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Tag: nirsevimab

Published on Leave a comment on The Future is Bright

2023 wasn't exactly the best of years, but at least we didn't slip back into pandemic circumstances. I fear we will see some "old" infections become new again in 2024. General immunization rates are falling; even before that, we saw plenty of pertussis and even some tetanus, but now we may become reacquainted with measles and varicella, among other vaccine-preventable diseases. Time for some of those younger pediatric healthcare providers who have never seen children with these infections to hit the textbooks again - how's that for a New Year's resolution!

Still, we have lots of reasons to hope for improvements in 2024. Maybe AI won't take over the world but instead will help us practice more effectively.

Short Course Therapy for Febrile UTI in Children

The literature just got a bit muddier with regard to treatment duration for pediatric UTI with a new study from Italy. Investigators in 8 pediatric emergency departments randomized 142 children ages 3 months to 5 years with fever and UTI to receive either 5 or 10 days of oral amoxicillin/clavulanate. The study wasn't blinded, and the randomization occurred on day 4 of therapy when urine culture results were available. UTI was defined as a single organism growing at >100,000 cfu/ml in clean catch urine or > 10,000 cfu/ml in catheterized urine, and subjects were followed for 30 days after completion of antibiotic. After a planned interim analysis the study was stopped early due to finding of noninferiority of the short course therapy.

As you can see, the short course group had numerically lower rates of UTI recurrences during this time period. However, this study's results contradict another study, with a somewhat more reliable study design and definitions, that showed short course therapy to be inferior. I reviewed this earlier study in my July 2, 2023 post. The editorial accompanying the new study is an excellent discussion of weighing the relative merits of the 2 studies. Suffice to say, the jury is still out, and I would stick with 10 days of therapy for febrile UTI in most children.

More Evidence for Using Nirsevimab to Ameliorate Bad Outcomes from RSV

Investigators in 3 European countries conducted a randomized trial of the long-acting monoclonal antibody nirsevimab showing benefits in preventing RSV-associated hospitalization, especially in younger infants. Note that subjects for this study were not eligible for receiving nirsevimab currently in these countries; they were all healthy infants less than 12 months of age, born at > 29 weeks gestation, who were entering their first RSV season.

This was a pragmatic trial, meaning that it was carried out under more "real-world" practice situations rather than within the strict confines of "explanatory" trials used with most therapeutic research studies. It lends more evidence to benefits of nirsevimab for young children.

WRIS (Winter Respiratory Illness Season)

Most pediatric healthcare providers across the country know that we are in the midst of a busy WRIS. This also is a time when data are least reliable due to the extended holiday season - reporting lags a bit, so trends seen now are more likely to be revised in the next few weeks. Still, it's worth a look.

Researchers in Stockholm, Sweden, looked at pediatric hospitalization rates for the 3 "tripledemic" viruses during the period 8/1/21 to 9/15/22 and found that rates were higher for RSV than for omicron covid (the time period was entirely omicron in Sweden) or influenza; note especially the numbers for younger children. I'll be interested to see if this pattern is seen in the US this winter.

CDC has a new (to me) section charting epidemic growth status for covid and influenza, i.e. it depicts, by locale, the growth rates but not the absolute numbers of these pathogens. Another interesting tidbit.

Along the same lines is a monthly crystal ball page from CDC, a bit of sticking their necks out to predict what's in our future for respiratory illnesses. The last report is from November 29:

Lots of uncertainties here, but I appreciate the attempt.

Now for a look at our usual sources for data.

FLUVIEW

Circulating strains are still well-matched to this year's vaccine.

Covid wastewater is increasing, and several healthcare facilities across the country have reinstituted masking and other mitigation practices due to high rates in their communities.

RSV is the one "tripledemic" component that seems to be decreasing in most areas.

So, WRIS this year seems to be a double-whammy rather than a tripledemic, still more than enough to strain healthcare resources. I can only dream how much better people's health would be with widespread vaccine acceptance.

We're Still Safe from the AI Bots

I tried to use an AI program, Microsoft Copilot's Suno, to compose a song about this blog. Specifically, I asked it to create a song about the Pediatric Infection Connection blog using the blues genre. Here's what I got.

Their link doesn't exist, nor is there a pediatric infectious disease specialist Dr. Sarah Jones certified by the American Board of Pediatrics. I did find a Sarah Jones infectious diseases pharmacist at Boston Children's Hospital, but she doesn't appear to have a blog and I don't know if she has children.

I think, for the next year, we'll still be able to keep AI from fooling all of us.

Have a Happy and Safe New Year!

Published on Leave a comment on Yellow Jack in the US? Are You Kidding Me?

It's nice to be back after my brief website repair hiatus. Please let me know if you have any problems or have any suggestions for the website. I'll continue to work on design issues.

I won't attempt to cover all the issues in pediatric infectious diseases appearing during the hiatus. Needless to say, at lot happened, mostly old news by now. Some newer things I won't mention because they appear only in abstract form at national meetings, such as this month's ID Week (Infectious Diseases Society of America and other ID groups) and the American Society for Tropical Medicine and Hygiene. I have seen dramatic changes from the time data are presented at a meeting, which can be preliminary and incomplete, to the final publication or lack thereof. I've become averse to propagating that type of information source.

Yellow jack is another name for yellow fever; it takes its name from the yellow nautical flag that alerted others that yellow fever was on board. A variation of this flag is still used today to alert other ships about health issues on board. You might want to brush up on your yellow fever knowledge now, keep reading if you're intrigued.

Nirsevimab Supply Chain Flop

This isn't news to any practicing primary pediatric healthcare provider. The supply of the newly-approved long-acting monoclonal antibody preparation to prevent RSV infection for all infants has hit a major snag: demand has far outstripped supply. Maybe we will eventually hear the true story of what happened, but basically we are dealing with a single manufacturer who couldn't produce enough product. Even some hospitals aren't able to get a supply to administer to newborns at the time of discharge.

The AAP has a nice RSV page that healthcare providers may find useful, as well as an October 17 webinar with practical strategies. Remember that maternal RSV vaccination at 32-36 weeks gestation is another option to encourage; talk to preganant people visiting your practices. Palivizumab (Synagis) is still available for high risk infants.

Tripledemic Update

We're certainly not anywhere close to a tripledemic at present. Only RSV seems to be on a significant upswing:

Flu season hasn't yet started for most of the country. COVID-19 disease is much more difficult to track now that our tracking methods have changed so dramatically from the pandemic area. I look to wastewater reports as the most consistent indicator over time, and they suggest that we did not have a big spike this fall.

Future Pandemic Preparedness

The Journal of Infectious Diseases finally got around to publishing a supplement on vaccine and monoclonal antibody development for potential future viral pandemic pathogens. It was put together from presentations at a meeting in 2021. Here's a quick overview of the types of pathogens considered:

Comparison of pandemic potential and countermeasures for viral families known to infect humans. Viral families were categorized as having either low/moderate or high pandemic potential and low/moderate or high levels of existing resources and countermeasures. Cross-comparison revealed 10 viral families with high pandemic potential and low/moderate existing resources or countermeasures upon which the National Institute of Allergy and Infectious Diseases will focus its pandemic preparedness activities. Asterisks denote existing vaccine solutions for some viruses in that family; boldface type, potential vaccine solutions for the entire virus family; shaded box, viral families chosen for prototype pathogen selection.

I'm sure many of these names except for Coronaviridae are unrecognizable to most physicians, and several at best are vague even for infectious diseases specialists. Orthomyxoviridae include influenza viruses. Let's hope research funding comes through for the entities in that lower right box.

Yellow Fever

You probably haven't thought much about yellow fever unless you've considered travel to an endemic area, either for yourself or for patients in your practice. We have an effective vaccine available, but it is a live virus vaccine. Risks for vaccine side effects increase with age greater than 60; I actually received yellow fever vaccine for travel when I was in this high risk group; more on that later.

A recent Perspective essay in this week's New England Journal of Medicine raised the possibility of yellow fever reappearing in the US, particularly in the southeastern United States. This is already a problem with other mosquito-borne infections like dengue, chikungunya, and Zika viruses. (Note these are in the family Flaviviridae, also included in the gray box above.) The vectors for yellow fever, Aedes aegypti and A. albopictus, are well represented in the US, and their range is increasing as our climate warms.

Yellow fever is endemic in some parts of South America and Africa, and its range appears to be spreading in recent years. (The maps below are a few years old, updated WHO country recommendations usually are published in November.)

Diagnosing yellow fever without a travel history will be very difficult in most instances. In about 85% of those infected, the clinical presentation is a self-limited, nonspecific febrile illness with chills, myalgia, headache, and some GI symptoms lasting about 3 days. An unlucky 15% have a more biphasic presentation with the second stage appearing after around 48 hours of improvement and characterized by more severe symptoms including jaundice, renal failure, coagulopathy, and other life-threatening problems. At that stage the diagnosis might occur to an astute provider and diagnostic testing can be obtained. No specific antiviral therapy is available.

Yellow fever vaccine is highly effective, and a single dose confers life-long immunity. It is relatively safe, but there are rare severe side effects. These severe reactions are 3- to 4-fold higher in vaccine recipients over 60 years of age:

Yellow fever vaccine associated neurologic disease (YEL-AND; mostly encephalitis, Guillain-Barre syndrome):

  • over 60 years of age = 2.2 cases per 100,000 doses of vaccine administered
  • less than 60 years of age = 0.8 cases per 100,000 doses of vaccine administered

Yellow fever vaccine associated viscerotropic disease (YEL-AVD; similar to severe infection itself with approximately 50% mortality):

  • over 60 years of age = 1.2 cases per 100,000 doses of vaccine administered
  • less than 60 years of age = 0.3 cases per 100,000 doses of vaccine administered

I was over 60 years of age when my travel to Ethiopia caused me to consider yellow fever vaccine. My reasoning wasn't based on the 3- to 4- fold increase in risk, which is a relative risk increase, but rather focused on the absolute risk. This is a topic I've revisited many times in this blog; it has immediately applicability to vaccination of any type but especially for COVID-19 and RSV now.

Adding together the risks for YEL-AND and YEL-AVD for the older population comes to 3.4 cases per 100,000 vaccinations, or 0.0034%. As a comparison, risk of airplane crash is about 1 in 11 million (o.oooo1%) and risk of being struck by lightening is 1 in a million or less (0.0001%). Of course these risks vary by how many miles you spend on airplanes and how often you are out walking around in thunderstorms. Weighing my yellow fever vaccine risks and benefits, I chose to receive the vaccine rather than not travel to Ethiopia where my specific yellow fever risk was very low because I was staying at high altitude for most of the time.

Speaking of Travel

I timed my blog hiatus with a major trip to the Umbria region of Italy. It was a hiking vacation through rural areas with occasional forays into medieval towns and was a wonderful experience. I'm still nursing a few minor musculoskeletal aches and pains - my muscles and joints aren't what they used to be.

In addition to beautiful churches, ruins, and the medieval towns, I was also surprised to see many unfamiliar butterfly species including this Hipparchia hermione example.

Published on Leave a comment on No Spoilers From Me

It's my usual Sunday to put the final touches on this week's post though working on it earlier than my usual late morning start since I had to watch the Women's World Cup soccer match. In case you recorded it to watch later, I won't reveal any spoilers.

It's Official for Nirsevimab

On August 3 the ACIP voted to recommend the long-acting monoclonal antibody nirsevimab (brand name Beyfortus) to prevent RSV. It is recommended for use in all infants under 8 months of age, just before or during the RSV season, and also for infants 8-19 months of age with the usual high-risk medical conditions just before their second RSV season. Dr. Mandy Cohen, the new CDC director, formally adopted those recommendations. It will eventually replace the current product, palivizumab (Synagis), which has been administered just to the high-risk groups monthly during RSV season.

I didn't log in to the ACIP meeting but did review the slides and reports (available here). Most of the information had already seen the light of day at the prior FDA meeting that approved the product, but a few items are noteworthy.

First, authorities now refer to this product as a vaccine, although that's not quite true in the scientific sense. This is a strategy to try to have this funded by the Vaccines for Children program. The product will be very expensive (probably around $450 - 500 for a dose), and even standard health insurance companies are notorious in avoiding reimbursement for new products.

For infants born just before or during RSV season, nirsevimab would best be administered by the birthing hospital prior to discharge. I was surprised to learn that only 10% of US birthing hospitals participate in the VFC program. Most provide bundled services for deliveries; hepatitis B vaccine is often covered in this manner, but that cost is only $13-16 per dose. Will bundling work for a much more expensive product? These payment issues could impact ability to administer the new therapy particularly for the upcoming RSV season. There isn't much time to figure out these details.

Presentations from CDC personnel helped show the potential impact of nirsevimab, using a Number Needed to Immunize (again with the vaccine nomenclature). Based on the available 2 randomized controlled trials in mostly healthy infants, where ICU admissions were rare and deaths thankfully absent in the study infants, NNI was favorable particularly for preventing hospitalization but also for prevention of medically-attended illness.

In other words, 128 infants would need to receive nirsevimab to prevent 1 additional child from being hospitalized for RSV. Various cost-effectiveness analyses showed this to be a good use of funds.

Data are not yet available to perform similar analyses for high-risk infants receiving therapy prior to their second RSV season, but antibody levels in those infants following treatment strongly suggest it will be effective.

CDC will provide us with more detailed recommendations soon. They did provide an example of timing for "vaccination" with nirsevimab. As mentioned above, for children born just before or during RSV season (October 1 through March 31 in most parts of the US), nirsevimab would be administered at birth. Otherwise, administration would be timed for the well-child checks in primary care provider offices, perhaps in October and November. The October batch could include infants born the previous April (at their 6-month visit), June (4-month visit), and August (2-month visit). Infants born the previous May (6-month visit), July (4-month visit), and September (2-month visit) would receive their dose in November. A bit complicated, but at the moment I can't think of a better plan to make this run smoothly for office practices.

We also need guidance if FDA approves the maternal RSV vaccine for pregnant people. Providing nirsevimab to infants whose mothers were vaccinated during pregnancy is probably unnecessary. FDA is supposed to decide this month on the maternal RSV vaccine once they receive updated results from the ongoing trials.

Regardless, all pediatric healthcare providers need to stay tuned; this could be a major change in office practice this fall.

Don't Go Home With the Armadillo, etc.

A case report of possble authochthonous leprosy in central Florida reminds us that, Jerry Jeff Walker notwithstanding, one can acquire leprosy in the US without having contact with humans or armadillos with leprosy. The report and other epidemiologic evidence suggests that leprosy may be endemic in southeastern US.

Cold air might aid in croup treatment according to a new randomized controlled trial in an emergency department. In addition to treatment with dexamethasone, children with croup were randomized (not in a blinded fashion, obviously) to outside cold air for 30 minutes, compared to room temperature indoors. The cold air kids seemed to improve faster.

Conflict in My Favorite Medical Feed

I've been reading ProMED posts several times a day for years and have donated funds to them during that time. They were the first to report all 3 coronavirus outbreaks this century. I was a bit disappointed to learn recently that they will start charging a subscription fee but was resigned to the fact that I'd be shelling out a few more bucks. Now I've learned there's a big kerfuffle in the background. The frontline folks who do all the work are protesting new management moves. I hope this is resolved, I can't imagine life without ProMED.

'Demic Doldrums

No big changes this week, CDC numbers are similar to last week and all indicators point to an increase in SARS-CoV-2 activity in the US and elsewhere. Not to rely too much on anecdotal data, but my own primary care provider remarked to me at a visit last week that he has seen an upswing in positive tests in his practice. Let's hope this will be a minor blip and not the start of a large new wave.

Some Good News From Down Under

Again, no soccer spoilers from me. But, maybe flu has peaked in Australia; if so, this season is a bit better than 2022 and might bode well for our own flu season.

Published on Leave a comment on More Dogs

Last week's post dove into the dog days of summer, and another article this week kept my canine focus centered; I learned about a new breed to me, the Pyrenean Mountain Dog.

New Hope for Group B Strep Vaccine?

I don't usually hype phase I or phase II trials, but this past week's article in the New England Journal offers a glimmer of hope for maternal GBS vaccination to prevent neonatal disease. Maybe it's just wishful thinking, but we might have a breakthrough after decades of failures. We'll need to wait for a definitive phase III trial before we know. I refer you to the accompanying editorial by Carol Baker, the investigator most responsible for "discovering" the emergence of neonatal GBS disease in the 1970s. As in aside, I was a subject in her phase I trial of a GBS vaccine in the early 1980s. The fact that she was my fellowship director at the time wouldn't pass ethical muster today, but I had no side effects and I recall that I did have a good antibody response. Still, that vaccine didn't make it past further testing.

Bacterial Vaginosis

Other than neonatologists, most pediatric providers don't think about BV that often. However, it is very likely a factor contributing to preterm delivery. It's a confusing infection, or perhaps better termed a dysbiosis, consisting of vaginal colonization with various anaerobic bacteria and absence of lactobacilli. A few diagnostic criteria have been in use, but lately molecular screening tools have improved. A new study suggests that molecular screening of pregnant people could be cost effective in preventing pre-term births by identifying individuals with BV and treating them early. Investigators randomized 6671 pregnant people before 20 weeks gestation to have self-administered screening swabs versus regular care. Molecular testing was with a research (not commercially available) tool looking for high levels of Atopobium vaginae and/or Gardnerella vaginalis, and those testing positive were treated with azithromycin or amoxicillin. The differences in the rates of pre-term births in the treatment (3.8%) versus control (4.6%) groups were not statistically significant. However, results in the 3000+ nulliparous (could have had previous miscarriage or abortion) subjects did reach significant difference: 3.6% versus 5.9%. In my current telemedicine practice I see many pregnant individuals who have undergone some type of BV screening. I'm hoping more studies like this will shed light on this somewhat confusing dysbiosis.

More Tick Reminders

Folks at the CDC remind us about tickborne relapsing fever, aka soft tick relapsing fever (STRF). As the name implies it is a relapsing/remitting type of fever and can be pretty tough to diagnose, especially since it isn't seen equally in all parts of the US and is reportable only in 12 states (Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Texas, Utah, Washington, and Wyoming) as of 2021. Think of it in campers or others who are active in the outdoors who have had recurrent fevers. CDC investigators reported on 251 cases over a 10-year period, 61 < 18 years of age. Here are some key geographic and clinical points to keep in mind for diagnosis:

'Demic Doldrums

Things remain calm, with a few things to report. Pediatrics published a supplement on covid and school management a couple weeks ago, took me a little while to go through everything. Hindsight usually is 20/20, but I'd say with the pandemic it's more like 20/60, largely due to incomplete data and a moving target with viral variants. However, I would draw your attention to one of the article about lessons learned. The authors include 8 lessons learned; I would put most of this still in the realm of opinion but it is well-reasoned:

  • School closures were necessary initially but should have been shorter
  • Masking works in schools (covered in 2 of the lessons)
  • In-person teaching with masking is better than school closure or hybrid education
  • Covid exposure is not a good reason to exclude school attendance
  • Efficacy of school ventilation improvement is not well-substantiated
  • Asymptomatic screening is ineffective
  • Vaccine trials should be carried out in adults and children in parallel, rather than delaying pediatric trials until adult data are available

Also in both covid and canine realms, the Pyrenean mountain dogs pictured below are actually sniffing out covid.

A new article reviewed evidence to date of dogs trained to sniff out the infection through various methods. A variety of dogs were trained, including mutts. However, the numbers are very low; it's hard for me to imagine a practical use of covid-sniffing dogs, but maybe this will lead to an effective breath test.

You also may have heard nirsevimab, the long-acting monoclonal antibody to prevent RSV in young children, was officially approved by the FDA. Next up is a CDC/ACIP meeting on August 3 to discuss nirsevimab and maternal RSV vaccination, with votes scheduled on recommendations for use.

Playing Games

No, I didn't forget that challenge in last week's post. Blame one of my sons for this. He told me that the New York Times games and puzzles are major revenue sources for the publisher. I receive bupkis for this blog, but I'm not above trying something that might keep readers interested. I couldn't find a credible study for his claim, but there is some evidence.

So, the answer to last week's challenge of the correct number of weather- and temperature-related references and puns in the Dog Days post is 16, including 1 in the Title (summer), 1 in the intro (steaming), 4 in the Bugs section (heating up, hot off the presses, febrile illness, tip of the iceberg), 2 in hep C (cool, clouded), 4 in 'Demic (hot air, cooled, boiling point, hot spots), and 4 in the Astrology section (summer, heat, cool, thunderbolt). Decision of the judges (me) is final.

And by the way, my house is back in the cool as of Friday, unfortunately following purchase and installation of a new air conditioner.

Published on Leave a comment on Always Something Entertaining

Last week I was watching my new washing machine at work. This week it was our "airborne toxic event" as Canadian wildfire haze, fumes, and particulate matter settled over the DC area for a couple days. I'll pick the washing machine any time.

Nirsevimab - Likely a Big Change for Pediatric Practice

Last Thursday the FDA's AMDAC (Antimicrobial Drugs Advisory Committee, expert panel advisors to CDER, the Center for Drug Evaluation and Research), met to discuss potential approval of a long-acting monoclonal antibody injection to prevent and modify RSV infection in infants. The panel voted unanimously to approve nirsevimab for this purpose in infants experiencing their first RSV season and favorably (19 yes, 2 no) to approve it in a second season for high-risk infants. The FDA has yet to announce any action on the panel's votes. However, the Advisory Council on Immunization Practices (ACIP) of the CDC is scheduled on June 22 to discuss nirsevimab along with the recently approved RSV vaccine for pregnant individuals to protect their infants.

I could only attend part of the AMDAC meeting on Thursday, but it was the most important part involving the panel's discussions of the data presented. Virtually all the data have already been published and it is pretty clear that a single dose of IM nirsevimab is safe and effective during a child's first RSV season, including infants at high risk (e. g. prematurity with or without BPD or other chronic lung disease, significant cardiac disease) but also for normal healthy infants born at term. I am departing from my usual practice of avoiding any suggestion of bias by not displaying any slides presented by the pharmaceutical sponsor. In this case I felt the FDA slides weren't good visual summaries. The sponsor's slides (at least the ones I'm showing) didn't overhype the data. Here's how nirsevimab works:

(Of course there is a little hype here - the title sneaks in their hope that nirsevimab will be approved for all infants, not just those at high risk for RSV complications. The items in the slide have nothing to do with that comparison. A typical pharmaceutical company subtle advertising ploy.)

Note that these trials (essentially 3 separate ones) started before the pandemic and then hit some real bumps in the road, with shutdowns in enrollment and absence of RSV disease during a couple winter seasons. Finally the main randomized trials were completed and showed favorable results.

MA RSV LRTI = medically attended RSV lower respiratory tract infection

I'm showing this Trial 04 because all of the subjects were at least 35 weeks gestational age, so not our traditional high risk population. Thus we see relatively low rates of medically attended disease and hospitalization but still primarily favoring use of nirsevimab.

Two big questions remain. First, how could this product be used (or not) for infants born to mothers who received the RSV vaccine during pregnancy? No studies address this. Second, what about administering the medication to high risk infants before their second RSV season? Although neutralizing antibody levels weren't zero a year after one injection, it isn't clear how much protection would remain. Normal healthy infants have even less risk of serious RSV disease during a second season, so the question really is just for the high risk kids. Those studies are ongoing but antibody studies of a second dose do suggest it would be protective.

I'm very interested to hear the ACIP discussion on June 22. From a practical standpoint, nirsevimab could be administered at hospital discharge for newborns born during or just before RSV season, but for others born at other times it could be given in healthcare offices as an outpatient sometime in the fall. We have a few months before RSV may return, I think it is likely nirsevimab will be part of our armamentarium in the fall. Stay tuned.

Deciding When to Administer Post-Exposure Rabies Vaccine

This has always been a tough issue: the disease is basically 100% fatal, so one would need to be pretty certain there was no significant exposure in order to withhold the vaccine series. An article trying to quantify risk appeared last week and reminded me of a former patient of mine. I saw a very intelligent high school student with pre-existing anxiety and other neurobehavioral issues who had developed something of a pathologic fear of rabies. (S)he had a recent concern for rabies exposure, but in the discussion of the events it was very clear that there was no exposure at all and no vaccine was indicated. Complicating the picture, however, was that later on (s)he was awarded a chance to study abroad in a country that had a higher rate of rabies in dogs and other animals, particularly in rural settings. The posting was actually in a major city with essentially no increased risk of rabies compared to the US, but the student asked for pre-exposure prophylaxis. I exhaustively reviewed everything about rabies in that country and presented my data to him/her and parent, stating that pre-exposure prophylaxis wasn't indicated. I never had follow-up for what happened, it was a tough situation and I couldn't help thinking that this setting was not a great choice for this student's learning.

If this situation presented itself to me again, particularly with a patient with high numeracy skills, I'd try to incorporate this article. The researchers used 24 different clinical scenarios and 10-year rabies rates in animals in the US to obtain opinions from 50 local and state public health practitioners who regularly advise on rabies prophylaxis. It's an interesting but complicated read that provides some quantification for risk.

Looking just at the graph on the left for Number Needed to Treat, you can see that for a low risk event such as a single bite to the arm from a vaccinated cat in Michigan that was ill and provoked, the graph becomes asymptotic. Using even more complicated logistic regression methods, the researchers concluded the best cutoff for providing prophylaxis was at a risk threshold (probability that a person was exposed to a rabid animal) of 0.0004. This is an appropriately very low number.

The bottom line for healthcare providers still is that they should discuss all rabies prophylaxis questions with their local health department experts. These folks do this all the time and are our best resources.

Checked Your QALY Lately?

That's Quality Adjusted Life Years, a commonly used measurement to aid in assessing value of a particular intervention such as a medication or vaccine. It attempts to place a number on how much better a person's life would be with the intervention and how long the benefit would last. So, QALY for a 70-year old usually is lower than for the same intervention in a 7-year old, assuming the intervention has equal benefits at both ages and that they both die at age 80. Shame on me for not realizing, until I read this opinion piece, that Congress is trying to forbid use of QALY in government health programs like Medicaid and Medicare!. Usually I try to stay away from politics, but this move is so ridiculous that I couldn't control myself. QALY is just one of many tools to use in judging effectiveness of health interventions, and it was never intended to be used for individual decision-making anyway. Banning it would only hinder healthcare program decisions.

Remember Where You Were on July 16, 1969?

Most medical students I've interacted with over the past couple decades weren't born yet and don't recognize anything about that date. For many years, I had a monthly session with groups of third-year medical students during their pediatric rotation. It was a game of sorts, guessing the disease from a CDC graph or map liberally sprinkled with hints from me. I used it to demonstrate the effect of vaccines, the lack of public health services in the Deep South, and other public health principles. For extra credit, I had this photo:

Most had no idea. A few times someone would recognize President Nixon. What's pictured is the quarantine station where the Apollo 11 astronauts were kept after splashing down in the Pacific, in case they were carrying moon germs. My next question was, "What is the incubation period of moon germs?" That met with a lot of blank stares, but the answer is 21 days since that is how long the astronauts were kept in isolation.

I mention this date of the first humans landing on the moon now, rather than next month, due to publication of even more details about this moment in history. Apparently there were so many leaks and other problems with the quarantine systems put in place that, if there were pathogens on the moon, likely we'd all have been caught up in a Moonicus germii pandemic that would have changed things forever.

'Demic Doldrums

Speaking of pandemics, thankfully we continue in the covid doldrums, with a few updates. We have even more data about vaccine safety in the 6 month to 5 year old age groups, courtesy of post-marketing systems in place maintaining our pharmacovigilance. Side effects are very minor.

WHO continues to report little covid activity worldwide.

The southern hemisphere has begun flu and RSV seasons in many places; Australia and South Africa have yet to see much of a bump in covid.

I logged into a CDC/COCA call on June 6 that included how our post-pandemic disease monitoring should be viewed. Here is a nice summary slide:

Wastewater is still a nice tool, but in the US this is still a voluntary reporting system and leaves much of the US without any data, so it's less helpful. Emergency room visits and hospitalizations for covid likely are the most effective indicators to signal a new wave.

Variant modeling continues, albeit with less specimens to test since less disease is going on. I included the latest from the UK (I think it's prettier than the US graphs).

XBB sublineages continue to predominate and may drive vaccine selection for the fall. The FDA VRBPAC meets on this on June 15. Will it be a monovalent vaccine focused on just 1 XBB strain? More on that next week.

Unless otherwise indicated, the content and opinions expressed on this web site are those of the author(s). They are not endorsed by and do not necessarily reflect the views of the George Washington University.
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