Uncategorized – Page 3 – Pediatric Infection Connection

Broadening My Entomologic Horizons

Bud WiedermannOctober 5, 2025October 5, 2025Leave a comment

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.

Please Don’t Take My Sunshine Away*

Bud WiedermannSeptember 28, 2025September 28, 2025Leave a comment

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.

Time Off

Bud WiedermannSeptember 21, 2025September 21, 2025Leave a comment

I mentioned I had a full schedule last week that, among other things, wouldn't permit me to watch the ACIP meetings live. What was not on my schedule was an acute illness, now well on the mend but leaving me both very fatigued and even further behind on my other duties than planned. From my brief scan of the ACIP presentation slides and the buzz in the news and medical communities, I'm sure if I had watched it live I'd have been in intensive care by now.

I'll eventually watch the sessions recordings, which aren't yet posted as of Sunday morning. Before my illness I had planned to discuss other issues this week, but instead I'll just mention those items briefly and provide you with links if you want to explore further.

CDC Weighs in on Ebola in the DRC

Last Thursday CDC sent out an official warning about Ebola on its Health Alert Network. Nothing significant to add to when I posted about the outbreak on September 7 - we can expect to learn about more cases for a while, then hope to see things come under control.

New FDA VRBPAC Meeting October 9

This was just announced, but unlikely to be too controversial. The agenda contains only 2 items: recommendations for flu vaccine strain composition for the 2026 southern hemisphere flu season and a discussion of an allergen standardization program.

Johns Hopkins County-Level Measles Surveillance

I had been looking at this site recently and mentioned it in a recent post. JHU has put together something similar to their covid dashboard they provided during the pandemic; that site was really useful and widely used by both scientific groups and lay press. As we have seen all too clearly this year, it only takes pockets of unimmunized people to set off a large measles outbreak. State-wide immunization levels don't really tell us much about this. County-level data should be about the largest sample size we look at to understand measles outbreak risks.

The JHU team provided more details about its platform in a new article last week. I'll be keeping an eye on this dashboard. Here's the past 2 weeks numbers, almost all represent local transmission.

FAERS

Not a typo. You know about VAERS where anyone can report an adverse event they think was related to a vaccination. It has long been misused by anti-vaccine groups who either don't understand the system or just want to use it to manipulate vaccine fear.

FAERS is the FDA Adverse Events Reporting System, sort of the equivalent of VAERS but for drugs. Now one of my go-to journal watch systems, Retraction Watch, sounds an alarm about misuse of FAERS primarily to funnel into paper mills. Be wary of any publication using FAERS data. This figure from a preprint article shows the potential scope.

Better Luck Next Week

Sorry for the brevity of today's post, I hope to be back full strength next week!

Voles and Shrews and Flying Squirrels, Oh My! 2

Bud WiedermannSeptember 14, 2025September 14, 20252 Comments

I've mentioned before that, whether I'm walking down the street or hiking in the wild, I can't help myself thinking of zoonotic diseases associated with every animal I see. Now I have a few more animals to add to my fauna paranoia list.

I'll be hand-wringing all this week that I won't be able to attend any of the ACIP meetings on September 18 and 19 due to other commitments. A draft agenda was posted September 12, and only 3 vaccines are being discussed: MMRV, hepatitis B, and covid. All have votes scheduled. As I said last week, I won't comment on the sessions until I've had a chance to review the recordings personally and make my own assessments; timing will depend on when CDC posts the recordings to their website.

In the meantime ...

Updates for Last Year's Flu Season

As they usually do around this time, investigators from CDC and around the country published more definitive data on hospitalizations associated with last year's flu season. As we all thought, it was fairly heavy compared to previous years (note the graph below includes all ages).

A little under one-third of these hospitalized flu patients had received a seasonal flu vaccine, on par with prior years. About 85% received antiviral medication, but the age group with the lowest treatment percentage, about 60%, were children 5 - 17 years of age. Once again, healthcare providers are presumably largely ignoring national guidelines for use of antiviral medications for influenza, though this detail is difficult to tease out from the database.

The discussion on limitations of the data was well done, typical of this influenza group, and bears listing their 5 points:

influenza-associated hospitalizations rates might be underestimated because of clinician-driven influenza testing.
influenza A subtype was missing for a median 56% (IQR 48%-64%; range 38%–72%) of patients, and the missingness could have been non-random. Thus the hospitalization rate estimates for A(H1N1)pdm09 and A(H3N2) subtypes derived from multiple imputation procedures using 3 predictor variables (site, age, month) are likely biased and should be interpreted cautiously.
nonclinical factors, such as hospital admission thresholds, that might have resulted in changes in the number of hospitalizations, could not be measured.
because influenza vaccination history is subject to more reporting delays than other outcomes in the analysis, 28.5% of hospitalized patients were missing this season’s influenza vaccination status.
the FluSurv-NET catchment area represents 9% of the U.S. population and might not be generalizable to the entire U.S. population; hospitalization rates in this report represent the FluSurv-NET catchment area.

Consider the thoroughness of this report and its limitations while reading this next topic.

The MAHA Strategy Report

This was a follow up to the original 73-page MAHA Report from several weeks ago. The Strategy Report is only 20 pages and basically offers nothing helpful; it's just too vague and even rambling at times. I found the section on vaccines worrisome, given the leanings of the HHS Secretary. Here's the strategy plan for vaccines (page 10):

Vaccine Framework: The White House Domestic Policy Council and HHS will develop a framework focused on:

Ensuring America has the best childhood vaccine schedule;
Addressing vaccine injuries;
Modernizing American vaccines with transparent, gold-standard science;
Correcting conflicts of interest and misaligned incentives; and
Ensuring scientific and medical freedom.

These points are exactly what has been the status quo all along, which of course signals that definitions of "best childhood vaccine schedule" and "gold-standard science" and all the other points will change, most likely to support predetermined endpoints to decrease vaccinations overall.

This report is in striking contrast to the 2024-25 flu hospitalization report I mentioned, which still represents CDC in partnership with other sites as an exemplar for public health.

Ciprofloxacin-Resistant Neisseria meningitidis

This past week I received a letter from the Maryland Department of Health informing clinicians that the state had exceeded the CDC's resistance criteria, and that ciprofloxacin should no longer be used for prophylaxis of meningococcal disease in close contacts of a case. Ciprofloxacin may still be utilized for prophylaxis in settings where it is known that the isolate from the contact source is susceptible to ciprofloxacin or is known to be a non-serogroup Y strain. Of course, usually we don't know this at the time we need to prescribe prophylaxis. Alternatives still include rifampin, ceftriaxone, or azithromycin.

Ideally all healthcare providers should be checking with local health department experts when managing someone exposed to an individual with meningococcal disease. Please don't reflexively prescribe ciprofloxacin without checking first.

Trying to Make Sense of COVID Data

Not only has FDA and ACIP thrown covid vaccine decision-making into complete chaos, it's also becoming harder to interpret covid infection trends. With less resources to track illness combined with less public interest in testing, prevention, and treatment, comparing rates now to those in the past becomes a comparison of apples to oranges. I continue to try still, so here's my latest dive into the national surveillance, with the caveat that regional variations can be considerable.

Early indicators are trending down...

... as are hospitalizations.

All this is good news, but it gets tough when one tries to trend over time, for the reasons stated above. COVID-NET has a fun (for me, anyway) interactive dashboard. Here's what things look like over the entirety of the pandemic and afterwards.

The light blue line represents current data; I don't doubt that numbers are greatly diminished, but take exact comparisons to earlier years with a grain of salt.

Also, here's what part of the pediatric age data for the 3 youngest age groups look like:

With the same caveats about comparing data from year to year, covid-associated hospitalizations in children were most pronounced in the first year of life. Rates for older children are even lower than for the 1 - 2 year-olds.

Alaskapox eMended

In another era, I had a blog for AAP called Evidence eMended where I took deep dives into understanding how to assess original research articles on general pediatric topics to help providers develop an approach to using such articles in everyday practice. AAP eventually ended the blog, and Pediatric Infection Connection was (re)born.

Now comes an emendation (I didn't make up that word) for Alaskapox. My post of 2/11/24 covered a report of the first fatality from this viral illness, in an immuncompromised person. This week, we now have more detail about the 6 of the 7 known cases of human Alaskapox infection, now termed borealpox as part of a general movement to get away from linking geographic communities to diseases. (A famous misuse of geographic tagging is the Spanish flu pandemic of 1918-20; for true accuracy, it should have been named the Kansas flu.)

I learned about the new borealpox name in a more detailed report on infections in humans and the animal reservoirs in Alaska which are mainly small mammals. Like most orthopoxviruses (e.g. smallpox, mpox) the characteristic lesion is on the skin; this new report contains the same lesion photos as in my 2024 post which were taken from a 2/9/24 State of Alaska Epidemiology Bulletin. If you ever find yourself wandering in the interior of Alaska, watch out for these small mammals.

Mode of transmission of borealpox to humans isn't known, but all the cases reported contact with dogs and cats (and in 1 case poultry as well) that had contact with voles and other small mammals. So, their pets may have transmitted the virus to their owners. Clearly these human infections are rare, but I expect future studies of humans and animals will expand our knowledge. If you're ever "travelin' .... where the winds hit heavy on the borderline" as Bob (with help from Johnny) said, keep your dog away from the voles.

Quaint Language

Bud WiedermannSeptember 7, 2025September 8, 2025Leave a comment

"His name is associated with bygone controversies as to priority which it would be unprofitable to recall." I found this excerpt in a 1908 obituary notice for the originator of terrain theory, currently a common excuse and obfuscator used by anti-vaccination activists.

Once again I will mostly bypass the political upheavals affecting public health this week and focus instead on reports of note in pediatric infectious diseases.

Whatever Happened to Bird Flu?

Well, nothing really, it's still around. The longer it circulates, the greater the chance that a new mutation will appear that could cause a turn for the worse in human disease. This week's MMWR finally gave us an update on that child who was infected with influenza A H5N1 but had no known contact with infected animals; it caused some concern that human-to-human transmission was occurring.

The child lived in urban San Francisco and had illness onset in December 2024 with fever, abdominal pain, myalgia, and conjunctivitis, resolving in about a week. On day 4 of illness he was seen in a healthcare facility and tested positive for influenza A. As part of an enhanced surveillance project for avian flu, his specimen was sent for further analysis and was identified as H5N1. An extensive history for travel and exposure risks failed to reveal any risk factor, though a family member did purchase poultry products from a live animal market; the meat was cooked and consumed by the family that same day.

Authors then reported information including small numbers of testing results for 84 possible contacts of the child:

As you can see above, all of the household members but relatively few contacts elsewhere had testing. No link to an infected human (or animal) was found. So, the source of this child's infection remains unknown. The most likely explanation is transmission from the wild bird population which has been known to be a source of H5N1 well before the current outbreak.

Meanwhile, H5N1 is still present but mostly quiet in the US.

Ebola Again

The Democratic Republic of Congo is now reporting a new outbreak of Ebola virus disease involving 28 suspected cases and 15 deaths, including 4 health workers. Although we've had Ebola spread to the US in the past, it's unlikely we will see international spillover from this outbreak for 2 main reasons. First, the DRC isn't a popular travel destination, a main facilitator of international spread. Second, the DRC's public health infrastructure, aided by WHO, has experience in managing Ebola outbreaks successfully. Cases will certainly increase in the near future; I'll be looking for any signs that the outbreak isn't being contained.

If you need to refresh your Ebola memory with a quick blurb, here's the last paragraph from the WHO link. "Ebola virus disease is a rare but severe, often fatal illness in humans. It is transmitted to people through close contact with the blood, secretions, organs or other bodily fluids of infected animals such as fruit bats (thought to be the natural hosts). Human-to-human transmission is through direct contact with blood or body fluids of a person who is sick with or has died from Ebola, objects that have been contaminated with body fluids from a person sick with Ebola or the body of a person who died from Ebola."

A Spray (or 3) a Day Keeps Covid Away?

I don't usually report on phase 1 or 2 therapeutic trials; too often things don't work out as well during phase 3. However, a phase 2 study of azelastine published this past week received a lot of media hype, plus the results are encouraging enough that I'll mention it here.

Azelastine is an antihistamine (specifically H1 receptor antagonist) spray primarily used for allergic rhinitis. It is available over the counter but note that it is not recommended for children under 6 years of age. Interestingly, it does have separate antiviral activity against some respiratory viruses including SARS-CoV-2, ergo these clinical trials.

This study was carried out in Germany in 450 healthy adults (18 to 65 years of age; mean age in early 30's) from March 2023 to July 2024. They were randomized to receive either placebo or azelastine nasal spray 3 times daily for a period of about 8 weeks. All of them were tested twice weekly with nasal rapid antigen tests for covid, followed by PCR testing for any positives. Any subject with respiratory symptoms and a negative covid test was tested with a multiplex PCR for multiple respiratory pathogens. Here's the big picture of the results:

As you can see in the top rows, azelastine demonstrated some efficacy in preventing covid infection, but overall numbers of infections were low; a larger study with more infections might come up with completely different results. Not mentioned extensively in the discussion, but I noted that laboratory-confirmed infections with other viruses were higher in the placebo group, making me wonder if placebo recipients had different exposure risks than the azelastine group. Other limitations noted by the authors included the fact that azelastine has a bitter taste which risks unblinding of study participants and also that components in the placebo (also present in azelastine spray) might also have protective effects or the ability to lessen test positivity due to dilutional effects.

Again, this study was just in adults and is only preliminary. I wouldn't recommend azelastine for covid prophylaxis based on current data. However, since the product is available without prescription, healthcare providers might well be seeing patients who are trying this, or at least have questions about it. I'm waiting for the phase 3 trial.

Should Providers Prescribe Vaccines Off-Label?

Pediatric providers likely will have parents requesting covid vaccination for their healthy children this fall, even though FDA has removed this indication. AAP already has come out in favor of vaccinating 6-23 month old children without risk factors; this age group is known to have a higher rate of hospitalization, including ICU hospitalization, for covid.

Tina Tan, a pediatric infectious diseases clinician and the current president of the Infectious Diseases Society of America, suggested that providers prescribe covid vaccine off-label. IDSA is an adult-focused organization though most pediatric ID people I know, including yours truly, are members.

The problem with Dr. Tan's suggestion is that providers may take on significant legal and financial risk by prescribing a vaccine off label. The Vaccine Education Center at Children's Hospital of Philadelphia has a good refresher on vaccine liability. The Vaccine Injury Compensation Program covers only vaccines that CDC recommends for routine immunization of children or pregnant women and that are subject to a federal excise tax. The Vaccine Injury Table has more specifics. Although ACIP hasn't officially made a recommendation yet (stay tuned this week), I'll bet the farm that they won't expand availability for covid vaccines. So, off label vaccinations won't be covered for compensation, leaving parents who believe their child was injured by an off label vaccine with the only recourse to sue the provider who administered it, maybe along with others like the vaccine manufacturer.

I can't endorse healthcare providers putting themselves at this risk, but I do expect various medical societies and states to step in with other protections. That still might leave providers in "red states" without great options.

I Thought Retirement Meant More Free Time

Well, it does, but I'm finding I'm booked to the max for the next several days, including September 18 and 19 when I had hoped to be tuned in to the ACIP meetings. I won't have a chance to watch any of the sessions, and I don't want to comment on anything without having personally viewed the slides and heard the discussions. The slides aren't posted yet, and I'll be relying on whenever the meeting videos are posted later. Also, we're still waiting for official notification of perhaps 8 additional ACIP members. I'll be keeping my eyes peeled, but don't expect any report from me on ACIP the weekend following the meeting.

Germ Theory Denialism

I stole that heading title from Wikipedia, it's a good description of a very popular trend with some of today's MAHA devotees who take terrain theory to more extreme degrees. It appears that an accomplished 19th century chemist named Antoine Béchanp eventually pivoted to create theories in opposition to Pasteur's germ theory of disease. Béchamp maintained that germs could not infect and sicken healthy animals, so all that was needed was to maintain a healthy "terrain" in our bodies to protect against infection. All of this was disproven during the 19th century, but strains (pun intended) of this theory have persisted in various forms of alternative medicine even today. There is an element of truth in this: malnutrition, HIV infection, alterations to microbiomes, and other "terrain" alterations can affect infection risks, but when taken to extreme make no sense. Readers will certainly note similarities of terrain therapy to views expressed by our current HHS Secretary.

Béchamp's complete obituary notice in the May 9, 1908, edition of the British Medical Journal was terse. However, he did survive to the ripe old age of 91 (not 92 as listed below), so maybe his terrain was pretty good!

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