2019-ncov/covidnetdashboard/de/powerbi/dashboard.html

[image]

Deaths — Below are two graphs of COVID-19-associated death rates in Oregon and the United States. Of note, no disproportionate increase was observed in Oregon’s death rates following the May 2023 policy change. These data are from the CDC COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_weeklydeathrateaa_00

[image]

[image]

It’s also important to consider that isolation is a policy that is typically used when the public health goal is to contain an infection. That is not OHA’s goal. Our goal is to help people in Oregon make informed decisions to protect themselves from severe infection—to understand who is at increased risk, who should be vaccinated, when to consider masking, when to test, how to interpret test results, and when to seek care given the current levels of COVID-19 transmission in Oregon.

…

Sure thing, Alexander. OHA did discuss our isolation policy changes and related data on regional partner calls which included CDC representatives.

CDC spokesperson on reported changes to COVID-19 guidance

No updates to COVID guidelines to announce at this time. We will continue to make decisions based on the best evidence and science to keep communities healthy and safe.

February 9, 2024

CDC spokesperson on lead applesauce poisonings

The median age is 1.7 years old. Virtually all reported cases are in children.

CDC spokesperson on potential BA.2.87.1 detection

As we discussed on the phone, the answer to the question you posed is NO, BA.2.87.1 was NOT sequenced from a traveler who traveled through Newark last year. The sample referred to in the post was missing regions that would be defining for BA.2.87 and did not meet standards to conclusively identify BA.2.87 based on current lineage definitions (<70% genome coverage).

February 8, 2024

CDC official on need for Vaccines for Adults program

Evelyn Twentyman, CDC [00:02:54]

As you probably know, CDC just recently this past fall launched the CDC Bridge Access Program for COVID 19 vaccines. This is a very exciting short term solution to provide continued access for adults to free COVID 19 vaccination, regardless of their insurance status.

However, it’s called the Bridge Access Program for a reason, and it must be a bridge to somewhere that’s somewhere. And I’ll agree with Peschin, we can agree on the name later, but that somewhere needs to be vaccines for adults, vaccines for all, or a program that will really complement what we’ve already done with vaccines for children and our 317 program, to bring vaccines to all people, regardless of their insurance status.

A comprehensive immunization program, like the kind I’m talking about that addresses needs from childhood through adulthood is a cornerstone of maintaining optimal health, as well as for preparing for any public health emergency that might come our way.

…

Evelyn Twentyman, CDC [00:23:05]

So through this sort of complement of availability, we’ve been able to reach quite a few adults. We’ve had about 1.2 million vaccines out the door through this program thus far, and are just hoping for ever more every day.

I do want to speak to one really, really, really important limitation of the bridge– actually, I’ll go ahead and add in a second, two critical limitations.

One, it is only COVID 19 vaccine. I know I’m preaching to the choir here, so I won’t talk about that too long. But COVID 19 vaccine is not the only vaccine that adults are recommended to receive. And so this is not the comprehensive program that we need. It’s not the comprehensive infrastructure that we need to provide equitable immunization, across the spectrum of needed vaccines. That’s the first really important critical limitation.

The second is a sustainability. The bridge access program will end by December 2024. That is this year. So we have part of one more vaccine season left to go.

We are of course working to see if there’s any way that we can extend this, but as it now stands, this will end. This was meant to be a temporary bridge to a more permanent solution like VFA. And I do hope that we get there.

…

Evelyn Twentyman, CDC [00:45:54]

Long term care facilities are largely filled with patients that have insurance. And so in theory, they’re not the target of the Bridge Access Program. In theory, they wouldn’t be part of VFA, but VFA would benefit them. And I’ll tell you, this is why we’ve been working so hard to enroll long term care facilities under eTrueNorth in the Bridge Access Program.

Because exactly like Peschin said, many of these facilities are staffed largely by uninsured adults. And again, viruses don’t respect borders. They don’t respect station either.

Like whether you’re a patient or a provider, you’re equally likely to get a virus. And I know that the care providers for these patients in long-term care facilities certainly don’t want to be the person that their patient caught flu from or caught COVID from.

February 7, 2024

Takeda spokesperson on shortage of lisdexamfetamine

We resolved the June, 2023 U.S. branded Vyvanse manufacturing delay for 40mg capsules in July and the two remaining impacted capsule doses of 60mg and 70mg in September.

Johnson & Johnson spokesperson on shortage of methylphenidate

There has been no change in the supply status of branded CONCERTA, which continues to be available without interruption. CONCERTA generics entered the market in 2011, and a majority of prescriptions today are filled by generic manufacturers.

How often does FDA ask drugmakers for updates of availability of these ADHD drugs in shortage?

The FDA regularly works with manufacturers to evaluate the entire supply chain of drug products to help prevent or reduce the impact of a drug shortage. For a drug in shortage, we are continuous contact with the manufacturers to get the latest info and we update our website daily.

How is FDA calculating total national historical demand, to decide that they are still in shortage?

The FDA receives information provided by manufacturers regarding their ability to supply the market, as well as market sales data on the specific products, then lists drugs on its shortages website once it has confirmed that overall market demand is not being met by the manufacturers of the product. The FDA does not consider a product to be in shortage if one or more manufacturers are able to fully supply market demand for the product.

February 6, 2024

Apotex spokesperson on shortage of lisdexamfetamine dimesylate

Thank you for reaching out to us on this important matter. Apotex strives to meet the demands of our patients and enable access to affordable generic medicines. The production limit on the drug’s active ingredient is one of the main drivers for our inability to fully supply the market. We have not been able to obtain enough raw material to commercialize the product at full commercial scale, and we have used our full quota for calendar year 2023.

February 1, 2024

After several weeks of declining flu activity indicators, some CDC surveillance systems have shown increases in parts of the country in recent weeks. It is not unusual for there to be a slight increase in activity during the weeks following holidays. During some seasons this is the start of a second wave of activity; in other seasons, it is a slight increase in activity prior to activity decreasing toward the spring. CDC is closely monitoring activity and will continue to provide weekly updates via FluView.

CDC clinician outreach call regarding influenza

Tim Uyeki, CDC [00:02:49]

I’m going to summarize influenza activity this season and cover disease burden. Next slide.

So this slide shows influenza positive tests that are reported to CDC from clinical laboratories throughout the U.S. it’s by a weekly basis, as of a week ago.

And what you can see from the slide is that, although the numbers of positive tests peaked at the very end of the year, there’s still a substantial amount of influenza activity occurring in the U.S.

From public health laboratory testing, we know that the majority of influenza viruses circulating this season in the U.S. are influenza A viruses and of those, the vast majority have been influenza A H1N1 pdm09 viruses, with a smaller proportion of H3N2 viruses and overall influenza B viruses have been circulating, but to a much lower extent.

…

Tim Uyeki, CDC [00:09:22]

So in terms of estimated disease burden, what you see on the upper right figure is 12 influenza seasons. It excludes data from the 2020 to 2021 season where we saw very, very little influenza activity in the U.S. and actually worldwide because of probably because of non-pharmaceutical interventions implemented to control the COVID 19 pandemic, but a wide range of disease severity from season to season.

We see seasonal epidemics that result in estimated deaths of about 5,000 to about 52,000 per season, and then hospitalizations wide range for anywhere from estimated a hundred thousand to 710,000 in a more severe season. About 9.4 to 41 million illnesses occurring.

And you can see from the top figure on the right that, among those 12 seasons, the most severe we had was during the 2017-2018 influenza epidemic in the U.S., which is the higher range of 710,000 estimated hospitalizations and 52,000 estimated deaths.

For this season, preliminary estimates as of January 20th, and we’ll update these regularly as we have data, estimated 18 to 35 million illnesses have occurred anywhere from 8.4 to 16 million medical visits, 210,000 to 440,000 hospitalizations and 13,000 to 38,000 deaths.

So based on these data, we would classify the season to date as a moderate season in terms of disease severity. There’s much more influenza still to go, although nationally we have peaked.

And just to say that, although I showed that hospitalization rates are highest in people 65 years and older, mortality rates are also much, much skewed towards people 65 years and older, they’re much higher the older you are above 65 years old.

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Tim Uyeki, CDC [00:36:12]

So just as a reminder, as I mentioned, although the influenza season has peaked nationally, there’s still a lot of influenza viruses circulating throughout the U.S. A lot of communities are still influenza. We do expect influenza activity to continue for many weeks to come this season.

So for unvaccinated people, I want to remind clinicians and public health colleagues that vaccination is the most effective way to protect patients against influenza.

State health department on BioFire norovirus testing

January 31st , 2024

Purpose of this Message:

To inform clinical laboratories of a recall issued by bioMerieux on 1/29/2024 regarding an elevated incidence of false positive Norovirus results from BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel.

Action Item:

• Please review the recall notice (FSCA 5812) for the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel.

• In cases where a positive Norovirus result appears inconsistent with clinical presentation, please refer the specimen to your send out reference lab for confirmation using alternative detection methods.

• If the confirmation result is discrepant from initial result using the BioFire, report the findings directly to bioMerieux technical support team at biofiresupport@biomerieux.com or via telephone by dialing 1-800-735-6544 and selecting option 5 for Product Technical Support.

Background:

Norovirus is the leading causes of vomiting and diarrhea from acute gastroenteritis with most Norovirus outbreaks in the US occurring in November to April. The CDC, along with other state Public Health Laboratories (PHL) including MDH PHL, have expressed concerns regarding an unusual surge in Norovirus positivity detected by the BIOFIRE®, coupled with a low concordance rate observed with alternative detection methods. On 1/29/24 bioMerieux released a recall notice for the BIOFIRE® FILMARRAY® GI Panel, necessitating appropriate follow-up actions.