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Tag: RSV vaccine

Published on Leave a comment on The Asterisk

When I saw the latest CDC online shenanigans I laughed, briefly. It's preposterous but also real.

The asterisked heading is contradicted by everything else on the page.

The remainder of the page is a useless compilation of "facts" ignoring the issue that it is impossible to prove, in an individual case, whether an exposure to something caused a particular outcome. One commentator has compared this to calling for studies investigating the role of ingestion of a popular soft drink on causing autism. Not only does this stance by the new CDC increase confusion and vaccine hesitancy, it risks diverting limited resources to studies that will not answer any useful question.

Diphtheria in Africa

WHO provided a situation update on diphtheria in the African region. It's discouraging.

Outbreaks are ongoing in 8 countries: Algeria, Chad, Guinea, Mali, Mauritania, Niger, Nigeria, and South Africa. As of November 2, the total number of suspected cases in Africa was 20,412 including 1252 deaths (case fatality rate 6.1%). Mali, Mauritania, and Niger seem to be the "hottest" spots for new infections recently.

Management of the outbreaks is complicated by limited laboratory resources and insufficient supply of antitoxin.

Vaccine coverage rates are somewhat variable among the affected countries.

Although the organism, Corynebacterium diphtheriae, is widely distributed in the environment worldwide, including the US, most infections occur following exposure to respiratory secretions or skin lesions of individuals with active disease. Transmission also can occur from asymptomatic carriers of the organism. The risk of this spreading to the US population is relatively low but could rise if population vaccination rates continue to fall. This includes adults who don't update their Tdap every 10 years.

MMWR is Back

MMWR may not be able to hold on to the W(eekly) in its title if this year's trends continue, but we did see a new issue appear on November 20; the previous issue was from October 2. The number of topics seems to be diminishing on average this year, only 2 this week, but both were excellent studies and dealt with RSV.

The first report looked at implementation of nirsevimab administration to newborns at birthing hospitals in the US. The Vaccines for Children program will pay for administration of this long-acting monoclonal antibody. The product is recommended to be administered within the first week of life during RSV season for infants born to mothers who did not receive RSV vaccine. However, this payment requires hospitals to enroll with the VFC. If the hospital isn't enrolled, those newborns won't receive nirsevimab during their stay, and we know that many may not be seen for outpatient follow-up by 7 days of age.

Hospital VFC enrollment has increased, but it is still a glass half-full situation. "A CDC effort with professional organizations and health departments to enroll birthing hospitals in VFC was associated with an increase in enrolled birthing hospitals from 763 (27.1% of 2,817 facilities) at the beginning of the 2023–24 RSV season to 1,021 (36.2%) by the end of the 2024–25 RSV season. The number of nirsevimab doses ordered approximately doubled." Rates for individual states varied widely. I was ashamed to see that my home state, Maryland, had only 6 of 33 hospitals enrolled by March 31, 2025.

The second report looked at effectiveness of nirsevimab in preventing ICU admissions in infants. It was a case-control study of 27 hospitals in 24 states in the Overcoming RSV Network which is an extension of the Overcoming COVID Network.

The study included 457 children admitted to ICU with a positive RSV test compared to 302 RSV-negative children. Nirsevimab was 80% effective (95% CI 70-86%) in preventing RSV-associated (positive test and admitted for respiratory symptoms) ICU admission and 83% (74-90%) against respiratory failure. These numbers are for children who received nirsevimab for a median of 52 days and 50 days, respectively, prior to onset of the endpoint. More evidence that nirsevimab is a game-changer for RSV disease.

Current Epidemiology

Winter respiratory infections still appear to be lowish nationally with covid, flu, and RSV all officially very low according to CDC. The map as of data through November 15 shows a little variability, typical for this time of year.

Again, look for RSV and influenza to take off soon.

Confirmed measles cases now stand at 1753 in the US.

If we've learned nothing else this past year, it seems that local pockets of mostly unimmunized individuals are feeding ongoing measles transmission, with overall falling immunization rates contributing to higher risk of spreading outside these communities. Here are the hotspots for the past 2 weeks according to the Johns Hopkins site.

I'm Thankful for ....

As we enter Thanksgiving week, I remain thankful for many things, chief among them my family who somehow continues to put up with me. It would take a few hours to compose a semi-comprehensive list of everything I'm thankful for, but I'll mention a few.

  • Friends - any friends I have are mostly because of my association with my LSW; they tolerate me so that they can talk with her. I'm the equivalent of the odd green jello salad that accompanies the beautifully-cooked turkey for Thanksgiving dinner. You take a few bites of the jello out of politeness, but what you really came for is the turkey, dressing, gravy, and other accompaniments.
  • My health - of course not perfect, but I've been a remarkably fortunate septuagenarian so far.
  • Asterisks
    • In these pages, I've mostly used the asterisk to follow "LSW" when referring to my Long Suffering Wife.
    • They are very useful as a wild card for searching in PubMed and other search engines.
    • I was surprised to learn that the asterisk dates back to the Ice Age.
    • Our HHS Secretary presumably used the asterisk to taunt a certain Louisiana senator:
      • "* The header "Vaccines do not cause autism" has not been removed due to an agreement with the chair of the U.S. Senate Health, Education, Labor, and Pensions Committee that it would remain on the CDC website."

Have a wonderful Thanksgiving!

https://homecookingmemories.com/lime-green-jello-salad-recipe-cottage-cheese-pineapple/ (This recipe is not quite the same as the family recipe I use.)

Published on Leave a comment on Gluttony

Alas, I lapsed into the sixth deadly sin due to a combination of leftover Halloween candy and a discovery of cookie butter. It's pretty easy to stuff my face while reading medical articles and typing this week's blog.

Maternal Covid Infection Associated With Neurodevelopmental Disabilities in Offspring

This retrospective cohort study from Massachusetts provides strong evidence that SARS-CoV-2 infection of a pregnant person carries with it an association with neurodevelopmental disabilities, including autism, in the offspring of that pregnancy. The lay press reported the findings quickly, but it's important to realize that a) this association is entirely expected, based on animal studies and experience in humans with other viruses like influenza, and b) at this point it is just an association, not proving causality, and the study design as a retrospective cohort dependent on database registries leaves it open to error. Having said that, let's dig a little deeper.

The cohort was comprised of all births at 2 academic and 6 community hospitals within a single medical system in Massachusetts from March 1, 2020, to May 31, 2021. The children's records were queried for any neurodevelopmental disability diagnostic codes up to 36 months of age. The timing of the cohort is important. It was early in the pandemic, at a time when the less reliable home testing kits weren't used as frequently and those home antigen tests during pregnancy were likely to be confirmed by PCR, assuming the women were receiving prenatal care. Also, the population in general was highly motivated to be tested for covid; in other words, ascertainment of covid episodes during pregnancy likely were more reliable than what we commonly see later in the pandemic and beyond. It's also important to note that vaccination wasn't available for much of the study period. Only 8% of mothers in the non-infected group had received at least 1 covid vaccine, compared to 2% of mothers who had been infected - the differences in vaccination rates most likely are due to socioeconomic factors.

Here's what the investigators found. Of a little over 18,000 live births in the cohort, 861 mothers (4.8% of the cohort of live births), were diagnosed with SARS-CoV-2 infection during pregnancy. By age 36 months, 140 (16%) of children exposed to maternal infection had received at least one neurodevelopmental disability diagnosis, compared to 1680 (a little less than 10%) in the unexposed birth group.

Now comes the hard part, trying to correct for all those other maternal factors that are associated with increased neurodevelopmental disabilities in infants. Known risk factors such as male sex, preterm birth, Hispanic ethnicity, and public insurance status had higher rates of disabilities in this cohort, lending support to the accuracy of the overall findings. Also supportive of the findings was an association with infection during the third trimester, an important time for fetal neurodevelopment.

After performing a multivariate analysis to correct for multiple confounding risk factors, the association with maternal covid infection during pregnancy remained significant independent of these risks. Unfortunately, one very important risk factor for autism and similar disabilities, genetics, couldn't be analyzed. This would likely require a prospective study with sibling controls.

Note that we aren't talking about vertical transmission of the virus from mother to fetus, such as occurs with CMV and toxoplasmosis. Vertical transmission of SARS-CoV-2 from mother to fetus is rare, although I did participate in the care of one such newborn early in the pandemic. The biologic plausibility of maternal viral infection without vertical transmission causing neurodevelopmental disability is supported by many animal studies and likely involves some sort of maternal immune activation that interferes with the developing newborn brain.

These findings shouldn't change practice now. First, we don't know if the findings would persist in an era where almost everyone has some form of immune experience with SARS-CoV-2. Second, we don't know the effect vaccination might have on this process. And again, remember we're talking about association rather than causation.

Respiratory Vaccines Are Good

In my August 24 posting I commented on the Vaccine Integrity Project's systematic review of respiratory vaccine effectiveness and safety. Now that report is fully available in a new publication this past week. It doesn't contain any substantially new material or conclusions, but it's a lot easier to evaluate the numbers in print than it is with the August slides and oral presentations. Vaccines for covid, RSV, and influenza all had significant benefit against a variety of outcomes in children and adults. (I'm not showing data for covid, the report didn't contain any nice tables or graphs for pediatric covid.)

Here is a forest plot for RSV vaccine effectiveness for preventing hospitalizations in various settings:

And for influenza vaccinations:

This should be the go-to study for any provider needing to explain respiratory vaccine benefits and risks to patients and families.

Wikipedia Under Attack

Some of you probably saw that Elon Musk and others are developing "non-woke" alternatives to Wikipedia. Regular readers of this blog certainly will have noticed I frequently link to Wikipedia articles, not with respect to medical issues but rather to whatever little quirks and digressions I find myself exploring in a particular week. I certainly haven't perceived any liberal or conservative bias in the postings. In fact, I would expect less bias in a publication that can be edited by multitudes online; any mistakes or biases tend to get corrected pretty quickly. Wikipedia even has its own entry on ideological bias in its pages.

I decided to look at a medically-related post, in this case ivermectin. Early in the pandemic I followed this topic very closely; all of us were desperate for any intervention that seem beneficial, at the same time worried about just trying something that could end up useless or, worse, harmful. It turns out that Wikipedia has a separate post specifically for ivermectin during the pandemic. I read through everything, it was very reasonable and didn't even mention the President's wild ravings about what he thought was a wonderful drug for covid. I found no bias, unless you count the bias where more credit is given to bonafide clinical trials published in a peer-reviewed journal compared to some podcaster's unsubstantiated opinion. Musk's new Grokipedia has an identically titled post that I reviewed. I found it to be credible in some areas but extremely opinionated in others to the extent that I felt that the content obscured the fact that the drug was ineffective.

Asymptomatic Bird Flu?

Influenza A H5N1, the "bird flu" that's been plaguing our dairy cow and poultry industry plus several humans in the US for a while now, hasn't been closely studied beyond symptomatic people mostly exposed to infected animals or cow milk. A recent review sheds more light on asymptomatic H5N1 infections. Investigators from the CDC looked for studies with molecular evidence of infection with or without serologic confirmation (note that some asymptomatic people with influenza never show seroconversion). They found a handful of cases, including a couple with both molecular and serologic evidence of infection,

H5N1 continues to lurk out there, waiting perhaps for some genetic reassortment that facilitates human spread. As an aside, I noted that the CDC article utilized the services of a medical librarian to find these articles, and I recalled that librarians have been cut from CDC recently.

H5N1 continues to infect animals and humans around the globe, perhaps waiting for that unfortunate reassortment that will facilitate human to human transmission. We need CDC and its librarians to help keep us safe.

WRIS

Winter respiratory infection season hasn't hit us yet, though the lay press has latched onto a mild upturn in respiratory illnesses in the past week. We should be a bit more wary of tracking accuracy this year due to the double wammy hit to CDC of funding cuts and now the federal shutdown, but I think we'll see significantly more respiratory illness starting in the next few weeks.

In my meanderings around the web, I noted a map on POPHIVE showing RSV queries in Google by state. Web searching activity has been advocated by many as one way to assess disease activity. RSV usually begins in the South, especially in Florida, so I was a little surprised to see a lot of Google RSV searches in places like Maine and the northern midwest and mountain states.

We'll see if those states start RSV season a little early.

Cookie Butter

About a week ago I happened on a recipe for "Holiday Rocky Road" by one of my favorite chefs, Sohla El-Waylly. She has some unusual cooking ideas, plus she is very entertaining. If you want to have a smile plus see how to gorge yourself on chocolate, cookie butter, and other goodies, take a look at her recipe video.

Bon Appetit!

Published on Leave a comment on Pumpkin Spice Season

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.

Published on Leave a comment on Broadening My Entomologic Horizons

Almost too many new reports available this past week, I'll try to provide brief take-home points for each.

However, what didn't happen this week was any word from HHS/CDC about action on the votes at the most recent ACIP meeting. Until this is finalized, none of us know what to expect for MMR + V, hepatitis B, and covid vaccinations, making planning more difficult for all providers. Maybe that's not an accident. On a related topic, I still haven't seen any formal announcement about topics to be covered at the next ACIP meeting later this month.

The rabbit hole I fell down this week was tied to a tiny bug.

More on "Long Covid" in Children

This past week saw the publication of a much-awaited update from a large, federally-funded consortium of institutions looking at long covid symptoms in the pediatric population via a retrospective cohort. I've said in prior posts that "long covid" probably is a heterogenous collection of entities, at a minimum representing direct sequelae of infection of specific organ systems (pneumonia, myocarditis) plus the more vague symptoms ("brain fog," dysautonomia/postural orthostatic tachycardia syndrome (POTS)) that are seen following a large number of common infections and likely have a different underlying mechanism and treatment than those resulting from direct organ infection and damage.

The study itself is immense, and to fully understand the findings one should read not only the 12-page article itself but also the accompanying 54-page supplemental information (access through link in the main article). Short of investigators engaged in similar studies, I'm maybe one of the few people to attempt to get through everything, and it was tough.

For front line pediatric healthcare providers, the main take home message is to encourage your patients with long covid, or in the case of this article, Post-Acute Sequelae of SARS-CoV-2 infection (PASC), that much work is ongoing to find better diagnostic and therapeutic options for these individuals. Secondly, specifically for the current study, is that PASC is still happening during the omicron era, even in children who have been infected with SARS-CoV-2 previously. Repeated covid infections may increase the risk of PASC in children. In the authors' words, "reinfections might contribute to cumulative morbidity."

The current study included about 400,000 children and adolescents who had a first covid infection on or after January 1, 2022, and about 58,000 who had a second infection on or after this same date. Here's a snapshot of some of the data showing fairly large additional PASC risks from second infections.

And a comparison of outcomes from second versus first infection, substantial (with wide confidence intervals) for some but not all of the categories.

The investigators also performed a deep dive and found that this increased risk was maintained in vaccinated and unvaccinated individuals as well as with both severe and non-severe acute covid illnesses, but the study could not determine whether vaccination or illness severity made a big difference in PASC characteristics.

I think virtually all major pediatric centers have long covid evaluation clinics now; it's worth referring your patients to such a center to at least get some preliminary help in management even though we don't yet have definitive answers.

HPV Herd Protection Data

I'll be brief. This study of a little over 2300 adolescent and young adult women showed that herd immunity exists for the HPV serotypes in the 2- and 4-valent HPV vaccines, looking at unvaccinated versus individuals who received at least 1 HPV vaccine dose. So, the unvaccinated are benefitting from others in their cohort who have been vaccinated.

Here's hoping that HHS doesn't start to sow vaccine misinformation leading to lower HPV vaccine acceptance.

Cochrane RSV Vaccine Review - What Can We Take Away From This?

The Cochrane Collaboration is the gold standard of meta-analyses; if a meta-analysis is published there, one can be assured that proper statistical methods were applied. However, it's important to note that this doesn't mean that real-world clinicians can take the findings and apply them in their clinical practices. Mostly this is because the Cochrane analyses consider only high quality randomized controlled trials employing a cadre of research team members who ensure study enrollees comply with the study rules including follow up and testing. In other words, a far cry from what happens in real world practice.

This review of efficacy and safety of RSV vaccines fits the typical Cochrane review mold. Note first that it is a determination of efficacy, not effectiveness; the latter term implies real-world usage. Just looking at the efficacy of the maternal F protein-based vaccine versus placebo, vaccine efficacy in preventing infant hospitalization from RSV infection was 54% with 95% confidence interval of 27 - 51%, with high-certainty of evidence.

I like to direct front-line healthcare providers to the "plain language summaries" of Cochrane reviews that I think can be very helpful in discussions with patients and parents. Here are the key points from that summary for the RSV vaccine review:

"Key messages

  • Respiratory syncytial virus (RSV) prefusion vaccines reduced RSV illness in older adults. When pregnant women received RSV F protein‐based vaccines, their babies had fewer serious RSV illnesses. This was true for both approved and unapproved vaccines.
  • The effectiveness of RSV vaccines in women of childbearing age and the impact of live RSV vaccines on infants and children remain uncertain. These trials used unapproved vaccines.
  • Further research is needed looking at RSV vaccines in women of childbearing age and the effects of live vaccines on infants and children."

As implied above, the article has a lot more information about other RSV vaccines and populations, but understand that the real-world studies are what we really need to hang our hats on. Those are ongoing with already great results.

New CDC Tularemia Guidelines

Nothing too surprising here, just be aware the CDC has provided us with a comprehensive update for management of both naturally-acquired and bioterrorism-related tularemia with new recommendations for drugs of choice. It's an excellent summary that includes pediatric-specific recommendations and is one-stop shopping for anyone evaluating someone for tularemia. First line agents for treatment of children >1 month old are ciprofloxacin, levofloxacin, gentamicin, or doxycycline, and ciprofloxacin or gentamicin for children < 28 days of age. Other details including use in pregnancy and dosage information are provided.

Modeling Outcomes From Withholding Covid Vaccines During Pregnancy

Regular readers of this blog know that I'm very wary of "crystal ball" studies that try to model the future. However, given the ridiculous attacks from ACIP on covid vaccines for pregnant people, this one is worth mentioning. I won't bore you with the methodology, but here are the predicted case numbers for different vaccination rates:

NOTE for Figure 2.B, the title is in error. It should be Averted maternal COVID-19-related hospitalizations, not infant.

Something to tuck away for future reference.

Age Cutoff for 2-Dose Requirement for Flu Vaccine in Young Children

I've saved the best (IMHO) of this week's reports for last, a systematic review and meta-analysis of age-related benefits of a 2-dose influenza vaccine schedule for the first flu vaccine year in young children. Most pediatric healthcare providers are aware that current recommendations are that a 2-dose flu vaccine regimen for the first year a child under 9 years of age receives flu vaccine, followed by a single dose in subsequent flu seasons. (Older children being vaccinated for the first time just need 1 vaccine dose.) The authors included 51 studies with a total of over 400,000 children and came up with some perhaps surprising results.

This is a pretty complicated task, in part because vaccine effectiveness (or efficacy) for influenza always varies somewhat from year-to-year and by strain type, with VE generally better for influenza A than for influenza B. Also, low numbers didn't allow for good assessments of the live attenuated (nasal) flu vaccine. I tried to pick out what I thought was the most important message, which happened to be from a figure in the supplemental content.

Look at the lower right part of the figure for VE difference. What that is showing us is that children under 3 years of age benefitted from a 2-dose rather than a 1-dose vaccine regimen for that first flu vaccine year, to the tune of 28 percentage points difference. However, above 3 years of age that benefit disappeared.

Does that mean we should immediately stop the 2-dose regimen recommendation for the 3 - 8 year olds receiving their first season of flu vaccination? Heck no. The numbers of participants in the different groups in the studies are way too small with resultant wide confidence intervals, and the season-to-season variability is too great, to be able to make any firm recommendations. However, this report does point the way to a future study to look at redefining age cutoffs for the 2-dose regimen. I hope those are underway.

Minute Pirate Bugs

A few days ago I found myself in a bug-bite situation. I can't verify it independently without a high-powered magnifying glass, but I endured some mildly painful bites from some very tiny flying insects. My companions informed me I was being attacked by minute pirate bugs; many different species exist, these probably were of the genus Orius.

I think of insects mostly in terms of the diseases they can transmit to me, so I was immediately consumed with finding out what I needed to fear from these minuscule Hemipterae were injecting into me. The answer? Nothing.

These guys are tiny, 2-3 mm, so I could see little specks flying around but that's about it. Of course that small size is where the "minute" name arises. The "pirate" description indicates their fairly aggressive plundering of their prey, mainly other insects and their eggs. They are actually good for plants, controlling some insects such as thrips, aphids, mites, and moths that damage agricultural crops. Unfortunately, when they run out of insect prey in the fall, they turn to people like me. I guess it's a small price to pay for the good that they do.

Published on Leave a comment on Out of Chaos Comes Order

It's not that I was expecting things to get better, but I didn't think we'd be seeing threats not only to the viability of the ACIP but now to the CDC itself. FDA and NIH also may be destined for near-irrelevance if current trends continue.

In the midst of this vaccine chaos, two more professional societies have stepped up. This past week the American College of Obstetricians and Gynecologists posted their recommendations for vaccination during pregnancy to include covid, influenza, and RSV. Unlike the AAP's recent recommendations (see last week's post), ACOG's referenced the Vaccine Integrity Project data and had an extensive bibliography. The recommendations are sound and should now be the preferred authority for vaccination during pregnancy. I hope the AAP will soon deliver a technical report for covid and RSV that incorporates VIP data.

Also, the American College of Cardiology published guidelines for adult immunization in the context of cardiovascular care. Vaccines covered are a bit broader, not only including covid, flu, and RSV but also pneumococcus and zoster. I also liked their table on FAQs from patients and suggested responses. Though the VIP data aren't mentioned (it did not focus on cardiovascular disease), the recommendations are sound and should be consulted when deciding on recommendations for adults with cardiovascular disease, including teenagers and young adults.

Who Can Receive a Covid Vaccine?

This is the biggest vaccine mess presently. At least the FDA updated its covid page last week. FDA revoked the emergency use authorization for the Pfizer vaccine for children under 5 years of age, not because of any new data but because they could. So, the Pfizer vaccine can only be used for pediatric patients starting at age 5 years, if they have a qualifying underlying condition. Those underlying conditions haven't changed recently and still appear in CDC's pediatric covid recommendations dated June 11, 2025. The Moderna vaccine is approved for use in children down to 6 months of age, but only with the presence of at least 1 high risk condition per FDA. Note that other entities have recognized that age 6-23 months is at higher risk for hospitalization, including ICU hospitalization. The Novavax vaccine is still approved starting at age 12 years, with the presence of at least 1 high-risk condition.

The FDA is requiring all 3 covid vaccine manufacturers to embark on new studies, throwing out previous immunogenicity studies which were used to approve minor strain changes in the vaccines, similar to flu vaccine changes each year. FDA is claiming (via executive fiat) that these now aren't good enough. The current FDA justification is: "First, the prior standard in CBER was acceptance of small immunogenicity studies using human sera, largely aimed at demonstrating numerical improvements in antibody formation against prevailing strains. These studies lacked formal statistical prespecification and power to test a clear scientific hypothesis. These studies were largely conducted, in CBER OCD’s opinion, to provide nominal justification for a strain change, even while there has been substantial uncertainty in whether such changes were necessary and/or beneficial. Moreover, these studies were not confined to the population of the current COVID-19 regulatory scheme, namely persons with 1+ risk factors for severe disease younger than age of 65 years and all those older than the age of 65 years." FDA will now require much larger randomized trials and also will require new trials to look at persistence of spike protein after vaccination (a rare occurrence at best, and likely less common than with infection itself) and a possible link to long covid. Mostly I see these new study requirements as a way to introduce even higher vaccine hesitance in the general population and to make it more expensive and difficult for vaccine manufacturers to continue covid vaccine production.

Healthcare providers have a lot to figure out in the coming weeks. First, how will ACIP's September meeting (now scheduled for September 18 and 19) alter covid vaccine recommendations? Second, how might practices and pharmacies be limited in administering covid vaccines, especially to children whose parents desire their healthy children to be vaccinated? Pharmacies in a few states are required by law to follow CDC guidelines only, and changing that requires changing state laws which could take time. Based on signals from the manufacturers, I expect the new mRNA vaccines, based on the LP.8.1 variant, to be available as early as next week.

Regardless of how this plays out in the next few weeks, practitioners need to be aware of the new FDA and ACIP recommendations as well as the more scientifically-based AAP recommendations. Also, the same issues as last year regarding dosing intervals for those needing a 2-dose regimen and the differences in dosage by age are still operative. A lot to swallow, but I expect more help from AAP and others as availability becomes clearer.

Clesrovimab for RSV Prevention

This week's MMWR summarized the outcomes of the June 2025 ACIP meeting that resulted in a recommendation to add clesrovimab as another option for RSV prevention in infants whose mothers did not receive RSV vaccine during pregnancy. It contains a lot of good information, here's an example of how to counsel mothers about choosing vaccination during pregnancy versus administering monoclonal antibody to their newborn infant:

Unfortunately, we're looking at an ominous turn that was signaled at the June ACIP meeting. Now one of the new ACIP members, an anti-vaccine proponent, is promoting ridiculous social media postings about safety of clesrovimab and also presuming it extends to nirsevimab. I think this may be a focus at September's ACIP meeting, with the ultimate goal of getting rid of monoclonal antibody prophylaxis for RSV in infants. I hope I'm wrong.

Bottom line, RSV prevention is indicated for all infants for their first RSV season, it is tremendously effective at preventing hospitalizations.

Chikungunya Vaccine Changes

Perhaps less of an issue as summer vacation season winds down, but I'm sort of getting whiplash with the back and forth of FDA consideration of the live chikungunya vaccine. There have been legitimate concerns about serious adverse events in older adults, including encephalitis in a vaccine recipient. On May 9 of this year, FDA issued a pause in administering this vaccine to those older than age 60. Then earlier this month, on August 6, that pause was lifted. Then on August 22 the license was completely suspended. I'm not sure what new information was available between August 6 and 22 other than a few more SAEs reported. I don't think it's necessarily wrong to take it off the market in the US, but the back and forth is a little unusual for the FDA of the old days. Fortunately another chikungunya vaccine is available and does not contain live virus, so US residents traveling to high risk areas have an alternative. I do see that the live viral vaccine is still available in Europe after a short pause. It will be interesting to see if they follow suit with the US.

Did We All Forget?

My August 17 post included an oseltamivir quiz - scenarios to determine willingness to prescribe antiviral treatment for influenza, based on national guidelines. I promised to include the answers in my August 24 post but I completely forgot. Apparently, since I didn't receive any messages about my omission, all of you forgot about it as well (or maybe just didn't care). Alas, you can't get off that easily. Here's a reminder of the outpatient scenario questions that were sent to variety of different pediatric providers.

1.a. A 6-year-old otherwise healthy male presents for a sick visit on his 2nd day of illness with cough, congestion, body aches, and intermittent fevers. In clinic he is afebrile, SpO2 98%, respiratory rate 24, and his lung exam is overall normal despite intermittent coughing fits. His rapid influenza test returns positive.

1.b. A 6-year-old otherwise healthy male presents for a sick visit on his 4th day of illness with cough, congestion, body aches, and intermittent fevers. In clinic he is afebrile, SpO2 98%, respiratory rate 24, and his lung exam is overall normal despite intermittent coughing fits. His rapid influenza test returns positive

2. An 8-year-old female with mild persistent asthma presents to the emergency department with 3 to 4 days of low-grade fevers and cough, now with 1 day of progressive shortness of breath and fast breathing at home. In triage she was found to be in moderate respiratory distress. She responds well to bronchodilators and steroids for her asthma exacerbation and is safe to discharge home. Prior to discharge her rapid influenza test returns positive.

3. A 10-month-old ex-full-term female is seen in urgent care for increased work of breathing. She is on day 5 of illness. She has mild respiratory distress that improves with suctioning, her SpO2 is 95% and respiratory rate is 36. She appears overall comfortable and well hydrated. Her rapid influenza test is positive.

4. A 1-year-old otherwise healthy female presents to urgent care for 2 days of vomiting and diarrhea. She has had slightly decreased oral intake and wet diapers. Her 5-year-old sibling has known influenza, and the infant’s rapid influenza test is also positive. In clinic, the infant is afebrile with stable vitals, well appearing, adequately hydrated, and has a benign respiratory and
abdominal exam.

According to various guidelines, all of these scenarios except one are indications to initiate oseltamivir therapy. The exception? It's vignette 1.b. above - the duration of illness is longer than recommended to initiate treatment in a healthy 6-year-old. What really interested me were the responses of the study participants. Participants who had managed the most cases of flu, i.e. the most experienced in the group, recommended oseltamivir the least frequently, only a third of the time. The general tone of the responses suggested to the study authors that practitioners are therapeutic nihilists when it comes to influenza treatment. However, we have fairly good evidence that oseltamivir is beneficial in influenza in many instances, avoiding medically-attended illness and shortening duration of symptoms. I'm generally a therapeutic nihilist, but show me the evidence and I'll change my tune as I have with oseltamivir for flu.

If you remember nothing else, know that if you don't plan on treating influenza with an antiviral agent in a particular patient, there is no point in testing for influenza. At least save money. Keep this in mind during our upcoming flu season.

I'm Not a Nihilist

Although I admitted I lean towards therapeutic nihilism unless evidence suggests otherwise, I'm not generally a nihilist about life. I realized this is a Debbie Downer post this week, ergo the quote at the top of this post attributed, not quite accurately, to the nihilist philosopher Friedrich Nietsche. The exact quote is in his 4-part tome Thus Spake (or Spoke) Zarathustra: "[O]ne must still have chaos in one, to give birth to a dancing star."

I never took a philosophy class and have never read anything by Nietsche except for the portion above. However, I am well versed in a variety other cultural matters, and I believe the correct source for the quote in the title is Mel Brooks. I hope that link provides enough cheer to counteract this downer post.

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