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Published on 2 Comments on Sapsicle

Happy 2026 to everyone! Let's hope for better things this year.

Yesterday I was briefly excited to think I had invented a new portmanteau; turns out many people before me had figured this out.

I had hoped to have the "new" website pretty much completed by now but hit a slight glitch for which I am waiting on outside technical help.

Last Week's Tidbits

Welder's Anthrax

I thought by now I had heard of everything in infectious diseases, but not surprisingly I was wrong. Perhaps I could be partially forgiven since it isn't a pediatric infection. Last week's MMWR informed me about a rare setting for anthrax infection - a welding worksite. The site was in Louisiana; 8 previous cases of welder's anthrax have been reported, interestingly all from Louisiana or Texas; 6 were fatal. The current individual survived, probably because he was "lucky" enough to have a positive blood culture for a bacterium in the Bacillus cereus group that produced B. anthracis-associated toxin genes. It sounds like the blood culture positivity was the key clue for his alert physician team to make the diagnosis and to administer the anthrax antitoxin monoclonal antibody obiltoxamab. The bacterial isolate was identified as B. tropicus by genetic methodology. I mention all this detail only to underline how complex the microbiology of Bacillus species is.

Welder's anthrax is a form of inhalational anthrax. The main reason I'm dinging myself for not knowing about the connection with welders is that I very heavily researched inhalational anthrax in 2001 when the postal letter anthrax cases appeared around the country, including in Washington, DC, where I was practicing. The earliest report of welder's anthrax, though not labelled as such, probably was in 1997.

Another Blow to Vaccination Policy

I don't recall seeing anything about this in the lay press, but the federal government is moving to limit data gathering that helps us track and control vaccine-preventable diseases in the US. Soon, states will no longer be required to report to CMS the numbers of children and pregnant people vaccinated; state officials can still do this, but it will be on a voluntary basis. Once data collection and reporting becomes voluntary, you can bet the data will dry up. A letter from CMS to state health officials spells everything out and appears to take effect for 2027 reporting.

"CMS is removing the following four measures related to pediatric and prenatal immunization status from the 2026 Child and Adult Core Sets.

  • Prenatal Immunization Status: Age 21 and Older (PRS-AD)
  • Childhood Immunization Status (CIS-CH)
  • Immunizations for Adolescents (IMA-CH)
  • Prenatal Immunization Status: Under Age 21 (PRS-CH)"

And that's not all. It appears that CMS will try to incentivize healthcare providers to discuss topics that serve to deter families from timely immunizations and to move away from using vaccination rates as a practice quality measure.

"In 2026 and beyond, CMS will explore options to facilitate the development of new vaccine measures that capture information about whether parents and families were informed about vaccine choices, vaccine safety and side effects, and alternative vaccine schedules. CMS plans to engage with stakeholders, including states, quality measure stewards, immunization registry managers, providers, and electronic health record vendors to learn how new measures could capture person and family preferences related to vaccines. CMS will also explore how religious exemptions for vaccinations can be accounted for in the data and the subsequent measures. CMS does not tie payment to performance on immunization quality measures in Medicaid and CHIP at the federal level. While states have flexibility and discretion to use quality measures in state developed value-based purchasing and payment incentive fee for service or managed care programs, CMS strongly discourages states from using immunization measures in payment arrangements."

Providers in states with governments that promote vaccine hesitancy and anti-vaccination views likely will be most affected by this new rule. I'd be surprised if any private insurance companies adopt this change in incentives.

For now, at least for influenza vaccination, we still have CDC's FluVaxView to consult. As an example, below is a comparison of vaccination rates among children in the higher risk age group of 6 months to <5 years.

Graph showing that flu vaccination rates for children under 5 have been dropping the last few years.

The colors are a little hard to see, but note that rates have been dropping since the 2019-2020 flu season. The current 2025-2026 season is the incomplete light blue line near the bottom that appears to be trending similarly to recent years so far.

In spite of the great challenges of the covid pandemic, I became a little spoiled during that time. I relied on very robust disease monitoring systems that gave us access to detailed epidemiologic happenings very rapidly. That type of monitoring is extremely expensive and was unsustainable. As the pandemic settled into an endemic pattern, data became less reliable on 2 fronts: first, an exhausted and, in some cases angry, public withdrew from testing and healthcare seeking measures; second, public health funding was cut. Now we appear to be going beyond the logical extension of this trend by making it harder to collect even the bare minimum of reliable data for judging the effectiveness of vaccines.

WRIS and Measles

Speaking of flu season, we are definitely in it.

Map of current US flu activity, patchy with some states still reporting minimal influenza-like illness

It's hard to know, but some of the patchiness may be due to poor reporting practices coupled with the usual holiday slowing of information. Laboratory confirmed influenza hospitalizations below may be a more reliable comparator among flu seasons. I'll be watching this year's red line to see if we exceed the recent high mark of last season's blue line.

Graph of recent rapid rise in lab-confirmed flu hospitalizations in US.

RSV hospitalizations are below last year's numbers so far. Here's what it looks like for children 0-4 years of age.

Graph showing weekly RSV hospitalizations in young children still rising but below last year's rates.

Covid is increasing slightly but still at low levels.

Although not specifically a winter respiratory pathogen, pertussis has been in the news lately. However, numbers are below last year's. So far CDC has tallied 28,152 cases compared to a little over 43,000 last year. Pertussis tracking is affected by a number of factors not seen with other respiratory pathogens: 1) diagnosis is difficult especially in adults who mostly do not display typical whooping cough; 2) testing methodology is difficult - a jump in case numbers started in the 1990s when PCR testing became more widely available; 3) the switch from the whole cell vaccine to the less reactogenic acellular vaccine in the late 1990s resulted in earlier waning of immunity with an increase of pertussis cases in immunized school-aged children (though it was now available to adults who had not been recommended to receive the whole cell product); and 4) changes in case definitions.

We also expect a bit of sawtoothed spikes - when we have a heavier pertussis year, infants (the population most likely to be accurately diagnosed) have immunity from disease, so there's a dip in numbers while waiting for a new population of unexposed infants who get sick when their maternal vaccination antibody wanes.

Graph showing variation in pertussis cases in the US from 1922 to 2023.

We expected a bump in cases after the pandemic era and perhaps that is now in a plateau. However, it's still a bad number and will only worsen as vaccination rates of both mothers and infants fall.

Last but not least, measles soldiers on at a rate of about 50 new cases per week in the US. In a few weeks we will officially qualify as having lost our elimination status.

US map showing 104 new cases in the past 2 weeks with largest hot spots remaining in South Carolina, Arizona, and Utah.

Icicles (not)

This week I was daydreaming, staring outside, when I saw a strange site. I quickly ran to the LSW* to tell her I saw icicles hanging from our large tree in the front yard. She cooly reminded me that the tree, a red maple (Acer rubrum) had been pruned recently, and the "icicles" were just frozen sap at the cut ends of the limbs. I should have figured that out, but then I was happy to invent a new name for this: sapcicle. Turns out this term is all over the web, I won't be able to patent it. One of the several sapsicles is indicated by the red arrow.

Photo of red maple tree with "sapsicles."

*For those new to this blog, this abbreviation refers to my long suffering wife.

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Published on 2 Comments on Study Design Matters

I'm still in my minimalist mode for postings as I struggle with a website redesign, but last week provided me with a relatively unique opportunity to comment on a big success of recent years, prevention of RSV infection and complications in infants. A trio of articles appeared that are great examples of different approaches to post-marketing surveillance of vaccine and monoclonal antibody products. All the articles are open access, no journal subscription required.

Systematic Review and Meta-analysis

Canadian investigators looked at postlicensure observational studies of nirsevimab effectiveness in preventing hospitalizations and emergency department visits for infants with lower respiratory tract infection. Like any systematic review worth its salt, the search methodology and all aspects of analysis are clearly reported and summarized. They ended up with 15 studies that could be analyzed in the systematic review, 11 of which could be analyzed with meta-analysis. (The discrepancy is that 4 studies did not have a concurrent control group and thus were inappropriate for meta-analysis.)

As seen in virtually every other study of nirsevimab, effectiveness was very high. Here's a sample of the results; note that effectiveness was higher against RSV-related disease compared to all-cause disease that included other infections in addition to RSV.

As the authors mention, looking at studies from real-world settings can introduce all sorts of confounding factors, including underlying medical conditions, household crowding, prior exposure to RSV or other respiratory pathogens, and access to care. Also, in this particular group of studies, high income countries were over-represented, and the studies were very heterogeneous likely due to differences in test ordering strategies and other clinical practices. So, combining these studies into a single number estimate of effectiveness comes with caveats.

I've often said that meta-analysis is the most dangerous study design in medicine, primarily because the statistical methods are complex and often draw criticism from statisticians promoting one approach versus another. Also, systematic reviews and meta-analyses probably are better suited to defining areas for future research rather than settling a clinical management question once and for all.

Test-negative Case Control Study

This study design is very commonly used to assess vaccine effectiveness - we see it every year to look at influenza vaccine effectiveness. This report combined data from 7 pediatric academic medical centers to compare effectiveness of nirsevimab administration to infants to maternal RSV immunization during pregnancy. The nice addition to this type of study is that a "number needed to immunize" (NNI) can be calculated. NNI can be defined as the number of infants needed to be immunized to prevent 1 additional event (e.g. hospitalization due to RSV) from occurring. Broadly speaking, nirsevimab was more effective that maternal immunization, and younger infants benefitted more than older.

A nice feature was that the authors included both observed effectiveness (comparing the 2024-2025 RSV season to prepandemic seasons) as well as a predicted ("counterfactual") analysis using predictive numbers for just the 2024-2025 season. The table shows aggregate results for RSV-associated hospitalizations.

You may have noticed a confounding factor in this study: parents seeking care for their infants at academic pediatric medical centers may not be reflective of the population as a whole. Maybe we would have seen different results from a group of urgent care centers or in a rural population.

Cohort Study

The third article is a cohort study from France also comparing nirsevimab to maternal vaccination. Again, nirsevimab was superior for most outcomes.

The authors didn't supply us with an NNI, but the 12-point absolute risk reduction in the primary outcome in the top row above translates to an NNI of about 8. This means that for using nirsevimab instead of maternal vaccination to prevent hospitalization for RSV-associated respiratory tract infection, 8 infants would need to receive the monoclonal antibody product to prevent 1 additional event of hospitalization for RSV. That's a very low number in the world of NNI.

Note that in this study and the test-negative trial mentioned above, another confounding factor is that families choosing maternal vaccination may differ significantly from those who chose infant monoclonal antibody administration. For example, it is likely that the nirsevimab group included mothers who received less, or no, prenatal care.

Take-away points from today:

  1. Different study designs produce different results, driven by appropriate use of statistical methods.
  2. Postlicensure assessment of medications and vaccines often use real-world data This is much more likely to show how the product will perform once it's commonly used, but it also creates many confounding factors not seen in randomized, prospective trials where strict research rules and monitoring lessen individual physician and patient variations. These confounding variables need to recognized, but they are difficult to measure objectively.
  3. Both RSV maternal vaccination and RSV monoclonal antibody administration to infants are highly effective in preventing bad outcomes from RSV infection in infants.
  4. Nirsevimab likely is more effective than maternal immunization for improving infant outcomes. It's too early for real-world data for clesrovimab, the other monoclonal antibody product approved for use in the US.
  5. Very effective systems are in place to track postlicensure vaccine safety and effectiveness.

A Poem for Your Thoughts

I never thought I'd see a poem entitled, "National Vaccine Injury Compensation Program," but hey, we're nearing the end of an unprecedented year on many fronts. Take a few moments to read it, and maybe a few more moments to look up the unknown (to me) allusions. A quick literature search yielded nothing about "woke mind virus."

Published on Leave a comment on A Noisy Holiday Season

I'm still in my semi-hiatus in posting while trying to figure out a new look for the website and its content. I don't think I can ever stop browsing all my feeds from around the world, and this past week seems to be mostly annoying noise. Such as .....

  1. HHS withdrew funding from several grants to the AAP, presumably for being too woke. Note that the AAP is party to a suit against the HHS for its changes to the vaccine schedule.
  2. The Acting Director of the CDC signed off on the ACIP's recommendation to change hepatitis B vaccine use, no surprise. I was slightly intrigued that he did not sign off on the second vote involving use of serologic testing to determine need for subsequent doses for those newborns who received a first dose. Readers may recall from my December 7 post that this second vote was clear proof that ACIP members were not acting based on any science, even contrived science. Look to AAP and other qualified organizations for vaccine advice.
  3. FDA has ongoing issues with industry noncompliance with food recalls, highlighted by the infant botulism outbreak connected to ByHeart brand infant formula. Apparently this is a longstanding general problem that predates the current administration.
  4. CDC awarded an unsolicited research grant to study hepatitis B vaccine to a group at the University of Southern Denmark that has long been criticized for faulty research methods and promoting an anti-vaccine agenda. The grant was never opened to competitive submissions, not that it would have mattered since the awardee was predetermined. The December 2025 issue of the journal Vaccine (subscription required) has an article spelling out concerns with this research group.
  5. Ending this section with some good news, WHO declared Brazil has eliminated mother-to-child transmission of HIV. This is an amazing accomplishment for a large country. Will the US ever get there?

CIDRAP/NEJM Evidence Collaboration

CIDRAP, home of the Vaccine Integrity Project, is partnering with the NEJM Evidence journal to publish a new series on public health alerts. This appears to be an attempt to counter potential censorship of CDC publications. The first topics cover mpox clade Ib transmission in the US and influenza strains from last season.

WRIS

Winter respiratory infection season continues is building up. RSV hospitalizations continue to increase. Percent respiratory test positivity is showing a sharp increase for influenza.

Hotspots for influenza-like-illness (includes flu and other respiratory pathogens) are growing but scattered.

JAMA (subscription required) had a nice Perspective on influenza A H3N2 subclade K. I had mentioned previously that early data from England suggests that our current influenza vaccines will have some effectiveness against significant illness caused by this subclade, even though it has drifted somewhat from the H3N2 vaccine strain.

Measles

We have reached 1958 cases and counting for this calendar year. South Carolina has had 60 cases in the past 2 weeks alone, and other outbreaks are appearing.

Location of cases in the past 2 weeks, as of December 19.

NEJM published a nice review article of the disease. I appreciated the concise listing of complication rates seen in developed countries.

A Less Noisy Week Ahead?

At least I hope so. I'm looking forward to a few gatherings with friends and family. Have a quiet, happy, wonderful week.

Published on Leave a comment on The Fire, It’s So Delightful

This is the first of my "hiatus" posts as I try to upgrade the appearance of the website. During this time my posts will be brief and not necessarily weekly.

Second Round of IDSA Streptococcal Pharyngitis Guidelines

I discussed the first iteration in my commentary last October 19 and mentioned that the Infectious Diseases Society of America said they would publish part 2 soon, which they did this week. Part 2 is all about using scoring systems to distinguish streptococcal pharyngitis from the many other (mostly viral) causes. Most studies have found these scoring systems aren't useful in children.

The new guidelines, while acknowledging low sensitivity and specificity of all scoring systems, do recommend using a scoring system for both children and adults, primarily to identify those with very low risk of streptococcal pharyngitis and thus avoid unnecessary testing and antibiotic therapy. The recommendation is classified as being conditional and with very low certainty of evidence. You can look back at my October 19 post to see the specifics; this newly published guideline just goes into further detail about methods used to make this recommendation. We really need better studies, especially in the new era where streptococcal PCR testing becomes the dominant diagnostic tool.

MMWR Unshackled

I was shocked, shocked to find that CDC scientists were allowed to publish anything favoring covid vaccination, especially for children. During the time period from August 29, 2024 to September 2, 2025, vaccine effectiveness in preventing emergency department and urgent care visits for children ages 9 months to 4 years was 76% (95% CI 58-97%) and for children 5 - 17 years of age was 56% (35-70%). They also reported a number of sensitivity analyses and discussed methods in detail.

As I've stated ad nauseum, covid vaccination provides real value to healthy children; it is more expensive to prevent these emergency department and urgent care visits because these events are much less common than in high risk individuals, but for children the vaccine benefits still outweigh risks even in the current covid era.

I'm Worried About South Carolina Measles

We continue our steady rise in measles cases, now officially 1912 cases this year nationally. The situation in upstate South Carolina continues to advance, now with 126 outbreak cases (out of 129 total this year in the state) originating from 11 different schools. Currently 303 people are in quarantine and 13 are in isolation as a result of potential exposures. Maybe the winter school break will bring some relief, but these outbreaks show no sign of slowing down.

No Association Between Vaccines and Autism, Again

For what it's worth (the anti-vaccine movement will care less), the World Health Organization has performed a new analysis and found no association between vaccines and autism.

WRIS

Winter respiratory infection season is still at low rates (very low for covid specifically) nationally. Influenza-like illness is clearly on the rise but spotty across the country.

More specifically, lab-confirmed influenza hospitalizations are increasing (red line below).

All evidence still points to a more severe flu season this year because influenza A H3N2 predominates and tends to cause more severe illness than does H1N1. Get vaccinated!

RSV hospitalizations are picking up, though at lower levels than this time last year. Below are the rates for children 0 - 4 years of age this year compared to last.

Let It Snow

With a nod to the seasonal song, this morning we had our second small snowfall in Silver Spring this month, a bit unusual this time of year. It was mostly a good excuse for us to have breakfast in front of the fire in our newly updated fireplace.

Speaking of updates, I mention again you are all welcome to suggest anything I can do to improve this website - just use the comments tab on the home page.

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Published on 2 Comments on Time for a Change

I spent a miserable day and a half viewing the ACIP's deliberations on hepatitis B. The scope of the sessions, so far outside any resemblance to scientific discussions, made my conclusion remarkably straightforward.

Believe it or not, a few other notable notices and publications also appeared last week.

Single Dose HPV Vaccine Might Work

An article in the New England Journal of Medicine showed that single dose HPV vaccination is noninferior to 2 doses in preventing new HPV types 16 and 18 (the 2 genotypes that account for about 3/4 of cervical cancers worldwide) persistent infections in adolescent girls. The fact that this was a noninferiority trial should be noted carefully - the trial didn't have enough enrollees to assess whether the 1-dose region was truly equivalent versus slightly better or slightly worse.

They started with 20,330 healthy 12 - 16 year-old participants in Costa Rica randomized equally into 1 of 4 groups: 1 or 2 doses of bivalent HPV vaccine and 1 or 2 doses of nonavalent HPV vaccine. An unimmunized group of 3005 participants also were included. Subjects were followed for 5 years.

It's mandatory that noninferiority trials include a prespecified margin of difference between the groups to define whether a particular regimen is noninferior to another. In this study, the margin specified was 1.25 infections per 100 participants. When all was said and done, about 4000 participants in each of the vaccine groups and just under 3000 unimmunized participants were included in the analysis. The table below shows that the single dose vaccine regimens were well within the noninferiority margin as seen in the 2 rate difference columns.

Vaccine effectiveness of both vaccines, compared to the unimunnized group, against the 2 major genotypes was in the high ninety percent numbers, and even the lowest level of the 95% confidence intervals was still a robust 94.3%. Of course the bivalent vaccine, which contained only HPV 16 and 18 components, was much less effective for the other genotypes.

The ability to administer just 1 dose of HPV vaccine would have very important ramifications worldwide, especially with deep cuts to international preventive care funding. For the US, the current AAP immunization schedule recommends a 2 dose HPV vaccine regimen to be offered starting at 9 - 12 years of age. It will be interesting to see whether these recommendations might change.

Miscellaneous Outbreak News

The infant botulism outbreak associated with the ByHeart Whole Nutrition Infant Formula has now reached 39 cases, as of December 3. It is concerning that FDA is still reporting that the formula remains available for purchase in some stores even though all products from this company have been recalled. CDC has a nice page with concise advice and links.

Also on December 3 the CDC Health Alert Network posted an alert about the Marburg virus outbreak in Ethiopia; not sure why it took so long. It didn't contain any new information from what was reported from WHO and mentioned in a previous blog post.

Measles is still rolling along steadily in the US with case count 1838 on December 3. Utah, Arizona, and South Carolina are the main hotspots, and all recent cases were acquired in the US rather than from foreign travel.

Finally, some good news. The Ebola outbreak in the Democratic Republic of the Congo is officially over. The tally was 64 cases, 45 of which were fatal.

WRIS

The winter respiratory infection season is starting to kick in, though the national average still qualifies as low activity. Influenza-like illness, which includes other respiratory infections beyond influenza, is patchy.

I somehow missed that fact that last week was National Influenza Vaccination Week. Let's hope it did some good. Please encourage your patients and families to be vaccinated.

ACIP Reaches Irrelevancy

I suffered through a day and a half watching the ACIP deliberations on hepatitis B vaccines. It would be sort of a whack-a-mole endeavor to address every instance of misinformation or worse; one attempt at fact checking the meeting was posted by The Evidence Collective. It's a sorry sign of the times that we even need such a website.

Instead of going over every instance of misinformation or worse, I'll focus on some key general issues I observed.

  • Lack of structured approach to evaluating evidence. ACIP Work Groups do a lot of the pre-meeting heavy lifting of data assessment, in the past relying heavily on subject matter experts from CDC and other institutions. As I stated last week and many times in the past, ACIP should follow a predetermined, standardized process for evidence evaluation and present those results at the meetings. This was standard in the "old days," relying on 2 processes: GRADE and Evidence to Recommendations (also mentioned last week). These systems not only analyze the data but present the level of confidence in the results. EtR provides in depth discussion of different components to consider when making a recommendation and includes vote tallies/opinions of working group members. It was clear this didn't happen for the hepatitis B discussions, leading to ....
  • Cherry-picking of evidence. The Work Group leadership presented whatever she/they thought was relevant, seemingly to support a pre-determined outcome.
  • Overt ignorance (presumably deliberate) of recently published key studies.
    • The very biased presentation on aluminum adjuvants (I didn't listen to it in entirety, it was clear very early it wouldn't be worthwhile) didn't mention in its 28-page slide deck a new review publication (with 469 references!) concluding "Collectively, the evidence strongly supports the safety of aluminum adjuvants and their necessity in certain vaccines. Clinicians can reassure caregivers that aluminum-containing vaccines provide clear benefits, with risks largely limited to transient local reactions and no systemic toxicity signal in large clinical and epidemiologic studies."
    • Similarly, no mention was made of the Vaccine Integrity Project's detailed report on hepatitis B vaccine safety, effectiveness, and public health impact.
    • A new viewpoint article on risks of altering the hepatitis B vaccine schedule in the US was enlightening but ignored by the ACIP. Using reasonable, conservative estimates for variables such as annual birth numbers, vaccine effectiveness, loss to follow-up, and others, the authors estimate that the new ACIP recommendations to not immunize newborns of HBsAg-negative mothers, if followed, would result in an increase of perinatally infected infants from 625 to 674 per year. Given that perinatal infection usually results in a chronic carrier state that leads to cirrhosis and/or hepatocellular carcinoma decades later, this is a very serious increase. Because of the long lag time in symptoms of chronic HBV infection, we likely won't know the consequences of the ACIP changes for decades. Also, this strategy increases the chance that these children would not be immunized as adolescents or adults, leaving a much larger susceptible population in the US. It would have been very helpful to include this information in the ACIP discussion.
  • Moving targets. This is another whack-a-mole strategy. When one concern, like hepatitis B vaccine safety, is raised and seemingly rebutted, another concern such as parental choice (which has never been removed) is brought up. And on and on.
  • Lack of knowledge. This was most obviously on display by all of the ACIP members including those in favor of the current hepatitis B schedule. It's not surprising that ACIP members wouldn't know everything about the current state about hepatitis B infection and vaccines, even the one person who had any legitimate vaccine experience and knowledge. However, plenty of people do possess this expertise and were available to committee members. They were seldom consulted.
    • In a decision not explained by ACIP leadership, the ACIP's chosen presenter on the entire childhood vaccination schedule was an attorney specializing in vaccine injury. At least he mentioned conflicts of interest honestly, with his firm having several hundred pending lawsuits against the government for vaccine injury. This isn't the background for someone to give me a valid overview of vaccine schedules.
  • Subtle barriers to subject matter experts. In the "old days" ACIP meetings were held in a large auditorium with regular members, ex officio members, liaisons from other organizations, and SMEs mostly all present in the room. Now, the meeting is in a smaller room populated only by members, ex officio members, and selected presenters. The ex officio members and SMEs, representing the majority of the scientific knowledge of the subject, were occasionally allowed to speak but their faces were never shown and they seemed (to me) to be more frequently interrupted by the ACIP vice chair who was running the meeting, in contrast to fewer interruptions of the anti-vax members of the group. This was a not-so-subtle dehumanization of the true experts. (One rational CDC expert, Dr. Langer, was shown speaking when he was called upon a few times; he is in a leadership position at CDC so apparently not sequestered with the other SMEs. He was excellent and obviously trying his best to politely push back on incorrect statements from committee members.)
  • Late posting and frequent changes of meeting agenda, voting statements, and slides. Less time to review these documents ahead of time results in less time for non-ACIP members comment appropriately. This strategy effectively dampens ability of everyone involved to discuss their views.
  • And coupled with the above, the discussion times allotted were very brief, especially given that GLOBE and EtR results weren't provided. This resulted in ineffective discussion at times dissolving into temper tantrums.

I could go on and on with this list, but I won't bore you any further.

The final recommendations centered on 2 votes. This first one was highlighed in the lay press is replete with mention that the hepatitis B vaccine recommendations from ACIP have changed with regard to infants born to mothers who tested negative for HBsAg sometime during pregnancy. Recommendations for infants born to mothers who are positive or who have unknown status haven't changed. There was little to no discussion on the long-term ramifications of this decision.

My final conclusions about the meeting were most affected by the approval of the second vote. It recommended (presumably just for the infants born to negative mothers, but it didn't specify) that parents could decide to obtain a hepatitis B antibody titer after a first vaccine dose to decide if subsequent doses would be necessary. This completely ignores the fact that no one has any data on how this single titer would relate to evidence of protection and doesn't even consider the role of maternally-derived antibody present in some infants. There was no discussion about the antibody test itself - why the various cutoff values were decided upon and how they have been studied. The entire statement in that second vote seemingly was pulled out of a hat.

For me, that was the last straw showing that the ACIP isn't serious about evidence-based guidance. The vote 2 approval wasn't fueled by cherry-picking data, because there was no data. This was acknowledged by the vote 2 proponents. The vice chair even voiced his glee at the fact that implementing vote 2 recommendations would be a great experiment to see what happens. The press apparently missed this statement; I think most parents would be horrified.

ACIP, in its present state, is irrelevant. We can disregard their recommendations and look to AAP and other reliable organizations for our vaccine schedules and recommendations. I've already received notice from the Maryland Department of Health supporting universal birth dosing of hepatitis B vaccine and for all infants to complete the full hepatitis B vaccine series.

Crying in My Chianti

Friday evening after taking a mental beating listening to the meeting, some friends joined my wife and me at an Italian restaurant in part to console me and provide a diversion. Table talk ranged from current movies to Royal Doulton Toby jugs. It worked very well, only a few tears in my wine glass. At least I won't feel the need to slavishly attend future ACIP meetings.

In the meantime, in addition to noting it's time to change my view of the ACIP, I'm also going to change this blog site. I will take a partial hiatus from the blog, posting less content and perhaps less frequently for a while. Instead, I'm going to try to spiff up some of the web site appearance and add some more pages beyond just the blog; I serve as both content creator and IT support for this site. I don't have an exact timeline for the revisions, but I will continue to post, especially for the most impactful happenings in pediatric infectious diseases.

If you have any suggestions for how I can improve the site, please let me know in the comments section.

Henry VIII and Catherine of Aragon soon will be reunited at my house.
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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