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Tag: nirsevimab

Published on Leave a comment on Seeing Spots Before Your Eyes?

Washington, DC, had a record high temperature 1 day during our heat wave this past week, and I suppose if you glanced at the sun you might see some spots for a few seconds. But of course I'm referring to different spots in this post.

Measles

I'm probably the only person who has read all of my blog posts over time, so you're forgiven if you don't realize I'm in broken record mode here. I can't count the number of times I've warned providers to be on the lookout for measles cases, and now we are facing a global decline in immunization rates that probably puts us at greatest risk since the modern-day measles vaccine was available in 1968 (the original Enders vaccine appeared in 1963). We've enjoyed some low numbers in the US recently, but that appears to be changing with 9 cases (from Georgia, Missouri, New Jersey, and Pennsylvania) reported to CDC so far this month.

CDC released an alert last week mentioning 23 US cases between December 1 and January 23.

I won't review everything about diagnosis of measles, the CDC website alert is a good resource with links to other sites, but I do want to highlight a few helpful nuances that aren't often mentioned. First, measles is fairly unique among exanthematous infections in that the prodrome interval, the time between onset of first symptoms and appearance of the rash, is long, usually a few days. Most infectious diseases accompanied by rash have very little or no time between onset of symptoms and appearance of the rash, with erythema infectiosum being a notable exception but not easily confused with measles clinically.

The measles prodrome consists of a febrile illness with cough, coryza, conjunctivitis, and Koplik's spots. You can find pictures of Koplik's spots everywhere on the web, but in my experience as an old geezer who has seen many cases of measles in children, they aren't that easy to see or photograph. Therefore, the photos available in textbooks and on line are skewed towards the most obvious. One needs to do a careful oral exam looking for gray or bluish-gray or white fine spots (almost sandpapery) anywhere on the buccal mucosa; the inside of the lower lip is particularly helpful. If you're not sure, find an old geezer clinician to confirm.

In the absence of Koplik spots, or if you don't see the child until the rash appears and the Koplik spots have resolved, pay close attention to the history. Specifically ask for a day-to-day accounting of symptoms; if you feel the parent or patient can recall reliably, noting at least a 2-3 day lag between the onset of high fever, cough, rhinorrhea, and conjunctivitis before the rash appears can be strongly suggestive of measles; the absence of this lag is against the diagnosis. Other alarms to increase your suspicion would be lack of 2 measles immunizations, international travel, and/or exposure to a suspected measles case.

"It ain't what they call you.....

..... it's what you answer to." - attributed to W.C. Fields, though I can't verify the origin.

I thought of Mr. Fields when I heard about administration errors involving the adult RSV vaccine (brand names Abrysvo and Arexvy) given to children and pregnant people. From my viewpoint, it was an accident waiting to happen, due to a name.

In order to speed payment allowance by the Vaccines for Children and other programs, the long-acting monoclonal antibody nirsevimab was officially designated a vaccine. Strictly speaking I guess this is correct: antibody administration is a form of passive immunization. However, the true RSV vaccines are intended only for adults with high risk conditions or for pregnant people to help protect newborns after birth. It was inevitable that confusion would ensue. The notice provides almost no details but does state that most administrations to young infants were "nonserious." Infants who wrongly received an adult RSV vaccine should be considered unprotected and still receive nirsevimab.

WHO Fans the Covid Mask/Distancing Controversy

WHO riled a lot of public health experts with its recent guidance for infection control in healthcare facilities. The main controversial elements involve recommendations to use physical barriers such as plastic windows for areas where patients first present (rated as conditional recommendation, very low certainty of evidence); maintaining a physical distance of at least 1 meter between people ("good practice statement"); and not sufficiently highlighting superiority of respirators (e.g. N95 masks) for general care - this particularly angered those who favor the aerosol, rather than droplet, mode of transmission for SARS-CoV-2. In general it seemed that the WHO panel carried over some details for infection control that do not have strong evidence for use and in some cases (plastic barriers) may be contradicted by other studies.

Note that much of the controversy involves how much weight to give transmission simulation studies - e.g. distances that SARS-CoV-2 travels under experimental conditions rather than real-world evidence which is much more difficult to come by. It's hard for an individual medical practice to make these decisions on their own, best to abide by state or local health department guidance.

Spring Covid Vaccination?

Canada released guidance for covid vaccination this spring, advocating for an additional dose of the XBB.1.5 vaccine recommended last fall. I'd look for the US to make similar recommendations soon. ACIP has a regular meeting scheduled February 28-29, but no agenda is yet available. FDA doesn't have anything scheduled, and they may not need a separate advisory committee meeting for this.

WRIS

In general we seem to be trending downward with our winter respiratory infections, but still lots of runny noses, coughs, and more around.

For RSV I still look primarily at hospitalization rates in young children, the purple line in the graph below, because I think it's the most accurate gauge of RSV. I suspect almost all of these hospitalized children are tested for RSV and flu. The rate clearly is trending down, it's looking like we won't replicate the horrible RSV season of last year.

Influenza-like illness seems to be cooling off as well, as seen in FLUView. Note this measurement includes respiratory illnesses mimicking flu so could be any respiratory virus; there are many more ways to look at flu activity in general, all with their own inaccuracies. In the past I have found this map to be representative of what I've seen clinically in my practice areas.

Covid wastewater (I've said before why I prefer this qualitative measurement) continues to trend downward, and levels are below that seen last year.

All told this is good news for those of you trying to manage your packed patient waiting rooms. Let's just hope you don't have a case of measles sitting in there somewhere!

Do You Even Know What a Broken Record Sounds Like?

I used this term when I said I was sounding like a broken record for repeating over and over my warnings about measles. I harp (pun intended) on this because measles is the most contagious infectious disease known and most younger clinicians in the US have never seen a case, meaning it can be missed easily. However, those same clinicians might never have heard a broken record either. Vinyl records made a bit of a comeback recently but even I no longer have a turntable to play vinyl records; I do have a few moldy vinyl albums from the 1960s and 70s. I'm occasionally tempted to purchase a good turntable, but I have no place for it and it's yet another diversionary rabbit hole I don't need. I ain't gonna call out the name vinyl around here.

Published on Leave a comment on Winter Distractions

My soon-to-be daughter-in-law recently gave me a bird feeder - not just any bird feeder, but a smart one that has a camera connected to my wifi that takes photos and videos of any birds that show up. I had my first visitors this morning, a few days after I stocked it with birdseed.

In the meantime, winter is here.

WRIS

A lot going on with our Winter Respiratory Infection Season, including some new items.

CDC issued new (or actually old) guidance for use of the long-acting monoclonal antibody nirsevimab for preventing RSV infection in young infants. The change was prompted by the announcement of greater availability of nirsevimab because the manufacturer released an additional 230,000 doses this month. Previously the guidance had indicated that the product should be prioritized for just a subset of infants at higher risk, but now recommendations are to go back to the original plan to administer to all infants less than 8 months of age as well as to infants 8-19 months of age with high risk conditions:

  • Children who have chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season
  • Children with severe immunocompromise
  • Children with cystic fibrosis who have severe disease
  • American Indian and Alaska Native children

If supply is still limited in your particular area, then prioritization should be used as before. Still a bit vague but very important are all the nuances for ordering, administering, and being reimbursed for the product.

Along that same line, RSV may have peaked nationally.

Even with some good news about RSV slowing down, there's still plenty to go around. Also, influenza continues to drive a lot of healthcare usage for all ages around the country. Here is the percentage of emergency department visits due to the various respiratory infections:

Be aware that this site allows you to look just at your local jurisdiction - here is Maryland:

Covid

This week covid deserves a separate heading with a few new twists. Wastewater tracking once again has accurately predicted a surge in infections.

The JN.1 variant has increased rapidly and is projected to be the predominant covid strain in the US, but without any indication (yet) that it has increased virulence.

This might be a good time to review a bit about variants and also some recent covid findings. Variant nomenclature is confusing to me, I can only imagine how the general public sees this. Here is an evolutionary tree from the same CDC weblink as above.

The nomenclature is from the Pango system, but most people are more familiar with the WHO classification: the delta variant (remember those horrible days?) is B.1.617.2 near the left of the diagram. Omicron is represented in both BA.1 and BA.2. Now here's the important part when we consider new variants, immune-escape, and vaccines: JN.1 has developed on the BA.2 side, just like XBB but on a different branch of the tree. Remember that our current vaccines are based on XBB. As I've mentioned previously, XBB vaccine antibody seems to neutralize JN.1 pretty well in the test tube, but all vaccine (and natural infection) immunity declines significantly within a few months after vaccination or immunization. I would still expect the current vaccine to be pretty good for protecting against severe disease with JN.1 infection.

Although near and dear to my heart, I don't usually talk about old folks in this blog. However, a study of old folks in the Netherlands lends support to the idea that current vaccines are effective against new variants. Without going into details, you can see this study has very recent data and show excellent effectiveness for hospitalization and ICU admission for old folks. It's likely this benefit translates to the younger population that of course has lower rates of hospitalization overall.

Another recent study sheds some light on a question I've been wondering about for some time, namely how common asymptomatic covid infection might be in the omicron era. You might recall that one of the early surprises in 2020 was that asymptomatic infection was both common and very important for viral spread. That made the pandemic much more difficult to control. Now we have data from Hong Kong where rather unique epidemiologic circumstances prevailed. With a population of 7.5 million, Hong Kong officials had still had managed to prevent covid spread very effectively prior to the omicron era, with only about 0.5% of the population having been infected. That ended in early 2022, but it also offered researchers an opportunity to look at rates of asymptomatic infection during the omicron period because virtually none of the population had been infected previously. Using antibody testing, they estimated that 16% of the population was infected during the first 6 months of 2022 and that the percentage of asymptomatic cases was at least 42% (taken from those with reported SARS-CoV-2 infections) and possibly as high as 72% (looking at combined reported and unreported infections). Wow. That doesn't necessarily mean we would have those same rates of asymptomatic infection in the US where we've had a very different epidemiologic curve over the years, but I think it's likely we have a lot of asymptomatic covid surrounding us now.

Some good news about long covid, AKA PCC (post-COVID-19 condition) in children. This Canadian study looked at pediatric emergency department data and found that PCC was present in only 0.67% at the12-month follow-up periods in children testing positive for SARS-CoV-2. That's not the only good news part of this; the rate in a control group of children testing negative for covid was 0.16%, suggesting once again that other infections can trigger some of these long term symptoms. We have NIH-funded studies in the US ongoing now, with good control groups, that should go a long way in giving us guidance for managing PCC as well as other long-term conditions triggered by infections.

The Tipping Point

FDA officials, including Peter Marks who is the director of CBER, recently published a viewpoint article about a vaccination tipping point, i.e. the fact that vaccine hesitancy issues have resulted in a severe decrease in immunization coverage, opening us up to major outbreaks soon. I mention this both because it perfectly supports my views expressed in recent weeks but also it gives me a chance to give credit where credit is due. The term "tipping point," as applied here, often has been credited to Malcolm Gladwell. However, his popularization of the term in a sociologic context earlier this century should go to Morton Grodzins who first adapted this for use in explaining racial integration of neighborhoods in the middle of the 20th century. I'm hoping Gladwell credited him.

In Case You Missed These

Two other articles caught my eye this past week. First is a quality improvement article about shortening treatment duration for children with community acquired pneumonia and skin and soft tissue infections. If you're one of those practitioners who still treats these for 10 days (because we have 10 fingers), check it out.

Secondly, I was attracted to a report about variation in rates of how primary pediatric providers use pediatric subspecialty consultations. Although not the main focus of the report, I was most drawn to the mention that the top 2 conditions for using a pediatric infectious diseases specialist were positive tuberculin skin test and inactive tuberculosis. This jives with my personal experience and certainly points to opportunities to lessen use of subspecialty health care. Multiple resources exist for managing latent tuberculosis infection, including the AAP's Red Book, the CDC, and UCSF's Pediatric TB Resource Page.

For the Birds

My first video stars at the bird feeder were a white-breasted nuthatch, maybe a tufted titmouse (looks a lot like the nuthatch, I couldn't figure it out), and a house finch. When I received the bird feeder, I immediately wondered how best to avoid attracting squirrels and other rodents. I did a bit of web searching and then journeyed to my local bird authorities at the Woodend Nature Sanctuary who of course turned out to be the most helpful. I armed my feeder with capsaicin-treated safflower seeds, not a favorite of squirrels and the like, plus birds can't taste the hot pepper. So far the birds seem to like it.

As for me, it appears I've fallen down another rabbit hole, similar to my butterfly fascination. My wanderings have now included a look at how climate change is affecting our bird populations, as projected by the Audubon Society (apologies for using his name, now controversial, but the Society hasn't yet changed it) in their field guide.

Here is how things will change for the white-breasted nuthatch's winter range with a 1.5 C increase in temperature.

For the tufted titmouse

and the house finch

With more severe temperature increases, the ranges are altered more dramatically. I still hope for some action that will reverse these trends.

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.

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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