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I'm still in my semi-hiatus in posting while trying to figure out a new look for the website and its content. I don't think I can ever stop browsing all my feeds from around the world, and this past week seems to be mostly annoying noise. Such as .....

  1. HHS withdrew funding from several grants to the AAP, presumably for being too woke. Note that the AAP is party to a suit against the HHS for its changes to the vaccine schedule.
  2. The Acting Director of the CDC signed off on the ACIP's recommendation to change hepatitis B vaccine use, no surprise. I was slightly intrigued that he did not sign off on the second vote involving use of serologic testing to determine need for subsequent doses for those newborns who received a first dose. Readers may recall from my December 7 post that this second vote was clear proof that ACIP members were not acting based on any science, even contrived science. Look to AAP and other qualified organizations for vaccine advice.
  3. FDA has ongoing issues with industry noncompliance with food recalls, highlighted by the infant botulism outbreak connected to ByHeart brand infant formula. Apparently this is a longstanding general problem that predates the current administration.
  4. CDC awarded an unsolicited research grant to study hepatitis B vaccine to a group at the University of Southern Denmark that has long been criticized for faulty research methods and promoting an anti-vaccine agenda. The grant was never opened to competitive submissions, not that it would have mattered since the awardee was predetermined. The December 2025 issue of the journal Vaccine (subscription required) has an article spelling out concerns with this research group.
  5. Ending this section with some good news, WHO declared Brazil has eliminated mother-to-child transmission of HIV. This is an amazing accomplishment for a large country. Will the US ever get there?

CIDRAP/NEJM Evidence Collaboration

CIDRAP, home of the Vaccine Integrity Project, is partnering with the NEJM Evidence journal to publish a new series on public health alerts. This appears to be an attempt to counter potential censorship of CDC publications. The first topics cover mpox clade Ib transmission in the US and influenza strains from last season.

WRIS

Winter respiratory infection season continues is building up. RSV hospitalizations continue to increase. Percent respiratory test positivity is showing a sharp increase for influenza.

Hotspots for influenza-like-illness (includes flu and other respiratory pathogens) are growing but scattered.

JAMA (subscription required) had a nice Perspective on influenza A H3N2 subclade K. I had mentioned previously that early data from England suggests that our current influenza vaccines will have some effectiveness against significant illness caused by this subclade, even though it has drifted somewhat from the H3N2 vaccine strain.

Measles

We have reached 1958 cases and counting for this calendar year. South Carolina has had 60 cases in the past 2 weeks alone, and other outbreaks are appearing.

Location of cases in the past 2 weeks, as of December 19.

NEJM published a nice review article of the disease. I appreciated the concise listing of complication rates seen in developed countries.

A Less Noisy Week Ahead?

At least I hope so. I'm looking forward to a few gatherings with friends and family. Have a quiet, happy, wonderful week.

Pumpkin spice season is in high gear, even though winter viruses haven't taken off.

It's a mixed infectious diseases bag this week, led by the almost complete silence from CDC due to the government shutdown. I've attempted to navigate through various sources to put together what is, at best, a semi-accurate state of affairs in the US. I also include mention of 3 significant articles that appeared in the past week.

Nimble News

My predilection for alliteration notwithstanding, I found a lot of tidbits in the news that I thought would be best summarized with brief mentions and links.

WHO announced that the last hospitalized patient with Ebola virus infection in the Democratic Republic of the Congo has been discharged. This starts a 42-day (2 incubation periods) countdown to declaring the outbreak over.

On Monday WHO also announced that Maldives is the first country in the world to hit the trifecta, i.e. elimination of mother-to-child transmission of HIV, hepatitis B, and syphilis. That may not seem so difficult for a group of islands in the Indian ocean with a total population of about 500,000, but it does have a brisk tourist industry that certainly challenges disease containment efforts. Given current trends, don't look for the US to come close to this achievement in your lifetimes.

Along similar lines, I noticed that the AAP is expanding their congenital syphilis toolkit, with much of it available to individuals who are not AAP members.

Details are scarce, but it looks like California now has 2 or maybe 3 cases of autochthonous (locally acquired without travel) cases of the clade 1 mpox that cropped up in Africa recently. The individuals are from Los Angeles and Long Beach and reportedly aren't connected to one another. This isn't unexpected; in fact, I'm mostly surprised that it took so long. Presumably California health authorities will provide updates in the coming weeks.

Speaking of autochthonous transmission, New York now has reported a case of locally-acquired chikungunya infection. Again, not a big surprise. Watch out for those tiger (Aedes albopicutus) mosquitoes, especially in the eastern half of the US.

First reported by the Wall Street Journal and then picked up by multiple news organizations (I can't supply a link, subscription required). a collection of "blue" states and a territory (California, Colorado, Connecticut, Delaware, Guam, Hawaii, Illinois, Maryland, Massachusetts, New Jersey, New York, North Carolina, Oregon, Rhode Island and Washington) have set up a consortium "to monitor disease outbreaks, establish public health policy guidance, prepare for pandemics and buy vaccines and other supplies." This was in response to CDC bailing on these duties. Effectiveness of this group will be constrained both by federal funding cuts as well as the fact that it (so far) lacks bipartisan membership.

Perhaps more futile as far as the US is concerned is a new report from the Global Preparedness Monitoring Board mapping strategies for pandemic preparedness for the future. In the past, even with more "pandemic-preparedness-friendly" US administrations, these types of reports have mostly been unheeded and forgotten.

WRIS

As best as I can determine, the winter respiratory infection season has yet to get underway. I'm mostly relying on Yale's POPHIVE resource, but it was last updated on October 6. Individual healthcare providers may be better served by consulting their local or state health departments.

Measles

South Carolina, specifically Spartanburg, seems to be the up-and-coming hotspot to watch. Thankfully CDC is still updating their case numbers, most recently on October 15. The official case count is 1596, which will lag from individual state reporting. Here's the current map:

Previously I had mentioned using the Johns' Hopkins county-level measles tracker, but I noticed a possible discrepancy in their reporting of a large number of imported measles cases in the twin cities area of Minnesota which was not reflected in the Minnesota state health department number which indicated these cases were locally-acquired. Possibly the discrepancy is due to different timing of reporting cases, but I'll continue to be wary of the Hopkins site even though the county-level data are more useful than statewide numbers.

New Streptococcal Pharyngitis Guidelines

Take special notice of this guidance from the Infectious Diseases Society of America because it is so long overdue and now recommends use of scoring systems for both adults and children with pharyngitis. The guideline is listed as "part 1" of the update, but I couldn't find any indication of when part 2 will be published. Here's an excerpt about use of scoring systems:

"In children and adults with sore throat, we suggest using a clinical scoring system to determine who should be tested for GAS (conditional recommendation, very low certainty of evidence)  

Remarks 

  1. High-risk individuals should be strongly considered for testing even if their clinical scores are low. Examples of high-risk individuals include those presenting with sore throat who have had household exposure to GAS (e.g., living or sleeping in the same indoor shared space as a person diagnosed with GAS infection), a history of a previous rheumatic fever diagnosis, or symptoms or signs suggestive of complicated local or systemic GAS infection (e.g., peritonsillar or retropharyngeal abscess, scarlet fever and/or toxic shock syndrome). 
  2. The panel recommends that a clinical scoring system be used as part of the evaluation of patients with sore throat. The principal utility of a scoring system is to identify patients with low probability of GAS pharyngitis, in whom further evaluation by diagnostic testing is unlikely to be helpful.  
  3. Given the lack of evidence favoring any particular scoring system, clinicians and patients may favor clinical scoring systems that do not include laboratory test(s).   
  4. The recommendation to use a scoring system does not apply to children under three years of age as GAS infection in this age group may not present with typical clinical features represented in these scoring systems.5 "

You will note that the recommendation is conditional with a very low certainty of evidence. In IDSA-speak, a conditional recommendation means that the majority of "informed" people would follow this recommendation, but "many" would not. Here is their Table 2 describing 3 scoring systems but recommending use of either Centor or McIsaac.

In the past my advice to frontline providers was against use of any particular scoring system, instead using the cluster of symptoms to make a judgment in individual cases. In general, the main focus should be on avoiding testing children with evidence of viral symptoms to decrease false positives due to detection of carrier states.

I predict we'll see some educational sessions from IDSA and AAP once the full guidelines are published.

1st Trimester Covid Vaccination Doesn't Cause Birth Defects

It's difficult/impossible to prove a negative, but this study adds reassurance that there is no suggestion of covid vaccination of pregnant women causing birth defects in their infants. It's a database study from France encompassing over 500,000 pregnancies; one-fourth of the infants were exposed to at least 1 covid vaccine dose during the first trimester. The results are reported in huge tables, too large for me to incorporate here. Suffice to say that there was no evidence of increased risk of major congenital malformations when correcting for maternal age, social deprivation, and folic acid consumption. The study did not include examination of stillbirths and terminated pregnancies because of difficulties identifying malformations in this population.

Fewer Ear Infections with RSV Vaccination

Also from France is a new report suggesting that RSV vaccination (maternal vaccination or infant nirsevimab) results in a lower risk of acute otitis media in infants. I was particularly intrigued because the study was carried out in a network of pediatric practices where practitioners where specifically trained to diagnose community-acquired infections. Based on the timing of implementation of these products in France, the post-immunization season of October 2024 - February 2025 was compared to the pre-immunization seasons, additionally accounting for non-pharmaceutical interventions during the covid pandemic. They also catalogued bronchiolitis and UTI diagnoses, the latter as sort of a negative control since RSV immunization shouldn't influence UTI rates.

Although the report included graphs, they're a little complicated so I'll just give you the takeaways. With over 70,000 AOM cases over the time period, the rates in children < 12 months of age decreased by about 23% with immunization, with no reductions seen in older children. Rates of bronchiolitis also decreased similarly in the younger children, but UTI rates were stable.

Don't Mess With My Espresso Drink

I'm proud to say I've never ordered a pumpkin spice-flavored drink at Starbucks, though I may have tested someone else's at some point. (I don't know why I should be proud of this, maybe just looking for something positive here.) I remain an espresso purist of sorts, now sipping a Bialetti "espresso" as I write these words. In researching the pumpkin spice craze more thoroughly, I discovered Starbucks started work on this flavored latte in 2003 with the original test sites being in Vancouver and Washington, DC - apparently I missed out on that focus group. Now everyone else has added this flavoring to their coffee menus.

I prefer my pumpkin in pies, though I usually go the lazy route with canned pumpkin rather than starting from scratch with the original fruit. For now, though, my pumpkin interactions focus more on jack-o-lanterns.

See you next week.

I continue to improve following my unscheduled illness a couple weeks ago. One thing I learned is that my mother's go-to remedy from my childhood, warm Dr. Pepper with lemon, didn't appear to help very much.

A Plea to CDC Staff Amid the Chaos

The recordings for the recent ACIP meeting appeared on their website this past week. I would have been better off never looking at them. The ACIP members, along with some new members of working groups, not only are unqualified and ill-prepared to assess vaccination policy but also are following an agenda of pseudoscience and disinformation designed to lessen vaccine uptake in the US. Presentations were extremely biased, and members repeatedly spouted ridiculous claims and even shouted at representatives of vaccine manufacturers.

I'll mention just a few things related to the covid vaccine discussions the second day. I didn't have the stamina to listen to all the presentations, just too painful.

There was a very unusual presentation about case reports of various cancers in covid vaccine recipients, buttressed by mention of several studies about persistence of mRNA vaccine products and rat immunologic data that stretch the limits of believability. The fact that such a presentation was even given a spotlight was sad, but I was interested to see if any of the attendees of the meeting spoke up about the fact that no control group or case definition was given. Are these cancer rates higher than what is seen in the unimmunized population? If it appeared in publication somewhere, anywhere, it must be true, according to the presenters. I tried to listen to the Q&A period after the presentations; surely someone would point out how ridiculous this was, but I only heard general thanks to the presenters. This was a complete sham.

The shouting match arose mainly with an ACIP member and Pfizer representatives. It appeared that the ACIP member was trying to trap the Pfizer folks into admitting some sort of variance in data presented to the FDA related to what actual products were submitted for testing. The Pfizer representatives seemed to be deliberately evasive in their answers, suggesting to me that they feared legal ramifications. A couple of slides would have resolved the issue, but I noted that neither Pfizer nor Moderna representatives were allowed to show slides.

On a slightly upbeat note, presentations by rank and file CDC staff contained the usual rigor, clarity, and transparency they have been known for. Missing was the standardization of the presentations, which usually would include a summary of GRADE criteria (Grading of Recommendations Assessment, Development, and Evaluation) that explains level of certainty in various data elements, as well as the Evidence to Recommendations framework that clearly weighs risks and benefits of different recommendations and also the degree of variability in Work Group member opinions. Lack of a predetermined, structured process on which to base recommendations and help ACIP members ask clarifying questions is perhaps the biggest problem with the "new" ACIP.

I was also grateful that some liaison representatives to the ACIP, instead of completely boycotting the meeting, did speak up against some of the wacky comments.

If you do want to see one voice of reason, look over the presentation 11 from September 19 by Perlman/Bernstein/Miglis, members of the covid Work Group who appear to be in the minority. It accurately summarizes (and refutes) much that was mentioned in the previous several hours of covid vaccine misinformation that day.

My heart goes out to the dedicated CDC staff. I don't know how they can hang in there in the face of such blatant destruction of the scientific method in service to political and ideological ends. I can only thank them and hope that they hang in there long enough to outlast this assault on vaccination and then try to put us back together again.

Lots to Watch in Africa

I don't know that we are at risk of any immediate spillovers from current infectious disease outbreaks in Africa, but I'm starting to wonder if a US map might start to resemble this recent one from the Africa CDC.

I've mentioned all of these entities previously, but keep in mind what's going on with dengue, Ebola, measles, mpox, and now especially cholera. WHO just published their final cholera report for 2024, but numbers for 2025 already exceed last years totals.

The most recent cholera surge in Africa is in Chad, with the original outbreak traced to a refugee camp. Cholera is both treatable and preventable, the latter predominantly by assuring adequate water safety but also by vaccination. Unfortunately, cholera vaccine stockpiles in Africa are below recommended levels, with foreign aid very much in doubt. A large vaccination campaign has just started in Sudan.

Mostly Good News About STIs

CDC released some preliminary numbers for sexually transmitted infections in 2024, showing slight decreases in some diseases. I'm desperate for good news these days.

Primary and secondary syphilis, gonorrhea, and chlamydia all showed modestly lower numbers.

Sadly, congenital syphilis did not show a decrease, still around 4000 cases last year.

Warm Dr. Pepper With Lemon Causes Fatigue and Back Pain

If I so desired, I could write and get published (at least in a paper mill journal) a case report with the title above, and it could then be used as evidence in a campaign to instill fear of Dr. Pepper and have it removed from the market. This is analogous to the evidence presented to ACIP about mRNA vaccines causing cancer. I haven't yet heard what the HHS Secretary will declare from the ACIP votes for MMRV, hepatitis B, and covid vaccines, but it's very clear we all need to keep working on and refining alternatives for appraising and guiding vaccination use in the US. The Vaccine Integrity Project will continue to provide regular literature reviews and make them available to organizations such as the American Academy of Pediatrics and others to develop immunization recommendations and schedules. Let's hope everyone, in every state, is able to access vaccines in keeping with sound guidance.

Note that I consumed diet Dr. Pepper during my illness, so perhaps I can add all kinds of other maladies to future case reports and blame lack of corn syrup or cane sugar. Stay tuned. In the meantime, don't anyone dare try to take away my Liquid Sunshine!

*Did you know that "You Are My Sunshine" is one of the state songs of Louisiana? It is an old song, writers disputed, but it was first recorded in 1939 by Jimmie Davis who later was elected governor of Louisiana. Take a listen.

I just watched a gentleman, probably close to my age, jog by my house. Current temperature is what should be a comfortable 79 degrees, but with humidity 87% the "feels like" temperature on my phone app is 82 and my real world experience walking the dog this morning I give a 4 on my 5-point uff da scale,* where 5 is completely miserable.

It's also been pretty steamy in the healthcare policy arena this past week. A group of medical and public health societies and an unnamed individual have filed a lawsuit against our HHS Secretary, FDA Commissioner, NIH Director, and CDC Acting Director seeking to overturn withdrawal of recommendations for covid vaccines. At about the same time, the HHS Secretary cancelled last week's meeting of the United States Preventive Services Task Force, a terrific group of 16 highly qualified medical and public health experts serving on a rotating voluntary basis under the auspices of the Agency for Healthcare Research and Policy. They publish recommendations for a variety of medical conditions; current work in progress includes statements on interventions for tobacco cessation in adults and vision screening in children ages 6 months to 5 years. So far in 2025 they had published 5 recommendation statements, including one for syphilis screening in pregnancy. The recommendations can in part determine insurance coverage for various tests and treatments. In general, the evidence bar to clear the USPSTF is pretty high; much of the time their recommendations serve to point out deficiencies in our knowledge base and provide direction for future study. Of course I'm wondering if USPSTF is headed for the same downhill trajectory we saw with ACIP - cancelled meetings followed by firing of experts who are then replaced with pseudo-scientists with an ax to grind.

Thankfully I found many intriguing topics to discuss this week. I picked a few.

High Consequence Infectious Diseases

This is an official designation in the UK, and I was interested to see a recent breakdown, especially noting infections that didn't qualify for HCID status. HCID definition includes an acute infectious disease that typically has a high case-fatality rate and may not have effective prophylaxis or treatment. HCID often are difficult to recognize and detect rapidly, have an ability to spread in the community and within healthcare settings, and require an enhanced individual, population and system response to ensure effective management. They are organized by mode of transmission as follows:

Contact HCIDs

  • Argentine haemorrhagic fever (Junin virus)
  • Bolivian haemorrhagic fever (Machupo virus)
  • Crimean Congo haemorrhagic fever (CCHF)
  • Ebola virus disease (EVD)
  • Lassa fever
  • Lujo virus disease
  • Marburg virus disease (MARD)
  • severe fever with thrombocytopaenia syndrome (SFTS)

Airborne HCIDs

  • Andes virus infection (hantavirus)
  • avian influenza A(H7N9) and A(H5N1)
  • avian influenza A(H5N6) and A(H7N7) [H5N6 has not yet been reported to have human-to-human transmission]
  • Middle East respiratory syndrome (MERS)
  • Nipah virus infection
  • pneumonic plague (Yersinia pestis)
  • severe acute respiratory syndrome (SARS) [this is the original SARS from the early 2000's, no known cases since 2004]

Looking at the HCID definition, I think it's clear why SARS-CoV-2 wasn't on the list - we now have effective diagnostic tests, preventive measures, and treatments available. I was a little surprised not to see mpox in the list of contact HCIDs. The supporting evidence stated that mpox was "derogated" by the UK Advisory Committee on Dangerous Pathogens. Yes, I admit I had to look up the definition of derogation; it indicates an exemption or relaxation of a rule. Both COVID-19 and mpox are still significant threats to global health, but for UK purposes not having them on the HCID list means that they can be managed outside of designated HCID treatment centers.

Chagas Disease in Florida Kissing Bugs

Not a huge surprise, but now we have evidence of significant colonization of Florida triatomine bugs with Trypanosoma cruzi, the parasite that causes Chagas Disease. Various investigators and community programs collected 310 Triatoma sanguisuma bugs from 23 counties (mostly northern and central Florida) over the period 2013 - 2023. About 35% of the bugs were found in human dwellings, so this isn't just a phenomenon taking place in Florida wilderness. About 30% of the insects carried T. cruzi. The investigators also analyzed the blood sources. Mammals comprised 60% of the sources, ectothermic vertebrates (amphibians and reptiles) 37%, and cockroaches 2.5%. Importantly, humans represented 23% of the infected blood meals.

Just in case you have a Florida trip upcoming, here's the distribution though note that not all geographic areas of the state were sampled.

Probably more importantly, here's what the bugs look like. At left is an adult female and on the right are nymphal stages. The bars represent 2 mm for each photo.

Triatomes commonly are referred to as kissing bugs because they like to bite us on the face. Kissing bugs can be found in most US states, generally sparing the northernmost states.

Association of First Trimester UTI with Congenital Malformations

I was surprised I didn't see anything about this in the lay press, maybe I'm not watching enough TV. Previous studies have variously suggested an association with first trimester exposure of pregnant people to trimethoprim-sulfamethoxazole (TMP/SMX) or nitrofurantoin and subsequent congenital malformations in their newborn infants. Investigators from multiple institutions now have published a cohort study of around 70,000 pregnancies identified through a commercial insurance database to have received either TMP/SMX, nitrofurantoin, a fluoroquinolone (ciprofloxacin, levofloxacin, or ofloxacin), or a beta-lactam antibiotic to treat a UTI during the first trimester of pregnancy in the years 2006 - 2022.

Results suggested a higher risk with TMP/SMX exposure but not with nitrofurantoin for some cardiac defects and for cleft lip and cleft palate, when compared to mothers who received beta-lactam antibiotics for their UTI. Part of the data are shown below.

You can see at the right of the table that the 95% confidence intervals do not cross 1.0 for these 2 circumstances, indicating a statistically significant association. Also note, however, that the total number of events are a relatively small percentage of the total exposures. Still, these malformations carry significant morbidity. The American College of Obstetricians and Gynecologists cautions against use of TMP/SMX and nitrofurantoin in the first trimester of pregnancy. It's easier to understand why TMP/SMX might be able to cause malformations because both components inhibit folate metabolism. This study lends support to avoiding TMP/SMX in this setting.

Some Potpourri

Measles

You've probably seen a lot about US measles cases now surpassing 2019's total, so we now have to go back to 1992 to see a higher number of cases; this occurred while the US was still trying to implement 2nd doses of MMR for the 4 - 6 yo age group. Although new cases are reported every week, it's important to note that things have tapered off a bit, enough for the CDC to go back to just weekly case count reporting.

I'm holding my breath that we won't have another big outbreak somewhere, but MMR vaccine hesitancy is against us.

West Nile Virus Review

A nice one was published in JAMA last week, worth reading for a general refresher. Remember that most infections are asymptomatic. Symptomatic individuals usually experience a self-limited febrile illness, but the real fear is neuroinvasive disease.

The live link to the testing algorithm is here.

*Uff Da

Those who know me personally might wonder why I would appropriate a Norwegian term since my ancestry is most certainly not Scandinavian. I think I can claim some rights to the term. My long-suffering wife was born in Minnesota, and both sides of her family have Scandinavian roots. Furthermore, my mother was born and grew up in the Upper Peninsula of Michigan, a hotbed of former Scandinavian residents.

I survived several (6-month-long) summers in Houston, a hotbed of humidity, but I never became accustomed to it.

Looking forward to September.

As summer approaches, infectious diseases travel risks are growing. Now more than ever it's important to check recommendations for protection.

But first, I had an interesting couple of days listening to a large chunk of the ACIP meetings this past week. I was pleasantly surprised that it went pretty well with minimal evidence of adverse effects of cost cutting and no evidence of lack of transparency or significant censorship. I'll give my take on the big picture of ACIP as well as some of the important discussions and decisions that impact child healthcare. I tried to distill the meeting points to essentials, but it's still long-winded. Apologies.

Advisory Committee on Immunization Practices Meeting April 15-16, 2025

The original meeting scheduled for February was planned to last 2 1/2 days but was shortened to 2 days, and it was jam-packed and fast-moving. Eleven different vaccine topics were on the agenda: mpox, Lyme disease, influenza, COVID-19, pneumococcal, HPV, CMV, meningococcal, RSV adult vaccines, RSV maternal/pediatric vaccines, and chikungunya. There was also a brief presentation on the measles outbreaks. The only votes taking place were for meningococcal, RSV adult, and chikungunya vaccines. Others may have votes at the regular June meeting if the specific products being discussed are approved by FDA as seems likely next month for a few products. All the slides are available at https://www.cdc.gov/acip/meetings/presentation-slides-april-15-16-2025.html.

General

Most importantly, ACIP still exists and appears relatively unscathed. The presentations contained a lot of information, sometimes a little too quickly for adequate digestion by those unfamiliar with minutiae of specific vaccine immunology. I did feel there was adequate time for discussion and questions from committee members. A few things I was particularly looking for:

  • Evidence of Funding and Personnel Cuts - This appeared minimally, maybe just with respect to AV support. There were 2 instances in the streaming where lack of AV support stalled the meeting briefly.
  • Conflicts of Interest - ACIP and CDC have always been very strict about this. In the past, some of the members had worked on vaccine trials, but with new members appointed last year (well before the presidential election), it seems that fewer members have that background. All were required, as usual, to state any COIs up front. None had any noteworthy conflicts, but a few members did abstain from certain individual votes based on some potential appearance of COIs, for example having some involvement with a vaccine a decade previously, or serving on a data safety monitoring board for a vaccine in the distant past. I wondered if those individuals were bending over backwards to avoid any opportunity for lay press and politicians to falsely claim they had COIs.
  • Membership - A couple new committee members were added, nothing controversial to my eye. I was also intrigued to see a new nonvoting ex officio member representing the FDA, Dr. Hoag. Usually the FDA representative is someone directly involved with reviewing vaccines and is an expert in both FDA regulations and all aspects of vaccines. In contrast, Dr. Hoag is a political appointee with a background in sports medicine and epidemiology.
  • DEI and "Wokeness" - One of the standard evaluation measures used by the CDC/ACIP is an "Evidence to Recommendations" assessment that includes 7 domains: (is the disease) a public health problem; benefits and harms of vaccination; values (of the target population); acceptability (to key stakeholders); resource use; equity; and feasibility. I was particularly worried about whether the important equity domain would survive, and I'm happy to report that it did. In terms of wokeness, I did see that CDC presentations used the term pregnant "women" rather than pregnant "people." Also, Dr. Hoag used the term "monkeypox" for mpox, perhaps just a slip for someone who hasn't been involved with mpox at all.
  • Public Comment Session - As for most meetings, 30-minute public comment sessions provide an opportunity for 10 individuals to speak for 3 minutes each. If more than 10 people apply to comment, the speakers are chosen by lottery which was the case for the single public comment session on April 16. Usually the speakers are a large mix - some from organizations and some individuals, some pro-vaccination and some anti-vaxxers, some well-informed and some misguided. The mix was very different this time around: all 10 speakers were very clearly in the pro-vaccine camp. Two were even from the same organization. For this to have resulted from a lottery process implies that the overwhelming number of applicants were pro-vaccine. I haven't heard about any unified effort to flood the ACIP public comment applications, but I suspect that the dramatic changes in HHS and CDC served to activate a large backlash from people who recognize the value of vaccines; after all, they do represent the majority of the US population.
  • Balancing Simplicity With Individuality of Recommendations - This is nothing new, but it was even more evident at these presentations that CDC is trying to simplify vaccine recommendations, including harmonizing among various risk populations. They hope to improve on the problem that occurs when recommendations vary for different individuals and it becomes difficult to explain all that to healthcare providers as well as to the general public. I think we'll see even more of a move towards harmonizing recommendations among different risk groups and less advice to use shared clinical decision making. I'm a bit sad about that, it probably results from many folks being tired of hearing about vaccines in general plus clinicians feeling like they don't have the time to explain this to their patients. On the other hand, there is a movement to have less universal recommendations, such as for covid vaccination, with more emphasis on vaccinating high risk groups. See the covid section below for more information. The modern practice of medicine has always involved translating general results from studies of groups of individuals to use in a specific patient who may or may not exactly fit the subjects in a research study. That requires thought and time. The best clinicians find a way to understand the evidence behind vaccine recommendations and incorporate this into shared clinical decision making.

Mpox

The discussion revolved around approval for mpox vaccine in the 12-17 year old age group based on subsequent vaccine trials, a pretty straightforward question that was approved. I did find a few of the slides helpful in understanding the history and recent trends in the outbreaks. Both the clade 1 and clade 2 outbreaks are currently problematic.

Recommendations differ for outbreak versus routine vaccination strategies for adolescents and adults at risk for mpox.

Influenza

Regular readers will recall that the usual annual FDA VRBPAC meeting to choose the components of next year's flu vaccine was cancelled, and the strain choices were determined without advisory committee input. The ACIP discussion centered on home administration of FluMist, the live attenuated intranasal flu vaccine. The data are pretty good, but the devil is in the details - all kinds of regulatory and tracking details, including but not limited to the fact that some states won't allow prescriptions across state lines, so if you live in West Virginia but your primary care provider is in Maryland you might have trouble. Also, there can be lots of bumps in the road ensuring that the vaccine was in fact administered at home and logged into the individuals vaccine records. We're going to hear more about this in coming months, hopefully decided well before the next flu season.

COVID-19

This discussion probably got the biggest headlines. First, some general points.

Most of our population has immunity to covid, either by vaccine, infection, or both.

As the bottom statement indicates, vaccine effectiveness should focus as what the added benefit of vaccination is for a population with pre-existing immunity. Unfortunately, given the very small numbers of children receiving any covid vaccines recently coupled with the good news that events like hospitalization and deaths are relatively infrequent in children infected with SARS-CoV-2, we don't have enough data to make any VE estimates in the pediatric population. Here's the adult data:

CDC presenters noted that we experienced an increase in virus circulation in late summer 2024 just before the 2024-25 vaccines were approved and available. Natural infection during this time may have increased population immunity against the most recent strains and could have caused measured VE to be lower than if this surge had not occurred just before most people received the new vaccine.

As I've said in numerous other posts, if one looks at the impact of covid vaccination on individual pediatric patients, rather than at a population and cost-effectiveness level, the benefits of vaccination far outweigh the risks; but, it's relatively expensive to vaccinate all children, looking purely from a cost-effectiveness standpoint. Note that the cost-effectiveness studies for pediatric covid probably are similar to those seen for universal meningococcal vaccination for adolescents - small numbers of cases so higher cost of prevention, even for a more deadly infection like meningococcus.

Also, it's worth remembering that covid deaths in children are in the same ballpark as influenza-associated deaths in the US (no final data yet from this year's flu season).

Previously I've mentioned how the UK has a much more restrictive use of covid vaccines, coming from the population-based approach with the National Health Service paying for all recommended vaccines. One of the CDC presenters had a nice comparison of covid booster recommendations from around the world. I'm glad I don't have a child or grandchild living in Australia.

What is being considered is now changing the US recommendations to look more like these other countries, without a blanket recommendation for certain low-risk groups, including healthy children, while still allowing anyone who wishes to receive a vaccination. If this is ultimately the recommendation, it seems likely that the low-risk populations will have to pay out-of-pocket for the vaccine, disadvantaging our low income families and worsening health equity.

As you might surmise, my bias is still to recommend covid vaccines for healthy children.

HPV

Again no votes on the human papillomavirus vaccine, but a lot of discussion and confusing options for what's to come which could involve changing to just 1 vaccine dose being routinely recommended. First, some really good news for VE. If you compare the prevalence of the 2 HPV genotypes represented, the HPV vaccine has resulted in a dramatic decrease over the past 10 years.

I'll spare you the tremendous amount of modeling studies that were discussed and just focus on conclusions that basically came down strongly in favor of switching to a single dose vaccine schedule, even using a worst-case scenario model for vaccine efficacy and duration of protection. Also, if the 1-dose protocol wasn't working, ongoing monitoring by CDC would allow for new mitigation strategies before vaccine strain prevalence and new cervical cancers appeared.

However, here's where another concern about budget cuts appeared. One of the committee members asked whether CDC will still be able to collect this data going forward, and the answer was a non-reassuring yes, "as far as we know."

A good deal of time was spent on the harmonization of recommendations, particularly with respect to the "adolescent platform" of regular visits and how a proposed recommendation that lumped 9-10 year-olds into the recommendation with the current 11-12 yo start of HPV vaccinations would disrupt this platform of adolescent primary care visits. There seemed to be large differences of opinion among stakeholders here. Expect a vote at the June ACIP meeting.

Measles

No new data here, but yet another comment on resources when discussing trying to get the various outbreaks under control. A CDC member stated they were "scraping to find resources" to handle things.

Meningococcus

By far the most complicated, with a new pentavalent vaccine on the launching pad and a multitude of discussion about how this could be accomplished without asking primary care practices to stock up to 5 different meningococcal vaccines. A key take-home for primary care providers: groups A, C, W, and Y vaccines are interchangeable, but meningococcal B vaccines are not - you really need to give a second dose of meningococcal B vaccine using the same manufacturer as the first, for both pentavalent and monovalent products. So, we potentially will have 2 pentavalent vaccines containing group B plus 2 monovalent group B vaccines. This is a potential nightmare for private practices in terms of stocking vaccines, and a potential problem for managing college outbreaks where one needs very accurate vaccine records to know which group B vaccine to use for at-risk students. Most colleges require this information up front, certainly it isn't very feasible to find missing information in a timely manner during a meningococcal outbreak in a college dorm.

I'd expect some new wording for meningococcal vaccines to be approved at the next (June) ACIP meeting, likely a simpler, harmonized recommendation.

Other discussions centered around another quadrivalent conjugate vaccine for high-risk infants, likely to be approved by FDA next month. The ACIP plans to discuss at the June meeting if FDA approval is granted.

Next Steps

The votes need to be approved by CDC, usually a task carried out by the FDA Director. However, this spot is vacant, filled only by an acting director who is not participating in any formal duties. It looks like the approvals, if they occur, will emanate from a higher bureaucratic level.

More Measles Milestones

But certainly nothing to celebrate. In the US, we ended the week at a round number, 800 confirmed cases; 11% have been hospitalized.

We are up to 25 jurisdictions reporting cases, and a total of 10 outbreaks (defined as 3 or more connected cases). Still no signs of slowing down.

Texas alone is up to 596 cases including 36 added in the past week. It seems likely the US will surpass the 2019 total of 1274 cases, which was the highest since the US was declared measles free in 2000. Meanwhile, Canada might be in even worse shape, largely due to measles in Ontario. They are up to 880 cases this year, although this total includes 132 probable but not yet confirmed cases. It is already the highest total since Canada was certified free of endemic measles transmission in 1998.

Measles is problematic in almost the entire world now. For travel in Canada and the US, check destinations to determine whether early vaccination for infants and children is warranted.

Yellow Jack is Back - New Warning

Last week CDC upgraded their traveler warning for South America to Level 2 - Practice Enhanced Precautions. Colombia reports 75 cases with 34 deaths since September 2024, likely an undercount, and new areas of Bolivia and Peru now have yellow fever cases reported. I worry that travelers and clinicians can't keep up with new yellow fever vaccine recommendations, it's confusing and changing.

For clinicians unsure about clinical findings of yellow fever, the CDC Yellow Book is an excellent resource. (It's called the Yellow Book because the original print version had a yellow cover; now it's mostly black.)

Ignorance is Bliss versus Knowledge is Power

One might think that having my background in infectious diseases is helpful in planning travel. Or, if you side with my long-suffering wife, it might just be the bane of your existence. We have travel plans to various areas planned in the next several months. I'm not too worried about measles, we both had natural infection as children and I know that my measles IgG titer was very high a few years ago. Unfortunately vaccinations won't help us with the list of other infections to which our itinerary might expose us: Vibrio vulnificus, chronic wasting disease, Cryptococcus gattii, to name a few. Fortunately, none are very likely; I'll concentrate on sun protection and keeping well-hydrated.