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.
